What if, during this consultative audit, the plant simply refused to file the RFR report? This may be the only situation where direct reporting has value to all stakeholders. Reporting directly to FDA if a plant refuses to could be an incentive for the plant to follow the RFR requirements. But it’s the only one.
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Auditors audit and most do it very well. They are not enforcers though, nor are they quasi inspectors or even consultants. And they do not act alone. There is an entire cast of staff at an accredited certification body who provide experience and support to the auditor on the ground. Auditors should not be expected to make serious judgments without the input of these support systems. Let the RFR and consultants play their role, and accredited certification auditors theirs. And allow that system, with all of its checks and balances, to work before requiring any reporting.
Wester is president of PA Wester Consulting. Reach her at firstname.lastname@example.org.