by Steve Gompertz, QRx Partners
Performing audits is great way to increase your understanding of quality management system requirements and their intents, especially since most people never get to participate in every part of the QMS. And the more years of experience you gain, the opportunities for you to become a consultant or contract auditor. It can be a great career opportunity and a way to ensure you stay current on the regulations and standards.
Most companies, and most certainly their quality leaders, welcome robust audits that help them identify where they can make their QMS more suitable, adequate, effective, and, yes, efficient. And of course, there’s the benefit of finding these opportunities before an external audit does. However, even those in quality leadership positions are not immune to the pressures of corporate politics, and sadly, self-preservation. Luckily, this isn’t common, but if you perform audits long enough, you will eventually find yourself defending your audit report.
The calm before the storm
Recently, the Quality Director for a potential new client wanted us to take over their internal auditing due to a lack of resources and made it clear that they wanted robust and detailed auditing. We were clear that this wouldn’t be a problem. A few weeks later, an audit was performed at two of their sites where one was doing everything correctly and the other was doing a lot of things wrong. It was what might be described as a “target-rich” environment. The Quality Director was not present during the audit, but the site Quality Managers and Engineers were, and were very transparent throughout the audit. They verbally agreed with everything observed. They almost seemed happy about everything found and there was no pushback during the closing meeting.
Reality sets in
It was several weeks before the Quality Director reviewed the audit report and asked for a follow-up meeting via Zoom. As the meeting started it was immediately clear that something was amiss. Only the Quality Director was speaking and disappointment about the audit report was made clear. There were comments about lack of detail, insufficient references to records inspected, and more opinion than fact. Having been a certified auditor for over 15 years, these comments were definitely a surprise. I’ve certainly had my share of debate over minor versus major and interpretation of cited requirements, but never implication that the audit was performed poorly. The catch was that I had no idea where any of this was reflected in my audit report. The report contained narrative of what was reviewed, who I spoke with, what records were reviewed, what requirements were not being met, and many Opportunities for Improvement (OFIs). So I asked for examples of where the report failed to provide the required information or where I may have misunderstood the information being provided so that I could make corrections or additions. The response was that the intent of the meeting wasn't to ask for the auditor to change the report.
So now what?
I offered again to make sure the report met their needs, but I needed to know where it specifically wasn’t meeting them. I received the same response, along with a request to sign the report and send it to them. Since we normally e-sign audit reports so that both parties have a fully executed document, I understood this to mean that they were not going to sign the report. I signed the report and closed out the audit.
Reading between the lines
As I reflected on all of this, a few thoughts occurred to me. During the audit, those present more than just agreed with the observations, they often seemed already aware of them and gave a sense that it has been a challenge to address them. Many of those with responsibility for quality management, while competent, were not very experienced and had little positional authority. And, the site that was doing things correctly happened to be the same site where the Quality Director’s office was located. I suspect that my report may have actually been much more robust and detailed than those produced by their less experienced internal audit resources, and likely much less biased. As a result, I was likely shining a bright light on obvious and known nonconformances that were not being addressed, and that the report was going to be an embarrassment for a Quality Director who may not have been as engaged as they needed to be.
Lessons learned
Auditing is not easy. If you’re internal to the organization being audited, you may have to overcome unintentional bias due to familiarity. If you’re external, you may not have enough time to fully understand what you're auditing, and you will definitely not be aware of any internal politics, hidden agendas, or cultural challenges. But you must do your best to mitigate all of these potential landmines. Auditing is more than having the regulations and standards memorized, being an eagle-eyed observer, and being aware of best practices. Remember that you’re auditing a management system where management responsibility is part of the foundation. Understanding how the dynamics of managing a business may play a role in decision-making, risk tolerance, and priorities, can help you foresee the landmines.
Besides reading the Quality Manual and previewing applicable procedures, be sure to research the company and its leadership. Is the company growing or shrinking? Both are distractions. What kind of experience does each leader bring to their current role? What was going on with companies they previously worked for? As in all things, good preparation is critical. But, during the audit, how you ask questions can also help uncover important deep dark secrets. In addition to asking about how work is performed and what records are being produced, are you asking how decisions get made? Are you asking questions only within the context of what is being observed in the moment, or expanding them to identify other scenarios that may be applicable?
Effective auditors have broad experience, deep technical knowledge, exceptional “soft” skills, and understanding of how organizations work at every level. If you need to strengthen your internal auditing, and welcome a little tough love (constructive criticism), QRx Partners is ready to help by contacting us at Contact@QRxPartners.com or 833-779-7278.