Non-conformity

Non-conformity is a failure to meet the requirements. Occurrence of non-conformity decreases quality of product, service or process. The failure can be related to lack of fulfilment of standards, documentation, quality regulations, requirements, contract requirements or customer and other interested parties requirements.

Non-conformity is often used in the context of quality control and compliance, and can refer to defects, deviations, or other issues that affect the performance or functionality of the product or service. Non-conformities can be identified through inspections, audits, testing, or other forms of evaluation, and may require corrective action to be taken in order to bring the product or service into compliance.

Categories of non-conformity

Fig.1. Non-conformity management process

• Systematic - a failure occurred at least once and can occur more times due to error in system or process structure, for example: dimensions of the product are not being checked during the production process which can lead to manufacturing a number of products with wrong dimensions.
• Random - a failure occurred at least once, but it's related to some random and rare causes, e.g. dimensions of only one product were not checked because of some accident that happened on production line.

Note: Large number of random non-conformities in one area can cause major malfunction of the system.

Non-conformity types and examples

There are several different categories of non-conformity, depending on the context in which the term is being used. Some common categories include:

• Major non-conformity: A non-conformity that has a significant impact on the product, service, or system, and that requires immediate attention and corrective action.
  • In a manufacturing setting, a major non-conformity may be a product that has a defect that affects its functionality or performance, such as a car engine that fails to start.
  • In a laboratory setting, a major non-conformity may be a test result that is not repeatable, indicating a problem with the equipment or method used.
  • In a compliance context, a major non-conformity may be a failure to meet regulatory requirements, such as a company not protecting customer data in accordance with data privacy laws.
• Minor non-conformity: A non-conformity that has a less significant impact and may not require immediate attention, but still needs to be addressed in a timely manner.
  • In a service industry, a minor non-conformity may be a service that is delivered late, but still meets the customer's needs.
  • In a food industry, a minor non-conformity may be a product that does not meet the specified packaging requirements, but is still safe to eat.
• Critical non-conformity: A non-conformity that poses a significant threat to safety, health, or the environment, and that requires immediate attention and corrective action.
  • In a construction project, a critical non-conformity may be a deviation from the approved plans or specifications that poses a significant safety hazard, such as a structural failure.
  • In a healthcare setting, a critical non-conformity may be a medication that is administered incorrectly, causing serious harm to the patient.
• Observation: A non-conformity that does not affect the product, service, or system, but that may indicate a potential problem that needs to be monitored or addressed in the future.

Extended classification can also include:

• Compliance non-conformity: A non-conformity that relates to a specific requirement or regulation that has not been met.
• Root cause non-conformity: A non-conformity that is caused by an underlying problem or defect that needs to be addressed in order to prevent the non-conformity from recurring in the future.
• Process non-conformity: A non-conformity that relates to a specific process or procedure that has not been followed correctly.

Examples of non-conformities

Here are some examples of non-conformities that may occur in different contexts:

• In a manufacturing setting, a non-conformity may be a product that does not meet the specified dimensions or tolerances, or that has a defect or malfunction.
• In a service industry, a non-conformity may be a service that is not provided as agreed or that does not meet the customer's expectations.
• In a construction project, a non-conformity may be a deviation from the approved plans or specifications, or a failure to meet safety or quality standards.
• In a laboratory setting, a non-conformity may be a test result that does not meet the specified criteria or that is not repeatable.
• In a food industry, a non-conformity may be a product that does not meet the specified food safety standards or that is contaminated.
• In a healthcare setting, a non-conformity may be a medical device or medication that does not meet the specified standards, or that has been administered incorrectly.
• In a compliance context, a non-conformity may be a failure to meet regulatory requirements, such as a company not adhering to data privacy laws.

Non-conformity management

Non-conformity management is described in management standards (e.g. ISO 9001, ISO 27001, ISO 14001, OHSAS). The main objective of non-conformity management is to deal with detected problem and also deal with its causes to prevent further occurrence.

