Root cause analysis is something you should be doing already as part of your non-conformance and corrective action processes. If your records simply state 'operator error' as the cause of your non-conformances, you might benefit from honing in on some of the underlying causes. An effective investigation process will not only prevent specific issues from reoccurring, but can also involve creative brainstorming that lead to real improvements.
What is root cause analysis?
Root cause analysis is the investigation into the underlying cause/s of a non-conformance.
The concept of root cause analysis is credited to the founder of Toyota, Sakichi Toyoda who suggested the method:
Ask why five times (or more) until the root cause(s) of the problem is found.
It's a brainstorming exercise.
The Five Whys.
Each question you ask leads you to another question.
Keep asking why until you find your cause/s, and can think of solutions.
For example, your problem might be a puddle of liquid on the floor. Why is there a puddle on the floor? Because the equipment is leaking. Why is it leaking? A seal is broken. Why is the seal broken? The seal degrades over time and we haven't had the equipment maintained since 2007. Why has it been so long? There is no prompt to remind us to check and maintain the equipment.... ahhh a solution - add this equipment to our maintenance schedule.
The Fishbone diagram.
All very well and good to keep asking why, but often there are a number of factors that contribute to a non-conformance event.
The fish bone diagram is a really nice visual tool which provides prompts for you and your team to consider causes from various origins; methods, equipment, measurements, people, materials, environment... and other factors that may be applicable to the specific non-conformance.
You could even use this tool to brainstorm causes of potential problems that haven't happened yet - so you can implement preventive action!
Root cause analysis and your NATA audit report.
Your response to NATA audits are going to look a bit different. In the past, if NATA finds an item of equipment without a current calibration certificate, you may have responded by simply providing a copy of a current calibration certificate. With the new report format, you don't necessarily have to draw a fish for every issue that comes up, but you are expected to demonstrate some kind of investigation. The outcome of the investigation should also outline action taken to minimise the problem coming up again.
Kommentare