SQF Conference 2015: PROPER RECORDKEEPING AND DOCUMENTATION: THE KEY TO REDUCING RISK AND LIABILITIES
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The document discusses the importance of proper recordkeeping and documentation in food safety to reduce risk and liabilities, outlining compliance requirements under the FSMA. It emphasizes the need for a written food safety plan, detailed recordkeeping for hazard analyses, preventive controls, and supplier verification, with a focus on legal considerations and audit requirements. Common pitfalls in documentation practices are identified, alongside a call for organizational discipline and the importance of consistency in recordkeeping.
SQF Conference 2015: PROPER RECORDKEEPING AND DOCUMENTATION: THE KEY TO REDUCING RISK AND LIABILITIES
- 2. Proper Recordkeeping and Documentation: The Key to Reducing Risk and Liabilities Melanie Neumann, The Acheson Group James P. Reynolds, Lineage Logistics Holly Mockus, Alchemy Systems
- 3. Melanie Neumann, J. D., M.S. EVP & CFO The Acheson Group, LLC 3
- 4. Overview What do the rules require for record keeping How do you approach record keeping and documentation for compliance Other legal considerations 4
- 5. FSMA Status Summary - “The 7 Pillars” Proposed Rule Final Deadline PC- Human Food-Final September 17, 2015 PC- Animal Food-Final September 17, 2015 Produce Safety October 31, 2015 FSVP October 31, 2015 Third Party Accreditation October 31, 2015 Sanitary Transport March 31, 2016 Food Defense May 31, 2016 5
- 6. Rules Enacted Upon Signing • Inspection of records • Suspension of registration • Expanded administrative detention • Authority to require import certificates • Mandatory recall 6
- 7. The Food Safety Plan-A Key Required Document • You must prepare, or have prepared, and implement a written food safety plan. • The food safety plan must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals. • Preventive controls qualified individual means a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system. 7
- 8. The Food Safety Plan Hazard Analysis Preventive Controls Monitoring Corrective Actions Verification Reanalysis Documentation 8
- 9. Implementation Records (§ 117.190) Records needed for: • Documentation for hazard analysis • Documentation for not establishing a preventive control • Monitoring of preventive controls • Corrective actions • Verification, including − Validation − Verification of monitoring − Verification of corrective actions; − Calibration of process monitoring and verification instruments; − Product testing − Environmental monitoring − Records review − Reanalysis • Document the supply chain program • Document training for the preventive controls qualified individual and the qualified auditor. 9
- 10. Records for Supply Chain (§ 117.475) • Must have a written plan • If importer must have documentation showing to be in compliance with FSVP • Documentation of the approval of a supplier • Procedures for receiving raw materials • Documentation demonstrating use of the written procedures for receiving raw materials • Documentation of the determination of the appropriate supplier verification • Documentation of the conduct of the onsite audit (lots of details) • Sampling and testing (lots of details) • Review of the suppliers food safety records • Verification activities other than onsite audit • Actions taken with regard to non-compliance 10
- 11. Required Records • All records can be stored off site, with exception of the written food safety plan, as long as they are accessible within 24 hours of a request for official review – Food Safety Plan records do not need to be stored in one location or in “one binder” • Record retention begins after the applicable compliance date • Records must also document – Training – Reanalysis • Electronic records exempt from 21 CFR Part 11, however must be equivalent to paper records and handwritten signatures 11
- 12. Legal Considerations • Admissions Against Interest • Speculation • Strict Liability – The Park Doctrine: • The Park Doctrine is based on a 1975 U.S. Supreme Court case affirming FDA’s right to bring a criminal misdemeanor case against corporate executives based on a strict liability theory. • A corporate official can be held criminally liable for violations of the FD&C Act even if the official did not intend for the violations to occur. • NO ACTUAL KNOWLEDGE OR NEGLIGENCE REQUIRED • Complaint Management People, Process & Systems are Key! 12
- 14. James P. Reynolds Director of Food Safety & Compliance Lineage 14
