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[null,null,null,null,null,null,null,null,null,"TABLE OF CONTENTS (ToC)"]
[null,null,null,null,null,null,null,null,null,"SECTION","CHAPTER","PAGE","RMAT","Pack"]
[null,null,null,null,null,null,null,null,null,1,"INTRODUCTION",3,"P","P"]
[null,null,null,null,null,null,null,null,null,1.1000000000000001,"For Brokers, Distributors, Traders",4,"P","P"]
[null,null,null,null,null,null,null,null,null,2,"CONFIDENTIALITY",4,"P","P"]
[null,null,null,null,null,null,null,null,null,3,"MDLZ QUALITY PERFORMANCE VERIFICATION PROGRAMS",5,"P","P"]
[null,null,null,null,null,null,null,null,null,3.1,"General Audit Requirements",5,"P","P"]
[null,null,null,null,null,null,null,null,null,3.2,"Global Food Safety Initiative (GFSI) Certification",5,"P","P"]
[null,null,null,null,null,null,null,null,null,3.3,"Technical Visits",6,"P","P"]
[null,null,null,null,null,null,null,null,null,3.4,"Audit Requirements for Packaging Material Suppliers",6,"x","P"]
[null,null,null,null,null,null,null,null,null,3.5,"Audit Requirements for Chemical Material Suppliers",7,"P","x"]
[null,null,null,null,null,null,null,null,null,4,"QUALITY SYSTEM CONTROLS",8,"P","P"]
[null,null,null,null,null,null,null,null,null,5,"MANAGEMENT RESPONSIBILITY",9,"P","P"]
[null,null,null,null,null,null,null,null,null,5.0999999999999996,"Notifying Mondelēz Global of Significant Events",9,"P","P"]
[null,null,null,null,null,null,null,null,null,5.2,"Regulatory Inspections and Contacts",9,"P","P"]
[null,null,null,null,null,null,null,null,null,5.3,"Food Safety and Quality Culture",9,"P","P"]
[null,null,null,null,null,null,null,null,null,6,"RESOURCE MANAGEMENT",10,"P","P"]
[null,null,null,null,null,null,null,null,null,6.1,"Good Manufacturing Practices",10,"P","P"]
[null,null,null,null,null,null,null,null,null,6.2,"Personnel Training",11,"P","P"]
[null,null,null,null,null,null,null,null,null,6.3,"Employee Illness and Communicable Disease",12,"P","P"]
[null,null,null,null,null,null,null,null,null,6.4,"Utilities Management",13,"P","P"]
[null,null,null,null,null,null,null,null,null,6.5,"Equipment and Facility Maintenance",17,"P","P"]
[null,null,null,null,null,null,null,null,null,6.6,"Sanitary Design: Plant Structure & Equipment Design",18,"P","P"]
[null,null,null,null,null,null,null,null,null,6.7,"Sanitation",20,"P","P"]
[null,null,null,null,null,null,null,null,null,6.8,"Pest Management",23,"P","P"]
[null,null,null,null,null,null,null,null,null,6.9,"Hygienic Zoning",24,"P","x"]
[null,null,null,null,null,null,null,null,null,6.1,"Pathogen Environmental Monitoring",26,"P","x"]
[null,null,null,null,null,null,null,null,null,6.11,"Food Defense",29,"P","x"]
[null,null,null,null,null,null,null,null,null,6.12,"Product Authenticity",30,"P","P"]
[null,null,null,null,null,null,null,null,null,7,"PRODUCTION PROCESS CONTROLS",31,"P","P"]
[null,null,null,null,null,null,null,null,null,7.1,"Specification Compliance and Contaminants Control",31,"P","P"]
[null,null,null,null,null,null,null,null,null,7.2,"Incoming Materials: Supply Chain Quality Management",36,"P","P"]
[null,null,null,null,null,null,null,null,null,7.3,"Receipt and Shipping Controls, Inspection and Testing",37,"P","P"]
[null,null,null,null,null,null,null,null,null,7.4,"Hazard Analysis and Critical Control Points",38,"P","P"]
[null,null,null,null,null,null,null,null,null,7.5,"Allergen Management",40,"P","x"]
[null,null,null,null,null,null,null,null,null,7.6,"Extraneous Matter",43,"P","P"]
[null,null,null,null,null,null,null,null,null,7.7,"Net Content & Packaging (for ingredients delivered to MDLZ)",46,"P","x"]
[null,null,null,null,null,null,null,null,null,7.8,"Label Control",47,"P","P"]
[null,null,null,null,null,null,null,null,null,7.9,"Traceability",48,"P","P"]
[null,null,null,null,null,null,null,null,null,7.1,"Warehousing and Transportation",50,"P","P"]
[null,null,null,null,null,null,null,null,null,7.11,"Calibration of Measurement and Monitoring Equipment",54,"P","P"]
[null,null,null,null,null,null,null,null,null,8,"MEASUREMENT, ANALYSIS AND IMPROVEMENT",55,"P","P"]
[null,null,null,null,null,null,null,null,null,8.1,"Internal Audits",55,"P","P"]
[null,null,null,null,null,null,null,null,null,8.1999999999999993,"Testing Controls",56,"P","P"]
[null,null,null,null,null,null,null,null,null,8.3000000000000007,"Rework Control",57,"P","x"]
[null,null,null,null,null,null,null,null,null,8.4,"Hold and Release and Control of Non-Conforming Product",58,"P","P"]
[null,null,null,null,null,null,null,null,null,8.5,"Corrective and Preventive Actions",60,"P","P"]
[null,null,null,null,null,null,null,null,null,8.6,"Transfer of Constituents from Food Contact Material to Food",62,"x","P"]
[null,null,null,null,null,null,null,null,null,null,"APPENDIX",64,"P","P"]
[null,null,null,null,null,null,null,null,null,"I","Definitions",64,"P","P"]
[null,null,null,null,null,null,null,null,null,"II","Revision Log",68,"P","P"]
[]
[]
[null,"Use the buttons above to filter requirements on all pages. Updating may require approximately one minute."]
[]
[null,"Issued by:","Yolanda Tong\nElena Grouios","Reviewed by:","Margaret May","Approved by:","Carolyn Nguyen"]
[null,"Function:","Supplier Quality","Function:","Supplier Quality","Function:","Global Quality Compliance"]
[null,"Supersedes:","30th Nov 2020","Issue Date:","9th Oct 2023","Effective from:","1st Oct 2024"]

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["CHAPTER 1 - INTRODUCTION","RMAT","Pack"]
["The safety and quality of our products are of the highest importance to us – as are the trust and confidence of our consumers and customers. At Mondelēz International (MDLZ) we inspire trust by making safe food. We recognize that the safety of our products is the foundation on which the success of our business is built. Safe food is at the core of our heritage and is ingrained in our culture.","P","P"]
["MDLZ is committed to delivering high-quality products. One of the ways we achieve this is by ensuring the strength of our food safety and quality systems. We expect that our suppliers share this commitment and for that purpose shall comply to the following documents where applicable:","P","P"]
["• Mondelēz International Supplier Quality Expectations (this document)","P","P"]
["• Processing Expectations for Cocoa, Dairy, Egg, Fruit and Vegetables, Tree Nuts/ Peanut/ Seeds and Extraneous Matter (Liquid Chocolate, Sugar, Fats and Oils, Flour, and Nuts)","P","x"]
["• CCP Models (see Table 7.4.3)","P","x"]
["These documents are available at the Mondelēz International Supplier Quality and Food Safety web site at www.mdlzsupplierquality.com or from your Mondelēz International Contracting Representative. The English version of these documents is considered the official contractual version, but alternative languages may be available.\n","P","P"]
["The Supplier Quality Expectations (SQE) outlined here are intended to help current and prospective new suppliers of ingredients and packaging materials ensure that their own food safety and quality systems meet MDLZ and industry standards. These expectations have been developed by MDLZ and Subject Matter Experts following a review of product defects, quality audits of manufacturing sites and a study of product retrievals throughout the food industry. This review has led us to identify which programs, if executed properly, help to prevent product retrievals, consumer complaints, rework and plant downtime, and produce high quality, safe products.\n\n","P","P"]
["The SQE outlines the general requirements for packaging suppliers. All packaging materials supplied to MDLZ shall comply with all applicable laws, regulations, and Codes of Practices and Standards of the production country and the destination to which the MDLZ finished products will be delivered (both national and local requirements, as applicable). As a minimum, packaging suppliers shall comply with current EU and FDA legislation applicable to them (i.e., direct food contact or not direct food contact). In particular cases, where any other legislation is applicable the supplier shall be informed by MDLZ.\n","x","P"]
["Each manufacturing location producing materials for MDLZ shall meet the expectations in this manual. Please note the following exceptions:\n• Packaging suppliers to whom some sections do not apply (see filter);\n• Raw material suppliers to whom some sections do not apply (see filter);\n• Material suppliers to whom the Sections 6.9 (Hygienic Zone) and 6.10 (Pathogen Environment Monitoring) may not apply (see further explanation under these sections);\n• This document does not apply to farm operations.\n","P","P"]
["The MDLZ SQE Manual, Processing Expectations and CCP Models (where applicable) contain the elements we believe are essential for the effective management of Food Safety, Quality and Food Defense. They are not intended to alter or eliminate any requirements that may be set in any contract, Specifications, or government regulation. Any questions about these standards should be addressed by contacting the appropriate MDLZ Contracting Procurement Representative.","P","P"]
["Terms defined in Appendix: Definitions of this document are highlighted (italic and underlined). \n\nThe terms used to designate requirements and recommendations stated in this document include:\n• Shall – Mandatory with no exclusions.\n• Should – Used to express a strong recommendation among other possible options.\n• May – Used to indicate an action which is permissible but not mandatory.\n","P","P"]
["To differentiate between the finished product produced by the supplier and MDLZ finished product, the MDLZ finished product will be called “finished product.” All other terms, such as “material,” “ingredient” and “product,” refer to the supplier’s product.\n\nThe supplier is the organization which provides MDLZ with a product. The supplier is usually the producer of the product, but in some cases may be a distributor or agent.\n","P","P"]
["1.1 For Brokers, Distributors and Traders","P","P"]
["In cases where materials are being procured through brokers, distributors and traders the following requirements shall be followed:","P","P"]
["• Materials shall come from MDLZ approved manufacturing sites and lines and shall adhere to the agreed MDLZ Specification","P","P"]
["• If the broker/ distributor/ trader is handling or transforming the material through processes that involve direct food contact, they shall be certified to a recognized industry standard (GFSI certification)\n","P","x"]
["• The broker/ distributor/ trader is responsible for ensuring that the requirements of the SQE are met and the manufacturer is clear on and has agreed to the material Specification\n","P","P"]
["• The contracted supplier, if in this case a broker/ distributor/ trader shall have the latest version of MDLZ Specification and inform MDLZ of any comments or questions if any, as part of Supplier Acknowledgement Report (SAR) for ingredients and food contact packaging.\n","P","P"]
["• In the event of the following, the supplier shall contact their MDLZ Contracting Representative in the first instance prior to any change:\n      ▪ Supplying a new material from an existing approved site\n      ▪ Supplying an existing material from a different approved site and lines\n      ▪ Supplying a material from a new manufacturing site\nIn the event of change as specified above, approval from MDLZ is required prior to the change. Additionally, an approval audit may be required (either on site or remote)\n","P","P"]
["• The supplier manufacturing locations shall be disclosed to the MDLZ Contracting Representative to assure that materials are only sourced from locations meeting MDLZ requirements for quality and food safety\n","P","P"]
["• Ensure that the MDLZ SQE Manual and MDLZ Specification are communicated to supplier and provide evidence to MDLZ of agreement to the requirements by the supplier\n","P","P"]
["• The broker/ distributor/ trader shall be required to notify MDLZ of any manufacturing location changes\n","P","P"]
["• The broker/ distributor/ trader shall demonstrate that traceability of materials to manufacturing location level is maintained according to the requirements in section 7.9 of this document\n","P","P"]
["• MDLZ can revoke the approval of the manufacturing site AND the broker/ distributor/ trader at any time on the basis of food safety or quality concerns\n","P","P"]
["• The broker/ distributor/ trader shall have a procedure for approving storage facilities and warehousing, including storage silos. The broker/ distributor/ trader shall ensure that any warehousing used to store goods operates Good Warehousing Practice (GWP) being able as a minimum to operate traceability of goods-in and out, stock rotation system (FIFO/ FEFO), pest management program and sanitation program.\n","P","P"]
["CHAPTER 2 - CONFIDENTIALITY","P","P"]
["The contracts between MDLZ and the supplier shall govern confidentiality of information shared by either company. All supplier personnel shall take care not to disclose supplier confidential information to MDLZ unless there is a contract in place protecting such disclosure. MDLZ personnel shall not be asked or required to sign confidentiality agreements as a prerequisite to gain access for audits prior to or at any time during a quality audit or other required technical visits/ assessments.","P","P"]

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["CHAPTER 3 – MDLZ QUALITY PERFORMANCE VERIFICATION PROGRAMS",null,null,null,null,null,null,"RMAT","Pack"]
[3.1,"General Audit Requirements",null,null,null,null,null,"P","P"]
["3.1.1","All facilities supplying raw materials and packaging to MDLZ shall be approved.",null,null,null,null,null,"P","P"]
["3.1.2","The frequency and type of approval audit required by MDLZ is dependent on the type of material supplied based on risk assessment and may include the following:\n• Second party auditing supplier on behalf of MDLZ selected by MDLZ (2nd Party SQE), or selected by the supplier from the MDLZ approved list\n• MDLZ employee SQE audit, or\n• Recognized industry standard (GFSI certification). All materials supplied shall be in scope of the certification\nFor the above audits the supplier shall not request any auditor to sign an additional agreement in order to conduct the audit. This is covered by MDLZ and supplier contractual requirements or PO terms before awarding business.",null,null,null,null,null,"P","x"]
["3.1.3","Each manufacturing site producing material for MDLZ is required to undertake one of the aforementioned audits. Note that the manufacturing site may be required to complete a questionnaire either in lieu of, or in advance of an audit, or that the site registers with and submit information to a second party that MDLZ has selected to manage audit information.",null,null,null,null,null,"P","x"]
["3.1.4","The audit/ inspection requirements are prioritized based upon the experience with the supplier, performance and the type of material produced at that location. MDLZ operates a risk assessment process for this.",null,null,null,null,null,"P","P"]
["3.1.5","The MDLZ audit/ inspection shall extend to all areas, including all pertinent production and storage areas deemed necessary to evaluate whether the material produced for MDLZ meets our requirements and Specifications. The audit/ inspection may include but is not limited to, equipment, finished and unfinished materials, containers, labeling, records, processes, and controls. Auditors checking compliance to the MDLZ SQE requirements shall not audit or inspect financial data, sales data (other than that directly related to MDLZ), or pricing data. Auditors shall not inspect personnel data, other than data relating to qualifications or training of technical and professional personnel performing functions pertinent to the audit.",null,null,null,null,null,"P","x"]
["3.1.6","To become and remain an approved supplier, the audit findings shall be acceptable to MDLZ. Any adverse finding in an audit shall result in a requirement that the supplier implement corrective action and may, depending on the severity of the finding and/ or the supplier’s quality or audit history, result in a down rating or termination of the supply relationship with MDLZ. The supplier shall implement all corrective actions identified in the MDLZ audit, record in the MDLZ audit management system, within the time frame agreed on in the audit corrective action plan.",null,null,null,null,null,"P","x"]
["3.1.7","MDLZ shall bear its own internal and 2nd party audit costs. The supplier shall bear all other audit costs (including those of the 3rd party auditors, such as GFSI, Organic, Kosher, Halal). If the supplier wants to share the MDLZ or 2nd party SQE report with other customers, a written authorization from MDLZ is needed.",null,null,null,null,null,"P","x"]
["3.1.8","In the event of changes to supplier’s processes, critically CCPs (Critical Control Points), critical limits, lines, equipment and/ or facilities and change in manufacturing location that could have an impact on materials supplied to MDLZ, the MDLZ Contracting Representative shall be contacted before the change is made to enable timely effective approval steps.",null,null,null,null,null,"P","P"]
[3.2,"Global Food Safety Initiative (GFSI) Certification",null,null,null,null,null,"P","P"]
["3.2.1","Industry accepted certifications are now part of MDLZ supplier approval requirements. MDLZ’s aim is to have all of its material suppliers GFSI certified. A current list of GFSI accepted certifications for materials in scope can be obtained at www.mygfsi.com. The certification scheme and scope shall be appropriate i.e., shall include all manufacturing areas relevant for ingredients/ packaging supplied to MDLZ.",null,null,null,null,null,"P","P"]
["3.2.2","The supplier shall share with MDLZ the current complete GFSI audit report and a valid certificate in order to become or continue as an approved supplier. The supplier shall also provide an updated audit report and certificate at certification renewal. The supplier shall notify the MDLZ Contracting Representative in the event that the certificate is surrendered or withdrawn by the certification body.",null,null,null,null,null,"P","P"]
["3.2.3","If during a MDLZ SQE audit, discrepancies between in audit findings versus the GFSI audit results in areas relating to food safety, MDLZ may choose to invite the supplier to discuss these with the Certification Program Owner (CPO), with the goal of continuous improvement for the MDLZ and GFSI audit programs. MDLZ shall have no liability for any loss or damage incurred by supplier as a result of or in connection with any information disclosed in accordance with the provisions above.",null,null,null,null,null,"P","x"]
[null,"Note: Suppliers of less than 50K$ spend/year, Venezuela supplier or any other approved specific case are exempt from GFSI requirements.",null,null,null,null,null,"P","x"]
["Table 3.2.4 Packaging Material Audit Matrix",null,null,null,null,null,null,"x","P"]
["3.2.4","Material Supplied Classification",null,"Tier Rating","Supplier Qualification - New","Supplier Re-approval (Current Suppliers)","Renewal Frequency","x","P"]
[null,"Food Contact with/ without an ingredient declaration1",null,4,"1) GFSI-recognized certification2\n2) Declaration of Compliance3\n3) PFAS certificate4\n4) Audit report or summary of non-conformances","1) GFSI-recognized certification\n4) Audit report or summary of non-conformances","1) As per certification expiry\n2) 5 years for DoC","x","P"]
[null,"Non-Food Contact with an ingredient declaration",null,4,"1) GFSI-recognized certification\n2) Declaration of Compliance\n3) PFAS certificate\n4) Audit report or summary of non-conformances","1) GFSI-recognized certification or ISO9001\n4) Audit report or summary of non-conformances","1) As per certification expiry","x","P"]
[null,"Non–Food Contact without a declaration",null,5,"1) PFAS certificate","N/A","None","x","P"]
[null,"1 When there is an ingredient declaration, specific controls are needed including 1) print copy verification and 2) label mixing controls​\n2 Current accepted GFSI certifications: BRCGS, FSSC 22000, SQF, IFS​\n3 Declaration of Compliance, requirement as per Section 3.4.2 of SQE​\n4 As per Section 7.1 of SQE, or most updated regulation(s) for the region​",null,null,null,null,null,"x","P"]
[3.3,"Technical Visits",null,null,null,null,null,"P","P"]
["3.3.1","MDLZ operates a risk-based approach for re-approval audits. Additional technical visits can be made by MDLZ Supplier Quality, Audit, Food Safety teams or approved external partner for specific improvement plans and/ or corrective action verification.",null,null,null,null,null,"P","P"]
[3.4,"Audit Requirements for Packaging Material Suppliers",null,null,null,null,null,"x","P"]
["3.4.1.1","All packaging suppliers shall be approved and re-assessed as per Audit Table Matrix (Table 3.2.4).",null,null,null,null,null,"x","P"]
["3.4.1.2","Where supplier approval is based on GFSI/ ISO certification, the supplier shall share with MDLZ the valid certificate and the complete GFSI/ ISO audit report to become (or remain) an approved supplier. Upon each certification renewal the supplier shall also provide the new renewed certificate and complete audit report.",null,null,null,null,null,"x","P"]
["3.4.1.3","Where a supplier does not have a GFSI/ ISO certification, or any exception applied or approved, MDLZ Corporate Auditing team based on risk shall define 2nd party assessment/ MDLZ technical visit/ remote assessment, to determine site quality program adequacy for use material to MDLZ.",null,null,null,null,null,"x","P"]
["3.4.1.4","The current accepted GFSI certification audits for approval of food contact and/ or contains ingredient line packaging materials are as follows: BRC Global Standard for Packaging Materials, FSSC 22000; SQF Packaging Standard; IFS PACsecure.  ISO 9001 can be accepted for non-food contact.",null,null,null,null,null,"x","P"]
["3.4.2","Declaration of Compliance",null,null,null,null,null,"x","P"]
["3.4.2.1","All food contact packaging materials shall have a Declaration of Compliance (DoC) covering materials and conversion (e.g., inks, adhesives, coatings) prior to the first material delivery and the DoC shall be validated by MDLZ Packaging Regulatory team.  The declaration or assessment shall demonstrate compliance of food packaging grade quality based on:",null,null,null,null,null,"x","P"]
["a","Overall migration limit, specific migration limits and regulatory requirements for direct or indirect food contact (per application),",null,null,null,null,null,"x","P"]
["b","Codes of Practices, and",null,null,null,null,null,"x","P"]
["c","Standards of the location where the products are produced and the destination to which products may be delivered (as disclosed by MDLZ to supplier)",null,null,null,null,null,"x","P"]
["3.4.2.2","The declaration or assessment shall encompass all potentially migrating substances, both intentionally added ingredients and non-intentionally added substances present e.g., due to reactions, impurities. This statement shall be renewed when any change in regulation, composition or production occurs that bring about changes in migration or when new scientific data becomes available or after five years, which ever sooner.",null,null,null,null,null,"x","P"]
["3.4.2.3","Where no dedicated national food packaging legislation exists, MDLZ requires compliance with the European or the U.S. federal (Food and Drug Administration (21 CFR), U.S. Department of Agriculture (USDA), U.S. Environmental Protection Agency (EPA) and state regulations.",null,null,null,null,null,"x","P"]
[3.5,"Audit Requirements for Chemical Material Suppliers",null,null,null,null,null,"P","x"]
["3.5.1","Some food grade raw materials (classified as chemicals) may be subject to different types of audits, such as MDLZ Chemical Audit, which is an audit focused on selected SQE requirements according to the nature of the material. Request for information is conducted to determine if a supplier qualifies for a chemical audit. These audits may apply to substances that meet the following criteria:",null,null,null,null,null,"P","x"]
["a","Single chemical substances that are commercially produced with chemical reactions, extractions, and/ or distillations using specialized processes. It may also include blending of the specialized chemicals.",null,null,null,null,null,"P","x"]
["b","The materials shall be food grade, NOT pharmaceutical grade (unless requested as such in the Specification), and shall comply with regulations in force for use in food and/ or pharmaceutical products, preferably produced in a closed system, and tested for levels of purity.",null,null,null,null,null,"P","x"]
["c","The material is non-sensitive (according to the Microbiologically Sensitive Ingredient Category List in Table 7.1.4)",null,null,null,null,null,"P","x"]
["d","There is no allergen risk.",null,null,null,null,null,"P","x"]
["3.5.2","The supplier shall provide a process description and Specification for the chemical in question.",null,null,null,null,null,"P","x"]
["3.5.3","A pharmaceutical audit may be applicable if the material has active pharmacological properties used in pharma licensed products (it is an Active Pharmaceutical Ingredients (API)) and are assessed on a case by case basis by Corporate Auditing. An audit can be accepted from licensed pharmaceutical auditors and GMP certificates issued by FDA or EU or other accepted country regulators.",null,null,null,null,null,"P","x"]

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["CHAPTER 4 – QUALITY SYSTEM CONTROLS",null,"RMAT","Pack"]
[4.0999999999999996,"General Program Requirements","P","P"]
["4.1.1","The supplier shall have implemented a written Quality Management System to ensure that the material produced conforms to our specified requirements. At a minimum, the Quality System shall ensure compliance with the MDLZ SQE and MDLZ Specifications for the specific material, and all applicable regulatory requirements of the production country and the destination to which the materials will be delivered.","P","P"]
["4.1.2","The Quality System shall clearly set out the source of each food safety and quality requirement. The Quality System shall also set forth the specific personnel responsible for compliance with each requirement through use of an organizational chart. The supplier shall review the Quality System on a regularly-scheduled basis.","P","P"]
["4.1.3","The supplier shall maintain records sufficient to show effective implementation of the Quality System. Records shall be legible. The Quality System shall clearly identify the records that shall be maintained to show effective implementation, and controls needed for identification, storage, protection, retrieval, retention and disposition of records. Records shall be retained as a minimum of shelf life plus two years unless otherwise specified by regulation.","P","P"]
["4.1.4","In addition to the requirements set out above, the supplier’s Quality System shall specifically include controls to ensure the following:","P","P"]
["a","Outsourcing: The supplier shall notify the MDLZ Contracting Representative of any material supplied to MDLZ which is produced or processed in a plant not entirely owned or operated by the supplier (e.g., sub-contractor). Any outsourced process that affects material or ingredients produced for MDLZ shall comply with the same requirements and be managed by the supplier. If a supplier is sub-contracting any part of the production process to a third party the supplier shall inform procurement and engage supplier quality and auditing. MDLZ shall define the approval process for outsourced processes based on risk.","P","P"]
["b","Repacking: The supplier shall notify the MDLZ Contracting Representative if material is being re-packed at a different location to the manufacturing site into either a different packaging format or being bulk stored for future packing or bulk loading.","P","P"]
["c","Manufacturing changes: The supplier shall notify MDLZ of their intention to make any change that may affect the safety, quality, security, shelf-life, ingredient statement, allergen profile, nutritional labeling or functionality of material produced for MDLZ, such as changes in material formula, raw materials, production line, production facility or processes – and any change shall be approved by MDLZ before being implemented. In addition, the supplier shall notify MDLZ of their intention to use new production lines and equipment for MDLZ production. MDLZ shall be notified of such changes in writing. MDLZ shall assess whether a new approval is needed.","P","P"]
["d","Special certifications: If MDLZ Specifications require particular certifications, such as Organic, Kosher or Halal certification, then the supplier facility shall be certified by an appropriate certifying body of the country in which MDLZ will receive the material.","P","x"]
["e","Genetically Modified Organism (GMO): All suppliers shall have a GMO management procedure in place to ensure that no raw material is supplied that would require GMO labeling, unless authorized on the Specification. The supplier shall ensure that raw materials do not contain any trace of unauthorized GMOs in accordance with the regulations in the destinations to which they may be delivered. Additionally, the supplier shall ensure that they comply with any additional regional or local MDLZ requirements. The MDLZ requirements are available from your MDLZ Contracting Representative. MDLZ local requirements include (but not limited to):\n• Certificate of origin\n• Certificate of analysis (on the ingredient and/ or the original raw material, e.g., analysis of the maize/ soy from where the ingredient comes from)\n• Traceability history","P","x"]
["f","No cloned animal products: No milk, meat, or other ingredients derived from cloned animals shall be used to make MDLZ materials.","P","x"]

{"sheet":"5","index":4,"n_rows":20,"n_cols":4,"rows_kept":20,"cut":false,"hidden":false,"merged":[[0,0,0,1]]}
["CHAPTER 5 – MANAGEMENT RESPONSIBILITY",null,"RMAT","Pack"]
[5.0999999999999996,"Notifying MDLZ of Significant Events","P","P"]
["5.1.1","Communication in the supply chain is critical when events occur that could affect food safety, food defense, quality, or processing. The supplier shall establish procedures to ensure MDLZ is immediately notified of any of these occurrences:","P","P"]
["a","Systematic product quality defect or process control deviation which could lead to a voluntary or involuntary recall or withdrawal of a MDLZ finished product, including unlabeled allergen of GMO","P","P"]
["b","Discovery of potentially defective, contaminated or adulterated ingredients or packaging materials associated with product already shipped to MDLZ","P","P"]
["c","Non-routine regulatory agency investigations, testing, sampling, reporting, or other contact or action with the potential to affect material produced for MDLZ. MDLZ does not need to be notified of routine inspections, unless the inspection reveals that material produced for MDLZ may not be in compliance with applicable law","P","P"]
["d","Inadvertent release from hold of any material produced for MDLZ","P","P"]
["e","Product tampering, acts of food fraud, threat of tampering, or any threat to product security on material produced/ shipped to MDLZ. Notification by law enforcement or other authority of a potential product security event","P","P"]
["f","Any presumptive and confirmed pathogen positive result in a supplier's product produced on shared equipment as MDLZ products (even if the specific lot is not sent to MDLZ) ","P","x"]
["g","A confirmed pathogen positive result in a supplier's product from a different equipment as MDLZ products (from the same supplier manufacturing site)","P","x"]
["h","A confirmed pathogen positive (Salmonella or Listeria monocytogenes) result from the supplier's PEM (pathogen environmental monitoring) program","P","x"]
["i","Loss of relevant certification e.g., GFSI/ ISO, Organic, GMO, Kosher, Halal","P","P"]
["5.1.2","The supplier shall notify MDLZ by a phone call with a live person and by email. Voicemail, even coupled with an email, is not adequate. Notification shall be made to MDLZ immediately, at maximum within 24 hours of identifying a significant event. The MDLZ Contracting Representative shall be the primary contact for any contact or notification required by this document. In addition, the MDLZ Supplier Quality representative shall be notified of the significant event by email at minimum. The supplier shall also have an emergency contact available 24/7 to the MDLZ Contracting Representative. If the MDLZ representative is not available in cases of emergency, contact MDLZ Security at +1.973.503.2900 (note: this number should be used for all regions globally) and explain who you are, the nature of the call giving all the necessary contact information.","P","P"]
["5.1.3","The supplier shall review such events fully, identify the root cause and put in place effective corrective and preventive action (CAPA). Relevant traceability, root cause and CAPA shall be documented and presented to the MDLZ Supplier Quality representative by live communication.","P","P"]
[5.2,"Regulatory Inspections and Contacts","P","P"]
["5.2.1","The supplier shall have written procedures and designated, trained personnel to manage inspections by and contacts with regulatory agencies. Procedures shall address how the supplier will follow up and obtain closure of any issues arising from such inspection or contact. The supplier shall maintain at the facility records of all regulatory inspections and contacts, including any reports issued by inspectors, facility responses, and corrective actions taken, for a period according to local regulatory requirements.","P","P"]
["5.2.2","Consideration shall be given to the potential impact of an adverse result. In some cases, it shall be necessary to place product and/ or material on hold, pending results of Inspector sampling, for example:\n• Where a non-conformity or defect has become apparent during the inspection.\n• Where the stated reason for the sample being taken concerns an issue which may impact MDLZ (e.g., sampling for pathogen or GMO testing).","P","P"]
["5.2.3","In the event a regulatory agency samples material produced for MDLZ, place the material on hold. However, no further testing shall be initiated by the supplier without prior authorization from MDLZ. For environmental samples taken, keep a close-up photo of the exact location of the site. The supplier shall contact the MDLZ Contracting Representative within 24 hours for instructions.","P","P"]
[5.3,"Food Safety and Quality Culture","P","P"]
["5.3.1","The supplier management shall have a program in place that defines and maintains a clear plan for the development and continuous improvement of their food safety and quality culture. This may include but is not limited to:\n• Clear management commitment to food safety and quality through documented policy and objectives\n• Objectives for management and shop floor workforce\n• Key Performance Indicators (KPIs)\n• Employee recognition program\n• Training, education and forums\n• Food safety and quality communications","P","P"]

