Re: 12 months, I was referring to guidance in FDA's Quality Systems Manual: A Small Entity Compliance Guide:
Manufacturers are responsible for deciding the frequency of audits. The frequency should depend upon previous audit findings, any indications of problems, and known stability of the manufacturing process. If an audit reveals no problems, the audit intervals could be lengthened -- if problems are identified, audits may need to be conducted more often. Audits are usually conducted every 6 to 12 months, but should not exceed 12 months. "
Re: "not auditing every line item of a regulation":
For example - CFR 820.30 Design Controls covers many facets, such as design and development planning, inputs, outputs, review, verification, validation, changes, DHF. If we decided to cover only design review, verification, and validation, for example in an audit (based on known weaknesses), could we take credit as an audit of 820.30-Design Controls? Or because we audited only part of 820.30, would it not be an accurate claim?