3M Food Safety and The Acheson Group present …© 3M 2015. All Rights Reserved 3MHealth Care Academy + 3M Health Care Academy SM 3M Food Safety and The Acheson Group present FSMA:

© 3M 2015. All Rights Reserved

3M Health Care Academy

+

3M Health Care AcademySM

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



+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



+

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



+

4About 3M Food Safety

3M™ Petrifilm™ Plates

3M™ Clean -Trace™ Hygiene Monitoring Tests

Quality Indicator TestingQuality Indicator TestingQuality Indicator TestingQuality Indicator Testing

PathogenPathogenPathogenPathogen & Toxin TestingHygieneHygieneHygieneHygiene MonitoringMonitoringMonitoringMonitoring

Sample HandlingHandlingHandlingHandling / Media

3M™ Molecular Detection System

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.

• Over 30 Years in Food Safety Industry.

• Global Experience. Local support.

• Trusted by Top Food Companies, Validated around the World.



+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 February 11, 2016@ 1:00PM CST

Today



+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



+

7The Acheson Group

Global Food Safety Risk Management Firm

10 FTE’s

3 TAG Professional Advisors

Vast Network of Partners

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

� Regulatory compliance (e.g. FSMA, USDA, allergens)

� Recall/Crisis response

� Social Media

� Crisis communications strategies

� Complaint management practices

OPERATIONALOPERATIONALOPERATIONALOPERATIONALRISK

REGULATORYREGULATORYREGULATORYREGULATORYRISK

REPUTATIONALREPUTATIONALREPUTATIONALREPUTATIONALRISKRISKRISKRISK



+

8 FSMA Status Summary FSMA Status Summary FSMA Status Summary FSMA Status Summary ---- “The 7 Pillars”“The 7 Pillars”“The 7 Pillars”“The 7 Pillars”

Proposed Rule Final Deadline

PC- Human Food-Final September 17, 2015 (final)

PC- Animal Food-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



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9

Today’sToday’sToday’sToday’s Presentation:Presentation:Presentation:Presentation:

How to Build a Food Safety PlanHow to Build a Food Safety PlanHow to Build a Food Safety PlanHow to Build a Food Safety Plan



+

10 OverviewOverviewOverviewOverview

�Who Can Prepare My Food Safety Plan?

�Basic Requirements

�The Law!

�Food Safety Plan Required Contents

�Next Steps



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11 Building your Food Safety Plan



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12 The Food Safety PlanThe Food Safety PlanThe Food Safety PlanThe Food Safety Plan----Basic ProcessBasic ProcessBasic ProcessBasic 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 preventive controls qualified preventive controls qualified preventive controls qualified

individuals (PCQI). individuals (PCQI). individuals (PCQI). 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



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13Who Can Prepare My Food Safety Plan?

� Preventive controls qualified individual Preventive controls qualified individual Preventive controls qualified individual 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: COMPARED TO: COMPARED TO: COMPARED TO:

� Qualified individual Qualified individual Qualified individual 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.



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14

TheTheTheThe Food Food Food Food Safety Plan Safety Plan Safety Plan Safety Plan

1414

Hazard Analysis

Preventive Controls

Monitoring

Corrective Actions

Verification

Reanalysis

DocumentationDocumentationDocumentationDocumentation

Hazard Analysis

Preventive Controls

Monitoring

Corrective Actions

Verification/ Validation

Reanalysis

Documentation



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15

Preventive Controls for Humans Subpart C

§ 117.126 Food safety plan.117.126 Food safety plan.117.126 Food safety plan.117.126 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 § 117.130(a)(2);

(2) The written preventive controls as required by § 117.135(b);

(3) The written supply-chain program as required by subpart G of this part;

(4) The written recall plan as required by § 117.139(a); and

(5) The written procedures for monitoring the implementation of the preventive controls as required by § 117.145(a)(1);

(6) The written corrective action procedures as required by § 117.150(a)(1); and

(7) The written verification procedures as required by § 117.165(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.



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16

What is Required in My Food Safety Plan?

