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Allergen Management & Recall Readiness
- 1. Allergen Management & Recall Readiness Dr. Bob Strong February 14, 2019
- 2. Welcome! • Participants will be on mute during the webinar • Q&A session at the end – please use the ‘Question’ button on the right hand side of your screen, click ‘Ask’ to submit. • The webinar will be recorded and the link sent out after the webinar with the slides. • Our presenter today – Dr. Bob Strong
- 3. Allergen Management & Recall Readiness Dr. Bob Strong February 14, 2019
- 4. Our Presenter Today Dr. Bob Strong, Senior Consultant, SAI Global Assurance Driving force behind our food safety operations in the areas of Good Manufacturing Practice (GMP) and supplier assurance programs (GFSI), including SQF, BRC and FSSC 22000. Over 45 years of experience in the food industry, while working for national and international companies in quality assurance, product development and auditing. He is an often requested seminar speaker in the areas of GMP, HACCP and HARPC. Ph.D. and BSC in Chemistry and an accomplished food safety trainer for numerous food safety manager certification courses In addition, he is a GMP/HACCP/HARPC instructor, a Lead Auditor trainer, and is also certified to consult on the Global Food Safety Initiative. He is certified in 21 SQF product categories
- 5. Agenda • Allergen Management • Supplier concerns • Label accuracy • Correct package • Cross-contact issues • Recall Readiness • Traceability of ingredients • Traceability of finished products • Recall readiness
- 6. Background • These two subject matters are closely related as almost 50% of Recalls in USA are caused by allergens in a consumer product that are not indicated on the product’s label. • Due to this fact the FDA is directing a lot of its efforts to trying to counter this by • FSMA regulations • Preventive Controls for Human Foods training • Picking up product samples at retail to examine for unlabeled allergens • Requiring Food Fraud programs so as to address allergen risks that fraud exacerbates
- 7. Do you have a qualified person designing your packaging ingredient statements? • Yes, we have a qualified person • Yes, team member is tasked with this but no formal • Unsure who is responsible for this task • No
- 8. Do you test your recall program at least once per year? • Yes • No • Unsure how often we test our recall program
- 10. Allergen Management Program Components Approved Supplier Program Considerations: • Purchase only from approved suppliers who have: • Solid allergen management programs • Good food fraud programs • Excellent 3rd party audits done by qualified auditors • No history of recalls caused by their lack of solid food safety programs • Compliance to foreign supplier regulations (if applicable) • Consider avoiding suppliers with: • Ingredients with the statement “May contain (allergen)” on the package • Statement “Made in a facility that also processes (allergens)”
- 11. Allergen Management Program Components Label Accuracy Allergen recalls are caused by the allergen not being clearly indicated on the label hence it is important that the label be accurate at all times. How is this achieved? Label Design Evaluate ingredients and verify label contents Validate allergen label compliance by country Consider impact on ingredient statement when changing suppliers Evaluate ingredient substitutions and resultant impact on the finished product label Discard all old labels and ensure misprints are not possible
- 12. Allergen Management Program Components Correct Package Placing the product in the wrong package is one of the major reasons for product recalls. Hence it is very important that the product and package always match each other. How is this achieved? Inspect new shipments Avoid packaging errors Consider a packaging control form Apply controls concerning pre-labelling of individual containers Remove all unused packaging materials post-packaging
- 13. Allergen Management Program Components Allergen cross-contact issues The presence of any allergen at any detectable amount is a reason by law to recall a product. This can be caused by: • Failure to store allergens correctly • Failure to remove all allergen residues from common processing/packaging equipment • Failure to control the packaging environment • Allowing employees who dump powder allergens
- 14. Allergen Management Program Components Avoidance of allergen cross-contact issues These can be avoided by: • Ensure approved suppliers have excellent allergen management programs to avoid allergen cross-contact. • Receiving ingredients only from approved suppliers. • Labelling all allergens upon receipt using trained Receivers. • Rigid allergen storage practices. • Having an allergen spillage clean up program. • Using dedicated equipment where possible to run common allergen containing products.
- 15. Allergen Management Program Components Avoidance of allergen cross-contact issues continued • Where dedicated equipment is not feasible, control with scheduling • Ensuring total removal of allergens from equipment by performing allergen swabbing after sanitation. • Controlling flow of people and common vehicles, pallets, etc. into areas where products are exposed. • Controlling rework to avoid adding an allergen that is not on the product label. • Keeping all in-process product and rework clearly labelled as to the allergen content.
- 16. Recall Readiness
- 17. What you need to do to ensure you are ready in case the day comes when you have to conduct a Recall? Have a detailed Recall program including: Recall team with names, positions, contact numbers and role responsibilities. Up-to-date Contact name and back up contact name, daytime phone numbers, after hour phone numbers and email addresses for each customer. Pre-prepared media announcements covering 3 Recall classifications. Contact number for FDA/USDA/CFIA and, where applicable, State/Province government offices. Are you ready? Or do you just think you are ready?
- 18. Preparing for a Recall • Annually check the accuracy of your customer contacts list. • Review Recall team as to its accuracy. • Ask a Recall team member questions about their role and what would comprise a reason to conduct a Recall. • Conduct an annual traceability test from receiving to finished packaged product based on an ingredient and also using a packaging material and record both test results.
