PepsiCo Foods North America for the production of Contract Manufactured Foods Issue #4, published March 2019
North America Foods Quality Manual PepsiCo Code of Conduct Guiding Principles State “Sell only products we can be proud of” You should never compromise product quality. We are committed to producing high quality products across all of our brands. We maintain consumer trust by manufacturing superior products, starting with the purchase of our raw ingredients and continuing until the finished product reaches the consumers’ hands. We are also committed to developing new products in an ethical and responsible manner, and to following applicable ethical standards and guidelines relating to research. The PepsiCo Foods North America Quality Systems Manual for the production of Contract Manufactured Foods, is designed to provide Contract Manufacturers and Packagers with guidance to attain this objective. As you read the manual, you will note that it does not detail how to establish food safety and product quality systems. Rather, it identifies the basic programs that are required to fulfill the objective of safe foods and consistent highest quality. Your product and process expertise will allow you to identify the approach best suited to ensure compliance with these expectations. If you are involved in any aspect of developing, handling, packaging, or storing our products, you are expected to: • know the product quality standards, policies, and procedures that apply to the products produced at your location. • follow good manufacturing practices and testing protocols. • comply with all applicable food safety laws and regulations. It is important to always be alert for situations that could compromise our products. If you see something that could negatively affect the quality of a PepsiCo product, speak up and report it immediately. Karl Schraer Supply Chain Senior Vice President The information presented in this manual is proprietary to PepsiCo Foods North America and cannot be transferred or used without written consent from PepsiCo Foods North America. © 2016 PEPSICO, INC. All rights reserved. 2 Supply Chain Quality Control NORTH AMERICA
North America Foods Quality Manual Contents 4Management Commitment 10Regulatory Quality 32 Systems Glossary 48 North America Foods Quality Manual 3
Management Commitment Organizational Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Food Protection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Quality & Food Safety Systems Compliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Crisis Management. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Management Commitment Organizational Responsibility Policy Each Third Party Manufacturer shall have a quality and food safety policy statement. In addition, all Third Party Manufacturing sites must define and identify the individuals within the organization who have responsibility and accountability for quality and food safety with backups identified. Requirements Document the site’s quality and food safety policy statement and include who has the responsibility to: • ensure understanding and compliance with Federal, State or Provincial, and local regulations. • place materials and products on hold. • provide disposition of materials and products previously placed on hold. • initiate actions to prevent the occurrence of any nonconformities relating to product, process, and food safety systems. • manage the Plant Sanitation Program. • monitor and execute the site’s Food Safety Plan. • ensure understanding and compliance with the PepsiCo Foods North America (PFNA) Third Party Manufacturing Quality Systems Manual. North America Foods Quality Manual Back to main contents 5
Management Commitment Food Protection Policy Each Third Party Manufacturer must have a program in place to ensure the safety of all personnel, property, products and information. The program must comply with all applicable Food Safety Modernization Act (FSMA) Intentional Adulteration (IA) rules issued by the Food and Drug Administration (FDA) and/or similar requirements by the Safe Food for Canadians Act (SFCA) (as applicable). Requirements Each Food Protection program must address the following: Intentional Adulteration [applicable to FDA registered facilities] • Identify vulnerabilities and actionable process steps. Actionable process steps are those steps in the process that pose a higher risk of intentional adulteration [applicable to FDA registered facilities] and are most likely to create wide scale public harm. Key Activity Types (KAT) as provided include: • Bulk liquid receiving and loading • Liquid storage and handling • Secondary ingredient handling • Mixing and similar activities • Implement site specific mitigation strategies and procedures at each actionable process step to ensure that vulnerabilities are minimized or prevented. • Establish and implement monitoring procedures and corrective actions. Procedures must define the frequency of monitoring, responsible person(s), and any activity/ corrective action taken if the strategy is not effectively implemented. • Verify compliance to ensure monitoring, appropriate decisions and corrective actions are completed. • Ensure that personnel assigned to the duties receive appropriate training and maintain certain records. Persons assigned to vulnerable (actionable process steps) areas receive appropriate training. Records for food protection training, monitoring, corrective actions, and verifications are all documented. 6 Supply Chain Quality Control NORTH AMERICA
Management Commitment Food Protection Requirements Food Security & Defense The program should include components to assess: • Plant Personnel – includes employees, visitors and contractors. Future employees should be screened for criminal history and key elements of their applications be verified. Drug screening is also recommended where permitted. • Property – includes the building structures and all equipment. Fencing (as required) and access controls should be installed to help ensure only authorized personnel can enter the plant. • Products – includes ingredients, in-process product and finished product. • All items delivered to the plant must be properly documented and checked to ensure that they match the documentation, are properly sealed in the packaging and are in good condition. • Access to ingredients and product in the plant shall be restricted to personnel who work in those areas only. • All shipments from the plant must be properly documented, properly packaged, in good condition before leaving the plant and secured (including seal and seal number). • Information – this includes formulas and recipes, manuals, customer lists, price lists and all other business data. This information should be secured and made available only to those who need it in order to properly perform their jobs. Food Fraud • Each site shall include Food Fraud (economically motivated) as a potential food safety hazard in their Food Safety Plan. • Economically motivated adulteration that affects product integrity or quality, but not food safety, should be addressed in a Food Safety Plan. North America Foods Quality Manual Back to main contents 7
Management Commitment Quality & Food Safety Systems Compliance Policy To maintain approval status as a Third Party Manufacturer, each site shall have audit systems and procedures to ensure compliance with this manual, regulatory requirements, and PFNA specifications. Requirements Internal Audit To ensure consumer and customer satisfaction, internal audits are required to evaluate product quality, food safety and plant security compliance. The Third Party Manufacturer is required to perform audits that: • shall be planned and their scope and frequency established in relation to the risks associated with the activity. • shall be carried out by appropriately trained competent auditors, who are independent from the audited area. • include reports that identify and verify conformity as well as nonconformity. • report results to the personnel responsible for the activity audited. • verify the completion of time bound corrective actions. • maintain a record of all internal audits and associated actions. Third Party Audit • GFSI certification is required for all Third Party Manufacturers and annual certification and full report with corrective actions provided to PFNA. • One unannounced audit per year using the AIB Consolidated Standards for Pre-requisite Programs. • One Regulatory Readiness and Food Protection audit per year. • No ‘termination’ of an audit once audit commences. • Any AIB score below 875 requires an unannounced re-audit within 30-90 days. • A notification upon arrival and summary of all regulatory and third party inspections and results pertaining to all PepsiCo products shall be submitted to PFNA. A corrective action preventive action (CAPA) is required for all findings. • Each Third Party Manufacturer shall comply fully to any audit or program requirements related to product claims (i.e. organic, non-genetically modified organisms (GMO), gluten free, etc.). 8 Supply Chain Quality Control NORTH AMERICA
