FSMA How The Food Safety Plan, Auditing and the Role of PCQI

Transcription

1 FSMA How The Food Safety Plan, Auditing and the Role of PCQI Mr. Gary Smith Director, Food Safety Systems May 2016

2 Agenda Review how traditional third party auditing will evolve in the world of FSMA Supplier preventive controls Foreign supplier verification program Describe the roles of a PCQI & Qualified Auditor Explore how food safety plans will evolve Explore how FDA inspections will move to FDA inspections of food safety plans 2

3 Foundational Rules for Implementation of FSMA Current Good Manufacturing Practice and Hazard Analysis and Risk Based Preventative Controls for Human Food Final Current Good Manufacturing Practice and Hazard Analysis and Risk Based Preventative Controls for Animal Food Final Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption Final Foreign Supplier Verification Program (FSVP) for Importers of Food for Humans and Animals Final Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certificates Final Focused Mitigation Strategies to Protect Food Against Intentional Adulteration March 31, 2016 Sanitation Transportation of Human and Animal Food May 31, 2016

4 Preventive Control Rule Requirements A written food safety plan Hazard analysis Preventative controls Monitoring Corrective actions and corrections Verification / Validation Supply chain program Recall plan Records 4

5 Preventive Controls Qualified Individual Definition 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. 21 CFR Definitions

6 Training Requirements management must ensure that all individuals are qualified to perform their assigned duties Qualified individual have education, training or experience necessary to perform assigned tasks Receive training in the principles of food hygiene and food safety Records maintained Preventative controls qualified individual Attend preventive control training course (FDA recognized) OR Qualified through job experience 6

7 Preventive Controls Qualified Individual Qualification Standardized curriculum recognized as adequate by the FDA Food Safety Preventive Control Alliance (FSPCA) 2.5 day human food course Qualified through job experience to develop a food safety system No defined criteria on what is acceptable in regards to training and experience, competency determined by state of food safety plan? 7

8 Requirements of Preventive Control Qualified Individuals ( ) A preventive controls qualified individual* must do or oversee the following activities: 1. Preparation of the food safety plan 2. Validation of the process preventive controls (CCPs) 3. Determine if validation is not required 4. Review of records within 7 days of creation 5. Reanalysis of food safety plan (at least every 3 years) *Individual does not needs to be an employee of the facility 8

9 Preparation of the Food Safety Plan HACCP Process PC Sanitation SOPs Sanitation PC Allergen mgt program Allergen PC Approved supplier programs Supplier PC Recall program Recall PC 9

10 Allergen Preventive Controls Requirements 1. Preventing allergen cross-contact Clean shared equipment potential sanitation controls Properly manage rework Avoid in-process or post-process allergen cross-contact 2. Accurate allergen labeling of finished food Ensure labels are correct potential supply-chain program Ensure the correct label or package is used Human error can be involved training is essential!

11 PRODUCT: Omelet - Plain PAGE 1 of X PLANT NAME: E.G. Food Company ADDRESS: 360 Culinary Circle, Mytown, USA Allergen Control Hazard(s) Receiving Undeclared packaging allergens (labeled carton) egg, milk, soy (wheat in biscuit only) Parameter All finished product labels must declare the allergens present in the formula per listing Ingredient listing and allergen information matches product Monitoring ISSUE DATE SUPERSEDES What How Frequency Who Visual Before Label If label is check of release to coordi- incorrect, carton production nator reject label to labels and match return to product formula E.G. Food Company Example mm/dd/yy mm/dd/yy Corrective Action Verification Records supplier or destroy. Identify root cause and conduct training as needed to prevent recurrence Review of Label verification, Corrective Action and Verification records within 7 working days Allergen Label Verification listing; Allergen Label Verification log; Corrective Action records;

12 Hazards and Conditions Relevant to Sanitation Preventive Controls Environmental pathogens when RTE product is exposed to the environment prior to packaging E.g., Salmonella and L. monocytogenes Pathogens transferred through cross-contamination E.g., from insanitary objects or employees handling raw and processed product Food allergen cross-contact Unintended milk, soy, egg, fish, crustacean shellfish, wheat, peanut or tree nut cross-contact

13 Sanitation Preventive Controls* Procedures, practices and processes for: Cleanliness of food-contact surfaces Prevention of allergen cross-contact and crosscontamination o From insanitary objects and personnel to food, food packaging material, other food contact surfaces o From raw product to processed products * When hazard analysis identifies a hazard requiring a preventive control

