FSMA’d outNow What?

Missing elements?

oPRPs

Sanitary Transportation of Foodsdeadline April 2018

Internal shipping policies?

Ensure compliance

from 3rd party

shippers

FSMA Intentional Adulteration

1. Requires a written food defense plan for all covered facilities unless an exemption applies

2. Requires “EDUCATION, TRAINING, to be “qualified”3. Requires implementation and reanalysis

Aka Food Defense

vulnerability assessment

mitigation strategies

monitoring, corrections, and

verifications

< 10 million annual sales = exempt, ≥ 10 million ≤ 500 employees = small = July 2020, ≥ 10 million ≥ 500 employees = large = July 2019

Background information

*Hazard analyses

*Control programs

*Implementation

FSMAFOOD SAFETY PLAN

*REQUIRED by FDA | Background information is useful and somewhat essential (not required)

Process | Allergen | Sanitation | | Supply | Recall |

Effective?

Develop, document, maintain and review the Food Safety Plan

Oversee effective implementation of the Food Safety Plan

Ensure personnel are trained to carry out their responsibilities

Anything missing?

1

2

Develop, document, maintain and review the Food Safety Plan

Oversee effective implementation of the Food Safety Plan

Ensure personnel are trained to carry out their responsibilities

Anything missing?

1

2

Compliance Checklist

Food Safety Plan (documented)

GMP update to 21 CFR 110 → 117 Part B

Process PC(CCP Summary ⇢ Process Summary)

Sanitation PC

Allergen PC Supplier PCRecall Training Program

IMPLEMENTATIONVERIFICATION VALIDATION

USDA FSISFDAISO 2200021 CFR 117GFSI schema

SAFETY INNUMBERS

Can we measure effectiveness

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?

21 CFR 117.3 21 CFR 117.3

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?

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

PRP VerificationEffective Documentation?

Regulatory compliantEffective Design?

End justifies the meansEffective Tools?

Everything's better with technologyEffective Instructions?Three rights make a left

Effective Training?“Qualified” and recorded

Parameters and valuesCritical 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 user-defined 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

Verify (validate where required) all parameters and values monitored as part of the PC food safety plan.

CCP VERIFICATIONProcess Control Hazard(s) Critical Limits Monitoring Corrective Action Ver Records

What How Frequency Who

Monitoring:Conductingaplannedsequenceofobservationsormeasurementstocontrolaprocess,procedure,orpoint

Effective Design?

Effective Tools?Effective Instructions?

Effective Training?

Right person?(Knowledge, skills, ability)

Right method?Right frequency?

Right tool(s)?Accurate tools?

Effective Execution?

Four rights make it right

DRIFT• Drift & monitoring frequency• Drift & verification frequency

Corrective ActionsCorrective Actions: Predetermined actions taken to correct a deviation and bring it back under control.

Failure results in potential foodborne illness or recall

Always have an eye on deviation PREVENTION

Verification straight forward for corrective actions. Effectiveness = bringing deviation under control.

Effective, but ??Costly, time consuming, quality

compromised, etc

CorrectionsFixing something BEFORE there is a deviation

Step-by-Step Allergen VerificationUsing “effective” criteria

Allergen Labeling Verification

Allergen PC Verification

Allergen cleaning verificationAllergen Cleaning SOP

1. Rinse FCS with warm water2. Spray foam cleaner detergent on all surfaces3. Use mild brush to scrub away any soils4. Rinse FCS with warm water5. Monitor allergen by “_____”

a. FAIL: Repeat 1-5b. PASS: Sanitize, then air dry

Measurement (analytical) tools

1. Visual2. ATP Swabs3. Total Protein (Swabs)4. Immunological (ELISA)

Determine EFFECTIVENESSIs 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)

