Title Page

  • Final Audit Score

  • Site

  • Facility
  • Conducted on

  • Participants

  • Assessor(s)

  • Assessor(s)

  • Type of Audit

Final Audit Score Outline

Final Audit Score Outline

  • Total Number of Recommendations

  • Total Number of Minors

  • Total Number of Majors

  • Total Number of Criticals

  • Total Number of Repeat Findings

Scoring Summary

Scoring Information

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  • If not corrected, repeated findings from the previous year will result in an escalation.
    Example: Section 7.2 .2 documented in 2022 as a Recommendation. Section 7.2.2 observed in 2023 as a Recommendation but due to this being a repeat it will be documented as a Minor.

  • A Critical finding results in an auto-failure for both the section and overall assessment. A re-assessment is required within 90 days.

1.0 Senior Management Commitment

1.1 Management Responsibility

  • 1.1.1 The site shall have a documented Food Safety, Quality and Regulatory Compliance Policy Statement which states the site's commitment to meet its obligation to produce and supply safe, legal, and authentic products to the specified quality and its responsibility to its customers. The policy includes: - site's intention to comply with all customer and regulatory requirements in the country where products are manufactured and also in markets products are exported to - site's commitment to continually improve food safety, quality and regulatory compliance management systems -site's commitment to assess and improve the food safety and quality culture -site's commitment to effective food defense and food fraud prevention. This Policy Statement shall: -be signed by the person with overall responsibility for the site -be displayed in prominent locations and effectively communicated to all site personnel in the languages understood by all site personnel -be reviewed at least once per year or when major changes are made in the organization. Method used to communicate the policy shall be stated in the Policy Statement. All employees shall be aware of the policy and should be able to demonstrate understanding of the Policy Statement. Written communication from managment to production employees encouraging feedback is present. Note: Even if the company has a company-wide FSQR Policy, the local facility must have a facility Policy Statement. Identification of objectives, key indicators and method to measure them. Senior management shall designate PCQI practitioner.

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  • 1.1.2 The company's senior management shall provide, document human & financial resources required to implement and improve the processes of the quality management, food safety / HACCP plan, infrastructure and quality culture. This includes: - availability of resources - adequate staffing - skill and competency level - training & documentation and resources including: - maintenance for production - suitable equipment - allocations of budget for food safety - HACCP training. The food safety and quality systems are designed, implemented and maintained. The plan shall also include behaviors needed to achieve the intended positive culture change. This shall include: - defined activities involving all sections of the site that have an impact on product safety. As a minimum, these activities shall be designed around: - clear and open communication on product safety - feedback from employees - behavior changes required to improve product safety processes - performance measurement on product safety, authenticity, legality and quality related activities - an action plan indicating how the activities will be undertaken and measured, and the intended timescales - a review of the effectiveness of completed activities. Site management shall ensure departments and operations are appropriately staffed.

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  • 1.1.3 There shall be clear communication & reporting channels to Sr. management for departments responsible for monitoring compliance. Each department responsible for compliance shall show evidence that they regularly report compliance to and deviations from targets. These objectives shall be: - documented and include targets or clear measures of success - clearly communicated to relevant staff - monitored and results reported at least quarterly to site senior management and all staff.

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  • 1.1.4 Senior Management shall establish food safety, authenticity, legality and quality objectives. These objectives are established, documented, monitored and reviewed at least quarterly with relevant staff. Significant food safety metrics shall inlcude: - environmental analysis - operators hygiene measures - microbiological analysis/ pathogen testing on products - identification of food safety risk /zones - customer complaints - continuous improvement

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  • 1.1.5 Senior Management shall ensure that there is a process to identify and address any safety, legal or regulatory issues at a strategic level. There shall be clear communication & reporting channels to Sr. management for departments responsible for monitoring compliance. Each department responsible for compliance shall show evidence that they regularly report compliance to and deviations from targets. Targets for food safety & quality and other key performance indicators, such as cost and productivity are equally measured. The site shall have a demonstrable meeting program which enables food safety, authenticity, legality, and quality issues to be brought to the attention of senior management. These meetings shall occur at least monthly. The company’s senior management shall have a process for assessing any concerns raised. Records of the assessment and, where appropriate, actions taken, shall be documented. Serious issues shall be addressed at the Senior Management level up to Corporate office. Implications to the company’s business are adequately addressed so changes may be made when necessary.

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  • 1.1.6 Organization chart & supporting documents shall provide a snapshot of how positions interact & share responsibility for Food Safety. (Org. chart, Job descriptions & backup personnel or other on a separate document). The interrelationship between FS & Quality must be defined. It shall be clearly documented who deputizes in the absence of the responsible person. A process is in place to ensure the integrity of food safety & quality management systems is maintained in the event of change within the company. Includes organizational or management change. Job descriptions that define food safety and quality responsibilities shall be documented (personnel performing key process steps and responsible for achieving quality requirements shall be documented and include provisions for coverage in the absence of key personnel). - The supplier will establish a food safety culture program at all levels of the organization. Senior management will provide evidence of the commitment to implementing and maintaining the organization's food safety culture. - Guidelines: Personnel roles, responsibilities and authorities for food safety and quality management are well defined, communicated and understood. - A member of the site's management team (and a designee) must be nominated having overall responsibility for compliance with SQMS standards and McDonald's Global and Market requirements.

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  • 1.1.7 There shall be a current version of any standards the site is audited against (BRCGS, Conagra, YUM!, GSF Readiness Assessment, SQF, Global GAP, or other programs approved by the customer.etc.).

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  • 1.1.8 Most senior Production or Operations manager shall participate in the opening and closing meetings of this assessment and be available during the audit for a discussion on effective implementation of the food safety and quality culture plan.

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  • 1.1.9 Operations manager or above shall accompany auditor during facilities walkthrough. The site is expected to be prepared to meet requirements at all times and to have appropriate team members available.

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  • 1.1.10 Operations, QA or any manager shall accompany auditor during QA & Sanitation walkthroughs.

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  • 1.1.11 Last GFSI audit CAPA completed according to established timeline. Note: Verification of CAPA to be performed during the plant visit.

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  • 1.1.12 Previous year's Readiness Assessment CAPA was submitted within 28 calendar days after final report was issued (variances requested and proof present, if applicable). All corrective actions have been completed according to established timelines.

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1.2 Management Review

  • 1.2.1 Senior management shall take responsibility for the review process, ensuring that a complete management review of the Food Safety (including HACCP) & Quality Systems occurs. All management reviews must have a formal agenda to cover the following items as a minimum: - customer requirements - operations - maintenance - effectiveness and - ongoing improvement The review process shall be undertaken at planned intervals, at a minimum of annually, to insure critical evaluation of the food safety plan & the HACCP system's suitability, adequacy and effectiveness.

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  • 1.2.2 Records of management reviews shall be comprehensively documented and retained. Reviews shall include, at a minimum: - internal, second party and third party audits - previous management review documents - action plans & timeframes - customer performance indicators - complaints and feedback - incidents (including both recalls and withdrawals) - corrective actions - out of specification results & non-conforming materials - process performance and deviation from defined parameters - reviews of the HACCP based system - review of latest quality culture surveys - food defense and authenticity - quality culture - previous managment review and action plan - legislative compliance - to include changes (and upcoming/potential changes) to legislation. - developments in scientific information associated with the products within the scope - customer specifications - microbiological results including the enviornmental monitoring program - allergen verification results (where applicable - foreign material results - emerging risks - resource requirements. Corrective actions, and timescales for their implementation, shall be agreed and their completion verified. As a minimum a summary of the results shall be reviewed in the management review meetings

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  • 1.2.3 Decisions and actions agreed upon within the review process shall be effectively communicated to appropriate staff, and actions implemented within agreed timeframes. Records shall be updated to show when actions have been completed. As a minimum the following must be included: - formal minutes - action tracker and timelines - specific responsibilities (single person) for all actions

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2. 0 HACCP/Food Safety Program

2.1 HACCP/Food Safety Team

  • 2.1.1 - A HACCP Food Safety Team is formed consisting of cross functional relevant skills and knowledge. - The HACCP Food Safety Team members have documented qualifications and training in the principles of HACCP. - A HACCP Food Safety Team Leader is present and has documentation of competency. This is by documentation of an industry recognized HACCP training course and demonstrated knowledgeable of the HACCP Plan and systems. - The lead individual who is responsible for the maintenance and updating of the HACCP program has had formal HACCP (or PCQI) training - For FDA plants, the Team leader is a Certified PCQI (Preventative Control Qualified Individual). - For sites complying with SQF criteria, the facility is to have a list of all McD's product made at the facility being audited. A Primary and substitute SQF practioner shall be designated for each site.

