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A TraceGains Webinar with Debby Newslow
Q&A
Today’s Presenters 
Debby Newslow 
President 
D.L. Newslow & Associates 
Gary Nowacki 
CEO 
TraceGains
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com 
5 
Who I Am 
Debby Newslow, President 
D.L. Newslow & Associates, Incorporated. 
– IRCA Certified Quality Assurance Lead Assessor 
– Author of Dec 2013 published- Food Safety Management 
Programs by CRC Press 
– Author of The ISO 9000 Quality System: Applications in 
Food and Technology (John Wiley & Sons Publishing) 
– 2013 winner of the NSF International Leadership Award for 
Training 
Debby has 30 plus years experience in quality, food safety, and 
basic management system (ISO, GFSI approved schemes) 
covering food, beverage, chemical, packaging and other 
related industries.
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com 
6 
What role does your supplier play 
in your HACCP Program? 
I have heard numerous times – we can’t control the 
supplier so why do we need to bother with defining 
requirements? They have been in business a long 
time – they wouldn’t be selling their products if they 
didn’t know what they were doing. 
We have to trust them – we just do! Can’t risk 
asking too much and then losing them. Or can we?
HACCP is not a stand-alone program 
The production of safe food products requires that 
the HACCP Program be built on a solid foundation 
of prerequisite programs. 
Prerequisite programs provide the basic 
environment and operating conditions that are 
necessary for the production of safe, wholesome 
food. (quotation borrowed from NACMCF) 
Things we first have to rememberabout our HACCP Programs 
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com 
7
8 
Definition 
A prerequisite programis a program in place that when maintained effectively will either eliminate a potential hazard or reduce it to an acceptable limit. 
Failure to meet prerequisite programrequirements increases the likeliness of failure… 
PRP programs must be effective!!! 
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
Examples of HACCPPrerequisite Programs 
• 
Allergen Control 
• 
GMP/Pest Control 
• 
Raw Material Control System 
• 
Sanitation 
• 
Chemical Control 
• 
Water Treatment 
• 
Receiving, Storage, Distribution 
• 
Traceability and Recall 
And our topic of the day 
Supplier Management Programs 
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
10 
Again: Why should we be concerned about our suppliers? 
• 
A hazard comes from two places 
– 
It is added during your process or 
– 
It is created and received from your supplier. 
• 
Let’s think about recent recalls…. 
• 
60% of recalls can be traced to a supplier? 
• 
We don’t need to think too long to realize that this figure could actually be a low figure. 
www.newslow.com 
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com(12/12)
11 
Let’s think of some examples 
• 
Pet food with melamine 
• 
Ice cream with the wrong ingredients 
• 
Peanut butter (where do we start?) PCA 
• 
Spinach –E. Coli in the water supply 
• 
Aflatoxin in corn supply 
• 
Packaging issues such as broken glass 
• 
Cross contamination from shipping conditions 
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
Protect the safety of yourproduct trust and verify 
• 
How do we ensure that our suppliers are not sending us food safety hazards? 
• 
Can this even be done? 
• 
Could due diligence be proved? 
• 
Who do we blame and does blame even matter? 
• 
We must be proactive! 
• 
No longer is the answer “this is how we have always done it” 
• 
Is doing the best we can enough? 
Dr. Deming said that doing the best we can may not be good enough. 
Henry Ford said that “Quality means doing it right when no one is looking.” 
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
13 
Engineer out the cause… 
Supplier Approval and Monitoring 
• 
Control the hazard before it gets to the plant 
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
Identify food safety critical supplies 
• 
Ingredients 
• 
Primary & Secondary Packaging Materials 
• 
Processing Aids (lubricants, cleaning chemicals, boiler chemicals, etc.) and their purpose 
• 
Product contact surfaces (equipment, gaskets, etc.) 
And don’t forget “service” suppliers 
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
Critical food safety service suppliers 
Examples may include: 
•Contractors, 
•Cleaning/Sanitation, 
•Janitorial, 
•Pest Control, 
•Laboratory Testing, 
•Calibration, 
•Transportation 
•Waste Removal 
•Temporary Services 
15
Critical food safety service suppliers 
• 
We don’t allow glass in our plant, where did that glass bottle of soda come from? 
• 
We have an approved chemical list, where did that bottle of glass cleaner come from? 
