The 5 key steps to optimising your non-conformity management

As a director, quality manager or QHSE manager, managing non-conformities is part of your remit, and you want to know how to streamline the process of dealing with them.

A non-conformity indicates that something has gone wrong with a process, a service or a product, and that the result does not correspond to the initial requirements.

In a context of open markets and strong competition, where the objective of customer satisfaction is more important than ever, the implementation of a non-conformity management system must be a priority.

To ensure the quality of your products and services, and avoid incidents and anomalies as far as possible, don't wait any longer to strengthen your quality management!

But where do you start? Follow the step-by-step procedure to implement this quality approach within your company, and get on the road to continuous improvement!

See all software Environment, Health and Safety (EHS)

What is a non-conformity?

The term " non-conformity"(or NC) is used to describe a fault in a process, service or product that does not comply with the regulations and standards defined by the sector concerned (agri-food, biotechnology, pharmaceuticals, etc.).

Non-compliance has a negative impact on a company's reputation, costs and efficiency.

Your company needs to put in place specific controls throughout the various stages of production, right through to transport, to ensure that all the processes in place comply with standards :

• quality
• hygiene
• health and safety,
• and environmental standards.

👉 For example, in the pharmaceutical industry, the quality department has to ensure that the right dosages and mixtures of active ingredients are used in medicines.

Some industries are governed by particularly strict regulations, as they have a major impact on the lives of end users. Any non-compliance in these sensitive sectors, such as the medical sector, can endanger the health and safety of consumers and patients.

What are the different types of non-compliance?

There are two types of non-conformity that can be distinguished during an ISO certification audit:

• major non-conformities
• and minor non-conformities.

The difference lies in the number of corrective measures you need to put in place to bring your organisation back into compliance.

☝️ Whatever the type of non-conformity, always bear in mind that :

• the non-conformity must be dealt with immediately,
• minor non-conformities can become major non-conformities. So don't turn a blind eye to a problem described as "minor"!

💡 An effective way of determining whether a non-conformity is minor or major is to look at :

• its frequency: will the problem be repeated often?
• its detection: does the system detect the problem in time?
• its impact: what will be the consequences if the problem is not corrected?

Minor non-conformity

A minor non-conformity is one that occurs rarely, is easily detected and has no direct impact on your customers.

Here are some examples of minor non-conformities:

• a single missing or unsigned document
• any unauthorised modification to a document,
• issuing a purchase order without prior approval,
• using a tool after its calibration date.

Major non-conformity

A major non-conformity is one that occurs repeatedly, is difficult to detect and has a negative impact on your customers if it is not corrected.

Here are some examples of major non-conformities:

• several missing or unsigned documents
• unauthorised changes to documents
• frequent violations of requirements,
• the occurrence of problems that have a negative effect on processes or operations.

How do you manage non-conformities?

Step 1: detect

The first step in your non-conformance management procedure is to implement measures to identify and understand the causes of non-conformances.

☝️Les non-conformities can be detected :

• internally: during regular quality control at each stage of production, from design to order preparation, or during a regular audit of products and protocols. In this case, if the company is able to detect the anomaly itself, the quality control system in place is effective;

• externally: by receiving negative comments or complaints from customers. In this case, the fault is detected while the product is in the customer's hands. The consequences are more negative for the company's image. This is a sign that the existing quality procedure needs to be reviewed and modified to reduce the rate of non-conformity.

Even in organisations with the most rigorous processes, the sources of non-quality or non-conformity can be linked to :

• human factors:
  • poor communication or misunderstandings
  • shortcomings due to inadequate training
  • incorrect execution of a task
  • non-compliance with a legal requirement, etc.
• organisational factors:
  • launch of a new product,
  • change in personnel
  • failure of an external service provider, etc.

Step 2: deal with it

Once a non-conformity has been identified, it must be dealt with appropriately. Depending on the nature of the non-conformity, corrective action or preventive action is taken.

Corrective action and preventive action ( CAPA) aims to improve the organisation's processes and protocols by eliminating non-conformities.

The CAPA process involves a series of steps that must be carried out effectively. Each action taken is rigorously documented to ensure continuous quality improvement. Correct execution of CAPA must comply with the guidelines of ISO 9001:2015.

As soon as a non-conformity occurs, it is necessary to react quickly in two stages:

• Controlling the problem: to limit the risks. This can be done by alerting the customer, isolating a product or reviewing a process immediately.
• Immediate corrective action: this involves planning the steps needed to bring the process or product back into compliance.