Management Commitment Crisis Management Policy Third Party Manufacturers shall have a written Crisis Management Plan to effectively manage product safety in order to protect the customer and consumer. The Crisis Management Plan should include provisions to escalate a crisis issue. Examples: • Regulatory involvement • A food safety incident • Media involvement • Product recall Requirements Crisis Management Plan shall include: • Roles and responsibilities • Identification and classification of crisis issue • Standard communication protocols for updates, escalation guideline summaries and postmortems • Procedures to investigate and manage a crisis • Procedures to take action and make adjustments during the crisis • Root cause, corrective action(s), and preventive action plan(s) • Annual updates of the site contact list Reportable Food Registry Notification • Promptly notify PFNA as soon as there is an awareness of a potential reportable issue and prior to submitting a report under the Reportable Food Registry (RFR) involving any PepsiCo product (or ingredient to be used in PepsiCo products). • Provide to PFNA the names of the primary and secondary persons authorized by the Third Party Manufacturer to access the RFR regarding any PFNA product or its ingredients. North America Foods Quality Manual Back to main contents 9
Regulatory Food Safety Plan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Hazard Analysis and Preventive Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Food Allergen Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Process Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Sanitation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Supplier Approval & Ingredient Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Ingredient and Product Receiving & Storage . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Pathogen Environmental Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Foreign Matter Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Pathogen Sensitive Ingredient Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Pest Management Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Good Manufacturing Practices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Corrective & Preventive Action. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Verification & Validation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Product Traceability & Recall. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Record Keeping. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Low Acid & Acidified Foods Manufacturing. . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Regulatory Food Safety Plan Policy Third Party Manufacturers are responsible to ensure that our products are not adulterated or misbranded within the meaning of the Federal Food, Drug and Cosmetic Act (FDCA), as amended, the Federal Fair Packaging and Labeling Act, or within the meaning of any state food and drug law. Each Third Party Manufacturer must comply with all applicable FSMA requirements issued by the FDA and/or similar requirements listed in SFCA issued by the Canadian Food Inspection Agency (CFIA) (as applicable). Requirements 1. Establish a multi-disciplinary Food Safety Team to identify and evaluate, based on experience, illness data, scientific reports, and other information “known or reasonably foreseeable hazards” for each type of food manufactured, processed, packed, or held at the facility to determine whether there are hazards requiring preventive controls (HRPCs). 2. Have a least one person on-site who is a preventive control qualified individual (PCQI). 3. Write and maintain Food Safety Plan for each site process and/or product produced, including multipack operations. 4. Identify and create Hazard analysis, including economically motivated adulteration. 5. Document and maintain line process flow diagram(s) that define the major processing steps. 6. Establish and document preventive controls including, as appropriate: monitoring, corrective actions, verification and validation programs supporting the preventive controls. 7. Construct Supply Chain Program or any HRPCs controlled by suppliers. 8. Institute recall plan. 9. Effectively control associated records. 10. Train Qualified Individuals on an annual basis. 11. Ensure the plan is current for all products and processes and conduct a review of the Food Safety Plan every three years or as changes occur. 12. The Food Safety Plan must be provided to PFNA upon request. North America Foods Quality Manual Back to main contents 11
Regulatory Hazard Analysis and Preventive Controls Policy Facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. Preventive controls must be identified and implemented to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated. Requirements Hazard Evaluation • The hazards identified must be evaluated to assess: • the severity of the illness or injury if the hazard would occur, and • the probability that the hazard will occur in the absence of preventive controls. • The hazard evaluation must consider the effect of the following on the safety of the finished food for the intended consumer: • The formulation of the food • The condition, function, and design of the facility and equipment • Raw materials and ingredients • Transportation practices • Manufacturing/Processing procedures • Packaging activities and labeling activities • Storage and distribution • Intended or reasonably foreseeable use • Sanitation, including employee hygiene • Any other relevant factors 12 Supply Chain Quality Control NORTH AMERICA
Regulatory Hazard Analysis and Preventive Controls Requirements Preventive Controls As appropriate to the facility and food: • Food Allergen Controls • Process Controls • Foreign Matter Control • Sanitation Controls • Supply Chain Controls • Other Controls All preventive control data involving PepsiCo products must be documented. Oversight and management of preventive controls require the following steps , as appropriate: • Monitoring • conducted as appropriate to the preventive control • performed at sufficient frequency to ensure preventive controls are performing consistently • documentation maintained for all monitoring of preventive controls • Corrective actions • Verification • Validation North America Foods Quality Manual Back to main contents 13
Regulatory Food Allergen Control Policy Third Party Manufacturers that produce products containing allergens are required to develop a Food Allergen Control Plan. Procedures must be in place to ensure the products do not contain any of the allergens or sensitizers as listed by the FDA for US product or the CFIA for Canadian product. All ingredients, processes, and packaging must be evaluated to determine if it is necessary to declare the presence of food allergens on the label. Requirements All allergen control data involving PepsiCo products must be documented and provided at a minimum annually and when any change occurs involving allergens within the facility. The allergen management system shall include the following: • Segregation of materials • Product scheduling • Air Flow Management • Use of changeover matrices • Separation of production lines • Dedicated production equipment where possible • Handling practices • Color coding • Control of semi-finished goods or work in process • Rework control • Sanitation practices and inspection • A plant schematic diagram showing segregation of materials, manufacturing lines, and foot traffic patterns for the facility • Proper traceability processes • Correct product & package verification process • Post sanitation allergen protein validation testing - minimum one time per year Corrective Action When allergen contamination is determined to be present, an investigation involving leadership management is required to determine root cause with immediate corrective action taken to prevent recurrence. The investigation and action plan must be shared with your PFNA Quality and Food Safety Manager. 14 Supply Chain Quality Control NORTH AMERICA