1. Detection. Anyone who detects non-conformity should report it to responsible person as soon as possible.
2. Evaluation. The severity of the non-conformity should be evaluated.
3. Treatment. All non-conform products should be treated to either remove the non-conformity, decrease its impact or remove the product.
4. Documentation. The documentation should include description of the non-conformity, its cause and treatment. It should be a base of further analysis.
5. Causes treatment. In case of systematic non-conformities, the causes should be analysed and treated accordingly. The treatment should remove the cause, reduce its impact, reduce its probability or at least implement tools that allow early cause detection.
6. Actions evaluation. After completing the activities, their performance should be checked. There should be an objective evidence of full implementation of corrective action and its effectiveness.

Reporting non-conformity in quality system

When documenting the occurrence of a non-conformity in a quality system, it is important to include the following information:

• Identification of the non-conformity: Describe the non-conformity in detail, including the product, service, or system that is affected, the specific requirement or expectation that is not met, and the extent of the impact or deviation.
• Date and location of the non-conformity: Record when and where the non-conformity was identified, as well as the name of the person who identified it.
• Root cause analysis: Identify and describe the underlying cause of the non-conformity, including any contributing factors or conditions.
• Corrective action: Describe the actions taken or proposed to correct the non-conformity and prevent it from recurring in the future.
• Verification: Record the results of any verification or validation activities that were performed to confirm that the corrective action has been effective.
• Follow-up: Record any additional follow-up activities that were performed, such as monitoring or inspections, to ensure that the non-conformity does not recur.
• Owner: Identify the person or department responsible for the corrective action and follow-up.
• Reference: Include any relevant reference numbers, such as a purchase order number, lot number, or regulatory compliance requirement number.

It is also important to ensure that the documentation is accurate, legible, and complete, and that it is accessible to the appropriate personnel. Additionally, the documentation should be reviewed and approved by the appropriate personnel before it is considered final.

Topics related to non-conformity management

Few other important topics related to non-conformities that may be of interest:

• Root cause analysis: Identifying the underlying cause(s) of a non-conformity is crucial in order to prevent it from recurring in the future. Root cause analysis techniques, such as Fishbone diagrams and Pareto charts, can help to identify the factors that contributed to the non-conformity and to prioritize corrective actions.
• Corrective and preventive actions (CAPA): Once the root cause of a non-conformity has been identified, it is important to implement effective corrective and preventive actions to address the issue and prevent it from happening again. CAPA process typically includes planning, implementing, evaluating and monitoring the effectiveness of the action taken.
• Audit: Auditing is a crucial tool for identifying and evaluating non-conformities in a quality system. It can help to identify potential problems, to evaluate the effectiveness of corrective actions, and to ensure compliance with relevant regulations and standards.
• Risk management: Risk management is the process of identifying, evaluating and prioritizing potential risks in order to minimize their impact. It can be used to identify potential non-conformities and to take proactive measures to prevent them from occurring.
• Continuous improvement: Continuous improvement is the ongoing process of identifying and implementing changes that lead to better products, services, or systems. It can be used to identify and address non-conformities, to improve quality and performance, and to achieve organizational goals.
• Statistical process control (SPC): SPC is a methodology for monitoring, controlling and improving a process by using statistical techniques. It can be used to identify and analyze non-conformities and to take corrective actions to improve the process.
• Quality management system: A quality management system (QMS) is a framework for organizing and managing the quality of products, services, and systems. It can be used to identify and address non-conformities, to ensure compliance with regulations and standards, and to improve overall performance.

Non-conformity — recommended articles

Quality control plan — Quality improvement — Failure Mode and Effects Analysis — Control plan — Quality inspection — PFMEA — Maintenance strategy — Quality plan — Quality control

References

• ISO 9001 Auditing Practices Group, ISO&IAF, 2005
• Chiarini, A. (2015). Effect of ISO 9001 non-conformity process on cost of poor quality in capital-intensive sectors. International Journal of Quality & Reliability Management, 32(2), 144-155.
• ISO 9001:2015 - Quality Management Systems Requirements