{"sheet":"6.1","index":5,"n_rows":33,"n_cols":4,"rows_kept":33,"cut":false,"hidden":false,"merged":[[0,0,0,1]]}
["CHAPTER 6 – RESOURCE MANAGEMENT",null,"RMAT","Pack"]
[6.1,"Good Manufacturing Practices (GMP)","P","P"]
["6.1.1","General Program Requirements","P","P"]
["6.1.1.1","All persons entering the supplier facility (plant personnel, visitors and outside contractors) shall comply with GMP requirements. No person shall be admitted into a GMP area if he or she carries, or has been exposed to, any potential source of a microbial or viral contamination. ","P","P"]
["6.1.1.2","GMP requirements shall be in writing and available to all personnel. Procedures shall address personal hygiene, handling and storage of equipment and materials, proper cleaning and sanitation, and receiving. Further specific requirements include the following unless risk assessment deems unnecessary e.g., completely enclosed production process (this shall be documented):","P","P"]
["6.1.2","Personnel Practices","P","P"]
["6.1.2.1","Holding toothpicks, matchsticks or other objects in the mouth shall not be allowed in GMP areas.","P","P"]
["6.1.2.2","Carrying objects above the belt or waistline (e.g., pens, flashlights, thermometers) shall not be allowed in GMP areas.","P","P"]
["6.1.2.3","Badges and clip-on identification cards, if used, shall be worn below the waist. Visitor identification badges are permitted but shall not be a source of contamination at the plant.","P","P"]
["6.1.2.4","Food shall not be stored in employee lockers.","P","P"]
["6.1.2.5","Medicines and pills shall not be permitted in GMP areas unless authorized on a case by case basis by defined site personnel","P","P"]
["6.1.3","Clothing and Personal Equipment","P","P"]
["6.1.3.1","All clothing shall be kept in good repair. Employee clothing shall not be a source of contamination, and provide adequate coverage to ensure that hair, perspiration or other foreign materials do not contaminate the product.","P","P"]
["6.1.3.2","Work wear dedicated to specific product areas shall be restricted to those areas. Such areas shall be defined in local procedures (typically high care areas where clothing change is required on entry and exit). They are not permitted in other areas where they may be subject to allergen or microbiological contamination (e.g., cafeteria, external rest areas, and any area not subject to GMP controls).","P","x"]
["6.1.3.3","Footwear shall be fully enclosed, made of non-absorbent materials, conform to local safety requirements, and be suitable and dedicated for use in production areas.","P","P"]
["6.1.3.4","Where temporary shoe covers are required for hygiene area controls, they shall be robust and not present an extraneous matter risk.","P","P"]
["6.1.3.5","Safety helmets shall be maintained in a sanitary condition. Helmets used in microbiologically sensitive areas shall be cleaned and sanitized.","P","P"]
["6.1.3.6","Ear protection devices shall be secured to prevent product contamination e.g., ear plugs attached by string or with a rigid attachment worn around neck, and earmuffs attached by headband.","P","P"]
["6.1.4","Hands","P","P"]
["6.1.4.1","Personnel working in GMP areas shall wash hands before entering a GMP area; upon re-entering the GMP area; after each visit to the toilet facility, and/ or lunch and break room facilities; prior to touching product or product contact surfaces; or any time when hands have become soiled or contaminated.","P","P"]
["6.1.4.2","Personnel working in a microbiologically sensitive area shall sanitize their hands after proper washing and after touching non-product contact surfaces. If soil is observed on hands, hands shall be washed prior to re-sanitizing. ","P","x"]
["6.1.4.3","Personnel with minor cuts or injuries on hands shall be able to protect the wound and keep it clean and free from infection. They shall be allowed to work on production lines provided the cuts are bandaged and covered with an impermeable sanitary material. Adhesive bandages shall be metal detectable in facilities where metal detectors are used or provided in a contrasting color to allow visual detection.","P","P"]
["6.1.5","Hair","P","P"]
["6.1.5.1","Hair shall be maintained as follows in GMP areas:","P","P"]
["a","Hair curlers, hair combs, and bobby pins are not allowed","P","P"]
["b","Barrettes, clasps, scarves or bandannas shall be worn neatly under the hair net.","P","P"]
["6.1.5.2","Hair restraints shall be worn in GMP areas:","P","P"]
["a","Hairnets/ restraints shall be of a close mesh type and be non-elastic mesh and shall completely contain the hair and cover the ears","P","P"]
["b","Hijabs and turbans are acceptable alternatives if they fully cover the hair and do not have clasps or other detachable fastening devices (in which case a disposable hair covering shall be worn over the top)","P","P"]
["c","If safety or bump helmets are used, they shall be worn over appropriate hair restraints.","P","P"]
["6.1.5.3","Facial hair shall be maintained as follows in GMP areas:","P","P"]
["a","Employees shall be clean-shaven or cover the exposed hair with a beard restraint","P","P"]
["b","Sideburns shall be trimmed and be no longer than the bottom of the ear or a beard net worn.","P","P"]

{"sheet":"6.2","index":6,"n_rows":13,"n_cols":4,"rows_kept":13,"cut":false,"hidden":false,"merged":[[0,0,0,1]]}
["CHAPTER 6 – RESOURCE MANAGEMENT",null,"RMAT","Pack"]
[6.2,"Personnel Training","P","P"]
["6.2.1","General Program Requirements","P","P"]
["6.2.1.1","The supplier shall ensure that all employees receive appropriate training for their job functions and shall maintain records of training. Specific training requirements are as follows:","P","P"]
["a","GMPs. All employees, including temporary and seasonal personnel, shall receive GMP training (including Employee Illness and Communicable Disease) as part of the orientation process. All employees shall also receive refresher training or verification of GMP knowledge at defined intervals. In addition, specific training programs to instruct personnel on the requirements of this document shall be provided as required and applicable","P","P"]
["b","Production Personnel. Training for supplier personnel who work in production areas shall include the following principles: Quality, HACCP, Allergens, Foreign Object Prevention, Sanitation and Food Defense","P","P"]
["c","Critical Control Point (CCP) Monitors. Employees monitoring CCPs shall receive further specific training on monitoring, documentation, verification and corrective actions if critical limits are not met. There should be a method to evaluate the operator’s competence","P","P"]
["d","GMOs. When appropriate, employees involved in handling GMO materials shall be trained as to procedures for handling these products (e.g., preventing co-mingling, how to handle non-GMO materials)","P","x"]
["e","Additional Requirements. Training requirements for Regulatory Inspections, Pest Management, Hold and Release and Pathogen Environmental Monitoring are set forth in the respective sections of this manual.","P","P"]
["6.2.1.2","Training shall be provided to new employees before starting work in production. Refresher training on these topics shall be provided. The supplier shall maintain records of personnel education, training, skills and experience. The supplier shall also periodically evaluate the effectiveness of its training programs.","P","P"]
["6.2.1.3","The supplier shall maintain records of personnel education, training, skills and experience.","P","P"]
["6.2.1.4","The supplier shall periodically evaluate the effectiveness of its training programs.","P","P"]
["6.2.1.5","The supplier shall provide visitors and contractors with site specific training programs, as necessary, prior to performing activities which may affect product safety or quality.","P","P"]

{"sheet":"6.3","index":7,"n_rows":28,"n_cols":5,"rows_kept":28,"cut":false,"hidden":false,"merged":[[0,0,0,2],[1,1,1,2],[12,1,12,2],[11,1,11,2],[4,1,4,2],[6,1,6,2],[7,1,7,2],[8,1,8,2],[9,1,9,2],[10,1,10,2],[3,1,3,2],[5,1,5,2],[16,0,27,0],[15,0,15,2],[14,1,14,2],[2,1,2,2],[13,1,13,2]]}
["CHAPTER 6 – RESOURCE MANAGEMENT",null,null,"RMAT","Pack"]
[6.3,"Employee Illness and Communicable Disease",null,"P","P"]
["6.3.1","Instructions",null,"P","P"]
["6.3.1.1","The supplier shall establish written instructions for the control of employee illness and communicable disease that may result in pathogen transmission by food. These instructions shall be available and communicated to all applicable personnel.",null,"P","P"]
["6.3.1.2","The instructions shall, at a minimum, include:",null,"P","P"]
["a","Provisions for recognition and identification of symptoms of employee illness or communicable disease prior or when present at work, communication to stakeholders, risk assessment and hold requirements, return to work procedures, and training",null,"P","P"]
["b","Key indicators for communicable disease include: Diarrhea, vomiting, open skin sores, boils, fever, dark urine, jaundice, discharge from eyes, ears, mouth or gums, or any other symptoms associated with geographical, region-specific diseases as defined by local medical experts ",null,"P","P"]
["c","A process by which the supplier can evaluate the potential impact to product should an active employee be diagnosed with communicable disease",null,"P","P"]
["d","Procedures to ensure that employees afflicted with a communicable disease are removed from the manufacturing facility or are reassigned to a non-food contact area. In determining suitable work areas for affected employees, the supplier shall consider the risk of cross infection to other employees",null,"P","P"]
["e","Documented procedures for return to work and re-assignment of affected employees (suspected or confirmed) following region/ country regulations, as well as related to visitors/ contractors not entering premises when suffering from illnesses (see Table 6.3.4 for guidance on relevant illnesses to consider)",null,"P","P"]
["f","No person shall be admitted into a GMP area if he or she carries, or has been exposed to, any potential source of a microbial or viral contamination.",null,"P","P"]
["6.3.2","Prevention",null,"P","P"]
["6.3.2.1","Waterborne and food borne outbreaks related to city/ municipal poor infrastructures (or other specific conditions in a region) may require preventative measures to be put into place. In those cases, a hazard assessment shall be conducted (as part of the HACCP) at each manufacturing location to determine the likelihood of an outbreak. If the hazard is likely to occur, preventative measures shall be considered and may include increased employee training, additional water purification, vaccination, etc.",null,"P","P"]
["6.3.3","Pathogens Involved with Transmission Diseases",null,"P","P"]
["6.3.3.1","The following list shows the currently recognized pathogens/ diseases from pathogens which can be transmitted by food that has been contaminated by an infected person.",null,"P","P"]
["Table 6.3.4 Currently Recognized Pathogens/ Diseases from Pathogens which can be Transmitted by Food that has been Contaminated by an Infected Person",null,null,"P","P"]
["6.3.4","OFTEN TRANSMITTED","OCCASIONALLY TRANSMITTED","P","P"]
[null,"Norovirus","Campylobacter jejuni","P","P"]
[null,"Hepatitis A virus","Cryptosporidium species","P","P"]
[null,"Salmonella Typhi and Paratyphi ","Entamoeba histolytica","P","P"]
[null,"Shigella species","Shiga toxin-producing Escherichia coli","P","P"]
[null,"Staphylococcus aureus","Enterotoxigenic Escherichia coli","P","P"]
[null,null,"Giardia lamblia and intestinalis","P","P"]
[null,null,"Non-typhoidal Salmonella","P","P"]
[null,null,"Rotavirus","P","P"]
[null,null,"Sapovirus","P","P"]
[null,null,"Yersinia enterocolitica","P","P"]
[null,null,"Vibrio cholerae","P","P"]

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["CHAPTER 6 – RESOURCE MANAGEMENT",null,null,null,null,null,null,null,null,"RMAT","Pack"]
[6.4,"Utilities Management",null,null,null,null,null,null,null,"P","P"]
["6.4.1","General Program Requirements",null,null,null,null,null,null,null,"P","P"]
["6.4.1.1","The supplier shall have implemented maintenance and reliability programs to ensure safe provision of whole infrastructure including production assets and Utility Services in food production areas. Utility Services include environmental air, compressed air, water, steam and special gases (N2, CO2 and other gases).",null,null,null,null,null,null,null,"P","P"]
["6.4.1.2","The supplier shall control access points for the above referenced utility services stations, as well as electricity, heating, and ventilation networks. Access shall be controlled by any means deemed effective, such as locked facilities which only authorized employees can open. Further specific requirements include the following:",null,null,null,null,null,null,null,"P","P"]
["6.4.2","Environmental Air",null,null,null,null,null,null,null,"P","P"]
["6.4.2.1","All plant exterior air intake ports shall be visually inspected for integrity as part of the overall preventive maintenance program. All anomalies and non-conformities shall be fixed as soon as practically possible, provided that the required spare parts are available.",null,null,null,null,null,null,null,"P","P"]
["6.4.2.2","Intakes shall be positioned and shrouded in a manner that will not allow rain or other precipitation to be drawn into the system. In cold climates, intakes shall be elevated sufficiently to avoid snow encasement. Fresh air inlet(s) into processed product areas (controlled/ high control zones) should be positioned at the opposite side of the building in relation to the raw zone air outlet(s). In cases where this is not possible, the supplier shall contact MDLZ Supplier Quality representative for guidance.\n\n",null,null,null,null,null,null,null,"P","P"]
["6.4.2.3","The integrity of air filters shall be checked as part of their preventive maintenance program.",null,null,null,null,null,null,null,"P","P"]
["6.4.2.4","The supplier shall ensure continuous air flow and pressure differential between adjacent hygienic zones in order to prevent airborne cross contamination (refer to Section 6.9 Hygienic Zoning). In order to maintain the pressure differential, it is recommended to use Table 6.4.3.",null,null,null,null,null,null,null,"P","x"]
["6.4.2.5","Air for Controlled or High Control zones shall not be sourced from an unprocessed product area (raw). ",null,null,null,null,null,null,null,"P","x"]
["6.4.2.6","If more than one type of process is used in a common area, the most stringent filtration standard shall be applied (i.e., in a space where cheese and crackers are packaged together, the filtration shall be according to that required for cheese which has a stricter filtration requirement than crackers). Air flow shall be from higher to lower zone and extracted from the lower zone.",null,null,null,null,null,null,null,"P","P"]
["6.4.2.7","Where air is contaminated with combustible dust, allergen dust, dust from raw zone, odors, flavors in processing rooms/ areas, proper suction with additional filtration shall be fitted in the location of generation that ensures the air is delivered outside the building.",null,null,null,null,null,null,null,"P","P"]
["6.4.2.8","Environmental air and low pressure air used in direct product contact (e.g., cooling, drying and transportation), should comply to microbiological air quality (refer to Table 6.4.6), but no less than the requirements in Table 6.4.4.",null,null,null,null,null,null,null,"P","P"]
["6.4.2.9","For external tanks and silos, ventilation air shall be controlled with filtration, based on risk assessment considering all foreseeable hazards (physical, chemical and microbiological) that may exist in the outside environmental air and their potential impact on the product.",null,null,null,null,null,null,null,"P","P"]
["6.4.2.10","Air quality shall be monitored, trended and reviewed by appropriate personnel, as necessary to ensure suitable quality against all contaminants:",null,null,null,null,null,null,null,"P","P"]
["a","For all materials, regardless of microbiological sensitivity, monitoring in production areas shall be performed at least annually to verify that environmental air filtration can adequately control all foreseeable airborne contaminants to product.",null,null,null,null,null,null,null,"P","P"]
["b","For microbiologically sensitive materials as identified in Table 6.4.5, monitoring in production areas with exposed product shall be performed.",null,null,null,null,null,null,null,"P","x"]
["6.4.2.11","Where there is no adequate air filtration (refer to Table 6.4.4) in production areas with exposed products, not supporting microbiological growth, air sampling shall be carried out.",null,null,null,null,null,null,null,"P","P"]
["6.4.2.12","The program shall describe the sampling locations, frequency, action limit, methods, corrective actions and responsible personnel. Table 6.4.6 provides guidance for Environmental Air acceptable limits.",null,null,null,null,null,null,null,"P","P"]
["6.4.2.13","Additional requirements for specific use:",null,null,null,null,null,null,null,"P","P"]
["a","Air blown on the surface of microbiologically sensitive materials shall normally be sourced from within the processing area complying with the filtration requirements",null,null,null,null,null,null,null,"P","P"]
["b","Air sourced from outside shall be filtered to the level required for the given product",null,null,null,null,null,null,null,"P","P"]
["c","The air supplied to the filler in an aseptic filling system (for beverages) shall be filtered through a HEPA filter (H13)",null,null,null,null,null,null,null,"P","P"]
["d","Where air is used to transport ingredients, it shall be filtered to F7 for any new installations and/ or new filter change",null,null,null,null,null,null,null,"P","x"]
["e","Vacuum cleaners shall be fitted with H13 filters",null,null,null,null,null,null,null,"P","P"]
["Table 6.4.3 Air Quality Guidance for AHU (Air Handling Unit) Installations",null,null,null,null,null,null,null,null,"P","P"]
["6.4.3",null,null,"Raw Zone/ Limited Processed Zone",null,"Controlled Zone ",null,"High Control Zone",null,"P","P"]
[null,"Positive air movement from higher to lower hygiene zone (controlled overpressure)1",null,"-",null,"Essential",null,"Essential",null,"P","P"]
[null,"Minimum air changes/hour2",null,"-",null,5,null,10,null,"P","P"]
[null,"Make Up Air (%)",null,10,null,10,null,10,null,"P","P"]
[null,"1 EHEDG recommends 5-15 Pa depending on the size of the controlled environment and the openings (e.g., doors). Such a high overpressure may be hard to achieve and require a large amount of supply air. Alternatively, positive air movement can be achieved and proven by an air velocity at the openings of 1 m/s or better",null,null,null,null,null,null,null,"P","P"]
[null,"2 Values may differ depending on the heat sources inside the room, the temperature control and height of rooms",null,null,null,null,null,null,null,"P","P"]
["Table 6.4.4 Minimum Requirements for Environmental Air and Low-pressure Air Used in Direct Product Contact",null,null,null,null,null,null,null,null,"P","P"]
["6.4.4",null,"Non-manufacturing\n(non-GMP) Zone",null,"Raw Zone /\nLimited\nprocess Zone","Controlled Zone ",null,"High Controlled Zone",null,"P","P"]
[null,"Filtration -\ncooling/ drying/ air added during process","Coarse filtration (G3/ MERV 5-6, equal to filter efficiency ˃ 25 at\n1 micron)",null,"G4 (MERV 7-8)","M5 (MERV 9-10)\n• Materials with water activity >0.6, post nut roasting cooling: F7 (MERV 13)",null,"H10 (MERV 16) - H13 (depending on risk)\n• The air supplied to the filler in an aseptic filling system (for beverages) shall be filtered through a HEPA filter (H13)",null,"P","P"]
["Table 6.4.5 Sensitive Raw Material Categories Requiring Environmental Air Monitoring",null,null,null,null,null,null,null,null,"P","x"]
["6.4.5","Cheese and Dairy products/ substitutes",null,null,null,"Ready-to-Eat Dessert products (excluding powder)",null,null,null,"P","x"]
[null,"Ready to Drink – Liquid Beverages (excluding aseptic)",null,null,null,"Ready-to-Eat Fruits products",null,null,null,"P","x"]
[null,"Ready-to-Eat Vegetable products",null,null,null,"Peanut butter and tree nuts paste products",null,null,null,"P","x"]
[null,"Ready-to-Eat Eggs products",null,null,null,"Ready-to-Eat Meat & Poultry products",null,null,null,"P","x"]
[null,"Cultures, Enzymes, Yeast and Starter Media",null,null,null,"Prepared Sauces, Spreads, Condiments",null,null,null,"P","x"]
[null,"Ready-to-Eat Fish & Seafood products",null,null,null,null,null,null,null,"P","x"]
["Table 6.4.6 Action Limits Guidance for Environmental Air and Compressed Air",null,null,null,null,null,null,null,null,"P","x"]
["6.4.6","Product Category",null,null,null,null,"Organism","Environmental Air",null,"P","x"]
[null,null,null,null,null,null,null,"Air Exposure Plates","Air Sampler","P","x"]
[null,"Dry sensitive ingredients (e.g., dairy powders, cocoa, nuts)",null,null,null,null,"Yeast & Mold","< 100 cfu/15 minutes","< 1,000 cfu/m3","P","x"]
[null,null,null,null,null,null,null,null,null,"P","x"]
[null,"Post heat treatment or pasteurization; products with Aw 0.65 - 0.95 (processing, filling and packaging)",null,null,null,null,null,"< 10 cfu/15 minutes","< 500 cfu/m3","P","x"]
[null,null,null,null,null,null,null,null,null,"P","x"]
[null,"Post heat treatment or pasteurization: products with Aw > 0.95 (processing, filling and packaging), hot filled",null,null,null,null,null,"< 10 cfu/15 minutes","< 500 cfu/m3","P","x"]
[null,null,null,null,null,null,null,null,null,"P","x"]
[null,"Post heat treatment or pasteurization: products with Aw > 0.95 (processing, filling and packaging), cold filled",null,null,null,null,null,"< 5 cfu/15 minutes","< 100 cfu/m3","P","x"]
[null,null,null,null,null,null,null,null,null,"P","x"]
[null,"Ready-to-Eat Vegetable products",null,null,null,null,null,"< 100 cfu/15 minutes","< 1,000 cfu/m3","P","x"]
[null,null,null,null,null,null,null,null,null,"P","x"]
["6.4.7","Compressed Air",null,null,null,null,null,null,null,"P","P"]
["6.4.7.1","Compressed air for general applications shall be dry, oil free and filtered to remove foreign particles.",null,null,null,null,null,null,null,"P","P"]
["6.4.7.2","Compressors that provide air for direct or indirect product contact should be of oil free design. Where air from existing oil lubricated compressors is used for direct or indirect product contact, the following requirements apply:",null,null,null,null,null,null,null,"P","P"]
["a","only food grade oil shall be used",null,null,null,null,null,null,null,"P","P"]
["b","vapor and odor filters shall be installed prior to use where possible",null,null,null,null,null,null,null,"P","P"]
["c","air pressure gauges shall be installed and monitored",null,null,null,null,null,null,null,"P","P"]
["d","oil and filter changes shall be captured in the preventive maintenance program",null,null,null,null,null,null,null,"P","P"]
["6.4.7.3","The final filter (prior to distribution - compressor output) shall be at minimum of purity class 1.4.1 according to ISO 8573-1:2010 (refer to Table 6.4.8).",null,null,null,null,null,null,null,"P","P"]
["6.4.7.4","The filter shall conform to the following requirements at the point of use, irrespective of its application point in the process:",null,null,null,null,null,null,null,"P","P"]
["a","where there is no application to product contact or product contact surfaces, the filter shall be coalescing of a high efficiency oil removal type for the removal of particles down to (or exceeding) 0.3 µm",null,null,null,null,null,null,null,"P","P"]
["b","where there is application to product contact or product contact surfaces, the compressed air filtration shall be coalescing 0.3μm + Fine 0.01μm + Active Carbon",null,null,null,null,null,null,null,"P","P"]
["c","in cases where the supplier is unable to comply with Requirement 6.4.7.4a-b, a definitive plan for achieving compliance by October 1st 2025, shall be established.",null,null,null,null,null,null,null,"P","P"]
["6.4.7.5","Piping and fittings after the final filter shall be of corrosion-resistant materials suitable for intended application.",null,null,null,null,null,null,null,"P","P"]
["6.4.7.6","Maintenance of air filters to manufacturer specifications is of prime importance and shall be documented.",null,null,null,null,null,null,null,"P","P"]
["Table 6.4.8 ISO8573-1:2010 Compressed Air Purity Classes",null,null,null,null,null,null,null,null,"P","P"]
["6.4.8","Class","Solid Particulate",null,null,null,"Water",null,"Oil","P","P"]
[null,null,"Maximum number of particles /m3",null,null,"Mass Concentr mg/m3","Vapor Pressure Dewpoint ⁰C","Liquid g/m3","Total Oil (aerosol liquid and vapor) mg/m3","P","P"]
[null,null,"0.1 - 0.5µ","0.5 - 1µ","1 - 5 µ",null,null,null,null,"P","P"]
[null,0,"As specified by the equipment user or suppliers and more stringent than Class 1",null,null,null,null,null,null,"P","P"]
[null,1,"≤ 20 000","≤ 400","≤ 10","-","≤ -70","-",0.01,"P","P"]
[null,2,"≤ 400 000","≤ 6 000","≤ 100","-","≤ -40","-",0.1,"P","P"]
[null,3,"-","≤ 90 000","≤ 1 000","-","≤ -20","-",1,"P","P"]
[null,4,"-","-","≤ 10 000","-","≤ +3","-",5,"P","P"]
["6.4.9","Water",null,null,null,null,null,null,null,"P","P"]
["6.4.9.1","The potable water supply system (including ice that contacts the product) shall meet all applicable local and national regulatory requirements.",null,null,null,null,null,null,null,"P","P"]
["6.4.9.2","Water shall be monitored for hardness, and pipework shall be protected against corrosion.",null,null,null,null,null,null,null,"P","P"]
["6.4.9.3","The site shall have effective programs to control water microbiological quality and to verify that water meets specified requirements. Microbiological and other test data from water testing shall be trended and reviewed by appropriate personnel. The plant water program shall describe the sampling locations, frequency, action limit, methods, corrective actions and responsible personnel.",null,null,null,null,null,null,null,"P","P"]
["6.4.9.4","Incoming water from municipal source shall be analyzed for microbiological indices quarterly. Certification from the municipal source is accepted.",null,null,null,null,null,null,null,"P","P"]
["6.4.9.5","Microbiological tests shall be performed based on product/ process sensitivity, however in a product processed without or after a pathogen reduction step all water used as an ingredient or to clean shall be analyzed weekly. The sampling plan shall cover all water circuits, and branches from main circuits.",null,null,null,null,null,null,null,"P","P"]
["6.4.9.6","Microbiological tests shall also be performed after maintenance or repair to the water system.",null,null,null,null,null,null,null,"P","P"]
["6.4.9.7","Microbiological tests shall as a minimum include but are not limited to analyses for TVC and coliforms. Limits for water of potable quality: TVC < 500cfu/ml and coliforms < 1cfu/100 ml. If there is a local regulation which is stricter than this requirement, the local regulation shall be followed.",null,null,null,null,null,null,null,"P","P"]
[null,"Note: Cocoa suppliers refer to Cocoa Processing Expectations for additional water testing requirements",null,null,null,null,null,null,null,"P","x"]
["6.4.9.8","Corrective action shall be initiated and documented for out of standard results (e.g., repeat sampling and testing, identification and elimination of the source of contamination, cleaning of piping, chlorination of water).",null,null,null,null,null,null,null,"P","P"]
["6.4.9.9","Disinfection (e.g., chlorination, ozonation, UV light) of surface, well (ground) water, and untreated municipal water for all direct product uses (e.g., ingredient, sanitation, rinse, drinking) and indirect product uses (e.g., re-circulated cooling water, hand wash) shall be subject to an assessment to determine if disinfection is required. The assessment shall include, but not limited to, historical data of microbiological compliance, history of waterborne outbreaks, and local regulation.",null,null,null,null,null,null,null,"P","P"]
["6.4.9.10","Where water disinfection is carried out at supplier’s facility, this shall be done after filtration to ensure effective disinfection.",null,null,null,null,null,null,null,"P","P"]
["6.4.9.11","Where chlorine treatment is used, residual chlorine and ozone shall be periodically tested (e.g., daily or less frequently if supported by historical data), including municipal water. Free chlorine shall be 0.1 ppm or mg/L minimum and if levels exceed 5 ppm, contact municipality to establish cause or correct dosing at own source; i.e., check internal water chlorination system (level, retention time, indicator probes etc.,). Corrective actions shall be taken when levels do not meet the required limits.",null,null,null,null,null,null,null,"P","P"]
["6.4.9.12","Ozone treated water shall be tested after de-ozonation, at each shift of production.",null,null,null,null,null,null,null,"P","P"]
["6.4.9.13","If ozonation is used as an equipment sanitizer, water shall be sampled at the end of the sanitization circuit.",null,null,null,null,null,null,null,"P","P"]
["6.4.9.14","The hazard of extraneous matter in incoming municipal water shall be subject of a HACCP assessment based on historical data.",null,null,null,null,null,null,null,"P","P"]
["6.4.9.15","The extraneous matter hazards in incoming water shall be controlled using filters, 200 mesh/ 75 microns for non-municipal water, including well, lagoon or surface/ rain water. Where alternative filtration methods are used, (sand filtration, reverse osmosis, etc.,) these shall be shown to be equivalent or higher. Filtration systems (e.g., charcoal, reverse osmosis) shall be regularly inspected and maintained within the facility’s maintenance program.",null,null,null,null,null,null,null,"P","P"]
["6.4.9.16","For non-municipal water, a visual turbidity assessment shall be carried out regularly, based on history. Testing shall be increased in the event of issues which may adversely affect water quality.",null,null,null,null,null,null,null,"P","P"]
["6.4.9.17","Potable water systems shall contain devices for preventing backflow, or a header tank, and shall eliminate cross-connection of fluids from used waste drains or sewage systems.",null,null,null,null,null,null,null,"P","P"]
["6.4.9.18","Production sites shall have documented circuit diagrams/ maps of their direct and indirect water system(s).",null,null,null,null,null,null,null,"P","P"]
["6.4.10","Steam",null,null,null,null,null,null,null,"P","P"]
["6.4.10.1","Process steam is steam used indirectly during processing (i.e., steam for jacketed equipment) or used for direct product contact surfaces with a subsequent rinse. Process steam shall be produced using water treatment and/ or boiler additive chemicals that are approved under relevant local/ national regulations. Levels of additives in process steam shall not exceed what is required for the intended functional purpose.",null,null,null,null,null,null,null,"P","P"]
["6.4.10.2","Culinary steam or clean steam are suitable for direct product contact and can be directly injected into the product without a subsequent rinse or primary packaging. Clean steam is the same as culinary steam but raised in a steam generator or taken from outlets on a multi effect still with a de-ionized or distilled water source. Culinary steam shall be produced using only approved food grade boiler chemicals.",null,null,null,null,null,null,null,"P","P"]
["6.4.10.3","The piping assembly for direct steam shall:",null,null,null,null,null,null,null,"P","P"]
["a","contain an entrainment separator capable of removing particles 30 microns in size and larger located just prior to the injection heater/ steam dispersal assembly and after the supply lines transporting steam from the boiler",null,null,null,null,null,null,null,"P","P"]
["b","be delivered through stainless steel pipework to the point of use. Stainless steel pipework shall meet specification AISI 304 and 316. For Dairy applications, the steam should be filtered after the separator.",null,null,null,null,null,null,null,"P","P"]
["6.4.10.4","Culinary, clean and process steam condensate quality shall be visually evaluated for turbidity (free from any suspended particulates and odors) at a minimum frequency of six months for culinary steam and annually for process and clean steam.",null,null,null,null,null,null,null,"P","P"]
["6.4.11","Special Gases (N2, CO2 and other gases)",null,null,null,null,null,null,null,"P","P"]
["6.4.11.1","Carbon dioxide, nitrogen and other gas systems used in manufacturing and/ or filling shall be constructed and maintained so as to prevent contamination.",null,null,null,null,null,null,null,"P","P"]
["6.4.11.2","Gases intended for direct or incidental product contact (including those used for transporting, blowing or drying materials, products or equipment) shall be of food grade purity consistent with the type of special gas used (e.g., N2 98%-99.5% by volume and CO2 99.9% by volume) and shall be certified for direct food contact applications.",null,null,null,null,null,null,null,"P","P"]
["6.4.11.3","Special gases used in the product and product contact areas shall meet at minimum purity Class 1.4.1 according to ISO 8573-1:2010 and be tested for purity class.",null,null,null,null,null,null,null,"P","P"]

{"sheet":"6.5","index":9,"n_rows":10,"n_cols":4,"rows_kept":10,"cut":false,"hidden":false,"merged":[[0,0,0,1]]}
["CHAPTER 6 – RESOURCE MANAGEMENT",null,"RMAT","Pack"]
[6.5,"Equipment and Facility Maintenance","P","P"]
["6.5.1","Maintenance Program","P","P"]
["6.5.1.1","The supplier shall ensure that the facility, equipment and their components used for production are suitable for their intended use and in good working order, maintaining their original condition as far as practically possible.","P","P"]
["6.5.1.2","The supplier shall have implemented a documented master maintenance program. The maintenance plan shall consider criticality of equipment for food safety. ","P","P"]
["6.5.1.3","Any construction and maintenance shall be risk assessed for any known and foreseeable food safety hazards to ensure there are no uncontrolled risk to the work. On completion, a re-commission process shall be in place that ensures proper final sanitation, housekeeping and start-up inspection. This shall be conducted prior to commercial production.","P","P"]
["6.5.2","Maintenance Hygiene","P","P"]
["6.5.2.1","Workshops for maintenance of food contact equipment shall be kept in hygienic condition with adequate controls to prevent cross-contamination.","P","P"]
["6.5.2.2"," There shall be a sanitation, inspection and clearance protocol following maintenance work on production equipment and food handling areas.","P","P"]
["6.5.2.3","A protocol shall be in place to control workwear for technicians and contractors preventing cross-contamination.","P","P"]

