Root Cause Analysis

It is the RISK, which provides us a scope for thinking one step ahead, so that we can be safe.   We all are RISK driven; at our home and or at a work place.  If we think a little deeper, “are we not using Risk management in all the arenas of our lives, knowingly or unknowingly”.

It is imperative that RISK, if not addressed adequately in time, will lead us to various Risk zones, resulting into the undesirable incidents.   An insincere glance & redressal of the RISK will add to chronic problems.   A makeover will never help us to address the risk & reach the real root cause.    The question is, “are we putting our optimum best efforts to identify all possible risks (known & unknown) in order to arrive at the most appropriate Root cause” (RC).

Risk assessment & Root cause analysis (RCA) are the two most important components of Quality Management System (QMS), irrespective of the nature of the organization.  A detailed Risk assessment is required to effectively address any gaps in the systems, which could lead to undesirable incidents.  Any deviations, Out of Specifications, Out of Trends and or failures, if not investigated in depth to comprehend the underlying causes & risks and the root cause for the incident, they will lead to inadequate Root cause identification and our efforts towards designing the “Corrective and Preventive actions” (CAPA) will not add value towards improving the working conditions and mitigating the risk.  It  is evident that, in the absence of an Effective RCA, CAPA won’t have an adequate value addition. 

WHY RCA IS NOT EFFECTVE

Effectiveness of an identified Root cause, supplemented with a strong CAPA, can be well reflected in the repetition of the incidents of similar kind.  In case the similar incidents are repeated, it reflects on poor RCA & a weak CAPA.  Why?

Why are we not able to perform an Effective RCA? 

ü  Everyone of us is over occupied with work and hence we are in a HURRY to conclude an incident?    Leading to inadequate review of the peripheral activities, which can add to the risk and hence they go un-noticed.  Result is “Root cause will be based on limited data”. 

ü  One possibility is that the team engaged in performing the RCA is not experienced and trained enough.  Absence of an in-depth understanding of the operations, won’t allow a detailed & adequate Risk assessment & so the RCA.  It is preferred that Subject Matter Experts (SMEs) and or First/second line are a part of the RCA activity, as it requires assessment of Risk followed by reaching a conclusion, for identification of probable Root cause. 

ü  Another possibility is that all the relevant functions might not have participated in the Risk assessment & RCA activity, leading to ineffective identification of RCA, i.e. cross functional inputs are missing. 

ü  Other important aspect to the RCA is, even if the incident has been assessed for its RCA in-depth but as an isolated incident, it won’t give us an assurance of effective CAPA.  If we require an effective implementation of the CAPA derived out of a RCA, it must be viewed as a Universal approach.  It is required to increase the SCOPE of the RISK and assess the impact on other similar activities, so as to have a comprehensive evaluation of all the risk factors, so as to reach the most appropriate Root cause.

As mentioned above, an in-effective RCA will result is Repetition of incidents with similar Root cause and will not only reflect on poor RCA but also will put a question mark on the capabilities of the Technical team. 

TOOLS TO PERFORM RCA

An effective RCA is a must, as discussed above.  We need to perform a detailed RCA using available RCA tools, for example Fault Tree Analysis (FTA), Ishikawa & 5 Why.  We can use either of these tools for RCA.   In principle there is not much difference among these, however the presentation differs. 

Whatever tool(s) we use, our SOP should mention this precisely.  It should be formalized in the form of a Formal document as a part of the SOP.

WHAT SHOULD WE DO TO ENSURE EFFECTIVE RCA

1.     Availability of all relevant data for review and analysis.

2.     A trend of incidents in the past, related RCA & CAPA effectiveness, so as to understand if it is a repetitive occurrence and earlier identified RCA & CAPA were adequate.

3.  Understand the difference between SPORADIC & Chronic problems, so as to plan CAPA accordingly.

4.  Only Trained & experienced personnel from cross-functional areas should be a part of the RCA process.

DON'T GET TRAPPED IN THE EASY FRUITS

There are situations, when we come across a Root cause and sometimes we are not able to arrive a suitable root cause.    

Important is that, we should not get trapped into the easy fruits, i.e. the direct cause.  Addressing a Direct cause, means taking up the RCA at its face value.   This process will remove the early warning indicator, thus making it little difficult to identify next time it happens.

Conclusively, we must understand the importance of in-depth Risk assessment & Root cause analysis, so that it can help us in making our Practices & processes robust.  Also it will ensure fixing  the problems effectively, the first time they occur, so as to ensure availability of more time to invest in other activities.