Regulatory Process Control Policy In order to manufacture products that meet food safety requirements, each site shall initiate procedures, practices and processes such as cooking, cooling, drying, etc., to ensure the process is understood and controlled. Requirements • Processing equipment must be monitored with key parameters documented. • Process capability for key process attributes must be known (e.g., temperature, dwell times, rpms). • All process control data involving PepsiCo products shall be shared upon request. • Heat Treatment as a Process Control • For production lines where heat treatment is a lethality process control, validation must be completed and overseen by a Thermal Process Authority. • Thermal Validation reports or summary letters shall be provided to PFNA for lines producing PepsiCo brands. • PFNA shall be notified of any formulation, equipment or process changes that may require revalidation of the lethality process control. North America Foods Quality Manual Back to main contents 15
Regulatory Sanitation Policy All PepsiCo products shall be manufactured under conditions and within facilities that are sanitary and in compliance with Good Manufacturing Practices (GMP) and have sound sanitary design. Requirements • Sanitation program construction should include master sanitation schedule (MSS) requirements, color code guidelines, changeover procedures, process validation, and relevant Sanitation Standard Operating Procedures (SSOP). • Formal cleaning schedules must be constructed within PepsiCo Food Safety guidelines and implemented for all areas of production facility at prescribed frequencies (e.g. routine cleaning, periodic infrastructure cleaning, periodic equipment cleaning, MSS daily, etc.), to include ingredient and finished product storage. • Cleaning methods must be documented in clear, easy-to-understand instructions and contain all pertinent information regarding frequency, chemical and concentration, cleaning verification, and responsibility. • As appropriate to the facility and the food; procedures, practices, and processes must be included for: • cleanliness of food-contact surfaces, including food-contact surfaces of utensils and equipment. • cleanliness of non-food-contact surfaces, including floors, drains, walls, ceilings, equipment frames and structures. • prevention of allergen cross-contact and cross-contamination from unsanitary objects and personnel to food, food packaging materials, other food-contact surfaces and from raw product to processed product. • Sanitation frequencies must be set to minimize opportunities for microbial growth or product contamination. • Cleaned and sanitized areas must be inspected for visual cleanliness and no residual moisture (for low moisture food processes) prior to start-up, and be Adenosine Tri- Phosphate (ATP) and/or microbiologically tested (as applicable). • If sanitation activities fail to deliver the specified criteria, the sanitation activities shall be repeated until the specified criteria are delivered. Corrective actions shall be documented and follow existing facility practices. Repeated failures or trends shall result in revision to the frequency and/or procedures which may then require re-verification and updated documentation. • Facilities shall provide adequate resources to execute and support the sanitation program. Resources are defined as but not limited to people, time, equipment, and cleaning, sanitizing or sterilizing agents. • Sanitation procedures must be verified at a minimum annually through a product contact surface swabbing protocol (where applicable). 16 Supply Chain Quality Control NORTH AMERICA
Regulatory Supplier Approval & Ingredient Monitoring Policy Third Party Manufacturers shall have controls in place to ensure purchased ingredients comply with PepsiCo Raw Material Quality and Food Safety Policy, Ingredient Specifications, and applicable government regulations. Requirements • Prior to newly processing, manufacturing, supplying or storing raw materials for PepsiCo, each supplier site must undergo a facility site evaluation to determine approval status. • Comply with the PFNA Microbiological Sensitive Ingredient Program, as applicable. • Have a Certificate of Analysis (COA) acceptance program that encompasses a review and notification process for all ingredients, including pathogen test results. • Suppliers must be approved and all supplier audit & ingredient control data involving PepsiCo products must be documented. • If a Third Party Manufacturer becomes aware that any raw materials are or may become infested, adulterated, contaminated, or otherwise in violation of applicable Laws, or are or may become harmful to persons or property (whether the raw materials are used in the same mode as when delivered or are used in the manufacture of, or otherwise become part of, a product), the Third Party Manufacturer must provide notice immediately to its PFNA Quality and Food Safety manager, including relevant information with respect thereto. North America Foods Quality Manual Back to main contents 17
Regulatory Ingredient and Product Receiving & Storage Policy Third Party Manufacturers shall implement, maintain, and document receiving procedures to address all incoming ingredients, packaging, and vehicles. Requirements • Procedures shall include inspection of incoming raw materials, vehicle (e.g. trailer, rail, truck, etc.) evaluation, incoming bulk material receiving, less than load (LTL) vehicle inspections, and procedures for foreign material, allergens, mycotoxin and pathogen- susceptible raw materials and temperature control issues. • Procedures shall be defined and implemented regarding storage condition inspections. Raw materials and ingredients, including packaging materials, shall be stored and distributed to prevent damage, deterioration or contamination. • Raw materials, work-in-process, packaging and finished products shall be inspected and stored under conditions that meet established PFNA specifications and requirements. • No direct container to trailer floor contact. • No “clear top” trailers. • All raw ingredients and packaging materials shall be rotated and managed, such as First In/First Out (FIFO) or date of expiry. • Refrigerated storage temperature must be routinely checked, documented and monitored with an alarm. • Any ingredient or product spillage observed shall be immediately removed and the source identified to mitigate any pest infestation. • Must comply with sanitary food transportation regulations, when applicable. 18 Supply Chain Quality Control NORTH AMERICA