{"sheet":"6.6","index":10,"n_rows":36,"n_cols":4,"rows_kept":36,"cut":false,"hidden":false,"merged":[[0,0,0,1]]}
["CHAPTER 6 – RESOURCE MANAGEMENT",null,"RMAT","Pack"]
[6.6,"Sanitary Design: Plant Structure and Equipment Design","P","P"]
["6.6.1","Plant Structure","P","P"]
["6.6.1.1","The facility shall be of adequate design and construction to ensure production of safe and high quality materials, and satisfactorily maintained. The facility and equipment, including utility fixtures, shall be designed to prevent potential contamination sources from affecting the products produced or handled. ","P","P"]
["6.6.1.2","The location and design of waste bins, toilets and hand washing, drying and sanitizing facilities shall be adequate to comply with GMPs.","P","P"]
["6.6.1.3","Construction materials used for the structure (e.g., floors, walls, ceilings, overheads and drains) shall be completely compatible with the product, environment, cleaning materials used, and the method of cleaning.","P","P"]
["6.6.1.4","The internal and external structure shall be free of cracks, holes, openings, pest entry or nesting areas. The roof shall not leak.","P","P"]
["6.6.1.5","All exterior doors shall be self-closing and shall form an adequate seal when closed. Loading docks shall be protected to prevent pest entry. Entrance of air shall be limited by vestibules or air curtains as appropriate.","P","P"]
["6.6.1.6","In GMP areas, there should not be direct access to external areas.","P","P"]
["6.6.1.7","Windows present in production areas that can be opened must be adequately screened. All vents and fans shall also be adequately screened.","P","P"]
["6.6.1.8","Doors, windows, and other openings shall prevent access by unauthorized people.","P","P"]
["6.6.1.9","Floors shall be properly maintained, free from cracks and crevices, fully drainable and pitch towards the drains with wall/ floor juncture to be smooth and rounded.","P","P"]
["6.6.1.10","It shall be assured that water, product, or CIP solutions do not pool in the product zones and that liquid cannot drain, be drawn, or drip onto product zone areas. Condensation control is required in exposed product zones.","P","x"]
["6.6.1.11","In facilities handling microbiologically sensitive ingredients, the plant structure shall be designed to prevent cross contamination of raw and processed zones (see Section 6.9 Hygienic Zoning). Dust in the air shall be minimized and allergen cross-contamination shall be prevented.","P","x"]
["6.6.1.12","Floor drains shall be trapped and vented to prevent sewer gas entry and shall be accessible and cleanable.","P","x"]
["6.6.1.13","Microbiology laboratories shall be separated from the production areas. At a minimum, laboratories shall be in a separate room with a door.","P","x"]
["6.6.1.14","The plant shall provide adequate space and separation from adjacent structures and equipment to prevent (microbiological or allergen) cross-contamination and to facilitate cleaning (allows for appropriate cleaning techniques for the application/ design, which may range from dry cleaning on secondary packaging equipment to wet cleaning of direct product contact surfaces).","P","x"]
["6.6.1.15","Adequate ventilation or appropriately filtered air shall be provided to prevent the formation of condensation, odor or mold.","P","P"]
["6.6.1.16","Facility design shall include correct and effective (following industry best practices and industry guidelines as they are documented under 3-A SSI and EHEDG) placement of all utilities required for sanitation.","P","x"]
["6.6.1.17","Any identified non-conformities with the above principles shall have a control in place to ensure there is no residual food safety risk to the production.","P","x"]
["6.6.2","Equipment Design","P","P"]
["6.6.2.1","The supplier shall ensure that equipment design is acceptable (all possible hazards to product and process are identified and prevented by design. All remaining risks are  controlled to acceptable level) for the production of materials that meet food safety and quality parameters. Equipment (e.g., batching, processing, storage, filling, transfer, piping) shall be constructed and maintained to sustain cleanability to reduce bacterial survival, growth and reproduction; the risk of chemical (allergen) cross-contamination; and the risk of extraneous matter contamination.","P","P"]
["6.6.2.2","All equipment, components and assemblies that handle and/ or process foodstuff shall be designed based on EHEDG and/ or 3A-SSI industry standards and guidelines as well, as risk assessed based on ISO1672-2.","P","P"]
["6.6.2.3","Hand cleaned or manually set up designs shall be readily accessible for cleaning, sanitizing and inspection.","P","P"]
["6.6.2.4","For equipment hygienic design, special attention shall be paid to the following principles:","P","P"]
["a","Framework","P","P"]
["b","Weldments","P","P"]
["c","Cable routing","P","P"]
["d","Compressed air in contact with product","P","P"]
["e","Materials of construction","P","P"]
["f","No product build-up or hold-up (cleaning solutions shall be drainable)","P","P"]
["g","No ingress","P","P"]
["h","No egress","P","P"]
["i","No leaching of chemicals","P","P"]
["6.6.2.5","Wet cleaned equipment shall be ACS (Assisted Cleaning System)/ COP compatible and/ or can be disassembled easily and efficiently with minimal use of simple hand tools.","P","P"]
["6.6.2.6","Any identified non-conformities with the above principles shall have a control in place to ensure there is no residual food safety risk to the production.","P","P"]

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["CHAPTER 6 – RESOURCE MANAGEMENT",null,null,null,null,null,null,null,null,"RMAT","Pack"]
[6.7,"Sanitation",null,null,null,null,null,null,null,"P","P"]
["6.7.1","Sanitation Program",null,null,null,null,null,null,null,"P","P"]
["6.7.1.1","The supplier shall have implemented a written sanitation program that ensures cleanliness of the processing environment, equipment (including tankers inbound and outbound) and tools. The program shall address:",null,null,null,null,null,null,null,"P","P"]
["a","Sanitation schedules, methods, and frequencies",null,null,null,null,null,null,null,"P","P"]
["b","Correct use of appropriate sanitation equipment and tools",null,null,null,null,null,null,null,"P","P"]
["c","Chemicals to be used and how they are to be used including chemical concentrations, contact time, temperatures, frequencies, and rinsing procedures",null,null,null,null,null,null,null,"P","P"]
["d","Equipment disassembly and re-assembly",null,null,null,null,null,null,null,"P","P"]
["e","Verification of sanitation effectiveness",null,null,null,null,null,null,null,"P","P"]
["f","Hygiene (non-pathogen) monitoring programs e.g., sanitation verification",null,null,null,null,null,null,null,"P","P"]
["g","Inspection procedures (including visual inspections)",null,null,null,null,null,null,null,"P","P"]
["h","Recordkeeping, record review, and corrective action plans.",null,null,null,null,null,null,null,"P","P"]
["6.7.1.2","The following considerations shall be taken into account when designing the sanitation program:",null,null,null,null,null,null,null,"P","P"]
["a","Situations when prolonged equipment downtime can lead to microbiological growth – idle time: additional sampling on start-up maybe required",null,null,null,null,null,null,null,"P","P"]
["b","Maximum run lengths of lines between cleans based on product sensitivity and historical experience, unless regulatory requirements specify otherwise",null,null,null,null,null,null,null,"P","x"]
["c","Protocols for extending production runs beyond established sanitation cycle times",null,null,null,null,null,null,null,"P","x"]
["d","Adequate product protection when sanitation activities occur adjacent to operating production areas",null,null,null,null,null,null,null,"P","P"]
["e","Cleaning in Place/ Cleaning Out of Place (CIP/ COP)",null,null,null,null,null,null,null,"P","P"]
["f","Equipment that is wet cleaned which needs to be used in a dry condition",null,null,null,null,null,null,null,"P","P"]
["g","Post-cleaning or pre-start up inspections to confirm that equipment is clean, properly assembled, free from chemical residues and sanitized prior to use",null,null,null,null,null,null,null,"P","P"]
["h","Periodic cleaning of processing equipment and overhead structures (Periodic Infrastructure Cleaning (PIC) and Periodic Equipment Cleaning (PEC)), including scheduled frequencies and documentation",null,null,null,null,null,null,null,"P","P"]
["i","Floor drain sanitation, including a facility map with the exact location of each drain. High pressure hoses shall not be used, and cleaning of drains shall not be performed during production or present a risk to product. The activity should be performed by a dedicated operator to prevent cross-contamination to other cleaning activities and equipment. Drains shall be of adequate size and number to ensure complete removal of all liquid from the floor within reasonable time",null,null,null,null,null,null,null,"P","P"]
["j","Use of cleaning and sanitizing products, which are suitable for the food industry",null,null,null,null,null,null,null,"P","P"]
["k","Calibration of sanitation-related measurement devices (e.g., thermometers, gauges and meters).",null,null,null,null,null,null,null,"P","P"]
["6.7.2","Tools and Equipment",null,null,null,null,null,null,null,"P","P"]
["6.7.2.1","Proper tools and materials shall be used to prevent extraneous matter, microbiological and/ or chemical contamination of the material. Items that are known to be potential sources of contamination shall be prohibited. ",null,null,null,null,null,null,null,"P","P"]
["6.7.2.2","Brushes and utensils for cleaning food contact surfaces/surfaces in contact with food contact material shall be clearly identified (e.g., labeled and/ or color coded) and stored separately from non-food contact tools. Floor drain cleaning brushes and equipment shall be clearly identified as such and maintained separately from other cleaning equipment. ",null,null,null,null,null,null,null,"P","P"]
["6.7.2.3","Equipment shall not be brought outside the GMP areas for cleaning, and additional precautions are required when equipment from Controlled zones and High Control zones are cleaned in Raw zones or vice versa.",null,null,null,null,null,null,null,"P","P"]
["6.7.2.4","Near sanitized equipment and in areas of exposed material, high pressure water hoses or compressed air hoses shall not be used to clean the floor or equipment due to formation of aerosols. High pressure water greater than 100 psi/ 7 bars shall not be used during operation.",null,null,null,null,null,null,null,"P","P"]
["6.7.2.5","Gaskets shall be handled and stored in a sanitary manner:",null,null,null,null,null,null,null,"P","P"]
["a","Product-contact gaskets shall be cleaned or replaced at a defined frequency",null,null,null,null,null,null,null,"P","P"]
["b","Used or damaged/ worn gaskets shall be discarded to prevent inadvertent later use",null,null,null,null,null,null,null,"P","P"]
["c","New gaskets shall be washed and sanitized before use.",null,null,null,null,null,null,null,"P","x"]
["6.7.3","Sanitation Verification (after wet cleaning)",null,null,null,null,null,null,null,"P","x"]
["6.7.3.1","The supplier shall document and implement a plant specific program to monitor hygiene conditions and the effectiveness of sanitation for wet cleaned equipment using swabbing. Clean equipment swabs shall be taken after the microbiological control step (e.g., heat treatment, formulation).",null,null,null,null,null,null,null,"P","x"]
["6.7.3.2","The procedure shall be documented and shall define the following:",null,null,null,null,null,null,null,"P","x"]
["a","Target organism (product and process dependent)",null,null,null,null,null,null,null,"P","x"]
["b","Sampling location",null,null,null,null,null,null,null,"P","x"]
["c","Frequency of testing (recommended minimum monthly)",null,null,null,null,null,null,null,"P","x"]
["d","Methods and test result acceptance criteria",null,null,null,null,null,null,null,"P","x"]
["e","Process for corrective actions (including testing to confirm the effectiveness of the actions taken).",null,null,null,null,null,null,null,"P","x"]
["6.7.3.3","Each manufacturing facility shall establish its own program and a baseline for the different microbial indicators taking into account the product, manufacturing process and plant history. Until a baseline is developed, plants may utilize the guidelines defined in the Table 6.7.4 for the product target organisms.",null,null,null,null,null,null,null,"P","x"]
["6.7.3.4","Swabbing shall be performed after cleaning, but before sanitizing procedures. If swabs must be taken after sanitizing, proper buffer solutions shall be utilized to prevent inaccurate results.",null,null,null,null,null,null,null,"P","x"]
["6.7.3.5","Individuals performing swabbing shall receive proper training. ",null,null,null,null,null,null,null,"P","x"]
["6.7.3.6","If the equipment is not in use, clean equipment swabs shall be taken prior to the next use of the equipment. Bioluminescence (ATP) testing of swabs or rinses are not a replacement for microbiological swabs, however it is an additional tool that can be used during post-cleaning or pre-operational inspections or for troubleshooting.",null,null,null,null,null,null,null,"P","x"]
["Table 6.7.4 Guidance for Actions Standards for Clean Equipment Swabs",null,null,null,null,null,null,null,null,"P","x"]
["6.7.4","Sample",null,"TVC/ APC",null,"ATP",null,"Coliforms/ Enterobacteriaceae",null,"P","x"]
[null,null,null,"Acceptable","Not acceptable","Acceptable","Not acceptable","Acceptable","Not acceptable","P","x"]
[null,"Clean equipment swabs",null,"≤ 1000 cfu/100cm2","> 1000 cfu/100cm2","Site to specify","Site to specify","≤ 10 cfu/100cm2","> 10 cfu/100cm2","P","x"]
[null,"Rinse water samples",null,"≤ 500 cfu/ml*","> 500 cfu/ml","Site to specify","Site to specify","< 1 cfu/100ml*","≥ 1 cfu/100ml","P","x"]
[null,"* same limit as for direct product contact water",null,null,null,null,null,null,null,"P","x"]
["6.7.5","Clean in Place (CIP)",null,null,null,null,null,null,null,"P","x"]
["6.7.5.1","The following shall be followed when setting up a CIP circuit. CIP systems are recommended for direct product contact surfaces that are to be routinely wet cleaned. Records shall demonstrate that conditions are met to assure adequate cleaning. The CIP documentation shall contain:\n",null,null,null,null,null,null,null,"P","x"]
["a","An index that lists all CIP units in the plant/ department and product circuits and tanks that each unit cleans\n",null,null,null,null,null,null,null,"P","x"]
["b","The CIP program used to clean each circuit shall describe the cleaning steps, time and temperature, the type of cleaner and sanitizer, and the solution strengths\n",null,null,null,null,null,null,null,"P","x"]
["c","Simple schematics of CIP circuits to trouble-shoot and guide personnel in making jumper connections with product tanks, pipes, fittings and equipment",null,null,null,null,null,null,null,"P","x"]
["d","A list of items in each circuit that require dismantling and manual cleaning",null,null,null,null,null,null,null,"P","x"]
["e","A description of automatic controls and interlocks.",null,null,null,null,null,null,null,"P","x"]
["6.7.5.2","The CIP operating requirements shall include, as a minimum:",null,null,null,null,null,null,null,"P","x"]
["a","Defined controls for shared CIP systems for raw and pasteurized/ RTE (ready-to-eat) operations and allergen change-overs",null,null,null,null,null,null,null,"P","x"]
["b","Sequenced cleaning (pasteurized/ RTE system cleaned before the raw side). For new installations, systems shall be separate for RTE and raw line cleaning",null,null,null,null,null,null,null,"P","x"]
["c","In case of any failed CIP cycles, corrective actions shall be documented",null,null,null,null,null,null,null,"P","x"]
["d","A validation and verification of the CIP cleaning shall be performed and documented",null,null,null,null,null,null,null,"P","x"]
["e","A formal, documented re-validation shall be completed every two years for any type of heat exchanger or after any major change (i.e., a change in equipment, line design, ingredients, allergens, cleaning chemical composition or cleaning parameters).",null,null,null,null,null,null,null,"P","x"]
[null,"Validation: typically, a tear down of the lines (dismantling of the line and inspecting key points e.g., valves, connection points) after the cycle to check for cleanliness and debris/ fouling removal. May include microbiological swabbing.",null,null,null,null,null,null,null,"P","x"]
[null,"Verification: can be visual inspection of rinse water (i.e., water is clear), parameters of cycle are satisfactory, microbiological swabs or visual inspection of key points.",null,null,null,null,null,null,null,"P","x"]
["6.7.5.3","The CIP system shall have:",null,null,null,null,null,null,null,"P","x"]
["a","Automatic recording of time, temperature, concentration and flow on the return line",null,null,null,null,null,null,null,"P","x"]
["b","An automatic recording of the supply pump discharge pressure or flow meter",null,null,null,null,null,null,null,"P","x"]
["c","A strainer located after the supply pump or in the return line.",null,null,null,null,null,null,null,"P","x"]
["6.7.5.4","If during a circuit the minimal conditions for temperature, concentration and/ or flow are not met the time shall be paused until acceptable conditions are re-established.",null,null,null,null,null,null,null,"P","x"]
["6.7.5.5","Exceptions to CIP Requirements: Simple cleaning processes (e.g., vat and kettle flushes or line flushes) that may be single pass and designed and operated without return flow or PLC controls are exempt but the process shall be documented and cleaning effectiveness shall be verified and validated.",null,null,null,null,null,null,null,"P","x"]
["6.7.6","Cleaning Out of Place (COP)",null,null,null,null,null,null,null,"P","P"]
["6.7.6.1","COP systems and semi-automated parts washers shall be monitored, verified and validated to demonstrate their cleaning effectiveness as is appropriate to the product and equipment.",null,null,null,null,null,null,null,"P","P"]
["6.7.6.2","If there is a HACCP-controlled kill step or allergen changeover and equipment parts used in raw and other manufacturing areas are cleaned in the same COP unit, the unit itself shall be cleaned and verified between the cleaning of equipment from raw and other manufacturing areas to prevent cross-contamination.",null,null,null,null,null,null,null,"P","x"]
["6.7.6.3","Zone 3 items shall not be cleaned in the same COP tank that is used to clean equipment from zones 1 and 2.",null,null,null,null,null,null,null,"P","P"]

{"sheet":"6.8","index":12,"n_rows":35,"n_cols":4,"rows_kept":35,"cut":false,"hidden":false,"merged":[[0,0,0,1]]}
["CHAPTER 6 – RESOURCE MANAGEMENT",null,"RMAT","Pack"]
[6.8,"Pest Management","P","P"]
["6.8.1","General Program Requirements","P","P"]
["6.8.1.1","Facilities shall have effective pest management programs and pest control practices. The pest management program shall be designed to address the reduction of pest activity as a continuous improvement.","P","P"]
["6.8.1.2","The program shall include an escalation procedure with action limits whose rationale shall be determined and documented for each target pest based on historical pest activity trends, the environment, the type of trap, bait or monitor used and advice from the Pest Control Operator (PCO).","P","P"]
["6.8.1.3","The facility shall implement and document appropriate and effective corrective and preventive actions (CAPA) and root cause analysis (RCA) plans whenever pest activity breaches the action limits for any targeted pest species. This shall be applicable for sporadic and recurring pest activity.","P","P"]
["6.8.1.4","The supplier shall contract the pest control service to a professional pest control company or designate an appropriately trained, competent person to perform the pest control service on site. The PCO may hold membership of recognized industry bodies, and where local regulations require official licenses, these shall be in place. ","P","P"]
["6.8.1.5","The supplier shall include the program in the internal audit plan and track the effectiveness of the program.","P","P"]
["6.8.1.6","The supplier shall take full ownership of the pest control program and shall work in partnership with the PCO to ensure that all these requirements are met. The supplier is fully responsible for ensuring that the program is compliant with the requirements laid down in this SQE Manual.","P","P"]
["6.8.1.7","The supplier shall maintain the facility, building and grounds to prevent pest entry into the facility.","P","P"]
["6.8.1.8","The pest management program shall include:","P","P"]
["a","All pests relevant to the facility, product, environment","P","P"]
["b","Pest management plans, methods, schedules and approved pesticides","P","P"]
["c","Regular inspection reports","P","P"]
["d","An up to date map showing the location of all pest control devices, such as indoor rodent traps, glue boards, insect light traps, outdoor bait stations, and pheromone traps","P","P"]
["e","Pesticide application log, bait and pheromone usage log","P","P"]
["f","Trend analysis for pest activity/ pest activity log","P","P"]
["g","Action limits for each target pest – these shall be reviewed annually with an objective to reduce limits","P","P"]
["h","CAPA for increased trends/ activity for all target pests","P","P"]
["i","Training requirements","P","P"]
["j","KPIs to measure the pest control program","P","P"]
["6.8.1.9","All monitors and control devices shall be kept clean and well maintained and shall not be positioned in a way that attracts pests into the facility. The use and placement of these devices shall be in line with industry best practice and comply with local regulatory requirements.","P","P"]
["6.8.1.10","All monitors and control devices shall be checked at a frequency based on risk and pest history of the facility and the frequency shall be sufficient to identify early signs of pest activity before infestation is established.","P","P"]
["6.8.1.11","The attractant shall be changed at a frequency based on the manufacturers recommendation.","P","P"]
["6.8.2","Pesticides","P","P"]
["6.8.2.1","If pesticides are required, they shall be restricted to trained personal, follow local regulatory legislation, and shall be controlled to avoid the risk of product safety hazards.","P","P"]
["6.8.2.2","Pesticides should be used as a last resort of control and non-chemical methods should be the preferred option.","P","P"]
["6.8.2.3","When using pesticides, the following practices shall be followed:","P","P"]
["a","Application of pesticides shall follow the label instructions and local regulatory legislation","P","P"]
["b","Pesticide lot numbers shall be documented on usage records to assure traceability","P","P"]
["c","Records shall be stored for a defined period in line with local or company requirement","P","P"]
["d","All pesticide labels and Material Safety Data Sheets (MSDS) or equivalent material addressing safety precautions shall be available at the facility where the pesticide is used","P","P"]
["e","All EPA (Environmental Protection Agency) registration numbers, where applicable, shall be maintained and available at the facility where the pesticide is used","P","P"]
["f","Disposal of unused pesticides and of empty pesticide containers shall comply with applicable regulatory requirements","P","P"]
["g","Baits shall be used in situations where a specific pest is the target. Where used, bait shall be placed in secured bait stations (e.g., securely anchored to the ground or building). Throw packs and loose rodenticide baits such as pellets and meals are not permitted, poisons shall not be used internally. Old bait shall be discarded periodically and replaced with fresh bait.","P","P"]

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["CHAPTER 6 – RESOURCE MANAGEMENT",null,null,null,null,null,"RMAT","Pack"]
[6.9,"Hygienic Zoning",null,null,null,null,"P","x"]
["6.9.1","General Program Requirements",null,null,null,null,"P","x"]
["6.9.1.1","Suppliers shall have a Hygienic Zoning program designed to reduce the potential for environmental microbial cross contamination of materials and products. Hygienic Zoning refers to the division of areas of the facility based on barriers, cleaning procedures, employee practices and control of movement of people, equipment and materials and air, necessary to protect products from potential microbiological hazards originating from the manufacturing environment and its surroundings. Hygienic Zoning programs shall focus on ensuring that appropriate controls exist to protect product, raw materials and packaging during their movement from one area to another in a facility, and to protect the processing environment where exposed product and materials might become contaminated from higher risk areas of the factory.",null,null,null,null,"P","x"]
["6.9.1.2","Hygienic Zoning controls shall also focus on the interfaces and movements between areas where the microbial profile changes such as between cooked and raw product.",null,null,null,null,"P","x"]
[null,"Note: Hygienic Zoning is not required for suppliers that handle only raw unprocessed agricultural materials (i.e., raw meat, raw agricultural vegetables).",null,null,null,null,"P","x"]
["6.9.1.3","The importance of Hygienic Zoning programs will vary based on the product type and design of the manufacturing process and process flow. The evaluation shall consider both potential pathogen and spoilage contamination.",null,null,null,null,"P","x"]
["6.9.1.4","The hygienic zoning program shall consist of three parts: assessment, implementation of controls, and evaluation and verification.",null,null,null,null,"P","x"]
["6.9.2","Hygienic Zoning Assessment",null,null,null,null,"P","x"]
["6.9.2.1","The supplier shall carry out a zoning assessment to identify and document potential sources of cross-contamination between processing areas and/ or products (e.g., product handling areas, storage areas, processing areas, raw materials, exposed RTE product). The hygienic zoning areas shall be documented on a map of the facility.",null,null,null,null,"P","x"]
["6.9.2.2","This assessment shall be reviewed and updated in the event of changes to plant layout and the introduction of new lines or processes.",null,null,null,null,"P","x"]
["6.9.2.3","Product, production, air, personnel and vehicle flows shall be organized in such a way to prevent cross contamination of any foreseeable food safety hazards.",null,null,null,null,"P","x"]
["6.9.2.4","The questions detailed in Table 6.9.3 can help in determining where a potential for microbiological cross contamination may exist, to design the plant map indicating the different zones, and for deciding which controls to put in place in transition areas (interfaces/ movements between areas).",null,null,null,null,"P","x"]
["Table 6.9.3 Guidance Questions to Support Hygienic Zoning Assessment",null,null,null,null,null,"P","x"]
["6.9.3",null,"Questions",null,null,null,"P","x"]
[null,"Physical Measures/ Barriers","Is there physical separation between raw product receiving/ storage and other manufacturing areas?\n\n",null,null,null,"P","x"]
[null,null,"Are waste areas physically separated from production areas?",null,null,null,"P","x"]
[null,null,"Are coolers/ warehouses for storing raw ingredients and finished products or packaging supplies physically separated?",null,null,null,"P","x"]
[null,"Traffic Control","Are common elevators, hallways, staging areas etc., between different classes of areas prevented/ adequately controlled?\n\n",null,null,null,"P","x"]
[null,null,"Are traffic patterns of people, trucks, materials, and equipment defined and controlled to prevent cross-contamination?",null,null,null,"P","x"]
[null,null,"Are separate vestibule facilities used as entrance/ exit with coat/ shoe changing measures and hand sanitation in place, where applicable?",null,null,null,"P","x"]
[null,"Infrastructure","Are effluent and wastewater drains coming from product areas with potentially higher contamination risk separated (i.e., no connection between drains in raw and other areas or back-flow prevention installed)?\n",null,null,null,"P","x"]
[null,null,"Is the building designed to prevent water seepage between rooms/ doors noted during sanitation?\n",null,null,null,"P","x"]
[null,null,"Are overhead drains adequately constructed/ protected to prevent product/ area contamination?",null,null,null,"P","x"]
[null,"Utility Controls","Are negative air pressures in place for raw areas when adjacent to process areas?",null,null,null,"P","x"]
[null,null,"Are high control zones under positive air pressures? Are relative humidity levels and levels of air turns/ hour maintained?",null,null,null,"P","x"]
[null,null,"Is air appropriately filtered in all areas?",null,null,null,"P","x"]
[null,null,"Is condensate adequately controlled in processing and storage areas to prevent product contamination?",null,null,null,"P","x"]
[null,"GMP Measures","Are employee uniforms and/ or footwear worn only in the plant?",null,null,null,"P","x"]
[null,null,"Is dedicated clothing (lab coats, aprons, jackets) used in product areas?",null,null,null,"P","x"]
[null,null,"Are clothing restrictions and GMP rules enforced for visitors and outside contractors?",null,null,null,"P","x"]
[null,null,"Are hand wash and sanitizer stations installed and used?",null,null,null,"P","x"]
[null,null,"Are hand sanitizing units available to all employees working with product contact?",null,null,null,"P","x"]
[null,null,"Are sticky mats/ footbaths/ foot washing stations in place and maintained where applicable?",null,null,null,"P","x"]
[null,null,"Are maintenance tools and operator utensils/ tools cleaned and sanitized after usage, or dedicated to one area?",null,null,null,"P","x"]
[null,null,"Are common pipe connections for receiving or unloading of different liquid ingredients avoided?",null,null,null,"P","x"]
["6.9.4","Hygienic Zoning Classifications",null,null,null,null,"P","x"]
["6.9.4.1","Based on the Hygienic Zoning assessment, the different zones of the production facility shall be classified as follows:",null,null,null,null,"P","x"]
["6.9.4.2","Non-manufacturing Zone:\nAreas where there are no exposed raw materials, intermediate or finished products or food contact packaging materials. This includes but is not limited to offices, laboratories, locker rooms, boiler rooms, waste water treatment plants, cafeteria/ break rooms/ smoking areas, toilets, outside areas, utilities, tank farms/ silos/ warehouses (except those containing raw agricultural materials or exposed materials), palletization areas etc.,",null,null,null,null,"P","x"]
["6.9.4.3","Raw Zone:\nAreas receiving, storing or handling or processing raw agricultural products/ material containing raw agricultural products (e.g., raw milk, raw cocoa beans, untreated flour, raw nuts) prior to a validated pathogen reduction step (thermal or other). This includes, but is not limited to:\n• Cocoa bean reception and processing\n• Silos containing raw agricultural materials/ products\n• Raw milk reception and processing\n• Warehouses holding raw agricultural products or ingredients\nThese zones often require the use of dedicated employees and may be physically separated from controlled zone or high control zone.",null,null,null,null,"P","x"]
["6.9.4.4","Controlled Zone:\nAreas containing materials or products of low to medium microbiological sensitivity that are not fully enclosed and therefore are exposed to the environment during routine operation or maintenance.\n• GMP practices are implemented and MDLZ air requirements are met\n• The controlled zone may also serve as transition from non-manufacturing or raw/ limited process zone to high control zone\n• Products of higher sensitivity may be present if they are completely enclosed.",null,null,null,null,"P","x"]
["6.9.4.5","High Control Zone:\nAreas containing products of high microbiological sensitivity that support growth of the pathogen (Salmonella or Listeria monocytogenes) of concern and can be exposed to the environment during routine operation or maintenance.\n• Additional GMP practices, such as captive footwear/ clothing, may be required and more stringent equipment/ building sanitary design requirements are followed\n• When products are exposed, additional production practices, such as prohibiting the use of cardboard, wooden pallets, etc., shall be implemented\n• Positive air pressure versus adjacent zone is required.",null,null,null,null,"P","x"]
["6.9.5","Identification and Implementation of Controls to Prevent Cross Contamination",null,null,null,null,"P","x"]
["6.9.5.1","The supplier may need to introduce or adjust controls such as physical measures or barriers, traffic management, utility controls, GMP measures and sanitation controls. Examples of control measures that should be considered but are not limited to:",null,null,null,null,"P","x"]
["a","The use of closed systems (e.g., closed tanks and pipes)",null,null,null,null,"P","x"]
["b","Structural separation of areas (e.g., separate building, walls), traffic control or and distance separation. If distance between a raw zone and exposed RTE product is used, it should be verified to be effective in the facility Pathogen Environment Monitoring Program (PEM)",null,null,null,null,"P","x"]
["c","Restricted access to microbiology susceptible product areas (applies to employees not working in the area, visitor, etc.,)",null,null,null,null,"P","x"]
["d","Use of a vestibule as entrance and exit with personnel hygiene and changing measures",null,null,null,null,"P","x"]
["e","Use of designated and/ or coded tools and equipment for microbiological susceptible product zoned areas or adequate cleaning programs for tools",null,null,null,null,"P","x"]
["f","Adequate filtration and pressure/ flow of room air",null,null,null,null,"P","x"]
["g","Prevention of entry/ exit from outside directly into the production area",null,null,null,null,"P","x"]
["h","Where non-RTE ingredients are used on shared lines that manufacture RTE ingredients without a further kill step, a defined changeover program is required before production of RTE materials begins.",null,null,null,null,"P","x"]
["6.9.6","Evaluation and Verification of the Hygienic Zoning Program",null,null,null,null,"P","x"]
["6.9.6.1","The supplier shall periodically evaluate the effectiveness and compliance of zoning requirements and also whenever a change occurs to the plant layout, process or product (e.g., new equipment installation, modification or introduction of a new material, moving production lines). The review may include, but is not limited to, environmental testing including pathogen testing, GMP audits, visual checks for product residues in environment/ infrastructure and routine pre-operational and operational inspections. ",null,null,null,null,"P","x"]
["6.9.6.2","Specific evaluation may be required prior to execution of major project works in production areas and unusual events (back flow, flooding, water leaks etc.,). This may include restricting access, diverting traffic flow.",null,null,null,null,"P","x"]
["Note","There are no Packaging Expectations for this section.  ",null,null,null,null,"x","P"]