• 
We only order food grade lubricants, where did that non food grade lubricant come from and how did it get here? 
• 
We don’t allow allergens in the facility. Our associates are trained. They know better. Where did this come from? 
What do you think the answers to these questions are? 
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
17 
How should a supplier 
be chosen and approved? 
• 
Choose suppliers that can meet your company needs both related to product and service requirements. 
•Know your ingredient requirements including any known food safety hazards and how these are normally controlled 
•Type and extent of control applied to a supplier is dependent on the effect of the purchased product on product safety, product parameters and customer specifications. 
•Based on the knowledge of the operation and its product, define the criteria for selection, evaluation, and monitoring that would ensure continued compliance with the organization’s defined requirements. 
•As always, maintain records that confirm compliance and effectiveness. 
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
Monitoring the supplier 
• 
Divide the suppliers by the area of responsibility. 
•Each responsible manager should review those suppliers at a predetermined time frame (recommend annually depending on the criticalness of the item being supplied). 
•Review must include any issues, nonconformances with the supplier during that time frame. 
•Results must be recorded and reported to top management during the management review meeting or other top management type meeting. 
•A company with a large number of suppliers could split the suppliers into different quarters for review such that all suppliers are reviewed annually. 
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com 18
19 
What if the supplier is required 
by your customer – 
• 
Your company is still responsible to produce a safe product that meets specifications. 
•Requirements for identifying and ensuring that ingredients and materials meet defined specifications related to food safety and quality must be defined and confirmed compliant. (May include temperature, seals, visual inspections, etc.) 
•Requirements must be defined such that any nonconforming situation is addressed in a timely manner (i.e., rejection, product put on hold, transports rejected, etc.) based on the potential risk. Also process must ensure that the source of the item (i.e., customer buyer) is notified of the situation. Overall the process must include regularly providing a performance report to those responsible for the sourcing the item. 
•“Fear factor” (making your customer mad) can not influence the decision. 
•Records must be maintained. 
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
Do we treat all suppliers all equally? 
• 
Does every supplier have to be audited? 
•This is an internal question based on the criticalness of the product being supplied. 
•It is recommended that the Food Safety/HACCP Team evaluate the products being supplied related to risk and use this basis to decide what is needed to ensure its safety and continued compliance to defined parameters. 
•In today’s world –more and more organizations are accepting compliance with a third party audit such as an approved GFSI food safety scheme. 
But remember, understand what is required, review the approvals, certificates, audit reports, and organization’s corrective actions. Be sure results reflect a credible organization based on credible criteria. 
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com 
20
Effectiveness? 
Measuring and ensuring the effectiveness of any PRP is a constant challenge for any organization. 
Based on my experience and observed success-I recommend that the Food Safety/HACCP Team maintain a matrix that is used to track and record supplier approval and monitoring. 
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com 21
Developing and maintaining a supplier matrix is highly 
recommended: 
– Name of the supplier 
– The product or service provided 
– Brief description of the risk assessment conclusion 
– A description of how the supplier is assessed 
– Monitoring requirements 
– Responsibility for performing monitoring 
– Outcome 
– Frequency 
– Date performed and next date due? 
This becomes an excellent record of performance and when 
necessary required actions to achieve compliance. 
*Quoted from Food Safety Management Programs. Debby Newslow. CRC Press 2013. 
The Supplier Matrix* 
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com 22
Common nonconformances* 
• 
Service suppliers are not identified 
•Ingredients, packaging suppliers are provided by corporate so we don’t have to do anything. 
•Issues with corporate required suppliers are not addressed because the site feels they can’t do anything about it. 
•No defined program for reporting issues. 
•Even with a defined program, records indicated that as long as a credit is received then reason or corrective action not important. 
•Defined frequency for evaluating suppliers was not supported by records to confirm compliance. 
•Suppliers used in the distant past (i.e., 3 years ago and not since) are automatically approved without any recent update or evaluation. 
*Quoted from Food Safety Management Programs. Debby Newslow. CRC Press 2013. 
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com 23
Common nonconformances* 
• 
List of approved suppliers included the company name and not the items the supplier was approved for. 
•Statement that supplier provided product per the current specification but the current specification was not available. 
•Suppliers are approved based on financial status with no evaluation, defined requirements related to food safety and quality identified. 