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  • 2.1.2 The HAACP Food Safety Team or designated person meets at a frequency that is sufficient to maintain the Plan(s), and when any changes in: -operations -structure -engineering or -formulation occur which may affect Food Safety. The process includes changes to raw ingredients and packaging that may affect Food Safety. The team's activities and meetings shall be documented and communicated to relevant personnel.

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  • 2.1.3 The HACCP Food Safety Team shall verify and validate the HACCP/Food Safety Plan a minimum of once per year even if there are no changes. This shall be documented and include: - Flow Diagram - CCPs - Critical Limits - Corrective Actions - Monitoring procedures - Scientific literature and - Validation. This includes any change to process flow, emergence of a known adulteration of an ingredient, following a recall or as identified as an emerging risk. A written revision history that includes the reason for the change(s) shall be maintained. Verification shall occur annually or when any of the following occur, but is not limited to: - Change in ingredients and/or recipe, - Change in processing conditions - Process flow or equipment, - Updated or new processing line for product - Change in food contact packaging - Storage or distribution conditions - Change in consumer use of finished product - Emergence of a new risk (e.g. known adulteration of an ingredient) - Responding to customer complaint reviews to prevent reoccurrence - Following a recall/withdrawal - New developments within industry including scientific information associated with ingredients, process or product. Food Safety Risk Assessments must addresses all potential hazards. Includes hazards identified by HACCP program and also potential hazards related to and include, but are not limited to: - Food allergens - Foreign material - Sanitation - Suppliers - Environment and others. A risk assessment is a thorough evaluation of the likelihood that a foreseeable hazard could be present and the severity this would have on a consumer. The HACCP food safety team shall specify and document the corrective action to be taken when monitored results indicate a failure to meet a control limit, or when monitored results indicate a trend towards loss of control. See RA 2.2.7 Dairy: YUM! FSAL 13.2 5 Only dairy products produced from pasteurized milk shall be used. In any case where unpasteurized dairy is considered, a risk assessment is required and use shall be approved by the Global Food Safety Council

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  • 2.1.4 The plan must be verified and validated before the product is mass produced. The food safety team shall validate all of the critical limits to ensure the level of control of the identified food safety hazard(s) and that all critical limits and control measures individually or in combination effectively provide the level of control required Validation includes (this is not an exhaustive list): - Internal audits - Review of records where acceptable limits have been exceeded - Review of compaints by enforcement authorities or customers - Review of incidents of product withdrawel or recall. Results shall be recorded and communicated.

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  • 2.1.5 All personnel who enter production areas should have adequate training about the importance of health and hygiene in preventing contamination of food and food production areas; - Human resource personnel should have training adequate to enable them to ensure that all personnel receive training necessary to perform their assigned functions. - Personnel with responsibilities for purchasing should have adequate training regarding the importance of applicable food safety specifications and supply-chain controls (with associated supplier approval and verification activities) for the raw materials and other ingredients that they purchase. - Personnel with responsibilities for receiving raw materials and other ingredients should have adequate training regarding the importance of inspecting shipments at receipt and using proper storage conditions, including when applicable refrigeration and segregation (e.g.,when applicable, segregation of raw foods from RTE foods and segregation of foods with different food allergen profiles). - Personnel with responsibilities for maintenance should have adequate training regarding the potential for maintenance activities to introduce contamination or lead to allergen cross-contact. - Personnel with responsibilities for cleaning and sanitizing the plant, including food-contact surfaces, should have adequate training regarding each step in the cleaning/sanitizing process and actions to take if there are visual observations or other indication that a step was not performed correctly or was not effective. - Personnel with responsibilities for food production should have adequate training in the procedures for food production, including the importance of each step in production and actions to take if there is a problem during production. - Personnel with responsibilities for sampling surfaces for environmental pathogen should have adequate training in the procedures for collecting the samples. - Personnel with responsibilities for laboratory testing of food or environmental samples should have adequate training in conducting that laboratory testing. - Supervisory personnel should have adequate training in the procedures, included in the food safety plan, applicable to their supervisory responsibilities. - Plant management should have adequate training in the food safety plan as a whole.

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  • 2.1.6 All management demonstrates knowledge of the HACCP/Food Safety plans and CCPs in each of their areas of responsibilities. The relationship between HACCP and legal compliance is understood. Employees monitoring CCPs are aware of CCPs and the critical limits in their area(s) and what action to take if the limit(s) are exceeded. (Determined through both interview and training records review). The HACCP / Food Safety plan team will be assessed.

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2.2 HACCP/Food Safety Plan follows Codex or NACMF requirements

  • 2.2.1 A description of the product is present considering all aspects that may affect food safety. The description/scope contains: - Composition (ingredients) - Target consumer - Consideration of vulnerable populations (infants, elderly, allergen suffers) - Physical and chemical properties impacting food safety - Processing - Packaging - Storage - Distribution - Shelf life - Instructions for use (intended use as well as any alternative uses), and - Consider misuse. - Country of Origin for Raw Materials and Packaging (if filed in external source, then must specify) Where any processes are outsourced, including production, manufacture, processing or storage, the risks to the product safety, authenticity, integrity, legality and quality shall form part of the site’s food safety plan (HACCP plan). For SQF Facilities ONLY: Shall include a list of the products covered under the scope of the certification.

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  • 2.2.2 An accurate flow diagram of the process containing all inputs and outputs, and CCP's is present. The HACCP food safety team shall verify the accuracy of the flow diagrams by on-site audit and challenge at least annually and whenever there are changes which may affect food safety. CCP (s) are identified in the process flow chart. Documentation of verification by the HACCP Food Safety Team is present for the diagram. Current flow diagram is signed & dated by HACCP team members. Included should be: -Site map of the premises, including equipment layout -Water distribution diagram for the site, including steam. - Raw Materials - Utilities - Packaging -Area zones (including high risk, high-care or ambient high-care) -Intermediate / semi-processed products -By-products (e.g. rework, recycle) -Waste. GSF Corp: Pre-weigh / Kitting process to be included in the process flow. Some of the components don't have to be in the actual HACCP/Food Safety plan on file, it could be part of the verification and validation by the team.

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  • 2.2.3 Documented, risk based hazard analysis for each process step identifying all potential hazards and measures to control the hazards is present. Justification for exclusion or evidence of the effectiveness of an alternative control measure must be documented. Hazards to be considered include: -Microbiological: Microbiological contamination control measures must be validated, documented, and implemented for any known and potential microbiological hazards. The control measures shall be reviewed whenever there are changes to the product, processes, or when a new hazard is identified in the industry. -Physical contamination -Chemical -Radiological contamination - for incoming ingredients and facility location to radiological sites -Fraud (e.g. substitution or deliberate/intentional adulteration) -Malicious contamination of products -Allergen risks It shall also take account of the preceding and following steps in the process chain. Hazard analysis shall take into account: -Likely occurrence of hazard -Severity of the effects on consumer safety -Vulnerability of those exposed -Survival and multiplication of micro-organisms of specific concern to the product -Presence or production of toxins, chemicals or foreign bodies -Contamination of raw materials, intermediate/semi-processed product, or finished product.