- 19. Preparing for a Recall • Conduct an annual reverse traceability using a finished product and trace back to ingredients and packaging materials used and record the test results. • Investigate any missing ingredients by conducting a Root Cause Analysis and then repeat the test. • Conduct annually a Mock Recall using a product that was made at least 1 month earlier. • Investigate any missing product by conducting a Root Cause Analysis and then repeat the test.
- 20. • Inaccurate recording of ingredient Lot numbers by employees when being used. • Not being able to account for normal “shrink”. • Losing track of ingredient lot numbers in rework when added back to another product. • Inaccurate accounting of amount of product produced. What makes a Recall Unsuccessful?
- 21. • Losing track of where all finished product went; so you need to keep records of: • Product shipped to customers • Product sold to own employees • Product discarded for any reason • Product used at food shows or sales demonstrations • Product donated • Not accounting for returned products • Being unable to find quickly 100+2% in < 4 hours What makes a Recall Unsuccessful? Consequences are significant – people will continue to become ill the longer your product is in the marketplace.
- 22. Thank you
- 23. Training & Improvement Solutions* - 3 Virtual Training Dates Offered! www.saiglobal.com/courses *SAI Global’s Training & Improvement Solutions (TIS) Business and Certification Services Business operate independently. Any audit provided by our Certification Services Business is totally independent of any work we may have done through our TIS Business and will not provide our clients with any special treatment. Course Topic Date Time Price Building a FDA Food Safety Plan March 13 1-3pm EST $199 Complying with the Foreign Supplier Verification Program (FSVP) March 20 1-3pm EST $199 Sanitary Transportation Act Requirements and Records March 27 1-3pm EST $199 Book more than one course, or multiple registrants and receive a discount
- 24. Training & Improvement Solutions* - Public Training, Onsite Training www.saiglobal.com/courses Food Defense Plan Development and Implementation Training FSPCA Preventive Controls for Human Food FSVP Foreign Supplier Verification Program Training Food HACCP Plan Development Implementing SQF Systems - Manufacturing 8th Edition SQF Quality Systems for Food Manufacturing 8th Edition Implementing SQF Systems - Manufacturing 8th Edition BRC - Internal Auditor Course BRC Global Standard for Food Safety Issue 7 to 8 - Conversion for Auditors BRC Global Standard for Food Safety Issue 7 to 8 - Conversion for Sites BRC Global Standard for Food Safety Issue 8 - Auditor Training BRC Global Standard for Food Safety Issue 8 - Lead Auditor BRC Global Standard for Food Safety Issue 8 - Sites Training *SAI Global’s Training & Improvement Solutions (TIS) Business and Certification Services Business operate independently. Any audit provided by our Certification Services Business is totally independent of any work we may have done through our TIS Business and will not provide our clients with any special treatment.
- 25. Training & Improvement Solutions* – Online Learning www.saiglobal.com/courses Allergen Management Auditing a Food Safety Management System Cleaning and Sanitation Food Safety Internal Auditor HACCP Validation and Verification Introduction to Food Safety Lead Auditor Training Pest Control Management Principles and Applications of HACCP Quality Assurance and Food Safety Management Refresher to HACCP Food Safety Systems Root Cause Analysis Shelf Life Validation Threat Assessment and Critical Control Point Traceability *SAI Global’s Training & Improvement Solutions (TIS) Business and Certification Services Business operate independently. Any audit provided by our Certification Services Business is totally independent of any work we may have done through our TIS Business and will not provide our clients with any special treatment.
- 26. Q&A
Editor's Notes
- Steve to briefly introduce Harriet, next slide she can expand!
- Have a qualified person design the label who is fully conversant with Regulatory Food Labelling Acts. Evaluate all ingredients for known allergens and then ensure they are on the finished product label. Ensure allergen label compliance with the allergen list for the countries where the product will be sold into commerce. Evaluate every ingredient supplier change for any impact on the ingredient statement of the finished product. Evaluate every ingredient substitution for its allergen content and the impact on the finished product label. Discard all old labels by destroying them immediately to avoid using them. Get back printing plates and artwork from printer to avoid printer accidentally printing old labels/packaging.
- When receiving new shipments of packaging materials from a supplier they should be inspected for accuracy and for lack of mixing different labels/packaging in the same box. Make sure that the only packaging materials in the packaging room match the product being packaged at that time. A packaging control form needs to be signed off on by the packaging operator showing that product to be packaged and packaging material match. Pre-labelling of individual containers, if applicable, should be controlled to “just in time” and excess pre-labelled containers should be discarded immediately. Once a product packaging run has been completed all unused packaging materials need to be removed immediately to a packaging/label storage area.
- Failure to store allergens correctly, thereby contaminating other ingredients with the allergen that was stored above them. Failure to remove all allergen residues from common processing/packaging equipment when changing products. Failure to control the packaging environment from allergen dust that then contaminates exposed product prior to packaging. Allowing employees who dump powder allergens access into packaging room where product is exposed prior to packaging without them changing their allergen contaminated clothing.