Conducting an Audit
It is essential that before the audit, a lead auditor is chosen, who will be responsible for organizing the audit and collating
the observations raised. Also, the lead auditor usually is the most appropriate person to be the primary author of the audit
report.
The Introductory Meeting
An introductory meeting is an essential and useful part of the audit because it gives the audit team an overview of the company
and facility that are being audited. This meeting will set the tone of the audit, so it is essential that this meeting be
given its due importance and not be seen as something to be endured before the "real" audit. There is often important and
useful information to be gleaned from this initial meeting of the respective parties.
The Facility Tour
During the facility tour, the audit team can get an early impression of the strengths and weaknesses of the company's procedures
and its commitment to quality. It is critical that the audit team listen carefully to what the staff ask and have to say,
and also to take the time to observe the condition and status of rooms and equipment, as this is often an indicator of the
status of the relevant systems in place at the facility.
The facility tour is sets the scene for the rest of the audit and its value should not be underestimated.
Conducting the Audit
As mentioned earlier, the audit team should comprise members with complementing areas of expertise, and following the facility
tour, they may split their focus to match their areas of expertise as well as to follow up on any observations identified
during the tour.
It is the responsibility of the lead auditor to manage the audit so that where possible, the majority, if not all, of the
critical items on the audit agenda are covered. However, if a critical or significant observation is noted, this should be
followed up, even if it is to the detriment of completing an inspection of all items on the original agenda.
It is inevitable that most auditors will at some point in their career find that their observations place them in a position
of conflict with an auditee. These situations must be managed carefully, and it is important for the auditor to take into
consideration any regional (e.g., EU versus US) differences in expectations, as well as the company policies of the auditee.
It is always beneficial to resolve any conflict by discussion. The use of factual examples for demonstrating an auditor's
points of view are often key to defusing any potential conflict.
Another key point is to ensure that every observation is clearly raised during the audit. This allows the auditee time to
investigate the issue and provide additional data, and may mitigate the impact of the observation or in many instances close
out the issue before the audit is complete.
Close-out Meeting
Before the final close-out meeting, the auditing team should meet in private and agree on the following content of the feedback:
- the categorization of the observations; normally based on guidelines from the EMEA, MHRA, or FDA, as well as internal company
policy;
- the content of the observations; these should all have been communicated to the auditees during the audit;
- the format for the feedback; the lead auditor or each individual auditor may provide feedback on the observations they raised
during the audit.
It is recommended that the close-out meeting begin with any positive observations noted during the conduct of the audit. All
observations should be clearly expressed and the response of the host taken into consideration. This is essential because
the close-out meeting will often include senior members of the CMO who have not been involved in the actual audit process.
This also is the time to be clear about expected timelines for responses related to any critical observations and the complete
response to the audit report once it has been received by the CMO.
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