Welcome back to another installment of MedTech Compliance Chronicles! Over the past few posts, we've been diligently ironing out our product and production requirements, ensuring that everything meets stringent standards. But what happens when something doesn't quite measure up? In this week's post, we'll explore the essential topic of nonconforming products, examining the necessary steps and regulatory guidelines for managing products that deviate from established specifications.
Any organization planning for the future needs to be realistic about its operations. It is an unfortunate fact of life that things never go perfectly 100% of the time. As such, an organization that has an effective means of dealing with issues as they happen will be much more capable of adapting as time moves forward than those who wait for issues to happen before determining how to deal with them. This is one of the basic ideas behind developing a QMS period, but a particularly important idea behind the control on nonconforming product. Defining a procedure for the control of nonconforming product is the organization preparing a plan for what will be done when things do not go according to plan. As with the rest of the QMS, the specifics of how you do it are up to you but there are some general requirements laid out that must be met each time a nonconformity is detected. These requirements relate to the identification, segregation and disposition of the product, as well as any rework that might be necessary to perform on the product.
Identification & Segregation
These first two requirements for nonconforming product have been alluded to in prior posts. The first step when encountering anything that fails to meet its requirements is to clearly mark the item such that it does not accidentally get used while its disposition is being determined and any necessary investigations are taking place. The next step is to segregate it from other conforming or in-process items. This is one part of US FDA regulations where a separate inventory/storage location is an actual requirement. There are many reasons to physically separate nonconforming product from conforming product. Some examples include preventing contamination such as with chemical mixtures or clean controlled processes and further preventing the unintended use of nonconforming product. The segregated area will often be an area frequented by QC personnel and not manufacturing personnel which will both facilitate the investigation of the nonconformity and prevent the products use. While not a requirement, it is common practice at larger organizations with a lot of personnel to keep the nonconforming product quarantine area locked with QC personnel holding the key.
Disposition
After the nonconformity has been identified and segregated the next step is to determine its disposition. This is just the formal wording of “figure out what to do with it.” Ultimately, ISO provides three, high level options to deal with nonconforming product; eliminate the nonconformity, preclude it from its original intended use or accept its use under concession. What to do with a nonconforming product depends on a couple of factors. First, what is the risk level of the specific nonconformity? Second, is it possible to fix or use as it currently is? And if so, is it safe to do so? Finally, was the nonconformity detected before or after the product left your facility?
All nonconformities require a documented determination of whether or not an investigation is necessary. What determines if an investigation is necessary or not is typically a combination of the risk of the nonconformity and what is known about what causes the nonconformity to present itself. When the cause of a nonconformity is known, investigations as to why they happened are usually restricted to high risk nonconformities. When the cause of a nonconformity is unknown it may be necessary to investigate medium and even low risk nonconformities. It is also more common to perform investigations when the nonconformity was able to leave your facility, as this means that it slipped through all of your in-process and final acceptance inspections. A future post on complaint handling will go more into this topic.
The next step is to determine whether or not the product is still capable of being used, either by rework or as it currently is. In ISO terms, rework would be eliminating the nonconformity and using it as it currently is would be accepting it under concession (except for the case where there is no real nonconformity and the product was mistakenly identified as nonconforming). Rework will have its own section to follow. When accepting a nonconforming product under concession, due care must be taken to the justification for doing so and all regulatory requirements for the product must still be met. The rationale for accepting the product, as well as the person who made the decision must be recorded.
Rework
Sometimes when a product is nonconforming, there are things that can be done to make it conforming. This process is called rework. A quick side note on the difference between rework and repair. Rework ensures the product conforms entirely to its original or revised specifications while repair is returning a product to a usable state without necessarily fully meeting original specifications. The requirements for rework are designed to ensure that reworked products are as reliable and safe as those that initially met specifications. To meet this intent, the rework requirements are quite similar to production process requirements. Rework must be performed according to documented procedures that were reviewed and approved in the same manner as the original production process procedures. Reworked product must also be verified to meet its specifications.
In addition to the basic procedural requirements there is a little more thought that goes into reworking product. First and foremost is, of course, the risk the rework poses to the product. You must analyze the risk of a rework process with the same scrutiny that you did on the original production process, paying particular attention to aspects that could be impacted by the rework. For example, many heat treatment processes are time dependent and it may not be possible to put the same part through the whole process twice without significantly affecting material properties. Additionally, any reworked product incorporated into a final device must be noted on the device history record (DHR).
Now you may be thinking “these sound like nice requirements but nonconformities happen unexpectedly, how am I supposed to have approved documented instructions for how to correct them?” This is a perfectly normal and appropriate question, so let’s answer it. The FDA expects manufacturers to have documented procedures for managing nonconforming products, including rework processes. However, flexibility is allowed for unforeseen nonconformities. It is not expected that all possible nonconformities will be identified and have pre-developed rework instructions. Instead, the focus is on common and foreseeable nonconformities. However, this does not preclude unforeseen nonconformities from the requirements. When such cases occur the organization must simply do their due diligence to perform the risk analysis and document a procedure as quickly as possible.
Conclusion
You should now have an understanding of the requirements around controlling nonconforming product. The control of nonconforming product requires that any product not meeting specified requirements must be identified, documented, and segregated to prevent unintended use or delivery. Corrections, including rework or repair, must be based on a risk evaluation, ensuring that the product meets all regulatory and safety standards before release. The intent is to maintain product quality and patient safety by ensuring only conforming products reach the market.
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