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TRACEABILITY IN SUPPLY CHAINS
PRESENTED BY BOB STRONG
Our Presenter
Dr. Bob Strong
Senior Consultant, SAI Global Assurance Services
• Driving force behind our food safety operations in the areas of Good
Manufacturing Practice (GMP) and supplier assurance programs (GFSI),
including SQF, BRC and FSSC 22000.
• 46 years of experience in the food industry, while working for national and
international companies in quality assurance, product development and
auditing. He is an often requested seminar speaker in the areas of GMP,
HACCP and Preventive Controls for Human Foods (HARPC).
• Ph.D. and BSC in Chemistry and an accomplished food safety trainer for
numerous food safety manager certification courses
• GMP/HACCP/FSVP/HARPC/SQF certified instructor, a Lead Auditor
trainer, and is also certified to consult on the Global Food Safety Initiative
approved audits. He is certified in 21 SQF product categories
Agenda
• What is traceability and why do I need it?
• Your responsibilities as a food supplier.
• Benefits of traceability.
• Where you’ll need to prove traceability
• Traceability challenges & issues
• What if my supplier does not practice traceability?
• What works well?
• What should you avoid?
• Q&A
Why do I need to do Traceability?
• EU Law: Regulation EC 178/2002 laying down the
general principles and requirements of food law,
establishing the European Food Safety Authority and
laying down procedures in matters of food safety
• Articles14, 16, 18 and 19
• Traceability shall be established at all stages of production, processing &
distribution
• Food business operators shall be able to identify any person from whom they
have been supplied with a food and shall have in place systems and procedures
which will allow information to be made available to competent authorities
• Food which is placed on the market shall be adequately labelled or identified to
facilitate traceability through relevant documentation or information
Why is Traceability important to me?
• GFSI requires proven effective traceability programs.
• Food Fraud requires knowing origin of foods/packaging
materials.
• Food Recall Plans require traceability.
• Good Business Practices.
• FDA’s Foreign Supplier Verification Program (FSVP) and
Preventive Controls for Human Foods (HARPC) require it based
on who is controlling a foreseeable hazard for products being
exported to USA
Traceability Defined
Traceability is the ability to track any food ingredient or
packaging material through all stages of receipt,
production, processing and distribution.
Thus your Supplier and your
Customers need to do it also.
In the near future, it is going to
require that Retailers keep records
as well.
Traceability Defined
• Traceability means that at any point in the process
the processor or food preparer can trace the
ingredients/products one step backward and one step
forward.
• Backwards includes back to your Supplier and then
their ability to trace back to the original source (farm,
processor, foreign country, etc.).
• Forwards means being able to show which food
product the ingredients/products were used in.
For a food processor or a food preparer traceability means the
ability to identify the source of all food inputs including:
• Raw materials
• Additives, including processing aids
• Rework
• Packaging materials
Clear Lot numbers and Country of Origin from Suppliers is
therefore essential.
Currently most food preparers (Chefs, Retail Delis) do not keep
track of product Lot numbers.
Your responsibilities as a food supplier
Benefits of Traceability
• Enables corrective actions to be implemented quickly
and effectively when something goes wrong.
• When a potential food safety problem is identified,
whether by a food business or a government agency, an
effective traceability system can help isolate and
prevent contaminated products from reaching
consumers.
• Traceability allows food businesses to target the
product(s) affected by a food safety problem,
minimising disruption of trade and potential public
health risks.
• Ability to reduce your liability by minimising the risk to
consumers health.
• Effective traceability systems can reduce the time
taken to find your product and also minimise the
extent of the Recall.
• Avoid Regulatory Actions.
• Other benefits include enabling you to measure
Sustainability compliance, Chain of Custody and
Country of Origin, where applicable.
Benefits of Traceability
Exporting food to the USA.
Food Safety Modernization Act (FSMA) (USA) Title 1
Section 103
• This includes the new cGMPs 21 CFR 117 for food
processors.
• Preventive Controls for Human Foods (HARPC) also
requires an effective Recall Plan -- Part 117.139.