Regulatory Pathogen Environmental Monitoring Sampling Zones Policy Zone 2 Refers to any non-food contact surface A pathogen environmental monitoring (PEM) program is a required and that is in close proximity essential program when producing Ready to Eat (RTE) foods that are exposed to food and food contact to the processing environment prior to packaging. This program shall be surfaces. used for monitoring effectiveness of sanitation and pathogen controls to Zone 3 Refers to minimize the risk of cross contamination. everything else in the processing area and Requirements includes floors, walls, ceilings, drains, and other Third Party Manufacturers shall comply with this policy by implementing the equipment. PFNA PEM Program or a PepsiCo approved equivalent: Zone 4 Consists of all non-production areas of • The sampling plan must be established based on hygienic zoning the facility. and sampling zones (2, 3, and 4) in combination with number of lines (producing PepsiCo product) and site risk assessment. Hygienic Zoning Primary Pathogen • Samples are collected weekly during manufacturing to represent Control Area (PPCA) normal running conditions. No composite sampling is permitted. Areas after a validated pathogen kill step • Sample analysis shall be conducted using PFNA approved where finished products methodology and laboratory. are exposed to the environment. • The Third Party Manufacturer must have a documented root cause Transition Area (TA) analysis and corrective action to respond to all presumptive and Includes pathways confirmed positive results, which must be shared with your PFNA or entries from a less Quality and Food Safety manager. stringent hygienic area to more stringent area. • PFNA Quality and Food Safety managers must be notified immediately Basic GMP Area of any presumptive positives and confirmed positives via COA. (BGMP) Includes raw receiving and storage All pathogen environmental program data involving PepsiCo products must areas, as well as general be documented and made available to PFNA upon request. food processing areas before the pathogen kill step. Non-manufacturing Area (NA) Includes offices and employee areas such as cafeterias. North America Foods Quality Manual Back to main contents 19
Regulatory Foreign Matter Control Policy Third Party Manufacturers must ensure that finished goods are not contaminated by foreign materials. This prevention is accomplished with proper GMPs, effective sanitary design of the facility and equipment, and the enforcement of appropriate personnel practices. Disposition of any product suspected of containing foreign matter shall only be approved by the appropriate management personnel. Requirements Each Third Party Manufacturer shall, at a minimum, have the following programs in place: • Metal Detection and/or X-ray Program • Magnet and Screen Program • Glass and Brittle Plastic Elimination Program • Knife/Sharp Objects Program • Wood and Wooden Material Control Program All foreign matter control data involving PepsiCo products must be documented. Metal Detection and/or X-ray Program All Third Party Manufacturers shall have functional metal detection and/or X-ray machines with rejection system on every packaging line. Each unit of finished product shall be screened by a working metal detection and/or X-ray machine. Rejection system shall have line-stoppage or auto rejection, and should include an audible alarm and/or visual (light) indicators. Detection trips must be logged for review. Metal detectors and X-ray machines must be capable of detecting the following minimum standards for metal detection size: • Certified test pieces are spherical • Ferrous metal 1.5mm • Non-ferrous metal 2.0mm • Stainless steel 2.0mm • When a metal detector or X-ray trip occurs: • Rejected packages or jars are checked immediately after the detector goes off. Product is rechecked with a functioning off line detector and destroyed regardless of whether foreign matter is found. • When foreign matter is found in the product, a documented investigation shall be conducted to determine the root cause and action taken to prevent recurrence. • Each Third Party Manufacturing plant must address multi trips as a critical issue and address them immediately. 20 Supply Chain Quality Control NORTH AMERICA
Regulatory Foreign Matter Control Requirements Magnet and Screen Program • Each Third Party Manufacturer shall evaluate potential sources for metal and foreign matter contamination and install magnets and screens as applicable. Standardized inspection of these devices must take place and be documented. • Perform annual certifications and magnet pull strength testing where appropriate. Glass and Brittle Plastic Elimination Program All Third Party Manufacturers shall establish a glass and brittle plastic breakage procedure to ensure that raw material, in-process, and finished products are not contaminated in the event of a glass or brittle plastic breakage incident. • The procedure shall include the elimination of all glass in storage, process and packaging areas. • Where glass elimination is not possible, in areas such as lighting, the glass shall be covered with a shatter proof material or equivalent protection. • Glass should be replaced with plastic in each application possible, such as dial covers and chart recorder windows. • In cases where glass cannot be replaced with plastic or cases where brittle plastic is in use, routine documented audits must be conducted to verify compliance with the policy. Knife/Sharp Objects Program • All Third Party Manufacturers shall have policies and procedures to manage and eliminate the source of sharp objects. • A knife control policy and procedure shall be written and monitored. The use of break-off blades in processing and packaging shall be prohibited. Wood and Wooden Material Control Program • All Third Party Manufacturers shall establish a program to eliminate or greatly restrict the use of wood. Wood should not be used in product sensitive areas. Wood can contribute to foreign matter contamination or insect infestation, as well as create an environment conducive to microbial growth that is difficult to clean and sanitize. Wood should not be used in areas that undergo wet cleaning. • Slip sheets are required for double stacked pallets and for any toted material intended for shipping as a semi-finished good. North America Foods Quality Manual Back to main contents 21
Regulatory Pathogen Sensitive Ingredient Program Policy Third Party Manufacturers shall have a Pathogen Sensitive Ingredient Program (PSIP) that identifies microbiologically sensitive and critical ingredients via risk assessment and establishes appropriate monitoring and control measures to ensure the safety of raw materials/ingredients used for the manufacture of products for PFNA. Requirements • A PSIP is in place to monitor ingredients for compliance against microbiological specifications using approved reference methods (i.e., FDA-Bacteriological Analytical Manual (BAM), Health Canada Compendium of Analytical Methods, AOAC International, or International Organization for Standardization (ISO)). • at minimum, a COA must be received for each lot of micro biologically sensitive and critical ingredients which includes microbiological test results, testing methods and units of measure (including sample size) • verification testing must be established as agreed upon with PFNA • the PSIP may be administered by PFNA for critical ingredients • Sensitive ingredient suppliers must be audited by qualified personnel. • No sensitive ingredient is to be released to production until all microbiological testing is completed and meets specification. 22 Supply Chain Quality Control NORTH AMERICA
Regulatory Pest Management Program Policy The Third Party Manufacturer must maintain a pest free, food safe environment through Integrated Pest Management (IPM) proactive intervention programs and procedures. Requirements PFNA requires each Third Party Manufacturer to control the pest population in and around the plant with pest control programs and approved pesticides. • Facilities shall develop, implement and maintain an Standard Operating Procedure (SOP) for monitoring and control of pests. Elements of the SOP should include: Inspection methods, sanitation methods, exclusion methods and a current site-wide map clearly indicating the location and type of rodenticide and pesticide at each location. • Any pesticide or material utilized for the control of insects, pests or foliage (rodenticides, insecticides, pesticides) must be approved by relevant regulatory authorities. All pesticides must be used according to the product label requirements and be registered where required by local government regulations. In addition, the current PFNA corporate approved list of pesticides must be on file. • The facility must use the services of a licensed Pest Control Operator (PCO). All records of monitoring and control activities shall be maintained and reviewed. • Rodenticides shall not be used within any buildings. It is imperative that only licensed personnel perform tasks associated with rodent control. • A list of locally approved pesticides used at the facility shall be maintained at each site. • All pesticides must be stored (if applicable) in locked areas with access strictly controlled. Usage logs of all pesticides must be maintained. • Pesticides must be FDA approved for use in food processing plants and Safety Data Sheets (SDS) must be available. • Insect Light Traps (ILT) (if applicable) must not be positioned within 10 feet close to food and food contact surfaces. North America Foods Quality Manual Back to main contents 23
