Rephine's Roger Smith, Consultant and Auditor, explains
Traditionally within pharmaceutical auditing, there has been much focus on technical skills and a good understanding of regulatory expectations, with numerous courses designed to increase competence in these areas. Whilst this is clearly vital to deliver an effective assessment of GxP compliance, the actual behaviours displayed by the auditor are frequently an undervalued element of this process.
The constant challenge for auditors is to use appropriate interpersonal skills throughout the audit cycle from preparation through to reporting and CAPA agreement, irrespective of familiarity with the auditee/site, language/cultural differences and potential defensive mindsets deployed by auditee personnel. The latter can sometimes create barriers to even an experienced auditor due to employee fear, and the implications of a blame culture on employment and sanctions for the company. The power of silence can be a tool for a skilled auditor in certain circumstances, but may also be used by auditee personnel to deny information.
Auditor competence is a blend of experience, flexibility and resilience. The objective is always to provide an audit outcome that meets the predefined objectives, identifies system errors, relates deficiencies to patient and compliance risk, leads to effective preventive and corrective actions and finally leaves a good document trail for the next auditor.
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