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  • 2.2.4 Risk assessments shall contain: -Ingredients (or group of raw materials), -Packaging (Food Contact) -Allergens (content or potential contamination) -Country of origin. Consider: foreign-body risks -Microbiological contamination -Chemical contamination -Variety or species cross-contamination, -Substitution or fraud -The storage location of where these assessments are filed needs to be documented in the HACCP / Food Safety Plan. -Risk Assessment justifications and hazards must match the Hazard Analysis if it is deemed a hazard. -Any risks associated with raw materials which are subject to legislative control or customer requirements. -Reference to reviewing FDA Appendix 1 needs to be documented in the HACCP / Food Safety Plan. Consideration shall also be given to the significance of a raw material to the quality of the final product. The risk assessment shall form the basis for the raw material acceptance and testing procedure and for the processes adopted for supplier approval and monitoring. The risk assessment for a raw material shall be updated when: -There is a change in a raw material or the processing of a raw material or the supplier of a raw material, if a new risk emerges, following a product recall or withdrawal, where a specific raw material has been implicated, at least every 3 years. Note: Country of origin is important for consideration of fraud. The site must have a written Vulnerability Assessment Critical Control Points (VACCP) process that identifies vulnerabilities (such as the potential for counterfeiting, dilution, mislabeling and intentional Adulteration) along with associated mitigations or corrective actions. The methodology used to develop the VACCP plan must be traceable to recognized science. The assessment shall be documented and reviewed periodically.

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  • 2.2.5 CCP's/Preventative Controls shall be established at the proper process step with a critical limit to control the hazard. A documented monitoring procedure for all CCPs and preventive controls (if facility is under US FDA's jurisdiction) shall be present. For each CCP, the appropriate critical limits shall be defined in order to identify clearly whether the process is in or out of control. Critical limits shall be: - measurable wherever possible (e.g. time, temperature, pH) - supported by clear guidance or examples where measures are subjective (e.g. photographs)

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  • 2.2.6 Validation is present for all CCP's/Preventative Controls and Critical Limits. Literature, challenge studies, in-process studies, etc. can all be used to validate CCPs/Preventative Controls. Validation must be present whenever the HACCP Food Safety Plan is changed. See RA 2.1.4 for details. The HACCP plan is validated, revalidated, and reviewed when product/process changes occur. If there have been no changes, the HACCP plan must be reviewed annually. Records are maintained.

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  • 2.2.7 Corrective Actions for any deviations beyond the critical limits are documented. Methods & responsibilities outlining how immediate corrections & corrective actions are investigated / resolved / managed shall be in evidence. Corrective Actions include root cause analysis and a permanent corrective actions. Records are analyzed for trends, then reviewed and signed by qualified management staff, to prevent reoccurrence.

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  • 2.2.8 Verification procedures are written for the HACCP Food Safety. Plan to include: - Flow Diagrams - Validation - Scientific data - CCP's / Preventative Controls - Monitoring effectiveness completed a minimum of yearly. Other verifications such as line audits and records may occur as frequently as daily.

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  • 2.2.9 A verification schedule shall be prepared and implemented for each activity. The schedule shall include: - Verification activities - Frequency of completion - (Designated) person responsible for each activity - A log of each of the activities. Results of verification shall be recorded and communicated to the HACCP food safety team. Record keeping and documentation is sufficient to demonstrate the HACCP controls are established and effective.

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  • 2.2.10 - All revisions to the HACCP Food Safety Plan are documented. Documentation includes a record of the reason for any changes or amendments to documents. - Changes to HACCP programs that impact customer products or are in conflict with existing specifications shall be approved by the customer prior to implementation.

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2.3 HACCP/Food Safety Plan Implementation and Execution

  • 2.3.1 CCP monitoring and documentation follows the HACCP Food Safety plan. Gaps in records indicate the reason. CCP / Preventive Controls checks are evaluated for continuity. Review of records, where acceptable limits have not been achieved, corrective actions for issues found are on file. Any gaps in records indicate the reason (e.g. line down). CCP / Preventive controls checks are evaluated for continuity.

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  • 2.3.2 HACCP / Food Safety records are present and include the date, time and result of the measurement. A Pre-shipment review/verification signature / intitals and date are present on all records. Where records are in electronic form, there shall be evidence that records have been checked and verified.

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  • 2.3.3 HACCP Food Safety deviations are recorded and communicated daily. Documented corrective actions containing root cause analysis and verification exist.

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  • 2.3.4 Corrective actions resulting in Holds, Recovery or other actions must have proper disposition and records. There shall be a procedure for handling and correcting failures identified in the food safety and quality management system. The corrective action records are reviewed and signed using initials or signature and dated by qualified management staff and analyzed for trends, to prevent reoccurrence. Completed root cause analysis and handling of preventive action shall be in evidence. The corrective action process shall include: -Clear documentation of the non-conformity -assessment of consequences by a suitably competent and authorised person -The corrective action to address the immediate issue -Completion of root cause analysis to identify the fundamental cause (root cause) of the non-conformity -Appropriate timescales for corrective and preventive actions -The person(s) responsible for corrective and preventive actions -Verification that the corrective and preventive actions have been implemented and are effective. Root cause analysis shall also be used to prevent recurrence of non-conformities and to implement ongoing improvements when analysis of non-conformities for trends shows there has been a significant increase in a type of non-conformity. The site shall ensure that any out-of-specification product is effectively managed to prevent unauthorised release.

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  • 2.3.5 The Facility's HAACP and Food Safety Plans are audited by a third party at least once per year. If required by law or the customer, a HACCP certification for the facility is present or, if in the USA a HACCP PCQI certification. Records shall be present.

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3.0 Food Safety & Quality Systems

3.1 Food Safety and Quality Plan

  • 3.1.1 All food safety and quality monitoring (not already documented in a HACCP Food Safety Plan) must have written procedures, which contain: -Person responsible -Frequency -Limits and corrective actions taken when those limits are exceeded. Monitoring must also be documented. Shall include: -Food Safety and Quality Policies (documentation that outlines the methods and procedures) -Processes and procedures comprising the Quality and Food Safety manual All polices and procedures must take account of and reference: -Customer requirements and expectations -Quality awareness with clear objectives -Applicable laws and regulations (as applicable in the country of manufacture and any countries exported to) -Clear identification of the person(s) responsible for approving changes to these documents Senior management has authorized and signed food safety and quality policies. The facility must be able to demonstrate that they have developed and maintained all documented procedures required for a food safety and quality management system. Documented procedures should show how the facility meets customer and local requirements. The facility must be able to show that they have access to laws and regulations by either having electronic access or maintaining a current list of laws/regulations.

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  • 3.1.2 Each pre-requisite program / preventive controls must be validated, verified and must be signed off by the specific expert (SQF/QS-FS designee) indicating that the verification and validation have been completed. Frequency (at least annually) & methods used to validate food safety fundamentals are documented and meet their intended purpose. As a guide these may include the following, although this is not an exhaustive list: -Cleaning and sanitizing -Pest management -Maintenance programs for equipment and buildings -Personal hygiene requirements -Staff training -Supplier approval and purchasing or Supply Chain -Transportation arrangements, including receiving and shipping -Processes to prevent cross-contamination -Allergen controls management -Chemical control -Environmental monitoring program -Traceability / Recall -VACCP -TACCP -Good Agricultural Practices (where applicable),etc.

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  • 3.1.3 The site shall have a documented procedure for handling and correcting failures identified in the FS & Quality system. Where a non-conformity places the safety, authenticity or legality of a product at risk, or where there is an adverse trend in quality, this shall be investigated and recorded including: -Clear documentation of the non-conformity -Assessment of consequences by a suitably competent and authorized person. Include: -The corrective action to address the immediate issue -Completion of root cause analysis to identify the fundamental cause (root cause) of the non-conformity -Appropriate timescales for corrections and corrective / preventive actions -The person(s) responsible for corrections and corrective / preventive actions -Verification that the corrections and corrective / preventive actions have been implemented and are effective. -A continuous improvement program shall be established for addressing failures. The program shall: - Define the process used for continuous improvement. - Define the measurement and tracking tools used. - Define goals and objectives. - Provide for performance to be measured against those goals.

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  • 3.1.4 Product quality risk assessments shall be developed, effectively implemented and maintained in accordance with a risk-based method such as HACCP for all product categories produced by the supplier. The product quality risk assessment shall be independent from the food safety HACCP plan and must identify quality threats, key quality control points, and control measures used. The product quality risk assessments shall be developed and maintained by a multidisciplinary team that includes those facility staff with technical, production, engineering and product development knowledge of the relevant products and associated processes. The product quality risk assessments shall be reviewed following any significant changes to process, equipment or raw materials. Where no changes occur, the risk assessment shall be reviewed annually. The product quality risk assessments shall identify and outline key quality control points (QCP). Procedures shall include provisions for ensuring the production of the product is controlled. The supplier shall have an implemented procedure which shows: - The flow of products from point of material arrival through to shipping, using a flow chart or similar format. - A number, letter or similar designation for each step of the process that is used to control product quality as defined by the product quality risk assessment The steps identified on the process illustration shall be listed in a matrix or similar format and will include: - A reference for each key process stage to the appropriate standard operating procedure or work instruction used to control that stage - Method used to control each stage of the process identified as a QCP - Role responsible for controlling each stage identified as a QCP - Critical limits for each stage which will ensure specification limits are met - Corrective action to be taken when limits are not achieved - Records shall be maintained QCP's shall be routinely monitored during the production of product with records maintained.

