1. The Validity of GFSI Food Safety Audits
Karl Kolb Ph.D.
Ceres Certifications, International
ceresci.com

2. Global Food Safety Initiative
GFSI
Global Food Safety Initiative
“An ISO level program for the food industry.”
(ISO: International Standards Organization)

3. 49 and 20 are aircraft builders ISO 16 is automotive ISO
GFSI: Its our ISO
GFSI is an ISO program
49 and 20 are aircraft builders ISO
16 is automotive ISO

4. Verification and validation A to Z Management involvement
GFSI: Robust
Verification and validation
A to Z
Management involvement
Audits are risk based
Standards are vetted

5. GFSI: Vetted Standards
Standards are constantly improved
Standards are written to be risk based
Standards allow for an infinite number of possibilities

6. GFSI: Presenter 19 Years in the food safety business
Education: Quality Programs
Owner of the High Sierra Group
Ceres Certifications, International
Ceres University
HSG/AME Certified Laboratories
High Sierra Chemical Company

7. GFSI: Is not: FDA Food Safety Modernization Act
For the first time, FDA has a legislative mandate to require comprehensive, science- based preventive controls across the food supply.  This mandate includes: 
Mandatory preventive controls for food facilities: Food facilities are required to implement a written preventive controls plan.  This involves: (1) evaluating the hazards that could affect food safety, (2) specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards, (3) specifying how the facility will monitor these controls to ensure they are working, (4) maintaining routine records of the monitoring, and (5) specifying what actions the facility will take to correct problems that arise.  
Mandatory safety standards:  FDA has established science-based, minimum standards for the safe production and harvesting of fruits and vegetables.  Those standards must consider naturally occurring hazards, as well as those that may be introduced either unintentionally or intentionally, and must address soil amendments (materials added to the soil such as compost), hygiene, packaging, temperature controls, animals in the growing area and water.

8. GFSI: Written Preventative Controls Plan
The Global Food Safety Initiative (GFSI) is an industry-driven initiative providing thought leadership and guidance on food safety management systems necessary for safety along the supply chain. This work is accomplished through collaboration between the world's leading food safety experts from retail, manufacturing and food service companies, as well as international organizations, governments, academia and service providers to the global food industry. They meet together at technical working group and stakeholder meetings, conferences and regional events to share knowledge and promote a harmonized approach to managing food safety across the industry. GFSI is facilitated by The Consumer Goods Forum (CGF), a global, parity-based industry network, driven by its members.

9. GFSI: Vision and Mission
Safe food for consumers everywhere.
GFSI Mission
Provide continuous improvement in food safety management systems to ensure confidence in the delivery of safe food to consumers worldwide.

10. GFSI: NOT
Make policy for retailers, manufacturers or food safety scheme owners
Undertake any accreditation or certification activities
Own any food safety schemes or standards
Undertake training
Have any involvement outside the scope of food safety, such as animal welfare, the environment or ethical sourcing

11. GFSI Big Difference Checklist Audits: Not robust Not vetted
Not benchmarked
Inspectors not normally qualified
GFSI Audits:
Robust
Vetted
Benchmarked
Auditors

12. GFSI TIP Checklist inspections: Are not vetted, Not benchmarked,
Cannot be defended
Inspectors are not certified

13. GFSI It is
Specify for the recognition of food safety management schemes to defined requirements in its Guidance Document.
Bring together food safety experts within a global network.
Drives global change through multi-stakeholder projects on strategic issues (eg. auditor competence, regulatory affairs, food safety for small suppliers).

14. GFSI Does NOT
Make policy for retailers, manufacturers or food safety scheme owners
Undertake any accreditation or certification activities
Own any food safety schemes or standards
Undertake training
Have any involvement outside the scope of food safety, such as animal welfare, the environment or ethical sourcing

15. GFSI: Background
During the 90s, there had been a series of high-profile international food safety crises including BSE, dioxin and listeria. Within the food industry there was a growing audit fatigue as retailers and brand manufacturers audited factories against their countless in-house standards, each developed in isolation and with no consideration of convergence. The results showed no consistency. Consumer and food industry confidence was low. The CEOs of the world’s food retailers, working through their independent network CIES - The Food Business Forum, now the Consumer Goods Forum (CGF), agreed to take collaborative action. In May 2000, the Global Food Safety Initiative, a non-profit foundation, was founded.

