The process of acquiring ISO9001:2015 will see you develop correcting actions as a key element of your Quality Management System. It is a critical element and yet, corrective action is one of the most problematic components of the process, and one that companies struggle with.
Non-conformances mean something is not right. As a business, you need to not only correct a defective process or action but also understand why it happened in the first place.
Therefore, an important part of non-conformances is undertaking a root cause analysis – why did it happen in the first place, and how can it be prevented in the future?
Correction & corrective – the fundamental difference
In some literature, you will see two terms used, sometimes interchangeably but, they both have slightly different meaning;
- Correction action – is the step you take to fix something immediately, making the product or service acceptable to use. This is a short-term fix.
- Corrective action – is the process of understanding in the longer-term why the problem arose and what needs to change to prevent it in the future.
In order to record and understanding non-conformances, you need to ask searching questions. Think of these questions in a funnel shape this will eventually bring to you to the problem, but also identifies what the issue is.
This means you can begin the process of changing what is impacting on non-conformances;
- Is it the material? – why is the material wrong in the process? What could change?
- Is it the equipment? – is machinery and equipment old, incompatible or proving problematic?
- Is it the method? – why is this a problem? Has something changed that makes certain parts obsolete?
- Is it an environmental issue, such as building being too small/no longer compatible?
5 tips for writing a non-conformance report
Thus, to write or record non-conformances you need to:
- Identify clearly what the problem was or is – this is called the ‘Problem Statement’. Include the ‘who, what, why, and when’.
- Raise the non-conformance against the system, and not a person and include the location and evidence needed.
- Investigate the problem by asking ’why?’ of the process, the method and the system.
- Use familiar terminology that the auditor will understand – badly written non-conformances are one thing, but one written with non-explained jargon are just as bad.
- Finish the non-conformance report with what changes have been made and how the process etc. will continue to be monitored.
How detailed do non-conformances need to be?
There are some problems that are simple, their resolution almost self-explanatory but still need to be recorded in detail.
Some non-conformances can be far more complex, requiring a far more-detailed and analytical approach to identifying what the problem is, and how to resolve it.
This can take some time and considerable input but, at the end of the investigation, there will be a resolution that will improve quality management systems, as well as the quality of the product or service you offer.