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  • 3.1.4.1 Supplier shall nominate customer specific Quality Teams if required who will drive quality management and improvement initiatives. Supplier shall nominate a cross functional Quality Team who, in addition to their normal roles, shall be responsible for coordinating product quality improvement initiatives. The quality team shall be at facility level and include functions who directly impact the production of product. The Quality team shall nominate a team leader. The leader shall not be the facility technical / quality assurance manager. The Quality Team shall be documented and have defined goals and objectives. Goals and objectives shall be reviewed at least annually. The Quality Team shall have action plans for goals and objectives which shall be subject to a quarterly senior management progress review. The Quality Team shall have a Management sponsor who has appropriate seniority to ensure quality improvement initiatives can be implemented. The Quality Team shall regularly review product quality and implement initiatives to drive continuous improvement. The Quality Team shall support in verifying the accuracy of the QAP against the production flow. A copy of the latest QAP, signed as accurate by the Quality Team leader shall be retained.

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  • 3.1.4.2 Key Performance Indicators (KPIs) shall be clearly defined for products. Supplier shall have documented, approved KPI's defined for all products unless otherwise approved in writing. KPI's shall be linked to the key steps of the process that define quality identified in the product quality risk assessment. Product KPI's defined shall be routinely monitored and analyzed. Product KPI's shall be monitored; with records kept at a frequency defined in the product specification. Records of KPI monitoring calibration shall be maintained and shall include: - Results of training sessions - Calibration records for all relevant monitoring equipment Production KPI data and analysis of the results shall be communicated to all levels at least monthly. Where KPI's are reported less frequently, the KPI's should be communicated each time. There is evidence that where appropriate Production KPI data is used to drive quality improvement.

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3.2 Allergen Management

  • 3.2.1 A written allergen management program is present and utilized. All allergens of interest, for the country where the facility is located are named. New & existing supplier verification for allergens is conducted. The program includes handling of raw materials, including: - receiving - color coding to designate allergens, including pre-weighing of allergen containing raw materials - dedicated storage bins & scoops for weighing, - WIP - rework - spills - cleanup - waste - tools - storage & segregation from non-allergen containing materials. The program includes compliance to specifications throughout the purchasing & supply chain, including the regulations in those countries where the product is to be shipped. A list of all allergen containing materials handled on-site, whether raw materials, intermediate products or finished products shall be present and maintained. Ingredients that are allergens are identified as such on all formulations, batch or raw material production records.

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  • 3.2.2 The allergen program addresses food brought onto the site by staff, caterers specifying where allergen containing food is stored or stocked (snack machines). The program shall assure that traceability of rework & WIP is maintained. The program addresses: -The use of protective clothing while handling allergens -The use of identified, dedicated equipment and utensils for pre-weigh / kitting / processing / spills. -Updates to the program when new allergens & allergenic sources are brought into the facility. -Actions to take when there is an inadvertent event of cross-contamination. -Defines frequency of program review and reports exist -Allergen containing waste. The potential for cross-contamination at the raw material suppliers sites has been assessed & includes sensitivities. Allergen-specific training, including documentation, is provided to all employees who work with or handle allergens. Program addresses inadvertent cross-contamination during manufacture. The program shall include consideration of allergens in the Sanitary Design process.

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  • 3.2.3 The program is verified & monitored regarding effectiveness & changed when & where necessary. Verification activities include -Incoming raw materials & subcomponents -Packaging & finished products -Manufacturing cross-contact -Label review -Label control for issuing, reconciliation from run to run, new & reprints. Results are documented.

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  • 3.2.4 A scheduling matrix has been developed and is used for scheduling production and sanitation activities. A procedure is established to maintain product quality during the startup and change over of operations and are documented. At a minimum, the procedures should include verification: -Ingredients -Allergen controls -Packaging material -Labels - pre-printed, batch printed, primary and secondary Changeovers: Removal of previous ingredients & verification, specifically addresses ensuring allergens are not transferred to a non-allergen containing product/other allergen products. -Sanitation -Change of ingredients -Packaging -Labeling. These shall include: - Start-up checklists that include verification of ingredients, packaging material, labeling with sign-off - A list of tasks for change-over that includes, removal of previous ingredients, allergen controls, sanitation, change of ingredients, packaging, and labeling, including any inconsistencies investigated and resolved. - Responsible parties for completing each task.

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  • 3.2.5 A program is in place that includes packaging, identifies all allergens in products, including sub-components, for all markets and customers (including International, where applicable). The identification shall, as required by the customer, assess risk for all allergens & sensitivities. The risk assessment shall consider: - Consideration of the physical state of the allergenic material (i.e. powder, liquid, particulate) - Identification of potential points of cross-contamination (cross-contact) through the process flow - Assessment of the risk of allergen cross-contamination (cross-contact) at each process step - Identification of suitable controls to reduce or eliminate the risk of cross-contamination (cross-contact). There is a formal record of the risk assessment. Raw materials / ingredients, processing steps, processing aids, rework, manufacturing carryover are included in the assessment. Where claims are made regarding the suitability of a food for allergy or food sensitivity (where applicable), the claims shall be fully validated, being backed by documented data such as analysis of finished product, raw materials and post-cleaning swabs for specific allergens.

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  • 3.2.6 Allergen testing including kits, PCR, visual, rinse water testing of CIP systems, external lab verification of presence/absence of allergens. Includes post Sanitation testing of lines and SSOPs that are specific to allergens, including dedicated cleaning equipment. An SSOP is present & in effect that addresses sanitation that occurs on an allergen containing line that is next to a non-allergen containing line. Frequency of testing shall be defined & backed by documented validation. CIP rinse water sample should be collected and tested for specific allergen on a weekly basis. Allergen testing should be performed randomly selected food contact surfaces on a weekly basis. Re-validation shall be done when process/product/ sanitation procedure changes occur. Limits of acceptable and unacceptable cleaning performance shall be defined for food contact surfaces and processing equipment. These limits shall be based on the potential hazards relevant to the product or processing area (e.g. microbiological, allergen, foreign-body contamination or product-to-product contamination). Therefore, acceptable levels of cleaning may be defined by visual appearance, ATP bioluminescence techniques (see glossary), microbiological testing, allergen testing or chemical testing as appropriate. Pre-Weight or Kitting Rooms are cleaned, inspected and swabbed on a frequency stated in procedures. High Risk Zone facilities: Production risk zones, including ambient- High-risk, high-care and ambient high-care production risk zones: Tested annually. - Layout, product flow and segregation - Building fabric - Maintenance - Staff facilities - Housekeeping and hygiene - Waste/waste disposal - Protective clothing

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  • 3.2.7 Ingredient statements must be verified to the: - raw material spec - ingredient disclosure or other - accompanying documents - including the COA for every raw material once every 12 months - when supplier is purchased by another company - when supplier is changed - as customer dictates. Where a justified, risk-based assessment demonstrates that the nature of the production process is such that: cross-contamination (cross-contact) from an allergen cannot be prevented, a warning should be included on the label. Legislation, national guidelines or codes of practice shall be used when making such a warning statement.

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  • 3.2.8 Finished product labeling verification for product and packaging occurs for every product through Optiva or other electronic Product Life Cycle Management (PLM) system and anytime changes are made to the formula or packaging. There shall be effective process in place to ensure that labeling information is reviewed whenever changes occur to: - product recipe - raw materials - supplier of raw mats - country of origin of raw mats - legislation. Further label verification occurs at a minimum of every three years or as dictated by the customer.

