Traditionally within pharmaceutical auditing, there has been much focus on technical skills and a good understanding of regulatory expectations, with numerous courses designed to increase competence in these areas. Whilst this is clearly vital to deliver an effective assessment of GxP compliance, the actual behaviours displayed by the auditor are frequently an undervalued element of this process.
The constant challenge for auditors is to use appropriate interpersonal skills throughout the audit cycle from preparation through to reporting and CAPA agreement, irrespective of familiarity with the auditee/site, language/cultural differences and potential defensive mindsets deployed by auditee personnel. The latter can sometimes create barriers to even an experienced auditor due to employee fear, and the implications of a blame culture on employment and sanctions for the company. The power of silence can be a tool for a skilled auditor in certain circumstances, but may also be used by auditee personnel to deny information.
Auditor competence is a blend of experience, flexibility and resilience. The objective is always to provide an audit outcome that meets the predefined objectives, identifies system errors, relates deficiencies to patient and compliance risk, leads to effective preventive and corrective actions and finally leaves a good document trail for the next auditor.
Fronters during interviews may perceive the auditor as police, judge, spy, reporter, mentor/coach or partner, and as a consequence the skilled auditor will need to read these positive and negative signals and adapt their behaviour accordingly. This approach is key from the very first stage of an audit, when the auditor will be in contact with an organisation to agree timescales, information requests, finalise agendas and local arrangements, and generally prepare for the actual fieldwork. During the current pandemic, most audits have been remote or desktop. However, ensuring that requests are handled in a polite, structured and professional manner is equally important here.
The following behaviours can be considered as essential elements in working through the audit process:
The ability to logically review a system, data or documentation in a timely manner, then challenge discrepancies, gaps and inconsistencies by asking precise questions. Remind yourself of the key stages – observe/ask/listen/verify/record – before concluding any topic. Be sufficiently confident outside your ‘comfort’ zone to provide a comprehensive assessment of risk.
Adapting to the situation and being prepared to drill down into a particular topic where you feel that there is a potentially greater or underlying risk. Whilst being mindful of the agenda and possibly limited time allocated on site, modify your approach so that the auditee responds quickly to more detailed requests for additional information. This might include being less predictable and adopting a ‘show me’ rather than ‘tell me’ behaviour.
This behaviour ensures that the auditor effectively leads the audit process, but also that they can handle adverse reactions and criticism if this occurs. There may be strong push back from middle and senior management at any stage, and the ability to have an evidence based, concise conclusion that can be presented in an objective and persuasive manner will increase the success rate. If a critical finding is identified, then being articulate and escalating in a timely and assertive manner to senior management is important. Overcoming a common auditee response in these situations (disbelief, denigration and/or dismissal) by reaching a collaborative agreement on the next steps will again demonstrate a positive behaviour.
Auditors will always need to be sensitive to the culture (country and site) and the involvement and interactions with all employees met during the fieldwork. Awareness of the importance of hierarchy, reporting lines, site ownership, personnel changes, recent regulatory inspection history and so on can greatly benefit the auditor where they may be unfamiliar with the organisation. Often a discrete word with the host will provide some useful insights into the above and avoid any embarrassing moments during the course of the audit.
Audits can be very stressful for organisations and their employees. Putting employees in front of you at ease by exhibiting some positive behaviours such as eye contact, open body language, politeness and gratitude as necessary will be seen by those encountered as genuine. A series of open questions followed by a closed question generally assists in reaching a conclusion on any given topic, and a clear summary to those present will avoid misunderstandings and surprises. In addition, active listening demonstrates that the salient points are being noted by the auditor, so that in any closing presentation (or informal feedback) the auditor can provide helpful feedback to the organisation. Remember the mantra ‘seek first to understand then to be understood’
A skilled auditor needs to be honest in both his feelings and his line of questioning. If the explanation is confusing or contradictory, then tell the auditee! Focussing on a challenging and complex topic which is outside your normal area of expertise requires resilience and concentration, particularly if you are unwell, jet-lagged or nearing the end of the fieldwork. However, the auditee will make allowances, adjust the agenda, bring some additional staff and/or data into the interview process if you are honest about having difficulty in reaching a fair and accurate conclusion.
Roger Smith, Consultant and Auditor
Roger Smith has more than 40 years of experience in pharmaceutical manufacturing and supply, with responsibilities in quality, production and technical support. After an extensive career working in a number of multinationals, over the last 5 years Roger has acted as an independent pharmaceutical quality consultant, offering QP services, inspection preparation, auditing and QMS/QRM support. He is a graduate chemist and has a Diploma in Management Studies.