supplier qualification program - nia-west · . supplier risk management. 3.5.1 low risk attributes...
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Quality Assurance Amy Caplette
Supplier Qualification Program
Quality Assurance Amy Caplette
Supplier Qualification Program
Why qualify?
Meet DS regulations - 21 CFR Part 111, Subpart E §111.75 Warning letters
Prevent product recalls and consumer alerts
Import Alerts, detentions, and refusals
Prevent seizures, injunctions and prosecutions
Public concerns = bad reputation
Why qualify?
Continuous supply chain
Ensure supplier integrity Raw material or component quality COA usage
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 Amount Time Money Resources
Vendors versus manufacturers Management
Joint SIDI™ Working GroupVoluntary Supplier Qualification
Guideline
Using your Supplier’s COA –Do I need to test incoming material?
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?
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 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: 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)
Total Number of Purchase Lines Received 10Total Number of Purchase Lines with a Supplier Related Quality Defect (1 ADR, 1 DMDO) 2
RFT Percent 80%
Right First Time Quality Metric Example
http://supplier.amway.com/sites/SupplierPortal/default.aspx
Supplier Risk Management
3.5.1 Low Risk Attributes – Suppliers and ComponentsThe 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
Supplier AttributesComponent 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 Well-Substantiated Claims for Product Performance
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
3.5.2 High Risk Attributes – Suppliers and ComponentsThe 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
Process capability Market requirements vs supplier capability Claim or no claim?
Change control Goes both ways
Auditing to qualify Direct GMP Audit
Independent 3rd Party Audit
Independent 3rd Party Certification
Shared Audit Information
What to look for?
OOS investigations and failures
Control of non-conforming product
Documentation & Record Keeping
Change Control
What to look for? Facilities &
Equipment
Supplier Management Program
HACCP/Production Controls
Summary
Develop a program Resource: www.crnusa.org/SIDI,
or trade associations
Identify resources Qualified Third party Shared audits
Identify risk matrix
Summary Document qualification
program Keep records
Follow-through
Re-qualify