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["CHAPTER 6 – RESOURCE MANAGEMENT",null,null,null,null,null,null,null,null,"RMAT","Pack"]
[6.1,"Pathogen Environmental Monitoring (PEM)",null,null,null,null,null,null,null,"P","x"]
["6.10.1","General Program Requirements",null,null,null,null,null,null,null,"P","x"]
["6.10.1.1","Suppliers shall have implemented a program for Pathogen Environmental Monitoring (PEM). The PEM program shall verify that the controls put in place during the hygienic zoning assessment are effective at preventing potential cross-contamination between different Hygienic Zones. The rigor of the plant PEM program depends on the product and process hazard evaluation, and the likelihood of pathogen(s) to survive or grow in the material during storage and distribution.",null,null,null,null,null,null,null,"P","x"]
[null,"Note: This requirement does NOT apply to the following raw materials suppliers: Raw milk and raw cream; green coffee beans, roast and ground coffee facilities; compressed gases; raw cereal products; raw nuts/ seeds/ peanuts/ coconut; sugar; oils and fats (except dairy and cocoa); raw meat and raw meat products; food chemicals; commercially sterile food and beverage products – aseptic/ UHT/ retort. Material specific advice on PEM can be requested from your Supplier Quality representative.",null,null,null,null,null,null,null,"P","x"]
["6.10.1.2","The PEM requirement focuses on two specific pathogens, Salmonella spp. and Listeria monocytogenes, as well as indicator organisms (e.g., Listeria spp.) to monitor conditions that could lead to presence of respective pathogens. The PEM program shall:",null,null,null,null,null,null,null,"P","x"]
["a","Enable facilities to detect conditions that may lead to the potential presence of pathogens in controlled zones, high controlled zones and in certain non-manufacturing zones",null,null,null,null,null,null,null,"P","x"]
["b","Enable facilities to conduct investigative sampling when a pathogen harborage area is identified, escalate sampling/ environmental analysis and potential product sampling and testing to assess the effectiveness of their corrective actions and assure sanitary conditions are maintained",null,null,null,null,null,null,null,"P","x"]
["c","Verify the effectiveness of control programs for preventing cross-contamination, including sanitation, GMP, preventive maintenance, and plant traffic controls.",null,null,null,null,null,null,null,"P","x"]
["6.10.2","Monitoring Requirements and Instructions",null,null,null,null,null,null,null,"P","x"]
["6.10.2.1","Requirements and instructions for the plant PEM program shall be documented and include the following:",null,null,null,null,null,null,null,"P","x"]
["a","Target organism(s) and sampling frequencies (refer to Table 6.10.3)",null,null,null,null,null,null,null,"P","x"]
["b","Testing methodology",null,null,null,null,null,null,null,"P","x"]
["c","Applicable products or processes",null,null,null,null,null,null,null,"P","x"]
["d","Sampling site locations which shall include the most critical location and are dependent upon such criteria as the material produced, equipment design, plant structure, traffic patterns, and previous findings",null,null,null,null,null,null,null,"P","x"]
["e","The time frame for taking samples (e.g., shift, midweek, end of week). Routine sampling shall take place during production, at least 3-4 hours after start-up",null,null,null,null,null,null,null,"P","x"]
["f","The time period between sampling and start of analysis shall be kept to a minimum. It is important that repeat routine samples from the same sampling site or for the same purpose are held under consistent conditions (e.g., time, temperature) such that variations between samples are minimized",null,null,null,null,null,null,null,"P","x"]
["g","Samples shall be transported and stored under chilled conditions (>0°C and <10°C) to minimize microbial growth. Samples without transport medium shall be processed within 12 hours. Samples with transport medium shall be processed within 48 hours. Samples shall not dry out",null,null,null,null,null,null,null,"P","x"]
["h","Test result acceptance criteria",null,null,null,null,null,null,null,"P","x"]
["i","Corrective action plans, including increased control procedures and verification requirements",null,null,null,null,null,null,null,"P","x"]
["j","Periodic training of personnel responsible for PEM activities.",null,null,null,null,null,null,null,"P","x"]
["6.10.2.2","The PEM program shall be reviewed periodically or whenever a change occurs to the hygienic zoning program. The PEM review shall be documented.",null,null,null,null,null,null,null,"P","x"]
["Table 6.10.3 PEM Reference Sampling Plans",null,null,null,null,null,null,null,null,"P","x"]
["6.10.3","Product Category",null,"Plan Reference Number","Zone","Salmonella spp.","Minimum Test Frequency","Listeria spp.","Minimum Test Frequency","P","x"]
[null,"Products consumed without further processing: Supporting Listeria growth (wet, chilled environments)",null,"A1","Zone 1","N/A","N/A","Yes","Weekly","P","x"]
[null,null,null,null,"Zone 2","N/A","N/A","Yes","Weekly","P","x"]
[null,null,null,null,"Zone 3","N/A","N/A","Yes","Weekly","P","x"]
[null,null,null,null,"Zone 4","N/A","N/A","Yes","Monthly","P","x"]
[null,"Products consumed without further processing: Listeria-static or Salmonella survival\nProducts consumed without further processing: Frozen",null,"A2","Zone 1","N/A","N/A","Yes2","Weekly","P","x"]
[null,null,null,null,"Zone 2","Yes1","Weekly","Yes","Weekly","P","x"]
[null,null,null,null,"Zone 3","Yes1","Weekly","Yes","Weekly","P","x"]
[null,null,null,null,"Zone 4","Yes1","Monthly","Yes","Monthly","P","x"]
[null,"Non-RTE Frozen",null,"A3","Zone 1","N/A","N/A","N/A","N/A","P","x"]
[null,null,null,null,"Zone 2","Yes","Monthly","Yes","Monthly","P","x"]
[null,null,null,null,"Zone 3","Yes","Monthly","Yes","Monthly","P","x"]
[null,null,null,null,"Zone 4","Yes","Monthly","Yes","Monthly","P","x"]
[null,"Products consumed without further processing: Low to Medium Moisture (water activity <0.85)",null,"B","Zone 1","N/A","N/A","N/A","N/A","P","x"]
[null,null,null,null,"Zone 2","Yes","Weekly","N/A","N/A","P","x"]
[null,null,null,null,"Zone 3","Yes","Weekly","Yes3","Weekly","P","x"]
[null,null,null,null,"Zone 4","Yes","Monthly","Yes3","Monthly","P","x"]
[null,"Products consumed without further processing: Ambient\nNo/ Low pathogen history\nMonitor hygiene of controlled areas",null,"I","Zone 1","N/A","N/A","N/A","N/A","P","x"]
[null,null,null,null,"Zone 2","Yes","Monthly","Yes3","Monthly","P","x"]
[null,null,null,null,"Zone 3","Yes","Monthly","Yes3","Monthly","P","x"]
[null,null,null,null,"Zone 4","Yes","Quarterly","Yes3","Quarterly","P","x"]
[null,"Hot fill/ Ultraclean filler\nValidated Sal-cidal or L. spp-cidal",null,"C","Zone 1","N/A","N/A","N/A","N/A","P","x"]
[null,null,null,null,"Zone 2","Yes","Quarterly","Yes","Quarterly","P","x"]
[null,null,null,null,"Zone 3","Yes","Quarterly","Yes","Quarterly","P","x"]
[null,null,null,null,"Zone 4","Yes","Quarterly","Yes","Quarterly","P","x"]
[null,"1 For cheese ONLY, optional indicator organisms (Enterobacteriaceae or coliforms) can be used as an alternative to Salmonella\n2 For cheese and RTE Desserts ONLY, optional indicator organisms (Enterobacteriaceae or coliforms) can be used as an alternative to Listeria spp.\n3 Listeria spp. testing is applicable for the product manufacturing plants in the United States of America (USA) and plants manufacturing finished, semi-finished products for inclusion in products for export to the USA. Testing should be implemented only in wet areas of the plant (Controlled Zone)",null,null,null,null,null,null,null,"P","x"]
["6.10.4","Sampling Locations",null,null,null,null,null,null,null,"P","x"]
["6.10.4.1","Site specific sampling locations shall be selected to identify potential harborage and niche sites, and the potential migration of pathogen(s) between zones. The sampling locations are identified as four different types of zones:",null,null,null,null,null,null,null,"P","x"]
["6.10.4.2","Zone 1: Sites that are direct or indirect product contact surfaces. Direct product contact surfaces are surfaces exposed to product during normal equipment operation. Indirect product contact surfaces are surfaces from which liquids or dust or other material may drain, drop, diffuse, or be drawn into the product or into the container, and surfaces that touch product contact surfaces or the container. Examples include but are not limited to: conveyor surfaces and product chutes, pipeline interior and storage fill hoppers, nozzles, formers, cut and wrap equipment, product scrapers/ utensils, product contact gloved hands, etc. Product must be placed on hold should samples be taken in Zone 1.",null,null,null,null,null,null,null,"P","x"]
["6.10.4.3","Zone 2: Sites that are environmental surfaces immediately adjacent to product-contact surfaces. All surfaces close to product contact surfaces that under normal operating procedures do not directly contact the product or the product contact surfaces of the container, including the exterior of processing equipment. Examples include but are not limited to: non-product contact gloves, equipment supports, frames, outside of tunnels, outside of enclosed filling cabinets or below filling equipment, control panels, weight scales, motor housings, scrap carts, etc.,",null,null,null,null,null,null,null,"P","x"]
["6.10.4.4","Zone 3: Sites that are non-product contact; environmental surfaces within the processing room that are more remote from product contact surfaces. Examples include but are not limited to: hand trucks, forklifts, walls, drains, floors, equipment legs, ductwork, ceilings, fork truck and cart wheels, tools, brooms, squeegees, floor scrubbers, from vacuum collection points (except vacuum used for Zone 1 collection), trash cans/ waste bins, traffic pathways into process area, ceiling drain pipes, wall/ floor junctures, wash stations, ingredient storage areas, etc.,",null,null,null,null,null,null,null,"P","x"]
["6.10.4.5","Zone 4: Sites that are remote from product contact surfaces outside the processing room but could impact processing areas through the movement of people, equipment or materials. Examples include but are not limited to: warehouses, hallways, break areas, locker rooms, mechanical rooms, offices, cafeteria, restrooms, coolers, floors, wheeled vehicles and materials, and trash/ recycle collection areas.",null,null,null,null,null,null,null,"P","x"]
["6.10.4.6","Further sampling requirements and guidance:",null,null,null,null,null,null,null,"P","x"]
["a","Sampling locations typically do not include raw, unprocessed products and raw processing areas e.g., raw meat, poultry, vegetables, fish, and unpasteurized milk and cream. However, the sampling of transition zones/ interfaces between Raw Zones, Controlled Zones and High Control Zones may be useful to verify the effectiveness of zoning controls",null,null,null,null,null,null,null,"P","x"]
["b","Floor drains located in relevant areas shall be included in any sampling plan",null,null,null,null,null,null,null,"P","x"]
["c","Large surface areas shall be sampled for qualitative analyses. A sponge is more effective for sampling large surface areas. For smaller hard to access or irregular shaped areas, a cotton swab is more effective",null,null,null,null,null,null,null,"P","x"]
["d","The number of sampling locations for each zone shall be in accordance to the complexity of the site",null,null,null,null,null,null,null,"P","x"]
["e","Once data on individual locations are available, pooling of samples may be considered. Samples within the same zone may be pooled with up to five sample points in one sample after pre-enrichment. Samples taken from floor contact areas (e.g., floor, steps, wheels) may be pooled only with other floor contact areas within the same zone. Note: “pooling” refers to individual pre-enrichments pooled together for detection. Compositing of samples (i.e., combining of test samples prior pre-enrichment) is only allowed when data are available that the sensitivity/ detection limit will not be impacted by that practice",null,null,null,null,null,null,null,"P","x"]
["f","Sample site locations should be changed on a periodic basis. The sites should be selected based on the potential to harbor pathogens",null,null,null,null,null,null,null,"P","x"]
["g","The plant team may develop a list of sites that could be sampled in rotation and be completely covered in a given timeframe, for example, monthly or quarterly. It is recommended that routine sampling should be varied to represent the entire production schedule (e.g., 2nd or 3rd shift, and different week days).",null,null,null,null,null,null,null,"P","x"]
["6.10.5","Sampling Plans and Results",null,null,null,null,null,null,null,"P","x"]
["6.10.5.1","The Table 6.10.3 specifies the PEM zones, organisms, and minimum test frequency for each type of product. For materials not specified in table, the PEM plan shall be agreed with MDLZ Food Safety. Please also note this frequency refers to the specific production area, not the frequency of sampling of each individual site specified in the plant PEM program. Collation and trending of PEM results is required.",null,null,null,null,null,null,null,"P","x"]
["6.10.5.2","In the event of a pathogen positive finding (e.g., Salmonella or Listeria monocytogenes), the MDLZ Contracting Representative shall be immediately notified, even if the specific lot is not sent to MDLZ, as described in Section 5.1.1. When sampling Zone 1 for non-pathogens (Listeria spp.), it is not necessary to place product on hold unless directed by a government or regional regulatory authority.",null,null,null,null,null,null,null,"P","x"]
["6.10.5.3","Whenever product contact surfaces (Zone 1) are tested for pathogens, affected product lots shall be placed on Hold pending the test results (see Section 8.4 Hold & Release).",null,null,null,null,null,null,null,"P","x"]
["6.10.5.4","Laboratories shall comply with requirements described on Section 8.2 Testing Controls.",null,null,null,null,null,null,null,"P","x"]
["6.10.6","Corrective Action Plans",null,null,null,null,null,null,null,"P","x"]
["6.10.6.1","In the event of a pathogen-positive result the supplier shall conduct an investigation to identify the source, root cause and document all corrective actions. If multiple sites were composited (pooled), then re-sample after a positive to find the single positive site. Corrective action plans shall be initiated as soon as practically feasible. Corrective action may include improved cleaning or sanitation, redesign of the structure or equipment, improved GMPs, redefined traffic patterns, etc.,",null,null,null,null,null,null,null,"P","x"]
["6.10.6.2","The implicated and specific test site locations shall be re-evaluated to verify the effectiveness of corrective actions. A minimum of three consecutive negatives or in-standard results shall be achieved prior to returning to the routine testing and sampling schedule.",null,null,null,null,null,null,null,"P","x"]
["6.10.6.3","The three samples shall be taken consecutively following the receipt of the previous sample result (i.e., when the first result is received the second sample shall be taken). This shall be completed within a 3-week timeframe. Trend analysis of positive findings shall be made in order to detect areas of concern.",null,null,null,null,null,null,null,"P","x"]
["Table 6.10.7 PEM Guidance for Indicator Organisms",null,null,null,null,null,null,null,null,"P","x"]
["6.10.7","Zone","Coliform/ Enterobacteriaceae (cfu/100cm2)",null,null,"E. coli (cfu/100cm2)",null,null,null,"P","x"]
[null,1,"< 10",null,null,"< 10",null,null,null,"P","x"]
[null,2,"<20",null,null,"< 10",null,null,null,"P","x"]
[null,3,"< 100",null,null,"< 10",null,null,null,"P","x"]
["Note","There are no Packaging Expectations for this section.  ",null,null,null,null,null,null,null,"x","P"]

{"sheet":"6.11","index":15,"n_rows":31,"n_cols":6,"rows_kept":31,"cut":false,"hidden":false,"merged":[[13,0,29,0],[13,2,13,3],[17,2,17,3],[27,2,27,3],[29,2,29,3],[16,2,16,3],[13,1,16,1],[20,2,20,3],[24,2,24,3],[21,2,21,3],[22,2,22,3],[23,2,23,3],[14,2,14,3],[15,2,15,3],[18,2,18,3],[19,2,19,3],[0,0,0,3],[2,1,2,3],[12,0,12,3],[6,1,6,3],[7,1,7,3],[8,1,8,3],[9,1,9,3],[10,1,10,3],[11,1,11,3],[30,1,30,3],[1,1,1,3],[3,1,3,3],[4,1,4,3],[5,1,5,3],[17,1,26,1],[28,2,28,3],[27,1,28,1],[26,2,26,3],[25,2,25,3]]}
["CHAPTER 6 – RESOURCE MANAGEMENT",null,null,null,"RMAT","Pack"]
[6.11,"Food Defense",null,null,"P","x"]
["6.11.1","General Program Requirements",null,null,"P","x"]
["6.11.1.1","Suppliers shall develop specific procedures to secure their product, to deter and prevent intentional contamination, and shall have protocols in place to quickly and accurately identify, respond to and contain threats or acts of intentional contamination. The program shall cover the supply chain including warehousing and transportation Likewise, suppliers shall ensure their suppliers adopt similar protocols and implement appropriate controls. At MDLZ we call these efforts Food Defense.",null,null,"P","x"]
["6.11.1.2","The laws and government expectations regarding Food Defense vary from country to country. In order to achieve a common standard that is industry recognized worldwide and simple to manage and maintain, MDLZ accepts audit schemes that complies with the current version of PAS 96. A current list of GFSI accepted certifications for ingredients can be obtained at www.mygfsi.com.",null,null,"P","x"]
["6.11.1.3","US-based suppliers, and international suppliers shipping direct materials into the United States, are expected to meet the requirements below and be prepared to provide confirmation to MDLZ that they have met all these requirements:",null,null,"P","x"]
["a","Adopt and maintain a facility Food Defense program (outlined above)",null,null,"P","x"]
["b","One-Up-One-Down records maintenance. Maintain records to identify the immediate previous source of food or ingredient received and the immediate subsequent recipient of food or ingredient shipped",null,null,"P","x"]
["c","Detained product. Ensure detained product is held as directed by MDLZ",null,null,"P","x"]
["d","Meet C-TPAT Import Security Criteria if making shipments to the US which originate elsewhere",null,null,"P","x"]
["e","Compliance with FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration",null,null,"P","x"]
[null,"Suppliers may check MDLZ Supplier Information Center to obtain additional guidance and information.",null,null,"P","x"]
["Table 6.11.2 Public and Government Websites to Assist with Food Defense Program Development",null,null,null,"P","x"]
["6.11.2","Customs-Trade Partnership Against Terrorism (C-TPAT)","C-TPAT Cargo Security CTPAT: Customs Trade Partnership Against Terrorism | U.S. Customs and Border Protection (cbp.gov)",null,"P","x"]
[null,null,"CTPAT Importer Security Importer Security Filing '10+2' | U.S. Customs and Border Protection (cbp.gov)",null,"P","x"]
[null,null,"CTPAT 10",null,"P","x"]
[null,null,"CTPAT 17 point Inspection Sample CTPAT Job Aid - 17-Point Inspection Checklist Sample - October 2021 (cbp.gov)",null,"P","x"]
[null,"Food and Drug Administration (FDA)","Food Safety Modernization Act (FSMA) Food Safety Modernization Act (FSMA) | FDA",null,"P","x"]
[null,null,"FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration | FDA",null,"P","x"]
[null,null,"FDA Food Defense Portal: Food Defense | FDA",null,"P","x"]
[null,null,"FDA Food Defense Training: Food Defense Training & Education | FDA",null,"P","x"]
[null,null,"Food Defense Awareness Training for Front Line Employees: U.S. FDA Food Defense Awareness Training",null,"P","x"]
[null,null,"FDA Food Defense Guidelines and Regulations, Food Defense Guidance Documents & Regulatory Information | FDA",null,"P","x"]
[null,null,"Reportable Food Registry Section 417 of the FDCA. Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 | FDA",null,"P","x"]
[null,null,"21 CFR 1-199, CFR - Code of Federal Regulations Title 21 (fda.gov)",null,"P","x"]
[null,null,"42 CFR 73, CFR :: 42 CFR Part 73 -- Select Agents and Toxins",null,"P","x"]
[null,null,"FDA Food Defense Vulnerability Assessments and Key Activity Types Vulnerability Assessments | FDA",null,"P","x"]
[null,"Department of Homeland Security (DHS)","CBP – Customs-Trade Partnership Against Terrorism Security Criteria CTPAT Minimum Security Criteria | U.S. Customs and Border Protection (cbp.gov)",null,"P","x"]
[null,null,"DHS Role in Food Defense and Critical Infrastructure Protection DHS' Roles in Food in Defense and Critical Infrastructure Protection, OIG-07-33",null,"P","x"]
[null,"Publicly Available Standard (PAS96)","Guide to protecting and defending food and drink from deliberate attack pas962017 (food.gov.uk)",null,"P","x"]
["Note","There are no Packaging Expectations for this section.  ",null,null,"x","P"]

{"sheet":"6.12","index":16,"n_rows":8,"n_cols":4,"rows_kept":8,"cut":false,"hidden":false,"merged":[[0,0,0,1]]}
["CHAPTER 6 – RESOURCE MANAGEMENT",null,"RMAT","Pack"]
[6.12,"Product Authenticity","P","P"]
["6.12.1","General Program Requirements","P","P"]
["6.12.1.1","The supplier shall have systems in place to minimize the risk of procuring fraudulent or adulterated raw materials and to ensure that all product descriptions and claims are legal, accurate and verified.","P","P"]
["6.12.1.2","Personnel engaged in vulnerability assessments shall understand potential fraud risks. This should include knowledge of the materials and process on site as well as the principles of vulnerability assessment.","P","P"]
["6.12.1.3","The supplier shall have access to information for both developing and historical threats. This may come from a variety of sources such as trade associations, government sources or publications.","P","P"]
["6.12.1.4","A vulnerability assessment shall be completed and documented on all raw materials (including but not limited to food/ feed, food/ feed ingredients, food/ feed packaging) which assesses the potential risk of economically motivated fraud including  dilution, substitution, mislabeling, concealment. The assessment shall have a defined periodical review to reflect any market intelligence which may change or affect the risk.","P","P"]
["6.12.1.5","Based on the output of the vulnerability assessment, the supplier shall have a control plan to manage the identified risks. This may be in the form of, but not limited to, targeted and non-targeted testing, traceability exercises including mass balance, supply chain mapping exercises and audits.","P","P"]

{"sheet":"7.1","index":17,"n_rows":114,"n_cols":6,"rows_kept":114,"cut":false,"hidden":false,"merged":[[90,2,91,2],[92,1,94,1],[102,2,105,2],[109,1,111,1],[109,2,111,2],[95,1,97,1],[95,2,97,2],[98,1,101,1],[98,2,101,2],[92,2,94,2],[73,1,73,3],[74,1,74,3],[75,1,75,3],[76,1,76,3],[86,1,87,1],[77,1,77,3],[78,1,78,3],[81,2,83,2],[79,0,79,3],[80,0,113,0],[112,1,113,1],[112,2,113,2],[81,1,83,1],[84,1,85,1],[102,1,105,1],[90,1,91,1],[71,1,71,3],[72,1,72,3],[49,1,49,3],[64,1,64,3],[66,1,66,3],[56,1,56,3],[53,1,53,3],[63,1,63,3],[52,1,52,3],[62,1,62,3],[61,0,61,3],[57,1,57,3],[60,1,60,3],[59,1,59,3],[54,1,54,3],[70,1,70,3],[0,0,0,3],[1,1,1,3],[3,1,3,3],[5,1,5,3],[6,1,6,3],[2,1,2,3],[4,1,4,3],[7,1,7,3],[9,1,9,3],[8,1,8,3],[10,1,10,3],[11,1,11,3],[12,1,12,3],[13,1,13,3],[14,1,14,3],[15,1,15,3],[47,1,47,3],[16,1,16,3],[25,0,25,3],[26,0,47,0],[17,1,17,3],[18,1,18,3],[21,1,21,3],[24,1,24,3],[19,1,19,3],[20,1,20,3],[23,1,23,3],[22,1,22,3],[65,1,65,3],[67,1,67,3],[68,1,68,3],[69,1,69,3],[48,1,48,3],[51,1,51,3],[55,1,55,3],[50,1,50,3],[58,1,58,3]]}
["CHAPTER 7 – PRODUCTION PROCESS CONTROLS",null,null,null,"RMAT","Pack"]
[7.1,"Specification Compliance and Contaminants Control",null,null,"P","P"]
["7.1.1","Specification",null,null,"P","P"]
["7.1.1.1","Upon request, the MDLZ supplier shall complete the Food Safety Supplier Questionnaire (FSSQ). Additionally, the supplier shall complete the MDLZ Ingredient Supplier Questionnaire (ISQ) within the expected time period of 10 business days, unless otherwise agreed. This applies to new ingredients for production or plant trial, or changes to existing ingredients. MDLZ shall then create or update the MDLZ Ingredient Specification should the data be acceptable.",null,null,"P","x"]
["7.1.1.2","Upon request, the MDLZ supplier shall complete the Packaging Supplier Questionnaire (PSQ) within the expected time period of 10 business days, unless otherwise agreed. This applies to new packaging materials for production or plant trial, or changes to existing packaging materials. MDLZ shall then create or update the MDLZ Packaging Specification should the data be acceptable.",null,null,"x","P"]
["7.1.1.3","Once the ingredient Specification is approved by MDLZ, a Supplier Acknowledgement Request (SAR) along with the Ingredient Supplier Specification Report will be sent to the supplier.",null,null,"P","x"]
["7.1.1.4","For packaging, the supplying site shall have the latest Specification available.",null,null,"x","P"]
["7.1.1.5","The supplier shall ensure that MDLZ Specifications are implemented at the supplier’s production location and that appropriate plant personnel have access to the latest Specifications for materials supplied to MDLZ. Specific testing methods are described in the Specifications. If the supplier uses a different method for analysis of parameters reported on the Certificate of Analysis (CoA), approval shall be requested from MDLZ. A validation/ correlation study shall have been performed in order to guarantee an equivalent output. The supplier is required to perform a validation/ correlation study to guarantee the supplier's method is equivalent to the MDLZ reference method and submit for approval. In case of any disputes, the testing method described in the Specification is applied to achieve a final conclusion.",null,null,"P","P"]
["7.1.1.6","The supplier shall deliver materials that meet MDLZ Specifications. If the supplier anticipates that it will not be able to meet the Specification, the MDLZ Contracting Representative shall be notified immediately (see Section 5.1.1).",null,null,"P","P"]
["7.1.1.7","Suppliers of ingredients and primary packaging materials that will be used in the manufacture or sale of products by MDLZ shall conform to local rules and regulations.",null,null,"P","P"]
["7.1.2","Certificate of Analysis (CoA)",null,null,"P","P"]
["7.1.2.1","Where a CoA is required, this shall be provided to MDLZ prior to acceptance of the material at MDLZ locations. CoAs shall be written in local language of the receiving MDLZ plant or in English. For the CoA, the bolded information shall be mandatory and the plain text is optional:  ",null,null,"P","P"]
["a","Supplier Name and manufacturing location, contact details",null,null,"P","P"]
["b","Material name, lot identity, production date and MDLZ identification number",null,null,"P","P"]
["c","Supplier purchase order number",null,null,"P","P"]
["d","MDLZ Specification number (or purchase agreement) and issue date",null,null,"P","P"]
["e","Test results for each lot, including MDLZ Specification and other parameters if required by local or national requirements",null,null,"P","P"]
["f","Parameter being tested, test method, sampling plan and for microbiological samples, the sample size",null,null,"P","P"]
["g","Laboratory name and location performing testing, or other information to identify the laboratory.",null,null,"P","P"]
["7.1.3","Certificate of Analysis for Pathogens",null,null,"P","x"]
["7.1.3.1","In cases where the MDLZ Specifications require pathogen analyses on the material that will be delivered to MDLZ plants, the samples shall be collected across the lot according to a statistical sampling plan as defined in the MDLZ Specification, and the sample(s) taken shall be representative of the lot received by MDLZ. The test shall be performed by a laboratory approved by MDLZ (see Section 8.2 Testing Controls: Laboratory Requirements). The CoA shall be provided to MDLZ and shall include the requirements specified in section 7.1.1. ",null,null,"P","x"]
[null,"Note: The pathogen CoA may be either the original copy, or the pathogen results may be transferred to a separate document, with all other analytical parameters. The original CoA shall be retained by the supplier.",null,null,"P","x"]
["7.1.3.2","MDLZ reserves the right to sample each delivery and to determine the appropriate disposition. If target pathogen(s) is detected in the lot or in similar products produced on the same line, prompt corrective action steps shall be taken and MDLZ shall be immediately notified according to Section 5.1.1, even if the specific lot is not sent to MDLZ.",null,null,"P","x"]
["7.1.3.3","For materials/ suppliers that require sampling as part of the MDLZ CoA Verification program, samples shall be taken against the agreed protocol and sent to the MDLZ approved laboratory. The material shall not be released/ shipped to MDLZ until acceptable results have been obtained. Where this is not possible, and it is necessary to ship materials pending results, this shall be agreed with the MDLZ Contracting Representative. The material shall not be unloaded at the receiving site until acceptable results are confirmed.",null,null,"P","x"]
["7.1.3.4","MDLZ has a Microbiologically Sensitive Ingredient list, these materials require pathogen analysis. See Table 7.1.4.",null,null,"P","x"]
["Table 7.1.4 Sensitive Ingredients",null,null,null,"P","x"]
["7.1.4","Biologically Sensitive Ingredient Category","Category includes (but not limited to)","Exclusions for vegetative pathogens (only those listed)","P","x"]
[null,"Milk/ dairy products","Proteins e.g.. caseinates, dulce de leche (liquid caramel)","Lactose, ultraclean filled sweetened condensed milk","P","x"]
[null,"Starter media","-","Starter cultures","P","x"]
[null,"Yeast/ yeast extracts","-","-","P","x"]
[null,"Enzymes/ rennets","-","Microbial origin","P","x"]
[null,"Meat/ fish/ poultry/ seafood","-","-","P","x"]
[null,"Eggs/ Egg products","-","-","P","x"]
[null,"Soy products","Soy flour (all types), Soy lecithin","Soy sauce (liquid and dehydrated)","P","x"]
[null,"Fruits/ fruit Products","-","Candied fruit, fruit in alcohol, jams/ jellies","P","x"]
[null,"Spices/ herbs","Flavors/ enhancers made from spices/ herbs ","Extracts (e.g., alcohol/ solvent based), e.g., oleoresins","P","x"]
[null,"Tea","Instant teas","Grain tea","P","x"]
[null,"Coconut","-","-","P","x"]
[null,"Vegetables/ vegetable products","Mushrooms, hydrolyzed vegetable proteins (HVP), liquorice root","Brined vegetables (high acid/ high salt), liquorice extracts","P","x"]
[null,"Seeds/ seed products","Sesame seed paste (tahini)","-","P","x"]
[null,"Grains/ grain products","Grinded grains, including all flour, powdered malt extract, pasta, gluten, native wheat starch, native rice starch, heat extruded, e.g., corn flakes, rice crisps","Other (modified) starch","P","x"]
[null,"Cocoa products","Pure pressed cocoa butter","-","P","x"]
[null,"Natural gums/ thickeners","Gelatine","Microbial origin (e.g., xanthan gum), pectin, agar, micro reticulated cellulose","P","x"]
[null,"Green coffee beans","-","-","P","x"]
[null,"Nuts/ nut products","Nut pastes, marzipan","-","P","x"]
[null,"Flavors","With sensitive carrier (e.g., gum arabic) or other components that are regarded as sensitive","Containing (w/w) (applicable to flavor and its sensitive ingredients) >10% ethanol, >30% propylenglycol, >80% triacetin, >2% benzyl alcohol, or essential oils as main carrier, or flavoring substances*","P","x"]
[null,"Talc and calcium carbonate (lime)","-","Except if Food Safety approved the thermal process","P","x"]
[null,"* “flavoring substances” as defined by European Flavoring Directive 1334/2008/EEC ",null,null,"P","x"]
["7.1.5","Chemical Contaminants and Adulteration",null,null,"P","P"]
["7.1.5.1","MDLZ sets numerical limits for certain chemical contaminants and residues (\"Food Safety Limits\") following a science-based risk assessment. The ingredient shall comply with all applicable laws of the MDLZ receiving sites. Additional requirements may be set in the Specification. The MDLZ Food Safety Limits given in the Specification apply in the absence of a regulation, or when the regulatory limits are less strict, see Figure 7.1.6. ",null,null,"P","P"]
["7.1.5.2","The MDLZ Food Safety Limits given in the Specification apply in the absence of a regulation, or when the regulatory limits are less strict, see Figure 7.1.6. If there is no regulation, the appropriate Codex Alimentarius Standard shall be met for all hazards for which there is no MDLZ Food Safety Limit. ",null,null,"P","P"]
["7.1.5.3","The following Codex Alimentarius Standards apply",null,null,"P","x"]
["a","CXS 193-1995: General Standard for Contaminants and Toxins in Food and Feed (in its latest version)",null,null,"P","x"]
["b","CXM 2: Maximum Residue Limits (MRLs) and Risk Management Recommendations (RMRs) for Residues of Veterinary Drugs in Foods (in its latest version)",null,null,"P","x"]
["c","Pesticide residue limits as set by the Codex Alimentarius Commission (CAC/MRL)",null,null,"P","x"]
["d","CXS 192-1995: General Standard for Food Additives",null,null,"P","x"]
["7.1.5.4","MDLZ requires that some specific incoming raw materials and packaging materials be part of the chemical contaminants testing program and/ or food fraud scanning (Materials Monitoring Program (MMP)). This is a due diligence program designed to check for potential contaminants and/ or adulteration across the supply chain by verifying that materials meet MDLZ Specifications and comply with applicable regulatory requirements. Testing may be used during new supplier/ site qualification prior to site approval.",null,null,"P","P"]
["7.1.5.5","MDLZ shall select the materials to be included in the program based on their MDLZ risk profile. The suppliers selected to submit materials for testing shall receive further communication from MDLZ detailing material(s) selected for testing, sample submittal date and shipping protocol. Suppliers shall submit samples representative of the specified materials to a designated MDLZ approved laboratory for analytical chemical testing. Test results shall be communicated to Suppliers directly by MDLZ or by the testing lab, on behalf of MDLZ.",null,null,"P","P"]
["7.1.5.6","Suppliers' contaminants testing programs can be used as a supplement or replacement of 7.1.5.5 with agreement from the chemical contaminants program owner.",null,null,"P","P"]
["7.1.5.7","The supplier shall implement internal contaminant monitoring programs to monitor for chemical hazards appropriate to the materials manufactured and related to industry risk prevalence and regulatory requirements. In addition to regulatory requirements, at a minimum, the supplier’s contaminant monitoring program shall include all contaminants on the MDLZ contaminants target list (refer to the Supplier Information Center) and contaminants included in MDLZ Specifications.",null,null,"P","P"]
["7.1.5.8","Suppliers shall place the material unique lot on hold and NOT ship to MDLZ until clearance has been given confirming the material complies with the Specification.",null,null,"P","P"]
["Figure 7.1.6 Chemical Contaminants Limits Decision Tree for Ingredients",null,null,null,"P","x"]
["7.1.6",null,null,null,"P","x"]
["7.1.7","Residual Solvents",null,null,"x","P"]
["7.1.7.1","The total residual solvents in printed and converted materials shall be kept as low as possible. \nAromatic compounds (e.g., toluene, xylene) shall not be part of the formulation added to packaging materials during the production, printing or cleaning processes. However, traces below 0.5 mg/m² are considered ‘aromatic’ free. The total amount of residual solvent shall not exceed 20 mg/m2 material or lower if local regulations are more stringent., thereof ketones and esters maximum 7 mg/m2 material or lower if local regulations are more stringent (e.g., ethyl acetate).",null,null,"x","P"]
["7.1.8","Packaging Material Ingredients and Processing Aids Derived from Allergenic and Genetically Modified Sources",null,null,"x","P"]
["7.1.8.1","Materials derived from allergenic and genetically modified sources shall not be used (exception: oils derived from allergenic sources which have been refined, bleached and deodorized are allowed). ",null,null,"x","P"]
["7.1.8.2","MDLZ shall be notified about the use of rubber-based natural latex used in adhesives or other indirect potential contact applications and about the use of any materials derived from Genetically Modified (GM) sources.",null,null,"x","P"]
["7.1.9","Active and Intelligent Packaging",null,null,"x","P"]
["7.1.9.1","MDLZ shall be notified of the delivery of any active or intelligent packaging articles intended to come into contact with food. Such materials shall be accompanied by a DoC according to EU Commission Regulation 450/2009",null,null,"x","P"]
["7.1.10","Other Requirements",null,null,"x","P"]
["7.1.10.1","The supplier shall certify for all packaging materials, that heavy metals are not introduced into MDLZ packages or packaging components. The supplier shall furnish a Heavy Metals Warranty to MDLZ prior to purchase of materials.",null,null,"x","P"]
["7.1.10.2","The supplier shall certify that packaging materials supplied to MDLZ or used for any MDLZ labeled products do not contain more than a combined total of 100 ppm by weight of the following heavy metals from any source: lead, mercury, cadmium and hexavalent chromium.",null,null,"x","P"]
["7.1.10.3","The supplier must conduct periodic monitoring of materials (including adhesives, labels, inks, dyes and stabilizers) to assure compliance with this policy. The materials shall be free from substances that are carcinogenic, mutagenic or reprotoxic (CMR substances) and substances classified as toxic. All materials delivered to MDLZ shall not contain substances with H statements H300, H301, H310, H311, H330, H331, H340, H350, H360, H370, H372.",null,null,"x","P"]
["7.1.10.4","MDLZ requires compliance with REACH Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) for all packaging items that are preparations or articles containing substances to which the REACH obligations relate. MDLZ does not permit any substances of very high concern (SVHC) above 0.1% and shall receive an early warning if packaging composition is going to change due to discontinuation of substances or restrictions.",null,null,"x","P"]
["7.1.10.5","The use of bisphenol A, PFAS and phthalates in food packaging shall be avoided or if not possible, MDLZ shall be notified.",null,null,"x","P"]
["7.1.10.6","MDLZ restricts or excludes certain substances in certain food contact materials in its Specifications.",null,null,"x","P"]
["7.1.10.7","Table 7.1.11 provides a list of packaging Regulations, Codes of Practices, and Standards. The list is a reference and is not all-inclusive.",null,null,"x","P"]
["7.1.10.8","Note: Any reference made to an EC Directive or Regulation should be understood to include all subsequent amendments and/or other new Directives which revoke or repeal the existing one.",null,null,"x","P"]
["Table 7.1.11 List of Packaging Regulations, Codes of Practices and Standards",null,null,null,"x","P"]
["7.1.11","Packaging Material/ Criteria","Specific U.S. Regulations 21 CFR Food & Drugs (includes method)","Specific Regulations E.U., national legislations, guidelines and methods","x","P"]
[null,"Food contact material in general","21 C.F.R. §§ 174.5 to 174.6 - Indirect Food Additives: General","EC-Regulation No 1935/2004","x","P"]
[null,null,null,"Commission Regulation 2023/2006 – GMP on materials and articles intended to come into contact with food.","x","P"]
[null,null,null,"Migration test conditions according to Plastics Implementing Measure (PIM) EU 10/2011 Plastic Materials and Articles Intended to Come into Contact with Foodstuffs","x","P"]
[null,"Organoleptically properties of packaging material","MDLZ requirement only; no specific regulation","EC-Regulation No 1935/2004","x","P"]
[null,null,"ASTM methods:\n•E460 Practice for Determining Effect of Packaging on Food and Beverage Products During Storage\n•E619 Practice for Evaluating Foreign Odors in Paper Packaging\n•E1870-04 Standard Test Method for Odor and Taste Transfer from Polymeric Packaging Film","Methods for paper & board:\n•EN 1230 –1 Odor evaluation\n•EN 1230 –2 Taint transfer test (“Robinson test”)\n•ISO13302 Methods to assess modifications to the flavor of foodstuffs due to packaging","x","P"]
[null,"Plastics, Laminates","21 C.F.R. §§ 177.1010 to 177.2910 - Indirect Food Additives: Polymers","Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with foodstuffs","x","P"]
[null,null,"21 C.F.R. §§ 178.1005 to 178.3950 – Indirect food additives: adjuvants, productions aids and sanitizers",null,"x","P"]
[null,"Regenerated Cellulose","21 C.F.R. § 177.1200 - Cellophane.","Regenerated Cellulose Film Directive 2007/42/EC","x","P"]
[null,"Ceramics",null,"Directive 84/500/EEC, 2005/31/EC","x","P"]
[null,"Paper, Paperboards","21 C.F.R. §§ 176.110 to 176.350 - Indirect Food Additives: Paper and Paperboard components","Council of Europe Policy statement concerning paper and board materials and articles intended to come into contact with foodstuffs (incl. Resolution AP (2002) 1);","x","P"]
[null,null,null,"Recommendation XXXVI Paper and Boards of the German Federal Institute for Risk evaluation (BfR) - www.bfr.bund.de","x","P"]
[null,"Elastomers and rubbers","see plastics","Nitrosamine Directive 93/11/EC;\t","x","P"]
[null,null,null,"Resolution AP (2004) 4 on rubber products intended to come in contact with food","x","P"]
[null,null,null,"Cold Seals BfR XXI on natural and synthetic rubbers","x","P"]
[null,"Silicones",null,"https://www.edqm.eu/sites/default/files/policy_statement_concerning_silicones_used_for_food_contact_applications_v1_june_2004.pdf ","x","P"]
[null,null,null,"Council of Europe Policy statement concerning silicones used for food contact application (inl. Resolutions AP (99) 3 and AP (2004) 5)","x","P"]
[null,null,null,"German BRF XV on silicones","x","P"]
[null,"Surface coatings (resins, lacquers, adhesives)","FDA approval","Regulation (EC) No 2023/2006 – GMP on materials and articles intended to come into contact with food","x","P"]
[null,null,null,"Swiss Ordinance on Materials and Articles in Contact with Food, 817.023.21, Section 8b, Packaging Inks, Art. 26e – 26i1","x","P"]
[null,null,null,"EuPIA guideline on printing inks applied to the non-food contact surface of food packaging materials and articles “low migration inks” ","x","P"]
[null,null,null,"Council of Europe Policy statement concerning Packaging inks applied to the non-food contact surface of food packaging (incl. Resolution ResAP (2005) 2)","x","P"]
[null,"Printing inks","FDA approval","Regulation (EC) No 2023/2006 – GMP on materials and articles intended to come into contact with food","x","P"]
[null,null,null,"Swiss Ordinance on Materials and Articles in Contact with Food, 817.023.21, Section 8b, Packaging Inks, Art. 26e – 26i1","x","P"]
[null,null,null,"EuPIA guideline on printing inks applied to the non-food contact surface of food packaging materials and articles “low migration inks” ","x","P"]
[null,null,null,"Council of Europe Policy statement concerning Packaging inks applied to the non-food contact surface of food packaging (incl. Resolution ResAP (2005) 2)","x","P"]
[null,"Recycled plastics",null,"Commission Regulation 1616/2022  on recycled plastic materials and articles intended to come into contact with food","x","P"]
[null,"Active and intelligent packaging",null,"Regulation (EC) No 450/2009 on active and intelligent materials and articles intended to come into contact with food","x","P"]
[null,"Glass",null,"Council of Europe Policy statement concerning lead leaching from glass tableware into food stuff","x","P"]
[null,"Packaging Safety",null,"GFSI recognized schemes: M- Production of Food Packaging \n•BRC/IoP Global Standard for Packaging\n•SQF\n•FSSC 22000\n•IFS PACSECURE","x","P"]
[null,null,null,"ISO/TS 22002-4 Prerequisite programs on food safety – Part 4: Food packaging manufacturing","x","P"]
[null,null,null,"EN 15593 Management of hygiene in the production of packaging for foodstuffs - requirements","x","P"]
[null,"Packaging as Waste",null,"Packaging & Packaging Waste Directive 94/62/EC","x","P"]
[null,null,null,"Methods: EN 13427 – EN13432; CR 13688; CR 13695","x","P"]

