What's worse than being audited?  Audit findings.  What's worse than audit findings?  Audit findings that are wrong. It's happened to all of us - the auditor misunderstands a complex issue and generates a finding that is not quite fair. There are productive and non-productive ways to push back on audit findings.  Let's review!

Productive methods:

• Correct the underlying assumptions. If a finding seems wrong, look at the evidence that the auditor has produced to support the finding. For example, if an audit finding states that there is no documentation that protocol deviations were reviewed per the deviation plan, but these discussions were captured in meeting minutes, explain and attach the meeting minutes.
• Describe adherence to standards. Summarize the steps in the regulations, GCPs, Standard Operating Procedures, and study-specific plans pertinent to this issue and describe how you complied with them. In the example above, cite the SOP or plan that permits documentation of review in meeting minutes.
• Defend your risk-based approach. Describe how you applied a risk-based approach to your interpretation of GCP.  For example, if the auditor objects to the fact that meeting minutes documenting protocol deviation review weren't signed and dated, you could state that you applied a risk-based approach to documenting group decisions.

Unproductive methods:

• Avoid addressing the finding. For example, a TMF audit finding states that the TMF index indicates that statistical documents will be filed in the eTMF repository, but they are not filed.  The CRO responds, "We're not responsible for statistical documents."  This response avoids the finding that the TMF index, which the CRO is responsible for, is inaccurate.
• Ignore contradictory evidence.  For example, the project plan states that a subcontractor has been retained to conduct participant interviews, but no contract or work product from this subcontractor has been filed. The auditee responds, "The subcontractor was never hired." Good to know, but we still have a Project Plan that states otherwise - what will be done about that?
• Claim, "We were inspected by FDA and they didn't have a problem with it." An FDA inspection is not an imprimatur on every quality practice that was followed during a clinical trial. Defend your choices with some evidence.

Above all, before you hit Send on any objections to audit findings, take a deep breath and consider....does the auditor have a point?  Any feedback you receive in an audit or inspection is valuable, but it is especially valuable if it's wrong, because it highlights weak spots in your quality story.  For example, if the auditor couldn't find documentation of deviation review, was it because the deviation plan didn't clearly state it where it was filed?  Or the TMF was difficult to search? 

We can choose to think of an audit as a productive conversation that educates both the auditor and the auditee, rather than a zero-sum game.