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© EAGLE Food Registrations Inc. 2013 CONFIDENTIAL 1
Food Safety
ASQ Milwaukee SectionNovember 18, 2013
Nancy BergerEAGLE Food Registrations, IncNovember 2013
2© EAGLE Food Registrations Inc. 2013 CONFIDENTIAL
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
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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
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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
− 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!
Prevent
Food
Hazards!
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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
− Starting with imports, but you know it will move to US manufacturers in near future
!Safety
BIG Focus
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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 (continued)
Supplier Implements The System
*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)
22© EAGLE Food Registrations Inc. 2013 CONFIDENTIAL
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
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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.
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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)
27© EAGLE Food Registrations Inc. 2013 CONFIDENTIAL
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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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
FSSC 22000 – Basic Facts & Benefits
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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
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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!!!!
31© EAGLE Food Registrations Inc. 2013 CONFIDENTIAL
Contact Information
Questions
For more information please call 800.795.3641,
visit www.eagleregistrations.com or e-mail