Non-Conformance Procedure
A Non-Conformance Procedure within a Quality Management System (QMS) is a structured and documented process that outlines the steps to be taken when a non-conformance is identified within the organization’s quality processes. A non-conformance refers to any instance where a product, process, or activity does not meet the specified requirements, standards, or expectations.
Non conformance procedure: Efficient Resolutions
A Non-Conformance Procedure within a Quality Management System (QMS) is a structured and documented process that outlines the steps to be taken when a non-conformance is identified within the organisation’s quality processes. A non-conformance refers to any instance where a product, process, or activity does not meet the specified requirements, standards or expectations.
The purpose of a non conformance procedure is to identify and document non-conformities, action non-conformances and ideally to stop similar non conformances from occurring in the future by identifying the root cause. This can be done using the following procedure:
- Identifying and documenting the non-conformity with evidence/proof in the form of photos.
- Root Cause analysis of the non-conformity by applying the 5 way method or the Ishikawa method (fishbone).
- Taking recommended corrective actions.
- Taking preventative actions which will stop the non conformance from occurring again.
- Checking the effectiveness of the taken actions.
- Closing out signatures once both or all parties have rectified and closed the non-conformance.
Furthermore, it is advisable to implement corrective and preventive actions (CAPA) in cases of significant non-conformance that can have adverse effects on design and manufacturing processes. Conducting a risk analysis allows organisations to pinpoint potential risks that may result in non-conformance. Once these risks are identified, businesses can establish measures to mitigate or eliminate them.
Certification Experts ensures efficient resolutions to streamline the non-compliance resolution process, minimising disruptions to your product development or manufacturing timeline.
What is a non-conformance procedure?
A non-conformance procedure, within the context of a Quality Management System (QMS), is a structured and documented process that an organisation follows when it encounters any instance of non-conformance. Non-conformance refers to any deviation from established quality standards, processes, procedures or requirements that can affect the quality of products or services. These procedures are an essential component of a QMS, which is designed to ensure that products and services consistently meet or exceed customer expectations.
Managing non-conformance within a Quality Management System (QMS) can be challenging due to issues like accurate identification, root cause analysis, timely resolution, documentation, resource allocation, and regulatory compliance. Effective solutions involve fostering a culture of open communication, implementing streamlined workflows, conducting thorough root cause analyses, and prioritising preventive actions. Additionally, staying updated on regulations, providing training, addressing resistance to change, and implementing continuous improvement strategies are crucial for successful non-conformance management in a QMS.
Certification Experts’ expertise in quality management and compliance can help your organisation manage non-conformance effectively within your QMS, ensuring that your products or services consistently meet high-quality standards and regulatory requirements.
Handling a non conformance procedure
Handling a non conforming procedure within a Quality Management System (QMS) involves a systematic approach to identify, address, and prevent non-conformances. A step-by-step guide on how to handle a non-conforming procedure regarding QMS:
- Establish clear criteria and procedures for identifying non-conformances.
- Document all details related to the non-conformance, including what was observed, where and when it occurred and any personnel involved.
- Assess the severity and potential impact of the non-conforming product procedure, customer satisfaction and compliance with standards or regulations.
- If necessary, take immediate actions to prevent further non-conforming products or services from reaching customers or entering the market.
- Investigate the non-conformance thoroughly to identify the root causes.
- Develop and implement corrective actions designed to address the root causes and eliminate the non-conformance.
- Establish preventive actions to prevent the recurrence of similar non-conformances in the future.
- Verify and validate the effectiveness of corrective and preventive actions through testing, monitoring, or validation processes.
- Maintain comprehensive records of the non-conformance incident, actions taken, and their outcomes.
- Once the non-conformance is effectively resolved and preventive actions are in place, close the non-conformance procedure.
- Conduct periodic reviews to ensure that the issue does not recur and the preventive actions remain effective.
- Use insights gained from non-conformance incidents to drive continuous improvement in the QMS and related processes.
- Communicate the outcomes of the non-conformance procedure and any resulting process changes to relevant stakeholders.
- Ensure that the non-conformance procedure aligns with relevant industry regulations and standards.
A Non-Conformance Standard Operating Procedure (SOP) within a Quality Management System (QMS) is a documented set of instructions that outlines the systematic process for handling non-conformances within an organisation. Non-conformances refer to instances where products, services, processes, or activities do not meet established quality standards, specifications, or requirements.
Certification Experts can guide you through this systematic approach, based on the Non-Conformance Standard Operating Procedure (SOP), so your organisation can effectively handle non-conformance within your QMS, promoting quality, compliance, and continuous improvement.
Non conformance procedure flowchart
Creating a non-conformance procedure flowchart within a Quality Management System (QMS) can help visualise the steps and ensure a systematic approach to handling non-conformances. For every company a different flowchart procedure is required, since it is created on the basis of what is specifically needed within that company. For this reason, it could be beneficial for every company to create a flowchart based on the non-conformances that occur. For example, a specific ‘ISO 9001 non-conformance procedure flowchart’ or ‘ISO 13485 non-conformance procedure flowchart’ can be compiled.
Certification Experts uses flowcharting software/tools to create detailed and customised non conformance procedure flowchart that aligns with your organisation’s non-conformance procedure and QMS.
Certification Experts: Non-conformance procedure services
Certification Experts can offer a range of services and support with regard to a non-conformance procedure within the context of a Quality Management System (QMS). We provide various services :
- We can assist your organisation in using insights gained from non-conformance incidents to drive continuous improvement in your QMS and overall quality processes.
Our services are tailored to your organisation’s specific needs. Certification Experts’ expertise in quality management and compliance can help your organisation effectively manage non-conformance within your QMS, ensuring that your products or services consistently meet high-quality standards and regulatory requirements.
Obtain a Non-Conformance Procedure with the help of our team of experts
All the answers you might need!
Writing about a non-conforming procedure can be a little bit tricky as there are different processes. This includes the input and output.
Input can come from:
- Complaint handling is about non-conforming products after they are released in the market (e.g. customer complaints about the product or service).
- There can be a non-conforming product in the production process (thus is found internally, due to in-process controls or a final release procedure).
- A non-conformity can be detected during an incoming goods inspection of raw materials. But normally this is handled as a complaint towards the supplier.
- After an internal- or external audit. These are non-conformities about processes.
Output can then be:
- Non conforming product handling procedure
- In-process or final release procedure
- Before delivery, for each product, the product qualifications and requirements should be clear and it should be determined on which aspects of the product should be checked. After the incoming goods inspection the product is either approved, rejected, or accepted under circumstances. This should be defined in a procedure
- All con-conformities from an audit will be handled according to the CAPA procedure
So depending on in input, the output should be handled accordingly
- The reason for developing the NCR report.
- Why the work or activity went wrong.
- Preventive measures.
- Explain the corrective action taken.
- All key players involved in the NCR report.
- The work specifications that are affected.
- Identifying and documenting the non conformance (With evidence/proof in the form of photos)
- Identifying who was at fault for the non conformance (was it a supplier, contractor)
- Recommended corrective actions
- Root cause analysis
- Preventative actions which will stop the non conformance from occurring again
- Close out signatures once both or all parties have rectified and closed the non conformance
A Non Conformance Report procedure documents the details of a non conformance identified in a structured way. As a result, organisations, projects, or people who do not meet the quality and safety standards can be held accountable for not following the requirements. This process is used to determine a resolution with the customer and documenting any corrective changes made through to the close out of the NCR, typically with acknowledgements of time and cost impacts.