EduQuest, a global team of compliance experts, recently answered a query regarding supplier evaluations and audits. You might find this to be of interest to your company as well!
Q: What's the difference between a supplier evaluation and an audit, from FDA's point of view?
A: Usually an audit is an on-site visit, whereas an evaluation is considered an external process of collecting and monitoring data about a supplier. FDA regulations require you to evaluate—but not audit—your suppliers, unless the supplier is a critical one.
On-site audits are nothing more than snapshots in time, so be careful how much reliance you place on them. Evaluations should look at all kinds of performance data over a longer period of time for as long as you deal with that supplier.
You should talk to other people who use the supplier's products. Check the supplier's website. Look for reports of problems. Check with user groups and industry associations. Request—or better yet, require—testing and validation reports as appropriate. Evaluations, when done right, are much more useful than audits because you can continously improve the data you evaluate.
EduQuest is a global team of FDA compliance experts. Regulated companies throughout the world seek EduQuest’s advice and hands-on expertise in quality systems, system validation, inspection preparedness, supplier auditing, and GxP compliance.
Headquartered near Washington, D.C., EduQuest was founded in 1995 by three former senior FDA officials, including Martin Browning, the co-author of the 21CFR Part 11 Regulations for Electronic Records and Signatures. The EduQuest staff – located throughout the U.S. and Europe – includes full-time consultants and experienced trainers with a combined 160 years of experience in industry and another 127 years of experience at the FDA.
For more Q&A with the FDA professionals at EduQuest, visit www.EduQuest.net.
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