3M Food Safety and The Acheson Group present FSMA: How do I comply? Webinar series

Transcription

1 3M Health Care Academy 3M Health Care Academy SM 3M Food Safety and The Acheson Group present FSMA: How do I comply? Webinar series

2 Host Kevin Habas, 3M Food Safety Active in the Food Safety market for over 20 years; Currently Global Scientific Marketing Manager; has held sales, marketing and technical leadership roles at 3M and Ecolab Member of the International Association for Food Protection (IAFP) since 1998, Global Food Safety Initiative (GFSI) TWG Global Markets member and the Minnesota International Food Technologists (IFT) affiliate member Founding member and treasurer of the recently formed MFPA local IAFP affiliate Certified SQF2000 Systems implementation

3 Agenda I. 3M Food Safety II. The Acheson Group III. FSMA presentation IV. Question & Answer Session V. FSMA presentation VI. Question & Answer Session VII. Closing comments

4 4About 3M Food Safety Every day and in more than 100 countries, 3M Food Safety products and people help food and beverage processors maintain the highest food safety standards and provide the highest levels of service and technical support. Quality Indicator Testing 3M Petrifilm Plates Over 30 Years in Food Safety Industry. Global Experience. Local support. Trusted by Top Food Companies, Validated around the World. Sample Handling / Media Hygiene Monitoring 3M Clean -Trace Hygiene Monitoring Tests Pathogen & Toxin Testing 3M Molecular Detection System

5 FSMA: How do I comply? Webinar series FSMA What is it all about and how do the rules fit together? PC for Human Food The concepts from HACCP to HARPC. How to build a food safety plan. How to build a supply chain control program. On Demand On Demand Today February 11, 1:00PM CST

6 Melanie Neumann J.D., M.S. EVP & Chief Financial Officer, The Acheson Group (TAG) Melanie has over 17 years experience advising food processors She has a Master s degree in food which allows her to tackle the ever changing global risks and food safety regulations She focuses her time on working with clients to prepare for FSMA and other pending FDA and USDA regulations Melanie also focuses on the growing area of international food safety in the growing global markets of China, Taiwan, Mexico and other global markets She has served as food law and intellectual property legal counsel for major multi-national food companies, helping those companies build holistic food safety management programs and leading their recall & crisis management teams Melanie also served as VP Crisis Management & General Counsel for a global recall and crisis management firm & helped launch a food risk consulting practice at Pricewaterhouse Coopers

7 7 The Acheson Group Global Food Safety Risk Management Firm 10 FTE s OPERATIONAL 3 TAG Professional Advisors RISK Vast Network of Partners REGULATORY RISK Helps Companies Manage 3 Core Risk Management Strategies: Facility risk management/internal process controls Supply chain risk assessments/management programs Recall/Crisis preparedness and planning REPUTATIONAL RISK Regulatory compliance (e.g. FSMA, USDA, allergens) Recall/Crisis response Social Media Crisis communications strategies Complaint management practices

8 8 FSMA Status Summary - The 7 Pillars Proposed Rule PC- Human Food-Final PC- Animal Food-Final Final Deadline September 17, 2015 (final) September 17, 2015(final) Produce Safety October 31, 2015 (final) FSVP October 31, 2015 (final) Third Party Accreditation October 31, 2015 (final) Sanitary Transport March 31, 2016 Intentional Adulteration(Food Defense) May 31, 2016

9 9 Today s Presentation: How to Build a Food Safety Plan

10 10 Overview Who Can Prepare My Food Safety Plan? Basic Requirements The Law! Food Safety Plan Required Contents Next Steps

11 11 Building your Food Safety Plan

12 12 The Food Safety Plan-Basic Process Gather your Food Safety Team to build the Plan But Remember that the food safety plan must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals (PCQI). More than a HACCP Plan / but you don t need to scrap it either! Think outside classic CCP s Now use both Critical Limits AND Parameters and Values Critical Limits=for Process Controls Parameters and Values=for all other Preventive Controls Sanitation Allergens

13 13 Who Can Prepare My Food Safety Plan? Preventive controls qualified individual means 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. A qualified individual may be, but is not required to be, an employee of the establishment. COMPARED TO: Qualified individual means a person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual s assigned duties.

