Conformity or conformance in quality is very important in process management, internal requirements and product or service quality. Therefore, when nonconformity is detected, fast reactions are required to address the problem to avoid any disruption of business operations. These non-conformities, regardless of their origin, regulatory, technical or organisational, can be sources of costly incidents or accidents for the company. The products’ quality can be affected, as well as the safety and health of the employees.
What is nonconformity in quality management? What is the process for reacting to nonconformities?
The nonconformity process or management aims to identify, document and resolve the detected anomalies within an organisation’s processes, products or services. The main target is to prevent nonconformities from occurring in the future and to continuously improve the organisation’s performance. Ensuring compliance with internal and external procedures leads to increased customer satisfaction and better performance. Moreover, this process provides company improvement detection points and implements corrective actions accordingly.
What is a Nonconformity?
Nonconformity (NC) refers to a malfunction or deviation occurring during an activity or a process. Nonconformities can be generated by an anomaly during the execution of an activity (human error, technical problem, etc.), by the occurrence of an external event that compromises the quality of the service (weather conditions, foreign object, contamination, etc.), or by the inadequacy of the operating procedure to the expected results.
An NC will always require corrective actions. Regardless of its type (minor or major), it can greatly affect the product’s or service’s quality and cause harm to the safety or health of stakeholders.
In quality management, detecting nonconformity (also referred to as nonconformance) is essential for continuous improvement, because they provide opportunities for the company to identify improvement points and take actions to enhance the quality of products or services. In addition, Clause 10.2 in the ISO 9001 standard emphasises the importance of continuous improvement and sets a procedure for reacting to a nonconformity.
Types of nonconformity
Nonconformity can arise from 2 sources, internal or external. When it is external to a company, it is a typical non-compliance with external regulations or certifications, such as ISO, government regulations, or supplier requirements. On the other hand, internal nonconformities are associated with procedures or requirements within the organisation.
When it comes to nonconformities, there are generally 2 types:
- Minor NC: When nonconformity does not significantly impact the product or service quality and safety and does not affect the reliability and integrity of the management system. Such as lack of documentation updates; incorrect calibration of a machine, etc.
- Major NC: It refers to an important issue that greatly affects the entire production process of an organisation, impacting the quality of the product or service. Major nonconformities can harm an organisation's reputation and often require great resources and time to implement corrective actions. Such as the shipment of uncontrolled products; failure to label an allergen on a product, etc.
Sometimes, during internal investigations, or a process review, some remarques and observations can be noticed, and they are not considered real nonconformities. They show potential signs of future nonconformities and there are already some corrective actions to avoid any deviation or emergence of problems in the short, medium or long term.
It is important to mention that the severity and the level of nonconformity may change depending on the context and industry. What is a minor nonconformity in one industry can be considered a major or critical in another.
What are the steps of the nonconformity management process?
A nonconformity management process is a systematic approach to identifying, documenting, analysing, and resolving nonconformities in products, processes, or systems.
The nonconformity management process involves several steps:
Step 1: Identification and documentation of the nonconformity
When a nonconformity is identified, the issue must be described down to the smallest detail to never omit valuable information. The responsible person for declaring the nonconformity must provide information related to the nature of the nonconformity, its type, date, location, the responsible person, and its potential impact. All the input data must be clear and understandable to correctly analyse the situation. This is important because the designated person to treat this non-conformity will have all the information to plan and implement the corrective actions if necessary.
In addition, it is essential to involve and encourage all employees to report any encountered nonconformity as soon as possible. Specifying that no employee will be penalised or blamed for reporting an NC is crucial.
Usually, the quality department receives all the declared NCs in an organisation. When it comes to major nonconformities, the quality head must be immediately alerted!
Relying on a digital tool, and a digitised form to document the nonconformity can be time-saving. The required information is easily filled in, and the concerned stakeholders can be automatically notified once the document is saved.
Recommended for you. Download our free "Example of NC Record Template"
Step 2: Immediate corrective actions
After the identification of nonconformity, in some cases, quick corrective actions must be taken depending on the types of deviation. It is essential to take effective action to eliminate or reduce the risk at its source. Stopping the production line and blocking products is generally recommended to prevent any additional impact on the current situation.
Step 3: Root cause analysis
In certain cases, and depending on the level of the non-conformity, a working group is created representing the concerned departments, to conduct a root cause analysis (RCA). This step is essential to identify the “error or malfunction” and prevent similar issues' recurrence. You can rely on quality tools to efficiently conduct the RCA, such as the 5-M method, the questioning method (WWWWHHW), etc.
Conducting a root cause analysis can be greatly facilitated thanks to digital technology, especially when all the necessary information and records are available and centralised on a single platform. Sometimes, a nonconformity is easily analysed and rapidly treated, especially if it is minor.
Step 4: Develop an action plan to implement the corrective actions
This is a crucial step because the action plan will contain the necessary instructions to develop and implement the corrective actions related to the identified nonconformity. However, when you build your corrective actions, you must be careful to act and eliminate the root cause and not only the consequences of the nonconformity. You must determine the actions required, responsibilities, deadlines and the necessary resources to implement and achieve these measures. Once all is set, you must test the developed actions to make sure that they will avoid the recurrence of the detected nonconformity. You can rely on the PDCA approach to test your actions. If everything goes according to plan, you can start the implementation phase and communicate to all concerned stakeholders the new action plan, and in some cases, additional training is required. Communication and alerting the stakeholders about the new corrective actions and the corresponding achievement deadline can be easily done via a digital platform. Everyone will be automatically notified once the new action plan is approved and implemented. Each stakeholder can directly report on the progress of their actions and the working group can easily monitor the correct implementation and achievement of the action plan.
Step 5: Monitoring and following-up
The working group must monitor the progress of the corrective actions to ensure they are effective and the noncofrmity’s resolution. The group can follow up with any necessary changes and improvements if necessary. The follow-up and monitoring step can be done via internal audits and investigation, or by monitoring the KPIs and the closure of actions by each concerned stakeholder.
The nonconformity report includes the actions leading to the resolution of the problem. If the nonconformity is not resolved, another report and other actions are launched with all the detailed and complete information of the original nonconformity.
Nonconformity management is essential for any organisation that wishes to maintain high quality and compliance in its operations. By implementing a systematic and proactive approach to identifying, evaluating, and addressing nonconformities, organisations can prevent quality issues from occurring, minimise the impact of any nonconformities that do occur, and continuously improve their processes and products. A successful nonconformity management system requires the commitment and participation of all levels of the organisation. With the right tools and processes in place, organizations can turn nonconformities into opportunities for growth and improvement, ultimately leading to increased customer satisfaction and business success.
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