Q: What is industry practice — or more importantly, FDA’s viewpoint — regarding re-audits?
Do we need defined and documented criteria for when to conduct re-audits? If so, what would such criteria include?
A: My experience is that industry rarely does what is required — which is to define in your procedures when re-audits are required.
So yes, you should have defined and documented criteria for re-audits. At a minimum, I believe re-audits should be performed when the initial audit finds:
- Product not meeting specifications
- The complete absence of a required procedure
- Personnel routinely not following procedures
- A required validation has not taken place, or the validation was not sufficient to show the process was truly validated
- A lack of required records — such as training records, service records, installation records, or calibration and equipment maintenance records
- Product not being properly accepted at incoming, in-process or final process stages
- Non-conforming product has escaped detection or has been distributed to the marketplace
- Product has been released to production without proper design validation and verification (V&V), or design transfer has not been done appropriately or completely.
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]Take into consideration the risks relative to product safety and efficacy.[/pullquote]
In general for re-audit decisions, you should take into consideration the risk associated with the original audit findings relative to product safety and efficacy. Also, take into consideration findings relative to data that indicates whether product meets design specifications or whether a process conforms to process parameters.
And finally, take into consideration findings relative to whether a specific portion of your quality system complies with relevant regulations.
This list is not meant to be exhaustive, but should get you started.
Answered by Denise Dion, Vice President of Regulatory and Quality Services for EduQuest, who served 18 years at the U.S. FDA as an expert field investigator and helped to develop FDA’s Quality System Inspection Technique (QSIT). Denise also is the lead instructor of EduQuest’s two-day training class on QSR Compliance Basics: Complying with FDA’s 21 CFR Part 820 Quality System Regulation.