Regulatory Good Manufacturing Practices Policy PFNA requires each Third Party Manufacturer to understand and comply with CFR Title 21, Part 117 Sub part B—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, OR HOLDING HUMAN FOOD and/or the CFIA Safe Foods for Canadians Division #4 Subdivision A-G (as applicable), each as may be revised from time to time. Requirements Third Party Manufacturer plants must have standardized facilities and procedures where personnel must perform grooming and sanitation tasks required by regulation before entering food-handling areas. Elements of GMP compliance are in place to control foreign matter from entering the production and process environment and at a minimum include: • A well maintained hand-washing area that includes a sink, water that reaches 100°F in one minute, antimicrobial soap and plant approved disposable towels or air hand dryers (as applicable). • An adequate stock of hairnets and beard nets and worn effectively to cover head and facial hair. • An adequate stock of gloves and proper use of gloves for food contact use is trained and monitored (as applicable). • A large non-glass mirror to ensure hairnets properly cover all hair (located before entering production areas). • Personnel who have contagious illnesses and/or infections that could contaminate the product shall not enter the plant floor until those conditions are cured or effectively treated (as applicable). • Personnel must remove all unsecured jewelry and other objects that could accidentally enter the product stream. Plain wedding bands are acceptable if allowed by local plant policy. • Personnel entering food-handling areas of the plant shall always wear plant-approved clothing and carry no items in shirt/blouse pockets. Ideally, uniforms should be provided made of cloth that does not attract hair or lint and have few, if any pockets. • Personnel shall only eat food in designated areas. • All visitors and contractors must comply with all internal GMP rules. 24 Supply Chain Quality Control NORTH AMERICA
Regulatory Corrective & Preventive Action Policy Third Party Manufacturers shall develop and implement a program that will ensure that any nonconformance is identified and investigated, root causes are determined, and effective corrective and preventive actions are implemented. If the preventive controls are not properly implemented or are found to be ineffective, the facility will take appropriate actions to: • reduce the likelihood of a recurrence of the implementation failure. • evaluate all affected food for safety. • not allow any affected food to enter into commerce if the facility cannot ensure that the food is not adulterated or misbranded due to undeclared allergens. Requirements Information such as audit results, quality trending reports, service reports, customer complaint data and other various reports will be used to analyze and mitigate sources of non- conformance. • Actions shall be accurately documented, assigning responsibility and accountability. • Actions shall be undertaken as soon as possible to prevent further occurrence of nonconformity. • Any action plan relating to food safety, legality or quality shall only be agreed by personnel who have a defined responsibility and accountability for these areas of control. • Corrective actions shall be verified and records reviewed within one week. • Corrective actions as a result of the above fore mentioned or any third party or regulatory audit shall be submitted to the PFNA Quality and Food Safety Manager. North America Foods Quality Manual Back to main contents 25
Regulatory Verification & Validation Policy Scheduled verification activities shall be implemented to ensure food safety, process and quality control effectiveness. In addition, records for validation of food safety, process and quality criteria shall be maintained. Requirements The Verification program shall identify methods, responsibility and criteria for evaluation of effectiveness on critical food safety/quality monitoring; all components shall be documented. • Verification of monitoring activities are conducted and appropriate decisions are being made about corrective actions. • Records must be verified within seven working days by a PCQI. Validation records shall stipulate the activities necessary to authenticate these critical quality limits, process controls and any other food safety/quality tests needed. Validation activity must be: • overseen by a PCQI. • conducted within 90 days of first production or within a reasonable timeframe as documented by the PCQI. • done prior to the implementation of the Food Safety Plan. • performed if there are changes that may impact control of the hazard. • performed if the reanalysis indicates a need for it. 26 Supply Chain Quality Control NORTH AMERICA
Regulatory Product Traceability & Recall Policy Each Third Party Manufacturer shall have a system to identify and trace product lots. This includes all raw materials, all stages of processing and the distribution of the finished product to the customer. Requirements Each Third Party Manufacturer must have an Ingredient and Product Traceability program that ensures: • finished products are identified with coding information that is specific to the product, time of production and manufacturing location. • ingredient lots/batches from supplier to customer are accurately traced and reconciled. • all food materials are tracked through lot numbers during usage; records must be maintained. • minimal once per year mock or practice recalls are conducted to test the effectiveness of the traceability program. Mock recall must be completed within 24 hours. • all one-up/one-back records include the date, production time frame, quantity, product description, received from & ship to information, and contact information. North America Foods Quality Manual Back to main contents 27
Regulatory Record Keeping Policy Third Party Manufacturers shall ensure all documents, records and data critical to the management of PFNA product safety, legality and quality are in place and effectively controlled. Requirements • Requirements apply to all records required by 21 CFR Part 117 • Records need to: • be originals, true copies (e.g., photocopies), or electronic records. • contain actual values and observations obtained during monitoring and, as appropriate, during verification activities. • be accurate, indelible, and legible. • be created concurrently with performance of the activity documented. • be as detailed as necessary to provide history of the work performed. • Include: • name and location of the facility • date and time of activity documented • signature/initials of person performing the activity • where appropriate, the identity of the product & production code 28 Supply Chain Quality Control NORTH AMERICA
Regulatory Record Keeping Retention Requirements These are PepsiCo’s minimum standards. If your company, state, provincial or local regulatory agencies require longer, comply to those regulations. Document Type Records Retention Time Process Control Data Two Years Food Safety Exception Reports Two Years Foreign Material Detector Records Two Years Magnet Records Two Years Hazard Analysis Plan Documentation Two Years Pathogen Environmental Monitoring Results Two Years Package Certification 1 ½ times Product Shelf Life Package Weight Control Records 1 ½ times Product Shelf Life Pesticide Records Indefinite Production Schedules Two Years Raw Material Receiving Inspections Two Years Sanitation Self-Inspections Two Years Training Records Two Years Hold Tags, Destruction & Donations Two Years Trailer Inspections Two Years Regulatory Agency Inspections Two Years Traceability One-up/One-back Records Two Years Sensory Records Two Years Documents Related to Import/Export Five Years Low Acid and Acidified Foods Records Three Years (1 Year on Location) North America Foods Quality Manual Back to main contents 29
