When my children were little, we spent a lot of time with many other young families. Having all of these playmates together was a wonderful time—until they misbehaved. We adults had a system in place called NAP, or “nearest available parent,” where we all agreed to keep a watchful eye on each other’s kids. All the children knew if they got out of line, they would be disciplined by an adult, even if that adult wasn’t their actual parent. Knowing where they were and what they were doing at all times gave the adults a great sense of peace of mind—even if it wasn’t always as much fun for the kids.
Being able to account for everything—or everyone, as we did with our children—is the key to traceability. This is especially true in the medical equipment field, where everything must be able to be tracked back to its source. When you build a piece of medical equipment, there are so many different parts, tracking them all is a major task—particularly when building a printed circuit board, as there several individual components and materials that go into the manufacturing of a PCB. We’ll take a look here at traceability requirements for medical devices as it relates to printed circuit boards, and how your contract manufacturer can fulfill these requirements.
The Importance of PCB Traceability Requirements for Medical Devices
Your PCB contract manufacturer must be able to fulfill the traceability requirements you have for the medical device you are manufacturing. What you are having built will determine which industry standard, such as ISO 13485, that you need to meet. To fulfill these requirements, a CM should have a complete understanding and be certified in the standards you are working with.
Documentation is the cornerstone of traceability, so that if there is a problem with a part or product, it will be easy to identify any other parts or products that might be similarly affected. Being able to accurately identify parts and products is an important part of being able to trace those parts and products. The FDA strictly enforces precise product identification, and therefore, it is vital that your CM has a robust identification system in place along with their tracking system so that they know what each part and product is that is being used.
This identification should also include certifications of compliance, test results, and other important electronic product data. Since many PCBA or subsystems appear similar but are configurable in either hardware or software, their performance can vary significantly and must also be precisely documented. This can save you all kinds of performance or reliability problems in the future.
Traceability also helps you as you continue to develop and improve the equipment that you are having built. The more that parts and performance are tracked, the better the performance data will be for analysis and improvement.
It’s critical to work with a CM that has the processes and certifications in place to comply with traceability requirements for medical devices.
Traceability Processes During PCB Manufacturing
The key to achieving the traceability you need is to work with a contract manufacturer that has the processes in place to accurately identify and track the information that you need. A good CM will have a work order documentation system in place for building circuit boards. The serial number that the completed board will carry once it has been built can then be traced all the way back to the original work order. The documentation system that your CM uses should include the following information on their work orders:
- Purchase order (PO) data: The work order should contain all of the POs that were used for procuring the parts and materials for the PCBA. This will include the unassembled PCB from the fabricator, components, sheet metal, cables, and other manufacturing materials. This data should also include supplier data codes when possible.
- Manufacturing process steps: It is also helpful for traceability to know the manufacturing steps that were taken during assembly. This could entail five to 15 different steps, including inspection and testing.
- Manufacturing technicians: Knowing which technicians performed specific operations also helps with traceability. If there are any questions on a PCBA, it is very helpful to know which technician to go to for further information.
To make an intricate system like this work takes several important pieces. A documentation system must be in place along with a method to assign and match up tracking numbers to products and parts that are being used by the CM. Then, there must be the ability to identify those products and parts, usually with a barcode tracking system. Finally, there has to be a database in place that can contain all of this data and present it in an organized and easy-to-understand format.
Partner with a CM That Meets Your Traceability Needs
At VSE, we have the type of identification and tracking system outlined above in place so that your medical equipment project will have the traceability you need to satisfy all of your regulatory requirements. In fact, our minimum level of traceability frequently exceeds our customers’ requirements.
Our work order traceability is handled by our customer tracking database and contains all of the PO, process, and personnel data recorded for each project. This can include dates, process times, process yields, non-conformances found, rework and repairs, and any product or process deviations and waivers.
As each technician begins an operation in the manufacturing of your board, they will scan the operation barcode as well as their own employee badge. The scanned information goes into our database for tracking along with all of the information by the technician on the results of the manufacturing process that has been completed. With all of the components and materials scanned and entered into the database as well, the work order has the complete picture of what has been done for that project. Our system is very flexible and allows us to easily conform to any unique requirements that you or any of our customers may have.
