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Top Tools to Qualify Suppliers

Greater scrutiny by FDA and EU regulators, along with an increase in merger & acquisition transactions, means that supplier management will be atop device companies’ focus areas in 2017. Tips on how companies pick, manage and control their supply base remain relevant, so we dipped into the archives to share Rob Packard’s article from 2013. This article is actually in the top five most-read BONEZONE articles for the last four years, and we think it’s still a valuable tool to assist with supplier collaboration in 2017. —Editor



Imagine that you are a QA consultant. Last night you wrote a blog about the three tools needed to qualify suppliers. Today you are auditing a supplier, and have just complimented the purchasing manager on his quality program. During lunch, Kim, the general manager, says, “Michael was just showing me the blog you wrote about how to qualify suppliers. I was confused—your blog seemed to say that we are doing everything wrong, but you just told us that our supplier quality program looks great.”

Your response to Kim is, “The blog you read was describing what your customers should be doing to qualify suppliers—not what you should be doing to qualify suppliers. In your case, most of your suppliers are customer-mandated.”

This leads Kim to ask, “What should we do to qualify suppliers? What do you recommend if the supplier is not capable of making good parts?”

Your response? “You should help that OEM by helping the supplier get better. If the supplier doesn’t listen, keep trying, and ask the customer for help as a last resort.”

OEMs often force suppliers to use other suppliers that they—the supplier—would never choose. However, if the OEM specifies weak second-tier component and raw material suppliers, its first-tier suppliers will have fewer resources to devote to its own internal processes. One weak link can prevent the best outcome from occurring. The blog mentioned in our opening story summarized three weak tools—and recommended three better tools for qualifying suppliers.

The first three tools mentioned were:

  1. Requiring ISO certification
  2. Requesting a copy of the supplier’s quality manual
  3. Reviewing supplier questionnaires

The second three tools recommended were:

  1. Statistical process control (SPC)
  2. Process validation
  3. Supplier auditing


Michael and Kim, our purchasing manager and general manager at our supplier, are using all six of these tools. The first three are used to qualify customer-mandated suppliers, while the second three evaluate existing supplier performance. It’s true that the process for qualifying suppliers can differ, depending upon your position in the supply chain. Still, OEMs will benefit from adopting this six-step program to ensure that they’re not recommending inferior suppliers anywhere in the chain.

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