Designing Internal Audits: Improve Results for Customer, 3rd Party & Regulatory Compliance
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The document outlines a webinar and podcast series aimed at process manufacturers, focusing on improving internal audits for enhanced compliance and productivity, hosted by industry experts from Mérieux Nutrisciences. Key topics include the importance of designing internal audits that protect consumer safety, meet regulatory requirements, and incorporate various audit types to ensure compliance. It also emphasizes the role of competent personnel in conducting audits and the need for continuous improvement in food safety practices.
![BEYOND COMPLIANCE
Regulation Number Short Description Frequency
21 CFR 1.502(a) Did not develop FSVP 796
21 CFR 117.35(c) Pest Control 88
21 CFR 117.80(c) Manufacturing, Processing, Packing, Holding - Controls 84
21 CFR 117.130(a)(1) Hazard Analysis - Identification of Hazard 83
21 CFR 1.504(a) Hazard analysis written 78
21 CFR 1.505(a)(2) Supplier Evaluation - performance, risk 74
21 CFR 1.505(b) Supplier Approval - document 71
21 CFR 117.35(a) Sanitary Operations - Plant Maintenance 70
21 CFR 1.506(a)(1) Approved supplier procedures - importer established 69
21 CFR 1.506(b) Supplier verification - establish written procedures 68
21 CFR 117.40 Equipment and Utensils - Design and Maintenance 67
US FDA Regulatory Inspection Observations [10/1/20 -
9/30/21]; Top 11 Reasons an Inspector Writes a 483!
Reference: https://www.fda.gov/inspections-
compliance-enforcement-and-criminal-
investigations/inspection-
references/inspection-observations](https://image.slidesharecdn.com/designinginternalauditsimproveresultsforcustomer3rdpartyregulatorycompliance-220216195700/95/Designing-Internal-Audits-Improve-Results-for-Customer-3rd-Party-Regulatory-Compliance-18-638.jpg)
Designing Internal Audits: Improve Results for Customer, 3rd Party & Regulatory Compliance
- 1. Beyond Compliance Webinar & Podcast Series for Process Manufacturers Designing Internal Audits: Improve Results for Customer, Third Parties & Regulatory Compliance with Tracie Sheehan, VP Technical Services, Mérieux NutriSciences
- 2. The Sponsor ✔Improve Yield ✔Maximize Productivity ✔Ensure Compliance Plant Management Platform BEYOND COMPLIANCE
- 3. Casual but Professional Format ✔Ask questions! (Q&A at end) ✔Only panelists are displayed ✔Recording link will be shared ✔Audio issues: use call-in number Before We Get Started BEYOND COMPLIANCE Helpful tips
- 4. About the Presenters BEYOND COMPLIANCE Tracie Sheehan VP Technical Services, Mérieux NutriSciences Food Safety Professional with 30+ years experience. Past roles include: ● Chief Health, Quality & Sustainability Officer with ARYZTA ● SVP Food Safety & Scientific Affairs at Sara Lee Corp ● Dir Food Safety & Supplier Management with Kellogg Co ● PhD from University of South Carolina in Analytical Chemistry Aaron Bolshaw CMO
- 5. BEYOND COMPLIANCE About Mérieux NutriSciences Mérieux NutriSciences Certification LLC is an independent subsidiary of Mérieux NutriSciences, established to provide clients with certification to many internationally recognized schemes. Auditing your suppliers and facility ensures your facility is meeting standards every day. We offer our training courses in a variety of different formats. Mérieux NutriSciences’ auditing and training services protect your products, and ensure compliance with national and international regulatory requirements. Training ■ Public Training ■ Online Courses ■ Streaming Videos Audits & Certification ■ GFSI Benchmarked Certification ■ Third Party Audits
- 6. BEYOND COMPLIANCE Agenda ● Purpose of Food Safety Internal Audits ● GFSI Benchmark Requirements for Internal Audits ● Customer Compliance ● Regulatory Compliance & Inspection Preparedness ● Audit Personnel ● Audit Records ● CAPA ● Incorporation of other audit types
- 7. What types of audits does your company conduct? Note: Multiple answers are allowed.
- 8. BEYOND COMPLIANCE ● Protect your Consumers! ● Comply with Third-Party Audits ● Satisfy your Customers’ Requirements ● Comply with Regulations ● Protect your Company Purpose of Food Safety Internal Audits
- 9. BEYOND COMPLIANCE Protect Your Consumers!
