Typically, when we think of quality audits, we’re thinking about internal quality audits which evaluate the organizations quality system to ensure compliance with the regulations.

However, this section of the regulations also refers to supplier audits which should follow a similar process and requirements.

Supplier Audits

The FDA see’s supplier audits as an extension of the quality audits regulation and therefore does not audit those audit reports either, but still may ask for evidence that the audits were performed.

There are typically two different ways to approach internal quality audits.

The first way is to have them performed by an outside contractor brought in to audit the quality system.

The second is to have an internal quality audit team composed of employees from cross functional areas who are trained to perform the audits.

The latter is a much better method as it engages employees to own and participate in the quality requirements and systems.

Annual Basis

In either case, a procedure needs to be written to meet the requirements as stated. The expectations are that the entire quality system will be audited at least on an annual basis.

Typically, audits are scheduled each quarter to cover portions of the system with a schedule that would
evaluate the entire quality system on a yearly basis.