Mr. Gary Smith

Director, Food Safety Systems May 2016

FSMA How The Food Safety Plan,

Auditing and the Role of PCQI

Food Safety Systems 2016

Agenda

• Review how traditional third party auditing will evolve in the

world of FSMA

Supplier preventive controls

Foreign supplier verification program

• Describe the roles of a PCQI & Qualified Auditor

• Explore how food safety plans will evolve

• Explore how FDA inspections will move to FDA inspections

of food safety plans

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Food Safety Systems 2016

Foundational Rules for

Implementation of FSMA

• Current Good Manufacturing Practice and Hazard Analysis and

Risk Based Preventative Controls for Human Food – Final

• Current Good Manufacturing Practice and Hazard Analysis and

Risk Based Preventative Controls for Animal Food – Final

• Standards for the Growing, Harvesting, Packing and Holding of

Produce for Human Consumption – Final

• Foreign Supplier Verification Program (FSVP) for Importers of

Food for Humans and Animals – Final

• Accreditation of Third-Party Auditors/Certification Bodies to

Conduct Food Safety Audits and to Issue Certificates – Final

• Focused Mitigation Strategies to Protect Food Against Intentional

Adulteration – March 31, 2016

• Sanitation Transportation of Human and Animal Food – May 31, 2016

Food Safety Systems 2016

Preventive Control Rule

Requirements

• A written food safety plan

• Hazard analysis

• Preventative controls

• Monitoring

• Corrective actions and corrections

• Verification / Validation

• Supply chain program

• Recall plan

• Records

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Food Safety Systems 2016

Preventive Controls Qualified

Individual Definition

• 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.

21 CFR 117.3 Definitions

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Training Requirements

• 117.4 – management must ensure that all individuals are

qualified to perform their assigned duties

• Qualified individual – have education, training or

experience necessary to perform assigned tasks

• Receive training in the principles of food hygiene and

food safety – Records maintained

• 117.180 – Preventative controls qualified individual

• Attend preventive control training course (FDA

recognized) OR

• Qualified through job experience

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Food Safety Systems 2016 www.eurofinsus.com

Preventive Controls Qualified

Individual Qualification

• Standardized

curriculum recognized

as adequate by the

FDA

• Food Safety Preventive

Control Alliance (FSPCA)

2.5 day human food

course

7

• Qualified

through job

experience to

develop a food

safety system

• No defined criteria on

what is acceptable in

regards to training and

experience, competency

determined by state of

food safety plan?

Food Safety Systems 2016 www.eurofinsus.com

Requirements of Preventive Control

Qualified Individuals (117.180)

1. Preparation of the food safety plan

2. Validation of the process preventive controls (CCPs)

3. Determine if validation is not required

4. Review of records within 7 days of creation

5. Reanalysis of food safety plan (at least every 3 years)

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A preventive controls qualified individual* must

do or oversee the following activities:

*Individual does not needs to be

an employee of the facility

Food Safety Systems 2016 www.eurofinsus.com

Preparation of the Food Safety Plan

• Process PC

• Sanitation PC

• Allergen PC

• Supplier PC

• Recall PC

• HACCP

• Sanitation SOPs

• Allergen mgt program

• Approved supplier programs

• Recall program

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Allergen Preventive Controls Requirements

1. Preventing allergen cross-contact

Clean shared equipment – potential sanitation controls

Properly manage rework

Avoid in-process or post-process allergen cross-contact

2. Accurate allergen labeling of finished food

Ensure labels are correct – potential supply-chain program

Ensure the correct label or package is used

• Human error can be involved – training is essential!