•Supplies noted in the storage areas were not sourced by a listed approved supplier with no record or explanation available to explain the situation. 
•Organization’s traceability program does not include traceability (i.e. lot numbers) back to the supplier. We will hear more about this shortly. 
*Quoted from Food Safety Management Programs. Debby Newslow. CRC Press 2013. 
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com 24
25 
Can your process effectively tracean issue back to the supplier? 
What if a supplier contacts you with a serious food safety issue and that ingredient is already in the product on the grocer’s shelf? 
–Does your lot traceability program provide the information needed to absolutely identify every finished product that contains the tainted ingredients? 
–Lives could be at stake? Even if it is just a quality issue – the brand could be at stake. 
–Are you sure the process works? Mock Recalls must be performed to confirm effectiveness. An emergency is not the time to find out there are flaws in your process. 
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
26 
Let’s review 
• 
Know your supplier, 
•Know your products, 
•Ensure confidence through every means possible (i.e., risk assessments) that your supplier is not sending food safety hazards with their product. 
•The extent of control that you have on your supplier must be managed based on the potential risk of the product being supplied. 
•Keep in mind that a large number of recalls are caused from supplier issues. 
•Even the small company –MUST communicate these messages to their suppliers. 
•Unfortunately, many small companies are taking the larger companies’ rejects and don’t even know it. 
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com 26
27 
Let’s review some more…… 
• 
Remember to maintain objective evidence of compliance (i.e., records) 
•PRP programs are the foundation to an effective HACCP Program 
•Never take your suppliers for granted 
•Never assume food safety 
•Everyone is responsible for food safety. 
“Quality/food safety is like our health, we tend to take it for granted until it fails.”** 
**Quoted from ASQ video “cost of poor quality” 
Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
Documentation —Turning Static Data Into Information 
Typical 
24/7 Detection& Compliance 
Automation 
TraceGains 
Dynamic Information 
AutomaticScorecarding 
Difficult to search, analyze, andtake action 
Instant eNotification 
Alerts 
No More Spreadsheets: Documents to Data 
Static Data 
COAs 
Supplier Documents 
Finished Goods Quality 
Machine Maint. 
Receiving 
Receiving Inspections 
Lab Results 
Auto. P.O. Acknowl. 
Plant Floor Feedback 
Finished Goods QA 
COA 
ActionForm™
TraceGains Automation Solves Many Problems 
GFSI 
Labeling 
FSMA 
Audits
Q&A 
Gary Nowacki 
gary.nowacki@ tracegains.com 
Debby Newslow 
debby@ 
newslow.com

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Creating an Approved Supplier Program as a Prerequisite for a Successful HACCP Program

  • 1. A TraceGains Webinar with Debby Newslow
  • 2. Q&A
  • 3. Today’s Presenters Debby Newslow President D.L. Newslow & Associates Gary Nowacki CEO TraceGains
  • 4. Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com 5 Who I Am Debby Newslow, President D.L. Newslow & Associates, Incorporated. – IRCA Certified Quality Assurance Lead Assessor – Author of Dec 2013 published- Food Safety Management Programs by CRC Press – Author of The ISO 9000 Quality System: Applications in Food and Technology (John Wiley & Sons Publishing) – 2013 winner of the NSF International Leadership Award for Training Debby has 30 plus years experience in quality, food safety, and basic management system (ISO, GFSI approved schemes) covering food, beverage, chemical, packaging and other related industries.
  • 5. Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com 6 What role does your supplier play in your HACCP Program? I have heard numerous times – we can’t control the supplier so why do we need to bother with defining requirements? They have been in business a long time – they wouldn’t be selling their products if they didn’t know what they were doing. We have to trust them – we just do! Can’t risk asking too much and then losing them. Or can we?
