Techniques for conducting quality audits
Article by Tim Sandle
Auditors should be direct and avoid asking questions to purposely try and stump the auditee. In addition, auditors should be instructive, explaining why they are requesting the information. Furthermore, auditors should be friendly and act in partnership with those being audited. Other positive behaviours include being attentive and proactive. Where this does not happen, audits may fail to achieve objectives set forth, raising concerns among auditees and clients alike. This article considers some techniques and pointers for planning audits and techniques that can be used when conducting audits.
During an audit, the auditor needs to collect evidence that confirms that the information produced by the management is accurate. It is not possible for an auditor to examine and physically verify everything within the pharmaceutical or healthcare facility; instead, a snapshot needs to be taken in order to gain sufficient audit evidence. Audit evidence includes written and electronic information that permits the auditor to reach conclusions through reasoning, and this rests on the appropriateness of the sample taken. How representative the snapshot is can be enhanced through the application of different techniques. The audit cannot run on indefinitely and so the auditor will need to maximise the time available. Hence, time will always be the enemy during an audit. Any activity which makes the audit more efficient or can save time is worth pursuing, and good questioning technique forms part of this. There are different techniques and methodologies aimed at auditing, some of which will be more suitable to different situations than others. This article considers some of the different auditing models that can be applied.
Interviews are a key part of the audit process. They are an important way of obtaining and confirming information and facts about the way systems and controls are being operated. At the same time, they represent an opportunity to create and maintain good relations between the auditors and the clients, and to impress the client with the professionalism of the audit. There is no ‘best’ method of interviewing. The approach depends on the person being interviewed, the nature of the audit, the type of information needed and the time available. There are two types of interview – directive and non-directive.To read more of this article subscribe to the GMP Journal and request a complimentary back copy of Vol 19 No. 4