14 The Food Safety Plan Hazard Analysis Reanalysis Preventive Controls Documentation Verification/ Verification Validation Monitoring Corrective Actions

15 Preventive Controls for Humans Subpart C Food safety plan. (a) Requirement for a food safety plan. (1) You must prepare, or have prepared, and implement a written food safety plan. (2) The food safety plan must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals. (b) Contents of a food safety plan. The written food safety plan must include: (1) The written hazard analysis as required by (a)(2); (2) The written preventive controls as required by (b); (3) The written supply-chain program as required by subpart G of this part; (4) The written recall plan as required by (a); and (5) The written procedures for monitoring the implementation of the preventive controls as required by (a)(1); (6) The written corrective action procedures as required by (a)(1); and (7) The written verification procedures as required by (b). (c) Records. The food safety plan required by this section is a record that is subject to the requirements of subpart F of this part. 15

16 What is Required in My Food Safety Plan? Hazard Analysis Corrective Action and Correction Procedures Preventive Controls Process Controls Allergen Preventive Controls Sanitation Preventive Controls Circumstances not requiring a Preventive Control Supply Chain Program Requirements Verification Procedures Validation Documentation Implement -ation records Recall Plan Reanalysis Monitoring Procedures Preventive Controls Qualified Individual and Qualified Auditor Requirements 16

17 Hazard Analysis: ( ) Must be written Hazard identification must consider known or reasonably foreseeable Biological, Chemical and Physical hazards Natural Unintentionally introduced Intentionally introduced for economic gain 17

18 Hazard evaluation Determine if the known or reasonably foreseeable hazards require a preventive control Consider severity and probability of occurrence in absence of preventive control Evaluation of environmental pathogen s must occur when ready to eat foods are exposed to the environment prior to packaging if the package food does not receive a treatment or otherwise include a control measure that would significantly minimize the pathogen 18

19 Hazard evaluation considerations Formulation of the food Facility and equipment Raw materials and ingredients Transportation practices Manufacturing/processing procedures Packaging and labeling activities Storage and distribution Intended or reasonably foreseeable use Sanitation, including employee hygiene Other relevant factors FACILTIES ARE REQUIRED TO CONSIDER THESE FACTORS 19

20 Preventive Controls ( (c)) Required (if relevant) for hazards requiring a preventive control Process Controls May or may not be CCP s Food Allergens Controls Sanitation Controls Supply-chain Controls Recall Plan Other Controls 20

21 Preventive Control-Not Required ( & ) Preventive controls are not required when an identified hazard requiring a preventive control is controlled by another entity later in the distribution chain if you: Disclose in written documents that accompany the food that the food has not been processed to control [ identified hazard] E.g. NOT PROCESSED TO CONTROL FOR SALMONELLA written on a Bill of Lading; Label on Product Obtain annual written assurances that the hazard will be controlled by your customer 21

22 Process Preventive Controls Critical Limits CCP s Minimum / maximum values required for food safety Time/temp is example Requires Monitoring procedures (what, frequency, how, who) Exception v affirmation records for temperature monitoring Corrective actions Verification Validation If not met product safety is in question Process control form looks VERY similar to HACCP Chart in practice Ahhhhh-sounds like HACCP! I know this! 22

23 Allergen Controls Tied back to hazard analysis determines which if any require a preventive control Some examples include: Need for allergen labeling-falcpa Ensure right product/right package (bar code scanners, etc.) Ensure correct labels (may be supply chain control upon receipt) Prevent allergen cross contact (ties to sanitation controls) Avoid cross contact during or post production Production scheduling, Color coding, etc. Clean shared equipment and utensils Manage rework appropriately No Validation Required; Verification of Preventive Controls is visually clean, allergen test kits, ATP and protein test kits. 23

