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Food Safety /Quality in the New Millennia
April 02, 2010
 Golden Pacific Foods, Inc. Issues Allergy Alert for Undeclared Milk







and Soy in Marco Polo Brand Shrimp Snacks
NY Gourmet Salads Inc. Recalls Chick Pea Salad Because of
Possible Health Risk (Listeria monocytogenes)
Glutino Food Group Issues Allergy Alert on Undeclared Egg Product
in Raisin Bread
Zatarain's Recalls Original Dirty Rice Mix Package Due to Unlabeled
Wheat and Barley Ingredients
Binell Bros. Cutlery Voluntarily Recalls Black Pepper (Salmonella)
Watkins Incorporated Recalls Crab Snack & Dip Seasoning Because
of Possible Health Risk from Ingredient Supplied by Kerry
Ingredients (Salmonella)
Salmonella Tennessee in HVP
 < Feb 12, 2010 – Company analysis revealed

Salmonella Tennessee in HVP
 Feb 12, 2010 FDA inspects and cites:
 Lack of microbial controls over product
 Lack of hygiene monitoring

 Lack of sanitation
 Building issues (Plumbing and Drains)

 Feb 26, 2010 Basic Flavors LV, NV recalls product
 Back to Sept 2009 (last FDA inspection)
 FDA finds S. Tennessee in plant
HVP Recall
 Over 178 products have been recalled containing





HVP
Do you have a recall plan?
What product(s) is it in?
What lot codes are effected?
What if I have a dry mix with HVP in it that must
be rehydrated and cooked by the consumer?
 5-7 log lethality validation
 Label instructions

 Does recalled HVP have to be discarded?
HVP Recall Lessons
 Once again Salmonella has been found in a dry

product at low numbers.
 Over 178 products have been recalled containing
HVP plus the original HVP ingredient back to Sept
2009.
 Hundreds of companies will incur costs of recalls.
 Do you have a recall plan? Are you prepared?
HVP Recall Lessons
 FDA cited lack of hygiene monitoring. Do you
monitor the sanitation of your plant?
 FDA cited plumbing and waste issues. Do you have
building maintenance issues of your own?
 Companies that could validate a cooking or lethality
step in their process did not have to recall product
provided the lethality was validated. Are your lethality
steps validated?
 Companies that provided consumer cooking
instructions were also exempt from recall. Do your
product(s) contain cooking instructions?
Salmonella & Pet Food
 PA Pet Food Contaminated with Salmonella
 70 human cases infection 19 states in 2006-7
 Still had cases from plant after clean-up 2008
 Recalled over 23,000 tons dog food

 Made multiple brands: Pedigree, Country

Acres, Members Mark, Ol' Roy, Paws &
Claws, Pet Pride, PMI Nutrition, Red
Flannel, Retriever, and Wegeman's
 This is every retailers fear
 Plant is now closed
Brand identity
in a small world

…and many employees have cell phones with
video cameras. Just think of the possibilities…
Changing Consumer
 Consumers are:
 Redefining value (lowering bar)


Less premium, more value
E.g., organic food sales flat

 Buying more private label
(Store brands gain market share)

 Higher coupon redemption rates
 Foodservice getting tighter
 Buying more “comfort foods”
Data from Dairy Management Inst.
Strategic Analysis 2010
Today’s
environment
has changed the way that food is
produced, processed, transported and consumed.
It presents all stakeholders with new challenges to
food safety and quality.
Food regulation ↑
 More Legislation

 FDA, USDA, & international

 Labeling, Claims, Benefits
 Supply Chain Transparency
 Animal Health
 Food Safety in the headlines





More recalls likely
Traceability
Testing for adulterants (melamine, etc.)
Ingredient identity (mislabeled fish)

 Bioterrorism a constant concern
Consumers Demand
 Balanced value (price vs quality)
 Confidence and transparency
 Consistency and predictability
 Regulatory compliance

 Adequate control over product –

security, recall and traceability (protect us)
 Above all else the food is safe to eat!
Retailers Demand
 Balanced value (price vs quality)
 Confidence and transparency
 Consistency and predictability
 Regulatory compliance

 Adequate control over product –

security, recall and traceability (protect us)
 Above all else the food is safe to eat!
 Brand Protection
Control
 Compliance with regulatory requirements?
 The safety of your food?
 Pre-process (ingredients and packaging)
 Process (GMP and HACCP)
 Post-process (retail and consumer handling)
 Your brand identity and reputation?
 The market for your product category?
Control food safety / quality
sanitation

regulatory

crisis
management

internal
audits
haccp and
gmps

external
audits

food
security

risk management

standards
GFSI: A global solution
 Launched at CIES Annual Congress (May
2000). Established as a non-profit
Foundation (June 2005)
 Holistic and integrated approach by

industry to establish uniform guidelines for
food safety and quality.

