Quality non-conformances play a very important role in the day-to-day running of an industrial company. If not managed correctly, they are an important source of loss of efficiency and productivity, and slow down the continuous improvement of organisations. In this article we explain what this problem is and how you can put an end to it.
What is a non-conformance?
A non-conformance is an unexpected event that arises during the manufacturing process and negatively affects the final quality of the product. According to ISO 9000:2005, the occurrence of this phenomenon is linked to the breach of a pre-established requirement in the company’s quality management system.
Having said that, a non-conformance can have an external or internal origin. In the first case, it is usually caused by non-compliance with external regulations or certifications such as ISO or by omitting a supplier’s requirements. In the second case, the problem is related to non-compliance with procedures or requirements voluntarily imposed by the company itself.
On the other hand, non-conformances can be major, when the integrity of the management system is breached, or minor, if they are small deviations that do not greatly affect the efficiency and integrity of the company’s management system.
In addition, we can also distinguish between real and potential non-conformances. If they are real, we have objective evidence of non-compliance and we can apply corrective actions. When they are potential, we have signs that help us to develop preventive actions and to avoid the emergence of problems in the short or medium term.
Non-conformance management according to ISO 9001 standard
As we have seen, non-conformances can be major or minor, and real or potential. But the classification is broader. The management of these events can be linked to any of the ISO standards that currently exist, being ISO 9001 one of the most common.
ISO 9001:2015 is a globally recognised quality management method implemented by many industrial companies to continuously improve their processes, boost the quality of their production, become more efficient and competitive, and increase customer satisfaction.
Within an ISO 9001 management system, the most frequent non-conformances are due to non-compliance with the technical requirements of the products (characteristics, materials, operation, etc.) or of the processes (delays in delivery times, errors in quantities, human failure due to lack of training, inadequate use of equipment, etc.).
The negative impact of non-conformances in an industrial company
Non-conformances can become a real nightmare for industrial companies that are not able to manage them correctly. Their impact on the final quality of products brings with it other negative consequences, such as efficiency, productivity and company reputation loss.
However, the early detection of a non-conformance should be seen as an opportunity for improvement. If the organisation has an effective protocol for dealing with such situations, it can take advantage of non-conformances and use them to its own advantage.
Below, we detail the steps to follow in dealing with non-conformances so that any company is able to analyse the root cause of the problem, find a solution and prevent future occurrences.
How should we deal with quality non-conformances?
To turn them into opportunities for improvement and remove them from the map for good, companies should establish a methodology for dealing with non-conformances based on the following five steps.
1. Detection of the non-conformance
Any stakeholder in the organisation (customers, internal staff, suppliers, external auditors or public administration) can detect a non-conformance. When this happens, whether during internal or external audits, quality controls or analysis of consumer complaints or claims, it is important that the non-conformance is reported as soon as possible.
In this first stage of the process, it is key to describe the non-conformance well and to provide data such as: the evidence that proves the non-conformance; the document indicating what should have been done but was not done; the date and the person who detected the non-conformance, etc.
2. Immediate correction of the non-conformance
Once the non-conformance has been detected and well documented, it must be corrected in order to eliminate in the short term the non-compliance situation that caused it. The work does not stop here; as this is not a one-off problem, but is likely to recur on more than one occasion, it will also be necessary to eliminate the root cause.
3. Detection and analysis of the root cause of the non-conformance
This third step is essential to avoid future reproduction of the non-conformance. When it comes to detecting and addressing the root cause (there may be one or more than one), there are several useful methodologies, such as the 5 Whys problem analysis and resolution tool..
4. Planning and implementation of corrective actions to eliminate the root cause
Once you know the root cause behind the non-conformance, you should define one or more corrective actions, the people responsible for carrying them out and the timeframe for implementation.
5. Verification of the corrective action’s effectiveness
This last stage is one of the most important, as it will be used to find out whether the corrective actions implemented have been effective or not. As soon as a situation similar to the one that generated the non-conformance appears, check that the deviation no longer occurs. Keep in mind that only when you can verify 100% the effectiveness of the corrective action, you will be able to close the problem.
MES systems to tackle non-conformances
Implementing an MES system can help you track non-conformances, identify them and speed up the implementation of corrective actions.
Thanks to the Mapex Quality module, our customers are able to obtain real-time data to detect non-conformances early and minimise their potential impact. In addition, they have detailed information and tools for root cause analysis of the non-conformance.
With our solution, companies increase the agility with which they make decisions and execute corrective actions; experience improved competitiveness and customer service levels; reduce non-quality costs, and comply with the company’s continuous improvement strategy.
If you would like to find out more about how we can help you manage quality non-conformances, please contact our sales team and request a demonstration.
