A non-conformity is a situation in which established requirements or expectations are not met. Non-conformities can occur in different contexts, such as in the quality of a product or service, in the safety of a process or in the compliance with legal requirements.

When a non-conformity is detected, it is important to identify and analyse the underlying causes to take the necessary actions to correct the problem. This may involve corrective actions to address the current situation and preventive actions to avoid future reoccurrence.

Non-conformities are usually managed through a quality management system, which includes procedures for identifying, recording, investigating, and resolving non-conformities. These systems may also include review and continual improvement processes to prevent the recurrence of non-conformities and to promote effectiveness and efficiency in the organisation.

Analysis of the root causes of a non-conformity

At SHAPYPRO we offer our clients support during CAUSE ANALYSIS, which must be carried out and documented by people who are independent of the reason for the non-conformity. A CAUSE ANALYSIS consists of a thorough investigation of the CAUSES, CONSEQUENCES and SCOPE.

The root cause analysis is the most important and sometimes the most difficult part. Often the root cause is not obvious and therefore a careful analysis of all potential causes of the problem is required. Potential causes could include the test requirements, processes, computerised systems, methods and procedures, personnel skills and training, equipment, consumables, etc.

Therefore, here are some TIPS for conducting a good root cause analysis.

The first thing is to establish a multidisciplinary working group that provides experience and knowledge in the fields of key impacted processes, quality assurance, technical management, with the possibility of other members of the team joining in to add value to the investigation.

Below, we detail how we should address each of the questions that arise in a root cause analysis, and what answers we are looking for:

  • Causes: The possible causes that led to it, we ask ourselves what happened?
  • Consequences: The consequences of the impact on the system, project, or process, we ask ourselves what impact does the impact have on our processes?
  • Scope: How far do the consequences of the incident affect us, we ask ourselves what processes, people, equipment, etc., have been affected?

If we correctly analyse the causes, we will be able to establish mitigating measures and, above all, maintain control over the affected processes and/or services.

Classification of deviations and non-conformities

Each cause analysis carried out must be formalised in a report, written by the person assigned independent of the origin of the deviation, where the conclusions obtained will be reflected.

Normally, 3 levels of affectation are considered:

Critical (C): The condition critically affects the technical competence and may affect the quality of the result of your product or service.

  • ACTION: Corrective action must be taken immediately.

Major (M): Evidence or suspicion of problems that could affect the quality of the end result of your product or service.

  • ACTION: Corrective action should be taken within a short period of time.

Minor (m): Isolated deviation that could affect the quality of the final result of your product or service, provided there is evidence that the test procedure is properly implemented and functioning.

  • ACTION: Corrective action should be taken.

It is important to note that the specific classification and terminology may vary depending on the quality management system used. Some systems or standards may use different categories or terms to classify non-conformities.

Do you need support on a non-conformity or deviation?

Call us without obligation, and we will put at your disposal all our experience in analysing causes, drafting mitigation plans, as well as our objective and independent vision that should be involved in your quality processes.


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