16. GFSI: Today
GFSI Today
GFSI has developed to become more than a benchmarking organization. Its collaborative approach brings together international food safety experts from the entire supply chain at Technical Working Group and Stakeholder meetings, conferences and regional events. They share knowledge and promote a harmonized approach with a shared vision of “safe food for consumers everywhere.” Strategic direction for GFSI is provided by an industry-driven GFSI Board of Directors from retailers, manufacturers and foodservice operators. It is supported by The Consumer Goods Forum Board of Directors, co-chaired by Dick Boer, CEO of Royal Ahold and Paul Bulcke, CEO of Nestlé. The daily management of GFSI is undertaken by The Consumer Goods Forum (CGF), a global, parity-based industry network, driven by its members.

17. GFSI: GFSI Board
The GFSI Board is made up of members drawn from major retailer, manufacturer and food service operators. They provide the strategic direction and oversee the daily management of GFSI. Having considered the views of the Stakeholder Group, they provide the mandate to the Technical Working Groups and GFSI Local Groups. 
GFSI Technical Working Groups
The GFSI Technical Working Groups were reconstituted from the original Technical Committee, which was formed in September 2006 and is composed of retailers, manufacturers, food service operators, standard owners, certification bodies, accreditation bodies, international organizations and other technical experts. In February 2009, the GFSI Board decided to restructure the Technical Committee into Technical Working Groups that meet physically three times a year and also continue to work together independently throughout the year.

18. GFSI: The Consumer Goods Forum
The Consumer Goods Forum (CGF) is a global, parity-based industry network that is driven by its members. It brings together the CEOs and senior management of some 400 retailers, manufacturers, service providers, and other stakeholders across 70 countries, and it reflects the diversity of the industry in geography, size, product category and format. CGF member companies have combined sales of EUR 2.5 trillion. Their retailer and manufacturer members directly employ nearly 10 million people with a further 90 million related jobs estimated along the value chain.
CGF is governed by its Board of Directors, which includes 50 manufacturer and retailer CEOs and Chairpersons.
CGF provides a unique global platform for knowledge and best practice sharing around the following strategic priorities: Sustainability, Product Safety, Health & Wellness, End-to- End Value Chain & Standards, which are central to the advancement of today’s consumer goods industry.

19. GFSI: Overview
A food safety management scheme is ‘recognized’ by GFSI when it meets internationally recognized minimum food safety requirements, developed by multi stakeholders, which are set out in the GFSI Guidance Document. GFSI is not a scheme in itself, and neither does it carry out any accreditation or certification activities.
Certification to a GFSI recognized scheme is achieved through a successful third party audit against any of the schemes listed as being recognized by GFSI. The third party companies that provide certification services are known as Certification Bodies (CBs). They are key stakeholders to GFSI and active participants, both in the professional network as well as in the GFSI Technical Working Groups. The Certification Bodies are authorized to audit against the recognized scheme through a formal agreement with the Scheme Owner (SO) combined with the scope of their accreditation.
Accreditation Bodies (ABs) are not-for-profit organizations, either government owned or under agreement with government, charged with ensuring that participating Certification Bodies in the country are subject to oversight by an authoritative body.
Accreditation Bodies may not be high profile in each country but they play a key role in the accredited certification process and ensuring international consistency in conformity assessment.

20. GFSI: Overview Accreditation Body GFSI Scheme Owners
Accreditation Body: ANSI
Certification Body:
CCI , NSF, WQS
Scheme Owners:
BRC, SQF, IFS
Audit Schemes:
PrimusGFS, BRC
Client: You
GFSI
Accreditation Body
Scheme Owners
Certification Body
Audit Schemes
Client

21. You select the Certification Body You have a choice in the auditor
GFSI TIPS
You select the scheme
You select the Certification Body
You have a choice in the auditor
You are part of the audit
You are paying for the audit

22. GFSI: Scheme
A food safety management scheme is ‘recognized’ by GFSI when it meets internationally recognized minimum food safety requirements, developed by multi stakeholders, which are set out in the GFSI Guidance Document. GFSI is not a scheme in itself, and neither does it carry out any accreditation or certification activities.
Certification to a GFSI recognized scheme is achieved through a successful third party audit against any of the schemes listed as being recognized by GFSI. The third party companies that provide certification services are known as Certification Bodies (CBs). They are key stakeholders to GFSI and active participants, both in the professional network as well as in the GFSI Technical Working Groups. The Certification Bodies are authorized to audit against the recognized scheme through a formal agreement with the Scheme Owner (SO) combined with the scope of their accreditation.
Accreditation Bodies (ABs) are not-for-profit organizations, either government owned or under agreement with government, charged with ensuring that participating Certification Bodies in the country are subject to oversight by an authoritative body. Accreditation Bodies may not be high profile in each country but they play a key role in the accredited certification process and ensuring international consistency in conformity assessment.

