food safety modernization act - dnv gl and fsma 552016_tcm14-64346.pdf · food safety modernization...
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DNV GL © 2016
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05 May 2016 SAFER, SMARTER, GREENER DNV GL © 2016
05 May 2016 Kathleen Wybourn & Leann Chuboff
Food Safety Modernization Act
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SQF and FSMA
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Meet the Speakers
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Kathleen Wybourn
Director Food & Beverage
DNV GL US & Canada
Leann Chuboff
Sr. Technical Director, SQFI
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Questions are Welcome
Enter your questions in the Chat Box at the bottom right hand corner of your screen. Questions will be answered at the end of the presentations.
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Globally Trusted Food Safety and Quality Certification
How Does SQF And FSMA Fit Together?
DNV Webinar Series May 5, 2016
LeAnn Chuboff Senior Technical Director, SQFI
Today’s Objectives Review the basic rules and timelines of FSMA Identify the differences within the PC Rule Answer the FAQs about FSMA List the available resources
Food Safety Modernization Act Signed into law January 4, 2011
Prevention
Increased Inspections Enhanced Response
Import Safety Apply Domestic Standards to Imported Foods
Enhanced Partnerships
7 Major FSMA Rules Rule Published Date Implementation Date
Preventive Controls- Human Food
Sept. 17, 2015 Sept. 17, 2016
Preventive Controls- Animal Food
Sept. 17, 2015
Sept. 17, 2016 (cGMPs) Sept. 19, 2017 (PC)
Produce Safety Rule Nov. 27, 2015 Nov. 27, 2016
Foreign Supplier Verification Program
Nov. 27, 2015
May 31, 2017
Accreditation of Third Party Auditors
Nov. 27, 2015 May 31, 2017
Sanitary Transportation April 6, 2016 April 6, 2017
Food Defense May 30, 2016 (expected)
one year from published date?
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FAQs for FSMA
What are the key differences? Will SQF change their Code based on the
new preventive controls? Will the FSMA food safety plan be accepted
instead of HACCP? What tools does SQF have available for
suppliers, CBs and auditors? What is the role GFSI will play within FSMA
Q. What are the Key Differences?
Requirement Comparison Comments
Written Food Safety Plan Comparable
FDA: Written food safety plan to include Preventive Controls (no identified PCs then recall plan not needed)
SQF: HACCP following CODEX required/ recall plan required
GFSI: HACCP following CODEX required / recall plan required
Experienced individual in charge Comparable
FDA: PCQI to have specific training or demonstration of knowledge
SQF: Designated SQF Practitioner with HACCP training
GFSI : No requirement
Trained staff Comparable
FDA: PCQI and QI required
SQF: Training required for HACCP and other food safety duties
GFSI: Employees are to be adequately trained, instructed and supervised in food safety principles and practices, commensurate with their activity.
Validation of Controls Different
FDA: Conducted within 90 days of production or when process changes. There are specific exemptions
SQF: required for HACCP and other programs. Reviewed annually or with process change
GFSI: as part of HACCP
Verification & Recordkeeping
Historically HACCP Focuses on the Process
Hazard Analysis
Critical Control Points (CCPs)
Critical Limits
Monitor
Corrective Action
Verification & Recordkeeping
Preventive Controls Include More Than HACCP
Hazard Analysis
Preventive Controls
(CCPs, allergen, sanitation,
supplier, etc.)
Parameters
& Values
Monitor
Corrective Action or
Corrections
Key Differences, cont. Requirement Comparison Comments
Corrective Actions Different
FDA: Correction is allowed without corrective action. Corrective action required for any PC violation
SQFI: Required for all identified NCs
GFSI: Procedures for the determination and implementation of corrective action in the event of any significant non conformity relating to food safety.
Record retention Comparable
FDA Records retained for 2 years. Exception records allowed but must be validated. Implementation records are to be kept as part of the food safety plan
SQF: Available, legible, and stored according to company, customer or regulatory requirement.
GFSI: Available, legible, and stored according to company, customer or regulatory requirement.
Food defense Not known
FDA: Not yet released.
SQF: Plan required
GFSI Plan required
Product Release Comparable
FDA: All monitoring and corrective action records must be reviewed within seven (7) working days from the time they were created. SQF: Product release procedure in place before shipment
GFSI: Product release procedure in place before shipment
What will your PC plan look like?
• Process PCs • Allergen PCs • Sanitation PCs • Supply Chain PCs
(1) Ingredient
/ Processing
Step
(2) Identify
potential food safety
hazards introduced,
controlled or enhanced at
this step
(3) Do any potential
food safety hazards require a
preventive control?
(4) Justify your decision for column 3
(5) What preventive control
measure(s) can be applied to significantly minimize or prevent
the food safety hazard? Process including CCPs,
Allergen, Sanitation, Supply-chain, other preventive control
(6) Is the
preventive control
applied at this step?
