Using Root Cause Analysis to drive an Effective Quality System

Reality Check! 

RCA should be conducted at a point where informed conclusions can be made, and realistic action plans formulated. In this way the process has the potential to drive real change in the short, medium and longer term.

SofemaOnline (www.sofemaonline.com) looks at the Root Cause Analysis (RCA) process

Introduction

Is RCA used for negative or positive purposes? In fact, often it is used in connection with negative reviews – means something has gone wrong and we are attempting to get to the bottom of it!

RCA can also be useful as a means to identify and promote positive outcomes and aspects which may not necessarily be a “finding” but which are however identified as an “opportunity” during specific audits.

It's all About the Cause!

RCA is about identifying the causes of an issue (Direct Cause, Contributing Cause & Root Cause). Dealing only with the symptoms dies not address the fundamental issues – means the underlying root cause. so the more “Root Cause” corrections we can make the stronger will be the system.

Delivering the Strongest Outcomes 

Strong Outcomes are available if we follow the basic rules, In reality there is no mystery and RCA does not have to be complicated, yet it can still be very beneficial if done well. 

A well-structured and systematic approach to understanding the RC will help to focus the issues and present management with a range of opportunities. 

Whilst addressing compliance shortfalls with additional training (Blame & Train) might be a common reaction, the reality is that without first exploring the root cause, there is a danger that the time and effort spent on the issue will be miss directed with the “genuine” underlying problem left unresolved.

Delivering RCA - An effective RCA exercise will: 

a) Not seek to establish a “culprit” – avoid the blame culture and focus on the best understanding;
b) Always challenge answers which seem superficial in nature – go as deep as possible;
c) By the same token always challenge preconceived notions;
d) Avoid the ‘quick-fix’ as often there is more to the story;
e) Identify root causes linked directly to one or several of the observed findings;
f) Stop when it is no longer worthwhile to use proceed with the RCA; and
g) Develop an action plan to address the identified root causes with clear ownership responsibilities allocated.

Who Should Perform RCA?

It is essential that the individual or team performing the RCA has the necessary technical knowledge and can understand the issues and, has the competence to identify suggested solutions.

Senior staff members are expected to have the necessary skills and experience and ultimately will bear responsibility to deliver mitigation's to address the Root Causes.

a) Consider the required level of skill and experience, objectivity and authority (How is it identified?)
b) Consider the audit team itself (But note that the business area owner is ultimately responsible)
c) Self-assessment processes – Whilst some form of self-assessment may be useful it is questionable whether it will be sufficiently objective

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