Quality System Procedure - Control of Non Conformance.pdf
- 1. ELMECH ENGINEERS, HOWRAH Doc. No.- EE/QSP/05 QUALITY SYSTEM PROCEDURE (CONTROL OF NON-CONFORMANCE) Rev No.- 00 Rev. Date: NIL Issue Date: 07/09/2024 Details: A Non-Conformances Process is a set of procedures and processes the team must take to understand the root cause and the best way to deal with a Non-Conformance. Non-Conformance procedures can involve a series of steps that have to be executed. Also, various players within the organization must be involved to facilitate thorough decision-making on the issues that could arise. Step1. Identification of Non-Conformance: This is the first and foremost step of a Non-Conformances Process. The objective here is to identify Non-Conformances, in other words, any areas within the organization or project that do not meet the standards, specifications, or requirements. Different factors can cause the identification of a Non-Conformance. For instance, it could result from a customer complaint, rejection, general observation, or an audit. An audit or review can be conducted internally by personnel within the organization, or an external body could do it. Step2. Understanding the Non-Conformance: Once you have identified a Non-Conformance, the next step is to investigate and understand what caused the Non-Conformance. The initial analysis will help you properly understand the situation before taking further action. The investigation aims to register the facts and gather evidence to support the decision-making in the following steps. The research should be able to answer essential questions such as when, where, how, and who. Step3. Non-Conformance Reporting: A Non-Conformance Report is generated, which documents all the relevant information about the issue. The report should contain details that have been or will/can be taken to mitigate the risks associated with the identified Non-Conformance. Depending on the requirements you have for reporting, the report contains information such as: Issue/Non-Conformance title Description of the issue Details of where and when the problem was identified Operational workflows affected Associated risks Actions taken or recommended Additional documents and files Step4. Notification to Relevant Personnel: The next step is to notify the relevant personnel within the organization of the Non-Conformance. This could be the senior management, or other individuals who must be aware of the issue. Notifying all relevant parties will help to ensure that everyone is on the same page and are aware of the actions that need to be taken. Not notifying appropriate personnel can lead to a lack of ownership and accountability, further escalating the issue. Step5. Non-Conformance Analysis: Once the team has been notified about the Non-Conformance, the responsible team should conduct a root cause analysis. The root cause analysis aims to understand why the Non-Conformance occurred and identify any systemic issues that might have led to the problem. A root cause analysis can be performed using various methods such as the 5 Why’s, Ishikawa diagrams, or cause and effect diagrams. Communication is critical during this step as it will help ensure everyone is on the same page and understands the problem. The team will typically have meetings, review documents and records, and analyse data.
- 2. During interviews with the team, you can ask a series of questions about the Non-Conformance, such as what went wrong, when it happened, and how it happened. By answering these questions, you can start to identify any systemic issues causing the Non-Conformance. Additionally, it’s essential to review any relevant documentation, such as procedures or process descriptions, to identify the issue. Once you’ve gathered all this information, it will be clear what actions need to be taken to address the root cause of the Non-Conformance. Step6. Recommending Corrective Action: This step brainstorms a couple of corrective action to deal with the identified problem. This is where a team of experts offers their insights and advice on stopping the impact of Non-Conformance. The best-case scenario is that the Non-Conformance that has been identified is minor and could not seriously impact the overall operation of the organization. On the other hand, the worst-case scenario could have a severe impact. For example, the comprehensive operational workflows may have been impacted, leading to severe damages, interventions from relevant authorities, and brand reputation setbacks. Now, interventional recommendations could be implemented based on the Non-Conformances identified. If it requires a complete overhaul of the entire workflow, then it could mean that the impact caused is likely to be severe. Step7. Recommending Preventive Action: When you understand what could have caused the Non-Conformance, you can learn from the issue and create preventive measure the problem doesn’t happen again in the future. The team could execute a series of measures to future proof the organization’s workflows and overall operations. This could involve: Changing material suppliers. Updating equipment. Modifying processes. Altering packing methods. Training organization’s teams. Implementing timely inspection. Adopting, integrating and standardizing. Adopting external auditing standards. Step8. Making Final Decision: The management personnel must decide on the final course of action at this step. This will include deciding which corrective and preventative measures will be implemented. The management team will also need to assign responsibility for ensuring that the corrective and preventative measures are put in place and carried out effectively. In some cases, it may be necessary to bring in external consultants or experts to help with this process. Once the decisions have been made, actions will be sent down the line to the relevant departments. Everyone must understand what they must do to avoid confusion or misunderstanding. Step9. Implementa on of CAPA: This will usually involve several different departments and team members, so it’s essential to have a clear plan. Each corrective and preventative action must be carried out according to the plan. Once actions are completed, check if they are effective and the problem is resolved. Step10. Closure of Issues: This is the final stage of the process, where you everything done to deal with the identified Non- Conformance. This includes updating the Non-Conformance register with new details about the issue, its root cause and how it was handled. The Non-Conformance can now be closed off. Prepared By Checked By Approved By