  • 6. HACCP is not a stand-alone program The production of safe food products requires that the HACCP Program be built on a solid foundation of prerequisite programs. Prerequisite programs provide the basic environment and operating conditions that are necessary for the production of safe, wholesome food. (quotation borrowed from NACMCF) Things we first have to rememberabout our HACCP Programs Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com 7
  • 7. 8 Definition A prerequisite programis a program in place that when maintained effectively will either eliminate a potential hazard or reduce it to an acceptable limit. Failure to meet prerequisite programrequirements increases the likeliness of failure… PRP programs must be effective!!! Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
  • 8. Examples of HACCPPrerequisite Programs • Allergen Control • GMP/Pest Control • Raw Material Control System • Sanitation • Chemical Control • Water Treatment • Receiving, Storage, Distribution • Traceability and Recall And our topic of the day Supplier Management Programs Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
  • 9. 10 Again: Why should we be concerned about our suppliers? • A hazard comes from two places – It is added during your process or – It is created and received from your supplier. • Let’s think about recent recalls…. • 60% of recalls can be traced to a supplier? • We don’t need to think too long to realize that this figure could actually be a low figure. www.newslow.com Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com(12/12)
  • 10. 11 Let’s think of some examples • Pet food with melamine • Ice cream with the wrong ingredients • Peanut butter (where do we start?) PCA • Spinach –E. Coli in the water supply • Aflatoxin in corn supply • Packaging issues such as broken glass • Cross contamination from shipping conditions Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
  • 11. Protect the safety of yourproduct trust and verify • How do we ensure that our suppliers are not sending us food safety hazards? • Can this even be done? • Could due diligence be proved? • Who do we blame and does blame even matter? • We must be proactive! • No longer is the answer “this is how we have always done it” • Is doing the best we can enough? Dr. Deming said that doing the best we can may not be good enough. Henry Ford said that “Quality means doing it right when no one is looking.” Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
  • 12. 13 Engineer out the cause… Supplier Approval and Monitoring • Control the hazard before it gets to the plant Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
  • 13. Identify food safety critical supplies • Ingredients • Primary & Secondary Packaging Materials • Processing Aids (lubricants, cleaning chemicals, boiler chemicals, etc.) and their purpose • Product contact surfaces (equipment, gaskets, etc.) And don’t forget “service” suppliers Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
  • 14. Critical food safety service suppliers Examples may include: •Contractors, •Cleaning/Sanitation, •Janitorial, •Pest Control, •Laboratory Testing, •Calibration, •Transportation •Waste Removal •Temporary Services 15
  • 15. Critical food safety service suppliers • We don’t allow glass in our plant, where did that glass bottle of soda come from? • We have an approved chemical list, where did that bottle of glass cleaner come from? • We only order food grade lubricants, where did that non food grade lubricant come from and how did it get here? • We don’t allow allergens in the facility. Our associates are trained. They know better. Where did this come from? What do you think the answers to these questions are? Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
  • 16. 17 How should a supplier be chosen and approved? • Choose suppliers that can meet your company needs both related to product and service requirements. •Know your ingredient requirements including any known food safety hazards and how these are normally controlled •Type and extent of control applied to a supplier is dependent on the effect of the purchased product on product safety, product parameters and customer specifications. •Based on the knowledge of the operation and its product, define the criteria for selection, evaluation, and monitoring that would ensure continued compliance with the organization’s defined requirements. •As always, maintain records that confirm compliance and effectiveness. Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
  • 17. Monitoring the supplier • Divide the suppliers by the area of responsibility. •Each responsible manager should review those suppliers at a predetermined time frame (recommend annually depending on the criticalness of the item being supplied). •Review must include any issues, nonconformances with the supplier during that time frame. •Results must be recorded and reported to top management during the management review meeting or other top management type meeting. •A company with a large number of suppliers could split the suppliers into different quarters for review such that all suppliers are reviewed annually. Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com 18
  • 18. 19 What if the supplier is required by your customer – • Your company is still responsible to produce a safe product that meets specifications. •Requirements for identifying and ensuring that ingredients and materials meet defined specifications related to food safety and quality must be defined and confirmed compliant. (May include temperature, seals, visual inspections, etc.) •Requirements must be defined such that any nonconforming situation is addressed in a timely manner (i.e., rejection, product put on hold, transports rejected, etc.) based on the potential risk. Also process must ensure that the source of the item (i.e., customer buyer) is notified of the situation. Overall the process must include regularly providing a performance report to those responsible for the sourcing the item. •“Fear factor” (making your customer mad) can not influence the decision. •Records must be maintained. Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