YES NO
Other FAQs for FSMA Q. Will SQF change their Code based on the new preventive controls? A. Maybe. SQF will look at the final rule and make the necessary changes to effect food safety
based on stakeholder feedback and comments Q. Will the FSMA food safety plan be accepted instead of HACCP? A. Depends. If the GFSI Guidance document provides us the latitude to make this
differentiation, SQF will consider this change. Q. What tools does SQF have available for suppliers, CBs and auditors? A. SQF has completed the comparison to the final PC Rule, Produce Rule, and the Sanitary
Transportation Rule. FMI is hosting several Train-the-Trainers for the QI and SQF will be considered for a Train-the-Trainer for Trainers. A FSMA resource page is available on the SQFI website: http://www.sqfi.com/suppliers/fsma-resource-page/ that will include on
Q. What is the role GFSI will play within FSMA A. That has not been completely defined. GFSI will more than likely play a part for foreign food
facilities and the foods they produce
Resources • Seek assistance from trade associations, consultants,
universities, regulators. • SQF – www.sqfi.com/news • FDA– www.fda.gov/fsma Validation resources: • Codex Alimentarius Commission (2008). “Guideline for the
validation of food safety control measures CAC/GL – 2008” • NACMCF (2006). “Requisite scientific parameters for
establishing the equivalence of alternative measures of pasteurization.”
SQF FSMA Resource Page
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SQF FSMA Resource Page http://www.sqfi.com/suppliers/fsma-resource-page • Access to gap analysis • Latest news Coming Soon: • FAQs • Contact Us • Checklists
Summary
• FSMA, SQF and GFSI have one thing in common– Preventive rather than Reactive
• Using a GFSI benchmarked standard prepares you to meet current and new legislation
• Utilize the resources available to help you through the process
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North America: LeAnn Chuboff Senior Technical Director [email protected] Kristie A. Grzywinski Senior Technical Manager [email protected]
Australia, Asia: Bill McBride Asia Pacific Representative [email protected] General Info: [email protected]
SQFI Technical Contacts
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FSMA & Accredited Third-Party Certification
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FDA FSMA – Accredited Third-Party Certification
Voluntary program for the accreditation of third-party certification
bodies, also known as auditors, to conduct food safety audits and
issue certifications of foreign facilities and the foods for humans
and animals they produce.
Certification audits under GFSI should not be confused with
Accredited Third-Party Certification under FSMA - THESE ARE
COMPLETELY DIFFERENT
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Foreign entities may use certifications under FSMA for 2 purposes:
Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food into the U.S. FDA can also require in specific circumstances that a food
offered for import be accompanied by a certification from an accredited third-party certification body.
In either case domestic facilities will not be audited under this program
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Interesting Facts regarding Third-party audits under FSMA
Auditors are required to perform unannounced facility audits and notify the FDA upon discovering a condition that could cause or contribute to a serious risk to public health. Accredited third-party certification
bodies requirements if auditing under FSMA.
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Audits
Accredited third-party certification bodies can perform as part of the program, both consultative and regulatory. In both kinds, auditors will examine compliance with applicable federal food safety requirements. – A consultative audit is conducted in preparation for a
regulatory audit and is for internal use. In addition to compliance with federal standards, a consultative audit also considers how the facility meets industry standards and practices. Only a regulatory audit can be the basis for certification.
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DNV GL A global business assurance partner
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10,400 Food and beverage companies partner with us to ensure safety and sustainability
Position One of the world’s leading certification bodies
People 2,000 highly skilled specialized employees
2,400 Healthcare organizations trust us to help them improve quality and patient safety
Partnership with more than 70,000 customers in over 180 countries
80,000 Management system (ISO 9001, 14001, 18001, etc.) certificates issued under more than 80 accreditations
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Experience and expertise
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DNV GL has extensive competence and experience in auditing, and solid track record in tailoring assessment programs based on customer needs
We are flexible … and we work with a project management approach
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Question & Answers
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Thank you for attending todays webinar
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Kathleen Wybourn
Director Food & Beverage
DNV GL US & Canada
Leann Chuboff
Sr. Technical Director, SQFI
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What’s Next
SQF and FSMA Webinar – May 26th, 11:00a.m
(for persons who could not attend today’s webinar)
http://bit.ly/DNVGLSQFandFSMAwebinar
DNV GL Symposium – Rosemont, IL
September 21 & 22 Register today for Early-Bird rate
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DNV GL © 2016
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05 May 2016
Leann Chuboff, Sr. Technical Director, SQFI [email protected] Kathleen Wybourn, Director Food & Beverage, DNV GL [email protected] April Lefebvre, BDR Food & Beverage, DNV GL [email protected] 678- 425-8168
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