24 Sanitation Preventive Controls Tied back to those hazards identified in Hazard Analysis Subset of sanitation procedures managed through GMPs (e.g. pest control, Used to significantly minimize or prevent hazards identified as requiring a preventive control such as: Environmental Pathogens when RTE product is exposed to the environment prior to packaging Pathogens transferred through cross contact E.g employees are handling raw and RTE product Food allergen cross contact E.g. unintentional peanut cross contact with non-peanut containing product HYGIENIC ZONING often used control 24

25 Sanitation Preventive Controls Required: Documented procedures Monitoring Verification Corrective actions CORRECTIONS associated with a sanitation event An action to identify and correct a problem that occurred during the production of food without other actions associated with a corrective action procedure (117.3). Validation not required 25

26 Subpart G Supply Chain Preventive Controls 26 The receiving facility must establish and implement a risk-based supply-chain program for those raw materials and other ingredients for which the receiving facility has identified a hazard requiring a supply-chain-applied control Exceptions Importer that is in compliance with FSVP Food for research Program must be written Supplier verification activities Onsite audit* Sampling and Testing Review food safety records Other appropriate activities When applied by an entity other than the receiving facility s supplier, facility must Verify the supply-chain-applied control was applied by someone other than the supplier; or Obtain documentation of an appropriate verification activity from another entity, review and assess the entity s applicable documentation, and document that review and assessment

27 Recall Plan ( ) Required when a hazard requiring a preventive control is identified for food. The following written elements are required in your recall procedures: 1 Directly notify the direct consignees of the food being recalled including how to return or dispose of product; 2 Notify the public when appropriate to protect public health; 3 Conduct a effectiveness checks to verify that the recall is carried out properly; 4 Appropriately dispose of recalled food. Even though a preventive control under the Rule it is a response tool. Therefore it can be kept outside of your food safety plan. Best practice: Have your recall plan apply to all products not just those requiring preventive controls 27

28 Preventive Control Management Components ( ) As appropriate to ensure the effectiveness of the preventive controls taking into account nature of the preventive control and the role in the facilities food safety system SM 3M Health Care Academy 28

29 Monitoring ( ) Written monitoring procedures are required Monitoring Frequency must be specified Monitoring must be documented and verified under direction of the PCQI Exception records are allowed for refrigeration and potentially other systems/records Exception records = demonstrate loss of control of required limit Affirmation records = demonstrate a system remained within required limits at all times As appropriate to the nature of the preventive control and its role in the facility s food safety system 29

30 Corrective Actions (a)(2) Must have written corrective action procedures for each preventive control requiring a corrective action (usually a process preventive control) containing these 4 elements: Identify and correct a problem Reducing the likelihood of recurrence Ensure the affected food is evaluated for food safety Ensuring that adulterated food does not enter commerce Must also include corrective action procedures in response to Pathogen or indicator organism detection in RTE product subject to verification testing Response to presence of environmental pathogen or indicator organism detection through environmental monitoring Corrective action records are required to be retained and must be reviewed by PCQI As appropriate to the nature of the preventive control and its role in the facility s food safety system 30

31 Unanticipated Corrective Actions I Can t Possibly Think of Everything! Unanticipated Issues (b) Follow the procedures in (a) we just talked about Perform a reanalysis to see if your Food Safety Plan needs to be revised to add a new corrective action 31

32 Corrections (c) If action is taken timely to correct certain problems Full corrective action procedures are not required for: a minor isolated problem that does not directly impact product safety Allergen cross contact controls Sanitation controls Focuses on sanitation controls problems Only need to keep records as appropriate to the situation vs. corrective actions which are required. 32

33 Verification Activities: Validation Verification of monitoring Verification that corrective actions are appropriate Verification of implementation and effectiveness Calibration, product testing, review of records, environmental monitoring Reanalysis Verification ( ) Required to show preventive controls are being consistently applied and are working! 33

34 Validation ( ) The scientific and technical basis to show that a PC significantly minimizes or effectively controls the hazard Required for Process Controls Prior to production or within first 90 days or Reasonable time upon written justification by PCQI NOT required for Allergen controls Sanitation controls Supply chain controls Recall Plan 34

