A case study in CAPA remediation

I was asked by one of my clients to optimize their CAPA process, in preparation for the next FDA inspection occurring at one of their manufacturing sites. The following tasks for this project were required to be completed within a 5- month time frame:
a. Review 120 CAPA records,
b. Document my review on a remediation form,
c. Design and provide training on CAPA and Root Cause Analysis,
d. Revise the CAPA procedures,
e. Mentor /coach the CAPA leaders, while they worked on remediating the CAPA records.

During the review process, I noticed the CAPA records were far from being compliant. They were missing significant details — but that doesn’t tell the whole story. The records didn’t include any root cause analysis tools. Each record lacked either the proper documentation of a problem statement, or the implementation of its corrective action, and the majority of the records didn’t possess any type of documentation concerning the verification of the Effectiveness Check.

The individuals I spoke with focused their comments primarily on what was most visible, or whatever appeared most politically convenient, rather than digging below the surface with substantive ideas that would solve the problem. Just think of what it feels like in an organization when everyone knows what the real cause of the problem is,but no one is willing to speak up. There was a serious disconnect between addressing the root cause of the issue, and addressing its symptoms. Furthermore, I noticed that nearly all the root causes were identified without RCA tools, or by an established method in which the identified root causes could be verified. As a result, there was no strong link between the identified root causes and the course of corrective actions implemented. In one discussion, a CAPA Owner mentioned to me that management was notorious for dictating the solution before ever identifying the root cause of the problem!!! To summarize, the FDA would never accept the CAPA records the way they were.

I was totally convinced that the issue at hand was more of an organizational culture issue than anything else, and I needed to find an effective way to fix these CAPA records correctly and professionally. And, on the top of that, to leave them convinced that I did the right thing.

To help the CAPA Owners establish a new way of thinking, I had to lead by example while coaching/mentoring them. For example, when using the 5 why tool, they wanted to focus on who did what wrong. My role was to keep reminding them that it was not about identifying the people who wrongly performed, but rather about what went wrong in the process and why. In other words, they needed to focus on the system– not the people. I had to impress upon them that tools are useful for helping make our thinking visible, and this increases our ability to see what is truly significant and therefore better to identify errors in our thinking. Once I got that across to them, we concentrated on how to select which tool to use effectively in different circumstances.

Amazingly, I quickly found that these employees could be receptive to my ideas and cooperative to the needed corrections. However, the resistance was coming from the site management, because they wanted to close the project, so they could focus on production and shipping of the products.
Therefore, I had to try and win over the site management by taking a different route to bring them over to my side. It was a serious risk, but I felt it was critical to show them that the CAPA investigation was not just another duct tape solution to temporarily fix the problem, but rather a philosophical shift –that CAPA would be a lifetime fix for the company. To accomplish this, I started developing customized training materials in CAPA for the site management team. I strongly believed that if they clearly understood the CAPA process, how it worked, and its impact on the compliance level of their quality system, they would support me.
I also invited those who were resistant to change, to come to each CAPA Review Board meeting, to allow them to offer their opinions, and to give their blessing to each record prior to it getting approved for closure.

At the end of the project, those who were initially stood against any change became my primary supports. By the time the project came to an end, and I had to say good bye, some of them expressed their gratitude for the amount of knowledge and experience they have gained during my time on this project.

If you were in my place, would you have done anything different?