- 10. BEYOND COMPLIANCE How Can an Internal Audit Protect Consumers? Design your audits for observations vs. checklists. Train your Internal Auditors to use their “senses:” ✓ SIGHT: Observation of a roof leak dripping on product (Salmonella from birds?) ✓ SMELL: Off odor in a spiral cooler or drain (microbiological?) ✓ HEARING: Grinder blade break or pump failure (foreign material?) ✓ TOUCH: Slimy feel of equipment at pre-op could be a biofilm (Listeria monocytogenes?) ✓ TASTE: Sensory assessment (conformance to specification?)
- 11. BEYOND COMPLIANCE Benchmark Requirements (v2019) An internal audit procedure shall be established, implemented and maintained to cover the scope of the Food Safety Management System. A risk-based microbiological, environmental monitoring programme shall be established, implemented and maintained. Global Food Safety Initiative (GFSI)
- 12. BEYOND COMPLIANCE ● SQF ● BRC ● IFS ● FSSC 22000 ● Global GAP Mérieux NutriSciences Certification, LLC is audited and accredited to perform these audits. GFSI Certification Program Owner’s (CPO’s) Internal Audit Requirements
- 13. BEYOND COMPLIANCE A procedure shall be established, implemented and maintained to ensure that analyses of food critical to the confirmation of food safety are undertaken by competent laboratories using appropriate sampling and testing methods, and that such analyses are performed in accordance within the applicable requirements of ISO 17025. ● Access control is restricted to authorized personnel ● Laboratory is designed and managed to prevent contamination ● Housekeeping and sanitation protocols ● Environmental monitoring via air, surface, and hand samples (EnviroMAP) ● Traceability linking all the events from the start of testing to producing the final result ● Proficiency Testing organized by an ISO 17043 accredited PT provider ● Personnel - competence to perform laboratory activities must be documented for each function ● Precision and accuracy performances monitored Mérieux NutriSciences Consulting Services can assist with laboratory requirements Incorporating Facility Laboratories into Internal Audits (GFSI or ISO 17025)
- 14. BEYOND COMPLIANCE Your Customers’ Supplier Approval Requirements may include: ● GFSI Audit ● Other Third-Party Audits ● Customer Audits Your Customers’ Ingredient or Finished Food Specifications may include: ● Compliance of Certificates of Analysis (COAs) ● Environmental Monitoring ● Metal Detector Limits ● Etc. Designing Internal Audits for Customer Compliance
- 15. What best describes your job function?
- 16. BEYOND COMPLIANCE Regulatory Inspection - Time Warp!
- 17. BEYOND COMPLIANCE In the United States, the Food Safety Modernization Act (FSMA) makes the “Owner, Operator, or Agent in Charge of a Facility” liable to: ● Monitoring of Effectiveness: “The owner, operator, or agent in charge of a facility shall monitor the effectiveness of the preventive controls implemented...” ● Corrective Actions: “The owner, operator, or agent in charge of a facility shall establish procedures to ensure that, if the preventive controls…are not properly implemented or are found to be ineffective:” (1) Appropriate action is taken to reduce the likelihood of recurrence of the implementation failure; (2) All affected food is evaluated for safety; and (3) All affected food is prevented from entering into commerce if the owner, operator or agent in charge of such facility cannot ensure that the affected food is not adulterated… Purpose of Food Safety Internal Audits
- 18. BEYOND COMPLIANCE Regulation Number Short Description Frequency 21 CFR 1.502(a) Did not develop FSVP 796 21 CFR 117.35(c) Pest Control 88 21 CFR 117.80(c) Manufacturing, Processing, Packing, Holding - Controls 84 21 CFR 117.130(a)(1) Hazard Analysis - Identification of Hazard 83 21 CFR 1.504(a) Hazard analysis written 78 21 CFR 1.505(a)(2) Supplier Evaluation - performance, risk 74 21 CFR 1.505(b) Supplier Approval - document 71 21 CFR 117.35(a) Sanitary Operations - Plant Maintenance 70 21 CFR 1.506(a)(1) Approved supplier procedures - importer established 69 21 CFR 1.506(b) Supplier verification - establish written procedures 68 21 CFR 117.40 Equipment and Utensils - Design and Maintenance 67 US FDA Regulatory Inspection Observations [10/1/20 - 9/30/21]; Top 11 Reasons an Inspector Writes a 483! Reference: https://www.fda.gov/inspections- compliance-enforcement-and-criminal- investigations/inspection- references/inspection-observations