PRODUCT: Omelet - Plain PAGE 1 of X

PLANT NAME: E.G. Food Company ISSUE DATE SUPERSEDES

mm/dd/yy mm/dd/yy ADDRESS: 360 Culinary Circle, Mytown, USA

Allergen Control Hazard(s)

Para-meter

Monitoring Corrective Action Verification Records What How Frequency Who

Receiving packaging (labeled carton)

Undeclared allergens – egg, milk, soy (wheat in biscuit only)

All finished product labels must declare the allergens present in the formula per listing

Ingredient listing and allergen informa-tion matches product

Visual check of carton label to match product formula

Before release to production

Label coordi- nator

If label is incorrect, reject labels and return to supplier or destroy. Identify root cause and conduct training as needed to prevent recurrence

Review of Label verification, Corrective Action and Verification records within 7 working days

Allergen Label Verifica-tion listing;

Allergen Label Verifica-tion log;

Corrective Action records;

E.G. Food Company Example

Hazards and Conditions Relevant to Sanitation Preventive Controls

• Environmental pathogens when RTE product is exposed to the environment prior to packaging

E.g., Salmonella and L. monocytogenes

• Pathogens transferred through cross-contamination

E.g., from insanitary objects or employees handling raw and processed product

• Food allergen cross-contact

Unintended milk, soy, egg, fish, crustacean shellfish, wheat, peanut or tree nut cross-contact

Sanitation Preventive Controls*

• Procedures, practices and processes for:

Cleanliness of food-contact surfaces

Prevention of allergen cross-contact and cross-contamination o From insanitary objects and personnel to food, food packaging

material, other food contact surfaces

o From raw product to processed products

* When hazard analysis identifies a hazard requiring a preventive control

Assemble, Wrap Table Sanitation Purpose: Cleaning and sanitizing of the assembly and wrapping table is important to remove potential allergens and reduce microbial cross-contamination or recontamination with environmental pathogens that may impact product safety. Frequency:

Cleaning: At lunch break, after Cheese Omelet Biscuit production, at the end of daily production. Sanitizing: Before operations begin, at lunch break, after Cheese Omelet Biscuit production, and at the end of daily production.

Who: Sanitation team member Procedure:

Note: Blue cleaning tools are to be used ONLY for cleaning after a cheese biscuit run to reduce the potential for unintentional allergen transfer. Cleaning 1. Remove unused packaging material to an area at the end of the shift to prevent it from getting wet. Cover it during the lunch

clean up. 2. Remove gross soil with a squeegee. 3. Wipe table surface with a clean cloth dipped in ABC cleaning solution (Y oz. per gallon). 4. Rinse table with clean water. Detergent remaining on the surface can inactivate the sanitizer. Sanitizing 1. Spray table surface with 200 ppm quaternary ammonium compounds solution, ensuring that entire surface is covered. 2. Allow table to air dry, about 5 minutes. Contact time required per label – 1 minute.

Monitoring (at frequency indicated above): Inspect table for residual soil and cleanliness. Record on Daily Sanitation sheet. Use test strip to measure the quat concentration BEFORE application. Record on Daily Sanitation sheet

Corrections: If residual soil is observed on the table, reclean and sanitize. If quat is not at the proper concentration, make a new solution.

Records: Daily Sanitation Sheet Verification: Supervisor reviews and signs Daily Sanitation Sheet within 7 working days

PRODUCT: Omelet – Plain, Cheese and Cheese Biscuit PAGE 21 of 36 PLANT NAME: E.G. Food Company ISSUE DATE

SUPERSEDES 09/20/2015 08/06/2015 ADDRESS: 360 Culinary Circle, Mytown, USA

E.G. Food Company Example

Easy to read text is in Appendix 3

Food Safety Systems 2016 www.eurofinsus.com

Supply Chain Program (Subpart G)

• Documented approved suppliers (117.405)

• Supplier verification program (117.410)

• Documented program

• Verification activities (risk based)

• On-site audits (117.435)

• Sampling and testing of raw material

• Review of supplier food safety records

• Other

• Receiving procedures for raw materials (117.415)

• Records (117.475)

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Supply-chain Program General Requirements

When applicable, verify a supply-chain-applied control applied by an entity other than your supplier

Document supplier verification activities

Conduct supplier verification activities

Determine supplier verification activities

Use approved suppliers

Appropriate Supplier Verification Activities

Conduct one or more of the following verification activities before using and periodically thereafter:

• Onsite audit

• Sampling and testing

By the supplier or the receiving facility

• Review supplier’s food safety records for the ingredient

• Other if applicable

Who Can Perform Supplier Verification?