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  • 3.2.9 Non-conformities relating to allergen control shall be included specifically in the management meetings. Complaints or issues, whether internal or external shall be discussed. The company shall have procedures in place to keep abreast of legislation or scientific information relevant to allergen containing materials (such as protein presence in highly refined soybean containing materials).

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3.3 Environmental Monitoring Program

  • 3.3.1 Zoning: the company shall assure that the process flow from receiving through finished product shall be arranged to minimize the risk of product contamination. Zones shall be defined and identified on a facility map. Establish mapping (Zone map) -Supplier shall have a clearly communicated microbiological monitoring and testing policy that states the facilities intentions to meet obligations to produce safe and legal products. The micro policy shall be: -Supplier shall have a microbiological and analytical monitoring and testing policy/procedure -Signed by the senior leader (s) -Available in languages appropriate to the staff -Communicated to all appropriate staff

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  • 3.3.2 A documented Environmental Monitoring Program is based on risk, present & includes requirements for a map and master list of sampling locations for each production line to allow tracking of trends, zone requirements and risk assessment for establishing test frequencies. At a minimum the program should include: - sampling procedures - identification of sample locations - frequency of tests - target organism(s) (e.g. pathogens, spoilage organisms and/or indicator organisms) - test methods (e.g. settle plates, rapid testing and swabs) - recording and evaluation of results. - air plates and compressed air is tested for lactic acid. The program and its associated procedures shall be documented. The facility shall actively look for potential areas / niches / harborage areas where the target microorganism is likely to be found and then aggressively swab this area. If a target microorganism is found, vector swabbing must be done, and additional cleaning and sanitation must be done. The area must be retested three times to obtain a negative. Root cause for the positive detection must be established.

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  • 3.3.3 The program requirements include: - frequency of testing - limits sampling procedures - guidance for retesting - which organisms are tested - methods used & where; i.e. at company microbiology lab, outside laboratory, etc. - the actions to take when trends indicate unacceptable results (corrective actions) and - when in the process testing is to occur. The program is to include food and non-food contact surfaces. Microbiological limits for acceptable and unacceptable cleaning performance shall be defined for high-risk / high-care production risk zones. Test results shall be recorded and reviewed on a regular basis to identify trends. The GENE-UP BACTVIAB PMAxx or EnviroPro with PMAxx methods (or equivalent) are recommended to ensure that false positive results are not acquired due to the test detecting free DNA/dead cells. The method used must be validated for the specific buffer/broth used as a neutralizing solution with the sponge swab.

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  • 3.3.4 The program is to include that results & trends are routinely communicated to & discussed with senior management. The significance of external lab results shall be understood & acted upon accordingly.

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  • 3.3.5 Refrigeration evaporators (such as coils, fans, inside drip pans, rubber-like cooler door seals, etc.) and areas in coolers shall be included in the Environmental Monitoring Program site list.

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4.0 Food Safety Process Control

4.1 Microbiology

  • 4.1.1 There is a documented Pre-Operational Swabbing /Bioluminescence Testing & Inspection program to verify effectiveness and line conditions of cleaning prior to startup of production. - Roles, personnel requirements & responsibilities are present: - Full time employee. - Trained employee. - Employee not performing cleaning / sanitation. - Tools to be used are listed with specifics to flashlights and mirrors. - The areas to be inspected are listed, especially hard to reach / inspect areas. - Access items to reach hard to reach / inspect area is listed. - Safety and LOTO requirements are stated. - The cleanliness of equipment shall be visually checked / verified and documented before swabbing or equipment is released back into production, based off zone. - Other pre-requisite programs are being followed while performing inspections and swabbing. - Foreign material contamination risk review / inspection adequately performed before the line is released. - Swab results are documented with documentation of failures and rechecks. - Records of findings are present and corrective actions are present. - Records to be reviewed and/or verified by a Lead or Supervisor. - Training for inspection personnel is stated and documented. Microbiological limits for acceptable and unacceptable cleaning performance shall be defined for high-risk / high-care production risk zones. Non-food contact surfaces in the area of the operation are to be included in the program including: - Ceilings - Packaging - Supplies in the area - Walls - Floors - Drains, etc. Effective cleaning practices are evident.

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  • 4.1.1.1a Pre-Operational Inspections are verified weekly by a trained member of the Quality department. - Inspections to be documented. - Notations of non-conformances documented. - Corrective actions documented. - Documentation of re-cleaning and re-inspection. - Verification needs to focus on the inspectors addressing pre-op conditions Pre-Operational Inspections are verified quarterly by Quality Assurance Management. - Inspections to be documented. - Notations of non-conformances documented. - Corrective actions documented. - Documentation of re-cleaning and re-inspection.

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  • 4.1.1.1b ATP Swabbing failure process followed: - First fail = retest - Second fail = Letheen swab taken for micro - Re-clean / CIP prior to releasing to production

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  • 4.1.1.2 Pre-Operational Inspections to be performed by Quality Assurance management at a minimum of quarterly. These inspections are to include: - Documentation of inspection. - Documentation of non-conformances. - Documentation of corrective actions take. - Documentation of re-cleaning, re-inspection and/or re-swabbing.

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  • 4.1.1.3 Compliance to the following requirements reviewed prior to releasing the line for production: - Hand wash station(s) have soap, sanitizer, paper towel (or a functioning hand dryer) and hot water - All packaging materials from previous run must be removed. - No uncapped lines/ports - Foreign material - Temporary repairs - GMP's - Disassembling of components to ensure effective cleaning and sanitizing - No condensation above food contact zones/product level - All drains shall be flowing and unblocked, no stagnant water - No equipment parts, clamps, hoses, gaskets in the hand wash sinks or on the floor - No foul odors present

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  • 4.1.2 Written record of the Pre-Operational inspection and swabbing records include: - Notations when non-conformances are found - Corrective actions - Re-inspection / re-swabbing of the area. The cleanliness of equipment shall be checked before equipment is released back into production. Swab results are documented with documentation of failures and rechecks. Verification of corrective actions is performed prior to releasing back into production. Records are present of findings to be reviewed and/or verified by a Lead or Supervisor, including: - Visual - Analytical - Microbiological checks - Corrective actions The results including failures are used to identify trends in cleaning performance and to investigate improvements where required. Non-food contact surfaces in the Operations areas are to be included in the program.

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  • 4.1.3 Lab coats that are worn in the micro lab are not worn anywhere else in the facility.

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  • 4.1.4 No pathogen testing is performed within the facility unless required by governmental regulations. Pathogen testing (including pathogens tested as part of the site environmental monitoring program) shall be subcontracted to an external laboratory or, where conducted internally, the laboratory facility shall be fully segregated from the production and storage areas and have operating procedures to prevent any risk of product contamination of products or production areas. Pathogen & spoilage organism testing is performed per customer's / governmental requirements. - Duplicate samples are pulled when customer/governmental agency, etc. removes samples from facility. Facility must demonstrate that sampling for product for inspection or analysis is completed using recognized sampling methods. Testing for indicator organisms, as appropriate (APC, Coliform, E coli) has been established. Investigations and corrective action plans are documented for out-of-spec conditions. PRODUCE: Suppliers are expected to develop a finished product pathogen testing program to verify that pathogens do not exceed the limits for the food matrix, established by the applicable regulatory authority. The supplier is responsible for understanding the environmental risk, the inherent risk of the pathogen in the food matrix and the applicable regulatory requirements when establishing their pathogen testing protocols. When testing for pathogens, McDonald’s expects a test and hold procedure to be established that is recognized and supported by the applicable food safety authority. When test and hold is not possible, process used should be aligned with applicable regulation and authorities. At a minimum McDonald’s expects finished product testing that includes Listeria Monocytogenes that meets the applicable regulatory requirements. Where multiple product types (e.g.: shredded lettuce, slivered onions, salad mix, etc.) are produced, spread out monthly sampling events over time. Testing must be conducted by credible analytical laboratories (including supplier’s own lab) using approved, published, official, validated methods; these methods shall be recognized by the local regulatory agencies. Where possible, the laboratories must be accredited for these analyses to an international standard (or a recognized national standard) and/or participating in a proficiency testing program.

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  • 4.1.5 Microbiologist is certified or degreed in microbiology. Proficiency Testing and training is conducted/updated once per year. A qualified individual may be a microbiologist, trained in microbiological practices or equivalent through experience. At a minimum, the person performing microbiological testing undergoes competency testing by an outside recognized lab (check sample testing).

