Requirements for Root Cause Analysis in ISO 9001:2015
The requirements for root cause analysis in ISO 9001:2015 are implied as part of the process for making quality improvements.
The standard doesn’t actually specify how the real causes of issues should be uncovered, but it does require that this occurs.
What is root cause analysis?
Root cause analysis (RCA) is a set of analyzing and problem-solving techniques targeted at identifying the actual cause – the root – of a non-conformance. It helps an organization find out what went wrong and why, and to find appropriate solutions.
Understanding and addressing a non-conformance at its source, rather than addressing any symptoms, should prevent its recurrence.
Clause 10.2 of ISO 9001:2015
The requirements for root cause analysis can be found in clause 10.2 of ISO 9001:2015.
The first part states the requirements for an organization’s reaction to a non-conformance. It must take action to control, correct and deal with the consequences (including environmental) of the non-conformance.
The second part deals with how an organization should evaluate the need for action to eliminate the causes of a non-conformance so that it doesn’t recur or occur elsewhere.
Documented information must be retained as evidence of the nature of the non-conformances, actions taken and results of corrective actions.
Does ISO 9001:2015 require root cause analysis for every non-conformance?
An organization must always look for the root cause of a non-conformance but it may not require corrective action.
The need for corrective action will depend on the severity of the non-conformance and whether it would add value to the QMS.
Remember, an auditor will look for a screening process that reviews non-conformances, so all organizations must have one in place.
The root cause analysis process
There are a number of steps in the root cause analysis process. How each step is implemented will depend on an organization’s product or service.
- Identify, review and analyze the non-conformance.
- Determine the factors that caused the problem.
- Investigate the existence or risk of similar non-conformances.
- Implement corrective actions to eliminate the root cause.
- Monitor and review effectiveness of corrective actions.
- Update risks and opportunities determined.
- Make changes to the QMS.
Popular tools for root cause analysis
There are a number of popular root cause analysis tools that make the process easier and more effective.
The 5 Whys
A team of people who are affected by the non-conformance come together to ask “why” five times. This brainstorming helps find the root cause of the problem.
Once the whys establish the root cause, improvement measures are applied and the team members assigned corrective and preventive actions.
Ishikawa (fishbone) diagram
An Ishikawa, or fishbone, diagram (it looks like a fish skeleton) can be used to help establish the causes and effects of a non-conformance.
Different fishbone diagrams can be used to explore the factors that prevent an outcome and to identify the factors needed to ensure the problem does not recur.
A scatter diagram is plotted using a collection of points to establish a relationship between two variables, such as cause and effect.
If a relationship is established, it’s possible that varying one variable will control the other.
Fault tree analysis
This is a visual tool that deduces the possible causes of a non-conformance.
The problem is placed at the top of the tree and the possible causes placed below.
This chart is based on the theory that 80% of problems result from 20% of the problem causes.
It’s a combination of a bar chart and line graph, with the length of the bars representing the frequency of faults. The chart helps prioritize problems based on the effect they have on a system.
How non-conformance management software can help
Non-conformance management software can help root cause analysis by ensuring that every non-conformance is properly recorded and addressed.
isoTracker’s non-conformance management software is simple, fast and helps businesses comply with standards and drive quality improvements. The module can stand alone or integrate with our other quality management software.