1. Validation and Verification Tasks March 8, 2016 Suzanne Finstad Vice President, Food Safety & Regulatory Compliance

2. Verification Tasks Calibration  Prior to use of the instrument (per shift) Direct Observation  Monitoring  Corrective Actions (per occurrence) Record Review  ALL of them  Prior to pre-shipment record review 2

3. The Evolution of Validation In the Beginning…  …There was paper. LOTS and LOTS of paper Mid to Late 2000’s  Articles  Statistical analysis  Summaries Present Day  Quality over quantity 3

4. FSIS on Validation In the Beginning…  …They were happy we had paper Mid to Late 2000’s  They read the articles  They reviewed the statistical analysis  They reviewed the summaries Present Day  HAV  PHRE  FSA 4

5. Industry Put on Notice Validation Compliance Guideline  Scientific support  In-plant data Organized Outreach  Federal Register notice  Meetings  Notice 78-15  Directive 5000.6  Directive 5100.1  YouTube video 5

6. Where Industry Went Wrong Design  Does the scientific support properly relate to the current process?  Have the critical operating parameters been identified? Execution  Have the critical operating parameters been included in the HACCP system?  Is there documented evidence that the HACCP system has been validated under in- plant conditions? 6

7. Post January 4 th … What are we doing?  Is it critical? Why are we doing it?  Relevant scientific support*  Test and hold How do we know we’re doing it correctly?  In-plant data What if we change our mind?  90-day validation 7 *Currently industry’s greatest need

8. Are We There Yet? Sanitary Dress  When, where, why, and how? Performance Standards  Past, present, and future 8

9. Where Are We Going?

10. What Are We Doing? Antimicrobial applications  Equipment  Sprays  Dips Research, research and more research  Food safety  Product quality 10

11. Why Are We Doing It? Scientific Support  Process specific?  Species specific?  Pathogen specific?  What’s critical? In-Plant Data  Does it work?  How well?  Relationship to the science Limitations  RELEVANT peer-reviewed support 11

12. How Do We Know We’re Doing it Correctly? Test the theory  Do YOU have data?  What kind of data?  What does it tell you? Commit it to memory  Keep the initial validation!  Stay on top of your system.

13. What If We Change Our Mind? Why Change?  Document the thought process After Change…  Collect some data  Draw some conclusions  Do it all within 90 days 13

14. Bringing It All Together Standing still gets you nowhere fast!

15. WE DON’T LIVE HERE!

16. Committed to continuous improvement.