Hazard AnalysisHazard AnalysisHazard AnalysisHazard Analysis Corrective Action and Correction Corrective Action and Correction Corrective Action and Correction Corrective Action and Correction Procedures Procedures Procedures Procedures

Preventive ControlsPreventive ControlsPreventive ControlsPreventive Controls� Process Controls� Allergen Preventive Controls� Sanitation Preventive Controls� Circumstances not requiring a

Preventive Control

Verification ProceduresVerification ProceduresVerification ProceduresVerification Procedures

Supply Chain Program RequirementsSupply Chain Program RequirementsSupply Chain Program RequirementsSupply Chain Program Requirements Validation DocumentationValidation DocumentationValidation DocumentationValidation Documentation

Recall PlanRecall PlanRecall PlanRecall Plan Reanalysis Reanalysis Reanalysis Reanalysis

Monitoring ProceduresMonitoring ProceduresMonitoring ProceduresMonitoring Procedures PreventivePreventivePreventivePreventive Controls Qualified Individual Controls Qualified Individual Controls Qualified Individual Controls Qualified Individual and Qualified Auditor Requirementsand Qualified Auditor Requirementsand Qualified Auditor Requirementsand Qualified Auditor Requirements

Implement-ation

records



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17

Hazard Analysis: (§117.130)

� Must be written

� Hazard identification must consider known or reasonably foreseeable

� Biological,

� Chemical and

� Physical hazards

� Natural

� Unintentionally introduced

� Intentionally introduced for economic gain



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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



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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 FACILTIES ARE REQUIRED TO CONSIDER THESE FACTORS FACILTIES ARE REQUIRED TO CONSIDER THESE FACTORS FACILTIES ARE REQUIRED TO CONSIDER THESE FACTORS



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20

Preventive Controls (§117.135(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



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21

Preventive Control-Not Required (§117.136 & §117.137)

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



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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!



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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.



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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



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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



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26

Subpart G Subpart G Subpart G Subpart G –––– Supply Chain Supply Chain Supply Chain Supply Chain Preventive ControlsPreventive ControlsPreventive ControlsPreventive Controls

� 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



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27

Recall Plan (§117.139)

• 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



+

© 3M 2015. All Rights Reserved3M Health Care AcademySM

28

Preventive Control Management Components (§117.140)

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



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29

Monitoring (§117.145)

� 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”



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30

Corrective Actions-§117.150(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”



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31

Unanticipated Corrective Actions –I Can’t Possibly Think of Everything!

Unanticipated Issues—§117.150(b)

• Follow the procedures in 117.150(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



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32

Corrections §117.150(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.



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33

Verification (§117.155)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

Required to show

preventive controls

are being

consistently

applied and are

working!



+

34

Validation (§117.160)

� 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



+

35

Verification of Implementation and Effectiveness (§117.165)

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



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36

Records Review (§117.165(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



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37

Verification of Written Procedures(§117.165(b))

� 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

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:



+

38

Reanalysis §117.170 (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



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39

Reanalysis §117.170 (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



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40

PCQI Responsibilities (§117.180 (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.



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41

Qualified Auditor (§117.180(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)



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42

Implementation Records (§ 117.190)Records needed for:

�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.



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43

Next Steps Next Steps Next Steps Next Steps � What Do I Do Next?

� 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



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44

Compliance Dates for cGMP and PCCompliance Dates for cGMP and PCCompliance Dates for cGMP and PCCompliance Dates for cGMP and PC

�Businesses with 500 + Full-Time Equivalent Employees

� September 19, 2016. 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, 2017. 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, 2018. Supply Chain Program has until September 17, 2018

�Qualified Facilities (also Very Small Businesses)

� September 17, 2018. (Except compliance date is January 1, 2016 for records to

support the facility’s status as a qualified facility).



+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, 2016@ 1:00PM CST



+

Thank you!Thank you!Thank you!Thank you!

The Acheson Groupwww.achesongroup.comwww.achesongroup.comwww.achesongroup.comwww.achesongroup.cominfo@[email protected]@[email protected]

3M Food Safetywww.3M.com/foodsafetywww.3M.com/foodsafetywww.3M.com/foodsafetywww.3M.com/foodsafety

Kevin Habas3M Food Safety

Melanie Neumann

Documents

3M Food Safety and The Acheson Group present …© 3M 2015. All Rights Reserved 3MHealth Care Academy + 3M Health Care Academy SM 3M Food Safety and The Acheson Group present FSMA: