FSMA d out. Now What?

Transcription

1 FSMA d out Now What?

2 Missing elements?

3 oprps

4 Sanitary Transportation of Foods deadline April 2018 Internal shipping policies? Ensure compliance from 3rd party shippers

5 FSMA Intentional Adulteration 1. Requires a written food defense plan for all covered facilities unless an exemption applies vulnerability assessment Aka Food Defense mitigation strategies monitoring, corrections, and verifications 2. Requires EDUCATION, TRAINING, to be qualified 3. Requires implementation and reanalysis < 10 million annual sales = exempt, 10 million 500 employees = small = July 2020, 10 million 500 employees = large = July 2019

6 FSMA FOOD SAFETY PLAN Background information *Hazard analyses *Control programs Process Allergen Sanitation Supply Recall Effective? *Implementation *REQUIRED by FDA Background information is useful and somewhat essential (not required)

7 Develop, document, maintain and review the Food Safety Plan Anything missing? 1 Oversee effective implementation of the Food Safety Plan 2 Ensure personnel are trained to carry out their responsibilities

8 Compliance Checklist Food Safety Plan (documented) GMP update to 21 CFR Part B Process PC (CCP Summary Process Summary) Allergen PC Recall Sanitation PC Supplier PC Training Program

9 IMPLEMENTATION VERIFICATION VALIDATION SAFETY IN NUMBERS USDA FSIS FDA ISO CFR 117 GFSI schema Can we measure effectiveness

10 VERIFICATION: Activities (beyond monitoring) that establish the validity of a food safety plan. Are you doing what you say you will do? Are plan components working EFFECTIVELY? VALIDATION: Activities related to collecting and evaluating scientific evidence. IT IS PART OF VERIFICATION REQUIRED for CCPs Are plan components based on sound science? Is the entire plan working? 21 CFR CFR 117.3

11 Hazard analysis verification All products included? Properly grouped? Flow chart verified via walk through Intrinsic properties obtained (ph, Salt, Aw, etc) All oprps identified All preventive controls identified

12 PRP Verification Effective Documentation? Regulatory compliant Effective Design? End justifies the means Effective Tools? Everything's better with technology Effective Instructions? Three rights make a left Effective Training? Qualified and recorded

13 Parameters and values Verify (validate where required) all parameters and values monitored as part of the PC food safety plan. Critical Limit: The defined minimum and/or maximum value that is required to control a (significant) process hazard that can result in foodborne illness Operating Limit: A userdefined criterion that separates acceptability from unacceptability (often a more stringent version of the critical limit) Failure results in a deviation (unsafe) Failure results in a user evaluation (not unsafe) Safe but inedible effects of excessive lethality or excessive parameters on quality

14 CCP VERIFICATION Process Control Hazard(s) Critical Limits Monitoring Corrective Action Ver Records What How Frequency Who Monitoring: Conducting Right person? a (Knowledge, skills, ability) planned sequence Right method? of Right observations frequency? or measurements Right tool(s)? to Accurate tools? control a process, procedure, or point Effective Execution? Effective Design? Effective Tools? Effective Instructions? Effective Training? Four rights make it right

15 DRIFT Drift & monitoring frequency Drift & verification frequency

16 Corrective Actions Corrective Actions: Predetermined actions taken to correct a deviation and bring it back under control. Verification straight forward for corrective actions. Effectiveness = bringing deviation under control. Effective, but?? Costly, time consuming, quality compromised, etc Failure results in potential foodborne illness or recall Always have an eye on deviation PREVENTION

17 Corrections Fixing something BEFORE there is a deviation

18 Allergen PC Verification Allergen Labeling Verification Step-by-Step Allergen Verification Using effective criteria

19 Allergen cleaning verification Allergen Cleaning SOP 1. Rinse FCS with warm water 2. Spray foam cleaner detergent on all surfaces 3. Use mild brush to scrub away any soils 4. Rinse FCS with warm water 5. Monitor allergen by a. FAIL: Repeat 1-5 b. PASS: Sanitize, then air dry 1. Visual 2. ATP Swabs 3. Total Protein (Swabs) 4. Immunological (ELISA) Measurement (analytical) tools N=9 Cleaning SOP verification Monitoring Determine EFFECTIVENESS ELISA Verification Sample Visual ATP Protein Peanut Dairy Egg Soiled 9/9 9/9 9/9 9/9 9/9 9/9 FCS After 0/9 0/9 0/9 0/9 1/9* cleaned Effective? In next product Is there an FDA standard? (Not present in another food) Is there an FDA threshold? (No) Is there guidance on N =? (No - maybe) Is there a customer threshold? (Maybe) Are there GFSI schema parameters? (Some, yes) Are there GFSI effectiveness protocols? (Some, yes) 0/9 NA 0/9 0/9 0/9 0/9 0/9

20 Sanitation PC Effectiveness No Lm In facility No Lm In food or Salmonella for low Aw processes

21 Tech Tools for Monitoring Trending software Luminometry Protein residue analysis ~$2-4 each ~$2000

22 Environmental pathogen verification Allergen Cleaning SOP 1. Rinse FCS with warm water 2. Spray foam cleaner detergent on all surfaces 3. Use mild brush to scrub away any soils 4. Rinse FCS with warm water 5. Monitor allergen by a. FAIL: Repeat 1-5 b. PASS: Sanitize, then air dry N=9 Cleaning SOP verification Monitoring Assay Verification Sample Visual ATP Protein Dairy Egg Soiled 9/9 9/9 9/9 9/9 9/9 9/9 FCS After 0/9 0/9 0/9 0/9 1/9* cleaned Effective? In next product 0/9 NA 0/9 0/9 0/9 0/9 0/9 Measurement (analytical) tools 1. Visual 2. Total Protein (Swabs) 3. ATP Swabs 4. Microbial a. General assay (Listeria spp)(enterobacteriacea) b. Specific Assay (L monocytogenes or Salmonella spp) Determine EFFECTIVENESS Is there an FDA standard? (Not present in another food) Is there an FDA threshold? (No) Is there guidance on N =? (No) Is there a customer threshold? (Maybe) Are there GFSI schema parameters? (Some, yes) Are there GFSI effectiveness protocols? (Some, yes)

23 Verify PC Sanitation Cleaning (Daily) Sanitation Control Hazard(s) Critical Limits Sanitation Monitoring Corrective Action Ver Records Clean LM ATP RLU low ATP RLUs Swab and luminometer What How Frequency Who 5 swabs of FCS only after sanitizing Cook Re-clean and sanitize until RLU s in hygienic category Monitoring: Conducting Right person? a (Knowledge, skills, ability) planned sequence Right method? of Right observations frequency? or measurements Right tool(s)? to Accurate tools? control a process, procedure, or point Purpose? Effective Design? Effective Tools? Effective Instructions? Effective Training? Goal is EFFECTIVE PC Sanitation

24 Verify Overall FS System Qualified auditor 1st party audits 2nd party audits 3rd party audits

25 Education and Training knowledge To be a qualified individual have the appropriate education, training, or experience (or a combination thereof) necessary to properly implement the actionable items of concern skills abilities

26 New course (workshop)? In planning VERIFICATION & VALIDATION FSMA PC SYSTEMS HAZARD ANALYSIS PREREQUISITE PROGRAMS PROCESS PC SANITATION PC ALLERGEN PC SUPPLIER PC RECALL FOOD SAFETY PLAN & SYSTEM

27 Overall Objectives Understand role of verification and validation within your food safety system, including verifying the major elements: FSS I. Identify the components of prerequisite program verification II. Identify the components of CCP verification III. Identify the components of FS system verification IV. Identify the components of FS plan validation V. Identify regulatory requirements for verification and validation Learning Objectives: A. Hazard analysis verification B. Prerequisite Programs (PRP) Verification 1) Verify minimal regulatory compliance 2) Identify verification and validation activities for prerequisite programs 3) Understand effectiveness measurements C. PROCESS PC Verification 1) Understand the components of CCP monitoring verification a) Critical limit scientific reference validation b) Measurement tool calibration c) Monitoring record review d) Independent observations/checks 2) Identify specific examples of each CCP verification activity 3) Identify parties responsible for, and the frequencies (when and how often) 4) of, conducting CCP verification activities 5) Identify the CCP verification records 6) Understand the role of microbiological testing in CCP verification D. SANITATION PC Verification E. ALLERGEN PC Verification F. SUPPLIER PC Verification G. Food Safety System Verification 1) Identify the differences between a FS Plan and a FS System 2) Describe the components of a FS System verification 3) Identify examples of activities conducted in a FS system verification 4) Identify parties responsible for, and the frequencies (when and how often) of, conducting FS system verification activities 5) Identify the FS system verification records 6) Demonstrate how to interpret and utilize the results of a FS System Verification H. Food Safety System Validation 1) Contrast the differences between FS System Verification and FS Plan Validation 2) Propose how to evaluate the Hazard Analysis and other components of a HACCP plan (i.e., CCP, critical limits, monitoring activities, corrective actions, verification, record-keeping) 3) Identify examples of activities conducted in a FS plan validation 4) Identify parties responsible for conducting FS plan validation activities and their frequencies 5) Identify the FS plan validation records 6) Demonstrate how to interpret and utilize the results of a FS Plan Validation I. Verification/Validation Regulatory Requirements (USDA, FDA, etc.) 1) Recognize the regulatory requirements related to verification and validation ("reassessment") requirements 2) Identify current, pending, and proposed regulatory activities relating to verification and validation

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