How to Hit the Easy Button for a FSMA-Compliant Food Safety Plan

Transcription

1 How to Hit the Easy Button for a FSMA-Compliant Food Safety Plan Bryan Armentrout, CEO The Food Leadership Group And Gary Nowacki, CEO TraceGains, Inc.

2 Bryan Armentrout CEO The Food Leadership Group Gary Nowacki CEO TraceGains

3 How to Hit the Easy Button for a FSMA-Compliant Food Safety Plan Bryan Armentrout CEO, The Food Leadership Group TraceGains 365 Audit Ready Webinar October,

4 Agenda Learning Objectives Why is This Important? Food Leadership Group Company Objective Qualifications Quality System Theory Food Safety Plan Theory Food Safety Plan Development Summary/ Closing Bonus Material/ Reference Material 4

5 Learning Objectives The first step is always the hardest The FDA timeline is a fallacy... How to make the most of this session What is your intention? What can you learn? Are you comfortable? Take note of your physical state Is your mind present? Multitasking does not work What are the action steps for me? 5

6 Why is this important? This is a reset button Use it to develop awareness in your company Park Doctrine/ C Suite accountability PCQI/ Legal ramifications Corporate and Plant system implications Your existing documents will get you into trouble Your story needs to be rewritten for an audience that has only read a few pages 6

7 Company Objective The Food Leadership Group helps people develop robust food safety and quality systems that make a difference for their company and for the consumer. 3 rd Party Auditor GFSI Standard Develop Audit Cert 7

8 Qualifications Twenty + years of Food Manufacturing QA Experience GMA Advisory Committee Foreign Supplier Verification SQFI Technical Advisory Council - Past Vice Chair 8

9 Quality System Theory What makes for a good system? It sets the rules of the game It tells a story (PDCA) Integrated system Hierarchical Segmented by purpose (FS vs FQ) Controlled and Documented Simple and Concise Audited by an accredited standard FSMA QAM Policy Procedure Work Instruction Recording Form The New Manager Mindset 9

10 Food Safety Plan Theory What comprises a good FS system? It identifies regulatory scope and risk It is easy to follow and understand Product Category by Plant Responsibilities are clear Issues are addressed and documented Preventive/ Prerequisite programs are separately identified Hazard Analysis cites references to source material Understand that it will leave your plant and your control 10

11 Food Safety Plan Development Set the stage Purpose/ Scope of FS Plan Facility Profile Team Members Responsibilities Role/ Duties Key Definitions Finished Product Profile Intended Use 11

12 Food Safety Plan Development Prerequisite Programs Chemical Control Biosecurity/ Intentional Adulteration Facility Design Storage and Shipment Document Control Food Safety Complaints GMP s Pest Control Etc. 12

13 Food Safety Plan Development Preventive Controls Allergen Control Food Contact Sanitation Recall Contingency Plans Receiving of Raw Materials Supplier Verification All deviations to a Preventive Control must have a corresponding Corrective Action 13

14 Food Safety Plan Development Dry Ingredient Receiving Liquid Ingredient Receiving Packaging Receiving Hazard Analysis Inspection Use a Risk Matrix for decision making QA Disposition N Pass? Flow Chart by FS Process Group Y Material Storage Be careful about level of detail Prep Hazard Analysis sections Batching Ingredient Process Pasteurization Filling Storage Shipment 14

15 Food Safety Plan Development Ingredient and Hazard Analysis 15

16 Food Safety Plan Development Verification activities are being done Validation the right activities are being done 16

17 Food Safety Plan Development Reanalysis Checklist 17

18 Food Safety Plan Development Resources 18

19 Summary You have a good base already Get PCQI certified Follow a hierarchy Tell your story to FDA Close the loop on preventive controls FDA does not expect perfection 19

20 Closing Remarks Where will FDA focus? Stay up to date on changes more to come Don t be the example Ask for help 20

21 Bonus Material! - Text FSMATool for my complete FS Plan Template - Dr. Robert Brackett interview Thanks! Contact information: barmentrout@foodleadershipgroup.com (720)

22 Reference Material Website LinkedIn Twitter Facebook Free Consultation 22

23 THE FOOD INDUSTRY S LEADING FSMA & 365 Audit Ready GFSI COMPLIANCE SOFTWARE

24 The Industry s Leading FSMA Compliance Solution Foreign Supplier Verification Ensure CoA for Each PO Define Product & Safety Requirements Monitors Food Safety Plan Standard Regulatory Docs GMO Country of Origin Allergen Other Document-based Risk Assessment for: Suppliers Materials Vendor Approval Process Food Defense Planning Documents for Audits Auto Reminders Auto CoA Compliance Against Spec CoA Compliancebased Risk Assessment Cross Check Supplier Results with Internal Lab Results Full Auditability on Who Did What/When Establish with Supplier: Acceptable Levels Storage/Shipping Requirements Temperature + Other Processes Creates Level Field with Supplier Regarding Specs Supplier Acknowledgement on Specifications Ensures Internal Regulatory Docs /SOPs Are Current Plant Floor Data Collection Pre-Requisite Operations Misc. Logs Ensures Timely Data Collection Supervisory Oversight of Plant Floor Data Collection and Corrective Actions Automates Training Tracking

25 Turning Data into Information Typical TraceGains PRPs SOPs Superviso r Sign-off GFSI Docs. Training Corrective Actions Critical Control Points Employee Training Static Data Supplier Documents Temperature Check Audits No More Spreadsheets: Documents to Data Lab Results 24/7 Detection & Compliance Instant enotification Alerts Difficult to search, analyze, and take action Automatic Scorecarding/Risk

26 Sorter Check

27 Bryan Armentrout Gary Nowacki