{"sheet":"7.2","index":18,"n_rows":7,"n_cols":4,"rows_kept":7,"cut":false,"hidden":false,"merged":[[0,0,0,1]]}
["CHAPTER 7 – PRODUCTION PROCESS CONTROLS",null,"RMAT","Pack"]
[7.2,"Incoming Materials: Management of Purchased Material","P","P"]
["7.2.1","General Program Requirements","P","P"]
["7.2.1.1","The supplier shall develop and document quality expectations, requirements and/ or Specifications for purchased materials that are consistent with the programs in this SQE and MDLZ Specifications, and provide them to their suppliers.","P","P"]
["7.2.1.2","Purchasing of materials which impact food safety and quality shall be controlled to ensure that the suppliers used have the capability to meet the specified requirements. The conformance of incoming materials to specified purchase requirements shall be verified. This includes that there is a process in place to assure that materials which do not undergo a kill step at the supplier’s own manufacturing site, are adequately reviewed as part of the HACCP implementation. ","P","P"]
["7.2.1.3","Where a MDLZ supplier is reliant on their supplier’s thermal processing kill step, the MDLZ supplier shall have in place a program to ensure the step has been validated with defined log kill for target pathogen. This shall be compliant with the relevant MDLZ Processing Expectations.","P","x"]
["7.2.1.4","The validation shall cover all MDLZ microbiological sensitive ingredients (refer to Table 7.1.4) and shall be documented within the HACCP program. It shall be available to MDLZ on request.","P","x"]

{"sheet":"7.3","index":19,"n_rows":16,"n_cols":4,"rows_kept":16,"cut":false,"hidden":false,"merged":[[0,0,0,1]]}
["CHAPTER 7 – PRODUCTION PROCESS CONTROLS",null,"RMAT","Pack"]
[7.3,"Receipt and Shipping Controls, Inspection and Testing (Inbound and Outbound)","P","P"]
["7.3.1","General Program Requirements","P","P"]
["7.3.1.1","The supplier shall have a program in place to manage incoming ingredients and packaging to ensure they comply with the Specification and regulations. The program shall be documented including method of checking, inspection, verification and frequency of sampling/ test. There shall be a system in place for recording traceability information such as batch or lot numbers.","P","P"]
["7.3.1.2","There shall be in place a hold and release procedure for materials that are tested for pathogens.","P","x"]
["7.3.1.3","Tankers shall be dedicated to food only. Inbound loads suspected of any type of tampering shall be investigated by the supplier. The shipment shall be rejected if the source of tampering cannot be determined.","P","x"]
["7.3.1.4","During unloading of bulk raw materials from trucks or railcars, the dome openings shall be adequately screened to protect the materials within the tanker from potential contamination. Bulk ingredients shall be properly transferred through hygienically designed pipes and/ or hoses, and filtered, screened and sifted as required based on known and foreseeable risks.","P","x"]
["7.3.1.5","Prior to accepting incoming materials, the supplier shall verify that delivery vehicles (such as trucks or railcars) have maintained the quality and safety of the materials during transit. Verification activities shall be documented and shall include:","P","P"]
["a","Inbound and outbound vehicles shall be verified to be clean, dry, free from leaks, off-odors and unusual residual materials (powder or liquid) prior to loading/ unloading","P","P"]
["b","Materials and products shall be inspected for damage, infestation, and temperature abuse, potential security concerns such as perforated cases, exposure to moisture, unusual odors or unauthorized co-loads and damaged security/ tamper evident seals","P","P"]
["c","Outbound truckloads/ containers, deliveries to MDLZ (full and less-than-full truckloads), shall be sealed at dispatch using a numbered, tamper resistant metal seal, number recorded on shipping documents. All trucks for multiple delivery drop points with no more than 24 hours delivery period from time of dispatch: it is sufficient for the vehicle to be under driver lock control, no seal requirement. MDLZ expects the transport company to maintain the integrity and security of the load throughout the transit and documentation shall be available to show the previous drop points.","P","P"]
["d","All openings (doors, inspection ports, hatches, etc.,) on outbound shipments shall be sealed with a numbered, tamper evident, resistant seal and the seal number(s) annotated on the shipping documentation and loading control documents","P","P"]
["e","In the event that a security seal has been broken by an authorized person (e.g., border/ customs, police officers) there shall be:\n• Appropriate records to describe the reason for the seal removal\n• A replacement numbered seal shall be applied, and details recorded on the load documents\n• Where permissible, the credentials of delivery drivers should be verified in addition to the delivery documentation (e.g., driver name shown on delivery documents, photo ID on license)\n• If there is evidence of unsatisfactory shipping practices or tampering, then the materials shall be either rejected and returned, or immediately placed on hold.","P","P"]
["7.3.1.6","Inbound and outbound bulk containers shall be sealed.","P","x"]
["7.3.1.7","Deliveries shall be palletized and wrapped according to MDLZ Specifications.","P","P"]
["7.3.1.8","Big/ bulk bag delivered ingredients shall have tamper evident seals on each bag.","P","x"]

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["CHAPTER 7 – PRODUCTION PROCESS CONTROLS",null,null,"RMAT","Pack"]
[7.4,"Hazard Analysis and Critical Control Points (HACCP)",null,"P","P"]
["7.4.1","General Program Requirements",null,"P","P"]
["7.4.1.1","The supplier shall have implemented a written HACCP plan/ Food Safety Plan (FSP) (for FDA registered sites) for all materials produced for MDLZ. ",null,"P","P"]
["7.4.1.2","The supplier’s products shall be designed, produced and stored using HACCP principles to systematically minimize product safety risks. ",null,"P","P"]
["7.4.1.3","The supplier shall establish a cross-functional HACCP team that is responsible for developing, reviewing, and modifying the plans and maintaining the system. ",null,"P","P"]
["7.4.1.4","The HACCP team shall ensure that each HACCP/ Food Safety plan and its implementation is properly verified and validated on a regular, documented basis. ",null,"P","P"]
["7.4.1.5","The supplier shall ensure and document that all relevant employees receive an appropriate training in HACCP.",null,"P","P"]
["7.4.1.6","A list of CCP Models is available in Table 7.4.3. Where applicable, suppliers shall comply to the requirements of the relevant CCP Model. Specific guidance and details can be requested from the MDLZ Supplier Quality representative.",null,"P","P"]
["7.4.1.7","Food Contact Packaging shall not be a source of biological (e.g., microbial), chemical or physical (e.g., foreign bodies) hazards. Suppliers shall demonstrate their ability to control food safety hazards in order to ensure that food is safe at the time of human consumption. Approval requirements for food contact suppliers are detailed in audit requirements.",null,"x","P"]
["7.4.2","Validation",null,"P","P"]
["7.4.2.1","FSP/ HACCP system validation involves the initial collection and evaluation of scientific, historical and technical information to assess whether the FSP/ HACCP plan effectively identifies and controls all food safety hazards and emerging issues associated with the product or process.",null,"P","P"]
["7.4.2.2","Validation of microbiological CCPs: As part of the HACCP implementation and validation, the performance objective of all processes/ technologies used to eliminate target pathogenic organisms shall be defined and validated.",null,"P","x"]
[null,"Note: Performance objective is the number of logarithmic (log10) reduction for the pathogen of concern (e.g., 2-log reduction for Salmonella). Refer to relevant Processing Expectations and CCP Models for the minimum logarithmic reduction for target pathogen required. It also includes the validation of data demonstrating that the process is capable of meeting those parameters.",null,"P","x"]
["7.4.2.3","Validation of allergen change over CCP (or equivalent e.g., Specific Prerequisite Program): The effectiveness of an allergen cleaning occurring between an allergen containing and non-allergen containing/ different allergen containing product shall be demonstrated. This procedure requires the physical validation of the cleaning and pre-operation inspection process and the analytical validation (based on a validated ELISA method for the nominated allergen). When no appropriate validated ELISA test kit for the analytical validation is available for target allergen or any other allergen marker from the validated line, allergen line validations shall comply with the visibly clean standard. Verification of the allergen cleaning shall be regularly verified (annually at minimum).  ",null,"P","x"]
["7.4.2.4","Where the microbiological CCP is part of the MDLZ supplier’s process, validation studies shall be available to MDLZ.  The validation is part of the overall audit process and it shall be complete as minimum requirement for approval.",null,"P","x"]
["7.4.2.5","Suppliers shall complete an in-depth verification of their microbiological CCP at a minimum frequency of every two years. There are also situations where a re-validation is required:",null,"P","x"]
["a","When there is a system failure resulting in process deviations that cannot be identified",null,"P","x"]
["b","Whenever there is a change in the design of the processing equipment or conditions used – only that part of the system affected by the change needs to be re-validated",null,"P","x"]
["c","Where MDLZ updates the target organism or log reduction target required, based on new information.",null,"P","x"]
["7.4.2.6","Where the MDLZ supplier is reliant on their supplier’s microbiological CCP, refer to Section 7.2.",null,"P","x"]
["Table 7.4.3 CCP Models",null,null,"P","P"]
["7.4.3","CCP Model","Process Step and Product Description","P","P"]
[null,"CCP 01 Acidification","Product acidification","P","x"]
[null,"CCP 02 Acidification – Vegetable Brine","Batch process for pickled vegetable products e.g., Cucumbers, Cabbage (Sauerkraut) and Green Tomatoes. See Fruit and Vegetable Processing Expectations","P","x"]
[null,"CCP 03 Aseptic Processing and Filling","Aseptic processing and filling of low acid (pH >4.6) products with a water activity sufficient to support the outgrowth of spore-forming pathogens","P","x"]
[null,"CCP 06 Fillings And Sauces Heat Treatment (Low Aw)","Filling and Topping with low water activity pasteurization. Minimum applicable aw is 0.74. Highest applicable aw is 0.93","P","x"]
[null,"CCP 08 Cheese Cure Time","Cheese Cure after make. Applicable to Swiss, Romano, and Parmesan, Asiago, Emmentaler, Gruyere cheeses when milk heat treatment is less than 154°F (67.7°C). See Dairy Processing Expectations","P","x"]
[null,"CCP 09 Cocoa Bean/ Nib Steam Treatment","Steam treatment of Cocoa Beans /Nibs. See Cocoa Processing Expectations","P","x"]
[null,"CCP 10 Cocoa Bean/ Nib Heat Treatment","Heat treatment of Cocoa Beans /Nibs. See Cocoa Processing Expectations","P","x"]
[null,"CCP 17 Cooling (Dairy Products) – Post Fill","Product (dairy products) cooling step after hot fill","P","x"]
[null,"CCP 18 Equipment Cleaning For Allergen Removal","The visual inspection of the processing/ packaging equipment and above exposed product to ensure no visual residue after a product changeover, from product containing known food allergen(s) to product that does not contain the same allergenic material(s). See Supplier HACCP Manual","P","x"]
[null,"CCP 22 Filtration In-Line","In-line Filtration","P","x"]
[null,"CCP 23 Fruit Filling And Sauces Heat Treatment (Low pH)","Fruit filling/ fruit sauce heat treatment (pH less than 4.6). See Fruit and Vegetable Processing Expectations","P","x"]
[null,"CCP 25 Beverages (pH < 4.6 High Acid), Juice Containing – Heat Treatment","Heat process – Juices or juice-containing beverages. See Fruit and Vegetable Processing Expectations","P","x"]
[null,"CCP 26 High Moisture Material Holding Time/ Temperature","This model applies to high water activity (aw>0.85) products with a pH range of > 4.5 and < 9.6 and hold temperature > 8°C and < 50°C that permit the growth of Staphylococcus aureus and therefore, potential toxin formation. See Supplier HACCP Manual","P","x"]
[null,"CCP 28 Holding time/ temperature during wheat cooling and curing process","This model applies to wheat cooling and curing processes that could permit the growth of Bacillus cereus. Emetic toxin is formed during stationary phase of growth, and this model prevents progress of the growth cycle to stationary phase and prevents organism levels, including spores, from exceeding 10E5/g if product is held at temperatures < 75⁰F (24⁰C).  ","P","x"]
[null,"CCP 29 Low Acid Food Retort Cook","Critical control points in a retort process that produces a low acid (pH>4.6), high moisture (aw>0.89) product in a hermetically sealed package with an acceptably low probability of having pathogenic microorganism survivors","P","x"]
[null,"CCP 30 Magnet","In-Line Magnets","P","P"]
[null,"CCP 35 Extraneous Matter Detection","Metal Detector, in line X-Ray unit or optical sorter. See Supplier HACCP Manual","P","P"]
[null,"CCP 37 Milk Heat Treatment","Raw Milk Heat Treatment - Plate heat exchanger (For use in natural cheese). See Dairy Processing Expectations","P","x"]
[null,"CCP 38 Tree Nut/ Peanut/ Seed Dry Heat Treatment","Dry heat treatment of Raw Tree Nut/ Peanut/ Seed. See Tree Nut/ Peanut/ Seed Processing Expectations","P","x"]
[null,"CCP 39 Tree Nut/ Peanut/ Seed/ Corn Oil Roasting","Surface treatment by immersion in oil (roasting, shallow or deep frying) of tree nuts/ peanuts/ seeds/ corn nut/ banana chips etc., See Tree Nut/ Peanut/ Seed Processing Expectations","P","x"]
[null,"CCP 47 Pasteurization-Batch","Batch Pasteurization (Fluid Milk Products, Cream, Whey, Ice Cream Mix, Starter Media). See Dairy Processing Expectations","P","x"]
[null,"CCP 48 Pasteurization – HTST/ HHST","High Temperature Short Time (HTST) Pasteurization (Fluid Milk Products, Cream, Whey, Ice Cream Mix, Starter Media, Whey/ Salt Mixture). Higher Heat Shorter Time (HHST) Pasteurization (Fluid Milk Products). See Dairy Processing Expectations","P","x"]
[null,"CCP 51 Process Cheese Cook","Process(ed) Cheese Cook (Continuous or Batch). Applicable only to process(ed) cheeses that re formulation stable or refrigerated with secondary control mechanism. See Dairy Processing Expectations","P","x"]
[null,"CCP 52 Product Cook – Fat Based Products","Product Cook (Continuous or Batch) – fat containing products (e.g., Cream Cheese, Dips including dairy and non dairy, Sauces, RTE Puddings including high acid).","P","x"]
[null,"CCP 53 Product Flushing For Allergen Removal (Product Change Over)","Allergen Control - Product Flushing – (Product Changeover). Product flush after a product changeover from a product containing a known food allergen to a product that does not contain that allergen. See Supplier HACCP Manual","P","x"]
[null,"CCP 58 Product Cook – Non-fat Based Products","Thermal process step for high water activity (aw>0.93) non fat containing products, e.g., BBQ, Catsup, Ketchup, Mustard, Tea Extracts, gelatin solutions","P","x"]
[null,"CCP 60 UHT Heat Treatment","UHT (Ultra High Temperature) heat treatment. See Dairy Processing Expectations","P","x"]
[null,"CCP 62 Viscous (Spoonable) And Pourable Dressing Formulation","Viscous (Spoonables) and Pourable Dressing Formulation (Formulas Containing Sensitive Ingredients)","P","x"]
[null,"CCP 63 Water Activity","Product water activity prior to packaging","P","x"]
[null,"CCP 68 Product Bake","Product Bake (Continuous or Batch – e.g., cakes, breads, soft baked items, brownies, moon cakes or where quality specifications (moisture, color or water activity) cannot be used to verify the pathogen reduction step of baking. See Supplier HACCP Manual","P","x"]
[null,"sPP Receipt and review of supplier CoA from an approved supplier","Vegetative pathogens in raw materials that are not subject to an applied pathogen reduction processing step. See Supplier HACCP Manual","P","P"]

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["CHAPTER 7 – PRODUCTION PROCESS CONTROLS",null,null,null,null,"RMAT","Pack"]
[7.5,"Allergen Management",null,null,null,"P","x"]
["7.5.1","General Program Requirements",null,null,null,"P","x"]
["7.5.1.1","The supplier shall have an effective program to evaluate, identify and control food allergens to ensure that specific allergens are not inadvertently incorporated as an undeclared component of any product. This program shall include the following key principles.",null,null,null,"P","x"]
["7.5.1.2","An Allergen Assessment shall be carried out as part of HACCP plan development to identify, review and document allergens present at site. This assessment shall consider all allergens on the MDLZ Allergen Category List in Table 7.5.2, as well as any others identified in local regulations and regulations of the countries that the product is shipped to. If area or line assessments indicate that different lines and/ or area profiles exist, the assessment shall be used to identify appropriate controls. The Allergen Assessment shall consider and appropriately manage:",null,null,null,"P","x"]
["a","Possible sources of allergens related to the raw materials and formulation",null,null,null,"P","x"]
["b","Process and site-specific practices, including: raw materials/ ingredients handling and rework addition",null,null,null,"P","x"]
["c","Potential cross-contact possibilities from receiving, storage over manufacturing to shipment practices",null,null,null,"P","x"]
["d","Potential implications of any change of raw/ packaging material supplier or implications to formula or process changes",null,null,null,"P","x"]
["e","Opportunity to design out allergens where ever possible.",null,null,null,"P","x"]
["7.5.1.3","A raw material supplier management program which is regularly reviewed.",null,null,null,"P","x"]
["7.5.1.4","Adequate systems to ensure the correct use of allergens in the formula, correct packaging materials and labelling.",null,null,null,"P","x"]
["7.5.1.5","Adequate plant and equipment design to minimize allergen cross-contact where practically possible, areas, lines and equipment should be dedicated to a specific allergen profile in the facility. This may also include factory layout (physical segregation, zoning principles, minimize cross overs of product lines, shielding, covers).",null,null,null,"P","x"]
["7.5.1.6","Tools to be color coded, appropriately labelled or a validated as part of the cleaning program in place.",null,null,null,"P","x"]
["7.5.1.7","Limit/ restrict/ control movement of people, materials, equipment, vehicles and maintenance tools between segregated areas. This may require change of work wear when moving from an allergen to a non-allergen area (dusty environment and an enhanced application of GMP) or an area of different allergen profile.",null,null,null,"P","x"]
["7.5.1.8","Carry-over of allergens on shared lines shall be mitigated, where this is not feasible then carry-over should be minimized, i.e., visible whole or partial pieces of allergen from the previous production are not regarded as cross-contact and are NOT acceptable. For processes where an allergen change-over is required a validated change-over regime (cleaning/ flushing/ sequencing) shall be in place and documented.",null,null,null,"P","x"]
["7.5.1.9","Where the supplier is producing a product that does NOT have any carry-over, the change-over procedure shall be validated and managed as a CCP (or equivalent e.g., Specific Prerequisite Program), unless the site has one unique allergen profile.",null,null,null,"P","x"]
["7.5.1.10","Allergen validation shall be undertaken using industry best practice (i.e., post clean swabs and finished product sampling, analysis conducted by a lab accredited to ISO17025 and performed on three consecutive runs). ",null,null,null,"P","x"]
["7.5.1.11","Verification of the allergen cleaning shall be regularly verified (minimum once per year). Carry-over levels shall be established by conducting sampling of finished product following the site standard product changeover practices. This shall be verified through analysis on a specified periodical basis (guidance document is posted on the Supplier Information Center).",null,null,null,"P","x"]
["7.5.1.12","Change-over procedure shall include: identified equipment and infrastructure; dismantling and cleaning instructions; visual inspection standards with photographs; identified hard-to-reach and hang-up locations; removal and clearance of packaging form the line and area; defined responsibility for approval of change-over standard; documented sign off as acceptable.",null,null,null,"P","x"]
["7.5.1.13","Scheduling should be such that it minimizes cross-contamination risk.",null,null,null,"P","x"]
["7.5.1.14","When confirmed that cross-contact is warranted the cross-contact level shall be minimized. The cross-contact labelling is a last resort and shall not be used as a substitute for GMP or an effective food allergen control program.",null,null,null,"P","x"]
["7.5.1.15","For all new suppliers or new raw materials from existing suppliers, where a cross-contact (may-contain) is declared on the Specification, this shall be below MDLZ indicative levels stated in Table 7.5.3.",null,null,null,"P","x"]
["7.5.1.16","In cases where cross-contact is identified, it shall be confirmed as unavoidable through documented HACCP assessment based on the following criteria and where possible supported with analytical data:",null,null,null,"P","x"]
["a","Allergen cannot reliably be cleaned off the line",null,null,null,"P","x"]
["b","Allergen presence is unintentional and sporadic",null,null,null,"P","x"]
["c","Theoretical calculated risk identified in risk assessment.",null,null,null,"P","x"]
["d","Allergen cross-contact below MDLZ Indicative levels (see 7.5.1.15)",null,null,null,"P","x"]
["7.5.1.17","Rework product containing allergens as an ingredient shall be used only in products which contain the same allergen as an ingredient that is declared on the package ingredient line (i.e., like into like). It shall not be used in products where the allergen is declared on the package as a result of manufacturing cross-contact.",null,null,null,"P","x"]
["7.5.1.18","Suppliers delivering raw materials for finished product labelled with “Allergen free from claims”, a “free from” claim is an absolute claim (unless a regulatory limit has been set). Therefore, a rigorous assessment of the raw materials, the suppliers manufacturing process and environment is essential. Depending on the plant situation, the allergen risk shall be managed appropriately, following the “Allergen Control and Labeling – “Free From” Labeling Manual, available on the Supplier Information Center.",null,null,null,"P","x"]
["Table 7.5.2 Food Allergens – MDLZ Global List",null,null,null,null,"P","x"]
["7.5.2","Category of Food Allergen","Positive List of Ingredients or Foods includes (but not limited to):","Examples of foods that often contain this material","Exemptions to the Category of Food Allergen","P","x"]
[null,"Crustaceans","e.g., Shrimp, crab, lobster, crawfish (crayfish)\n\nEach species within this category, shall be regarded as a separate allergen","Glucosamine hydrochloride containing foods",null,"P","x"]
[null,"Egg","e.g., Hen's and other avian species\n\nOvalbumin, whole egg, egg yolk, egg white, lysozyme, hydrolyzed egg protein","Mayonnaise, meringue",null,"P","x"]
[null,"Fish","e.g., Cod, haddock, flounder, trout\n\nEach species within this category, shall be regarded as a separate allergen","Mixed seafood, fish sauce, Worcestershire sauce","Gelatin from fish used as a carrier for vitamin or carotenoid preparations\n\nGelatin from fish used as a fining agent in wine, beer and cider","P","x"]
[null,"Lupine/  lupin","Lupine flour, lupine beans","Flour and baking mixes",null,"P","x"]
[null,"Milk ","e.g., Cow’s, sheep’s, goat’s\n\nButter, buttermilk, casein, cheese, cottage cheese, curds, whey, lacto globulin, lactose*, malted milk, cream, sodium caseinate, sour cream, yoghurt, hydrolyzed milk protein\n\n*Only if it contains protein","Margarines, milk chocolate, ice cream, custard, nougat pudding","Lactose and lactitol which contains no protein (Specification shall indicate process for protein removal)\n\nAlcoholic distillates derived (including ethyl alcohol) from whey","P","x"]
[null,"Mollusk / Mollusc","e.g., Clams, oysters, mussels\n\nEach species within this category, shall be regarded as a separate allergen","Mixed seafood, oyster sauce",null,"P","x"]
[null,"Peanut","Peanut butter, nut pieces, peanut flour, peanut protein, hydrolyzed peanut protein","Mixed nuts",null,"P","x"]
[null,"Seeds:\nSesame seeds","Sesame paste, tahini paste","Hummus, tahini, biscuits, dressings and sauces",null,"P","x"]
[null,"Soybean/ soya bean/ soy","Soya derived vegetable protein or textured vegetable protein, miso, tofu","Soya sauce","Soy lecithin; tocopherol extracts (antioxidant used in flavors) purified by vacuum distillation or purified by other means if they are not a source of allergenic proteins\n\nAcid hydrolyzed soy proteins greater than 62% Amino Nitrogen/ Total Nitrogen (85% minimum degree of hydrolysis)\n\nPhytosterol or phytosterol esters derived from soy ","P","x"]
[null,"Tree nuts1","Only those tree nuts identified.  Each tree nut type within this category shall be regarded as a separate allergen","Mixed nuts\nSome chocolates","Alcoholic distillates including ethyl alcohol of agricultural origin derived from treenuts ","P","x"]
[null,"Wheat","Wheat derived bran, wheat extracts, dextrin, meal, farina, graham flour, malt, flour, germ, gluten, starch including enzymatically/ acid treated or chemically modified starches, semolina, hydrolyzed wheat protein, spelt, khorasan wheat, kamut","Breadcrumbs, crackers, bread, pasta","Wheat derived glucose, glucose syrup, dextrose, dextrose monohydrate, maltodextrin (all DEs), sugar alcohols, and caramelized glucose\n\nAlcoholic distillates including ethyl alcohol of agricultural origin derived from wheat\n\nVinegars (including spirit vinegar) derived from wheat ","P","x"]
[null,"1 Almond Prunus dulcis (Rosaceae); Brazil Nut Bertholletia excelsa (Lecythidaceae); Cashew Anacardium occidentale (Anacardiaceae); Hazelnut (Filbert) Corylus spp. (Betulaceae);Macadamia nut/ Bush nut Macadamia spp. (Proteaceae); Pine nut/ Pinon nut Pinus spp. (Pineaceae); Pistachio Pistacia vera L. (Anacardiaceae); Pecan Carya illinoensis (Juglandaceae); Walnut Juglans spp. (Juglandaceae)"]
["Table 7.5.3 MDLZ Indicative Levels",null,null,null,null,"P","x"]
["7.5.3","Allergen","Indicative Level (ppm protein)",null,null,"P","x"]
[null,"Peanuts",60,null,null,"P","x"]
[null,"Tree nuts",100,null,null,"P","x"]
[null,"Egg",30,null,null,"P","x"]
[null,"Milk ",60,null,null,"P","x"]
[null,"Soya",250,null,null,"P","x"]
[null,"Wheat",100,null,null,"P","x"]
[null,"Mustard/ Celery/ Sesame","Insufficient data available – please consult with MDLZ Food Safety for support with assessment",null,null,"P","x"]
["Note","There are no Packaging Expectations for this section.",null,null,null,"x","P"]

