Validation And Verification Of Preventive Controls In Your Food Safety Plan

Validation and Verificationof Preventive Controls inYour Food Safety PlanKathy Knutson, Ph.D.,Kornacki MicrobiologySolutions, Inc.

Verification and ValidationProcedures ObjectivesIn this module, you will learn: The definitions of verification and validation Preventive controls qualified individualinvolvement in validation and verification Verification procedure requirements for:– Calibration– Product sampling and testing– Monitoring, corrective actions and record review Food Safety Plan reanalysis requirements

Preventive Controls Qualified IndividualResponsibilities (§ 117.180(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 correctiveaction records timeframe exceeding 7 working days– Reanalysis of the Food Safety Plan

Preventive Controls Qualified Individual(§ 117.180(c)(1)) Must have successfully completed training inthe development and application of riskbased preventive controls– At least equivalent to that received under astandardized curriculum recognized as adequateby FDA Or be otherwise qualified through jobexperience to develop and apply a foodsafety system. Can be an external consultant Training must be documented in records –date, type of training, person(s) trained

Definitions21 CFR 117.3 Validation– “Obtaining and evaluating scientific and technicalevidence that a control measure, combination ofcontrol measures, or the food safety plan as a whole,when properly implemented, is capable of effectivelycontrolling the identified hazards.”– Are you doing the right thing tocontrol the hazard?

Definitions21 CFR 117.3 Verification– “The application of methods, procedures, tests andother evaluations, in addition to monitoring, todetermine whether a control measure or combinationof control measures is or has been operating asintended and to establish the validity of the foodsafety plan.”– Are you doing what you say youare doing in your food safetyplan?

Validation (§ 117.160) Required for process preventive controls Performed or overseen by a preventivecontrols qualified individual

Validation Exceptions You do not need to validate:––––Food allergen preventive controlsSanitation preventive controlsSupply-chain programRecall plan May be useful to validate some sanitation orallergen controls, e.g.,– How long a processing line can run between cleaning– Allergen controls for complex equipment

Validation Procedures Documented scientific and technical evidencethat the preventive control will effectivelycontrol the hazard Validation establishes the scientific basis forprocess preventive controls in the FoodSafety Plan

Validation Procedures May include:– Using scientific principles and data– Use of expert opinion, e.g. extensionprofessors, process authorities, contractlabs, & consultants– Conducting in-plant observations or testswith surrogates– Challenging the process at the limits of itsoperating controls– Inoculated challenge study

Validation InformationSources 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 gridGMAAIBCalifornia Almond Board Cooperative extension websites for universities Internal scientific studies

Required ValidationFrequency (§ 117.160) Before the Food Safety Plan isimplemented (ideally) or Within the first 90 calendar days ofproduction or Within a reasonable timeframe with writtenjustification by the preventive controlsqualified individual When a change in control measure(s)could impact efficacy When reanalysis indicates the need

Definitions Parameter– A characteristic, feature ormeasurable factor that can help indefining a particular system– Example: temperature Value– The number with unit or observation– Example: 160oF

Safe Harbor ExamplepH and aW combinations that inhibit growth of vegetative cells andsporesCritical aWvalues 4.2No growthCritical pH values4.2 – 4.6 4.6 – 5.0No growth No growthNo growthNo growthNo growth?No growthNo growth?No growth? 5.0No growth 0.880.88 – 0.90 0.90 –0.92 0.92? Requires time/temperature control unless product testingdemonstrates otherwiseAdapted from: IFT. 2001. Evaluation and Definition of Potentially Hazardous Foods,IFT/FDA Contract No. 223-98-2333.

Verification (§ 117.155) As appropriate to the nature of the preventivecontrol and its role in the facility’s food safetysystem, must include:– Validation (§ 117.160)– Verification that monitoring is being conducted– Verification that corrective action decisions areappropriate– Verification of implementation and effectiveness (§117.165) Calibration, product testing, environmentalmonitoring, review of records– Reanalysis

Verification of Implementationand Effectiveness (§ 117.165) Verification of implementation andeffectiveness includes, as appropriate tothe facility, the food and the nature ofthe preventive control– Calibration– Product testing for a pathogen orappropriate indicator or other hazard– Environmental monitoring if anenvironmental hazard requiring apreventive control is identified– Review of records

Sampling and Testing Periodic verification may alsoinclude targeted sampling andlaboratory testing of:– Ingredients– In-process materials– Finished products

Environmental Monitoring Applies to RTE foods exposed to theenvironment after processing and beforepackaging and eaten raw without furtherprocessing See FDA Listeria draft guidance