• A Recall Plan requires the ability to trace a product
that is contaminated and of human health concern.
• Suppliers selling products for consumption in the USA
need to comply with this Act.
Subpart C of GMPs Hazard Analysis and
Risk-Based Preventive Controls (HARPC)
• 117.126 Food Safety Plan
• 117.130 Hazard Analysis
• 117.135 Preventive Controls
• 117.136 Preventive Controls
exemptions
• 117.137 Assurances required
for exemption
• 117.39 Recall Plan
• 117.140 Preventive control
management components
• 117.145 Monitoring
• 117.150 Corrective actions
and corrections
• 117.155 Verification
• 117.160 Validation
• 117.165 Verification of
implementation and
effectiveness
• 117.170 Reanalysis
• 117.180 Requirements
applicable to preventive
controls qualified individual and
a qualified auditor
• 117.180 Implementation
records required for this
subpart
GFSI Schemes
• GFSI Schemes (SQF, BRC, IFS and FSSC 22000)
require companies to have traceability programs and
Recall Plans.
• They require these programs to be tested annually to
show they are effective.
• Although not stated the industry best practice
expects you to find 100+2% of your ingredient and
your product within 4 hours.
• Mass balance requires you to know how to calculate
your normal shrink (processing losses).
Can you do this?
http://www.mygfsi.com/
POLL
Do you currently have a good traceability
program?
14
• Yes
• Not yet, but we have started the process
• We have yet to verify our Suppliers traceability
programs
Traceability Challenges
• Only 50% of companies surveyed in 2012 by Institute
of Food Technologists (IFT) in the USA said they
could trace a raw material from receiving to end
product within four hours.
• Over 25% of companies use a “mock recall” as their
method for tracing an ingredient.
• This does not address the trace back and is not
compliant with GFSI scheme requirements.
• Food Retailers and Foodservice operators currently
do not practice traceability other than at Retail they
scan their sales.
Processor Traceability Challenges -
Ingredients
Manually by employees doing recordkeeping:
• Prone to human error.
• Failure to record correct Lot number.
• Failure to recognise a Lot number
change.
• Resistance to paperwork.
• Slow to retrieve information unless
entered into a computer to enable data
search.
Recall Issue
• A current problem happening in Europe as we speak with regard to a
baby product highlights the consequences of not having an effective
Recall system.
• Recall has now expanded to 83 countries and 12 million packages of
the product.
• Accusations of leaving the product on-sale.
• Regulatory actions.
• Multiple law suits from families affected.
• Plant closed down.
What if my supplier does not practice
traceability?
• This can cause you problems if they have a problem.
• If they do not know where they used the ingredient then they cannot
tell you if you received products from them made with this
contaminated ingredient.
• This is especially troubling if you have no step in your process to take
care of any hazards that they shipped to you.
• You need to avoid buying from Suppliers who do not have good
traceability and Recall programs.
POLL
What is your biggest traceability concern?
• Inaccurate recording by employees of ingredient Lot
numbers
• Speed to find ingredient Lot number data when
needed
• Suppliers illegible Lot numbers on ingredient
containers
• Suppliers not including Lot Numbers on their B-O-Ls
• Problems with recording Finished Product Lot
numbers
Traceability -- What Does Work?
• UPC Codes.
• GS1 Codes.
• Commercially available systems.
• Internal Traceability
UPC Codes
• What is a UPC Code (bar code)?
• It is method of automatic identification and data
collection.
• The first patent for a bar code type product (US
Patent #2,612,994) was issued to inventors, Joseph
Woodland and Bernard Silver, on October 7, 1952.
• The Woodland and Silver bar code was described as a
"bull's eye" symbol, made up of a series of concentric
circles.
• Today these bar codes are much more sophisticated
and can contain extensive data.
Bar Code Usage
Retailers use them extensively and successfully to:
• Record sales.
• Track inventories.
• Place orders to re-stock.
• Ensure correct pricing especially with discounts.
• To track customer preferences.
• Expedite Recall notices (Costco).
Bar Code Usage
DCs uses them extensively and successfully to:
• Scan products into their Distribution Center.