- 19. BEYOND COMPLIANCE Global Regulatory Compliance & Inspection
- 20. BEYOND COMPLIANCE Reference: https://foodcompliance.mxns.com/ Global Regulatory Compliance: Recalls
- 21. BEYOND COMPLIANCE ● Supplier changed ingredient information for allergens or food additive ● Printer missed a line on the ingredient statement ● Allergens in “Contains” statement don’t match allergens in the ingredient statement ● New company owner didn’t know there were legal requirements for the food product name ● Illegal nutrient content claims & health claims ● Exported food that was not compliant with labeling regulations in country of sale How Often Does Your Internal Audit Check Your Labels for Regulatory Compliance? Reference: Mérieux NutriSciences Global Labeling Expert Services Team
- 22. BEYOND COMPLIANCE ● Traceability exercise with 100% recovery ● Mock recall scenarios or REAL crisis management ○ Foodborne outbreak attributed to your food ○ Allergic reaction and death attributed to your food ○ Sharp metal object ingested by a customer’s child ○ Regulatory Inspector wants to take samples or swab ■ Listeria monocytogenes swabs ■ Mycotoxins ■ Allergens ■ Etc. Do You Really Audit Your Crisis Management? Mérieux NutriSciences Consulting Services can assist with developing plans, scenario tests, or actual crisis situations.
- 23. BEYOND COMPLIANCE ● Define Corrective Actions ● Define Preventive Actions ● Align on Timeline for Implementation ● Verify & Document Completion ● Continuous Improvement CAPA (Corrective and Preventive Actions)
- 24. BEYOND COMPLIANCE External Food Safety Audit Types ● Designing “external” food safety audits into your “internal audit” program: ○ Ingredient Suppliers ○ On Farm / Produce ○ Logistics / Sanitary Transportation ○ Packaging Suppliers ○ Co-Manufacturers ○ Warehouses
- 25. BEYOND COMPLIANCE Design Considerations: Audit Types ● Design into food safety internal audits: ○ Maintenance Audits ○ Sanitation Audits ○ Capital Expenditures Progress for Food Safety Compliance ● Consider separate audits for: ○ Employee Safety ○ Ethical Audits ○ Environmental Compliance ○ Sustainability Claims ○ Financial Audits
- 26. BEYOND COMPLIANCE Supplier Registration and Compliance
- 27. BEYOND COMPLIANCE Supplier Conformity ● Design internal audits to check compliance to your requirements: ○ Supplier Approval Process ■ Domestic ■ Foreign Supplier Verification Program (FSVP) ○ Ingredient Approval Process ■ Food Additive Approval ■ GRAS Approval ○ Packaging Approval Process ■ Labeling Conformance ■ Food Contact Approval
- 28. BEYOND COMPLIANCE Audit Personnel ● Internal audits ○ Auditors trained & competent in Food Safety with documented training records ○ Knowledge of applicable regulations ○ Independent (do not audit their own work) ● Supplier & Co-Manufacturing Audits ○ Trained & competent in auditors with documented training records ○ Prior knowledge of that ingredient, packaging, or co-manufacturing industry ○ Knowledge of “best practices” for that type of supplier
- 29. BEYOND COMPLIANCE Designing Audit Records (Paper or Digital) ● Demonstrate Regulatory Compliance ○ Design your internal audit to document conformity with objective evidence of the findings to demonstrate to a regulator that you were in compliance at a point in time ● Demonstrate Continuous Improvement ○ Design audit to document non-conformity with objective evidence of the findings ○ Design audit to document the personnel responsible for the activity audited, the CAPA and who will execute, & due date ○ Close the loop – never leave an non-conformity open! ● Protect Consumers! ○ Never ship food that could cause harm ○ Document destruction of unsafe food with pictures
- 31. BEYOND COMPLIANCE Contact the Speaker Tracie Sheehan VP Technical Services, Mérieux NutriSciences tracie.sheehan@mxns.com 312-598-5198
- 32. More Resources at www.safetychain.com White Papers & Surveys Webinars & Videos Product & Partner Info Solution Consultation 2/25/22: FSMA Fridays: The Psychology of Product Allergen Labeling 3/2/22: 3 Key Methods to Unlock Continuous Improvement across Your Plant 3/17/22: Leveraging OEE to Minimize Downtime and Maximize Performance safetychain.com/resources/webinars-events/ BEYOND COMPLIANCE