Cleaning SOP verificationMonitoring ELISA Verification

Sample Visual ATP Protein Peanut Dairy Egg

Soiled 9/9 9/9 9/9 9/9 9/9 9/9

FCS After cleaned 0/9 0/9 0/9 0/9 1/9*

Effective?0/9

In next product NA 0/9 0/9 0/9 0/9 0/9

N=9

Sanitation PC Effectiveness

No Lm In food

No Lm In facility

or Salmonella for low Aw processes

Tech Tools for Monitoring

Luminometry

Protein residue analysis

~$2000

~$2-4 each

Trending software

Environmental pathogen verificationAllergen Cleaning SOP

1. Rinse FCS with warm water2. Spray foam cleaner detergent on all surfaces3. Use mild brush to scrub away any soils4. Rinse FCS with warm water5. Monitor allergen by “_____”

a. FAIL: Repeat 1-5b. PASS: Sanitize, then air dry

Measurement (analytical) tools

1. Visual2. Total Protein (Swabs)3. ATP Swabs4. 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)

Cleaning SOP verificationMonitoring Assay Verification

Sample Visual ATP Protein Dairy Egg

Soiled 9/9 9/9 9/9 9/9 9/9 9/9

FCS After cleaned 0/9 0/9 0/9 0/9 1/9*

Effective?0/9

In next product NA 0/9 0/9 0/9 0/9 0/9

N=9

Verify PC Sanitation Cleaning (Daily)Sanitation

ControlHazard(s) Critical Limits Sanitation Monitoring Corrective Action Ver Records

What How Frequency Who

Clean LM ATP RLU low ATP RLUs Swab and luminometer

5 swabs of FCS only after sanitizing

Cook Re-clean and sanitize until RLU’s in hygienic category

Monitoring:Conductingaplannedsequenceofobservationsormeasurementstocontrolaprocess,procedure,orpoint

Goal is EFFECTIVE PC Sanitation

Purpose?Effective Design?Effective Tools?

Effective Instructions?Effective Training?

Right person?(Knowledge, skills, ability)

Right method?Right frequency?

Right tool(s)?Accurate tools?

Verify Overall FS System

1st party audits

2nd party audits

3rd party audits

Qualified auditor

have the appropriate education, training, or experience (or a combination thereof) necessary to properly implement the actionable items of concern

knowledge

skills

abilities

Education and Training

To be a qualified individual

New course (workshop) ?

VERIFICATION & VALIDATION FSMA PC SYSTEMS

HAZARD ANALYSISPREREQUISITE PROGRAMS

PROCESS PCSANITATION PCALLERGEN PCSUPPLIER PC

RECALLFOOD SAFETY PLAN & SYSTEM

In planning

G. Food Safety System Verification1) Identify the differences between a FS Plan and a FS System2) Describe the components of a FS System verification3) Identify examples of activities conducted in a FS system verification4) Identify parties responsible for, and the frequencies (when and how often)

of, conducting FS system verification activities5) Identify the FS system verification records6) Demonstrate how to interpret and utilize the results of a FS System

VerificationH. 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 validation4) Identify parties responsible for conducting FS plan validation activities and

their frequencies5) Identify the FS plan validation records6) 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") requirements2) Identify current, pending, and proposed regulatory activities relating to

verification and validation

Overall ObjectivesUnderstand role of verification and validation within your food safety system, including verifying the major elements: FSSI. Identify the components of prerequisite program verificationII. Identify the components of CCP verificationIII. Identify the components of FS system verificationIV. Identify the components of FS plan validationV. Identify regulatory requirements for verification and validation

Learning Objectives:A. Hazard analysis verificationB. Prerequisite Programs (PRP) Verification

1) Verify minimal regulatory compliance 2) Identify verification and validation activities for prerequisite programs3) Understand effectiveness measurements

C. PROCESS PC Verification 1) Understand the components of CCP monitoring verification

a) Critical limit scientific reference validationb) Measurement tool calibrationc) Monitoring record reviewd) Independent observations/checks

2) Identify specific examples of each CCP verification activity3) Identify parties responsible for, and the frequencies (when and how often) 4) of, conducting CCP verification activities5) Identify the CCP verification records6) Understand the role of microbiological testing in CCP verification

D. SANITATION PC VerificationE. ALLERGEN PC VerificationF. SUPPLIER PC Verification

Masters FS&Q

1100

Outreach or Online Workshop (Courses)

Food ToxicologyEmployee Food Safety

Preventive ControlsAcidified Foods

Fermented FoodsTrain-the-Trainer

Formal or more Online Courses

Regulatory ShadowingMentored Leadership

ResearchSpecial Projects

ORD Courses

Experiential

You earn a “Professional”

Masters in Food Safety

Get a Masters FS

1100 11001100

1100

1100

Get credit for workshops

Take online courses

Add experiential credits