• Scan products into their correct storage location.
• Control improper storage by controlling where items
can be stored.
• Scan them onto pallets when assembling orders.
• Scan full pallets out onto trucks.
• To track customer orders.
• To control inventories.
• Etc.
Bar Code Usage
• Processors have been slow to adopt using them.
• Packaging manufacturers have been more proactive.
• Some processors do create bar codes internally.
• Ingredient Suppliers could start the process and make
it easier for food processors by placing bar codes on
their ingredient containers.
• These bar codes could then be used to facilitate :
• Country of Origin verification.
• Chain of Custody to support label claims.
• Verify Sustainability.
• Help detect Food Fraud.
GS1 SYSTEM
• GS1 is an international nonprofit association with
member organisations in over 100 countries.
• GS1 is dedicated to the design and implementation of
global standards and solutions to improve the
efficiency and visibility of supply and demand chains
globally and across sectors.
• The GS1 system of standards is the most widely
used supply chain standards system in the world.
• GS1 has over 30 years of experience in global
standards.
GS1 Barcodes
• Barcodes are symbols that can be scanned
electronically using laser or camera-based systems.
• They are used to encode information such as product
numbers, serial numbers and batch numbers.
• Barcodes play a key role in supply chains, enabling
parties like retailers, manufacturers, transport providers
and hospitals to automatically identify and track
products as they move through the supply chain.
• GS1 manages several types of barcodes. Each is
designed for use in a different situation.
Ten Steps to Barcode Implementation
• Step 1 Get a GS1 Company Prefix
• Step 2 Assign numbers
• Step 3 Select a barcode printing process
• Step 4 Select a "primary" scanning environment
• Step 5 Select a barcode
• Step 6 Pick a barcode size
• Step 7 Format the barcode text
• Step 8 Pick a barcode color
• Step 9 Pick the barcode placement
• Step 10 Build a barcode quality plan
Contact info for GS1 barcodes
http://www.gs1.org/barcodes
What should you avoid?
• Employees who are not diligent in capturing the Lot numbers.
• Placing products in the wrong package resulting in allergen concerns.
• Having Suppliers who control hazards for you not practicing good
traceability themselves and/or with their suppliers.
• Pencil whipping your traceability tests and mock Recalls.
• Underestimating the costs to your business if you cannot rapidly trace
and Recall your ingredients and products.
POLL
What is your top challenge in preparing for
compliance to Traceability/Recall requirements?
• Acquiring commitment from Management to
automate
• Getting suppliers to begin the procedure
• Our current system is slow
• We have no traceability issues
In Closing – Remember the costs of recalls
According to the US Grocery Manufacturers Association, the
financial impact of a recall in the U.S. is quite significant:
• 52% of all recalls cost more than $10 million;
• 23% cost more than $30 million.
Food Safety News states:
• For businesses, it’s all about risk management and
mitigation — lowering the impact of recalls and lowering
liability costs.
• For the supply chain, efficiencies relate to productivity,
cash flow improvements, innovation, and reducing waste.
• And, for consumers, it’s about access to markets and
specialty foods and enhancing or strengthening brand
confidence.
Trust in SAI Global to support you
As one of the world’s largest and respected certification companies,
SAI Global is the certification body of choice for over 24,000
organisations.
Our clients value our worldwide reach combined with local
experience, and the personal support we provide at every step along
your certification journey and beyond.
