We often perform audits and wonder why, when they’re complete, they didn’t go very well. This article will offer insight on how to better anticipate and solve the common problems that all auditors face. This is going to take some personal work on the readers’ part. My hope is that after reading this article, you can apply these insights to your auditing practices to make you a better auditor and ultimately get more out of the audit process.
There are a multitude of issues and problems auditors will encounter during auditing that must be addressed individually. As we cannot discuss every one of them, I have highlighted common problems that auditors experience. Throughout my auditing career, I have had the opportunity to observe different auditing styles, from Food and Drug Administration (FDA) inspectors to third-party auditors for International Organization for Standardization (ISO) certifications. Many of the problems I’ve observed boil down to the following four causes:
Of course, this isn’t a complete list; you may already be thinking of other issues that you’ve encountered. The remainder of the article will discuss the listed problems, the resulting struggles for auditors, and some solutions on how to deal with them constructively.
When starting an audit, the first question we ask ourselves is, “Why are we doing this?” We may be performing the audit for compliance reasons, financial reasons, or because a procedure tells us that we must. All of these are good reasons, though we must understand that conducting audits is a business tool that improves our quality system. How do we then convey to management, the CEO, or the board of directors that audits are an essential part of business processes and not something to resent and neglect?
According to ISO 19011, the executive management team is required to set the audit criteria and support the audit program. How many of your executive managers have read ISO 19011? Probably not many. Our obligation as audit program managers is to explain this to them and help them understand the reasons for performing internal audits, supplier audits, or other quality audits.
Still, we often struggle with knowing that our management team relies on us to tell them what needs to be done. With some time, encouragement, and understanding, individual companies may change this aspect. To gain management support, we auditors must help managers understand that auditing is an important process that can help them. Below are some ways to help encourage executive managers to support the audit program:
Communication is key. We often perceive internal audits or supplier audits as just part of our job, but we need to understand that they play a much larger role. If we can communicate to upper management that audits lower the regulatory risk, help improve processes, find waste, and ultimately save the company money, they start to pay attention. This communication occurs in the form of audit reports. How can we make these audit reports stand out? Try to associate a cost to the observations on the report or to a specific regulatory risk. During reviews of audit findings in monthly or semiannual management meetings, take the opportunity to re-emphasize management’s role in the audit process.
When the audit schedule is published in the beginning of each new year, we auditors often promise ourselves that this year’s audits will be different and better. Then the first scheduled audit comes around and we realize that the audit has to be performed tomorrow. What happened to our good intentions? This is something that even I have experienced and see often with auditors: too little audit prep time. When we’re slammed to get an audit ready, we must take the procedure(s) home and stay up all night writing a checklist and audit questions. External audits are typically easier to prepare, as we have to make travel arrangements and don’t have immediate access to the auditee’s procedures.
Audit preparation is the most crucial part of an audit program. So how do we make sure that we are prepared for our audits? It all boils down to time. This is something we never seem to have enough of, especially when it comes to any type of planning. There needs to be a schedule and time allotted for conducting audit preparation. A week before the audit is to be performed, schedule time for an hour on Monday morning to prepare for the audit. Audits that are performed haphazardly are the result of no preparation, planning, or process review.
Auditees will know that proper planning wasn’t completed when you read their procedures during interviews or ask irrelevant questions. The worst that can happen is the auditor goes off on tangents outside of the audit scope. Proper audit preparation allows you to generate checklists, a list of questions, and review the procedure(s) prior to starting the audit. The first time auditing a process is generally the most difficult, as there are no checklists and its procedures must be read carefully. Below are some additional ways to assist you in properly preparing for an audit:
To get the most out of any audit, you must successfully interact with the owner of the process while reviewing his or her processes, procedures, and records. In some instances, you may encounter auditees who exhibit difficult behaviors. These can be anything from auditing a person who is “too busy” for the audit, to someone that doesn’t care about it, to someone that’s aggressive because you’re interrupting his or her schedule.
In my experience, the most difficult auditees are those who just don’t care about the audit. They answer questions with a disinterested or nonchalant “Yes” or “No,” revealing nothing insightful about the process. Audits are supposed to be preventive actions to help organizations find nonconformities and areas for improvement. If the auditees are challenging the auditor at each question or are disinterested in the process, there is no benefit to conducting the audit. There are many ways you can manage difficult auditees:
As an auditor, it may seem as though you have to receive training by the Federal Bureau of Investigation. However, you should obtain training in communication skills, dealing with difficult people, and interview techniques.
If an auditee is being negative or overly aggressive with you, stop the audit and notify the audit program manager, the auditee’s supervisor, or the company president. There is no benefit from an audit process when the situation is confrontational. Take a class from the local university or a seminar on communication skills. I have found these classes invaluable in understanding how to diffuse difficult situations, understanding nonverbal communications, and even cultural differences in worldwide business applications. There are also interview techniques that you can learn that will help you gain valuable information from the audit. For example, starting off a sentence with “Do …” almost always leads to a yes or no answer. As discussed previously, properly preparing for an audit lets you generate questions on your checklist that begin with “How do you…,” “Tell me…,” or “What does this…” An auditor must literally become an expert in communication skills to ensure that his or her interviewing techniques can overcome difficult situations.
Audit reports are often one of the least-liked aspects of an auditor’s job. Audit reports take more time to complete than was planned for, which usually results in them being published later than expected. A common expectation is that audit reports are formally published no more than a week after the audit has been performed. This may be easier for organizations that include their audit checklists in the audit report. However, for frequent supplier audits or external audits, there is an expectation of a formal report, not just a checklist. The audit report must be generated to clearly communicate audit findings to managers so they can make appropriate decisions. Following are some techniques to assist in publishing an audit report in a timely manner:
Many auditors struggle with problems they encounter during the audit process without understanding how to deal with them. Hopefully this article provided some solutions and insight into ways that you can make your auditing process more productive, less stressful, and more beneficial. The key is knowing that the audit process is designed to help the organization find issues or nonconformities before someone else does or before they become major issues. These problems or issues could result in regulatory action by an outside agency or cost the company thousands (or millions) of dollars in wasted expense. An issue not found during an audit of a company may even result in costly recalls.
An auditor can work through getting management support, preparing for an audit, dealing with difficult auditees, and properly reporting the audit results in a much more proficient audit process.
About the author
Richard A. Vincins is a Certified Quality Auditor and regulatory affairs consultant with Emergo Group. He is responsible for the implementation of quality systems, conducting internal audits, training on quality system tools, and providing regulatory expertise in national and international regulations. Vincins has more than 19 years of experience in the medical device industry, including worldwide regulatory compliance efforts for in vitro device, medical device, and pharmaceutical companies.