Root Cause Analysis

The “5 M’s” or sometimes known as the “Fishbone (Ishikawa) Diagram” is an excellent tool for performing a structured root cause analysis (RCA), and is found in many GXP investigations.  I have seen it used all over the world, with varying degrees of success when it comes to finding the root cause(s) in the context of an issue (say: deviation) potentially affecting patient safety.  For the sake of this blog, let’s take a step back for a moment and gain some perspective…  When we gain perspective, we are then able to think critically and act decisively.  Without perspective, sometimes we get lost in the mundane world of “compliance” and act without clear direction. So:

Q: Why do we do GXP root cause analysis?

A: To identify the source(s) of the (deviation), to set us up for proposing a meaningful and effective CAPA.  In theory, this prevents re-occurrence of the event.

Great, I think we can all agree with the above thought process, it’s simple and universal.  So why is it then, that despite the widespread use of this tool, we continue to see repeating issues within our organizations that often demonstrate an unacceptable trend during Health Authority inspection?  Maybe, it is due to lack of perspective leading to failure to use the tool to the best of its ability.  A “compliance mindset” puts pressure on personnel to find the root cause within a pre-defined timeframe (typically 30 days) and lose the perspective that drive us to do the best we can with what we have.  We try to fit a square peg through a

The goal with any RCA tool used in a GXP setting is to trigger critical thinking by the user.  Facilitating a dedicated workshop session to the use of the tool and expanding the SOPs to include model examples are easy improvements to achieve this goal.  But, if we are being serious, this isn’t going to do much, otherwise this blog entry would not be necessary.  What we really need is a paradigm shift in the way RCA is done in our industry – which (in my opinion) starts by taking the advice of the FDA written in many recent Warning Letters (since ~2019): focus on the “management strategy”.  RCA outcomes are only as good as the tools available.  We can’t expect industry leading investigations when our tools are not kept up to date with CGMP expectations!  There is a reason why the regulators are pointing us in this direction, as we see in ICH Q10:

“Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that roles, responsibilities, and authorities are defined, communicated, and implemented throughout the company.”

So if no one is evaluating the effectiveness of the abovementioned expectations, then maybe we have lost perspective?  Chasing our tails with layer upon layer of CAPAs which generally increase burden on front line employees and decrease the “right environment”…

There are two ways I see this getting done (evaluating the management strategy using our RCA tools):

1.       Transform 5 M’s into 6 M’s, with the addition of “Management Strategy”

a.       Although this is listed as the first option, it may not be ideal in some cases.  For sites with a long history of operations, the addition of the extra branch might be necessary to ensure a change (old habits die hard), however, for new sites, management strategy can be integrated into the personnel branch right from the beginning.

2.       For major/critical investigations, apply a secondary RCA tool once the fishbone is completed – the “5-whys” – with a special emphasis on examining the current management strategy and “why” the event was allowed to occur in the first place. 

a.       For example:

           i.      Why has management failed to invest sufficient resources? 

           ii.      Why did our leading Quality Indicators fail to adjust the process before failure?

b.       For further guidance on this point, check out the “Right Environment” concept within MHRA’s Data Integrity guide. 

RCA is no walk in the park, and it takes a bold team of individuals within management to be open to honest evaluation (= vulnerability), but when we take a step back and gain perspective (why we do what we do), we see clearly that a true Quality Culture (and ultimately the patient) would expect nothing less.  Without this deeper evaluation, we might imagine a cook tasked with preparing a gourmet meal, but only provided canned ingredients – it is a guaranteed failure.  In essence, it is a guarantee that we will continue to see adverse trends if we do not adjust the tools (or ingredients!).

The culture that exists within an organization when management expresses vulnerability by reacting to what the data tells us (even if it means admitting our original efforts were wrong) is one that fosters growth and will emerge in the future as an industry leader. 

Oh and BTW – is a workplace where employees thrive, and find meaning in labor.  Very cool.

Let’s get to it.

Pete