Supplier Qualification Program

Quality Assurance Amy Caplette

Supplier Qualification Program

Quality Assurance Amy Caplette

Why qualify? 

Meet DS regulations - 21 CFR Part 111, Subpart E §111.75 

Warning letters

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Prevent product recalls and consumer alerts

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Import Alerts, detentions, and refusals

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Prevent seizures, injunctions and prosecutions

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Public concerns = bad reputation

Why qualify? 

Continuous supply chain

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Ensure supplier integrity  

Raw material or component quality COA usage 

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Verify supplier information

Economical adulteration 

Test to protect yourself from fraud

Companies should continue to “raise the bar” on their product safety and quality programs by further integrating anti-fraud strategies.

Grocery Manufacturers Association and A.T. Kearney titled Consumer Product Fraud – Detection and Deterrence: Strengthening Collaboration to Advance Brand Integrity and Product Safety

Grocery Manufacturers Association and A.T. Kearney titled Consumer Product Fraud – Detection and Deterrence: Strengthening Collaboration to Advance Brand Integrity and Product Safety

Challenges 

Global suppliers    

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Amount Time Money Resources

Vendors versus manufacturers 

Management

Joint SIDI™ Working Group Voluntary Supplier Qualification Guideline

Using your Supplier’s COA – Do I need to test incoming material? 

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Specifically, your firm was unable to provide documentation of the results of tests or examinations to meet this requirement for the dietary ingredients you used to manufacture your dietary supplements. Your response does not adequately address your failure to meet this requirement. Your letter stated that you think this requirement is unnecessary because your ingredients are considered generally recognized as safe (GRAS) and that your suppliers test them and provide a Certificate of Analysis (CGA) for each ingredient. Under 21 CFR 111.75(a)(1), a manufacturer must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use.

Using your Supplier’s COA – Can I randomly test ingredients? 

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You failed to conduct at least one appropriate test or examination to verify identity of a dietary ingredient prior to its use…you only performed identity testing on randomly selected dietary ingredients. You failed to qualify suppliers of components (other than dietary ingredients) by establishing the reliability of the suppliers' certificate of analyses through confirmation of the results of their tests or exams, prior to their use.

All suppliers are measured on the following quantitative metrics:       

Perfect Order Quality Delivery Order Fulfillment Invoicing Lead Time Pricing

Right First Time Quality Metric Example Total Number of Purchase Lines Received Total Number of Purchase Lines with a Supplier Related Quality Defect (1 ADR, 1 DMDO) RFT Percent

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2 80%

Right First Time 

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10

Each incoming Purchase Order Line is assigned a score of 100% or 0%. Any Purchase Order line that is assigned either a Supplier-related DMDO or ADR will be assigned a score of 0%. (Severity Factors are not assigned)

Definitions: 

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DMDO (Defective Material Disposition Order) - All lot rejections of product/material that does not conform with the agreed upon specifications are assigned a DMDO ADR (Arrival Defect Report) – Non-conforming shipments (Missing or inaccurate paperwork, bad pallets, inaccurate labeling, etc)

http://supplier.amway.com/sites/SupplierPortal/default.aspx

Supplier Risk Management

3.5.1 Low Risk Attributes – Suppliers and Components The following Table lists some of the major attributes associated with a Low Risk Supplier and a Low Risk Component: Table 3.5.1 Low Risk Attributes Component Attributes Supplier Attributes Strong Technical Dossier (SIDI)

Comprehensive Specifications

Mature Company – Many Years in Production with Regulatory Oversight

Comprehensive Certificate of Analysis

Stability Studies Conducted on Bulk Dietary Ingredient or Excipient – Well Documented Specifications

Identity, Strength, Purity, Composition Well Characterized & Consistent with Material Complexity

Comprehensive Change Control System

Compendial Grade Material

Formal Process Capacity Studies

Material of Simple Composition

Low Incidence of Customer Complaints Material has No or Limited Potential for Economically Motivated Adulteration Favorable Regulation History Direct Purchasing Relationship Favorable Audit Results by Third Party Favorable Direct Due Diligence Audit History of Working with the Supplier on other Ingredients

Well-Substantiated Claims for Product Performance

3.5.2 High Risk Attributes – Suppliers and Components The following Table lists some of the major attributes associated with High Risk Suppliers and High Risk Components: Table 3.5.2 High Risk Attributes

Supplier Attributes

Component Attributes

Incomplete Technical Dossier

Incomplete Specifications – Critical to Quality Attributes Omitted

Start-up Company with Limited Production Experience

Certificate of Analysis based on Historical Data and/or Input Values

Company Manufactures in Country with Less Mature Regulatory Oversight

No Compendial Monograph Established

No Regulatory History

No Stability Data on Bulk Dietary Ingredient or Excipient

Lack of Data to Support Specifications

Material of Complex Composition

Immature Change Control System

Material is Substantially Transformed by Complex Process

No Process Capability Studies

Unknown Origin of Raw Agriculture Commodity or Natural Starting Material

High Incidence of Customer Complaints or Undocumented Program

Performance Claims Lack Substantiation

Material is on Watch List for Potential Economically Motivated Adulteration Indirect Purchasing Relationship Weak Supply Chain Management Controls

Preventive measures 

Biggest contributors to OOS/rejects  

Test method Specification alignment   

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Process capability Market requirements vs supplier capability Claim or no claim?

Change control 

Goes both ways

Auditing to qualify 

Direct GMP Audit

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Independent 3rd Party Audit

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Independent 3rd Party Certification

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Shared Audit Information

What to look for? 

OOS investigations and failures

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Control of non-conforming product

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Documentation & Record Keeping

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Change Control

What to look for? 

Facilities & Equipment

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Supplier Management Program

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HACCP/Production Controls

Summary 

Develop a program 

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Identify resources   

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Resource: www.crnusa.org/SIDI, or trade associations

Qualified Third party Shared audits

Identify risk matrix

Summary 

Document qualification program 

Keep records

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Follow-through

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Re-qualify

Thank you!

Amy Caplette Amway Global – Nutrilite [email protected] *LinkedIn*