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How to be a Good GxP Auditor?

The success and value of an audit rests largely on the shoulders of the lead auditor and the audit team. Given the importance of auditor performance, do managers responsible for audit programs solicit and provide feedback on auditors? Very rarely.

Although knowledge is the basis of everything, it is not synonymous with competence; even a (high) qualification does not guarantee competence: competence only becomes observable in action!

The basis of any development of competence is knowledge, both cognitive and emotional, as well as the associated skills.

In order to make the transition from qualification to competence, further development processes are necessary.

Values, standards and rules are linked to existing knowledge and skills and become internalised on the path of competence development; important motivational and emotional connections are created.

If we look a little deeper into these categories, we find the so called key competences as components of being competent":

  • Social communicative competences, such as the ability to solve conflicts, conscientiousness, adaptability, eloquency etc.
  • Professional methodical competences, such as subject-specific knowledge, analytical thinking, knowledge orientation, objectivity, etc.
  • Activity and action related competences, such as decision-making ability, mobility, quick-wittedness, result-oriented action, etc.
  • Personal competences, such as openness to change, credibility, personal responsibility, willingness to learn, etc.

In more and more sets of regulations, the formulation of "competent" personnel, to be deployed to carry out tasks, can be found explicitly; sometimes only very briefly, but sometimes described more extensively in terms of associated requirements and characteristics.

As examples, we can refer to the EU GMP Guideline and DIN EN ISO 19011:2018-10.

Auditor evaluation criteria should be developed by company or third-party audit programs and include these principles foresees by ISO 19011: Professional and ethical conduct is the underpinning of the auditor’s work and requires good judgment in handling audit information and confidentiality.

  • Independence ensures the auditor is free of any bias and conflict of interest in conducting an audit.
  • Fair presentation requires factual and truthful reporting of findings.
  • An evidence based approach requires a logical and rational approach to managing audit findings.
  • Exaggerating or escalating findings without good reason risks auditor credibility.
  • The closing meeting is one of the most important stages of an audit.
  • The auditor will have a rank-ordered list of findings ranging from major to minor and, in some cases, critical findings.

Resource Person: BARBARA PIROLA

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