How to Create a Nonconformance Report in 7 Steps
Creating a nonconformance report is not that difficult. The 7 steps described in this article will go a long way in helping you write a report that will form an integral part of your company’s continual improvement process.
Many quality managers are not happy when they hear the word nonconformance. This is however unrealistic as we live in a world of imperfect processes that delivered imperfect products.
That does however not mean that nonconformances are all bad. Nonconformance can in fact be seen as both an opportunity and a risk. To transform a nonconformance into an opportunity it is crucial to create a well-constructed nonconformance report.
Nonconformance reports (NCRs) are retrospective. You can only start to create this document once you have identified the details of the nonconformity. Simply follow the 7 steps described below to create an effective nonconformance report. Most Corrective Action Request Software will have these steps included.
1. Open the nonconformance report and manage the nonconformance
When you identify a nonconformance, the first step open the nonconformance report and to manage the nonconformance.
You need to do this as soon as possible after you have identified a nonconforming process or product. You can identify nonconforming products at any stage of the production and shipping process.
A nonconformity could be a product that is ready to ship or has just about arrived at a customer.
A nonconformance may also be a component that is later used in different assemblies. Identifying a product that uses the nonconforming part can be tricky. It will also be relatively costly to scrap or rework because labor has already been used to assemble it.
Unless you are very confident that an inspection process will identify every non-conforming part, you should shut down any nonconforming processes until you have identified and addressed the nonconformance’s root cause. You should manage any parts or products that are impacted as nonconforming products.
You should manage the nonconforming products every time you identify new or incorrect quality control processes. Don’t wait for the results of an investigation, a review, or for a material review board to convene, as this will probably be too late.
Companies often control nonconforming products in a Quality Control Hold. This may be a closed-off area on a production floor that holds the nonconforming product. Only designated employees can access the area. If you control the nonconforming processes or products, it will give you time to assess the nonconformance properly and make appropriate decisions.
2. Evaluate the nonconformance
The next step you need to take on the nonconformance report is to evaluate the nonconformance that was found.
Bigger organizations often do this by convening a material review board (MRB). The company determines the key players that are part of this group before nonconformance occurs.
In smaller companies, the Quality Manager does the evaluation, often together with a relevant departmental or functional manager.
An important part of the evaluation process is to control and segregate the nonconforming product if it hasn’t been done yet. You definitely don’t want the problematic part to move into manufacturing or a defective product to end up with the end user.
3. Decide on the nonconformity disposition
After you have evaluated the nonconformance, you must identify the disposition actions that you should take to correct the nonconformity. The term disposition is used for whatever action you decide to take for corrective actions.
You should be aware that disposition might mean that you don’t take any action. If a nonconformance is due to a process problem that you already know about, you may decide not to undertake a new investigation.
It is more however more likely that the nonconformity will fall into one of these 5 types of categories for disposition:
- Return to the supplier: You should use this when a supplier provides you with the wrong component or part, and it should be returned.
- Scrap: You should use this when you decide to destroy the product rather than using it.
- Rework: You should use this when the product does not meet requirements during a specific stage of quality assurance testing, but once you correct the problem, it will still meet the specifications after retesting.
- Use as is: You should use this when the defect you found is not that important. This may for example be a cosmetic flaw, and you determine that users can still use the product as intended.
- Downgrade: You should use this when you find a problem with a new version of the product after it has been changed. Until you identify and implement a solution, the previous version should be used.
You must keep track of all actions you take regarding nonconformances, even if the action you take is minimal. If you for example find that you have to scrap more products than normal, you may be looking at a process nonconformance instead of a product nonconformance.
4. Conduct a root cause analysis on the nonconformance
The purpose of doing root cause analysis is to determine the primary reason for a non-conformance. Once you know the reason, you can determine whether you need to do further investigations.
Many nonconformances likely have numerous possibilities for the root cause. Your goal is not to find any reason for the nonconformance to have occurred but to find the actual underlying reason.
Create a problem statement that includes all the information that is available about the nonconformance, including the potential and actual impact. Conduct the research required to uncover the data so you can present objective evidence as needed.
After you have gathered all the data, you must evaluate all the factors that may have caused the non-conformance. As you conduct the investigation, consult with all available experts who know the type of nonconformance, as well as employees who were involved in the processes that led to the nonconformance.
You can use various methodologies for your root cause investigation with the team, like a fishbone diagram, fault tree analysis, or five whys.
If you use one or several of these methodologies it will help you to determine the root cause. You will need to be persistent and keep exposing layers until you’ve identified the fundamental issue.
As usual, keep the nonconformance report up to date as you go through the steps.
5. Take action to prevent reoccurrences
You may take minor actions to prevent the nonconformance from reoccurring and record these on the nonconformance report. These could include things like refining non-conforming products, clarifying work instructions, or retraining activities to meet quality standards.
If the nonconformance is major and has become a systemic trend, impacts multiple processes, or is highly critical to the product, additional corrective action through CAPA corrective action preventive action may be required. A nonconformance report is a gateway mechanism for CAPA.
Any nonconformance can be reason for starting a CAPA plan if enough of them recur.
Remember that CAPAs are best used to prevent problems that are ambiguous and overly complex, have a high criticality, or have become systemic. Creating CAPAs when not required can lead to a burdensome volume of work.
6. Monitor for effectiveness
Although monitoring for effectiveness in the case where you have taken actions to correct the root cause may appear to be more passive than the other steps, it is still equally important.
You will have to monitor the products produced and your processes after you have taken action to address the nonconformance’s root cause.
The steps you took will ideally eliminate the problem, and the nonconformance won’t reappear upon closer inspection or after testing.
If it does reoccur, this means the root cause determination wasn’t accurate. If this is the case, you have to go back to step four and dig deeper to find out if there are more problems.
7. Write the nonconformance report
You should generate documentation throughout all the steps described in this article. The nonconformance report must include documents that show you have completed all the steps. You should include all actions taken during the process as well as all other relevant details.
Make sure that your nonconformance report guides its readers through the nonconformance management process. The audience could include team members that examine previous nonconformances as well as auditors. Actions should be reviewed and approved as they are taken and once the nonconformance report is finalized.
Leverage nonconformance management software to ensure compliance
Nonconformance procedures are typically defensive and reactive in nature. Quality managers often understand that a preventive, proactive approach would be better, but they are stymied. This is because they work with a system that works against them.
NCR-Software’s end-to-end system will enable you to eliminate the inefficiencies related to quality event processes by automating your nonconformance reporting process and removing excess documentation.