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
Food Safety Systems 2016 www.eurofinsus.com
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
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• 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: [email protected]
www.eurofinsus.com/food-safety
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