{"sheet":"7.6","index":22,"n_rows":62,"n_cols":4,"rows_kept":62,"cut":false,"hidden":false,"merged":[[0,0,0,1]]}
["CHAPTER 7 – PRODUCTION PROCESS CONTROLS",null,"RMAT","Pack"]
[7.6,"Extraneous Matter","P","P"]
["7.6.1","Extraneous Matter Control Program","P","P"]
["7.6.1.1","The supplier shall have implemented an extraneous matter control program that prevents, detects/ rejects and controls all extraneous matter. These requirements apply to any re-packing operation or bulk storage operation, which is either company owned or outsourced. This requires that each supplier shall have a documented program in place, based on a hazard assessment, to minimize the potential of extraneous matter being introduced into the product.","P","P"]
["7.6.1.2","Key elements of the hazard assessment are to:","P","P"]
["a","Determine potential sources of extraneous matter","P","P"]
["b","Minimize the potential of extraneous matter being introduced into the product","P","P"]
["c","Minimize hazards prior to commercialization of new equipment, or modification to (or relocation of) existing equipment.","P","P"]
["7.6.1.3","Suppliers shall develop an appropriate strategy for minimizing extraneous matter may include (but is not limited to):","P","P"]
["a","Confirming control strategies at raw material and packaging material suppliers or sources of materials","P","P"]
["b","Building and infrastructure maintenance programs e.g., to prevent flaking paint, temporary repairs from rope/ string/ tape/ wire ties, especially over exposed product areas","P","P"]
["c","Appropriate sanitary design of equipment/ processes","P","P"]
["d","Ensure cleaning equipment or practices do not contribute to extraneous matter in the product streams","P","P"]
["e","Enhance and enforce GMP programs, i.e., ensure covers are on tanks/ kettles/ mixer openings or above conveyor belts over exposed product ","P","P"]
["f","Establishing an effective preventive maintenance program, especially all product manufacturing equipment and surrounding infrastructures","P","P"]
["g","Usage of an appropriate control device to effectively detect and remove extraneous matter from receiving of raw materials to finished goods packaging e.g., installation of strainers, screens, filters, magnets, sieves, metal detectors, X-ray, optical sorters, or other devices/ programs deemed necessary on the line or within a process that protects the product, i.e., assuring all incoming ingredients shall be subjected to inspection with the use of a separation or detection device before further processing if necessary based on the risk assessment.","P","P"]
["h","Where practical for bulk materials, a filter or sieve shall be located in the vehicle discharging line (e.g., bulk tanker unloading hose) as close as reasonably practical to the MDLZ unloading connection point","P","P"]
["i","Inspection of packaging materials, (product and non-product contact) integrity e.g., to prevent string, loose stitching/ fibers, excess material from cutting etc., from entering the product stream. ","P","P"]
["7.6.1.4","Annual reassessments of an extraneous matter program shall be conducted and documented, particularly following changes to the plant environment/ equipment/ processes and instances of non-conformities (e.g., consumer complaints, PP/ CCP/ sPP (oPRP) failures).","P","P"]
["7.6.1.5","The supplier shall have a documented program in place based on the documented risk assessment to manage all pieces of equipment designed to detect/ reject and remove extraneous matter (e.g., X-ray, laser, optical sorter, metal detector, magnets, filters and sieves). ","P","P"]
["7.6.1.6","The program shall include detailed work instructions for each device that includes but is not limited to: integrity checks of sieves and filters, strength testing of magnets at a frequency sufficient to demonstrate control. It shall also include the monitoring activities (e.g., internal regular verifications, control of incoming flow and rejected quantities), and the maintenance and sampling plans. ","P","P"]
["7.6.1.7","A record of what is being found on all of the protection/ detections device shall be recorded during the specified monitoring verifications (e.g., the number of abnormal findings which includes type, weight and/ or size on extraneous matter), along with investigative and corrective action programs.","P","P"]
["7.6.1.8","Where metal detection or X-ray detection devices are managed as a CCP or sPP (oPRP), refer to the MDLZ Supplier and External Manufacturer HACCP Manual Appendix E “Extraneous Material Detection” for details on managing the frequency of verifications and other information.","P","P"]
["7.6.1.9","The extraneous matter detection devices (optical sorters, metal detectors and X-Ray) shall either have a validation currently documented or be validated that shall include determining the Probability of Detection (PoD) and False Reject Rate (FRR). MDLZ has templates to document these activities which can be found on the Supplier Information Center.","P","P"]
["7.6.1.10","Validation of the extraneous matter separation/ detection devices shall be performed to assess its effectiveness in preventing and controlling extraneous matter. The validation protocol shall be used for all existing and new devices:","P","P"]
["a","During commissioning, before first production run ","P","P"]
["b","After diagnostic maintenance activity of the device (e.g., changing to a new sensitivity level, changing a bulb in the X-Ray etc.,)","P","P"]
["c","After major change in the product intrinsic properties that influence the sensitivity of the device","P","P"]
["d","If a device demonstrates poor performance (false rejects calls for validation).","P","P"]
["7.6.1.11","These detection devices shall be calibrated on an annual frequency. ","P","P"]
["7.6.2","Glass and Plastic","P","P"]
["7.6.2.1","Glass and all plastic materials, components and equipment should be avoided in product areas where possible. If their use is necessary, a glass and plastic inspection program and breakage procedure shall be in place and documented. The master list shall include location of item, number(s) of items, type, and condition of the glass and plastic.","P","P"]
["7.6.2.2","Sites shall use the following key criteria to define the frequency of inspection:","P","P"]
["a","Potential for damage","P","P"]
["b","Location of the glass and/ or plastic","P","P"]
["c","Likelihood of broken fragments contaminating food","P","P"]
["7.6.2.3","The condition of the glass and plastic during audits shall be recorded (e.g., intact, broken, damaged but intact, undamaged but not working).","P","P"]
["7.6.2.4","Any issues raised shall be investigated to establish if the glass/ plastic breakage procedure has been followed and if not, whether product has been put at risk.","P","P"]
["7.6.2.5","Product determined to be potentially at risk for glass/ plastic contamination shall be handled in compliance with the procedure for non-conforming product.","P","P"]
["7.6.3","Use of End-Point Metal Detection Devices","P","P"]
["7.6.3.1","The detection limit for an end-point metal detector will depend on type of product, package, and the detection equipment. Detection equipment settings shall be determined and applied to achieve the most sensitive level possible to provide maximum protection from metal contamination from the validation process.","P","P"]
["7.6.3.2","Where end-point metal detection is not feasible or practical, the metal detector shall be placed before, but as close as practical to the point where the product enters the package. A documented risk assessment shall be performed to show that the risk of metal introduction into the product after the detector is low, or controlled by other measures. These measures shall be sufficient to control the metal risk identified (e.g., inline magnets, filters, screens, sieves, conveyor covers or various manual checks at a given frequency) and shall be approved during HACCP development and reviews.","P","P"]
["7.6.3.3","Metal detection units shall be capable and validated of detecting and rejecting spherical test piece standards equal to or smaller than 1.5 mm ferrous, 2.0 mm non-ferrous (e.g., brass), and 2.5 mm stainless steel (recommended 316 grade, minimum same grade as used in production equipment). X-ray units shall too be capable of detecting and rejecting spherical test piece standards equal to or smaller than 2.5mm stainless steel (recommended 316 grade, minimum same grade as used in production equipment). These limits are defined in the validation protocol.","P","P"]
["7.6.3.4","Where the minimum test piece standards cannot be detected (e.g., due to the product matrix, metalized foil or size/ bulk), alternative control measures such as magnets, filters, screens and/ or line modifications to prevent extraneous matter introduction shall be considered and their effectiveness be verified. This shall be documented and reviewed with your MDLZ Supplier Quality contact for agreement. Alternative technology should be evaluated to deliver the same or better level of protection).","P","P"]
["7.6.3.5","Functional verification shall be carried out during production with the normal product flow. Where this is not feasible, the reasons shall be documented. If the detector is a CCP, the frequency of checks during production shall be defined in the HACCP Plan. If not a CCP or sPP (oPRP), the information shall be documented in the work instructions.","P","P"]
["7.6.3.6","Functionality verification shall take place at minimum based on the criteria below:","P","P"]
["a","At the start and end of the manufacturing run and/ or batch should a manufacturing run extend beyond a batch","P","P"]
["b","After a shut down for sanitation","P","P"]
["c","At the restart of production after any unplanned downtime (downtime exceeding agreed frequency of checks or exceeding 24 hours)","P","P"]
["d","At start up after product change where the physical form, size or composition of the pack changes","P","P"]
["e","After repair, maintenance or adjustment to the detection equipment.","P","P"]
["7.6.3.7","Functionality verification shall ensure 100% detection and rejection of every pass of each of the test pieces used (one pass of each test piece where a validation has been completed and a False Reject Rate (FRR) <0.1%). If the equipment is not validated, then two passes of each test piece shall be completed and documented to assure repeatability. Suppliers shall determine and document the frequency of the functionality verification (recommended maximum every four hours). The reject mechanism shall divert 100% of the product rejects from the process flow into an identified and secured (locked) bin or container to prevent re-entry into the process or product flow.","P","P"]
["7.6.3.8","Note: Rejection of product can be accomplished in different manners depending on the configuration of the system, i.e., rejection device removes the product from the stream, belt stoppage, product flow stoppage etc., Whatever the process, it shall be documented as to the functionality of the system and demonstrate the process.","P","P"]
["7.6.3.9","For metal detectors, the test pieces shall pass through the center of the metal detector aperture (least sensitive path).","P","P"]
["7.6.3.10","Where the packed product is >18cm (7 inches) in length and travels through a detection device, the test pieces shall be passed through both the leading edge and trailing edge.","P","P"]
["7.6.3.11","A limit for rejections shall be defined over a defined time frame, x-number of rejects in y-determined number of hours. If this limit is exceeded the rejects shall be investigated and documented to understand cause and source.","P","P"]
["7.6.3.12","If a metal detection system is not working at its design limit (e.g., if it fails to detect a test piece), the material produced since the last successful verification test shall be placed on hold (see Section 8.4 Hold and Release) and a risk assessment conducted on it. This may include repassing of product on a validated device with the same or better test limits than the device in the process, or the same device after maintenance has adjusted and it has been verified and documented functioning. The risk assessment and corrective actions taken on the product shall be documented.","P","P"]
["7.6.3.13","Fail-safe devices which form part of metal detection/ rejection systems shall be tested and documented at the start of every shift. Testing shall be carried out by passing a test pack down the line while temporarily interrupting the electrical and/ or air supply to the reject device solenoid (e.g., by using a key switch held by an authorized person) and observing that the reject mechanism does not allow product to pass, and that the conveyor belt then stops.","P","P"]
["7.6.4","Use of Other End-Point Detection Devices","P","P"]
["7.6.4.1","For other extraneous matter hazards, a documented hazard assessment shall be performed to show that the potential for extraneous matter introduction into the product is low or measures are in place sufficient to control the hazard identified (e.g., X-ray, inline magnets, filters, screens, sieves, conveyor covers or various manual checks at a given frequency).","P","P"]
["7.6.4.2","For a control device to control extraneous matter hazards other than metal (e.g., glass, sticks, stones, stems, fruit pits), operating settings shall achieve the most sensitive detection level possible. In such cases, appropriate test piece sizes shall be defined and documented.","P","P"]
["7.6.4.3","All people responsible for selection, maintenance and operations of extraneous matter control devices shall be trained in compliance with the requirements of this SQE.","P","P"]

{"sheet":"7.7","index":23,"n_rows":11,"n_cols":4,"rows_kept":11,"cut":false,"hidden":false,"merged":[[0,0,0,1]]}
["CHAPTER 7 – PRODUCTION PROCESS CONTROLS",null,"RMAT","Pack"]
[7.7,"Net Content and Packaging Material (for ingredients delivered to MDLZ)","P","x"]
["7.7.1","Net Content Control","P","x"]
["7.7.1.1","The supplier shall have implemented a written net content control program that complies with all applicable regulatory requirements. The plan, net contents claims and targets shall be reviewed on an annual basis or in the case of major changes to process, equipment, material or formulation likely to impact net contents results.","P","x"]
["7.7.1.2","The program shall include routine scale (off-line weighing scale), check weighed and dynamic scale (in-line) verification, periodic calibration, corrective action plans and guidelines for handling non-compliance. ","P","x"]
["7.7.1.3","Where weights are used for verification, these should be calibrated, and verification frequency should be defined e.g., every shift. Statistical process controls may be used. Sampling criteria for all packaging lines shall be specified in the control plan. Data shall be collected and documented routinely and across the compliance lot of one shift of packing.","P","x"]
["7.7.2","Packaging Material","P","x"]
["7.7.2.1","All packaging in food contact with the delivered materials (e.g., big bags, multi-layer paper, etc.,) shall be fit for purpose and shall have food-contact material certificates (e.g., DoC, CoA, Letter of Guarantee).","P","x"]
["7.7.2.2","Packaging shall not alter product organoleptic characteristics and shall not be source of foreign material nor allergens. Staples or metal objects of any kind shall not be used on packaging or on the pallet. All plastic bags or liners in direct contact with materials shall be of a different color, preferably blue, from the material itself.","P","x"]
["7.7.2.3","Any proposed change in the size or type of packaging shall be submitted to the appropriate MDLZ Contracting Representative for approval prior to modification.","P","x"]
["Note","There are no Packaging Expectations for this section.  ","x","P"]

{"sheet":"7.8","index":24,"n_rows":21,"n_cols":4,"rows_kept":21,"cut":false,"hidden":false,"merged":[[0,0,0,1]]}
["CHAPTER 7 – PRODUCTION PROCESS CONTROLS",null,"RMAT","Pack"]
[7.8,"Label Control","P","P"]
["7.8.1","General Program Requirements","P","P"]
["7.8.1.1","The supplier shall ensure that labels are correctly and consistently applied to materials supplied to MDLZ, and that labels meet applicable regulatory requirements and MDLZ Specifications.","P","P"]
["7.8.1.2","The supplier shall verify, the accuracy of labels, where applicable, for allergen profile, ingredient information (including GMO status), nutritional information, net quantity, specific claims, legal designation (product name), and appropriate registration information/ number.","P","P"]
["7.8.1.3","Each label should clearly exhibit the material name, the name and address of the manufacturing site, packer and distributor (if applicable), as well as the lot number, net quantity, durability date (shelf life), storage conditions, preparation instructions (if applicable), allergens and the appropriate Kosher and Halal symbols if Kosher or Halal certifications are required. The durability date shall be consistent with the shelf life of the material as stipulated by the MDLZ Specification and regulations (where prescribed). All other voluntary claims such as “suitable for vegetarians”, “GMO free”, “gluten free” and organic claims etc., shall be validated and verified before being applied to the label copy.","P","P"]
["7.8.1.4","The supplier shall ensure through its procedures that labels and pre-printed packages are stored in a manner that minimizes mixed label batches and mixing together with other labels and packages. Special attention shall be given to packaging material changeover practices in-line. Unused pre-printed labels at the end of a run shall be accounted for or destroyed to ensure that the next run of materials is not inadvertently mislabeled. Strict control is necessary in cases where different material varieties have similar labels. ","P","P"]
["7.8.1.5","The supplier shall have implemented procedures to ensure that labels match products.","P","P"]
["7.8.1.6","Packaging suppliers of materials shall ensure that print runs items are not mixed on a pallet. The risk of mixing during the process of guillotining, punching, die cutting, packing and palletizing shall be assessed and controlled. Procedure and compliance should be in place for a line change-over protocol or line clearance that ensures there is no product mix. This may include equipment clearance and inspection, start-up sign-off, bar-code readers and scanners.","x","P"]
["7.8.2","Printed Material Management: Destruction or Recycling of MDLZ Labeled Packaging Material","x","P"]
["7.8.2.1","The supplier shall ensure that any discarded or recycled materials (including any scrap or waste) containing any MDLZ name, trademark or logo, or any other MDLZ identifying information, cannot be reused. ","x","P"]
["7.8.2.2","The supplier shall have a documented process for destruction and recycling of materials. When done by a third-party company, responsibilities and methods for assuring the destruction of the packaging material shall be specified in contracts including the verification of destruction.","x","P"]
["7.8.3","Label Control and Print Copy Verification ","x","P"]
["7.8.3.1","The supplier shall have controls in place to assure that labels are correctly and consistently applied to packaging materials supplied to MDLZ.","x","P"]
["7.8.3.2","Label controls shall assure that labels applied to packaging materials supplied to MDLZ meet all regulatory requirements and Specifications of MDLZ.","x","P"]
["7.8.3.3","Any MDLZ labeled finished packaging material that is to be discarded for trash shall be disfigured or destroyed (crushed, shredded, etc.,) so that the container labels, or caps could never be reused in any manner.","x","P"]
["7.8.3.4","Destruction of defective or obsolete MDLZ labels or MDLZ labeled packaging materials, cartons, and caps by disposal in a trash compactor is viewed as acceptable means of disposal/ disfigurement. Materials shall be physically de-faced/ disfigured if disposal is in bulk trash bins.","x","P"]
["7.8.3.5","Scrap or waste packaging material (e.g., paper, corrugated, plastic) that is to be recycled by an external recycling site which contains intact materials with MDLZ labeling shall be physically defaced or disfigured so that the material could never be reused in any manner.","x","P"]
["7.8.3.6","Suppliers producing actual labels or labeled packaging materials for MDLZ shall have adequate controls in place to prevent inadvertent mixing of labels or labeled materials prior to delivery to MDLZ. This includes a detailed risk analysis of the production processes and procedures and shall be addressed in the plant’s HACCP plans.","x","P"]
["7.8.4","Print Copy Verification of Materials","x","P"]
["7.8.4.1","Suppliers producing actual labels or printed packaging materials for MDLZ shall have an adequate program in place to ensure print copy verification is undertaken for each print run or batch of materials produced. Print copy verification shall ensure the accuracy of the run, including verification of actual print quality, legibility of print and be compared to specifications or master templates. Records of verification of print runs shall be maintained.","x","P"]

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["CHAPTER 7 – PRODUCTION PROCESS CONTROLS",null,null,null,null,null,null,"RMAT","Pack"]
[7.9,"Traceability",null,null,null,null,null,"P","P"]
["7.9.1","General Program Requirements",null,null,null,null,null,"P","P"]
["7.9.1.1","The supplier shall have a documented and verified system for the identification and traceability of all materials sent to MDLZ. Where internal plant identification systems are used, these shall link back to the original lot code in receipt records.",null,null,null,null,null,"P","P"]
["7.9.1.2","This system shall allow the site to target trace within four hours, the entire history of a specific lot from raw material reception through manufacturing process, storage and shipping. This shall include identification of all materials handled and the customers to whom products were distributed (one step upstream – material received and handled; one step downstream – products distributed to MDLZ sites and contracted sites). Time in excess of four hours may be allowed providing MDLZ have sufficient time to trace the full history of products within 24 hours.",null,null,null,null,null,"P","P"]
["7.9.1.3","Traceability requirements apply to all finished products and material components including ingredients/ base materials, in process products, bulk materials, rework, primary packaging materials, secondary packaging components when product ingredient line information printed on pre-packed subcomponents, premiums and part finished products and/ or process intermediates being shipped to other locations for further processing.",null,null,null,null,null,"P","P"]
["7.9.1.4","Periodic mock recall exercises shall be carried out to verify system capability (minimum annually) and documented, including corrective actions identified.",null,null,null,null,null,"P","P"]
["7.9.1.5","All supplied material and documents shall bear information that allows effective product traceability. For ingredients that may not have a specific lot number, a method for unique identification and tracking shall be developed and implemented. Bulk use of ingredients/ materials shall be required to have a documented timeframe of known use and a defined procedure to calculate usage and dilution. The documented method for establishing the time frame of known use for bulk ingredients and bulk/ continuous processes shall be defined and documented.",null,null,null,null,null,"P","P"]
[null,"Upon request, MDLZ can support with a calculation template for bulk ingredients usage and dilution. Contact your MDLZ Supplier Quality representative for assistance. See 7.9.2 and 7.9.3 for guidance.",null,null,null,null,null,"P","P"]
["7.9.1.6","For microbiological sensitive materials, steps shall be taken to reasonably practicably deliver material to MDLZ containing only one batch/ lot number and shall not be a split lot i.e., the batch/ lot shall not be delivered to more than one MDLZ location. The preference is that at a minimum, each individual pallet is to be made up of a single batch/ lot number, however, up to a maximum of two lots may be accepted on the same pallet. Comprehensive traceability data shall be readily available and available from start to finish. If, due to special circumstances, more than two batches per pallet must be sent, this situation shall be previously communicated and the respective authorization from the MDLZ Supplier Quality representative shall be obtained.",null,null,null,null,null,"P","x"]
["7.9.1.7","Where split lot delivery is unavoidable, the supplier shall inform the receiving site.",null,null,null,null,null,"P","P"]
["7.9.2 Guidance for Traceability Calculation – Batch Process – Solid ",null,null,null,null,null,null,"P","x"]
["7.9.2","Enter Data:","Tank diameter:",null,2,"m",null,"P","x"]
[null,null,"Material density:",null,0.65,"ton/m³",null,"P","x"]
[null,null,"Lot quantity tracked: ",null,5,"ton",null,"P","x"]
[null,"For traceability of solid bulk materials, considering piston flow, 1 meter is considered up and down in the affected lot.",null,null,null,null,null,"P","x"]
[null,"For tanks with less than 2 meters, consider the affected lot and the subsequent lot.",null,null,null,null,null,"P","x"]
[null,"Calculations:","Height of problematic lot:",null,{"$f":"IF(E15=\"\",\"\",(E15)/(E14*PI()*(E13/2)^2))","v":2.4485375860291589},"m",null,"P","x"]
[null,null,"Quantity to be removed (up and down):",null,{"$f":"IF(E15=\"\",\"\",1*E14*PI()*(E13/2)^2)","v":2.0420352248333655},"ton",null,"P","x"]
["7.9.3 Guidance for Traceability Calculation – Batch Process – Liquid",null,null,null,null,null,null,"P","x"]
["7.9.3","Enter Data:","Storage tank capacity:",null,30,"ton",null,"P","x"]
[null,null,"Load received:",null,20,"ton",null,"P","x"]
[null,null,"Quantity of previous lot remaining:",null,2,"ton",null,"P","x"]
[null,"Calculations:","Dilution factor:",null,{"$f":"IF(E23=\"\",\"\",E23/(E22+E23))","v":9.0909090909090912E-2},null,null,"P","x"]
[null,null,"Lot",null,"Dilution",null,"LOG","P","x"]
[null,null,"Contaminated lot",null,1,null,{"$f":"-LOG(E26)","v":0},"P","x"]
[null,null,"1st consecutive lot ",null,{"$f":"E26*$E$24","v":9.0909090909090912E-2},null,{"$f":"-LOG(E27)","v":1.0413926851582249},"P","x"]
[null,null,"2nd consecutive lot ",null,8.2644628099173556E-3,null,2.0827853703164503,"P","x"]
[null,null,"3rd consecutive lot ",null,7.513148009015778E-4,null,3.1241780554746752,"P","x"]
[null,null,"4th consecutive lot ",null,6.8301345536507077E-5,null,4.1655707406329006,"P","x"]
[null,null,"5th consecutive lot ",null,6.2092132305915523E-6,null,5.206963425791125,"P","x"]
[null,null,"6th consecutive lot ",null,5.6447393005377753E-7,null,6.2483561109493504,"P","x"]
[null,null,"7th consecutive lot ",null,5.1315811823070687E-8,null,7.2897487961075749,"P","x"]
[null,null,"8th consecutive lot ",null,4.6650738020973349E-9,null,8.3311414812658011,"P","x"]
[null,null,"9th consecutive lot ",null,4.2409761837248498E-10,null,9.3725341664240247,"P","x"]
[null,null,"10th consecutive lot ",null,3.8554328942953182E-11,null,10.41392685158225,"P","x"]
[null,null,"11th consecutive lot ",null,3.5049389948139258E-12,null,11.455319536740475,"P","x"]
[null,null,"12th consecutive lot ",null,3.186308177103569E-13,null,12.496712221898701,"P","x"]
[null,null,"13th consecutive lot ",null,2.8966437973668807E-14,null,13.538104907056926,"P","x"]
[null,null,"14th consecutive lot ",null,2.6333125430608006E-15,null,14.57949759221515,"P","x"]
[null,null,"15th consecutive lot ",null,2.3939204936916367E-16,null,15.620890277373375,"P","x"]