Regulatory Training Policy Each individual engaged in manufacturing, processing, packing, or holding food (including temporary and seasonal personnel) or in the supervision thereof must be a qualified individual and all training records must be established and maintained. Requirements • Receive training in the principles of food hygiene, food safety, and food protection including the importance of employee health and personal hygiene, as appropriate to the food, the facility, and the individual’s assigned duties. • Regulatory required training (PCQI, Actionable Process Step Individuals, etc.) is completed and documented. • Additionally, supervisory personnel are assigned responsibility for verifying compliance by individuals and establish and maintain records that document training. • GMP Management shall ensure that all employees are trained in the following areas: • disease control • cleanliness - Personal Hygiene • garment control • washing hands • removing jewelry • maintaining gloves, as applicable • covering hair • personal item storage • confining areas where food is eaten or beverages are consumed • Foreign Matter Control: • the operation, testing and calibration of detection equipment • GMPs • Allergen Prevention: • allergen awareness • equipment cleaning and evaluation • rework controls • disposition of rejected product • Hazard Analysis and Preventive Controls: • receive training annually • must have an understanding of Preventive Controls and Critical Control Points (CCP); associated critical limits; measurement methods; operation, testing and calibration of the measuring equipment; and corrective actions to be taken 30 Supply Chain Quality Control NORTH AMERICA
Regulatory Low Acid & Acidified Foods Manufacturing Policy Third Party Manufacturers manufacturing low acid or acidified food must ensure their products are free of viable micro organisms having public health significance, as well as micro organisms of non-health significance capable of reproducing in the food under normal non-refrigerated conditions of storage and distribution. Third Party Manufacturers of low acid foods must comply with low acid manufacturing requirements, laws and regulations of the country in which the product is manufactured and distributed. Requirements A low acid food safety program will ensure compliance with the following elements: • Third Party Manufacturers will comply with a documented scheduled process for the manufacturing of low acid foods which was established by a Thermal Process Authority. • The scheduled process shall document actual thermal processing, sterilizing, and packaging conditions. Actual operating limits shall be specified. • Any deviations to the scheduled process shall result in the placement of product on hold pending investigation and disposition. Investigations shall be conducted under the guidance of a thermal process expert. • All new processes or proposed changes to the scheduled process shall be validated to ensure that the product and package are commercially sterile and hermetically sealed. The validation process shall be defined and approved by a Thermal Process Authority. • All processes must be validated annually by a Thermal Process Authority. • Third Party Manufacturers shall comply with 21 CFR part 113 or 21 CFR part 114 and/or Canadian Processed Product Regulations 30.1 and Canadian Food and Drug Regulations Division 27 for low acid foods (as applicable). • A system that includes an incubation and a product release program must be approved by your PFNA Quality and Food Safety Manager. North America Foods Quality Manual Back to main contents 31
Quality Systems Analytical Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Specification Compliance and Quality Reporting . . . . . . . . . . . . . . . . . . . . . . 34 Sensory Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Aroma & Flavor Mitigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Package Net Weight. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Checkweigher . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Code Dating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Nonconforming Product (Holds). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Rework & Product Pour-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Product Donation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Variance Approval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Consumer & Customer Satisfaction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 R&D Trials, Trade Call, or Sale Sample Product. . . . . . . . . . . . . . . . . . . . . . . . . 45 Change Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Positive Release and Finished Product Testing. . . . . . . . . . . . . . . . . . . . . . . . . 47
Quality Systems Analytical Testing Policy Product, ingredients, in-process and finished product shall be tested to ensure that finished product specifications are met. Requirements Third Party Manufacturers must comply with all analytical testing requirements as defined in the PepsiCo Ingredient, Packaging and Product/Process Specifications. • Analytical testing instrumentation shall have an established calibration program. The calibration program must address and document: • unique identification of instrumentation, calibration procedures, acceptance criteria, procedures for validating results, calibration schedules and records of compliance. • Facilities shall have methods that are validated against primary industry standards for analytical testing. • Facilities shall have procedures to address the integrity of product produced when instrumentation is found to be out of calibration. • Facilities shall have at least one person on site or third party who has received equipment calibration training. • Facilities shall have procedures to ensure proficiency amongst Quality Control (QC) technicians. • All analytical data pertaining to PepsiCo products shall be shared upon request. North America Foods Quality Manual Back to main contents 33
Quality Systems Specification Compliance and Quality Reporting Policy Third Party Manufacturers shall have a program in place to ensure that a completed Quality Report is submitted to PFNA on a monthly basis. Requirements The Quality Report shall contain the following information: • Finished product specification compliance summary results for product shipped. • Product summary data trended over time for key variables and attributes. • An analysis of centering, range and process capability data for all key product variables. • The results of the sensory product evaluation program for each product. • All significant product and process deviations. • All control point deviations resulting in documented corrective actions. • Unit volume reports for each stock keeping unit (SKU). 34 Supply Chain Quality Control NORTH AMERICA
Quality Systems Sensory Program Policy Third Party Manufacturers must have a sensory program in place that identifies flavor, texture and appearance issues that would be considered non-representative of the product design. Requirements • Have at least one person on site that has been trained in sensory evaluations. • Complete and document annual training of key individuals that monitor and control product processes. • At a minimum, sensory evaluations must be conducted at the frequency set within the PepsiCo Product/Process Specifications, and no less than twice per shift and results documented for all products produced. • Products that do not meet sensory product design require documented corrective actions to be taken. • In the event analytical data meets specification but sensory attributes do not, sites must hold product and consult with their PFNA Quality and Food Safety Manager. • Facilities must use a systematic scoring method when evaluating product for sensory attributes. • Best Practice —Train cross functional team members (Mgmt., QC, process operators, maintenance, etc.) and include in sensory evaluations. North America Foods Quality Manual Back to main contents 35