Receiving facility

Supplier Testing; provide 3rd

party audit

Another entity

(e.g., broker)

Receiving facility must document review and assessment of documents provided by others

Onsite Audit Requirements

• For serious hazards requiring a supply-chain-applied control

Documented onsite audit before using the raw material

At least annually after the initial audit

• Exception

You document that other verification activities or less frequent auditing provides adequate assurance

Onsite Audits – Who and What

• Must use a qualified auditor

• Review supplier’s written HACCP or other Food Safety Plan and implementation documents for hazard identified in your hazard analysis

Food Safety Systems 2016 www.eurofinsus.com

Qualified Auditor

• An individual with a combination of training and

experience to perform the auditing function

A government employee

An audit agent of a certification body that is accredited

by a recognized accreditation body

An individual with the required training and experience

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Supply-chain Program Not Required:

1. When no hazards requiring a supply-chain-applied control exist

OR

2. When you (the receiving facility) control the hazard OR

3. When a Customer or downstream entity provides written assurance that they control the hazard

Food Safety Systems 2016

Foreign Supplier Verification

Program

• An extension of the supplier preventive controls from a

manufacturers food safety plan

• For hazards that are addressed by suppliers who are

importing product into the US

• The importer of record must ensure that the supplier meets

the elements of the preventive controls rule

• Audits must be conducted by a qualified auditor

FDA inspections

Audit agent of a FDA recognized CB

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Food Safety Systems 2016

FDA Recognition of Certification

Bodies

• FDA will build a recognition program for accreditation bodies

• FDA recognized accreditation bodies will then accredit

certification bodies, which a separate accreditation, for FDA

regulatory auditors

• FDA regulatory audits – can be done in conjunction with other

third party audit programs

Must be unannounced

Must be in stage 1 and stage 2 phases

Include a summary of findings and verification of compliance

with the regulation

Cannot be done by the same auditor 2 years in a row

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Food Safety Systems 2016

FDA Transition to FSMA Audits

• FDA will conduct audits in which they are building a

facilities food safety plan, based on input received from the

facility

• Goal is to audit to compliance, wanting facilities to adjust

their food safety plans based on input from government

auditors

• Recognition of existing certification

FDA has stated that they will be recognizing existing

certifications that a facility may hold, however, no

specifics have been defined how that will impact a facility

inspection schedule from the agency

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Food Safety Systems 2016 www.eurofinsus.com

SQF V7.2 GAPs to FSMA

• Need for Preventive Control

Qualified Individual

A bit different than practitioner

PC training vs. HACCP

• Training

Preventive control

Food safety – all staff

Hygiene – all staff

• Foreign supplier verification

program

Agent of a recognized CB

• Record sign off must be at least

every 7 days

• Preventive controls

Allergens

Sanitation

Supplier approval

• On-site audits from

qualified auditor

• Environmental monitoring for

RTE product with environmental

contamination reasonably likely

to occur

• Food defense – vulnerability

assessment

• 2 year record retention

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Food Safety Systems 2016

Summary

• The FSMA regulation has placed additional emphasis on

an individual designated as the Preventive Control

Qualified Individual (PCQI)

• One key in supplier management is the identification of the

hazards which need to be controlled and who will be

responsible for controlling those hazards

• The role of auditing of suppliers has an important role in a

facilities food safety plan

• Existing third party audits can be utilized to supplement a

facilities supplier audit programs, but will not replace

regulatory inspections

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Food Safety Systems 2016

Thank You

Contact Details

Gary M. Smith

Director of Food Safety Services

Eurofins Scientific, Inc.

email: garysmith@eurofinsus.com

www.eurofinsus.com/food-safety

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