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  • 4.1.6 Analytical & Micro: Outside lab is certified for all tests that are performed by the plant. Proof of certification is present to show that the laboratory is authorized to conduct specific tests. Laboratories and testing methods are licensed/approved with documented training of lab personnel.

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  • 4.1.7 Facility must demonstrate that sampling for product for inspection or analysis is completed using recognized sampling methods. There shall be a scheduled program of product testing which may include: - Microbiological - Chemical - Physical - Organoleptic testing according to risk The methods, including: - Processes for obtaining product samples (including where appropriate, their delivery to a laboratory) - Frequency - Specified limits shall be documented. Microbiological and analytical testing for dairy products is conducted as required.

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  • 4.1.8 Analytical & Micro: A written contingency (backup) plan is present for equipment that does not function properly. Procedures are established for the calibration and accuracy of "key" measurement equipment and testing equipment for: - Labs - QC - Manufacturing process, including schedules and reference standards. Repairs and equipment modifications are professionally completed without the use of: - String - Tape - Wirer - Other improvised materials and in a manner to prevent potential contamination.

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  • 4.1.9 Product that is tested for pathogens is segregated and in a "lock-down" mode (cannot be shipped). Effective Test and Hold program in place. A full cleaning and sanitizing cycle to be performed for all equipment and food contact utensils / tools while manufacturing the tested lot(s). Product matrices shall be reviewed and update when new pathogen testing is added. Rework cannot be added to product lots that are tested for pathogens. Pre-shipment reviews shall not be considered complete until all pathogen / adulterant testing results ae reviewed and confirmed acceptable. All pathogen / adulterant testing results must be reviewed by a member of Quality Systems. Product that has tested presumptive positive for a pathogen has had the inventory count verified. Product that has tested positive for a pathogen is counted at least weekly until disposition is made. YUM! Finished product, for the required Yum products, must be tested for Salmonella and E coli at a frequency specified by Yum! QA (or other testing method as defined in Yum! commodity specific testing requirements.

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4.2 Analytical

  • 4.2.1 Testing equipment is clean and well maintained. Lab is clean and free of clutter. No food, beverages or personal items are stored in the laboratory. All chemicals are properly labeled (e.g. chemical name, lot number, day received, day opened). Labs are physically separated from processing areas and restricted access signage is present. Lab shall be located, designed and operated to eliminate potential risks to product safety. Controls shall be documented, implemented and include consideration of: - operating procedures to contain laboratory activities, including the design and operation of drainage and ventilation systems. - access and security of the facility. - movement of laboratory personnel. - hygiene and protective clothing arrangements. - movement of materials that may pose a risk to products, raw materials or the production area, into and out of the laboratory, including the disposal of laboratory waste. - the management and monitoring of laboratory equipment. Where testing activities are performed in production or storage areas (e.g. at the line tests or rapid tests) these shall be located, designed or operated to prevent product contamination.

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  • 4.2.2 All test methods shall be documented and be based on recognized, official test methods. Procedures for testing are documented. Test frequencies shall be specified and the laboratory methods validated for accuracy and reproducibility. End product testing is conducted. Testing areas are designed so that a separation is present so that there will not be a detrimental effect on manufacturing. Critical limits and testing methodologies for food safety critical equipment shall be based on risk assessment unless otherwise defined.

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  • 4.2.3 All employees executing analytical testing are to be calibrated to a single appropriate standard of working. Lab participates in outside competency testing (accuracy and precision). Lab is accredited. If so, by what body? Testing includes batching, processing and packaging areas of manufacturing. Training / retraining is conducted once per year. Training / retraining is documented. Split samples are sent to an outside qualified lab twice per year OR lab belongs to internal competency check program. List the 3rd party used for proficiency / competency testing.

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  • 4.2.4 The facility has a finished goods inspection program to ensure conformance to internal or customer specifications. Review of analytical testing records confirm results conform to specifications. Inspection records are reviewed before finished goods are released for delivery. A 'near miss' reporting system for food safety non-conformance must be in-place and linked to a review, action process and communication plan. The site shall track 'near misses' and they are used as to bring the process into control. There shall be a microbiological and analytical testing policy / procedure.

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  • 4.2.5 Documented procedures are in place for reviewing and accepting all customers product specifications and related testing methods. McD's SQMS: Applicable to all formulated products and bakery suppliers: - Palm oil users: compliance with McDonald's Land Management Policy pertaining to Roundtable on Sustainable Palm Oil (RSPO) membership and certification according McDonald’s Palm oil policy - Compliance to McDonald’s oil product specification

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  • 4.2.6 A process is in place to verify: - In-house capability - Sampling plan - Required test methods - Equipment and - Analyst training to ensure conformance with all customers specifications. This may be part of the in-house internal audit program.

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  • 4.2.7 Specification Compliance Report based on format agreed with each customer is available, where specified, and is submitted to each customer, as required, at the agreed frequency. There is a process to monitor specification compliance and corrective actions taken. Test results are presented graphically so that trends may be noted.

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  • 4.2.8 All raw materials, shall have written specifications, including packaging, hazardous chemicals & processing aids). Appropriate processes and procedures shall be established and implemented to verify the consistency of the raw materials according to the specifications. An effective process is in place to verify compliance of the materials with the respective specifications prior to their use in the manufacturing of the customer's products. Must be documented, current & comply with relevant legislation. Specifications must be current and include defined limits which may affect quality or safety of the final products ((e.g. chemical, microbiological, physical or allergen standards). Guidance: All raw material, ingredients and primary packaging (packaging that comes in direct contact with the product) specifications have been communicated with suppliers/vendors of these raw materials, ingredients and primary packaging. BEEF: Applicable to raw material suppliers of beef: - Verification of supplier on Approved Supplier List - Evidence of a “pass” for BSE Firewall and animal health and welfare audits - Evidence of a score of ≥ 75% for GMP/HACCP audit or GFSI certification - Evidence of passing Halal/Kosher audit, by an authority recognized by the country of origin and consumption where applicable - Compliance with VAS - If using an on-site laboratory performing e Coli O157:H7 testing – must meet 3rd party annual audit requirement, certified by an external accredited laboratory and a COA submitted with each raw material lot where required - Laboratory data and trend analysis confirm microbiological criteria (APC/TPC, E coli, etc.) meet local regulatory requirements and McDonald’s specifications FRESH PRODUCE: - Supplier shall have documented approved raw material sourcing (e.g. farms, packing house) - Supplier shall be able to demonstrate that raw material sourcing is in compliance with Good Agriculture Practice (GAP) - Global G.A.P., Global G.A.P. Risk Assessment on Social Practice (GRASP) plus McD’s addendum. Formulated Products: Supplier shall be able to demonstrate that raw material sourcing is in compliance with a Good Agriculture Practice (GAP) scheme that has been benchmarked to Sustainable Agriculture Initiative (SAI) platform Farm Sustainability Assessment (FSA) for all crops.

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4.3 Process Monitoring

  • 4.3.1 Appropriate monitoring is performed by trained personnel. Includes daily, weekly, monthly, on some set schedule, including batching, pre-weigh, etc. Monitoring is performed according to a published schedule. Monitoring addresses all quality attributes. When there is a loss of control, the measurement or monitoring activity is able to detect this. Frequency & quality of samples is adequate to detect loss of control.

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  • 4.3.2 Pasteurization/cooking temperatures are monitored and recorded. Monitoring is performed according to a published schedule and by trained personnel. When there is a loss of control, the measurement or monitoring activity is able to detect this. Frequency & quality of samples is adequate to detect loss of control.

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  • 4.3.3 Process specifications shall be in accordance with the agreed customer finished product specification. Monitoring records state process parameter and target.

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  • 4.3.4 Records of checks shall be retained for frequency & methodology. Documented procedures shall be in place to ensure that products are packed into correct packaging & correctly labeled. Procedures shall be in place to ensure that all products are packed into the correct packaging and correctly labelled. These shall include checks: - at the start of packing - during the packing run (e.g. at predefined intervals and when printed packaging or labels are brought to the line during the production run) - when changing batches of packaging materials - at the end of each production run. When changing batches of packaging materials, the checks shall also include verification of any printing carried out at the packing state, including: Date coding, batch coding, quantity indication, bar coding, Country of Origin, as applicable. The verification of film requires 2 signatures for every change. The checks shall also include verification of any printing carried out at the packing stage including, as appropriate: - date coding - batch coding - quantity indication - pricing information - bar coding - country of origin - allergen information.

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  • 4.3.5 Employees are sufficiently knowledgeable to be able to carry out corrective actions so that control of the process is regained. There are documented process procedures available (batch cards, Pre-weigh, etc.) for every process. Associated documents are reviewed by designated officials of the company. Frequency is to be determined by company or customer. Procedures are in place to re-establish control & to determine the fate of the affected product. Process audits are documented and measured for alignment to written specification from customer, corporate, internal criteria. Results are communicated to appropriate associates. Each facility shall establish the parameters within which the production line is expected to operate. Process control and monitoring activities shall be established to document the plant’s ability to produce products within the established parameters. A formal system exists for the recording and resolution of corrective actions.

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  • 4.3.6 Processing parameters or in-process measurements shall be established, validated, and verified at a determined frequency to meet all appropriate requirements. Adequate statistical process control shall be implemented where applicable to improve product consistency, reduce process variation and improve overall capability of the process.

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  • 4.3.7 There shall be a documented procedure on handling rework (also may be called WIP, Work-In-Progress), which may be reintroduced into the process immediately or at a later time. This procedure shall include: - Means of ensuring proper traceability - Allowed amount of rework per batch - Allergen / sensitive ingredients considerations (e.g. "same into same" or "like into like") - Addition methods - Any products that are forbidden to be reintroduced (specifically, returned product) - Allowable shelf-life prior to reintroduction, and - Any other special handling instructions. There must be a record of rework when it is reintroduced back into the process. There shall be no rework from products held for microbiological failures without the specific permission of Global FS, QS and Regulatory.

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  • 4.3.8 Where process parameters or product quality are controlled by line-monitoring devices these shall be linked to a suitable failure alert that is routinely tested.

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  • 4.3.9 Visible Process: Real time control chart is used at all identified locations on processing lines for all products requiring SPC. The operator keeps the process at target, and only makes necessary and effective adjustments when the process is OUT OF CONTROL AS INDICATED BY THE CHART. YUM! QSA: Implementing statistical methods into production process will include: - Statistical process control integrated into the processing procedures and practiced by production personnel at a minimum for all KPIs identified on the Yum! Brands KPI reports, Quality Assurance Programs, or Specification. - Control charts have defined upper and lower control limits, not specification limits. - Operating personnel demonstrate fundamental understanding of statistical control. - Documented procedures for the use of charts and how to identify and respond to "special causes". - SPC rules should be documented and personnel trained. - Production personnel appropriately respond to out-of-control circumstances or decision rules for control charts. Control Charts should be in the area where measurements are taken, and updated when the tests are completed. QC can conduct the actual charting, but production personnel must understand and react appropriately to "out of control" processes. Confirmation of the proper use of control charts may be made through observation. Simply having control charts does not support an automatic award of points. For batch systems it may not be used for real time process control but must be used for long term continuous improvement.

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  • 4.3.10 Capable Process - All processes are capable as determined by all five criteria below have been met at all process locations where there is an applicable specification: 1. The analysis is based upon a minimum of 150 data points. 2. Real time control charting is being effectively used to control this point in the process. 3.There are no unexplained out of control conditions. 4. The data fits a normal curve, and 5. 99.97% of the process output falls within the specification limits. More specifically, the spec limit that is closest to the process average, minus the process average, when divided by three standard deviations equals at least 1. If less than 1 the process is not capable (CpK determination).

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  • 4.3.11 Optimized Process - A process is in place to update the process sigmas and optimize the targets on the real time control charts. Statistical data is used to manage process improvement and optimize processes. Increased efficiency, reduction of waste, increased product quality and consistency, and cost savings are evident as the result of the process control implementation. Weight Control is present

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5.0 Sanitation Program

5.1 General Facility/ Housekeeping

  • 5.1.1 Added high touch areas All housekeeping cleaning activities are documented and located on a Master Cleaning Schedule. This schedule lists all equipment, utensils and areas that require cleaning and sanitizing, and their cleaning frequency. The master cleaning schedule is internally audited on a regular basis, at a minimum, monthly basis, to verify compliance. • This includes non-food contact equipment, interior / exterior, overhead piping, lights & light fixtures, storage racks, structure, ceilings, walls, floors, air ducts and vents, hand trucks, forklifts, etc. The schedule identifies the frequency of cleaning. Procedures & records exist for all tasks. • Where hand dip stations and/or foot baths are used, they must be cleaned and free of particulates, dirt and debris and changed often enough with potable water at the appropriate temperature to keep the sanitizer concentration in the acceptable range. • For non-disposable items (e.g., gloves/aprons/hard hats/PPE) the condition and frequency for the cleaning and changing shall be established. • Trash receptacles are emptied frequently to prevent overflow and kept in sanitary condition with no offensive odors. • Identified high touch areas or areas of concern shall be added to the Master Cleaning schedule.

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  • 5.1.2 All employee areas such as restrooms, wash areas, change rooms and lunch rooms / canteens (inside and outside) are cleaned on a scheduled frequency with records of completion. - Change rooms and toilets are segregated from the production area. - These facilities are clean, orderly and well lit. - Exhaust is vented to outside. - Lockers suitably designed to disallow inappropriate use (e.g., storage of items on top). - Work clothes and street clothes appropriately stored to prevent cross-contamination. - Verification of the records and inspection is evident.

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  • 5.1.3 General areas (e. g., warehouse, aisles, battery charging maintenance shop & satellite locations, chemical cages) are clean and in good repair. Standing water or evidence of aged spillage are not evident on the floors. Walls, ceilings and overheads inside and outside production areas are clean without condensate. Drains all function properly.

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  • 5.1.4 Chemicals and equipment are suitable for use in a food manufacturing establishment or stored in a secured area outside of processing/manufacturing areas. In-use food process sanitation equipment should not be stored with Housekeeping. Color coding, or labeling may be used. Restroom cleaning utensils are separated and identified. When chemicals will not fit into designated storage there shall be a written risk assessment to determine the level of risk. Color coding, or labeling may be used. Restroom cleaning utensils are separated and identified. When chemicals will not fit into designated storage there shall be a written risk assessment to determine the level of risk. Additonal expectations include: - an approved list of chemicals for purchase - availability of material safety data sheets and specifications - confirmation of suitability for use in a food-processing environment - avoidance of strongly scented products - the labelling and/or identification of containers of chemicals at all times - a designated storage area (separate from chemicals used as raw materials in products) with restricted access to authorized personnel - use by trained personnel only. - procedures to manage any spills - procedures for the safe, legal disposal or return, of obsolete or out-of-date chemicals and empty chemical containers

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  • 5.1.5 Restrooms and washrooms have adequate supplies. Restroom fixtures work properly, no offensive odors, trash receptacles are covered. Water is hot at the hand wash stations. - There are hand wash reminder signs placed at the entrance to the facility and at all hand wash stations. They are operational and provided with hot / warm water at 38 °C / 100 °F minimum, where appropriate. Such hand-washing facilities shall provide, at a minimum: - Advisory signs to prompt handwashing - A sufficient quantity of water at a suitable temperature - Water taps with hands-free operation - Liquid / foam soap - Single-use towels or suitably designed and located air driers.

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  • 5.1.6 Freezers do not have aged ice build-up. No mold or mildew present in coolers. Products and area temperatures at receiving, storage and loading are monitored and documented and meet required specifications.

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5.2 Processing Sanitation Program

  • 5.2.1 Added High Touch A documented Master Cleaning Schedule is in place for all tasks other than daily. Identified high touch areas or areas of concern shall be added to the Master Cleaning schedule. This includes inside and outside the plant: - e.g., bulk tanks - processing equipment - packaging equipment - bins (such as kitting of bulk ingredients) - structure - doors - floors - lights - storage areas - staff amenities - toilet facilities - drains: a schematic drain map is present for each operational room and used to document and verify drain cleaning. The schedule identifies the frequency of cleaning and shall address cleaning between breaks. Procedures exist for all tasks and frequency is based on risk. Assessment shall include risk from cleaning chemical residues on food contact surfaces. The detailed schedule shall be internally audited periodically for its maintenance and effectiveness. The facility sanitation plan will be effectively implemented and routinely verified including maintenance for food safety. McD's SQMS: There is no evidence of significant build-up present during production. Excess moisture, standing water and condensation are removed from equipment and the environment prior to start of operations. Tools such as knives, saws, trimmers and others used in processing are adequately cleaned and sanitized during processing. A process is in place to ensure suitability of use of any piece of equipment that has not been used for over 4 hours after last sanitation, based on risk assessment.

