Ways to Ensure Supplier Compliance

Checkmark Stock ImageYour suppliers are critical to your success. They can increase your company's efficiency-in terms of time, cost, and quality. But in some cases, suppliers can put their clients in hot water; this is especially true if those clients are regulated companies.

For example, Epimed International, a medical device company, received a warning letter from the U.S. FDA for quality violations involving its supplier. The FDA said in a 2012 warning letter that Epimed conducts acceptance testing on the radio frequency of thermocouple electrodes without knowledge of the device manufacturer's original specifications from the initial manufacturer, or how changes made to the device (e.g., sterilization cycles) will affect the device. (1)

Quality problems stemming from supplier violations are not confined to FDA-regulated companies. Last year, BMW voluntarily recalled its 2013 coupe sedan M5 and M6 due to defective engine oil pump. The company discovered the defect during its in-house test-bench quality audit. The defect was detected after automobiles containing the pumps were already in the market.

Quality problems stemming from supplier violations are not confined to FDA-regulated companies. In a letter to the U.S. National Highway Traffic Safety Administration, BMW said that "An examination of its supplier manufacturing records revealed that there was an oil pump manufacturing error." (2)

Twofold Quality Problem

Kevin Marcus, a senior product manager at MasterControl Inc., talked about the importance of ensuring supplier compliance at the Masters Summit held in Park City, Utah, last October. He cited media reports that said BMW's problem was twofold: first, BMW trusts its suppliers to provide quality components that should be thoroughly tested by the supplier before shipping them to BMW; and second, BMW should have its own tests for every part provided by suppliers.

The Masters Summit is an annual conference sponsored by MasterControl, a software solutions provider that serves life science and other regulated industries. Marcus has more than 25 years of quality, regulatory compliance, and auditing experience in both the medical device and pharmaceutical industries.

FDA & ISO Requirements

Marcus noted that the number of FDA warning letters have risen from 474 in 2009 to 1,720 in 2011. Included in this increase were supplier-related issues. He discussed the requirements under 21 CFR 820, saying that the FDA will look at how medical device manufacturers conduct such things as supplier qualification and selection; supplier management, oversight, and re-evaluation; and risk evaluation and mitigation associated with materials and suppliers.

Both the QSR and ISO 13485 (for medical device manufacturers) require documented procedures to ensure that purchased materials or parts conform to specified purchase requirements. The requirement includes evaluation and selection of suppliers based on their ability to supply products according to the organization's requirements.

Recommendations for Supplier Compliance

Marcus said that FDA-regulated life science companies and general manufacturers that adhere to ISO quality standards are increasingly turning to automation as a basic tool for ensuring regulatory compliance. He said that by switching from a paper or manual supplier management system to an electronic platform, companies can increase their efficiency, optimize their supplier relationships, and facilitate compliance among all stakeholders, including suppliers.

In evaluating supplier management systems, Marcus said companies should look for "one-stop shopping" software solutions that integrate supplier management with other critical quality processes such as document control, audit management, supplier corrective action request (SCAR), contract documentation and management, risk management, and reporting/analytics.

Marcus said that implementation of a robust supplier management solution will assist organizations in the following areas:

  • Standarizing processes and attaining consistent quality;
  • Complying with regulations and quality standards;
  • Fostering supplier partnerships;
  • Improving part availability;
  • Improving efficiencies;
  • Meeting customer needs; and
  • Reducing risks.


  1. FDA Warning Letter to Epimed International viewed on April 15, 2013:
  2. BMW's letter to NHTSA dated Sept. 27, 2012, viewed on April 15, 2013 at:

Cindy Fazzi, a copywriter at MasterControl Inc., writes about the life sciences industry and other regulated environments. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York. She has a master's degree in journalism from Ohio State University.

Note: The views expressed in this article are those of the author and do not necessarily represent those of his or her employer, GxP Lifeline, its editor or MasterControl Inc.