Example:

1. You quarantine the products in an affected batch, label them "On Hold", and transfer them to a predefined holding area under the supervision of Quality Assurance.
2. You assign a team to check whether one or more batches of the product are non-compliant, and whether any of these defective products have been dispatched. If this is the case, these products must be recalled as quickly as possible.

👉 You assign responsibilities, deadlines and demonstrable evidence for each task.

Step 3: Analyse.

💡 How do you carry out an analysis of the causes of a non-conformity?

The analysis of the causes of a non-conformity must answer the question "What caused the non-conformity?" This step is crucial.

If you don't identify the reason(s) for the non-conformity, you won't be able to find long-term solutions. The root cause analysis must be factual and answer all the questions.

Ask the department concerned, in collaboration with the quality and safety manager, to determine the causes of a non-conformity and assess them in a detailed report.

👉 The non-conformity report (or non-conformity sheet) is drawn up to deal with the problem in greater depth. The main objective of this report is to describe the anomaly clearly, concisely and logically, indicating :

• its nature
• the people involved
• the stage in the process at which it occurred,
• the time,
• location, etc.

This helps the quality management department or company management to react and implement the appropriate changes.

Once you have fully identified the root cause of the non-conformity, you can implement corrective action that will have a long-term impact.

☝️Comme for immediate corrective action, you assign responsibility for execution, deadlines, methodologies used and demonstrable evidence.

Step 4: Follow up

Once implemented, corrective actions must be followed up to validate the effectiveness of the approach.

Meticulous monitoring of the entire production chain can be organised to ensure that the non-conformity does not recur.

You check the entire process, in conjunction with all those involved. Products are scrupulously examined over a given period. If the non-compliance does not recur, this is a sign that the corrective action has worked.

Stage 5: Capitalising

Finally, the aim is to capitalise on the experience gained to ensure the prevention of similar non-conformities.

The quality management system documents are reviewed and amended if necessary, taking into account the anomalies identified and corrected. They list not only the non-conformity and the identification of its causes, but also the solutions to be implemented to prevent it recurring.

In this way, documentation is made accessible and work instructions are always up to date, to give you the best chance of preventing the risks of non-compliance.

Equip yourself with the right tools to manage and trace non-conformities

While there are various quality tools available, it's up to you to choose the ones that are best suited to the specific features of your sector and the regulatory requirements that govern it.

Certain criteria will guide your choice, such as :

• the size of your organisation
• its activities
• its processes
• its objectives
• its direct environment, etc.

In addition to the non-conformity form, you can use other tools and methods to manage and prevent anomalies.

For example, the FMEA method (Failure Modes, Effects and Criticality Analysis) is a preventive analysis tool that can be applied to a process, a product or a piece of equipment. Its aim is to identify and treat the causes of malfunctions and defects before they occur.

☝️ And why not turn to software designed to facilitate the management of non-conformities? Such a tool offers a number of advantages:

• your teams can report non-conformities directly in the field ;
• You can define corrective and preventive actions following these declarations and manage your action plans via a centralised interface;
• you organise your work more effectively:
  • circulate information and regulatory obligations,
  • sharing best practice,
  • and put in place precise procedures with the assurance that they are followed by everyone.

🛠 Examples of software :

• Agilium SMQ is a software package that digitises your entire quality approach, including the management of non-conformities. Thanks to the evaluation grids, you can easily measure the level of compliance of each element. All the resulting data, together with the evidence, is then recorded in the tool. This centralisation of information simplifies the creation of action plans associated with NCs.
  
  
• AppQual is a complete web-based solution for digitising your entire QHSE system. Using an intuitive, configurable interface, you can easily declare incidents or NCs using detailed fields. The tool also helps you to draw up effective action plans, identify areas for continuous improvement and comply with the ISO 9001 standard.
  
  
• Auditool detects non-conformities, triggers corrective actions and monitors their implementation as a team. With this software, the customisation of control grids and scoring scales enables you to standardise the recording of non-conformities and ensure a consistent approach in your audit process.
  
  
• DocuWare is an EDM/ECM suite that helps you better manage all your documents and automate the associated processes, by centralising and tracking all information relating to non-conformities. This solution facilitates the rapid detection of anomalies, improving the efficiency of internal quality control procedures.
  
  
• Ermeo is a web and mobile platform that simplifies, standardises and digitises all your anomaly management processes. Easily record and follow up anomalies by taking photos and annotating them, all with a complete view of the condition of your equipment. Then pass on non-conformities to your teams and optimise their management.

See all software Environment, Health and Safety (EHS)

In conclusion

You now know a little more about the differences between the different types of non-conformity, as well as the 5 steps to follow to manage them as effectively as possible.

What's more, it's now essential to equip yourself with a dedicated tool to improve performance and efficiency.