 Managed by CIES – The Food Business

Forum
GFSI GOALS
 Converge FSQ standards globally
 Reduce audits to 1
 Protect the brand
 Remove competitive element from
product safety
 Seek continual improvement
 Cover farm to fork
Get Started
1. Understand GFSI standards
Optional training course

2. Self assessment
Gap analysis

3. Certification scheme
Get specific
standards

Select audit company

4. On-site Audit

Identifies non-conformities
Major

Minor

Correct non-conformities

Certification decision

Continuous improvement
1. Get Standards
a) CIES GFSI –version 5 benchmark

http://www.ciesnet.com/pfiles/programmes/foodsafety/GFSI_Guidance_Document_5th%20
Edition%20_September%202007.pdf

b) SQF (Safe Quality Foods) Schemes
a) SQF 2000

http://www.sqfi.com/SQF_2000_Code_Edition6.pdf

b) Implementing SQF http://www.sqfi.com/SQF_2000_Guide.pdf

c) BRC (British Retail Consortium)

http://www.brcbookshop.com/ ($$)

d) FSSC (Food Safety System Certification)
http://www.fssc22000.com/downloads/1.pdf

Presentation (with links) will be posted
on foodsafety.usu.edu
What are standards
a) Senior management and continual
b)
c)
d)
e)
f)
g)

h)

improvement commitments
Foundation food safety (GMP/HACCP)
Food safety management
Food quality management
Site standards
Product control
Process control
Personnel control
2. Gap Analysis
 Document Control

 Control of Nonconformity

 Control of Quality Records

 Verification Planning

 Management Responsibility

 Traceability

 Communication

 Validation of Control

 Emergency Preparedness
 Competence, Awareness

and Training
 Infrastructure
 Work Environment

Measures
 Control of Monitoring and
Measuring Devices
 Food Safety Management
System Verification
 Internal Audits
2. Gap Analysis
HVP recall lessons learned

 Document Control

 Control of Nonconformity

 Control of Quality Records

 Verification Planning

 Management Responsibility

 Traceability

 Communication

 Validation of Control

 Emergency Preparedness
 Competence, Awareness

and Training
 Infrastructure
 Work Environment

Measures
 Control of Monitoring and
Measuring Devices
 Food Safety Management
System Verification
 Internal Audits
3a. Choose Program*
a) SQF
a)
b)
c)

(Safe Quality Foods)

Level 1 – HACCP and GMPs
Level 2 – Expanded Food Safety
Level 3 – Expanded Food Quality (GFSI approved)

b) BRC (British Retail Consortium)
c) IFS – (International Food Standards)
d) Dutch HACCP
e) FSSC 22000 (ISO 22000 + PAS 220)

new

f) SQF 1000 & NZGAP for Farm related safety
3b. Choose Cert. Body
a) Must be certified to GFSI scheme
b) Consider largest customers in choosing

vendor and scheme
c) SQF has 3 levels to gradually obtain full
GFSI compliance
d) SQF requires trained practitioner on-site
(take relevant course then exam online)

e) If previously ISO 22000 certified consider

FSSC 22000 program
f) Negotiate all costs
4. On-site Audits
 Usually 2 days
 75% document verification
 25% physical inspection
 1 day of report writing

 Non-conformities usually handled via

correspondence

(especially documents)
Annual Certification Cost
>$9 -12 K per year
Desk Audit
Pre-Assessment Audit
Certification Audit
Typical Total
Annual Certification Fee
Auditing Body Fee
Travel Expenses
Employee Time/Effort

1-2 Days
1-2 Days
1-3 Days
3-5 Days
$650
$1200 per day
Variable
?
Risk Management
 Identify risks (food safety and quality)
 Analyze risks

