Validation and Verification of Preventive Controls in Your Food Safety Plan. Kathy Knutson, Ph.D., Kornacki Microbiology Solutions, Inc.

Transcription

1 Validation and Verification of Preventive Controls in Your Food Safety Plan Kathy Knutson, Ph.D., Kornacki Microbiology Solutions, Inc.

2 Verification and Validation Procedures Objectives In this module, you will learn: The definitions of verification and validation Preventive controls qualified individual involvement in validation and verification Verification procedure requirements for: Calibration Product sampling and testing Monitoring, corrective actions and record review Food Safety Plan reanalysis requirements

3 Preventive Controls Qualified Individual Responsibilities ( (a)) Oversees or performs Preparation of the Food Safety Plan Validation of the preventive controls Justification for validation timeframe exceeding 90 days Determination that validation is not required Review of records Justification for review of monitoring and corrective action records timeframe exceeding 7 working days Reanalysis of the Food Safety Plan

4 Preventive Controls Qualified Individual ( (c)(1)) Must have successfully completed training in the development and application of riskbased preventive controls At least equivalent to that received under a standardized curriculum recognized as adequate by FDA Or be otherwise qualified through job experience to develop and apply a food safety system. Can be an external consultant Training must be documented in records date, type of training, person(s) trained

5 Validation Definitions 21 CFR Obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards. Are you doing the right thing to control the hazard?

6 Definitions 21 CFR Verification The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the food safety plan. Are you doing what you say you are doing in your food safety plan?

7 Validation ( ) Required for process preventive controls Performed or overseen by a preventive controls qualified individual

8 Validation Exceptions You do not need to validate: Food allergen preventive controls Sanitation preventive controls Supply-chain program Recall plan May be useful to validate some sanitation or allergen controls, e.g., How long a processing line can run between cleaning Allergen controls for complex equipment

9 Validation Procedures Documented scientific and technical evidence that the preventive control will effectively control the hazard Validation establishes the scientific basis for process preventive controls in the Food Safety Plan

10 Validation Procedures May include: Using scientific principles and data Use of expert opinion, e.g. extension professors, process authorities, contract labs, & consultants Conducting in-plant observations or tests with surrogates Challenging the process at the limits of its operating controls Inoculated challenge study

11 Validation Information Sources FDA Hazards Guides Seafood, Juice Dairy See Draft August 2016 CFIA Hazard Reference Database FDA Food Code and Annexes Peer-reviewed, external scientific literature Use Google Scholar Validated microbial modeling programs Professional and trade association guidance IFT Safe Harbor grid GMA AIB California Almond Board Cooperative extension websites for universities Internal scientific studies

12 Required Validation Frequency ( ) Before the Food Safety Plan is implemented (ideally) or Within the first 90 calendar days of production or Within a reasonable timeframe with written justification by the preventive controls qualified individual When a change in control measure(s) could impact efficacy When reanalysis indicates the need

13 Parameter Definitions A characteristic, feature or measurable factor that can help in defining a particular system Example: temperature Value The number with unit or observation Example: 160 o F

14 Safe Harbor Example ph and a W combinations that inhibit growth of vegetative cells and spores Critical a W values < > >0.92 Critical ph values < > >5.0 No growth No growth No growth No growth No growth No growth No growth? No growth No growth?? No growth???? = Requires time/temperature control unless product testing demonstrates otherwise Adapted from: IFT Evaluation and Definition of Potentially Hazardous Foods, IFT/FDA Contract No

15 Verification ( ) As appropriate to the nature of the preventive control and its role in the facility s food safety system, must include: Validation ( ) Verification that monitoring is being conducted Verification that corrective action decisions are appropriate Verification of implementation and effectiveness ( ) Calibration, product testing, environmental monitoring, review of records Reanalysis

16 Verification of Implementation and Effectiveness ( ) Verification of implementation and effectiveness includes, as appropriate to the facility, the food and the nature of the preventive control Calibration Product testing for a pathogen or appropriate indicator or other hazard Environmental monitoring if an environmental hazard requiring a preventive control is identified Review of records

17 Sampling and Testing Periodic verification may also include targeted sampling and laboratory testing of: Ingredients In-process materials Finished products

