How do you cover all aspects stated in the proposal during one-day audits?
The process is challenging. Even if you want to audit in just one day (or even two or three days), it is important to cover as much as possible. Time management is essential here. This means that the auditor needs to keep careful watch over the clock to avoid wasting time.
Audit preparation plays an essential role here as well. Gathering similar information in advance will help to identify the most critical parts of the audit.
What documents are involved in the preparation of an audit?
Every audit should include as much documentation as possible, including workflows, lists of SOPs, lists of certificates, and more.
What happens when an auditee does not want to share the requested evidence?
In these situations, the auditor should reformulate the question to emphasize the importance of their request. This may result in the auditee changing their mind. If the auditee is still reluctant to share, the auditor should clarify the criticality of their request.
The requested information may be confidential. In this case, the auditor will record the lack of evidence (including the stated reason for the lack of evidence) as an observation. The auditee can then address it later in their CAPA plan.
What should you do if the auditee does not accept an observation from the audit?
It’s important for the auditor to make their point clear and address why they are concerned about the observation. Citing the applicable guideline can help here as well. Here again, the auditee can address their approach later in their CAPA plan.
If the auditee is being rude or uncooperative, the auditor can share this feedback in the report as well.
Do you recommend the use of checklists and data collection during the audit?
In general, checklists can be used as a tool to remember what is most important during an audit. They aren’t necessary per se, but they can be useful in this regard. That said, while it is fine to follow checklists, auditors should not rely on them. This is because auditors need to keep their eyes open and prioritize their actual observations.