{"sheet":"7.10","index":26,"n_rows":112,"n_cols":4,"rows_kept":112,"cut":false,"hidden":false,"merged":[[0,0,0,1]]}
["CHAPTER 7 – PRODUCTION PROCESS CONTROLS",null,"RMAT","Pack"]
[7.1,"Warehousing and Transportation","P","P"]
["7.10.1","General Program Requirements","P","P"]
["7.10.1.1","The supplier shall have implemented systems to manage warehousing and transportation to ensure that the safety, quality, and security of materials and products are maintained at all stages from receipt of raw materials through delivery of products to MDLZ.","P","P"]
["7.10.1.2","The supplier shall use designated storage areas or stock rooms to prevent damage to, deterioration of or tampering with material. Storage facilities shall be neat and orderly.","P","P"]
["7.10.1.3","If the supplier uses third party warehouses to store raw materials, packaging materials, semi-finished or finished products, the supplier shall conduct documented periodic assessments to ensure that the requirements of this SQE Manual are met.","P","P"]
["7.10.1.4","Where specified, monitoring of temperature and humidity shall be carried out using calibrated recording equipment located in representative locations. A reporting system with corrective action plans for out-of-range results shall be in place. Where local regulations or material Specifications specify conditions for Warehousing, Handling, Storage, Re-packing and Transportation of products these shall also be met. Effective operation of vehicle chiller units shall be verified by temperature measurement.","P","P"]
["7.10.1.5","Conditions for transport are list below (unless Specification requires otherwise):","P","P"]
[null,"Ambient Storage: Prevailing conditions with no control over temperature or humidity required or expected","P","P"]
[null,"Dry Storage: Prevailing conditions controlled to avoid absorption of humidity from air. Temperature range +10°C to +25 °C / 50°F to 77 °F, relative humidity <65%","P","P"]
[null,"Conditioned Storage: Temperature controlled within a defined range of +10°C to +20°C / 50°F to 68 °F. Humidity maximum 65%","P","P"]
[null,"Chilled Storage: Temperature controlled within a defined range of +1°C to +8°C / 34°F to 45 °F. Humidity control not required. Consistent with US FDA requirements","P","P"]
[null,"Refrigerated: Temperature controlled within a defined range of +1°C to +4°C / 35°F to 40 °F. Humidity control not required. Procedures in place to assure that products are pre-chilled to required temperature prior to loading, and vehicles are pre-chilled prior to loading for distribution","P","P"]
[null,"Frozen Storage: Temperature controlled within a defined range, typically -18°C to -30°C / 0°F to -22°F. Humidity control not required. Procedures in place to assure that products are pre-frozen to required temperature prior to loading and vehicles are pre-frozen prior to loading for distribution","P","P"]
[null,"Super Chill: Temperature controlled within a defined range of -3°C to -0.5°C / 27°F to 31°F. Humidity control not required. Procedures in place to assure that products are pre-chilled to required temperature prior to loading, and vehicles are pre-chilled prior to loading for distribution","P","P"]
[null,"Protected: Temperature controlled within a defined range of +1°C to +35°C / 34°F to 95°F. Humidity control not required","P","P"]
[null,"Tanker Transfer of Chocolate Masses and Fillings sold as product (e.g., to external manufacturer): Temperature controlled within a defined range typically within +40°C to +55°C / 104°F to 131°F. Humidity control not required","P","x"]
["7.10.2","Warehousing and Storage Requirements","P","P"]
["7.10.2.1","GWP shall be followed.","P","P"]
["7.10.2.2","Fork lift trucks (FLT) shall be in good repair, clean, free from leaks.","P","P"]
["7.10.2.3","FLT utilized inside a facility should be electric powered. Liquid Petroleum Gas (LPG) (propane) is acceptable. Gasoline or diesel-powered FLT shall only be used outside the facility.","P","P"]
["7.10.2.4","FLT batteries shall be stored in a designated area in such a way as to avoid risk of material or product contamination. New technology batteries, which have a lower risk level, may require less strict segregation.","P","P"]
["7.10.2.5","Access to storage areas, including products, packaging materials and exterior storage areas (e.g., tanks, silos) shall be restricted to authorized personnel only.","P","P"]
["7.10.2.6","An effective stock rotation system shall be in place for all materials and products stored for MDLZ. This may be FEFO (First Expired First Out) or FIFO (First In First Out), or otherwise specified by MDLZ.","P","P"]
["7.10.2.7","Products or materials which have a strong odor or display any other quality or food safety risk shall be segregated to avoid cross contamination.","P","P"]
["7.10.2.8","Pallets, racks and equipment shall be maintained in good condition to prevent any physical damage to materials or products (free from nails, wood splinters etc.,).","P","P"]
["7.10.2.9","Airflow from heaters/ refrigeration units shall be directed away from materials and products.","P","P"]
["7.10.2.10","Food, returned products, waste and non-food items shall be handled and stored in a manner to avoid taint/ contamination (e.g., moths in dry pet food), transfer of odors or any quality or food safety risk. Dividers or other precautions (e.g., traffic controls, separate air systems) should be used for protection.","P","x"]
["7.10.2.11","Racking and storage areas (e.g., staging areas, bins) shall be adequately spaced from the walls (minimum 12 inches/ 30 cm) to allow for inspection of areas for cleanliness, insect or rodent activity. Additionally, where rodent control devices are placed, there shall be an 18 inch/ 45 cm gap to allow for inspection. Where this is not possible, alternative means of access shall be demonstrated.","P","P"]
["7.10.2.12","Direct sunlight on product should be avoided.","P","P"]
["7.10.2.13","Packaging materials in full or partial quantities shall be adequately protected and stored in a sanitary manner. Identification and traceability shall be maintained. All items should be stored to avoid direct contact with the floor (e.g., on pallets, slip sheets, or racks). Sitting or standing on product shipping cases is not acceptable. Over stacking of product shall be avoided.","P","P"]
["7.10.2.14","Glass and brittle materials including hard plastic components and equipment should be avoided in product areas where possible. If their use is necessary a glass and hard plastic inspection program and breakage procedure shall be in place and documented.","P","P"]
["7.10.2.15","Pallets shall be stored in areas that are free of moisture, dirt and litter and free of bird, insect or rodent contamination.","P","P"]
["7.10.2.16","A pallet inspection program shall be in place to verify that pallets are suitable for use (e.g., clean, dry, free from mold, off-odors and infestation, no broken wood or loose nails).","P","P"]
["7.10.2.17","Pallets shall be maintained so they cannot pose any risk to the product. Product and packaging shall have a pallet slip between the goods and the pallet.","P","P"]
["7.10.2.18","Grounds requirements:","P","P"]
["a","Collection or storage areas (e.g., trash, recycling, idle equipment) shall be clearly identified and kept neat and tidy)","P","P"]
["b","Doors and gates (e.g., cargo doors) shall not be left open when not in use","P","P"]
["c","Vegetation and grass close to the facility needs to be cut regularly and managed.","P","P"]
["7.10.2.19","Ingredients shall be adequately protected and stored in a sanitary manner in their original, labeled container, or in another authorized sanitary container that is clearly marked for the use of the specific ingredient (e.g., sanitary pails or tote bins).","P","P"]
["7.10.2.20","Ingredient identification and lot number/ traceability shall be maintained. Containers shall be properly closed/ sealed/ covered. When returning ingredient containers to storage, ingredients shall be stored in the proper temperature environment.","P","x"]
["7.10.2.21","Bulk pre-weighed ingredients shall be stored in appropriate containers, under appropriate conditions and properly identified.","P","x"]
["7.10.2.22","Bulk storage of ingredients susceptible to microbiological spoilage shall have adequate controls in place to prevent spoilage or contamination (e.g., insulated, temperature controlled and monitored).","P","x"]
["7.10.2.23","Where packaging materials are not in individual containers (e.g., film roll stock, cartons), the pallets shall be covered and stretch wrapped, shrink wrapped, strapped, or net wrapped to maintain integrity and prevent potential for contamination.","P","P"]
["7.10.3","Transportation Requirements – Bulk Tankers","P","x"]
["7.10.3.1","Bulk tankers shall be of stainless steel construction, or other suitable food grade material. They shall bear the following or equivalent statement: \"For Food only\".","P","x"]
["7.10.3.2","The supplier shall have a protocol/ procedure in place for the approval of hauliers and bulk tanker providers.","P","x"]
["7.10.3.3","The supplier shall ensure that tanker providers are using cleaning facilities which are fit for purpose and have been approved by the tanker company.","P","x"]
["7.10.3.4","The Tanker Cleaning Company shall conform to EFTCO (European Federation of Tank Cleaning Organizations) requirements or other equivalent regional/ national associations where they exist","P","x"]
["7.10.3.5","Custom numbered seals or equivalent (e.g., electronic seals) shall be used for all opening of the container after filling.","P","x"]
["7.10.3.6","Tankers (including pipes, air ducts and loading/ unloading equipment) shall be verified to be in good condition, dry, clean and free of off-odors before loading.","P","x"]
["7.10.3.7","Truck compressor: compressed air shall be of purity class 1.4.1 according to ISO 8573-1:2010. A one-way valve shall be installed between compressor and silo container.","P","x"]
["7.10.3.8","Transportation system (pipes and pumps) shall be assembled using seals and gaskets that are easily accessible and replaceable. The process of replacement shall be clearly documented and carried out in a safe manner. Transport air shall be filtered with F7 filter at minimum.","P","x"]
["7.10.3.9","Truck shall have boxes for hoses, connections, gasket and sealing. Boxes shall be locked and sealed.","P","x"]
["7.10.3.10","All conveyor hose ends shall be capped for hygiene and foreign matter control reasons.","P","x"]
["7.10.4","Unloading and Loading of Products - Bulk Tankers","P","x"]
["7.10.4.1","During loading and unloading, chemical, physical and microbiological contamination shall not occur.","P","x"]
["7.10.4.2","Any pumps and hoses, tools, air system (used to dry the tankers and empty the tanks) used during unloading or loading of product shall meet all applicable GMP guidelines. Hoses and connection boxes shall be maintained in proper hygienic conditions (clean, free from foreign body and pests).","P","x"]
["7.10.4.3","The supplier shall confirm that the tanker has undergone a cleaning procedure and has been inspected before it is loaded. This should be documented in a procedure including how the inspection is done and on which parts of the tanker.","P","x"]
["7.10.4.4","The supplier shall have a loading matrix which defines when cleaning is required and load-on-load can be exercised. Microbiological sensitivity, allergen, GMO, taint and compatibility shall be considered.","P","x"]
["7.10.4.5","EFTCO certification or other regional/ national equivalent shall be the basis for the cleaning certificate, which shall include all detachable parts. In any other cases, cleaning certificates shall indicate as a minimum:","P","x"]
["a","ID of truck tank","P","x"]
["b","Seals number for tankers","P","x"]
["c","Previous three cargo/ loaded product (note: will vary if tank truck consists of separate chambers)","P","x"]
["d","Name of the station/ location where the cleaning was performed","P","x"]
["e","Name of the operator who performed the cleaning and their signature","P","x"]
["f","Applied cleaning technique","P","x"]
["g","Date and hour of cleaning","P","x"]
["h","Numbers of the cleaned compartments","P","x"]
["7.10.4.6","Visual inspections prior to loading to verify efficacy of cleaning and the validity of the cleaning certificate is required. The result of the inspection shall be documented.","P","x"]
["7.10.4.7","To prevent extraneous matter and water contamination of the product, any scraping of tankers and containers shall not be done and hatches shall remain closed.","P","x"]
["7.10.5","Cleaning and Disinfection Details – Bulk Tankers","P","x"]
["7.10.5.1","Associated parts which cannot be cleaned in place (fittings, pipe and hoses, connections, gaskets, lids, dustcovers, etc.) shall be dismantled and cleaned off line (manually, in a COP tank or part washer) under hygienic conditions. After the wash/disinfection solution has drained, a final rinse with cold to warm water to remove all remains of the washing/ disinfecting solution shall be done. The last rinse shall be followed by a thorough draining. Chemicals shall be suitable for food industry. If steam is used for product contact surfaces, it shall be food grade (culinary). For disinfection, the steam shall be filtered to prevent foreign matter and/or microbiological contamination according to the raw material risk.","P","x"]
["7.10.5.2","Air supply used for drying shall be oil free and adequately filtered (minimum filter size: F5).","P","x"]
["7.10.5.3","Verification, Monitoring and Validation of cleaning shall include physical inspection, microbiological tests (if applicable) and cleaning parameter checks that are performed and documented at a specified frequency. Physical inspections shall cover:","P","x"]
["a","Absence of visual residues in tank and pipes","P","x"]
["b","Absence of strong odors","P","x"]
["c","Absence of humidity/ condensate/ water","P","x"]
["d","Check of gaskets/ connections/ pipes/ hoses for cleanliness and function.","P","x"]
["7.10.5.4","The need for microbiological test done by the cleaning company shall be individually defined based on the microbiological susceptibility of the transported material. Microbiological swabbing or ATP testing for target organisms should be used for validation of the cleaning process, and should be performed at a defined frequency, minimum annual.","P","x"]
["7.10.6","Trucks and Delivery Vehicles","P","P"]
["7.10.6.1","Trucks and containers shall be verified to be in good condition (e.g., no holes, rust), dry, clean and free of off-odors and pests before loading. Wooden racks are prohibited in trucks used for MDLZ materials deliveries.","P","P"]
["7.10.6.2","Product quality and integrity shall be preserved during transport.","P","P"]
["7.10.6.3","Solid top, hard-sided, lockable or reinforced soft-sided vehicles shall be used. In regions where such equipment is not practical or available, the supplier shall ensure the integrity of the material is not compromised.","P","P"]
["7.10.6.4","Vehicles should not contain mixed loads of materials that can pose a risk of cross-contamination to the material supplied to MDLZ. Conditions to guarantee the safety and integrity of materials supplied shall be guaranteed and in all cases, the food/ packaging material shall be protected.","P","P"]
["7.10.6.5","Temperature controlled vehicles should have a method to record the conditions during transit.","P","P"]
["7.10.6.6","Procedures for dealing with vehicle or refrigeration systems breakdown shall be in place and include notification to the MDLZ receiving plant.","P","P"]
["7.10.6.7","Inbound and outbound bulk containers shall be sealed. Acceptable seals include:","P","P"]
["a","Drums with a locking ring secured with a numbered seal and number annotated on the shipping documentation","P","P"]
["b","Large bags such as super-sacks or totes containing plastic liners having a bag closure that will readily reveal any tampering and will not permit removal and reinstallation without breaking the seal","P","P"]
["c","Corrugated cases effectively sealed with tamper-evident tape.","P","P"]
["7.10.6.8","Storage of product should not be directly in front of cooling equipment where this may impact product quality.","P","P"]
["7.10.6.9","All trailers used for the transport of MDLZ product shall comply with:","P","P"]
["a","The relevant legislation governing the transportation of such products as laid down but not necessarily limited to local legislations","P","P"]
["b","All trucks shall be sealed once loaded, seal numbers shall be reflected on the paperwork","P","P"]
["c","Product supplied to MDLZ shall be protected for food defense purposes and therefore have appropriate seals and/ or packaging to show evidence of tampering. If the pack type is unable to have a tamper evident device or the packaging itself does not provide tamper evidence, then the delivery truck itself shall be sealed.","P","P"]
["d","For multi-drop deliveries, a procedure shall be in place to ensure the integrity of the product throughout the delivery duration","P","P"]
["e","Clean, pest and odor free","P","P"]
["f","Dry (no condensation on floor, walls or roof)","P","P"]
["g","In good overall condition","P","P"]
["h","Robust floor, to enable safe loading and unloading operations","P","P"]
["i","Doors/ curtains shall maintain an effective seal to the external environment","P","P"]
["j","Free from any material that may damage products","P","P"]
["k","Where internal lighting is present in trailers, it shall be protected. No unprotected glass bulbs no broken glass or broken hard plastic protective covers","P","P"]
["l","Curtains should be in good condition (e.g., no holes) and completely closed in such a way to avoid ingress of water etc.,","P","P"]
["7.10.7","Intermittent Unloading","P","x"]
["7.10.7.1","Bulk railcars or trucks that are docked and/ or connected to the facility for intermittent unloading for a period over 24 hours, shall have adequate controls in place to prevent unauthorized access. Examples of these controls include:","P","x"]
["a","Sealed connection points","P","x"]
["b","Doors and hatches re-sealed or locked in between unloading","P","x"]
["c","Bulk railcars or trucks are contained within an enclosed space with a roof and secure doors (Note: Gates and fences are not considered sufficient to prevent access).","P","x"]
["7.10.7.2","The controls shall be checked daily or upon resumption of unloading after a lapse of more than 24 hours to ensure there has been no unauthorized access.","P","x"]
["7.10.7.3","Where specified, monitoring of temperature and humidity shall be carried out using calibrated recording equipment. This recording equipment shall be located in representative locations. A reporting system with corrective action plans for out of acceptable range results shall be defined and documented.","P","x"]

{"sheet":"7.11","index":27,"n_rows":21,"n_cols":4,"rows_kept":21,"cut":false,"hidden":false,"merged":[[0,0,0,1]]}
["CHAPTER 7 – PRODUCTION PROCESS CONTROLS",null,"RMAT","Pack"]
[7.11,"Calibration of Measuring and Monitoring Equipment","P","P"]
["7.11.1","General Program Requirements","P","P"]
["7.11.1.1","The supplier shall have implemented a written process to inspect, test, and calibrate measuring and monitoring equipment. The process shall ensure the precision and accuracy of the equipment such that measurement capability is consistent with the measurement equipment requirements.","P","P"]
["7.11.1.2","Calibration procedures for each piece of measuring and monitoring equipment, including equipment used to control, measure, or monitor CCPs and equipment used for material testing, shall include the following information:","P","P"]
["a","Whether the equipment is used to control, measure, or monitor CCPs","P","P"]
["b","Minimum required accuracy or allowable tolerance for the device","P","P"]
["c","Corrective actions to be taken when the results of a calibration are out of specified limits","P","P"]
["7.11.1.3","The supplier shall establish and maintain a master list of all measuring and monitoring equipment that can affect food safety and/ or product quality to be controlled by the program including:","P","P"]
["a","Name of the equipment and a unique identifier","P","P"]
["b","Location of the equipment","P","P"]
["c","Frequency of the calibration. Note: Equipment used to measure a CCP shall be calibrated at frequency sufficient to demonstrate control (at least once per year)","P","P"]
["d","The method of calibration","P","P"]
["e","Use of the measurement device","P","P"]
["f","Personnel responsible for the activity","P","P"]
["7.11.1.4","Calibration shall be against known and valid standards which are traceable to international or national measurement standards (whichever is stricter). Where no such standards exist, the method of establishing and maintaining the standard for calibration shall be documented.","P","P"]
["7.11.1.5","Calibration shall be performed by qualified personnel and/ or by the instrument supplier as a minimum during yearly service unless another frequency is specified by the manufacturer, or by shipment to a certified company for the device.","P","P"]
["7.11.1.6","Special attention shall be given to critical machine set points which affect the functional and/ or analytical properties of the material produced.","P","P"]
["7.11.1.7","Calibration shall be performed under suitable environmental conditions, based on stability, purpose and degree of usage of such equipment. Calibration checks shall be documented including date, personnel initials, actual comparison results, and calibration results, indicating the degree of inaccuracy, and any adjustments made to bring the equipment back into calibration.","P","P"]
["7.11.1.8","In cases where it is not feasible to calibrate the equipment (e.g., flow meter), an assessment of the equipment is required. If the equipment is out of the calibration range for that specific application, the equipment shall be replaced by other equipment that meets the calibration requirements for the specific application.","P","P"]
["7.11.1.9","Product that may have been affected due to equipment being out of calibration shall be evaluated. If the equipment is used to monitor or measure a CCP, a risk assessment shall be carried out to determine any potential food safety risk with regard to product tested during the period when the equipment was possibly out of calibration.","P","P"]

{"sheet":"8.1","index":28,"n_rows":11,"n_cols":4,"rows_kept":11,"cut":false,"hidden":false,"merged":[[0,0,0,1]]}
["CHAPTER 8 – MEASUREMENT, ANALYSIS AND IMPROVEMENT",null,"RMAT","Pack"]
[8.1,"Internal Audits","P","P"]
["8.1.1","General Program Requirements","P","P"]
["8.1.1.1","The supplier shall establish and maintain written procedures for conducting internal audits to verify whether the Quality System and food safety programs are adequately implemented. The internal audit program shall ensure that each function/ area is audited at a defined frequency.","P","P"]
["8.1.1.2","Results of previous audits shall be taken into account when planning future audits.","P","P"]
["8.1.1.3","Trained competent employees shall conduct the audits but should only be assigned to audit areas in which they do not work. They shall have strong knowledge on the audit scope and there shall be a process to monitor auditor competency.","P","P"]
["8.1.1.4","The audit procedures shall provide for follow-up audit activities to verify and record the implementation of corrective actions taken.","P","P"]
["8.1.1.5","The audit shall be completed and closed-out within an established timeframe. ","P","P"]
["8.1.1.6","Supplier management shall review audit results, corrective actions and follow-up as part of regular meetings.","P","P"]
["8.1.1.7","Repeat findings in internal audits shall have thorough root cause analysis conducted due to corrective action not being effective.","P","P"]
["8.1.1.8","Results of audits shall be published within the business to leadership and used to drive food safety culture.","P","x"]

{"sheet":"8.2","index":29,"n_rows":21,"n_cols":4,"rows_kept":21,"cut":false,"hidden":false,"merged":[[0,0,0,1]]}
["CHAPTER 8 – MEASUREMENT, ANALYSIS AND IMPROVEMENT",null,"RMAT","Pack"]
[8.1999999999999993,"Testing Controls","P","P"]
["8.2.1","General Laboratory Requirements","P","P"]
["8.2.1.1","Through procedures in a written program, the supplier shall ensure that personnel responsible for conducting testing or monitoring have access to all necessary information, such as laboratory methods manuals, raw material Specifications, packaging specifications, finished product specifications, test requirements and parameters, and laboratory procedures.","P","P"]
["8.2.1.2","All supplier plant laboratories and laboratory personnel shall comply with Good Laboratory Practice requirements including, but not limited to, the following:","P","x"]
["a","Identification of samples submitted to the laboratory to ensure traceability from the sample to the reporting of a final result","P","x"]
["b","Laboratory chemicals with high toxicity, bacterial positive control cultures and solvents not in immediate use shall be secured and locked, with access restricted to authorized personnel. A secured laboratory (access controlled, locked when not occupied, and periodic inventory) is adequate for the storage of chemicals used on a routine basis","P","x"]
["c","Laboratory materials shall be restricted to use in the laboratory, except as needed for sampling or other appropriate use activities. Unexplained additions and withdrawals shall be immediately investigated and reported to appropriate law enforcement and public health authorities","P","x"]
["d","Procedures shall be in place for positive control, tracking and disposition of sensitive materials.","P","x"]
["8.2.2","Laboratory Requirements for Pathogen Testing","P","x"]
["8.2.2.1","Pathogen testing required for materials delivered to MDLZ shall only be performed by laboratories that have been approved by MDLZ Global Food Safety. A list of approved laboratories in each country is available from your MDLZ Contracting Representative and can be found on the Supplier Information Center www.mdlzsupplierquality.com.","P","x"]
["8.2.2.2","Samples from a PEM program may be analyzed at an external laboratory accredited to ISO 17025 or equivalent, or at the supplier’s pathogen laboratory, provided requirements for internal laboratory are met as follows:","P","x"]
["a","The laboratory has demonstrated the ability to provide accurate and valid results","P","x"]
["b","The laboratory design and practices shall prevent the potential for cross-contamination of pathogens by restricting access to authorized personnel. At minimum, a sign shall be posted to indicate that the area is restricted, there should be a footwear and lab coat change moving into and out of the pathogen restricted area","P","x"]
["c","In the event of any positive results (pathogen findings) laboratory errors shall be excluded (e.g., by characterizing the isolates to be distinct from the laboratory control strain(s) or other samples handled in parallel)","P","x"]
["d","The laboratory shall participate in and successfully pass an annual proficiency test","P","x"]
["e","Relative air pressure of the pathogen laboratory shall be kept negative to the adjacent rooms by appropriate air velocities through openings. A differential pressure control system shall be in place to ensure pressure differentials will not drop below 0.019 mm Hg (2.5 Pa)","P","x"]
["f","The air in microbiology laboratories shall be filtered by a F8 (MERV 14-15) filter. Laminar flow cabinet is also an acceptable solution if the air cannot be filtered","P","x"]
["g","Any potentially infectious material shall be sterilized prior to disposal","P","x"]
["8.2.2.3","Irrespective of the laboratory used for testing environmental samples for pathogens, they shall use either a MDLZ approved method or alternative method validated using a recognized protocol e.g., ISO 16140-2, AOAC and formally approved and certified by a validation organization e.g., AOAC RI, MicroVal, AFNOR.","P","x"]
["Note","There are no Packaging Expectations for this section.  ","x","x"]

{"sheet":"8.3","index":30,"n_rows":16,"n_cols":4,"rows_kept":16,"cut":false,"hidden":false,"merged":[[0,0,0,1]]}
["CHAPTER 8 – MEASUREMENT, ANALYSIS AND IMPROVEMENT",null,"RMAT","Pack"]
[8.3000000000000007,"Rework Control","P","x"]
["8.3.1","General Program Requirements","P","x"]
["8.3.1.1","The supplier shall have implemented a written program to control the use of rework materials. This program shall include:","P","x"]
["a","The type and quantity of rework that can be added to the target product","P","x"]
["b","Conditions of storage","P","x"]
["c","Reprocessing steps in which it will be added","P","x"]
["d","Method of addition","P","x"]
["e","Identification of allergens","P","x"]
["f","Shelf life","P","x"]
["g","Special handling requirements","P","x"]
["h","Lot number identification for traceability","P","x"]
["8.3.1.2","If rework is identified as potentially containing allergens, it shall be segregated, controlled, and incorporated only into the same and/ or appropriately labeled product.","P","x"]
["8.3.1.3","Material that has had confirmed pathogen results shall not be reworked into material for MDLZ.","P","x"]
["8.3.1.4","The supplier shall ensure that its use of rework complies with all applicable regulations, including labeling requirements, for the use of specific materials in the target product. For example, use of rework shall not cause the nutritional data or allergen information provided to MDLZ to be incorrect.","P","x"]
["Note","There are no Packaging Expectations for this section.  ","x","P"]

{"sheet":"8.4","index":31,"n_rows":28,"n_cols":7,"rows_kept":28,"cut":false,"hidden":false,"merged":[[26,2,26,3],[26,1,27,1],[11,1,11,4],[20,0,27,0],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,1,15,4],[16,1,16,4],[17,1,17,4],[18,1,18,4],[1,1,1,4],[19,0,19,4],[25,2,25,4],[0,0,0,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[24,1,25,1],[2,1,2,4],[8,1,8,4],[9,1,9,4],[10,1,10,4]]}
["CHAPTER 8 – MEASUREMENT, ANALYSIS AND IMPROVEMENT",null,null,null,null,"RMAT","Pack"]
[8.4,"Hold and Release and Control of Non-Conforming Product",null,null,null,"P","P"]
["8.4.1","General Program Requirements",null,null,null,"P","P"]
["8.4.1.1","A written hold and release control program shall be in place to assure that materials and products which need to be specifically identified/ isolated and held, pending determination of their final disposition, shall not be inadvertently dispatched. The frequency of inventory check shall be defined.",null,null,null,"P","P"]
["8.4.1.2","Personnel shall be designated with the authority and responsibility for management of hold and release programs, including monitoring, documenting and tracking held product through to final disposition.",null,null,null,"P","P"]
["8.4.1.3","The program shall include controls for non-conforming raw materials, materials pending testing (e.g., pathogen testing, sterility testing, CoA verification), packaging, labels, semi-finished product (work-in-progress), finished product, and rework. The supplier shall maintain records sufficient to enable reconciliation of each hold event (e.g., quantities, code dates, lot numbers, product numbers, reasons for hold and/ or release, investigative information, disposition, and traceability information).",null,null,null,"P","P"]
["8.4.1.4","The site shall assure that product which does not conform to specified requirements is identified and controlled to prevent its unintended use or distribution.",null,null,null,"P","P"]
["8.4.1.5","The site shall ensure that all holds are classified based on severity. There shall be a minimum, two hold classifications based on the following:",null,null,null,"P","P"]
["a","Level 1 related food safety and regulatory issues",null,null,null,"P","P"]
["b","Level 2 related to quality issues",null,null,null,"P","P"]
[null,"Table 8.4.2 may be used as guidance.",null,null,null,"P","P"]
["8.4.1.6","A systematic evaluation/ audit of the hold and release program shall be conducted at least annually at each site to assure the system functions properly. This audit and the follow up and close out of relevant identified corrective actions shall be to be documented.",null,null,null,"P","P"]
["8.4.1.7","Where product or material placed on holds needs to be moved to external storage or between facilities, procedures shall be in place to maintain the integrity of the hold status.",null,null,null,"P","P"]
["8.4.1.8","Held product inventories shall be reconciled at the time when final disposition is implemented and at any inventory count action taking place.",null,null,null,"P","P"]
["8.4.1.9","A training and awareness session shall be conducted at least annually for all personnel involved with hold and release activities.",null,null,null,"P","P"]
["8.4.1.10","After release of a lot/ code of product to MDLZ, the supplier shall not initiate pathogen testing on either that lot/ code of product or any ingredients used in that product. If any material produced for MDLZ is either inadvertently released from hold or is suspected of non-conformance but has already been shipped to MDLZ, the MDLZ Contracting Representative shall be immediately notified (see Section 5.1.1 Notifying MDLZ of Significant Events).",null,null,null,"P","x"]
["8.4.1.11","If the product has tested positive for pathogens, the product shall not be supplied to MDLZ. regardless of any further test results.",null,null,null,"P","x"]
["8.4.1.12","Where product is sent for destruction, destruction certificates shall be retained or any other proof of destruction.",null,null,null,"P","P"]
["8.4.1.13","If a supplier needs to retrieve product which has been dispatched, there shall be a procedure in place to manage the retrieval and account for the product.",null,null,null,"P","P"]
["Table 8.4.2 Hold Categories",null,null,null,null,"P","P"]
["8.4.2",null,"Category 1 Hold","Category 2 Hold","Category 3 Hold\n[Also called Controlled Hold]","P","P"]
[null,"Use for:","When a non-conformity poses a confirmed product safety issue, or major quality concern, for example:\n• Undeclared allergens identified in product or material\n• Failure to meet CCP/ sPP requirements as defined in individual CCP/ sPP models\n• Contamination due to employee illness\n• Unacceptable pathogen test result (presumptive or confirmed positive)\n• Presence of an undeclared ingredient","When a non-conformity, or any suspected non-conformity, poses a potential food safety issue or regulatory non-conformance, or a minor product or material quality defect, for example:\n• A non-conformance which causes the ingredients on the ingredient list to be in the wrong order\n• Net contents compliance lot average is below the stated label weight claim\n• Non-conforming product pending corrective action completion, re-testing and, or final disposition decision (e.g., wrong product on pallet, open product, soft packs).\n• Deviation from a CCP/ sPP requirement pending investigation or further actions\n• Finished product awaiting results of testing related to food safety parameters or regulatory parameters e.g., pathogen, allergen, chemical contaminants\n• In cases where pathogen testing on every lot of finished product is not specified:\na) Rework pending pathogen testing results\nb) Finished product made using materials or rework with pending pathogen test results\nc) Finished product awaiting the results of verification pathogen testing (e.g., quarterly testing)\n• Finished product awaiting pathogen testing results where testing has been initiated by a government or regulatory agency, e.g., FDA returned material","When other reasons exist for needing to hold product or material, unrelated to food safety or regulatory issues, for example:\n• Finished product awaiting results of testing related to quality parameters e.g., moisture\n• Product produced as a result of a trial","P","P"]
[null,"Notify MDLZ","Required","Required if the material has been shipped to MDLZ and there is a suspicion of non-conformity related to food safety or regulatory parameters.","Required if the material has been shipped to MDLZ and there is a suspicion of non-conformity related to quality parameters.","P","P"]
[null,"Disposition","Designated person to manage disposition in collaboration with MDLZ Quality representative.","Designated person will maintain communication with the appropriate facility manager and manage disposition activity.","Designated person will conduct the necessary communication to assure adequate control and manage disposition activity.","P","P"]
[null,"Identification and Segregation","Each of the following requirements shall be met:\n• Each shipping unit of product or material shall be visually identified with hold stickers, tags or tape\n• Product or material shall be placed in a segregated and secured area","All affected product or material shall be visually identified as being on hold within its storage location (e.g., segregation of an entire bay using ‘ON HOLD’ tape/ placard, or specified area within a high-rise facility designated only for product on hold).\n\nWhere product or material need to be moved to external storage or between facilities, each shipping unit shall be visually identified as being on hold. Product or material should be placed in a segregated area.","All affected product or material must be visually identified, or computer controlled, or both.\n\nThe method adopted must provide effective control.","P","P"]
[null,null,"For all Hold Categories:\n• Inadvertent movement or use shall be prevented\n• Where computerized stock control systems are in use, product shall be electronically obstructed from movement/ use and only designated, authorized employees shall have the ability to modify the status or location. Where it is feasible, physically obstruction of the goods shall also be used for additional control. In addition, there shall be a defined, documented and effective system in place and agreed with MDLZ to prevent inadvertent movement or use\n• Where no computerized stock control system is in place, or it is not possible to assign responsibilities only to specific authorized employees to modify the status or location of the product, product/ materials shall be physically obstructed.",null,null,"P","P"]
[null,"Inventory Checks","Inventory checks for Category 1 and 2 holds shall account for physical quantities present and be reconciled against all hold records (including electronic warehouse records, hold forms, and electronic hold files).",null,"A defined frequency, documented in local procedures, which is adequate to assure control.","P","P"]
[null,null,"Verification daily on facility operating days.","Inventory verification minimum monthly, or at close-out of hold event if sooner.","Inventory verification at close-out of hold event if sooner.","P","P"]

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["CHAPTER 8 – MEASUREMENT, ANALYSIS AND IMPROVEMENT",null,null,null,null,null,"RMAT","Pack"]
[8.5,"Corrective and Preventive Action (CAPA)",null,null,null,null,"P","P"]
["8.5.1","General Program Requirements",null,null,null,null,"P","P"]
["8.5.1.1","All programs mandated by this SQE Manual require that CAPA be taken in the event of non-conformities. The supplier shall have an effective CAPA program tracking such actions to ensure that non-conformities in any program are addressed in an appropriate and timely manner. ",null,null,null,null,"P","P"]
["8.5.1.2","After closure of CAPA relevant for MDLZ, the supplier shall inform MDLZ and provide objective evidence that actions have been closed out (from audit or another source). If it is identified through technical visit/ SQE audit that previous non-conformities have not been actioned, this may affect the site’s approval status. Therefore, suppliers shall review non-conformities and corrective action status prior to any such site assessment.",null,null,null,null,"P","P"]
["8.5.1.3","An effective CAPA program shall include the following steps:",null,null,null,null,"P","P"]
["a","Identification of CAPA opportunities",null,null,null,null,"P","P"]
["b","Determination of immediate action(s) to be taken (including responsibility and timing)",null,null,null,null,"P","P"]
["c","Root cause analysis and quantification of the problem (prioritization)",null,null,null,null,"P","P"]
["d","Identification of long-term (permanent) solutions (including responsibilities and timing). When required, resources (e.g., personnel, equipment) shall also be identified",null,null,null,null,"P","P"]
["e","CAPA plan implementation",null,null,null,null,"P","P"]
["f","Further analysis of data to validate if the desired results were achieved (i.e., was the plan effective in resolving the root cause)",null,null,null,null,"P","P"]
["g","Periodic review of CAPA by the management team",null,null,null,null,"P","P"]
["h","A process to verify CAPA effectiveness which is documented.",null,null,null,null,"P","P"]
["8.5.1.4","The CAPA program shall include procedures for analysis of effectiveness of corrective actions for, at a minimum, each of the following data sources:",null,null,null,null,"P","P"]
["a","Out of Specification process or product",null,null,null,null,"P","P"]
["b","Products found to deviate from critical limits of a CCP",null,null,null,null,"P","P"]
["c","Customer/ consumer feedback, including complaints",null,null,null,null,"P","P"]
["d","Failure to meet external, regulatory or customer requirements",null,null,null,null,"P","P"]
["e","Issues arising from internal audits, external audits, and regulatory inspections/ contacts, MDLZ assessments/ audits",null,null,null,null,"P","P"]
["f","Product retrieval",null,null,null,null,"P","P"]
["g","Supplier performance measures",null,null,null,null,"P","P"]
["8.5.1.5","A formalized process shall be in place to identify root cause and implement appropriate CAPA for supplier quality notifications raised by MDLZ against your site (for Priority 1 and Priority 2 categories as a minimum, out of specification MMP results, incidents that have led to MDLZ early warnings or special situations – for definitions see Table 8.5.2). These may include techniques such as:\n• 5 whys\n• Cause & Effect/ Ishikawa/ Fishbone (Guidance is available at the Supplier Information Center)",null,null,null,null,"P","P"]
["8.5.1.6","A preliminary update and overview of the issue and root cause analysis should be provided within five days by the CAPA party, to include immediate mitigation of risks. Root cause analysis should be completed within 30 days by the CAPA party. If the CAPA party is unable to meet the defined time frames, both parties should mutually agree to the choice of:",null,null,null,null,"P","P"]
["a","Using a mutually agreed consultant",null,null,null,null,"P","P"]
["b","Provide CAPA party specialist support",null,null,null,null,"P","P"]
["c","Use an industrially recognized expert",null,null,null,null,"P","P"]
["Table 8.5.2 Quality Notifications",null,null,null,null,null,"P","P"]
["8.5.2","Priority Level","Definition","Acknowledgement from supplier","Preliminary Investigation result (potential cause + size of the issue) + immediate correction","RCA + CAPA (plan agreed with MDLZ)","P","P"]
[null,1,"An issue that poses a potential product safety risk (microbiological, chemical or physical contaminants, allergens), regulatory impact, or any significant quality issue leading to business interruption","1-2 business days","Maximum 5 business days from initial communication – QN may follow","Target 10 business days, maximum 30 calendar days unless otherwise agreed with MDLZ","P","P"]
[null,2,"Material non-conformity to specification or requirements with impact on process and product (functional/ organoleptic parameters, packaging integrity etc.,) without food safety risk",null,"Maximum 5 business days from initial communication – QN may follow","Target 20 business days, maximum 30 calendar days unless otherwise agreed with MDLZ","P","P"]
[null,3,"Non-conformity to specification or requirements with no impact on food-safety, process or product (quality of palletization, missing non-critical parameter in certificate, delivery conditions). Minor documentation errors",null,"Maximum 5 business days from initial communication – QN may follow","Maximum 30 business days","P","P"]
[null,"Note: In case of high impact on MDLZ finished product or MDLZ production lines, a daily update on progress of investigation from the supplier may be required in order to minimize the risk of business disruption.\nAcknowledgement and Preliminary Investigation timescales are guidance to address the issue swiftly and may not be tracked.",null,null,null,null,"P","P"]

