Get those flashlights and notepads ready! In order to understand how to properly perform the audit, we are going to need to examine appropriate audit behavior, record keeping, and examination techniques.
As part of the scheduling process we discussed in our previous episode, all of the people involved in the internal audit need to be aware that the audit is happening in advance.
Communication about the upcoming audit should include a reminder for everyone involved to gather relevant information and prepare employees in order to help complete the audit efficiently.
At this stage in performing the audit, it is most important that management or leadership involved takes the internal audit seriously, and does everything in their power to demonstrate their intention to cooperate and fully participate in the process.
The auditor, who is the person or team performing the audit, along with the auditee, who is the person or group being audited, should understand what is being audited and what time period of records is under review. This is called the scope of the audit.
Where the internal audit has been properly communicated in advance, an unexpected absence of an employee from that area should not result in postponing the audit.
If a person calls off or leaves suddenly during the audit, the focus of the audit should shift to an assessment of the preparedness of the department in that person’s absence.
Sticking to the audit checklist or list of questions is important to having an effective and efficient audit. Depending on who is performing the audit, who is being audited and the circumstances of the area of operations at the time of audit, an audit could be friendly, contentious, argumentative or all of the above!
A good way to think of the internal audit is a master verification action. What this means is that the internal audit is a facility’s chance to review all of the monitoring actions that are supposed to be performed as part of the safety or quality program. To do so, the auditor or audit team needs to ask the person or group being audited for the appropriate records and written information appropriate to the audit.
With our audit checklist or prepared questions, we need to document if the area under audit either conforms or does not conform to organizational requirements. Where ever we find a non-conforming response we need to fully document so that we can determine a corrective action after the audit has concluded.
One of the most common concerns for people new to performing an internal audit is how to properly look for issues during the audit. When an audit is on the right track, the major issues have a way of jumping out and making themselves obvious. Whether we find every error or non-conformance is not the ultimate point of an internal audit, and does not need to be the measure of a successful audit. Instead, evaluating the completeness of understanding of the system, as well as gauging the readiness of the auditees to provide documented evidence of the system is the end goal.
As an internal auditor, it is important to remember to ask questions and leave plenty of time for the person to respond, no matter how awkward the silence may be. It is equally important not to answer for the auditee and not to minimize difficulty or conflict where an issue is discovered. Just stay calm and respectful, remain insistent on the information required to address the audit subject and properly document the interaction.
The last thing to remember is , auditing co-workers whom we have a close relationship with is best to avoid wherever possible. Internal auditing is not meant to be a contentious or difficult process by any means. However, personal relationships with co-workers can very easily compromise our ability to remain focused and objective and can result in a poorly performed audit, or section of an audit.
In our next episode, we’ll look at corrective actions and preventive actions resulting from a successful internal audit, and how these CAPA actions are used in the larger organizational review of the quality or safety management system.
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