Root Cause Analysis (RCA) is defined by the process of discovering the root causes of problems to identify the best solutions. In this case utilising RCA in ISO 9001:2015 Quality Management Systems is the process of identifying and removing non-conformance through process improvement.
Approaches to Root Cause Analysis?
RCA is a pivotal process to determine the root issues that are creating non-conformances which usually lie deep within an organisation and are not surface level.
There are various ways to do RCA including:
- The Ishikawa Fishbone Diagram
An Ishikawa diagram shows the potential causes of a specific non-conformance. It is commonly used in discovering the root causes of issues and supports decisions to appropriately allocate resources and determine whether quality control issues are likely to arise in the future.
- The Pareto Chart
Pareto charts identify which areas to focus on during corrective action. This graph is based on the Pareto principle which states that 80% of the problems come from 20% of the causes.
- The 5 Whys
The 5 Whys is a straightforward approach which is asking why a problem happened and then repeating “Why?” four more times until you find the main cause.
- Failure Mode and Effects Analysis (FMEA)
A Failure Mode and Effects Analysis (FMEA) is a tool used to look ahead to predict non-conformances or to see the consequences that could arise from that non-conformance.
How Does RCA Fit Into ISO 9001:2015?
Root Cause Analysis is an essential part of ISO 9001:2015 corrective actions. To ensure that an ISO 9001:2015 Quality Management System works long-term ensuring that non-conformances are eliminated are pivotal.
Clause 10.2 of ISO 9001:2015
The importance of Root Cause Analysis can even be found in ISO 9001:2015 as Clause 10.2 focuses on when non-conformances occur that are addressed and systematically eliminated to prevent reoccurrence.
Is Root Cause Analysis Required for Every Non-Conformance?
After any QMS failure, RCA needs to be conducted to find the exact cause and processes put in place to prevent the incident from reoccurring if necessary.
So yes, RCA is always necessary to identify the root of non-conformance however corrective action is not always required. The need for corrective action depends on the severity of the non-conformance and whether it would add value to the QMS long-term.
Tips for Effective Root Cause Analysis
Here are a few tips we can follow and can give to organisations who are implementing RCA system
Establish RCA Systems from the Start
Don’t wait for a non-conformance to pop up, establishing an RCA system from the first time a root cause analysis is performed. Ask related questions and test techniques and methods to find one that suits your organisation the best.
Utilise RCA as a Step Towards Success
Root cause analysis is not just an incredible tool for figuring out the causes of non-conformance, but it can also be used to find the root cause of a success.
Finding the root cause of why a project is seeing positive results can significantly benefit teams across the organisation and can help prioritise and protect certain processes that are key factors in success.
Get a Pair of Fresh Eyes
If you’re able to involve other team members or colleagues, it’s always a good idea to get an extra pair of eyes to help brainstorm causes and solutions. By involving other colleagues you’ll be able to incorporate other points of views.
The WWISE Root Cause Analysis Way
At WWISE our expert facilitators are able to provide training to support your staff and organisation through effective Root Cause Analysis processes and techniques. We’ve trained hundreds of delegates ways to effectively perform and RCA across the last 15 years.
If your staff requires Root Cause Analysis training or just a refresher course get in touch with our training team at admin@wwise.co.za and speak to an expert today.