5 key steps to optimize your non-conformity management
As an executive, quality manager or QHSE manager, managing non-conformities is part of your remit, and you'd like to know how to streamline the process of dealing with them.
A non-conformity indicates that something has gone wrong with a process, service or product, and that the result does not correspond to the initial requirements.
In a context of open markets and fierce competition, where the goal 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 to start? Follow the step-by-step procedure to implement this quality approach within your company, and set yourself on the road to continuous improvement!
What is a non-conformity?
The term " non-conformity"(or NC) refers to a failure in a process, service or product, which then fails to 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 implement specific controls at every stage of production, right through to transport, to ensure that all processes in place comply with standards :
- quality,
- hygiene
- health and safety,
- and environmental standards.
👉 For example, in the pharmaceutical industry, the quality department must 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 be a danger to the health and safety of consumers and patients.
What are the different types of non-conformity?
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 organization 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 examine:
- 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 unauthorized modification of a document,
- release of 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 not corrected.
Here are some examples of major non-conformities:
- several missing or unsigned documents,
- unauthorized document modifications,
- frequent violation of requirements,
- the occurrence of problems having 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 take steps to identify and understand the causes of non-conformances.
☝️Les non-conformities can be detected :
- internally: during regular quality control at every stage of production, from design to order preparation, or during regular audits 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-conformance.
Even in organizations with the most rigorous processes, 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 legal requirements, etc.
- organizational 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. This involves either corrective action or preventive action, depending on the nature of the non-conformity.
Corrective action and preventive action ( CAPA) aims to improve the organization's processes and protocols by eliminating non-conformances.
The CAPA process comprises a series of steps which must be carried out efficiently. Each action taken is rigorously documented to ensure continuous quality improvement. Correct execution of CAPA must comply with ISO 9001:2015 guidelines.
As soon as a non-conformity occurs, we need 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 revising a process immediately.
- immediate corrective action: this involves planning the steps needed to bring the process or product back into compliance.
Example:
- You quarantine products from an affected batch, label them "On Hold", and transfer them to a predefined holding area under the supervision of Quality Assurance.
- 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 shipped. If so, these products must be recalled as quickly as possible.
👉 You assign responsibilities, deadlines and demonstrable evidence for each task.
Step 3: Analyze
💡 How do you analyze 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 questions.
Ask the relevant department, in collaboration with the quality and safety manager, to determine the causes of a non-conformity and evaluate them within a detailed report.
👉 The non-conformity report (or non-conformity sheet) is drawn up to deal with the problem in greater depth. The main aim 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,
- time of day
- 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 their effectiveness.
Careful monitoring of the entire production chain can be organized to ensure that the non-conformity does not recur.
You check the entire process, in liaison with all those involved. Products are scrupulously examined over a given period. If the non-conformity does not recur, it's a sign that the corrective action has worked.
Step 5: Capitalize
Finally, the aim is to capitalize on the experience acquired to ensure the prevention of similar non-conformities.
Quality management system documents are reviewed and amended where necessary, taking into account the anomalies identified and corrected. They list not only the non-conformity and its causes, but also the solutions to be implemented to prevent recurrence.
In this way, documentation is made accessible and work instructions are always up to date, giving you the best chance of preventing the risk of non-compliance.
Equip yourself with the right tools to manage and trace non-conformities
While there are a variety of 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 organization,
- activities
- processes
- objectives,
- direct environment, etc.
In addition to the non-conformance sheet, you can draw on other supports and methods to manage and prevent anomalies.
For example, the FMEA method (Failure Mode, Effect and Criticality Analysis) is a preventive analysis tool that can be applied to a process, product or 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 non-conformance management? Such a tool offers several advantages:
- your teams can report non-conformities directly in the field;
- you can define corrective and preventive actions in response to these declarations, and manage your action plans via a centralized interface;
- better organization of work:
- circulation of information and regulatory obligations,
- sharing of best practices,
- and set up precise procedures with the assurance that they are followed by all.
🛠 Examples of software :
- Agilium SMQ is a software package that digitizes your entire quality process, including non-conformance management. Thanks to evaluation grids, you can easily measure the level of conformity of each element. All the resulting data, including evidence, is then recorded in the tool. This centralized information simplifies the creation of action plans associated with NCs.
- AppQual is a complete web-based solution for digitizing your entire QHSE system. Within an intuitive, configurable interface, you can easily declare incidents or NCs using detailed fields. The tool also helps you draw up effective action plans, identify avenues for continuous improvement and comply with ISO 9001 standards.
- Auditool detects non-conformities, triggers corrective actions and monitors their implementation as a team. With this software, customizable control grids and scoring scales enable you to standardize non-conformance reporting and ensure a consistent approach to your audit process.
- DocuWare is an EDM/ECM suite that helps you better manage all your documents and automate related processes, by centralizing 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, standardizes and digitizes all your anomaly management processes. Easily record and follow up anomalies by taking photos and annotating them, all with a complete view of the state of your equipment. Then pass on non-conformities to your teams and optimize their management.
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 in the best possible way.
What's more, it's now essential to equip yourself with a dedicated tool to improve performance and efficiency.
Article translated from French