Our services & solutions:
• Auditing & Certification
• Training Solutions
• Supply Chain Management
• Food Safety Management Systems
• Advisory
Global Audit Coverage
Americas APACEMEA
SAI Global with offices in 28 countries employs more than 2,000 people and
conduct over 40,000 audits annually across in 130 countries
Training solutions
Public training / on-site / online /
• TACCP, Food Defence, Bio-vigilance and Bio-terrorism
• Root Cause Analysis (Food Industry)
• RSPH HACCP for Manufacturers
• Supply Chain Traceability
• Food Labelling and Legislation
• RSPH Allergen Awareness
• FSPCA Preventive Controls for Human Food
• Internal Auditor
To view full schedule visit www.saiglobal.com - ‘Risk Solutions –
Assurance training’
Contact us
Standards – Training - Certification
Tel: +44 (0)1908 793246
Email : information@saiglobal.com
www.saiglobal.com

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SAI Global Traceability in Supply Chains

  • 1. TRACEABILITY IN SUPPLY CHAINS PRESENTED BY BOB STRONG
  • 2. Our Presenter Dr. Bob Strong Senior Consultant, SAI Global Assurance Services • Driving force behind our food safety operations in the areas of Good Manufacturing Practice (GMP) and supplier assurance programs (GFSI), including SQF, BRC and FSSC 22000. • 46 years of experience in the food industry, while working for national and international companies in quality assurance, product development and auditing. He is an often requested seminar speaker in the areas of GMP, HACCP and Preventive Controls for Human Foods (HARPC). • Ph.D. and BSC in Chemistry and an accomplished food safety trainer for numerous food safety manager certification courses • GMP/HACCP/FSVP/HARPC/SQF certified instructor, a Lead Auditor trainer, and is also certified to consult on the Global Food Safety Initiative approved audits. He is certified in 21 SQF product categories
  • 3. Agenda • What is traceability and why do I need it? • Your responsibilities as a food supplier. • Benefits of traceability. • Where you’ll need to prove traceability • Traceability challenges & issues • What if my supplier does not practice traceability? • What works well? • What should you avoid? • Q&A
  • 4. Why do I need to do Traceability? • EU Law: Regulation EC 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety • Articles14, 16, 18 and 19 • Traceability shall be established at all stages of production, processing & distribution • Food business operators shall be able to identify any person from whom they have been supplied with a food and shall have in place systems and procedures which will allow information to be made available to competent authorities • Food which is placed on the market shall be adequately labelled or identified to facilitate traceability through relevant documentation or information
  • 5. Why is Traceability important to me? • GFSI requires proven effective traceability programs. • Food Fraud requires knowing origin of foods/packaging materials. • Food Recall Plans require traceability. • Good Business Practices. • FDA’s Foreign Supplier Verification Program (FSVP) and Preventive Controls for Human Foods (HARPC) require it based on who is controlling a foreseeable hazard for products being exported to USA
  • 6. Traceability Defined Traceability is the ability to track any food ingredient or packaging material through all stages of receipt, production, processing and distribution. Thus your Supplier and your Customers need to do it also. In the near future, it is going to require that Retailers keep records as well.
  • 7. Traceability Defined • Traceability means that at any point in the process the processor or food preparer can trace the ingredients/products one step backward and one step forward. • Backwards includes back to your Supplier and then their ability to trace back to the original source (farm, processor, foreign country, etc.). • Forwards means being able to show which food product the ingredients/products were used in.
  • 8. For a food processor or a food preparer traceability means the ability to identify the source of all food inputs including: • Raw materials • Additives, including processing aids • Rework • Packaging materials Clear Lot numbers and Country of Origin from Suppliers is therefore essential. Currently most food preparers (Chefs, Retail Delis) do not keep track of product Lot numbers. Your responsibilities as a food supplier
  • 9. Benefits of Traceability • Enables corrective actions to be implemented quickly and effectively when something goes wrong. • When a potential food safety problem is identified, whether by a food business or a government agency, an effective traceability system can help isolate and prevent contaminated products from reaching consumers. • Traceability allows food businesses to target the product(s) affected by a food safety problem, minimising disruption of trade and potential public health risks.
  • 10. • Ability to reduce your liability by minimising the risk to consumers health. • Effective traceability systems can reduce the time taken to find your product and also minimise the extent of the Recall. • Avoid Regulatory Actions. • Other benefits include enabling you to measure Sustainability compliance, Chain of Custody and Country of Origin, where applicable. Benefits of Traceability
  • 11. Exporting food to the USA. Food Safety Modernization Act (FSMA) (USA) Title 1 Section 103 • This includes the new cGMPs 21 CFR 117 for food processors. • Preventive Controls for Human Foods (HARPC) also requires an effective Recall Plan -- Part 117.139. • A Recall Plan requires the ability to trace a product that is contaminated and of human health concern. • Suppliers selling products for consumption in the USA need to comply with this Act.