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  • 5.2.2 Procedures are present and specific to the site exist for all tasks to include: Frequency of cleaning, based on risk. - organisms of concern - person responsible - area to be cleaned & include detailed procedure steps - equipment & utensils, including dismantling equipment for cleaning purposes where required - cleaning chemicals - concentrations of dilution - water temperature - Records to be kept - Verification / Inspection / effectiveness - Safety / precautionary notes - Include CIP & COP systems & each task involved. - Visual inspection verifying valve movement Management representative shall review records for completeness.

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  • 5.2.3 Brushes & Equipment are color coded to indicate usage. • Food • non-food • drains, • house-keeping utensils are identified. The color coding is posted and is dedicated for use in an area or to a specific purpose.

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  • 5.2.4 A procedure exists for verification and Validation of the CIP and COP systems. New CIP Systems are validated for proper cleaning function before they are commissioned and after changes and monitored per the cleaning program to ensure they are working properly. Master flow meter calibrations and validations performed at a minimum of annually. CIP cleaned circuits are validated annually. The CIP System temperature charts are verified and signed daily. - Chemical concentrations / detergent concentrations are checked for cleaners and sanitizers daily for CIP & COP systems. - Velocity and temperature are verified at a defined frequency. - Filters, where fitted, shall be cleaned and inspected at a defined frequency Where used, flexible hoses shall be stored hygienically when not in use, and inspected at a defined frequency to ensure that they are in good condition. CIP facilities, where used, shall be monitored at a defined frequency based on risk. This may include: - Ensuring correct connections, piping and settings are in place - Confirming the process is operating correctly (e.g. valves opening/closing sequentially, spray balls are operating correctly) - Ensuring effective completion of the cleaning cycle - Monitoring for effective results, including draining where required. Procedures shall define the action to be taken if monitoring indicates that processing is outside the defined limits. Design includes no potential cross contamination risks.

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  • 5.2.4.1 If CIP systems are controlled by PLC systems; the addition, modification or removal of set points are to be restricted to Management and above. Set points are defined as, but not limited to: - Time - Temperature - Concentration - Flow

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  • 5.2.4.2 The CIP systems electronic chart record system should document the following: - Temperatures - Flow rates in gallons per minute or per square inch - Conductivity or chemical concentration - Each CIP cleaning steps' total time

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  • 5.2.5 - A schematic diagram of the layout of the CIP system including process piping circuits shall be available. - An inspection report or other validation that shows scavenge/return pumps are operated to ensure there is no buildup of CIP solutions. - Recovered post-rinse solutions shall be monitored for build-up of carry-over from the detergent tanks. - Spray balls / rotating spray devices provide full coverage. - CIP equipment has adequate separation from active product lines, including make or break connections with proxy switches as interlocks; to prevent or safeguard against cross-contamination. - CIP equipment shall include detergent tanks are kept stocked up and a log maintained of when these are drain cleaned filled and emptied.

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  • 5.2.6 All reports are present for in-house inspection, third party audits verifications, including those from chemical companies, regulators and contractor activity. Findings have corrective actions and are acted upon.

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  • 5.2.7 Cleaning is verified. Cleaning verifications such as Swabs and/or ATP on CIP cleaned surfaces that include (when applicable): - Vessel /tank interior - Vessel / tank components attached - Line associated PD pumps - Line associated fillers Pre-op findings are trended & corrective actions are verified. Limits for acceptable and unacceptable cleaning performance shall be defined for high-risk/high-care production risk zones. Acceptable levels of cleaning shall be defined, for example, by: - Visual appearance - ATP bioluminescence techniques - Microbiological testing or - Chemical testing as appropriate. Deficiencies are addressed and records are maintained before production start-up and corrective actions are documented. These may include: - Process steps and/or microbiological interventions - Implemented to minimize or eliminate a microbiological hazard shall be: - validated - monitored - verified.

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5.3 Process Sanitation Implementation

  • 5.3.1 Cleaning assignments are based on skill qualifications with documented training and skills assessment for each task. Skills assessed yearly. - Sanitation procedure/SOPs used to conduct the training - On-the-job training/other methods of training available for each employee, when applicable - Training is completed annually and records are maintained

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  • 5.3.2 Sanitation equipment is in sound condition and properly stored when not in use. - All cleaning chemicals and equipment are properly cleaned and stored in a secured area away from unauthorized use. - Cleaning chemicals and sanitizers may be in processing/production areas if they are secured and do not pose a risk of product contamination (e.g., sanitizer bottles, sanitizers on a dispensing unit, entrance sanitizer foam and hand dip stations). - Equipment is designed for effective sanitation and sanitation impact is considered when any upgrades or changes are made to equipment.

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  • 5.3.3 Product labels and MSDS / SDS for all cleaners and sanitizers are available. Cleaners and sanitizers application and concentrations comply with the Sanitation Program and manufacturer's guidance.

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  • 5.3.4 Records exist for all daily and periodic tasks completed. - Each task is and signed by the individual sanitation worker. - Verification and effectiveness (who is responsible) by an assigned person (manager, supervisor, etc.) is present on the records. - Includes CIP and COP Chart recording system. - Flow meter calibrations and verifications - Includes chemical testing kits for detergents and sanitizer concentrations. - Precautionary and/or safety notes are recorded, where necessary - Records to be kept, including records for completion and sign-off

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  • 5.3.5 Chemical concentrations are checked for cleaners and sanitizers daily from: - The dispensing systems - Any hand mixed solutions such as: - a foot bath - COP Tank - hand dip etc. They will be recorded daily, dated, signed and verified.

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  • 5.3.6 Each facility shall have a written procedure that outlines the equipment teardowns which include who is responsible for each task. The facility shall perform extensive plant equipment self-inspections at least two times a year. This should include disassembling equipment and swabbing. This inspection is designed to be very thorough and detailed – beyond normal pre-op. This inspection is typically conducted on the weekend, after the “final cleanup”. Equipment should be inspected for: - Dead ends - “Ts” in the piping - Rough welds - Valves that do not pulse during the C.I.P. cycle - Improper drainage - Worn gaskets - Rubber impellers and other equipment made of materials that can wear or deteriorate over time - Including and other conditions that may result in inadequate cleaning. All CIP'd equipment (pumps, valves, gaskets, CIP skids, transfer line circuits, air blowing assemblies, etc. should be torn down. Engineering support provided where access within equipment is required for cleaning. Equipment should be accessible for cleaning. Modifications should be made where possible to facilitate better cleaning.

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  • 5.3.7 Each facility shall have a program in place for dismantling, inspecting, cleaning and sanitizing all product contact gaskets and clamps. The frequency should be based on risk assessment and take into account the physical stresses placed on the gasket material as well as any periodic chemical stress which may cause etching of the surfaces. At a minimum, all gaskets shall be dismantled, inspected and cleaned at each allergen changeover (if applicable). Any gaskets showing evidence of damages, cracking, pitting, or etching of the surface shall be replaced. The program should have in place food contact gasket replacements and inspections. All gaskets shall be replaced every 6 months at a minimum. Higher frequency may be appropriate based on risk assessment.

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  • 5.3.8 Sanitation and production are separated to prevent any possible contamination to products. This includes CIP circuits, over spray from hoses, etc. For ambient high-risk areas exist, a written risk assessment is present and it determines that risk of cross-contamination with pathogens. Also taken into account: - The raw materials and products - The flow of raw materials, packaging, products, equipment, personnel and waste - Air flow and quality - The provision and location of utilities (including drains).

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  • 5.3.9 Sanitation workers follow GMP to include: - hose nozzles. - food contact parts off the floor. Lubricants and solutions are clean and food grade.

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