(matrix)

 Identify risk mitigation factors

 Implement risk mitigation factors
 Assess Mitigation

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Global food safety Apr 2010

  • 1. Food Safety /Quality in the New Millennia
  • 2. April 02, 2010  Golden Pacific Foods, Inc. Issues Allergy Alert for Undeclared Milk      and Soy in Marco Polo Brand Shrimp Snacks NY Gourmet Salads Inc. Recalls Chick Pea Salad Because of Possible Health Risk (Listeria monocytogenes) Glutino Food Group Issues Allergy Alert on Undeclared Egg Product in Raisin Bread Zatarain's Recalls Original Dirty Rice Mix Package Due to Unlabeled Wheat and Barley Ingredients Binell Bros. Cutlery Voluntarily Recalls Black Pepper (Salmonella) Watkins Incorporated Recalls Crab Snack & Dip Seasoning Because of Possible Health Risk from Ingredient Supplied by Kerry Ingredients (Salmonella)
  • 3. Salmonella Tennessee in HVP  < Feb 12, 2010 – Company analysis revealed Salmonella Tennessee in HVP  Feb 12, 2010 FDA inspects and cites:  Lack of microbial controls over product  Lack of hygiene monitoring  Lack of sanitation  Building issues (Plumbing and Drains)  Feb 26, 2010 Basic Flavors LV, NV recalls product  Back to Sept 2009 (last FDA inspection)  FDA finds S. Tennessee in plant
  • 4. HVP Recall  Over 178 products have been recalled containing     HVP Do you have a recall plan? What product(s) is it in? What lot codes are effected? What if I have a dry mix with HVP in it that must be rehydrated and cooked by the consumer?  5-7 log lethality validation  Label instructions  Does recalled HVP have to be discarded?
  • 5. HVP Recall Lessons  Once again Salmonella has been found in a dry product at low numbers.  Over 178 products have been recalled containing HVP plus the original HVP ingredient back to Sept 2009.  Hundreds of companies will incur costs of recalls.  Do you have a recall plan? Are you prepared?
  • 6. HVP Recall Lessons  FDA cited lack of hygiene monitoring. Do you monitor the sanitation of your plant?  FDA cited plumbing and waste issues. Do you have building maintenance issues of your own?  Companies that could validate a cooking or lethality step in their process did not have to recall product provided the lethality was validated. Are your lethality steps validated?  Companies that provided consumer cooking instructions were also exempt from recall. Do your product(s) contain cooking instructions?
  • 7. Salmonella & Pet Food  PA Pet Food Contaminated with Salmonella  70 human cases infection 19 states in 2006-7  Still had cases from plant after clean-up 2008  Recalled over 23,000 tons dog food  Made multiple brands: Pedigree, Country Acres, Members Mark, Ol' Roy, Paws & Claws, Pet Pride, PMI Nutrition, Red Flannel, Retriever, and Wegeman's  This is every retailers fear  Plant is now closed
  • 8. Brand identity in a small world …and many employees have cell phones with video cameras. Just think of the possibilities…
  • 9. Changing Consumer  Consumers are:  Redefining value (lowering bar)  Less premium, more value E.g., organic food sales flat  Buying more private label (Store brands gain market share)  Higher coupon redemption rates  Foodservice getting tighter  Buying more “comfort foods” Data from Dairy Management Inst. Strategic Analysis 2010
  • 10. Today’s environment has changed the way that food is produced, processed, transported and consumed. It presents all stakeholders with new challenges to food safety and quality.
  • 11. Food regulation ↑  More Legislation  FDA, USDA, & international  Labeling, Claims, Benefits  Supply Chain Transparency  Animal Health  Food Safety in the headlines     More recalls likely Traceability Testing for adulterants (melamine, etc.) Ingredient identity (mislabeled fish)  Bioterrorism a constant concern
  • 12. Consumers Demand  Balanced value (price vs quality)  Confidence and transparency  Consistency and predictability  Regulatory compliance  Adequate control over product – security, recall and traceability (protect us)  Above all else the food is safe to eat!
  • 13. Retailers Demand  Balanced value (price vs quality)  Confidence and transparency  Consistency and predictability  Regulatory compliance  Adequate control over product – security, recall and traceability (protect us)  Above all else the food is safe to eat!  Brand Protection