- 15. Lineage Logistics • Refrigerated warehousing • 100+ locations / 12 certifications • Food product storage and handling • Wide array of services 15
- 16. Background • Joined Lineage Logistics in 2012 • 20+ year career in Naval Aviation • Documentation – Operational status – Lessons learned – Compliance 16
- 17. Overview 1. Objectives & relationships 2. Role of management 3. Common pitfalls 17
- 18. Recordkeeping Objectives 1. Operations/communication 2. Demonstrate effective food safety 3. Audit & regulatory compliance 18
- 20. Operations 1. Incoming & outbound inspections 2. Storage temperatures 3. Inventory control 4. Value-added services – Effectiveness – Capturing of costs 20
- 21. Food Safety 1. Chemical Control 2. Personal Hygiene 3. Product Equipment 4. Cleaning and Sanitation 5. Training 6. Receiving, Storage and Shipping 7. Traceability and Withdrawal (Recall) 8. Pest Control 9. Allergen Control 21
- 23. SQF requirements “Records…shall be maintained” • 2.1.4 Management Review • 2.1.5 Complaint Management • 2.1.6 Business Continuity Planning • 2.2.2 Records • 2.3.1 Product Development and Realization • 2.3.2 Raw and Packaging Materials • 2.4.6 Non-conforming Product or Equipment • 2.4.7 Product Rework • 2.4.8 Product Release • 2.5.1 Responsibility, Frequency and Methods • 2.5.2 Validation & Effectiveness • 2.5.4 Verification of Monitoring Activities • 2.5.5 Corrective and Preventative Action • 2.5.6 Product Sampling, Inspection and Analysis • 2.5.7 Internal Audits • 2.6.1 Product Identification • 2.6.2 Product Trace • 2.6.3 Product Withdrawal and Recall • 2.9 Training • 12.2.7 Premises and Equipment Maintenance • 12.2.8 Calibration • 12.2.9 Management of Pests and Vermin • 12.2.11 Cleaning and Sanitation • 12.6.8 Transport • 12.6.9 Unloading 23
- 24. FSMA: Preventive Controls 1. Hazard Analysis • Develop controls • Justify decision to not include 2. Associated steps • Monitoring • Corrective actions / Corrections • Verification 3. CGMPs (GDPs for Lineage) 24
- 25. FSMA: Sanitary Transportation • Trailer inspection – Sanitation – Structure – Temperature • All captured on inspection form 25
- 26. HACCP 1. CCP management 2. Temperature control 3. Corrective actions 26
- 27. Role of Management 1. Prioritization – Corrective action processing – Root cause investigations – Trend analyses 2. Personnel accountability 3. Support / Resources 27
- 28. Common pitfalls 1. “Check in the block” record format 2. Overly complex documentation 3. Poor system of verification 4. Inadequate management commitment 28
- 29. Summary 1. Commitment to consistency 2. Pay attention to the details 3. Organizational discipline 29
- 31. Record Description • An account of something, preserved in a lasting form. • Typically made as the activity occurs • Functions as evidence of activities performed • Proves you did what you said you were going to do • Required by regulation(s) • Paints a picture of the product, process, plant, and culture 31
- 32. Preparation 32 • New form development – Involve the end user – Train – Test – Learn – Pivot • KISS • Set your team up for success!
- 33. Customize 33 • Create forms that meet the exact need • Reassess – Changes – High level of errors – Feedback – Procedure updates • Track and Trend – Don’t collect data to collect data
- 34. Include: 34 • Date • Product • Facility name and location • Initials / Signature • Time • Work Instructions • Critical limits / Action limits
- 35. Uniformity 35 Require consistency in all documentation • AM / PM or military time • Date format • Signatures or initials • Product name or product code • Header info • Footer info • Logo
- 36. Demand Perfection 36 Do Don’t Use ink Fill out in real time Fill out initials, date and time ABCDEF Review document before submitting Use exact time Fill in all information as required Write clearly – use best penmanship Use pencil – can be erased Fill out in advance Use hash marks, lines, ditto Use cheat sheets Estimate time Leave blank spaces – use N/A or other Use markers or pastel ink – can run or fade
- 37. Mock Exercises 37 • Pull records from several months ago for review with management team – Can you find the document? – How long did it take to retrieve? – Is it complete? – Does it paint an accurate picture? – Are you following your procedure? – Is record review a part of mock exercises? • Providing records to a regulator – Notify your legal counsel – Provide copy / keep original – Verify marked Confidential
- 38. Questions?