Q: What’s the difference between a supplier evaluation and an audit, from FDA’s point of view?
A: Usually an audit is 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.
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]On-site audits are nothing more than snapshots in time, so be careful how much reliance you place on them.[/pullquote]
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 continuously improve the data you evaluate.
Answered by Martin Browning, President and Co-founder of EduQuest and the former Special Assistant to the Associate Commissioner of FDA’s Office of Regulatory Affairs. (ORA). Martin also is the chairman of the EduQuest training class on FDA Auditing of Computerized Systems and Part 11/Annex Compliance.