Potential problems during Audit

In our series regarding various auditing techniques, we have touched upon many topics namely qualities of an Auditor, time management during audit, conflict management during audit, interviewing techniques and various types of communications during audit etc. In the present article, we shall be discussing about the potential problems that may arise during the conduct of an audit. Experience, knowledge and training may help an auditor to alleviate nervousness of an auditee as well as himself.

Potential problems:

• Communication: One of the root causes of major problems happen around us is miscommunication, lack of communication or at times no communication at all. During an audit any type of communication issues may have grave consequences. Hence, necessary steps shall be taken to overcome the communication issues. The effects of miscommunication can be minimized by relying on the escort to correct misunderstandings. Wherever necessary other means and documents can be referred and relied upon for corroborating all information.

• Lack of knowledge: An auditor can never be master of all the activities and processes being performed in the plant. An auditor with hands on experience in production of drug products can never be a master of testing drug products and vice versa. Hence, an auditor who does not have a good grasp of the process being audited may not ask the right questions and may realize only after completing the interview that important issues were not addressed. To recover from such an oversight, the auditor may revisit the area or raise the issue at the daily meeting for necessary action. To ensure that the right questions are asked during the interview, an auditor could end the interview by asking if the person is responsible for any other activities or ask for his or her opinion on how well the process is performing.

• Handling the delay tactics: Another problem that auditors should be able to recognize and overcome is delay tactics, hence, time management during audit is very important. Various type of delay tactics are:

1. 1. Having lunch at far off restaurants
   2. Delay in providing documents and information sought
   3. Beating round the bush: Sometimes the auditee do not intend to give a definite answer and hence keep on narrating the incidents or keep on citing the examples which are not directly linked to the information sought.

Any repeated attempts by the auditee for time wastage that may hinders the progress of an audit and threatens to severely compromise the audit schedule shall be immediately notified to the auditee management.

 

• Steering the auditor: An auditee may attempt to steer the auditor toward specific interviewees or areas. At times the auditees tend to introduce irrelevant information during the interview. They do so in a manner such that the information may be related but is not pertinent to the topic. The end result of this the wastage of time and not getting the relevant information. The auditor must bring the auditee back to the topic of interest without alienating the interviewee. This may be done by reminding the auditee that there is a limited amount of time for the interview and that the audit plan may be adjusted if necessary. Other methods are to ask for specific evidence in the manner in which the process or operation is performed, or show the person the checklist question that you are seeking to verify.

• Getting the right person interviewed: At times the auditor wishes to interview the actual doer of the process. In case the auditee management insists that the particular person is unavailable or is busy in work then the auditor shall be considerate but persistent if the interview is vital to the success of the audit. Without being intimidating, the auditor can suggest that the person’s unavailability may prolong the audit. A statement such as “I may have to stay over for another shift” may gain the auditor the desired cooperation.

• Answering for the auditee: It is often observed that the senior management or area supervisor or the escorts accompanying the auditor starts answering for the interviewee. There mere presence sometimes intimidates the interviewee or auditee. Ideally, the escort is responsibility is of an observer only and he should refrain himself from disrupting unless there are communication problems. An ideal arrangement is for an auditor to sit or stand between the interviewee and the escort, facing the interviewee. An auditor can minimize an escort’s participation in the interview by directing questions to and maintaining eye contact with the interviewee. If an escort starts to answer for an auditee, the auditor needs to redirect the question to the interviewee, avoiding eye contact with the escort. If an escort continues to interfere, the auditor should say, “I prefer to get the information from the staff member.”

• Delay in Response: During an audit the auditor sometimes face challenge w.r.t. getting the information in timely manner. However, depending on the auditee’s state of mind, the response may get delayed. The reason for delayed response may be both positive and negative. The positive reason may be the fact that the auditee might be busy in performing his daily activity and any delay in performing the same may hamper the overall process. The negative reason may be the “intention to hide” or the “feeling of intimidation.” Often, people fear to inform the auditor that they are busy and will join them later. An experienced auditor will sense when an interviewee is preoccupied and will find other ways to keep the audit moving. Other times it is appropriate to go ahead and ask to see the interviewee perform the work if the auditor needs to observe it anyway. All such issues may be avoided by stating that the audit team will complete the audit within the allotted time but will remain on-site as long as necessary to complete the audit objective. However, the audit team leader and the audit team members should communicate any potential problems so that they may be resolved quickly and the audit team leader can avoid having to extend the audit.

Reference: ISO19011:2018