Interviews during audits are critical components of the auditing process. Whether you're auditing a pharmaceutical company, a manufacturing facility, or any other regulated industry, the goal of the interview is to gather information, understand processes, and assess compliance. Conducting interviews efficiently ensures that you get accurate insights, helps in identifying potential risks, and supports overall audit findings.
In this blog article, we will discuss how to interview effectively during audits, emphasising key strategies that will help auditors ask the right questions, manage the interview process, and ensure productive outcomes.
1. Preparation: Know What You Need to Learn
Before you step into an interview, preparation is key. Understanding the scope of the audit and identifying the key objectives will guide the questions you need to ask.
- Review Audit Scope and Objectives: The first step is to review the audit scope and objectives. Understand what areas are being audited and what you're aiming to achieve in each interview. For example, are you focusing on compliance with specific regulations, evaluating process efficiency, or investigating potential safety concerns?
- Study Relevant Documents: Familiarise yourself with documents that may help in your interview, such as SOPs (Standard Operating Procedures), previous audit reports, regulatory guidelines, or training records. Having a solid understanding of these documents will help you ask relevant questions and verify the answers you receive.
- Identify Key Personnel: Determine who the relevant stakeholders and subject matter experts (SMEs) are. These could be individuals in charge of specific processes, quality control, maintenance, or safety protocols. Knowing who to interview based on your audit objectives will make the process smoother.
2. Build Rapport and Create a Comfortable Environment
Interviews, like any conversation, should be built on trust and rapport. If interviewees feel at ease, they are more likely to provide honest, insightful answers.
- Start with Small Talk: Before diving into the audit questions, begin the interview with some casual conversation to build rapport. Ask about their role, how long they’ve been with the company, or any other neutral topic to establish a comfortable atmosphere. This can help break the ice and ease nerves.
- Set a Collaborative Tone: Make it clear that the interview is not an interrogation but rather a collaboration aimed at gathering information to improve processes or ensure compliance. For example, you could say, “My goal today is to understand how this process works and identify areas for improvement. Please feel free to share any challenges or suggestions you have.”
- Ensure a Non-Threatening Approach: Auditees may feel nervous or defensive during audits, especially if they anticipate that problems may be uncovered. To combat this, emphasise that your role is to assess processes, not to blame or criticise individuals. Maintain a neutral tone and ensure that the interview feels like an opportunity for open discussion.
3. Ask Open-Ended Questions
The key to gathering valuable insights during an audit interview is to ask the right type of questions. Open-ended questions allow for more comprehensive answers and can reveal deeper insights into processes and issues.
- Use the "Who, What, When, Where, How" Framework: Begin with open-ended questions that encourage the interviewee to explain their responses in detail. For instance:
- "What steps do you take to ensure compliance with GMP?"
- "How do you handle deviations or issues that arise during production?"
- "Can you walk me through the process of documentation verification?"
- Avoid Yes/No Questions: Closed-ended questions can limit the responses you receive and may not provide enough depth. Instead, encourage the interviewee to explain their reasoning or provide examples to support their answers.
- Follow Up for Clarification: If an interviewee’s response seems vague or incomplete, ask follow-up questions to probe deeper into the issue. For example, “Can you explain that in more detail?” or “Could you walk me through the steps you took in that situation?”
4. Listen Actively and Be Attentive
Effective listening is just as important as asking the right questions. An auditor should be fully engaged in the interview process, actively listening for clues, inconsistencies, or areas that need further exploration.
- Focus on the Interviewee: Avoid distractions during the interview, such as checking your phone or multitasking. Pay full attention to the person you are interviewing and maintain eye contact to show you’re listening.
- Take Detailed Notes: Document responses accurately, and note any follow-up questions that arise during the conversation. Your notes will help ensure that you don’t miss any important information and will be critical when preparing your audit report.
- Observe Non-Verbal Cues: Sometimes what’s not said is just as important as what is said. Pay attention to body language, tone of voice, and facial expressions. These non-verbal cues can provide valuable context and help you gauge the sincerity or confidence of the interviewee’s responses.
5. Stay Neutral and Avoid Leading Questions
- Your questions mustn’t inadvertently lead the interviewee toward a specific answer. Leading questions can bias the response and affect the credibility of your findings.
- Be Neutral in Your Questioning: Rather than asking, “Why did you overlook this mistake?” which implies blame, ask, “Can you explain the process that was followed when this issue occurred?” This allows the interviewee to provide an unbiased account of the situation.
- Avoid Making Assumptions: Do not assume you know the answer to a question before the interview. Ask questions that allow the interviewee to explain their perspective, and avoid guiding the conversation toward a particular conclusion.
6. Stay Calm and Handle Resistance Professionally
During some audits, you may encounter resistance or defensiveness from the interviewee, especially if they feel uncomfortable with the audit or are aware of potential non-compliance issues. Handling resistance in a professional, calm manner is crucial for a productive interview.
- Acknowledge Their Concerns: If an interviewee becomes defensive, acknowledge their concerns respectfully. For example, you might say, “I understand that audits can be stressful, but my goal is to gather information so we can ensure that everything is operating smoothly.”
- Maintain Objectivity: Stay objective and avoid getting emotionally involved in the conversation. If you feel tension rising, take a brief pause to allow both parties to regroup.
- Redirect the Conversation: If the interviewee tries to avoid or deflect certain questions, politely steer the conversation back to the topic at hand. For example, “I understand this is a complex issue, but we need to understand how the process is managed to ensure compliance.”
7. Summarise and Confirm Key Points
As the interview draws to a close, summarise the key points that were discussed to ensure you’ve captured the correct information.
- Confirm Understanding: Ask the interviewee if your summary aligns with their understanding of the processes. For example, you could say, “Just to confirm, the process you’ve described involves X, Y, and Z, and these are the key controls in place. Is that correct?”
- Clarify Any Ambiguities: If you still have uncertainties or if you feel that some answers were unclear, ask for clarification before wrapping up the interview.
8. Maintain Professionalism and Confidentiality
Lastly, always maintain a high level of professionalism and ensure that confidentiality is respected throughout the interview process.
- Confidentiality: Assure the interviewee that their responses will be treated with confidentiality and that the purpose of the audit is to identify opportunities for improvement, not to place blame.
- Professional Conduct: Stay respectful and courteous, even in the face of difficult situations or responses. Your professionalism will help you maintain the integrity of the audit and build trust with the interviewees.
Conclusion
Effective interviewing is a critical skill for auditors. By preparing thoroughly, asking open-ended questions, listening attentively, staying neutral, and handling resistance professionally, auditors can gain valuable insights during interviews that will shape their audit findings. Remember, the goal of the interview is not only to assess compliance but also to foster a collaborative environment where open communication can help drive improvement.
By following these best practices, you’ll be better equipped to gather the information you need, ensure audit success, and contribute to the overall improvement of the processes being audited.
Published on May 28, 2025 by Mustafa Edik