Quality Systems Aroma & Flavor Mitigation Policy Third Party Manufacturers shall have a process to identify, assess, evaluate, and eliminate/ mitigate risks from flavor migration from one product to another. Requirements Each Third Party Manufacturer shall: • survey locations to identify high risk odorants such as: • coffee • menthol/peppermint • maple • cinnamon • jalapeno/hot • evaluate application and transfer methodology such as: • atomize • dusting/topical • baked • verify mitigation steps to ensure that they are adequate in eliminating product contamination. • share data collected during the survey, evaluation, and validation steps with PFNA on an annual basis. 36 Supply Chain Quality Control NORTH AMERICA
Quality Systems Package Net Weight Policy Third Party Manufacturers will provide value to our consumers in terms of quantity of product received. Each site shall adhere to the guidelines set forth in the U.S. Department of Commerce, Handbook 133, entitled Checking the Net Contents of Package Goods and/or Canadian Consumer Packaging and Labeling Regulations, Sections 17-19 (as applicable). Requirements • Average weight must meet or exceed print weight • Achieve less than 10% underweights with no maximum allowable variation (MAV) North America Foods Quality Manual Back to main contents 37
Quality Systems Checkweigher Policy Checkweighers must be used to verify the correct weight and count on all multi-pack units. A documented procedure must be followed which demonstrates the checkweigher accurately reads weights and will reject from the product stream all multi-pack units which do not meet the established weight or count requirements. Requirements • Every multi-pack unit shipped for distribution must be verified for correct weight and count by a checkweigher. • Weight limits for each type of multi-pack unit are established and documented for over- weights and under-weights. • The checkweigher must be calibrated using the certified weights at the start of each shift. All results must be documented. • The checkweigher must be verified for proper operation every two hours using the procedure outlined below: • Verification includes removing one package from a multi-pack unit, placing it in the following multi-pack unit and sending both units through the checkweigher. • Both units should be rejected; the first for under-weight and the second for over- weight. All results must be documented. • Documented training for those monitoring and operating checkweigher equipment. 38 Supply Chain Quality Control NORTH AMERICA
Quality Systems Code Dating Policy Code dates and all printed information on packages must be accurate and readable and in compliance with the applicable PFNA Code Dating Policy. Requirements Third Party Manufacturers shall train packaging personnel to: • print the correct date, codes and other information on packages and cases as specified by PFNA. • ensure that the date, codes and any other information printed on primary, secondary and tertiary packaging are readable and correctly positioned or registered. • monitor and verify the correct code date utilizing a written bag or package certification program. 24 AUG 13 5202237TB06:16 7MAY2019 3.49 579203206 06 21:36 BEST BEFORE 2020 FE 02 10:02 MEILLEUR AVANT North America Foods Quality Manual Back to main contents 39
Quality Systems Positive Release and Finished Product Testing Policy Third Party Manufacturers shall have a Finished Product Microbiological Testing & Product Incubation Policy and written, documented controls in place to ensure that products tested are secured until specification conformance has been confirmed. Requirements • Written procedures and controls must be in place to: • prevent shipment of product undergoing microbiological testing or incubation. • define production and/or lot separation for product undergoing microbiological testing. • PFNA Quality and Food Safety must be notified prior to testing for any products that share equipment with PepsiCo products. • All PepsiCo products that require finished product testing must be tested leveraging PepsiCo approved methodology and Laboratories. 40 Supply Chain Quality Control NORTH AMERICA
Quality Systems Nonconforming Product (Holds) Policy Third Party Manufacturers shall have effective controls in place to prevent the inadvertent shipment of non-conforming products to PFNA, customers, and consumers. A documented program shall be implemented which defines the controls, responsibilities, identification, evaluation, disposition, segregation and notification to affected parties for non-conforming products. This includes (but is not limited to) raw material, ingredients, work-in-progress, packaging and equipment. Requirements The Third Party Manufacturers must have an electronic or physical Product Holds program that: • labels and stores product and product ingredients in a dedicated quarantine area if the product or ingredient is: • a potential food safety hazard. • a regulatory concern. • a quality concern. • conducts inventory assessment on suspect product or ingredients daily until it is determined that the product or ingredient is safe. • documents hold processes. • trains personnel on how to handle and secure suspect product or ingredients. • determines the cause of a hold and documents the corrective actions taken to prevent repeat occurrences. • identifies who is responsible for product disposition or release of product on hold. Product Destruction All product or material to be destroyed must be verified by those with proper authority and the packages must be rendered useless prior to leaving the site location. A Certificate of Destruction must be completed by appropriate site personnel and include supporting photos. The certificate of destruction must be kept on file with a copy sent to PFNA. • A regulatory hold or out of specification product may not be donated to charitable organizations or sold in company stores as a means of disposition. • All non-shippable product held for distribution as animal food without additional processing by the human food processor must comply to Animal Food Preventive Controls (PCAF) regulations. North America Foods Quality Manual Back to main contents 41
Quality Systems Rework & Product Pour-up Policy Third Party Manufacturers shall have controls in place to ensure compliance with product rework and pour-up requirements. Requirements Rework: • PFNA approval must be obtained prior to reworking any product. • Out of spec product cannot be reworked. • Products not meeting food safety cannot be reworked. Pour-up: • Product pour-up is not allowed 42 Supply Chain Quality Control NORTH AMERICA
Quality Systems Product Donation Policy Third Party Manufacturers must have a system in place to control product donations. All product donations must be approved in advance. Requirements • Only PFNA approved food banks may receive finished product donations. • Donated product must be within shelf life and in the proper package. • No regulatory or product quality hold finished products can be donated. • Finished goods must be broken down into loose pack units before donating. • All required documentation must be submitted to PFNA. North America Foods Quality Manual Back to main contents 43
Quality Systems Variance Approval Policy Third Party Manufacturers must have documented procedures for handling deviations from raw material, process, package or finished product requirements and specifications. Deviations shall be captured in a variance and can only be authorized after the approval by designated individuals from PFNA. Requirements Variance approval will include: • authorized PFNA management notification in writing prior to any changes in a formula or process used for the manufacture of products for PFNA. • identification of any effect on ingredient statements, nutritional labeling or functionality of the product. 44 Supply Chain Quality Control NORTH AMERICA
