Take the ISO 9001 course exam and get the ISO 14001 or ISO 13485 course exam for free
LIMITED-TIME OFFER – VALID UNTIL SEPTEMBER 30, 2021
  • (0)
    ISO-9001-blog

    ISO 9001 Blog

    Five steps for ISO 9001 non-conforming products

    Do you have difficulty with deciding what steps to follow to best deal with non-conforming products? Do you have trouble seeing how making sure this is done well can save time and customer loyalty? The process for non-conforming products is one of the most critical processes to understand and get right in your Quality Management System, in order to sustain control of customer expectations when the delivery of products or services does not go according to plan. Having a process to handle this well is essential in order to maintain customer satisfaction in these situations.

    Steps in the Non-conforming Products Process

    Companies may have many different procedures and forms in place to deal with non-conforming products, but the basic process distils down to five main steps. You need to properly identify the problem, contain it, disposition the product or service, carry out the decided disposition, and finally, decide if a corrective action is needed to prevent recurrence. Below is an explanation of the five main steps in the Non-conforming Products process.

    1) Identify

    What is the non-conformance? What was expected? If a product is made of aluminum, but should be stainless steel, or the service time should be within 5 minutes and it is taking 10 minutes, this needs to be identified. Addressing the non-conformance may rely on knowing not only what is found, but what was expected. It is often equally important to know what the problem isn’t, such as identifying if it has already been determined that this is not a repeat of a similar problem that has previously been found. Properly identifying the problem up front can prevent wasting time and resources looking at the wrong thing.

    2) Contain

    What do you need to do to fix the problem on this process right now for any products or services that are still being produced? Are there any other processes that might have a similar problem occurring, or could have if not prevented? Basically, what do you need to do to keep the problem from spreading? This can mean adding an additional inspection after the process to check for the problem on future products or services, or checking other products or services that were already created by the process. Additionally, if it is immediately evident that a certain parameter of the process has changed (such as the running temperature of a machine), then correcting this back to the previous setting would be a containment action.

    3) Decide on Disposition Option

    This is the step where you decide what to do with the non-conforming products. There are several options that you can choose from:

    Eliminate the non-conformance: By applying rework to the product or service, you can bring it back to fully meeting the requirements. The main difference between a rework and a repair (identified below) is that the non-conformance is fully eliminated to be compliant with a rework, but it is only eliminated enough to make it usable with a repair. Finding a bracket with holes that were too small and drilling them bigger to meet a drawing would be an example of a rework.

    Authorizing use: If there is a concession from the requirements and the product or service is useable, although not fully compliant, then you can accept to use the product or service as is. Sometimes a repair to the product will be required to change the product enough to make it usable, although it will not fully meet the requirements. If a bracket has holes out of position, you could make the holes into slots so that the part fits in place. This would be an example of a repair.

    Preclude original use: This is when you decide to either scrap the product or to re-grade the product or service (such as product sold as seconds).

    4) Correct per Disposition

    This is simply doing the actions you decided to do in step 3. If you are accepting the product or service as is, then allow it to continue. If you are reworking or repairing something, have the steps carried out to do so as planned (and make sure it is re-verified afterwards). If you are using the unit to sell as a second, how do you identify it so that it ends up being used properly at the end of the process?

    5) Corrective Action

    Finally, after deciding how to fix the product or service, take a look at why the non-conformance happened, and try to find and fix the cause so that it doesn’t happen again. If there is an error in the instructions that caused the problem, get the instructions fixed. If a program bug caused a service error, fix the program. If you have found that a part of the machine is wearing out, implementing a preventive maintenance check on that machine could go a long way toward helping prevent similar problems in the future. If this is a recurring problem, then maybe switching the investigation over to the Corrective Action process would allow for greater improvements. Often, the Non-conforming Product process is the biggest input to the Corrective Action process.

    ISO 9001 Non-conforming Product: Steps for customer satisfaction

    Why Customer Satisfaction depends on this

    As one of the most important processes in the QMS, the Non-conforming Products process must be well planned and followed to ensure customer satisfaction. In many ways, customer satisfaction doesn’t just depend on what is expected at first, but also on what is done when the expectations aren’t met. Think about how many times there was a problem with your food at a restaurant, and how important it was that the server took care of the problem right away. If this was done well, you likely visited the restaurant again, but if it was done poorly, you may never return. This applies to all products and services: dealing with problems correctly can keep customers coming back, but doing a poor job will drive them away.

    Enroll in this free online training: ISO 9001 Foundations Course to learn more about nonconformities.

    Advisera Mark Hammar
    Author
    Mark Hammar
    Mark Hammar is a Certified Manager of Quality / Organizational Excellence through the American Society for Quality, and has been a Quality Professional since 1994. Mark has experience in auditing, improving processes, and writing procedures for Quality, Environmental, and Occupational Health & Safety Management Systems, and is certified as a Lead Auditor for ISO 9001, AS9100, and ISO 14001.