Recently at work, we faced that most real time products coming out of the chamber were dictated as non-conforming upon pressure decay testing. At first, R&D engineers thought that probably the technician was not performing the test as specified in the test instruction. Nevertheless, after trying the test by themselves, they found out that the product was failing. Then quality engineers got involved in this issue since non-conforming products under real time testing are a delicate matter due to the fact that this product is already in the market. It turned out that the instrument used for this special test has been sent for repair four times already. Therefore quality decided to start a CAPA investigation, which is still undergoing, in order to find out the causes in which the machine keeps on failing and keep this situation from happening in the future. I think and believe this is the case in which a product was deemed as non-conforming but was caused due to the malfunctioning of the instrument.

In addition to your the previous input, it would depend on the type of nonconformity. For example, after googling examples. I became aware that that there are three types of nonconformities: minor, major, and critical.

Minor nonconformity would be when the durability, interchangeability, reliability, maintainability, or effective use of a product are not adversely effected. And if there are two many minor nonconformities than it would result in a critical or major nonconformity.

Major nonconformity results in failure or reduced usability of the product of the intended purpose.

Critical nonconformity results in hazardous or unsafe conditions individuals using it.

And when you see the types of nonnconformities, it actually gives us an idea of how well regulated the project itself was. If its a critical type, then research and development did not do a great job and the product can be brought back to them. And this would also raise legal issues if this product was to go on market. So if you are able to determine if the nonconformity is minor, major, or critical you will have a good idea of which phase or process to go back to.

From my experience with a CAPA usually an ER is filled out with the non-conformity which initiates the CAPA process. An example that occurred in my company was a minor one but there was a labeling issue due to a change in a requirement in the asian market. There were already products in stock out with distribution, so there were steps taken through the CAPA procedure to print new labels for that specific market. As well as, deciding on a way to identify any products that were getting shipped out to customers with the old label on them since they were already in inventory with distribution.

I have personally dealt with a non-conformity, on a material that we manufacture, the material failed one of the critical inspection areas within Quality assurance, which opened an investigation to find the route cause of what caused the failure within the manufacturing aspect. A CAPA was opened to address the problem and correct it.

Non-conforming materials is a very common issue that almost all manufacturers deal with on daily bases. it ranges from regular suppliers to product coming out of the line that does not meet specifications. The most recent non-conformity that have dealt with was when parts from a certain supplier started failing incoming inspection due to the presence of moisture. A root cause investigation was initiated to determine the cause of moisture getting into the device, despite all the parts passing all shipping tests earlier. The root cause investigation revealed that the heat sealer that is used by the supplier to seal the device was not covered while not in use, which led to dust to accumulate on the sealing line, thus creating an imperfect seal when use. A corrective and Preventive action was issued to the supplier to correct the failure and to prevent such problem from reoccurring

As tn58 mentioned that there are three types of nonconformances: minor, major, and critical, I would also say that another huge factor that determines the type of nonconformance is when the nonconformance was found. If it was caught prior to the product being released to the field, it will greatly reduce the criticality of the nonconformance and the corrective action of the resulting CAPA should be relatively easy, since all the product is contained. However, if the product was released, the corrective action of the resulting CAPA becomes very difficult, because you have to try to track down the product in the field and it may result in field actions or recalls.

At my company most non-conforming issues usually stem from either operator mistakes or product not conforming to QC testing.

When non-conforming issue occurs due to operator error an investigation is initiated. The investigation report usually entails a 6M (Man, Method, Material, Measurement, Mother Nature (Environment), and Machine). The operator usually makes a mistake with documentation, forgetting a step in the batch record, or conducting a step in correctly. After the investigation is complete an update to an SOP or a batch record is done. The investigation concludes it was Man as the root cause. This doesn't require a CAPA.

When something fails QC testing such as a device failing dimension specification an investigation is also initiated. If, for the example, the conclusion of the investigation states its Machine related, then a CAPA is usually opened to initiate a change to the machine. At my company we had some devices failing QC dimension specification as the product was falling out of specification after the product was "cut". Therefore, a CAPA was opened to replace the blades that were cutting the product to new blades.

Recently, we received notification of a nonconformance within our instructions for use document which is sold in one of our major product lines. It escalated to a CAPA and HHE. A section of the document was inadvertently omitted. A complete analysis of all the products sold with that instructions for use document was completed along with a complaints analysis. Luckily, no complaints were associated with the nonconformity, Immediate containment actions were placed, and the omission was corrected. Rework procedures were created specifically for the nonconformance. In this case, the nonconformity resulted in many serious and fast paced decision makings. Never worked on a project which had such high scrutiny and stress because of the risk that could have resulted from the nonconformance.

In my experience with nonconformance with one of our products, it was related to an issue that was identified through receiving feedback from our QC team. In addition, this finding matched with the findings discovered from our field technicians that provided technical support to our clients. Once this issue was discovered, we documented the number of complaints and began to initiate a CAPA with regulatory, QC, and R&D. We had to establish the severities of the problems and how to fix the problem and formulate a preventative action plan. This would trigger an SOP for QC to follow along with R&D to ensure the problem can be recreated and fixed. A rework would not be involved because the problem was related to only a few units since the device was being beta tested, this caused these units to return to fix the problem. Once again, this puts high emphasis on the importance of testing medical equipment prior to release. The problem here was related to a grounding issue that caused interferances to the results of the test that the device was intended to do.

Non-conformance can occur at any point in the production process, and this does not always indicate the need for a CAPA. A non-conformance for a singular unit of the device can just indicate a minor human error from an operator. This non-conformance can be fixed through a rework unless the problem is too big to salvage the product, in which case it would have to be scrapped. CAPAs occur if there is something inherently wrong with the process itself and a CAPA could prevent future non-conformance. CAPAs kick off a series of changes in the QMS, starting with the problem itself and webbing out into many different procedures and work instructions and even specifications to fix the problem consistently throughout.

Usually, non-conformities occur during the production process but from what I have experienced it is usually a minute error by a production worker on the production line. Usually, the product is salvageable but it can be scrapped. However, in a procedure incident, there was a non-conformity which lead to a CAPA. Depending on the severity and if the occurrence of the problems is repeatable or not is relative to the investigation which.

A couple of weeks ago my company had to place product on hold and initiate a CAPA because of nonconforming product. At a high level, a custom component from a supplier was not made to specification and was used to make the final device. Thankfully, the bracketed product was not shipped to customers so we were able to quarantine all affected devices immediately. However, we had to assess the risk of the non-conforming component to the device performance and function as well as the risk to patient/user safety before taking the product off of hold. The CAPA investigation highlighted that the supplier polished the tool used in the validated process and this seemingly harmless activity, actually manifested into a huge problem for us.