Supplier Audits: Tips for Evaluating Suppliers Not Familiar with FDA Expectations

Q: I’ve been added to my company’s team to perform supplier audits of some potential new vendors and contractors. Some of their facilities have not done work previously for an FDA-regulated company like ours. One of our biggest concerns is whether they can meet our (and FDA’s) expectations for process control and validation.

Can you provide me with some suggestions of what specifically to look for during our supplier audits?

A: First of all, you want to determine if these suppliers have any type of quality assurance or continuous improvement program. Sometimes we don’t have to use the same verbiage FDA uses. During your supplier audits, you want to make sure we’re talking the suppliers’ language and that they understand our expectations.

A lot of people are afraid of the “validation” word – so let’s not use it, at least not at first. Instead, talk with potential suppliers about their experience with good process development, implementation, and testing to make sure their processes meet our needs and produce a product that matches our pre-determined specifications and quality attributes.
Some of the suppliers’ equipment likely will be installed already, so you might ask if they did an installation qualification. If they say no, you might ask, “OK, how do you know that the installation met the manufacturer’s specifications for installation?” For example, are the water lines and electricity and everything else hooked up properly?

[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]Suppliers should have a calibration and/or maintenance schedule.[/pullquote]

You might ask if they have done any operational qualifications to identify the equipment’s operating parameters. Even if the suppliers don’t have those parameters documented, they should have — at a minimum — a calibration and/or maintenance schedule, and they should be monitoring and recording that information.
You want to ask them if they have a process or procedure for developing the process itself. If not: “Explain to me how you’re going to do this, and let’s write it down.” Perhaps you’re going to have to do a lot of the documentation yourself.
Eventually, you do want to bring up the word validation. “Have you validated processes before, or have you done process capability studies on your other products?” The answers may influence how (and if) you work with that vendor.
And then of course, you always should ask, “How do you train and qualify your employees? How do you know they understand how to operate the equipment and meet product specifications?”
There are obviously lots of other questions you should ask during your supplier audits, but these few can start a meaningful and revealing dialog with a supplier who may not be familiar with the world of FDA regulation.

Answered by Janis Olson, EduQuest’s Vice President of Regulatory and Quality Services, who was an expert field investigator during her 22-year career at the U.S. FDA and who also served on the PDA committee that wrote Technical Report 32 on Auditing of Suppliers Providing Computer Products. Jan is the co-instructor of EduQuest’s 1.5 day Managing and Auditing Supplier Quality training class.


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