How to Manage Non-Conformances?

05 September 2018


Blog by Ruud Lans, Quality and Regulatory Affairs Consultant
Almost every company will have to deal with non-conformances at one point, whether relatively minor or potentially major. In the Medical Devices Industry, these non-conformances can cause serious problems, and there for the way of handling such problems is important. Here are a few tips for dealing with them, or being proactive to mitigate them:

Have good supplier management practices

Suppliers play a critical role in the safety and efficacy of medical devices. They are responsible for the delivery of parts, pieces, materials, firmware or software. Even if we can’t touch and feel that firmware, there may be problems with it that can harm your circuit board.

We rely on those suppliers sending your product, which means they need to be properly evaluated and qualified. The process of evaluating and qualifying should begin before you start receiving materials and may include a survey of critical elements to assess initial suitability.

When it comes to the point of having chosen a supplier and receiving goods from them, it is about managing and monitoring them well. Keep documentation to make this easier, for example, a chart or software that allows us to track orders and the number of non-conformances per supplier.

Have good inspection criteria

We need good inspection criteria for each stage of the part’s journey; incoming, in-process and prior to shipping out. From my experience, the incoming process is often the process where inspection activities can be improved.

We do not want the products checked in and stored in the warehouses, and then three steps later in the process finding out that there are problems with the parts. There are standards available which you can apply to improve this process, such as those found with acceptance quality limit sampling plans.

An important step is to define the critical dimensions of our inspection criteria. For example, we might have specifications for dimensions shown on your drawing – usually there will be two or three critical dimensions you can check very quickly to determine if the part is good.  Identified 15 dimensions as critical is too many. Usually three to five will do.

We also have to recognise that some steps of the process require different levels of process validation. If we have such a process in place, it should be rigorous, thorough and complete. A lot of information can be found for “manufacturing process validation.”

Do a good job of design transfer

Next to being thorough about inspection criteria, we also need to be detailed and careful about describing  manufacturing criteria and requirements. Non-conformances often occur when the design transfer is not done well and when there almost is a “throw it against a wall” attitude. This mentality often means that when production receives the product, they do not understand what is involved as they were not part of the briefing.

A good way of design transfer helps prevent future non-conformances by informing manufacturing resources on the importance’s of the product. We should improve the transfer of knowledge, as this is a significant challenge for all of those involved.

Define the disposition criteria

If you have a non-conformance, there are a few paths you can take:

  • We could scrap the part, component or product.
  • Send the part back to the vendor.
  • Use ‘as-is’. This is tricky – why is your specification something else if you are willing to accept this? Should your specification be changed?
  • Rework the product. This is also tricky – we need defined processes to describe the rework. Take the time to document them and make sure you have training and inspection criteria established.

Track and trend any of these options that we use to discover patterns and help to find solutions. Any non-conformance should trigger an investigation process anyway. We need to document the occurrence, how you went about an investigation and any actions we took to remedy the situation.

Occasionally, a non-conformance might move forward to trigger a CAPA, although remember that this isn’t always the case. It’s relatively rare for a nonconformance to escalate to a CAPA because usually, you can manage it through your regular nonconformance process. CAPA might be triggered when you see the same non-conformances repeatedly, which may indicate a systemic issue. This further highlights the importance of tracking and trending our non-conformances – more work needs to be done to identify root causes if your regular process is not remedying the non-conformance.

As an example, perhaps we find that a certain part keeps breaking during the manufacturing process. The part comes from a supplier and you opt to send parts back to them. When the same problem keeps occurring you trigger a CAPA and initiate an investigation into root cause. Perhaps we find that the wrong alloy was used in creating the part, so it is not strong enough for the defined purposes. We would then examine the specifications that the supplier should ensure they are correct and would work with them to ensure that you are getting correctly made parts.

We want to thank Ruud Lans for his time and sharing his knowledge. Can you relate to Ruud’s story, or do you have a different way of dealing with non-conformances? Share your story with us via or call us on 023-7548660

Ruud J. Lans, MSc BSc, Consultant Quality & Regulatory Affairs, Certification and Certified Lead Assessor

Sources: ISO 13485:2016, ISO 9001:2015, ISO 14001:2015, 21 CFR 820, 20 QSR, MDSAP, MDD/MDR Network discussions, opinions, governmental publications, newsletters, et cetera.

Image by Shutterstock


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