  • 19. Do we treat all suppliers all equally? • Does every supplier have to be audited? •This is an internal question based on the criticalness of the product being supplied. •It is recommended that the Food Safety/HACCP Team evaluate the products being supplied related to risk and use this basis to decide what is needed to ensure its safety and continued compliance to defined parameters. •In today’s world –more and more organizations are accepting compliance with a third party audit such as an approved GFSI food safety scheme. But remember, understand what is required, review the approvals, certificates, audit reports, and organization’s corrective actions. Be sure results reflect a credible organization based on credible criteria. Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com 20
  • 20. Effectiveness? Measuring and ensuring the effectiveness of any PRP is a constant challenge for any organization. Based on my experience and observed success-I recommend that the Food Safety/HACCP Team maintain a matrix that is used to track and record supplier approval and monitoring. Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com 21
  • 21. Developing and maintaining a supplier matrix is highly recommended: – Name of the supplier – The product or service provided – Brief description of the risk assessment conclusion – A description of how the supplier is assessed – Monitoring requirements – Responsibility for performing monitoring – Outcome – Frequency – Date performed and next date due? This becomes an excellent record of performance and when necessary required actions to achieve compliance. *Quoted from Food Safety Management Programs. Debby Newslow. CRC Press 2013. The Supplier Matrix* Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com 22
  • 22. Common nonconformances* • Service suppliers are not identified •Ingredients, packaging suppliers are provided by corporate so we don’t have to do anything. •Issues with corporate required suppliers are not addressed because the site feels they can’t do anything about it. •No defined program for reporting issues. •Even with a defined program, records indicated that as long as a credit is received then reason or corrective action not important. •Defined frequency for evaluating suppliers was not supported by records to confirm compliance. •Suppliers used in the distant past (i.e., 3 years ago and not since) are automatically approved without any recent update or evaluation. *Quoted from Food Safety Management Programs. Debby Newslow. CRC Press 2013. Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com 23
  • 23. Common nonconformances* • List of approved suppliers included the company name and not the items the supplier was approved for. •Statement that supplier provided product per the current specification but the current specification was not available. •Suppliers are approved based on financial status with no evaluation, defined requirements related to food safety and quality identified. •Supplies noted in the storage areas were not sourced by a listed approved supplier with no record or explanation available to explain the situation. •Organization’s traceability program does not include traceability (i.e. lot numbers) back to the supplier. We will hear more about this shortly. *Quoted from Food Safety Management Programs. Debby Newslow. CRC Press 2013. Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com 24
  • 24. 25 Can your process effectively tracean issue back to the supplier? What if a supplier contacts you with a serious food safety issue and that ingredient is already in the product on the grocer’s shelf? –Does your lot traceability program provide the information needed to absolutely identify every finished product that contains the tainted ingredients? –Lives could be at stake? Even if it is just a quality issue – the brand could be at stake. –Are you sure the process works? Mock Recalls must be performed to confirm effectiveness. An emergency is not the time to find out there are flaws in your process. Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
  • 25. 26 Let’s review • Know your supplier, •Know your products, •Ensure confidence through every means possible (i.e., risk assessments) that your supplier is not sending food safety hazards with their product. •The extent of control that you have on your supplier must be managed based on the potential risk of the product being supplied. •Keep in mind that a large number of recalls are caused from supplier issues. •Even the small company –MUST communicate these messages to their suppliers. •Unfortunately, many small companies are taking the larger companies’ rejects and don’t even know it. Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com 26
  • 26. 27 Let’s review some more…… • Remember to maintain objective evidence of compliance (i.e., records) •PRP programs are the foundation to an effective HACCP Program •Never take your suppliers for granted •Never assume food safety •Everyone is responsible for food safety. “Quality/food safety is like our health, we tend to take it for granted until it fails.”** **Quoted from ASQ video “cost of poor quality” Thank you for using the services of D. L. Newslow & Associates, Inc. www.newslow.com
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  • 28. Documentation —Turning Static Data Into Information Typical 24/7 Detection& Compliance Automation TraceGains Dynamic Information AutomaticScorecarding Difficult to search, analyze, andtake action Instant eNotification Alerts No More Spreadsheets: Documents to Data Static Data COAs Supplier Documents Finished Goods Quality Machine Maint. Receiving Receiving Inspections Lab Results Auto. P.O. Acknowl. Plant Floor Feedback Finished Goods QA COA ActionForm™
  • 29. TraceGains Automation Solves Many Problems GFSI Labeling FSMA Audits
  • 30. Q&A Gary Nowacki gary.nowacki@ tracegains.com Debby Newslow debby@ newslow.com