Food Safety
ASQ Milwaukee Section
November 18, 2013
Nancy Berger
EAGLE Food Registrations, Inc
November 2013
© EAGLE Food Registrations Inc. 2013 CONFIDENTIAL
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Agenda
 FSMA – what it means to the consumer
 GFSI – what it is & how it is making the food chain safer
 Food Safety – heading in the future
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Challenges
 Food Safety Crisis – global
 Government FDA/USDA budget cuts/not enough
manpower
 Too many individual audits with different expectations
 Recalls and Media
 Consumer health # 1 priority
© EAGLE Food Registrations Inc. 2013 CONFIDENTIAL
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FSMA
FDA Food Safety Modernization Act (FSMA)
 Signed into law January 4, 2011
 Most sweeping change in 70 years
 Applies to human and animal food products
 Special areas of the law for imports and produce
 Helps the food chain build consumer confidence
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FSMA
 7 Foundation Standards (such as food safety defense)
still under development, deadline 6/30/2015 for
feedback to finalize
 5 Areas of FSMA Law
Prevention
GMPs/HACCP
Inspection &
Compliance
Import
Safety
© EAGLE Food Registrations Inc. 2013 CONFIDENTIAL
Regulatory
Response
Enhanced
Partnerships
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FSMA
 Prevention goal of the entire FMSA revisions:
• Preventative rather than reactive approach
•
Stop it before it happens
•
Reduce the likelihood of bad product
out in the industry
•
HACCP Program defined and implemented
Prevent
Food
Hazards!
− Some exclusions apply (seafood; juice; small business
less than $500,000 annual revenue)
− Hazard Analysis Critical Control Points - Evaluate
hazards; identify and implement preventive controls;
monitor performance; maintain records
− Sounds like a FMEA doesn’t it!
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FSMA
 Inspection and compliance
-greater access to reports and plant
 Catching up to USDA
 USDA has been strong in this for a long time – USDA
plants have inspection in each day; each shift
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FSMA
 Regulatory Response – stronger recall processes if
reasonable probability of causing serious adverse health
consequences or death to humans or animals
•
Registration of all food manufacturing facilities
− Any manufacturer, processor, packer or
warehouse/distribution
− Not farms, restaurants, retail food establishment
•
Detainment of product or suspension if reasonable
probability of causing serious adverse health
consequences or death to humans or animals
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FSMA
 Import Safety is a big focus of FSMA
• Foreign supply verification program - 3rd Party Audits
• Importer will have to have the audit certificate on file
• Set criteria for who can do the audits – approved
government agencies/staff and approved auditing
companies
− Not enough FDA inspectors to do audits
!
− Auditors will also have to be accredited
Safety
BIG Focus
− Starting with imports, but you know it
will move to US manufacturers in near future
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FSMA
 Enhanced Partnership
• FDA staff will not be able to do it alone
− Budget restraints
• Look to other agencies and organizations
involvement
− State health agencies
− Local health agencies
− Third Party Certification Bodies or Groups
− BRINGS US TO GFSI AUDITS
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What is GFSI?
 GFSI launched in 2000, following a
directive from the CEOs in the food business
 Now managed by The Consumer Goods Forum
 Benchmarking process of schemes against guidance
documents (by sectors)
 Encourages stakeholders to share knowledge and
strategy for food safety – develop best practices for
common global framework
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Benefits of an FSMS
 Preventive system
 Provides systematic approach to managing food
safety
 Provides standards and guidelines for food safety
 Provides verification and validation of system
 Improves compliance to regulatory standards
 Provides confidence to consumers
 Demonstrates due diligence by processor
 Auditable
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Oversight vs. Non-oversight
 Non-oversight, Third-Party Audits
• Audits which are the product of a specific company
− Examples = AIB, Silliker, Cook & Thurber
• These audits are created and controlled by the
company who developed the audit criteria
• Type of audit used at Peanut Butter Corporation of
America
 Oversight Third-Party Audits
• All GFSI schemes
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Certification Process
 Which program is best for their company?
• What are the reasons for seeking certification?
− Required by customer
• Global business
• Mature vs. New FSMS
 Standards are similar in a lot of ways, but unique
• Let’s share some of them
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Certification Process
Training on the
Standard
Implementation
- Internal or consultant
- What fits your
company’s needs
On-site
Pre-Assessment
GAP analysis
– internal or external
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Certification Process (continued)
 Supplier Implements The System
Create
Documentation
Identify gaps &
correct the
gaps
Implement
System & Train
Verify - you do
what you say
you are doing
Validate Is it working?