{"sheet":"8.6","index":33,"n_rows":40,"n_cols":4,"rows_kept":40,"cut":false,"hidden":false,"merged":[[0,0,0,1],[3,9,3,23]]}
["CHAPTER 8 – MEASUREMENT, ANALYSIS AND IMPROVEMENT",null,"RMAT","Pack"]
[8.6,"Transfer of Constituents from Food Contact Material to Food","x","P"]
["8.6.1","General Program Requirements","x","P"]
["8.6.1.1","Packaging materials that come in direct contact with the product, either by design or by foreseeable use, are defined by MDLZ Food Contact Packaging. Under their normal or foreseeable conditions of use, materials shall not transfer their constituents (intentionally added substances (IAS) and non-intentionally added substances (NIAS)) to foodstuffs in quantities that could endanger human health, cause an unacceptable change in the composition of the foodstuffs (color), or result in deterioration of the organoleptic (tainting, odor) characteristics thereof. This requirement applies to all materials and articles intended to come in contact with food, either by physical contact, by head space exchange, or by insufficient barrier, under actual, intended, or foreseeable conditions. The requirement encompasses safety and consumer acceptance during both storage and after opening i.e., during the preparation and consumption phase. MDLZ via its Specifications set additional requirements for chemicals of specific concern.","x","P"]
["8.6.2","Constituents from Plastic Materials","x","P"]
["8.6.2.1","Plastic material and articles shall be tested by suppliers under conditions for intended, food type, time and temperature during filling, processing, storage and preparation. If there are no applicable regulations in that case, follow EU10/2011 or 21 CFR guideline.","x","P"]
["8.6.3","Constituents from Paper and Board Materials","x","P"]
["8.6.3.1","Paper and board for direct food contact shall be of suitable microbiological quality and shall not release any antimicrobial agents into food. In the absence of applicable regulations, materials shall be compliant with FDA’s regulations in 21 CFR Part 176 or the German BfR Recommendation XXXVI (BfR reports to the Federal Ministry of Food and Agriculture - BMEL) .","x","P"]
["8.6.3.2","Films made of regenerated cellulose fibers shall be of food grade quality and should comply with European Regulation 2007/42/EC or U.S. 21 CFR Part 177.1200. ","x","P"]
["8.6.4","Metal in Contact with Packaging ","x","P"]
["8.6.4.1","For primary packaging intended for use with dairy products, there shall be no direct contact between the packaging and copper or any alloy containing copper. Suppliers shall take steps to ensure that primary packaging does not come into contact with these compounds either directly or indirectly through regular machine wear.","x","P"]
["8.6.5","Recycled Post-Consumer Material","x","P"]
["8.6.5.1","MDLZ favors the use of recycled materials provided that strict requirements are established to ensure food safety. MDLZ typically does not permit post-consumer recycled materials used for primary packages to come in direct contact with food, unless food safety and compliance are ensured. For materials defined as food contact packaging, a DoC is required from the vendor.","x","P"]
["8.6.5.2","Recycled PET for direct food contact can be used if allowed by local regulation where the food product is sold and a declaration from the vendor in the DoC is available, affirming that only recycled plastic from a safety assessed recycling process has been used. The safety assessment shall be from an official Food Safety Authority (e.g., EFSA, FDA) and the DoC shall list the register number (or equivalent) of the assessment.","x","P"]
["8.6.5.3","Recycled plastics made by pyrolysis or gasification chemical recycling processes and produced through mass balance approach can be used in direct food contact applications if safety and compliance are ensured by a DoC, and all testing requirements for regulatory compliance are followed and included in the DoC.","x","P"]
["8.6.5.4","Recycled paperboard shall not be used for direct food contact unless sufficient evidence of food safety and compliance is provided, and the use is approved by MDLZ Global Food Safety.","x","P"]
["8.6.5.5","MDLZ may make an exception for glass, metal, and specific product applications when agreed and included in MDLZ packaging Specifications.","x","P"]
["8.6.5.6","If post-consumer recycled material is part of a multi-component primary packaging system, but is not in the layer where it contacts the food, the use of the post-consumer recycled material will only be permitted subject to three requirements:","x","P"]
["a","MDLZ shall be pre-notified;","x","P"]
["b","the food additive/ migration status shall be ascertained with respect to the intended use; and","x","P"]
["c","the material shall be identified as being recycled in the MDLZ packaging Specifications.","x","P"]
["8.6.5.7","Recycled materials are allowed for packaging applications which have a functional barrier as primary packaging around the food. Functional barriers are defined as one or more layers of food contact materials which ensure that compounds of concern do not migrate into the food above regulatory and safety limits during the shelf-life of the product.","x","P"]
["8.6.6","Odor and Taste Transfer Testing","x","P"]
["8.6.6.1","Food contact materials shall not change the organoleptic properties of the packed food. Food contact packaging materials supplied to MDLZ shall comply with odor and taste transfer testing.","x","P"]
["8.6.6.2","Paper and board: The organoleptic characteristics of food contact paper and board materials (including promotional items) in direct or indirect contact with food shall be evaluated per batch according to the following methods:","x","P"]
["a","EN 1230 –1 Odor assessment test","x","P"]
["b","EN 1230–2 Taint transfer test (“Robinson test”)","x","P"]
["8.6.6.3","For direct and indirect confectionery packaging both of the above mentioned sensory tests are mandatory.","x","P"]
["8.6.6.4","Other materials: An odor assessment shall be performed per batch for printed films for direct and indirect contact. For other materials the testing, of the organoleptic characteristics can be based on risk assessment (Guideline EN 10955 or ISO 13302 can be used). Acceptance criteria:","x","P"]
["8.6.6.5","These tests are based on a rating scale from 0 = no off-flavor or odor to 4 = strong off-flavor or odor. Primary packaging materials in direct or indirect food contact are acceptable if:\n• at the taint transfer test the off-taste is just perceptible, but difficult to define (median taste score 1.5 with above mentioned methods);\n• at the odor assessment test a slight off-odor is perceived (median odor score < 2.5 with above mentioned methods).","x","P"]
["8.6.6.6","Sensory tests shall be conducted systematically by trained panelists in a suitable environment. Other methods may be used if agreed to by MDLZ and provided that the comparability is documented and reports should be made available for MDLZ when required.","x","P"]
["8.6.7","Printing Inks for Non-Food Contact Side ","x","P"]
["8.6.7.1","Printing inks applied to the non-food contact side of a packaging shall not transfer any residues of toxicological concern. The inks shall be of high purity to ensure that there is no migration of substances that have not been toxicologically evaluated and that there is no violation of any specific migration limit imposed for other materials.","x","P"]
["8.6.7.2","Aromatic compounds (e.g., toluene, xylene) shall not be part of the formulation added to packaging materials during the production, printing or cleaning processes. However, traces below 0.5 mg/m² are considered ‘aromatic’ free.","x","P"]
["8.6.7.3","MDLZ requires compliance with the “EuPIA guideline on printing inks applied to the non-food contact surface of food packaging materials and articles” (www.eupia.org) and Swiss Ordinance SR 817.023.21.","x","P"]
["8.6.7.4","In the U.S., suppliers shall have an FDA regulatory approval letter on file for approved use of specific inks used for indirect or direct product contact.","x","P"]
["8.6.8","Printing in Direct Contact With Food","x","P"]
["8.6.8.1","When packaging materials are printed on the side that will be in direct contact with food and no functional barrier is in place, only food contact colorants shall be used. Colorants shall be approved for food use in the locations where the products are produced and may be delivered.","x","P"]
["8.6.8.2","This requirement applies to printings on the inner side of a package (e.g., for promotions). It also applies to outside printed packages that could be taken into the mouth or placed in close or direct contact to an unpacked food (e.g., multi component packs that comprise of packaged and unpacked food).","x","P"]
["Note","There are no Raw Material Expectations for this section.  ","P","x"]

{"sheet":"Definitions","index":34,"n_rows":62,"n_cols":2,"rows_kept":62,"cut":false,"hidden":false,"merged":[[0,0,0,1]]}
["APPENDIX I - DEFINITIONS"]
["Term","Definition"]
["Accuracy","The repeatability of closeness to the target value of a certified reference or other standard."]
["Allergen Category List","MDLZ list of recognized food allergens, available from MDLZ Food Safety."]
["Allergen Profile","The totality of the allergens which are present in a product by design or are likely to be present due to cross-contact. The complete allergen profile shall be properly identified on the label."]
["Calibration","The adjustment of measuring and monitoring equipment to assure that:\n1) for equipment that measures across a range of values, the measurements are accurate across the entire range to the degree of accuracy stated;\n2) for equipment that is used to measure a single point, that the measurement reaches the degree of accuracy stated."]
["Carry-over","Traces of product from the previous product run, which cannot be adequately cleaned from the product line due to technical limitations."]
["Certificate of Analysis (CoA)","A document provided by the supplier which indicates results of specific tests/ analysis performed on a defined lot of the supplier’s product. The tests are done either by the supplier or an external testing firm and shall be based on protocols/ methods that have been approved and agreed by technical experts within MDLZ."]
["Clean in Place (CIP)","A method of cleaning the interior surfaces of pipes, vessels, process equipment, filters and associated fittings, without dismantling or opening of the equipment and with little or no manual involvement on the part of the operator."]
["Clean out of Place (COP)","Clean out-of-place (COP) is defined as cleaning disassembled equipment out of place in a tank or in an automatic washer that has a method of circulating a cleaning solution and capable of maintaining a minimum temperature throughout the cleaning cycle."]
["Critical Control Point (CCP)","A specific point, procedure or step at which control can be applied to prevent, eliminate or reduce a food safety hazard to an acceptable level."]
["Cross-Contact","The introduction of pathogens from a raw product to a cooked product, or the introduction of allergens into a product which are not part of the intended formulation, through environmental conditions. For example, cross-contact may arise from:\n1) traces of product from a previous production run that cannot be adequately cleaned from the production line due to technical limitations;\n2) physical contact at any point in the manufacturing process with products or ingredients that are produced on separate lines, or in the same or adjacent processing areas."]
["Declaration of Compliance (DoC)","A written statement describing the migration potential of the packaging material. Where content is not legally defined, it shall contain at minimum the following elements such as identification of the business operator and the material manufacturer, applied legislation, information about all potential migrants and their restrictions and conditions suitable to use the material safely. Disposition: Determining and authorizing what shall be done with product, ingredient or packaging which has been placed on hold. Examples would include:\n• Accept – may be sold through normal channels\n• May be further processed by rework, repair or reclaim to meet specifications\n• May be accepted, with or without further processing, for alternative applications (re-graded, for example to liquidation or distressed sales).\nReject or scrap. Destruction of products and packaging shall be carried out in a secure manner to prevent recovery or re-use."]
["Dry Cleaning","Any equipment that is not wet cleaned for its regular cleaning but may be wet cleaned on an infrequent basis. Only a limited amount of water is used and drying after this wet cleaning is crucial. Usually with this “controlled” wet cleaning the surrounding production area (e.g., walls, ceilings) stay dry. This includes parts of equipment that are removed and taken to another room for wet washing. Typically dry cleaning is applied in plants producing confections/chocolate, dry mixes (flour, starches, coffee) or dry milk products etc.: sweeping, scrapping, brushing, wiping with proper tools (scraper, brush, broom cloths), vacuum cleaning."]
["Extraneous Matter","Any object or matter that may become part of the product being produced, which is not designed to be part of such product. Extraneous matter may be a foreign object, foreign material or an aberration in the product or product ingredient. Examples may include: metal; stones; wood; plastic; paper and matter inherent to raw materials (e.g., bone, nut shells)."]
["Farm Operations","Growing and harvesting of crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves of, and cooling produce are considered part of harvesting."]
["FEFO/ FIFO","Both these terms describe effective stock rotation systems:\n• FEFO = First Expired, First Out; Describes a stock rotation system whereby items with the shortest remaining shelf life are taken from stock before items with longer remaining shelf life\n• FIFO = First In, First Out; Describes a stock rotation system whereby the first item booked in as stock is taken from stock before items that were booked in later (where the items are the same type)."]
["Food Contact Packaging (also “Primary Packaging”)","This encompasses any physical contact (i.e., solid, liquid, or gaseous exchange) between packaging and food under actual and foreseeable conditions. It includes packaging which has:\n• a surface in direct contact with the food product, and/ or\n• a surface in air contact with the product e.g., material touching another packaging component that is not hermetically sealed (air tight ) or that has low barrier properties, and/ or\n• a surface in contact with the food product after opening"]
["Food Defense","Steps to safeguard the food supply against intentional acts (or the threat of an act), such as a mass contamination or product tampering."]
["Food Fraud","Fraudulent activity in food products such as some forms of adulteration, counterfeiting, diversion and relabeling for purpose of economic gain."]
["Frequency to Demonstrate Control","The frequency to demonstrate control is a frequency which would not likely result in an excursion out of the prescribed limits between the two events."]
["GMO","Genetically modified organism."]
["Government Regulations","The laws and regulations of the location in which products are stored and the laws and regulations of the destination to which products may be shipped."]
["Hazard","A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect."]
["Heavy Metal","Examples: arsenic, barium, selenium, lead, mercury, cadmium and hexavalent chromium."]
["Hold","A status assigned to specified product indicating it shall all remain stopped from normal handling processes until further notice. Synonyms include: quarantined, blocked, segregated, contained, embargoed, etc."]
["Indicator Organisms","Microorganisms whose presence may indicate unsanitary conditions and/ or potential presence of specific pathogens. For the purposes of this standard, indicator organisms for Salmonella in wet environments would include Enterobacteriaceae or coliforms. Indicator organisms for L. monocytogenes would be Listeria genus, or Listeria spp."]
["ISO/TS22002-1 (PAS 220)","Specifies requirements for establishing, implementing and maintaining prerequisite programs to assist in controlling food safety hazards."]
["Lot (Lot Number)","A unique identity given to a defined quantity of a material usually based on time and location of manufacture. For continuous processes, a lot shall not exceed the amount of material produced in one 24-hour period. For non-continuous processes, the batch, blend, shift, or other time segment may be used to identify a lot. For materials received in bulk, the lot is usually identified as the contents of the bulk vehicle."]
["Manufacturing Location","The supplier facility where the ingredient or packaging material is produced and/or packaged into the final product that is sent to MDLZ locations. This includes blending operations, chopping and any direct handling of the ingredient with the potential to introduce physical, microbiological or chemical risks including allergens."]
["Microbiologically Sensitive Materials (also “Sensitive Ingredient”)","An ingredient deemed to be susceptible to contain pathogens or support the growth of pathogens. Sensitivity of an ingredient is based on origin, the manner in which it is processed, and/ or on epidemiological and historical data. Sensitive ingredients are described as such in the micro section of the MDLZ specification."]
["Mock Recall","A simulated recall process. This exercise helps to ensure that traceability procedures are adequate and identify opportunities for improvement in the event of a real recall situation."]
["Mondelēz Global (MDLZ) Contracting Representative","The MDLZ Contracting Representative shall be the primary contact for any contact or notification required by this document. The Mondelēz Global Contracting Representative will vary depending on the region and the product category."]
["Non-Conforming (also \"Non-Conformity\")","Non-fulfilment of a need or expectation that is stated, generally implied, or obligatory."]
["Our","Belonging to Mondelēz Global LLC"]
["Packaging Component","All elements of packaging including adhesives, labels, inks, dyes and stabilizers."]
["PAS 96","Publicly Available Specification 96 available at http://shop.bsigroup.com/en/Browse-by-Sector/Food--Drink/PAS-962010/. Provides guidance on approaches to the protection of food business, of all sizes and at all points in the food supply chain, from all forms of malicious attack including ideologically motivated attack and the procedures to mitigate and minimize the impact of such an attack."]
["Pathogen","A food borne microorganism recognized as a public health hazard that can cause illness or death in humans."]
["Pesticides","Compounds classified as such by the regulatory authorities of the location where materials or products are produced and the destination to which they may be delivered. These include, but are not limited to, fungicides, insecticides, rodenticides and herbicides."]
["Product Retrieval","Any voluntary or involuntary retrieval of product that has been released for distribution."]
["Purchased Materials","Any equipment, services or materials purchased for use in the MDLZ operations."]
["Quality (Management) System","Documented organizational structure, policies, programs and procedures needed to manage product quality."]
["Quality Program","A logical sequence of documented actions designed to assure specific product quality specifications are met."]
["Ready-To-Eat (RTE)","Product in a form which is consumable without additional preparation to achieve food safety (e.g., RTE cheese, RTE raw vegetables)."]
["Recall","Removal of a product from commerce because it is believed to be in violation of applicable law or regulations (e.g., misbranded or adulterated)."]
["Recycled Material","A pre- or post-consumer use material that has been treated, salvaged, refurbished or otherwise reworked for re-use."]
["Regulatory Action","A seizure, embargo, hold of any product or a prosecution, injunction, citation, regulatory letter or notice of adverse findings from a regulatory authority or any federal, state, provincial or local court. Regulatory Agency: State or Government body appointed or authorized to oversee activities of the food manufacturing and supply industry. Examples include European country specific Food Standards Agencies, Trading Standards Agencies, USA agencies such as FDA, USDA, FSIS, and in Canada CFIA."]
["Regulatory Authority","Any duly authorized agent or employee of any government agency empowered to enforce laws relative to food products. Any religious organization which defines requirements for special product certification (i.e., Kosher or Halal)."]
["Regulatory Contact","A visit, inspection, audit, survey, inquiry or other contact by any regulatory authority that results in the identification of objectionable conditions which require a response. This does not include those visits made on a regular basis (i.e., daily, weekly, monthly), unless such a visit reveals a material or product destined for a MDLZ facility is not in compliance with applicable laws or regulations."]
["Release","The action to discharge a product from hold status for use after the cause of the hold has been investigated, and disposition determined."]
["Rework","Any product or product component that fails to make it completely through the manufacturing process in its first pass but is suitable to be returned to the process stream. Rework may include non-conforming product (finished or semi-finished), intermediate material or product used to flush ingredient and product delivery lines."]
["Risk","An estimate of the likely occurrence of a hazard or illness."]
["Sanitation","All actions dealing with cleaning or maintaining hygienic conditions of the facility. This ranges from cleaning/ sanitizing specific equipment to periodic cleaning activities throughout the facility, including plant and grounds cleaning activities."]
["Special Situation","A Special Situation includes any product, facility issue or set of circumstances that has the likely potential, to expose:\n• Consumers, employees or other individuals or entities or the environment to injury, loss, harm or damage, or\n• The company, its employees, products, tangible or intangible assets to serious legal or regulatory liability, severe adverse publicity, sustainable negative public opinion or damage to the reputation of the company, or\n• MDLZ Business Operations to severe disruption."]
["Specification","A detailed documented description or enumeration of parameters, including permissible variations and tolerances, which are required to achieve a defined level of acceptability or quality. An Ingredient/ Packaging Specification contains the required attributes as agreed by Mondelez."]
["Supplier Acknowledgement Report (SAR)","SAR is generated from the approved raw material specification and sent to the supplier for formal agreement."]
["Tankers","Closed bulk haulage."]
["Tolerance","Allowable deviation from the target value of a certified reference or other standard."]
["Traceability","The ability to track materials on a lot number basis up and down the distribution chain; for example, to trace a specific lot of ingredient/ component from the supplier who delivered it, to the product that contains it and to track a finished product to the primary external customer(s) or destination(s)."]
["Validation","Validation is obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome."]
["Verification","The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure is or has been operating as intended– Codex definition\n• Verification in its most simple terms is the actual comparison of design output with design input (settings done during Validation)\n• Verification answers the question “Are we doing what we planned to do?”"]
["Wet Cleaning","Any equipment that is wet cleaned without restrictions in terms of the amount of water or a cleaning solution for its regular cleaning. Not only direct product contact surfaces should be considered, but also surfaces with indirect contact (e.g., splash areas). Typical wet cleaning: CIP (ACS), COP, foam/ gel cleaning, high/ low pressure cleaning."]

{"sheet":"Revision Log","index":35,"n_rows":66,"n_cols":4,"rows_kept":66,"cut":false,"hidden":false,"merged":[[0,0,0,3]]}
["APPENDIX II - REVISION LOG"]
["Revision","Section No.","Section","Main Changes"]
[2020,1,"INTRODUCTION","MG changed to MDLZ throughout the document."]
[2020,1.1000000000000001,"For Brokers, Distributors, Traders","Section reworded to break out more clearly the requirements. Responsible for ensuring warehousing being used is fit for purpose and follows GWP."]
[2020,3.1,"General Audit Requirements","Any discrepancy between MDLZ SQE audit and GFSI audit supplier could be invited to discuss with CPO"]
[2020,3.4,"Audit Requirements for Packaging Material Suppliers","Added additional guidelines to be in line with GFSI requirements."]
[2020,5.0999999999999996,"Notifying Mondelēz Global of Significant Events","Food Fraud added as a requirement, some other wording amendments."]
[2020,5.3,"Food Safety and Quality Culture","New section detailing the need for a program to improve site food safety and quality culture."]
[2020,6.1,"Good Manufacturing Practices","Risk assessment can be completed to adjust GMP requirements depending on product risk."]
[2020,6.3,"Employee Illness and Communicable Disease","Pathogen and disease list updated."]
[2020,6.5,"Equipment Maintenance Controls","Specified maintenance plan should be based on equipment criticality to food safety. Maintenance hand-back procedure should be in place."]
[2020,6.7,"Sanitation Programs","Operating requirements listed for CIP in 6.7.2. Line idle time requirements have been added and requirements for COP."]
[2020,6.8,"Pest Management","The program must be effective"]
[2020,6.9,"Hygienic Zoning","A zoning assessment shall be completed AND documented"]
[2020,6.12,"Food Fraud","New section added on food fraud requirements."]
[2020,7.1,"Specification Compliance and Contract Review","Section 7.1 has been reworded. Timescale added for completion of SAR. Packaging added to the scope of MMP in 7.1.3."]
[2020,7.2,"Incoming Materials: Supply Quality Management","New requirements about validation of the process used to eliminate pathogenic organisms when this step is not performed on the supplier’s facility."]
[2020,7.4,"HACCP","Food Safety Plan referenced in this section, validation section has been reworded with more specific detail."]
[2020,7.5,"Allergen Management","Carry-over levels should be established. Change-overs shall be clearly documented with procedures, visual standards, line acceptance, validation and verification of cleaning."]
[2020,7.6,"Extraneous Matter","More detail on false reject rates and probability of detection. Requirement to record abnormal findings on detection device. Rejection limits to be set and double pass of test piece not mandatory."]
[2020,7.9,"Traceability","Detail on split lots i.e. split lots not to be delivered to more than one MDLZ location unless unavoidable"]
[2020,7.1,"Warehousing and Transportation","New sub section on bulk tanker management and cleaning requirements."]
[2020,8.1,"Internal Audit","Output of internal audits shall be brought to the attention on site leadership."]
[2020,8.3000000000000007,"Rework","Rework control requirements have been split out."]
[2020,8.4,"Hold and Release & Control of Non- Conforming Product","Whole section has been restructured and combined with Control of Non-conforming product. The hold categories are for guide and not mandatory. The Product Retrieval section has been removed and incorporated into this section."]
[2020,8.5,"Corrective and Preventive Actions","Requirements laid out for supplier quality notifications, definitions are referenced Table 12. Root cause analysis added as a requirement"]
[2020,9.1,"Introduction of Packaging\nrequirements","This statement shall be renewed when any change in regulation, composition or production occurs that bring about changes in migration or when new scientific data becomes available or after 5 years which ever sooner."]
[2020,"9.1.1","Packaging Manufacturing","Added Line Clearance Expectation to Avoid Mix-up and Added expectation about bar-code readers and scanners"]
[2020,"9.1.3","Label Control & Print Copy\nVerification","New section added for suppliers to control label processes"]
[2020,"9.2.3","Metal in contact with packaging","New section Added"]
[2020,"9.2.4","Recycled post-consumer material","Functional Barrier point edited for recycled material"]
[2020,"9.2.5","Odor and taste transfer testing","Testing method & acceptance criteria updated"]
[2020,9.4,"Others requirement","All other packaging requirement updated here e.g. Heavy metal, REACH etc. either they were at different places in previous version ."]
[2020,"APPENDIX","Table 1\nTable 8\nTable 11\nTable 12","Packaging Material Audit Matrix updated\nPEM Reference Sampling Plans updated\nList of Packaging regulations, Codes of Practices and Standards updated with current standard\nQN CAPA timelines expectation guideline updated"]
[2023,"ALL","ALL","Document changed to Excel. Tables moved out of Appendix and into the relevant Sections. Requirements broken down and numbered. Language changed from 'must'/ 'will' to 'shall' to indicate mandatory requirements. "]
[2023,1,"INTRODUCTION","List of Processing Expectations updated, including new Extraneous Matter Processing Expectations. Updated terms to have 'shall' to indicate mandatory requirement. Added reference to change in format and filters for raw vs pack. Added term for 'supplier'."]
[2023,1.1000000000000001,"For Brokers, Distributors, Traders","Added requirements for broker/ distributor/ trader to be GFSI certified if their process involved direct food contact. Inclusion of stock rotation management as the responsibility of the broker/ distributor/ trader to ensure. Reiterate requirement that broker/ distributor/ trader shall have the latest version of the MDLZ Specification and to inform MDLZ of questions during SAR process."]
[2023,3.1,"General Audit Requirements","Reference added to PO terms. Correction of terms used to describe 2nd party"]
[2023,3.4,"Audit Requirements for Packaging Material Suppliers","Update Packaging Tiering Matrix. Moved requirements from Section 9.1 in 2020 version into new subsection 3.4.2"]
[2023,4.0999999999999996,"QUALITY SYSTEM CONTROLS","Removed requirements referencing ionization as no longer applicable. Set expectation that approval process of outsourced processes are to be based on risk. Changed terminology from 'product' to 'material' for clarity. Added expectation that MDLZ shall define the approval process for outsourced processes based on risk. Added expectation that the supplier shall notify MDLZ of their intention to use new production lines and equipment for MDLZ production."]
[2023,5.0999999999999996,"Notifying Mondelēz Global of Significant Events","Removed vagueness from wording around suspect that a non-conformance exists in product already shipped. Added expectation that MDLZ is informed in the event that leads the supplier to suspect their product being presumably contaminated with foreign matter in product already shipped to MDLZ. Clarified that in the event of a finished product positive, notification shall be made for presumptive and confirmed results if the line/ equipment is shared with MDLZ; if the line/ equipment is not shared with MDLZ, then notification is to be made in the event of presumptive results. Clarified that in the even of PEM positive, notification shall be made for confirmed results and applies to the whole facility. Added the requirement that notification shall be made at maximum within 24 hours of identifying a significant event and communication shall include MDLZ Supplier Quality. Added the requirement for traceability, root cause and CAPA to be documented and presented to the MDLZ Supplier Quality representative by live communication."]
[2023,5.2,"Regulatory Inspections and Contacts","Removed the requirement for duplicate sampling and added requirement for the MDLZ batch to be placed on hold. Added requirement that a photo of the location of environmental sampling to be taken. Added requirement that notification to MDLZ is to be made within 24 hours."]
[2023,5.3,"Food Safety and Quality Culture","Wording amended to clarify that a food safety an culture plan is to be in place"]
[2023,6.1,"Pathogen Environmental Monitoring","Added requirements for medicines/ pills"]
[2023,6.3,"Employee Illness and Communicable Disease","Updated table of communicable diseases. Wording updated to ensure that employee reassignment would be based on local regulatory requirement. Added requirement for provisions for recognition and identification of symptoms"]
[2023,6.4,"Utilities Management","Update of requirements to consider all hazards, not just microbiological. Added requirements for air monitoring. Updated requirements on air filtration. Added guidance table on Air Quality Guidance for AHU (Air Handling Unit) Installations. Removed exception on materials that do not require air filtration on external tanks, risk assessment required. Updated compressed air and special gases filtration requirements. Updated requirement on special gases purity. Air filtration requirements table updated."]
[2023,6.5,"Equipment and Facility Maintenance","Section title updated to include 'Facility'. Added requirement that type of construction and maintenance works are to be risk assessed"]
[2023,6.6,"Sanitary Design","Added reference to EHEDG and/ or 3A-SSI industry standards and guidelines"]
[2023,6.7,"Sanitation","Added requirement on maximum run lengths. Added requirement on drain size and quantity. Added re-validation requirements for CIP"]
[2023,6.8,"Pest Management","Clarified that the supplier has ownership of the pest control program, even if a PCO is contracted. Added recommendation for PCO to hold membership of recognized industry bodies and the requirement for official licenses where regulations apply."]
[2023,6.9,"Hygienic Zoning","Hygienic zoning definitions updated. Added changeover requirements for lines shared between RTE and non-RTE."]
[2023,6.1,"Pathogen Environmental Monitoring","Updated terms in Exceptions list. PEM table updated."]
[2023,6.11,"Food Defense","Added FSMA requirements for US-based suppliers and suppliers shipping to the US"]
[2023,6.12,"Product Authenticity","Section title and wording changed to cover pack. Added requirement for responsible persons to be knowledgeable in vulnerability assessments. Added more information on controls that could be put in place."]
[2023,7.1,"Specification Compliance and Contaminants Control","Section title updated to include Contaminants Control. Updated specification creation process. Clarified that equivalent analytical methods is the supplier's responsibility and approval from MDLZ is required. CoA requirements clarified with bold text. Added wording to allow for transit time to be used as holding time where agreed. Added requirements around chemical contaminants food safety limits and Codex Standards. Added requirement that MMP can be used to screen potential new suppliers. Added requirement that suppliers are to include monitoring of contaminants in MDLZ risk-based target list. Added total residual solvents requirements for packs. Added chemical restrictions on packaging. Moved requirements from Section 9 in 2020 version. Sensitive ingredients table updated for soy lecithin and heat extruded materials."]
[2023,7.4,"HACCP","Added list of MDLZ CCP Models. Moved requirements from Section 9 in 2020 version"]
[2023,7.5,"Allergen Management","Requirements on Indicative Levels added. Clarified that allergen cleaning validation is to be performed on three consecutive runs"]
[2023,7.6,"Extraneous Matter","Specified situations that require validation of extraneous matter sorting devices. Added more information on strategies for minimizing contamination. Added reference to HACCP Standard for CCP/ sPP devices. Added further requirements frequencies for glass and plastic inspections. Added requirements placement of test pieces. Added wording around re-passing of material. Updated requirements on rejection limits. Updated requirements for situations where minimum test piece sizes cannot be met. Added training requirements for manual sorting."]
[2023,7.8,"Label Control","Moved requirements from Section 9 in 2020 version"]
[2023,7.9,"Traceability","Added calculator for bulk traceability. Added wording that allows for mixed lots only where necessary."]
[2023,7.1,"Warehousing and Transportation","Updated terms in Transport Storage and Conditions. Updated requirements for filtration of compressed air and transport air. Updated requirement for cleaning certificates of previous three loads."]
[2023,8.1999999999999993,"Testing Controls","Updated requirements for laboratories testing PEM samples vs product samples"]
[2023,8.4,"Hold and Release and Control of Non-Conforming Product","Added requirements for Level 1 and Level 2 Hold classifications."]
[2023,8.5,"CAPA","Updated table to clarify differences between Priority levels of QNs"]
[2023,8.6,"Transfer of Constituents from Food Contact Material to Food","Moved requirements from Section 9 in 2020 version. Added requirements for DoC for food contact packaging. Added requirements around recycled material for packaging."]
[2023,"APPENDIX","Definitions","Added definitions for COP, FEFO/FIFO, our, Validation, Verification, Specification. Removed GKIT, quality records, quarantine, transport incident. Updated definitions for CIP, CCP, hazard, indicator organisms."]