Application Note – GLP N.3 – Audit
Audit
The interview is often the most challenging aspect of an audit for new auditors. Yet the interview process may be the most important element of an audit. Auditors should be able to apply various techniques to gather information without challenging the auditee. The manner in which an auditor initiates the interview process may well determine the success of the interview.
Relaxed and conversational interview
Interviews should be relaxed and conversational. Auditors should not simply dive into the checklist.
Instead they should take time for introduction by the guide, then ask about the interviewee’s position and duties. After a short time, the interviewee should have mentioned a topic that is of interest to the auditor, who may ask for more information about the topic. From that point, the audit is underway, with the auditor linking questions to other topics of interest and documenting evidence, as appropriate.
The auditor’s focus should be to understand the process and the person’s role in that process. If the focus shifts from the process to the checklist, the conversation and the information the auditor needs to verify effectiveness will lag.
References
Some useful information are reported from the publication Regulatory Compliance Newsletter
“The GMP Labelling System” – Spring 2006 written by J. Russell March 2006.