System
Operational*
*System must be operational for minimum of two months so
records are created and it can be verified and validated
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Certification Process (continued)
 Certification Steps
• Different by Standards
− FSSC: Stage 1 and Stage 2
»
Readiness visit (1) Certification Audit (2)
− SQF: Document Review & Certification Audit
 Close out Findings
 Certification Granted
• Some GFSI audits are scored / some mirror ISO
9001 and are not scored
• Surveillance and or recertification audits
− Requirements by standard
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GFSI Schemes
The Three Major FSMS in the U.S. are:
 Safe Quality Food (SQF)
 British Retail Consortium (BRC)
 FSSC 22000
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SQF – Overview
SQF = Safe Quality Food
 Developed in Australia in 1994
 Food Marketing Institute purchased in 2003
 One code with defined modules for industry specific
operations
 3 Levels of Certification (Benefit)
• Level 1 = Food Safety Fundamentals (GMPs, PRPs)
• Level 2 = Food Safety Plan (HACCP)
• Level 3 = Food Quality Plan (HACCP driven)
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SQF – Basic Facts & Benefits
 All documentation is free on their website (Benefit)
 Auditor approval controlled by scheme (Benefit)
 Nine basic elements and HACCP based
 Includes some elements found in 9001 and 22000
 Document Control, Management Review, Internal Audit,
Corrective and Preventive Action
 Standard by modules by food sector categories (Benefit)
 Offers additional tools such as guidance documents for
specific industries to strengthen program (Benefit)
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SQF – Basic Facts & Benefits
 Provides discipline for document control
 SQF Practitioner responsible for program (Benefit)
 Includes 12 Step HACCP Plan
 Food Safety Fundamentals
• Details for building and equipment design and
construction
• Specific PRPs with defined criteria
 Special attention to identity of preserved foods
(i.e.; Kosher, Organic)
 Requires verification and validation of system
 Includes quality – based on HACCP method (Benefit)
© EAGLE Food Registrations Inc. 2013 CONFIDENTIAL
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BRC - Overview
 Developed in 1998
 Published by the British Retail Consortium
 Developed in response to retailer demand
 Developed by BRC with contributions from retail,
manufacturing, industry associations, and certifying
bodies
 Edition 6 released 2011, effective 1/2012
© EAGLE Food Registrations Inc. 2013 CONFIDENTIAL
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BRC – Basic Facts & Benefits
 Different schemes/standard by food sector categories
 Eight fundamental requirements
 HACCP based
 Includes quality (Benefit)
 Includes some elements found in ISO programs
• Document Control, Management Review, Internal
Audits, etc.
© EAGLE Food Registrations Inc. 2013 CONFIDENTIAL
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BRC – Basic Facts & Benefits
 Provides discipline for document control
 Includes 12 step HACCP plan
 Very prescriptive PRPs
 Special attention to foreign material control such as
sharps control (Benefit)
 Requires verification and validation of system
 Auditor qualifications (Benefit)
 Strong in Europe/Canada and for exporting there (Benefit)
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FSSC 22000 - Overview
 Newest of the three major GFSI standard
 Combination of ISO 22000, PAS 220
(ISO 22002-1:2009) and a few more requirements
in Part 1 of FSSC 22000
 ISO 22000 was published in September 2005
 Developed by joint effort of ISO & the food industry
 Truly a global standard - 14 different countries
represented
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FSSC 22000 – Basic Facts & Benefits
 100% Food Safety driven (Benefit)
• Does not include a quality component
 HACCP based – very specific requirements
 Includes pre-requisite programs PAS 220
(ISO 22002-1:2009)
 Most aligned elements to 9001 (Benefit)
• Document control, resource management,
management review, internal audit
 Not scored – aligns with 9001 progress (Benefit)
© EAGLE Food Registrations Inc. 2013 CONFIDENTIAL
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FSSC 22000 - Basic Facts & Benefits
 Provides discipline for document control
 Foundation for continual improvement
 Creation of a Food Safety Team
 Includes all steps in the development and
implementation of a HACCP plan
 Control of non-conforming product critical
(Benefit)
 Validation & verification of system
 Traceability
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FSSC 22000 – Basic Facts & Benefits
 Last revision changes to FSSC22000
• Category M – food grade packaging - added to
scope of standard with the use of PAS 223
− Previously it did not offer an approved GFSI
standard to the packaging industry
• Audit time requirements – minimum on site
• Surveillance audit are FULL SYSTEM audits
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Future of Food Safety
 SQF, FSSC and BRC are benchmarking to FSMA
• Show gaps
• SQF completed GAP analysis and only a few FMS
requirements fell short but they have many
requirements that are more stringent
• Copy of this comparison is on the SQF website –
www.sqfi.com
© EAGLE Food Registrations Inc. 2013 CONFIDENTIAL
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Future of Food Safety
 Complete roll-out of FSMS
• More accountability
• Proactive not Reactive Culture
 GFSI keeping up with the changes in industry
• Unannounced audit
• Adding HACCP Hazards when identified
• More involvement with certified client recalls from
auditing requirements
• Making a safer food chain!!!!
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Contact Information
Questions
For more information please call 800.795.3641,
visit www.eagleregistrations.com or e-mail
Nancy.berger@eagleregistrations.com
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