18 Environmental Monitoring Applies to RTE foods exposed to the environment after processing and before packaging and eaten raw without further processing See FDA Listeria draft guidance

19 Verification Written Procedures ( (b)) Must have written procedures specific to your facility, the food, the nature of the preventive control, and role in the food safety system Instruments: Method and frequency of calibration and accuracy checks for monitoring Ingredient & Product Testing: Procedures to identify sample and relation to production lot(s) Procedures for sampling (number and frequency) Environmental Monitoring Identify sample locations, number of sites tested must be adequate to determine whether preventive controls are effective Timing and frequency for collecting and testing Methods and Results Scientifically valid methods Identify test microorganism(s) or chemical analyte Test(s) conducted and method(s) used Laboratory conducting the testing Corrective action procedures

20 Verification Procedures Demonstrates that the Food Safety Plan is consistently being implemented as written Required as appropriate to the food, facility, and nature of the preventive control: Calibration of process monitoring and verification instruments Targeted testing: Product testing Environmental monitoring Records review Monitoring records Corrective action records Verification records E.g., product testing and environmental monitoring; supplier program

21 Equipment Calibration Essential to assure that the data generated are correct Performed on equipment and instruments used to monitor or verify parameters in the Food Safety Plan Performed at a frequency that ensures equipment will provide an accurate measurement

22 Calibration and Accuracy Calibration (Periodic) Check Accuracy Examples check (Routine) A dial thermometer is checked against an NIST* standardized thermometer for two or more temperatures Meter is adjusted to read between two ph points of buffer standards Thermometer ph Meter Thermometer used to monitor cold temperatures measures the correct temperature of an ice slurry (32 F (0 C)) ph of a single standard near that of the product is measured correctly under plant conditions Detector is adjusted by manufacturer to detect standardized metal slugs Metal Detector Detector rejects product with metal standards *NIST = National Institute of Standards and Technology

23 Calibration and Accuracy Records must: Check Records Document results of accuracy checks and calibration procedures Be reviewed or review overseen by a preventive controls qualified individual Records should: Provide a traceability to a reference device

24 Review of Records ( (a)(4)) Within 7 working days after records were created Monitoring records Corrective action records Preferably, before release of the product Preventive controls qualified individual may provide written justification for a longer reasonable timeframe Within a reasonable timeframe after records were created Calibration Product and environmental monitoring testing Supplier and supply-chain verification activities Other verification activities

25 Verification Record Review Performed or overseen by a preventive controls qualified individual When issues are identified during the review, corrective action is required.

26 Trend Analysis During records review, look for: Differences between suppliers Locations of positive EM samples Transient or in-house strain Higher counts during processing Higher ATP readings after sanitation

27 Food Safety Plan Reanalysis A food safety system changes with time Periodic reanalysis must be done to verify that the whole system works A verification activity must be conducted for the full plan: At least every 3 years When FDA determines it is necessary to respond to new hazards

28 Reanalysis ( (a) and (b)) When Applicable sections of the plan: When there is a significant change that creates the potential for a new hazard or a significant increase in one previously identified When you become aware of new information about potential hazards associated with a food When appropriate after an unanticipated food safety problem ( (b)) When you find that a preventive control, combination of preventive controls, or the Food Safety Plan as a whole is ineffective

29 Significant Changes May Include: Changes in raw materials or suppliers Changes in product or process Adverse review findings Recurring deviations New scientific information on hazards or control measures relevant to the product New distribution or consumer handling practices

30 Reanalysis ( (c), (d) and (e)) Complete the reanalysis BEFORE you make any changes OR (when necessary) within 90 days (or a reasonable timeframe with written justification) after production first begins You must: Revise the Food Safety Plan if significant changes occur that create a reasonable potential for a new or significant increase in an identified hazard OR Document the basis for concluding that no change is needed A preventive controls qualified individual must perform or oversee the reanalysis

31 Verification and Validation Summary Validation demonstrates that the Food Safety Plan will effectively control the identified hazards Validation and most verification activities are overseen by a preventive controls qualified individual Verification demonstrates that the Food Safety Plan is properly implemented by those involved Verification activities are conducted at a frequency identified in the Plan Reanalysis is conducted as needed and at least every 3 years.