23. GFSI: Why should a food safety scheme apply for GFSI recognition?
Benefits of GFSI recognition:
The GFSI benchmarking process provides an independent verification of their scheme.
Recognition of their scheme by the GFSI Board provides credibility that is backed by the food industries biggest buying companies.
The systematic revision of the GFSI Guidance Document by global stakeholders meant that it remains relevant to the needs of the industry, leading to continuous improvements in the schemes that apply for re-benchmarking after every revision.
The GFSI network provides them with an insight into what is relevant to their scheme development. This may range from implications for new legislation through to new approaches for helping auditors do their work.

24. GFSI How to choose my scheme?
If you are seeking to achieve certification to a GFSI recognized scheme, in order to choose a scheme you will first need to find out which scope is applicable to your type of activity. When the scope is identified, the choice of GFSI recognized schemes will be limited to those that cover that specific scope and has successfully achieved GFSI recognition.
Once this is known, an operation will need to consult with the following stakeholders:
Even though this goes against the principle of working within the GFSI framework of acceptance of any recognized scheme, key customers may have a preference for one scheme or another. Their response may make the decision process very simple.
Technical service providers can provide good advice; ask about their experience of the various schemes.
If the service provider is also a Certification Body, then what insights can they provide on the audit process?
The scheme owners themselves will provide further information.

25. GFSI TIP
You choose your scheme

26. GFSI TIP Consultants: Schooled (SQF Courses, GFSI Courses, HACCP)
Long list of successful audits
Will stay through the audit
$500 to $950 a day (Target $750 to $850 per day, week: $500 per day)
Auditors:
Certification company employed
Independents

27. GFSI: GFSI Recognized Schemes
Food safety schemes are assessed against the GFSI Guidance Document Sixth Edition to verify if they meet the and, if successful, the scheme achieves formal recognition.
Through this benchmarking process, GFSI continues to provide a rigorous, scientifically based method that recognizes competent food safety schemes.
It allows food businesses to select a food safety management system that is recognized by leading retailers and manufacturers internationally and has itself been exposed to a demanding peer assessment.

28. GFSI: As they pertain to dry Beans
Farming of Grains and Pulses
Pre-Processing Handling of Plant Products
Processing of Plant Perishable Products
Processing of Ambient Stable Products
Provision of Storage and Distribution Services

29. GFSI: Categories Farming of Grains and Pulses PGFS
Pre-Processing Handling of Plant Products
GlobalGAP
IFS
BRC
FSSC 22000
Canada GAP
SQF

30. GFSI: Categories Processing of Plant Perishable Products and,
Ambient Stable Products
PGFS
GlobalGAP
IFS
BRC
SQF

31. Provision of Storage and Distribution Services SQF IFS BRC
GFSI: Categories
Provision of Storage and Distribution Services
SQF
IFS
BRC

32. GFSI: Achieving certification against a GFSI recognized scheme
Certification to a GFSI recognized scheme is achieved through a successful third party audit against any of the schemes that have been recognized by the Global Food Safety Initiative.
To become certified to a GFSI recognized scheme:
Determine the scope of your business
Contact the GFSI recognized scheme owners that cover your scope to determine which of the schemes fits best with the type of activities that your company carries out.
Request from the selected scheme owner an approved list of certification bodies that can carry out audits against their schemes, or
Contact your preferred certification body and find out against which GFSI recognized scheme they can offer an audit.

33. GFSI: Accreditation and Certification
Accreditation and certification are terms that are often used incorrectly. Inevitably, in an industry full of auditable schemes, standards, regulations, and requirements, there is extensive technical jargon. To help you, in Part IV of the GFSI Guidance Document 6th Edition you will find a comprehensive glossary of terms.
A good starting point is to make sure that you understand the following definitions:

34. GFSI: Accreditation Accreditation: How it works
The Certification Body must have systems in place to ensure the capability of all their staff. In particular they need to demonstrate that their auditors are competent. To confirm that such systems are in place, the Accreditation Body uses one of two standards from the International Standards Organization (ISO): ISO/IEC Guide or ISO/IEC