  • 12. Subpart C of GMPs Hazard Analysis and Risk-Based Preventive Controls (HARPC) • 117.126 Food Safety Plan • 117.130 Hazard Analysis • 117.135 Preventive Controls • 117.136 Preventive Controls exemptions • 117.137 Assurances required for exemption • 117.39 Recall Plan • 117.140 Preventive control management components • 117.145 Monitoring • 117.150 Corrective actions and corrections • 117.155 Verification • 117.160 Validation • 117.165 Verification of implementation and effectiveness • 117.170 Reanalysis • 117.180 Requirements applicable to preventive controls qualified individual and a qualified auditor • 117.180 Implementation records required for this subpart
  • 13. GFSI Schemes • GFSI Schemes (SQF, BRC, IFS and FSSC 22000) require companies to have traceability programs and Recall Plans. • They require these programs to be tested annually to show they are effective. • Although not stated the industry best practice expects you to find 100+2% of your ingredient and your product within 4 hours. • Mass balance requires you to know how to calculate your normal shrink (processing losses). Can you do this? http://www.mygfsi.com/
  • 14. POLL Do you currently have a good traceability program? 14 • Yes • Not yet, but we have started the process • We have yet to verify our Suppliers traceability programs
  • 15. Traceability Challenges • Only 50% of companies surveyed in 2012 by Institute of Food Technologists (IFT) in the USA said they could trace a raw material from receiving to end product within four hours. • Over 25% of companies use a “mock recall” as their method for tracing an ingredient. • This does not address the trace back and is not compliant with GFSI scheme requirements. • Food Retailers and Foodservice operators currently do not practice traceability other than at Retail they scan their sales.
  • 16. Processor Traceability Challenges - Ingredients Manually by employees doing recordkeeping: • Prone to human error. • Failure to record correct Lot number. • Failure to recognise a Lot number change. • Resistance to paperwork. • Slow to retrieve information unless entered into a computer to enable data search.
  • 17. Recall Issue • A current problem happening in Europe as we speak with regard to a baby product highlights the consequences of not having an effective Recall system. • Recall has now expanded to 83 countries and 12 million packages of the product. • Accusations of leaving the product on-sale. • Regulatory actions. • Multiple law suits from families affected. • Plant closed down.
  • 18. What if my supplier does not practice traceability? • This can cause you problems if they have a problem. • If they do not know where they used the ingredient then they cannot tell you if you received products from them made with this contaminated ingredient. • This is especially troubling if you have no step in your process to take care of any hazards that they shipped to you. • You need to avoid buying from Suppliers who do not have good traceability and Recall programs.
  • 19. POLL What is your biggest traceability concern? • Inaccurate recording by employees of ingredient Lot numbers • Speed to find ingredient Lot number data when needed • Suppliers illegible Lot numbers on ingredient containers • Suppliers not including Lot Numbers on their B-O-Ls • Problems with recording Finished Product Lot numbers
  • 20. Traceability -- What Does Work? • UPC Codes. • GS1 Codes. • Commercially available systems. • Internal Traceability
  • 21. UPC Codes • What is a UPC Code (bar code)? • It is method of automatic identification and data collection. • The first patent for a bar code type product (US Patent #2,612,994) was issued to inventors, Joseph Woodland and Bernard Silver, on October 7, 1952. • The Woodland and Silver bar code was described as a "bull's eye" symbol, made up of a series of concentric circles. • Today these bar codes are much more sophisticated and can contain extensive data.
  • 22. Bar Code Usage Retailers use them extensively and successfully to: • Record sales. • Track inventories. • Place orders to re-stock. • Ensure correct pricing especially with discounts. • To track customer preferences. • Expedite Recall notices (Costco).
  • 23. Bar Code Usage DCs uses them extensively and successfully to: • Scan products into their Distribution Center. • Scan products into their correct storage location. • Control improper storage by controlling where items can be stored. • Scan them onto pallets when assembling orders. • Scan full pallets out onto trucks. • To track customer orders. • To control inventories. • Etc.