35 Verification of Implementation and Effectiveness ( ) Includes as appropriate to the facility, the food and the nature of the preventive control: Calibration required for instruments used for process control monitoring must designate the frequency Product testing for a pathogen or indicator organism / other hazard Environmental monitoring if an Environmental hazard is identified that requires a preventive control Review of records Must be overseen by the PCQI 35

36 Records Review ( (a)(4)) Within 7 working days after records are created: Monitoring records Corrective action records Within reasonable timeframe after records created: Calibration Product and environmental monitoring testing Supplier / supply chain verification Other verification activities Unless the PCQI has written justification for longer reasonable timeframe Benefit of Onsite PCQI 36

37 Verification of Written Procedures( (b)) Written procedures required as appropriate to the facility, the food and the nature of the preventive control, and the role in the food safety system: Method and frequency of calibration (or accuracy checks) Product Testing Scientifically valid/ recognized Identify sample/ relation to production lot Identify tests and methods used Identify test microorganisms/analytes Identify labs conducting tests Identify corrective action procedures Environmental monitoring procedures Scientifically valid/ recognized Identify test microorganisms Identify sample locations/number sites (adequate to determine PC is effective) Timing/frequency of sample collection/testing Identify labs conducting tests Identify corrective action procedures 37

38 Reanalysis (a) and (b) A verification activity must be conducted for the full plan: At least every three years When FDA states needed in order to respond to a new hazard When there is a significant change that creates potential for a new hazard or significant increase in one previously identified When you gain new information about potential hazards associated with a food After an unanticipated food safety problem When a preventive control is found ineffective 38

39 Reanalysis (c) and (d)-the How If reanalysis shows increase in risk, food safety plan must be revised Complete entire reanalysis before you make changes to your food safety plan If validation is needed complete within 90 days after production first begins Or longer reasonable timeframe if written justification by PCQI If determine no revisions are needed you need to document this decision and reason for it! All of the above must be overseen or performed by the PCQI 39

40 PCQI Responsibilities ( (c)(1)) Employee or third party consultant Oversees or Performs: Food Safety Plan Validation of preventive controls Justify >90 days of production Determine if validation not required Records review Justify >7 days review for monitoring and corrective action records Reanalysis Justify >90 days of production for additional or changes of preventive controls MUST successfully complete 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 Document training, date, content. 40

41 Qualified Auditor ( (b) and (c)(2) Audits may be required for certain verification activities like supply chain applied control program Qualified auditor must have: Technical experience in auditing function Training must be documented Must also be a qualified individual (QI) 41

42 42 Records needed for: Implementation Records ( ) Documentation for not establishing a preventive control Monitoring of preventive controls Corrective actions Verification, including Validation Verification of monitoring Verification of corrective actions; Calibration of process monitoring and verification instruments; Product testing Environmental monitoring Records review Reanalysis Document the supply chain program Document training for the preventive controls qualified individual and the qualified auditor.

43 43 What Do I Do Next? Next Steps Create your FSMA Team to help your PCQI prepare the Food Safety Plan Who is your PCQI? Do they have required training? Secure the training/document the training Review what you are documenting today Pick a date to complete your Food Safety Plan Pick a date to start your hazard analysis The rest flows from the hazard analysis! 43

44 44 Compliance Dates for cgmp and PC Businesses with 500 Full-Time Equivalent Employees September 19, Supply Chain Program has until the later of March 17, 2017, or 6 months after a supplier is required to comply with the applicable rule Small Businesses (< 500 FTE Employees) September 18, Supply Chain Program has until the later of September 18, 2017, or 6 months after a supplier is required to comply with the applicable rule PMO Businesses September 17, Supply Chain Program has until September 17, 2018 Qualified Facilities (also Very Small Businesses) September 17, (Except compliance date is January 1, 2016 for records to support the facility s status as a qualified facility).

45 FSMA: How do I comply? Webinar series FSMA What is it all about and how do the rules fit together? PC for Human Food The concepts from HACCP to HARPC. How to build a food safety plan. How to build a supply chain control program. On Demand On Demand Today February 11, 1:00PM CST

46 Thank you! The Acheson Group 3M Food Safety Melanie Neumann Kevin Habas 3M Food Safety