Flame On

Today has been a trying day.

I have performed two formal Quality Audits for the company and the brand new, built from scratch Quality System. The first, performed over a month ago, was specifically geared towards one department. That department fought, a little, but ultimately agreed with my decisions and Corrective Actions.

The second has been ongoing since January 18th. This one covered every department, including the CEO. When I audited each department, I got a good deal of pushback, which I redirected on an individual level to impress upon each department manager that they were not above reproach or beyond the reach and application of the Quality System.

The CEO took his audit very well. During the audit he communicated that he agreed with the Corrective Action that I would be recommending for him personally. He also agreed with the concept of issuing Corrective Actions to others who have failed to follow the process. He insisted that all Department Managers be a part of the Audit Report Out meeting. I, of course, agreed. It is how I run a closing meeting anyway.

Today was that meeting. Today was me in a room with one Manager, four Directors, and the CEO. Today was a six on one free for all.

It started simply enough. I explained the scope of the Audit and clarified my intention and purpose with the Corrective Actions prior to handing out the audit reports. I explained that I was going to issue departmental Corrective and Preventive Actions (CAPAs) for several specific reasons. 1. Not all departments have problems. 2. I feel it is terribly important that we each learn from this experience the importance of being accountable as Managers and the responsibility to follow procedures. 3. I believe that we can address the problems with this Audit effectively by reviewing the contributing factors and owning up to our own deficiencies to correct not only the problems found this time, but to stem the flow of problems that will reach far beyond this incident if we do not learn how to follow procedures.

As I began to go over the CAPAs, which, by the way, each Department head not only knew would be coming, but I had explained what they would say in the audits, I was interrupted by the CEO. He exclaimed, with some distress, that he was not aware of one of the situations of his CAPA. I briefly explained that we had spoken about it during the audit in generalized terms, but that the CAPA itself will always be specifically detailed.

One of the Directors complained that there “had to be a better way” to correct problems without “issuing a CAPA to every little thing.”

“That is not the scenario here.” I explained. “I am only issuing CAPAs to system wide, recurring issues that have been proven to be noncompliant. CAPAs are the best way to formally document our recognition of a problem and our resulting response to it.”

I then went over the other three departmental CAPAs that were to be issued with only minimal interruption. When I got to the recommendations for future action, I was interrupted again by the CEO. He began to explain, in no small detail, the problem with the Quality System, the currently in place procedures, and the lack of efficiency afforded by both. I parried in turn, as I have seen these things deteriorate, and explained that one of the benefits of a Quality System and, in turn, an Internal Audit program is finding gaps and problems, bringing them to a public forum, and resolving them.

His response? It bothers him that we have not resolved these issues prior to the audit and he is now greatly concerned that the Quality System is lacking knowledge of other great problems that should already be resolved.

I tried a different tact. In setting up a Quality System, I explained, there are always going to be instances where you can’t see the forest for the trees. It is these particular issues that are meant to be discovered and resolved with the feedback loops of a Quality System. More specifically, using an analytical approach to reviewing the whole system from the perspective of the regulations and standards as well as internal procedures.

You know what he said? “I have so much to teach you.”

Oh no. That was the line.

You know that moment in Aliens when Ripley is backing out of the incubator egg room and one of the eggs starts to hatch? You know that look she gives the Queen? That little tilt of the head that says “Okay, I was going to leave here on equivalent terms and you were going to keep your spawn and I was going to take Newt off this planet, but now look what you’ve done. Now I have to kill you.”

Flame on.

That is the look that I gave him.

My civility, professionality, and fierce belief in the benefits and applications of a Quality System rose to a critical mass.

I interrupted him. This is not something that I do as it is rude, belittling, improper, and I was raised better than that. But I did it anyway.

“First off, that would be where you and I disagree. I do not believe, as you do, that this process, this Audit, is a “gotcha” way of me finding you out and taking this opportunity to scold the Managers for not following the process. This is not an indication of a greater flaw with the Quality System since issues were found during the audit. Quite the opposite. The fact that the Audit Program is running so smoothly as being able to identify some of these issues so that we have the opportunity of addressing them before the FDA or a Registrar comes through our door is proof that the system and its associated feedback loops are working appropriately. Besides that, this is not finding out “at the last minute,” as you put it, but rather allowing our system to point out the areas for continual improvement. “At the last minute” would be finding out what your problems are when the FDA comes in. That being the case I am also not going to back down in issuing these Corrective Actions because I believe that it is imperative that all of you take away from this meeting the importance and necessity of following procedures and of asking questions when you do not understand something. Just ask. There are plenty of people who are following these processes right now that could help you to understand your own discrepancies. That is my job. My job is to perform these audits and decide where CAPAs need to go and in so doing allow for process improvement. If the FDA comes in here and sees consistent problems with this process that were never addressed with a Corrective Action, they look to me and say ‘Tell us why, Auditor, when you were in a room surrounded by Executive Management, did you back down and not issue CAPAs where the system was failing?’ And so I won’t back down, and four of you are leaving with CAPAs. But let me say one other thing. When that Auditor does come in, I am in that room with them. I am your first line of defense. I am the one who talks them through the processes, shows them our evidence, demonstrates our compliance and I can only do that if I am confident that you have all done your best to remain compliant as well. If you can prove that to me, by completing your CAPAs appropriately, then I am your best friend when someone else comes in to audit us.”

They were pretty quiet after that. I believe I performed very well. Especially considering that I was the youngest person in the room and the only woman.