35. GFSI Certification: How it works
There is an initial administration process following the selection of a Certification Body. This involves the completion of application documents and becomes the basis of the contract. It helps to calculate audit duration and the assignment of the right auditor.
The audit must be scheduled on a date that is within a peak production period.
The audit determines how well a facility identifies and implements food safety controls to comply with the requirements of the standard.
Certification audits are always non-consultative. This means the auditor is not allowed to instruct or advise.
The auditor reviews HACCP plans, procedures, policies, physical conditions and records and observes the implementation of the plans in the factory.
Any non-conformances observed are documented and at the conclusion of the audit the factory will be informed.
A formal report is prepared to a format laid down by the scheme. To achieve certification, the food business is required to correct all non-conformances and to prevent their recurrence. Each scheme has its own timeline requirements for these closures.
The Certification Body reviews the evidence submitted and decides whether to accept or request a resubmission. In some cases, which may be prescribed by the scheme, a further site visit may be required to verify closure.
The final decision on certification is not with the auditor but with an individual within the Certification Body who was not involved with the audit or the factory.
Annual recertification is required. The rules may vary according to the scheme but typically timing will be close to the date of the initial certification audit.

36. GFSI Creditability
In recent years third party food safety audits have come under critical scrutiny from the mainstream media. Sites with reportedly excellent ratings by these independent auditors have been linked to outbreaks associated with serious illness and death, and have subsequently been closed down by regulators. In most reported cases to date, these instances were one-to-one arrangements between suppliers and independent non- accredited audit agencies, without any oversight or recognition.
Accredited certification does not deliver a guarantee of food safety nor prevent food safety incidents. It provides a proven framework of checks and balances that significantly improves the rigor of the audit process and reduces the risk of food safety failures.
Food businesses should not rely solely on third party audits to provide evidence of their food safety compliance, they are a tool to be used in a risk-based strategy for food safety management. However, accredited third-party certification audits, if used correctly, are worthwhile tools for any food business seeking to implement and maintain behaviors and practices within their facilities.

37. GFSI TIP Select a solid certification company: NOT on the price or,
NOT the length of the audit

38. BRC Global Standards 21 Dartmouth Street, London SW1H 9BP United Kingdom Tel.: +44 (0)

39. FSSC 22000 P. O. Box 693 4200 AR Gorinchem The Netherlands Tel
FSSC P.O. Box AR Gorinchem The Netherlands Tel.: +31 (0)

40. GLOBALG.A.P. c/o FoodPLUS GmbH Spichernstrasse 55 Cologne Germany Tel.:

41. IFS Am Weidendamm 1 A Berlin GERMANY

42. PrimusGFS Leslie Dick PrimusGFS Scheme Manager 715.723.5143

43. CanadaGAP 245 Stafford Road West Suite 312 Ottawa, ON K2H 9E8 Canada Tel.: +1 (613) ext

44. SQF
2345 Crystal Drive, Suite 800 Arlington Virginia USA Tel:

45. GFSI Standards
SCIENCE
INDUSTRY
REGULATORY

46. GFSI Lets look at a standard:
: Are all exposed materials (product, packaging, etc.) protected from overhead contamination (e.g. ladders, motors, condensation, lubricants, walkways, loose panels, degrading insulation, etc.)?

47. GFSI Expectation
Total compliance (15 points): Ceilings and/or any overhead fixtures above lines and storage are free from condensation or dust. Ladders or walkways (catwalks) above exposed product or packaging material have kick plates at least three inches high and are covered in some way that protects the product underneath. Drips or condensate (e.g. from fixtures, ducts, pipes, etc.) should not contaminate food, food contact surfaces or packaging material; adequate measures should be in place to protect from condensate.
V2.1 PrimusGFS GMP (Module 2) Guidelines Page 26 of 93

48. Gfsi Risk Analysis Process
Policy
Program (What is being asked, what is my commodity, process, how best do I do it?)
Specifications
Report

49. GFSI TIP The RA should indicate: Research, Validation and,
Commonly accepted industry practices
The Auditor:
Is the process expert
You are the expert of your commodity, industry and your process

50. GFSI Is continuous improvement
Standard
Policy
Program
Specifications
Corrective Actions
Analysis
Verification
Reporting
Training

51. GFSI
Questions

52. Ceres Certifications, International (CCI) 715.723.5143 Office
Thank you
Karl Kolb Ph.D.
Ceres Certifications, International (CCI)
Office
Cell