Hello all and welcome back to another week of MedTech Compliance Chronicles. As we continue down our path to product realization we are beginning to break out of the conceptualization parts of things and starting to work with real, physical product(s). As such, this week’s topic will be on a very crucial but sometimes hard to get right concept: Identification and Traceability. What identification and traceability are is fairly straightforward, they essentially boil down to how your organization keeps track of all of the parts/components to make devices and the finished devices themselves. This is one topic where we will explore a bit more on how to actually meet the requirements and go into more practical examples as the actual requirements here are fairly short, it is in the implementation of them where confusion sets in.
Identification and traceability requirements serve critical roles in the medical device industry, ensuring that products are consistently manufactured to the highest standards of quality and safety. These requirements help manufacturers, regulatory bodies, and healthcare providers maintain a clear record of each device's journey from production through to end-use. These requirements also tend to be critical aspects in the facilitation of recalls and adverse event investigations.
Identification
Identification is as simple as it sounds. The requirement is that suitable means are used to identify the product (or sub-assemblies, components, etc.) throughout all stages of product realization. The goal of this requirement is to prevent mix-ups during production and, ultimately, the use or release of nonconforming product.
There are three main things to consider when thinking about identification requirements. The first is what is being identified? This usually takes the form of a part number for the item in question. The next thing that must be clear is where in the process is this item at? For example, if the same part is processed through multiple processes before becoming or being incorporated into the final device, it should be clear which of these processes have already been performed and which have not. This is where some creativity enters the identification process. You can accomplish this requirement in any way you choose so long as it is effective. Some common methods are having a traveler (sometimes called a router or a work order depending on your organization) travel with the part throughout production where the personnel performing each process mark off what has been done already. Another common method, if your warehouse space allows, is simply clearly segregating inventory locations and storing parts in different locations depending on what processes they have already been through. The third and final aspect that must be identified is the part’s acceptance status. Inspection of product is required by the FDA at various points throughout production. The specifics will be covered in another post focused on inspections but for identification purposes, whether the product has or has not already been inspected and, if it has, whether it has or has not passed inspection must be part of the identification.
Whichever method you choose for identification, remember that the objective is to be able to walk up to any part in the warehouse and, without having to go do a bunch of digging, know what it is and what has been done to it. Of note, when it comes to product that has failed inspection, though technically not a prescribed requirement, it is common practice to have a dedicated, segregated inventory location for nonconforming product. Oftentimes this segregated location is also kept locked and only opened by quality control personnel.
Traceability
Traceability requirements are mostly applicable to implantable and/or life supporting/sustaining devices. There are some general traceability requirements for all devices but those tie into the more general labeling and unique device identification (UDI) requirements, which will be the focus of future posts. The goal of traceability is to facilitate effective corrective action if something goes wrong in the field.
The general concept of traceability means being able to track the history of the device from receiving of raw materials/components to the end user. This ties into identification and depending on how you set up your identification system you may have it set up to meet traceability requirements already. However, not all systems of identification facilitate traceability. The idea is that, say you receive notice that device A experienced an issue in the field. Based on the issue, you deduce that the issue must have been present before leaving your facility. You now want to investigate what went wrong with device A. The first step of traceability is having a system of identification for the end devices back to their release documentation. This is almost always in the form of a UDI (sometimes called a serial number). If there is nothing clearly wrong with the final release documentation your investigation might lead you further back in the processing history. This would require that the final release documents include some type of reference to other records of device A (or components of device A) further back in production. You have full traceability when you can do this all the way back to the specific lots of incoming materials that make up the device. These records should be set up to give you dates, times, individuals performing certain actions, etc. and if nothing turns out wrong on your organization’s end, should show you which suppliers you need to contact about issues with their supplied product.
Traceability is most easily accomplished by having a form that is filled out and kept as recorded information with each process a component goes through until it is a final device. The forms will uniquely identify the input materials (with receiving report #’s, lot #’s, etc) and then also uniquely identify in some way the output of the process. Traceability is much harder to keep when identification methods are primarily accomplished via physical inventory locations because once the product has left the location in question it is hard if not impossible to identify where it was and at what days/times it was there.
Remember also, that traceability is risk based. You would need not require the same degree of traceability for a screw holding the outer housing together on a dialysis machine as you would for a screw that is drilled into a bone during a surgical procedure. Another important note is that traceability must be to the finished device. Therefore, if your organization’s business model is such that you have third parties who distribute your devices, part of your controls (see last week’s post on purchasing controls) on these distributors is that the distributor must keep records of device distribution and make them readily available for inspection.
Conclusion
All processes ultimately produce some amount of errors. While it is not possible to be perfect, it is possible to be orderly and disciplined in an effort to minimize such errors and, in doing so, it will also help in identifying the sources of errors when they do occur. Identification and traceability requirements are essentially the requirements the FDA has put forth to ensure that medical device manufacturers are operating in an orderly fashion and that dedicated efforts have been made to prevent mix-ups in production. When things do go wrong, these requirements also serve as a means to facilitate timely response.
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