Verification WrittenProcedures (§ 117.165(b))Must have written proceduresspecific to your facility, thefood, the nature of the preventive control, and role in the food safetysystem Instruments:– Method and frequency ofcalibration and accuracy checksfor monitoring Ingredient & Product Testing:– Procedures to identify sampleand relation to production lot(s)– Procedures for sampling(number and frequency) Environmental Monitoring– Identify sample locations,number of sites tested – mustbe adequate to determinewhether preventive controls areeffective– Timing and frequency forcollecting and testing Methods and Results– Scientifically valid methods– Identify test microorganism(s)or chemical analyte– Test(s) conducted andmethod(s) used– Laboratory conducting thetesting– Corrective action procedures

Verification Procedures Demonstrates that the Food Safety Plan isconsistently being implemented as written Required as appropriate to the food, facility, andnature of the preventive control:– Calibration of process monitoring and verificationinstruments– Targeted testing: Product testing Environmental monitoring– Records review Monitoring records Corrective action records Verification records– E.g., product testing and environmental monitoring; supplierprogram

Equipment Calibration Essential to assure that the datagenerated are correct Performed on equipment andinstruments used to monitor or verifyparameters in the Food Safety Plan Performed at a frequency that ensuresequipment will provide an accuratemeasurement

Calibration and AccuracyCalibration (Periodic)Accuracy check (Routine)Check ExamplesThermometerA dial thermometer is checkedagainst an NIST* standardizedthermometer for two or moretemperaturesThermometer used to monitorcold temperatures measures thecorrect temperature of an iceslurry (32 F (0 C))pH MeterMeter is adjusted to readbetween two pH points of bufferstandardspH of a single standard near thatof the product is measuredcorrectly under plant conditionsMetal DetectorDetector is adjusted bymanufacturer to detectstandardized metal slugsDetector rejects product withmetal standards*NIST National Institute of Standards and Technology

Calibration and AccuracyCheck Records Records must:– Document results of accuracy checks andcalibration procedures– Be reviewed or review overseen by apreventive controls qualified individual Records should:– Provide a traceability to a reference device

Review of Records (§117.165(a)(4)) Within 7 working days after records were created––––Monitoring recordsCorrective action recordsPreferably, before release of the productPreventive controls qualified individual may providewritten justification for a longer “reasonabletimeframe” Within a reasonable timeframe after records werecreated––––CalibrationProduct and environmental monitoring testingSupplier and supply-chain verification activitiesOther verification activities

Verification RecordReview Performed or overseen by a preventivecontrols qualified individual When issues are identified during thereview, corrective action is required.

Trend AnalysisDuring 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

Food Safety PlanReanalysis A food safety system changes with time Periodic reanalysis must be done toverify that the whole system works A verification activity must beconducted for the full plan:– At least every 3 years– When FDA determines it is necessary torespond to new hazards

Reanalysis (§ 117.170(a)and (b)) – When Applicable sections of the plan:– When there is a significant change that creates thepotential for a new hazard or a significant increase inone previously identified– When you become aware of new information aboutpotential hazards associated with a food– When appropriate after an unanticipated food safetyproblem(§ 117.150(b))– When you find that a preventive control, combinationof preventive controls, or the Food Safety Plan as awhole is ineffective

Significant Changes MayInclude:Changes in raw materials or suppliersChanges in product or processAdverse review findingsRecurring deviationsNew scientific information on hazards orcontrol measures relevant to theproduct New distribution or consumerhandling practices

Reanalysis(§ 117.170(c), (d) and (e)) Complete the reanalysis BEFORE you make anychanges OR (when necessary) within 90 days (or areasonable timeframe with written justification)after production first begins You must:– Revise the Food Safety Plan if significant changesoccur that create a reasonable potential for a new orsignificant increase in an identified hazard OR– Document the basis for concluding that no change isneeded A preventive controls qualified individualmust perform or oversee the reanalysis

Verification and ValidationSummary Validation demonstrates that the Food Safety Planwill effectively control the identified hazards Validation and most verification activities areoverseen by a preventive controls qualifiedindividual Verification demonstrates that the Food SafetyPlan is properly implemented by those involved Verification activities are conducted at a frequencyidentified in the Plan Reanalysis is conducted as neededand at least every 3 years.

- Validation (§ 117.160) - Verification that monitoring is being conducted - Verification that corrective action decisions are appropriate - Verification of implementation and effectiveness (§ 117.165) Calibration, product testing, environmental monitoring, review of records - Reanalysis