Root cause analysis is one of the important parts of a quality management system – and key for continual improvement.
Its objective is to identify the true origin of an issue or nonconformity. This is necessary so you can resolve the issue properly, ensuring it won’t be repeated. In turn, this improves the quality of a product or process, or both.
Root cause analysis is time critical. It should be done as soon as an issue is identified. Rather don’t wait for a problem to escalate first.
Below, we take a closer look at 7 vital steps of root cause analysis.
1 | Identify and prioritize problems
Identify any and all quality management problems the business might be facing and prioritize them based on the level of risk they pose to the organisation.
This will help you decide which ones to tackle immediately. Always deal with the most urgent issues or nonconformities first.
2 | Create a problem statement
Give each problem a straightforward definition so you can be accurate about each one’s urgency. This will also give you an idea of where to start to find a solution.
Don’t go into too much detail or this step may generate confusion. The definition is just a starting point for finding solutions.
3 | Identify possible causes
Put a team together and start by asking “why?” each problem happened. Asking “why?” 5 times is a good way to drill down to the root causes of a problem.
Once you’ve identified the root causes, choose the necessary corrective actions as a team.
Keep the focus on the root causes, not the overall problem. Remember, a problem can have more than one root cause.
4 | Implement corrective actions
Implement the corrective and preventive actions (CAPA) making sure to communicate these changes to everyone involved. Clearly communicate the reasons, benefits and any timelines or deadlines.
This communication must include anyone affected by the original problem, not just the team that worked to resolve it.
5| Analyze effectiveness
Once they’ve been implemented, review the results of the corrective actions. You may need to modify the corrective actions if the issues aren’t satisfactorily resolved.
A completely different approach might be needed if the suggested CAPA isn’t doing anything to solve the problem. You may even need to review the root causes again.
6 | Update procedures
Write up the new procedural documents or edit existing ones as needed. Determine if any new training is needed or if anyone needs to be retrained.
You can also use these documents to see if the new procedures could be applied to other areas to solve quality issues. For example, on a production line in a different factory but using the same equipment.
7 | Check and control
Revisit the new procedures after a few months to make sure they are being followed and that they are still effective at fixing the issue.
Do this every three to six months to make sure the original problem has not recurred.
What else to consider with root cause analysis
Some of the outcomes of root cause analysis may include identifying which procedures need to be changed, which supporting documents need to be modified, and who will need to be trained or re-trained.
Don’t forget that root cause analysis must lead to an effective corrective and preventive action plan. One without the other can mean that an issue will recur or have time to escalate into a more serious problem.
isoTracker’s quality management software offers effective tools for root cause analysis and for managing subsequent corrective and preventive actions. Contact us for more information or consider signing up for our all-inclusive 60-day free trial.
