So there’s root cause analysis and gap analysis and now performance cause analysis? Is there a difference? Do they use different tools? It can be overwhelming to decipher through the jargon, no doubt! I think it depends on which industry you come from and whether your focus is a regulatory / quality system point of view or performance consulting perspective. To me, it doesn’t change the outcome. I still want to know why the deviation occurred, how the mistake that was made and /or what allowed the discrepancy to happen. Mix and matching the tools allows me to leverage the best techniques from all.
Why we love root cause analysis
For starters, it’s GMP and we get to document our compliance with CAPA requirements. It allows us to use tools and feel confident that our “data doesn’t lie”. This bodes well for our credibility with management. And it provides the strategic connection between our training solution (as a corrective action) and site quality initiatives thus elevating the importance and quite possibly the priority for completing the corrective action on time.
Asking the right questions
Root cause analysis and problem solving steps dove tail nicely. See sidebar below. It requires us to slow down and ask questions methodically and sequentially. More than one question is asked, for sure. When you rush the process, it’s easy to grab what appears to be obvious. And that’s one of the early mistakes that can be made with an over reliance on the tools. The consequence? Jumping to the wrong conclusion that automatic re-training or refresher training is the needed solution. Done, checkmark. On to the next problem that needs a root cause analysis. But when the problem repeats or returns with a more serious consequence, we question why the training did not transfer or we wonder what’s wrong with the employee – why is s/he not getting this yet?
No time to do it right, but time to do it twice!
Solving the problem quickly and rapidly closing the CAPA allows us to get back to our other pressing tasks. Unfortunately, “band-aids” fall off. The symptom was only covered up and temporarily put out of sight, but the original problem wasn’t solved. So now, we must investigate again (spend more time) and dig a little deeper. We have no time to do it right, but find the time to do it twice. Madness!
Which tool to use?
My favorite human performance cause tool is the fish bone diagram, albeit the “ 5 Whys Technique” is a close second. Both tools force you to dig a little deeper into the causes. Yes, the end result often reveals something is amiss with “the training”, but is it man, machine, method or materials? Ah-hah, that is very different than repeat training on the procedure! Alas, when we have asked enough right questions, we are led to the true cause(s). That is the ultimate outcome I seek no matter what you call the process or which tool is used. -VB
(c) HPIS Consulting, Inc.