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We have encountered many companies that claimed that they operated a ‘no blame culture’, where employee regulatory compliance is questioned. They in their infinite wisdom seemed to think this was perfectly acceptable. The harsh facts are that the regulators expect everyone to be accountable for their respective actions and are quite prepared (after due legal process) to demand custodial sentences for serious infringements. We have on several occasions had to edit client policy documents (in the light of regulatory comments) to reflect that certain regulatory infringements by staff, would no longer be considered as minor mistakes and would carry more severe penalties; such as employment termination and accountability assessment. Below is an extract from an FDA document regarding CAPA compliance; it is informative to note how often they refer to the individual’s responsibility and accountability.
Content of the Corrective Action Operating Plan (CAPA) - The corrective action operating plan should include:
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