I’m creating a new supplier audit procedure, I’ve been asked to include service suppliers (sterilization) to be audited every 12 month, is this a reasonable request ?
Sterilization process is critical in the Medical Device industry…. I do not know what industry you are working in, but if you are selling sterilized products then the sterilization process is actually an outsourcing of your organization’s manufacturing. Now how often do you internally audit your own manufacturing process ? At least once per year…..
In addition sterilization is not a process that you can verify at incoming inspection, the process has to be validated, is there a revalidation schedule ?
Sounds not like a bad idea to audit your “critical suppliers” once per year.
SYMA consultants can help you in developing your Supplier Audit Procedure, in training your auditors and/or providing you 2nd party audits.
www.symaconsulting.com