Quality Systems Consumer & Customer Satisfaction Policy Each Third Party Manufacturer shall have procedures in place to monitor consumer satisfaction and to reduce all complaints. Requirements • Consumer data shall be reviewed weekly with site employees and reported in an attempt to identify trends and/or isolated instances where food safety issues or regulatory non compliance may have occurred (as applicable). • Corrective and preventive actions shall be completed as part of the complaint reduction strategy and submitted to PFNA. • Sites will be expected to investigate specific incidents and report back with findings and corrective actions within a required time frame. • Food safety and regulatory issues shall be tracked and escalated to the respective organization for purposes of engagement, resolution and record- keeping. • Third Party Manufacturers must provide contact information for their General Liability Insurance Carrier to PepsiCo Consumer Relations for the handling of tendered complaints. • Third Party Manufacturers shall have a tracking mechanism in place to keep PFNA informed of the progress made in reaching closure on all injury related consumer complaints. North America Foods Quality Manual Back to main contents 45
Quality Systems R&D Trials, Trade Call, or Sale Sample Product Policy Third Party Manufacturers may be required to start-up a new line, a new product on an existing line, or produce trade call sale samples which must meet regulatory, analytical, sensory and microbiological requirements. Requirements • Meet Global Third Party Manufacturing Standards. • Meet all product, packaging and code dating specifications. • Complete all regulatory, analytical, sensory and microbiological tests. • Submit all requested data and review samples to PFNA for approval prior to shipping out any new product. • Dispose of any remaining raw materials following a trade call, sale sample, or plant trial run, as directed by PFNA. 46 Supply Chain Quality Control NORTH AMERICA
Quality Systems Change Management Policy Third Party Manufacturers are required to inform PFNA in a timely manner of any permanent, critical factor changes that may have an impact on quality and food safety of the product. These changes shall be reviewed and approved as a part of the change management process. Requirements Assigned personnel of Third Party Manufacturing facilities initiate the process by submitting the Global Change Management Request form to the PFNA Quality and Food Safety Manager for any change, including, but not limited to the following: • Building Infrastructure or Location • Equipment • Raw Materials and Package Specifications • Processing Parameters • Food Safety and Quality Programs • Staffing North America Foods Quality Manual Back to main contents 47
Glossary Glossary Acidified foods: Products that are naturally Sanitation Controls: Procedures, practices, high acid to a pH of below 4.6 and processes to ensure the facility is Low Acid Food: The pH refers to the degree maintained in an appropriate sanitary of acidity in a food and it is measured with condition adequate to significantly minimize a pH meter. Foods with a pH 4.6 and above or prevent hazards such as environmental and a water activity of greater than 0.85 are pathogens, biological hazards due to classified as low acid. employee handling and food allergens. Hot Fill & Hold: A method of pasteurizing Audit: An assessment of a Third Party acidified or acid foods where hot product is Manufacturer facilities for compliance, filled into the container, sealed and held for effectiveness and improvement in a short period of time to provide heat to the accordance with PepsiCo Foods North container prior to cooling. America policies and procedures. Allergens: Foods or food constituents Rework: Product which will be added back known to produce allergic reactions in an to a production run in the processing area. at risk or high risk subpopulation. (milk, Pour-up: Product which will be added back eggs, fish, crustacean shellfish, tree nuts, to a production run in the packaging area. peanuts, wheat, soybeans). Trade Call/Sale Samples: Product samples Risk: An estimate of the likely occurrence of a that are shipped to the field team to sell-in to hazard or illness. retail customers. Hazard: A biological, chemical or physical Quality System: Organizational structure, property that may cause a food to be unsafe policies, programs and procedures needed to for consumption. manage product quality. At risk or high risk subpopulation: Preventive controls qualified individual: The part of the population with increased A qualified individual who has successfully susceptibility to a potential hazard. completed training in the development and Pathogen: A food, water or airborne application of risk-based preventive controls organism of public health significance that at least equivalent to that received under can cause illness in humans. a standardized curriculum recognized as Foreign Matter: Any foreign object or adequate by the FDA or is otherwise qualified material that is not intended to be part of the through job experience to develop and apply product (e.g. glass, metal, plastic, wood, rust, a food safety system. dirt, rocks, paper, cloth, insect parts, rodents, Hazard Analysis: Process to identify a hair, feathers). known or reasonably foreseeable hazard (biological, chemical/radiological, and physical) of which includes an assessment of the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence 48 Supply Chain Quality Control NORTH AMERICA
Glossary of preventive controls. The Hazard Analysis Lot: A defined quantity of a product or must also take into account economically ingredient produced within a given time motivated adulteration. The Hazard Analysis period or using a specific piece of equipment. shall be prepared and signed by a Preventive Qualified individual: A person who Controls Qualified Individual. has the education, training, or experience SMOP: Significantly minimized or prevented. (or a combination thereof ) necessary to Hazard Requiring a Preventive Control: manufacture, process, pack, or hold clean and A known or reasonably foreseeable hazard safe food as appropriate to the individual’s for which a person knowledgeable about assigned duties. A qualified individual may be, the safe manufacturing, processing, packing, but is not required to be, an employee of the or holding of food would, based on the establishment. outcome of a hazard analysis, establish one Supplier Audit: The systematic, or more preventive controls to significantly independent, and documented examination minimize or prevent the hazard, as (through observation, investigation, records appropriate to the food, the facility, and the review, discussions with employees of the nature of the preventive control and its role audited entity, and, as appropriate, sampling in the facility’s food safety system. Includes and laboratory analysis) to assess a supplier’s an assessment of the severity of the illness or food safety processes and procedures. injury. And the probability that the hazard will Gov’t Regulations: The laws and occur in the absence of preventive controls. regulations of the location in which products Critical Control Point (CCP): A point in a are produced and the laws and regulations process at which controls can and should be of the destination to which products may be applied to prevent, eliminate or minimize a delivered. potential food safety hazard. Materials: Ingredients or packaging Sensitive Ingredient: An ingredient known purchased for use in the production or to have been associated with a biological packaging of products for PepsiCo Foods hazard (based on origin, historical and North America. epidemiological data) and for which there is a Validation: Validation means obtaining and reason for concern. evaluating scientific and technical evidence Critical Ingredient: A sensitive ingredient that a control measure, combination of that is used in a product that does not receive control measures, or the food safety plan an inactivation step during processing. as a whole, when properly implemented, Traceability: The ability to establish the is capable of effectively controlling the production history of all components of a identified hazards. product lot and the complete disposition of Verification: Verification means the that lot (where and when shipped, used or application of methods, procedures, tests and destroyed). other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the food safety plan. North America Foods Quality Manual Back to main contents 49
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