  • 14. Control  Compliance with regulatory requirements?  The safety of your food?  Pre-process (ingredients and packaging)  Process (GMP and HACCP)  Post-process (retail and consumer handling)  Your brand identity and reputation?  The market for your product category?
  • 15. Control food safety / quality sanitation regulatory crisis management internal audits haccp and gmps external audits food security risk management standards
  • 16. GFSI: A global solution  Launched at CIES Annual Congress (May 2000). Established as a non-profit Foundation (June 2005)  Holistic and integrated approach by industry to establish uniform guidelines for food safety and quality.  Managed by CIES – The Food Business Forum
  • 17.
  • 18. GFSI GOALS  Converge FSQ standards globally  Reduce audits to 1  Protect the brand  Remove competitive element from product safety  Seek continual improvement  Cover farm to fork
  • 19. Get Started 1. Understand GFSI standards Optional training course 2. Self assessment Gap analysis 3. Certification scheme Get specific standards Select audit company 4. On-site Audit Identifies non-conformities Major Minor Correct non-conformities Certification decision Continuous improvement
  • 20. 1. Get Standards a) CIES GFSI –version 5 benchmark http://www.ciesnet.com/pfiles/programmes/foodsafety/GFSI_Guidance_Document_5th%20 Edition%20_September%202007.pdf b) SQF (Safe Quality Foods) Schemes a) SQF 2000 http://www.sqfi.com/SQF_2000_Code_Edition6.pdf b) Implementing SQF http://www.sqfi.com/SQF_2000_Guide.pdf c) BRC (British Retail Consortium) http://www.brcbookshop.com/ ($$) d) FSSC (Food Safety System Certification) http://www.fssc22000.com/downloads/1.pdf Presentation (with links) will be posted on foodsafety.usu.edu
  • 21. What are standards a) Senior management and continual b) c) d) e) f) g) h) improvement commitments Foundation food safety (GMP/HACCP) Food safety management Food quality management Site standards Product control Process control Personnel control
  • 22. 2. Gap Analysis  Document Control  Control of Nonconformity  Control of Quality Records  Verification Planning  Management Responsibility  Traceability  Communication  Validation of Control  Emergency Preparedness  Competence, Awareness and Training  Infrastructure  Work Environment Measures  Control of Monitoring and Measuring Devices  Food Safety Management System Verification  Internal Audits
  • 23. 2. Gap Analysis HVP recall lessons learned  Document Control  Control of Nonconformity  Control of Quality Records  Verification Planning  Management Responsibility  Traceability  Communication  Validation of Control  Emergency Preparedness  Competence, Awareness and Training  Infrastructure  Work Environment Measures  Control of Monitoring and Measuring Devices  Food Safety Management System Verification  Internal Audits
  • 24. 3a. Choose Program* a) SQF a) b) c) (Safe Quality Foods) Level 1 – HACCP and GMPs Level 2 – Expanded Food Safety Level 3 – Expanded Food Quality (GFSI approved) b) BRC (British Retail Consortium) c) IFS – (International Food Standards) d) Dutch HACCP e) FSSC 22000 (ISO 22000 + PAS 220) new f) SQF 1000 & NZGAP for Farm related safety
  • 25. 3b. Choose Cert. Body a) Must be certified to GFSI scheme b) Consider largest customers in choosing vendor and scheme c) SQF has 3 levels to gradually obtain full GFSI compliance d) SQF requires trained practitioner on-site (take relevant course then exam online) e) If previously ISO 22000 certified consider FSSC 22000 program f) Negotiate all costs
  • 26. 4. On-site Audits  Usually 2 days  75% document verification  25% physical inspection  1 day of report writing  Non-conformities usually handled via correspondence (especially documents)
  • 27. Annual Certification Cost >$9 -12 K per year Desk Audit Pre-Assessment Audit Certification Audit Typical Total Annual Certification Fee Auditing Body Fee Travel Expenses Employee Time/Effort 1-2 Days 1-2 Days 1-3 Days 3-5 Days $650 $1200 per day Variable ?
  • 28.
  • 29.
  • 30. Risk Management  Identify risks (food safety and quality)  Analyze risks (matrix)  Identify risk mitigation factors  Implement risk mitigation factors  Assess Mitigation