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The Importance of Supplier Oversight. November 7, 2011 Lisa McClintock Director of Supplier Quality. Not if, but when…. May 7, 2007 80 children die in Haiti due to contaminated glycerin in acetaminophen syrup .

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The importance of supplier oversight

The Importance of Supplier Oversight

November 7, 2011

Lisa McClintock

Director of Supplier Quality

Not if, but when…

May 7, 200780 children die in Haiti due to contaminated

glycerin in acetaminophen syrup

Complex and Insecure Supply Chains have Consequences: Tainted Glycerin ~ 100 Deaths

  • 2. CNSC Fortune Way (Beijing, China)

    • Removes mfg name from CofA and replaces with own

    • Translates to English

    • No testing

  • 3. Rasfer International (Barcelona, Spain)

    • Removes mfg name from CofA and replaces with own

    • No testing

  • 4. Medicom Business Group (Panama)

    • Changes expiration date

    • No testing






  • 5. Social Security Administration (Panama)

    • No testing

    • Manufactures cough medicine using tainted glycerin

  • 1. Taixing Glycerin Factory (Hengxiang, China)

    • Chemical plant not inspected by SFDALabeled Glycerin, USP

    • Symbol means glycerin substitute

    • CofA reads 99.5% pure

Illicit Activity is Present and Threatens the Safety of Medicines


Counterfeit DVDs

Illegal drugs

Counterfeit medicine




  • The criminal element is present, active, and business savvy

  • ‘Benign’ consumer actions may have tragic consequences

Supply chain security protecting patients from economically motivated adulteration
Supply Chain Security – Protecting Patients from Economically Motivated Adulteration

“Companies that sell contaminated products because of loose supply chain oversight need to face serious penalties and cannot excuse themselves by blaming their suppliers.”

Dr. Margaret Hamburg, Commissioner, FDA

Working from the source we must strengthen each of the links in our supply chain
Working from the Source, We Must Strengthen Each of The Links In Our Supply Chain

  • Know the Source

    • Original manufacturer

    • Demand total supply chain transparency

  • Raise Expectations

    • Require tamper evidence

  • Distributors

    • Perform Quality system audits

  • At Our dock

    • Photo library inspections

    • Adulteration screening for at risk materials

    • Melamine screening

Supplier qualification and monitoring
Supplier Qualification and Monitoring Links In Our Supply Chain

  • Physical site audits

    • Frequency based on risk

  • Quality Agreement execution and oversight

    • Define Requirements

    • Change Notification

  • Monitoring

    • Supplier Audits

    • Quarterly (Nonconformances by supplier and material)

    • Quarterly Scorecards

Embracing the idea that our shop floor begins with our raw material suppliers
Embracing the Idea that Our ‘Shop Floor’ Begins with Our Raw Material Suppliers

Know your supplier!

The entire raw material supplier base is segmented annually via the 9 block approach
The Entire Raw Material Supplier Base is Segmented Annually via The 9-block Approach

  • Supplier Relationship Management Activities

    • Spend more time with your preferred suppliers

  • Marginal → Up or Out plans documented in CAPAs

Supplier location on 9-block drives cross-functional actions

Every patient every time
Every Patient, Every Time via The 9-block Approach

Supplier Quality makes certain that our suppliers reliably provide quality raw materials so that manufacturing can produce vital medicines for our patients worldwide.

  • Oversight (Audits)

  • Expectations (Quality Agreements)

  • Supply Chain Security (Tamper evidence, Adulteration screening)

  • Operations (Investigations and CAPAs, Supplier Changes)

  • Performance Management (Quarterly Scorecards, Business Meetings)

  • Continuous Improvement (Kaizen Events, Op Ex Projects)

Patient safety should never be a competitive advantage.

Thank you

Thank You! via The 9-block Approach