14 PRODUCT: Omelet Plain, Cheese and Cheese Biscuit PAGE 21 of 36 PLANT NAME: E.G. Food Company ISSUE DATE 09/20/2015 ADDRESS: 360 Culinary Circle, Mytown, USA SUPERSEDES 08/06/2015 Assemble, Wrap Table Sanitation Purpose: Cleaning and sanitizing of the assembly and wrapping table is important to remove potential allergens and reduce microbial cross-contamination or recontamination with environmental pathogens that may impact product safety. Frequency: Cleaning: At lunch break, after Cheese Omelet Biscuit production, at the end of daily production. Sanitizing: Before operations begin, at lunch break, after Cheese Omelet Biscuit production, and at the end of daily production. Who: Sanitation team member Procedure: Note: Blue cleaning tools are to be used ONLY for cleaning after a cheese biscuit run to reduce the potential for unintentional allergen transfer. Cleaning 1. Remove unused packaging material to an area at the end of the shift to prevent it from getting wet. Cover it during the lunch clean up. 2. Remove gross soil with a squeegee. 3. Wipe table surface with a clean cloth dipped in ABC cleaning solution (Y oz. per gallon). 4. Rinse table with clean water. Detergent remaining on the surface can inactivate the sanitizer. Sanitizing 1. Spray table surface with 200 ppm quaternary ammonium compounds solution, ensuring that entire surface is covered. 2. Allow table to air dry, about 5 minutes. Contact time required per label 1 minute. Monitoring (at frequency indicated above): Inspect table for residual soil and cleanliness. Record on Daily Sanitation sheet. Use test strip to measure the quat concentration BEFORE application. Record on Daily Sanitation sheet Corrections: If residual soil is observed on the table, reclean and sanitize. If quat is not at the proper concentration, make a new solution. Records: Daily Sanitation Sheet Verification: Supervisor reviews and signs Daily Sanitation Sheet within 7 working days E.G. Food Company Example Easy to read text is in Appendix 3

15 Supply Chain Program (Subpart G) Documented approved suppliers ( ) Supplier verification program ( ) Documented program Verification activities (risk based) On-site audits ( ) Sampling and testing of raw material Review of supplier food safety records Other Receiving procedures for raw materials ( ) Records ( ) 15

16 Supply-chain Program General Requirements Use approved suppliers Determine supplier verification activities Conduct supplier verification activities Document supplier verification activities When applicable, verify a supply-chain-applied control applied by an entity other than your supplier

17 Appropriate Supplier Verification Activities Conduct one or more of the following verification activities before using and periodically thereafter: Onsite audit Sampling and testing By the supplier or the receiving facility Review supplier s food safety records for the ingredient Other if applicable

18 Who Can Perform Supplier Verification? Supplier Testing; provide 3 rd party audit Another entity (e.g., broker) Receiving facility Receiving facility must document review and assessment of documents provided by others

19 Onsite Audit Requirements For serious hazards requiring a supply-chain-applied control Documented onsite audit before using the raw material At least annually after the initial audit Exception You document that other verification activities or less frequent auditing provides adequate assurance

20 Onsite Audits Who and What Must use a qualified auditor Review supplier s written HACCP or other Food Safety Plan and implementation documents for hazard identified in your hazard analysis

21 Qualified Auditor An individual with a combination of training and experience to perform the auditing function A government employee An audit agent of a certification body that is accredited by a recognized accreditation body An individual with the required training and experience 21

22 Supply-chain Program Not Required: 1. When no hazards requiring a supply-chain-applied control exist OR 2. When you (the receiving facility) control the hazard OR 3. When a Customer or downstream entity provides written assurance that they control the hazard

23 Foreign Supplier Verification Program An extension of the supplier preventive controls from a manufacturers food safety plan For hazards that are addressed by suppliers who are importing product into the US The importer of record must ensure that the supplier meets the elements of the preventive controls rule Audits must be conducted by a qualified auditor FDA inspections Audit agent of a FDA recognized CB 23

24 FDA Recognition of Certification Bodies FDA will build a recognition program for accreditation bodies FDA recognized accreditation bodies will then accredit certification bodies, which a separate accreditation, for FDA regulatory auditors FDA regulatory audits can be done in conjunction with other third party audit programs Must be unannounced Must be in stage 1 and stage 2 phases Include a summary of findings and verification of compliance with the regulation Cannot be done by the same auditor 2 years in a row 24

25 FDA Transition to FSMA Audits FDA will conduct audits in which they are building a facilities food safety plan, based on input received from the facility Goal is to audit to compliance, wanting facilities to adjust their food safety plans based on input from government auditors Recognition of existing certification FDA has stated that they will be recognizing existing certifications that a facility may hold, however, no specifics have been defined how that will impact a facility inspection schedule from the agency 25

26 SQF V7.2 GAPs to FSMA Need for Preventive Control Qualified Individual A bit different than practitioner PC training vs. HACCP Training Preventive control Food safety all staff Hygiene all staff Foreign supplier verification program Agent of a recognized CB Record sign off must be at least every 7 days Preventive controls Allergens Sanitation Supplier approval On-site audits from qualified auditor Environmental monitoring for RTE product with environmental contamination reasonably likely to occur Food defense vulnerability assessment 2 year record retention 26

27 Summary The FSMA regulation has placed additional emphasis on an individual designated as the Preventive Control Qualified Individual (PCQI) One key in supplier management is the identification of the hazards which need to be controlled and who will be responsible for controlling those hazards The role of auditing of suppliers has an important role in a facilities food safety plan Existing third party audits can be utilized to supplement a facilities supplier audit programs, but will not replace regulatory inspections 27

28 Thank You Contact Details Gary M. Smith Director of Food Safety Services Eurofins Scientific, Inc