  • 24. Bar Code Usage • Processors have been slow to adopt using them. • Packaging manufacturers have been more proactive. • Some processors do create bar codes internally. • Ingredient Suppliers could start the process and make it easier for food processors by placing bar codes on their ingredient containers. • These bar codes could then be used to facilitate : • Country of Origin verification. • Chain of Custody to support label claims. • Verify Sustainability. • Help detect Food Fraud.
  • 25. GS1 SYSTEM • GS1 is an international nonprofit association with member organisations in over 100 countries. • GS1 is dedicated to the design and implementation of global standards and solutions to improve the efficiency and visibility of supply and demand chains globally and across sectors. • The GS1 system of standards is the most widely used supply chain standards system in the world. • GS1 has over 30 years of experience in global standards.
  • 26. GS1 Barcodes • Barcodes are symbols that can be scanned electronically using laser or camera-based systems. • They are used to encode information such as product numbers, serial numbers and batch numbers. • Barcodes play a key role in supply chains, enabling parties like retailers, manufacturers, transport providers and hospitals to automatically identify and track products as they move through the supply chain. • GS1 manages several types of barcodes. Each is designed for use in a different situation.
  • 27. Ten Steps to Barcode Implementation • Step 1 Get a GS1 Company Prefix • Step 2 Assign numbers • Step 3 Select a barcode printing process • Step 4 Select a "primary" scanning environment • Step 5 Select a barcode • Step 6 Pick a barcode size • Step 7 Format the barcode text • Step 8 Pick a barcode color • Step 9 Pick the barcode placement • Step 10 Build a barcode quality plan
  • 28. Contact info for GS1 barcodes http://www.gs1.org/barcodes
  • 29. What should you avoid? • Employees who are not diligent in capturing the Lot numbers. • Placing products in the wrong package resulting in allergen concerns. • Having Suppliers who control hazards for you not practicing good traceability themselves and/or with their suppliers. • Pencil whipping your traceability tests and mock Recalls. • Underestimating the costs to your business if you cannot rapidly trace and Recall your ingredients and products.
  • 30. POLL What is your top challenge in preparing for compliance to Traceability/Recall requirements? • Acquiring commitment from Management to automate • Getting suppliers to begin the procedure • Our current system is slow • We have no traceability issues
  • 31. In Closing – Remember the costs of recalls According to the US Grocery Manufacturers Association, the financial impact of a recall in the U.S. is quite significant: • 52% of all recalls cost more than $10 million; • 23% cost more than $30 million. Food Safety News states: • For businesses, it’s all about risk management and mitigation — lowering the impact of recalls and lowering liability costs. • For the supply chain, efficiencies relate to productivity, cash flow improvements, innovation, and reducing waste. • And, for consumers, it’s about access to markets and specialty foods and enhancing or strengthening brand confidence.
  • 32. Trust in SAI Global to support you As one of the world’s largest and respected certification companies, SAI Global is the certification body of choice for over 24,000 organisations. Our clients value our worldwide reach combined with local experience, and the personal support we provide at every step along your certification journey and beyond. Our services & solutions: • Auditing & Certification • Training Solutions • Supply Chain Management • Food Safety Management Systems • Advisory
  • 33. Global Audit Coverage Americas APACEMEA SAI Global with offices in 28 countries employs more than 2,000 people and conduct over 40,000 audits annually across in 130 countries
  • 34. Training solutions Public training / on-site / online / • TACCP, Food Defence, Bio-vigilance and Bio-terrorism • Root Cause Analysis (Food Industry) • RSPH HACCP for Manufacturers • Supply Chain Traceability • Food Labelling and Legislation • RSPH Allergen Awareness • FSPCA Preventive Controls for Human Food • Internal Auditor To view full schedule visit www.saiglobal.com - ‘Risk Solutions – Assurance training’
  • 35. Contact us Standards – Training - Certification Tel: +44 (0)1908 793246 Email : information@saiglobal.com www.saiglobal.com