Folks, this week Dr. D is going to tackle an often overlooked topic by device manufactures, Identification and Traceability. In fact, many device manufacturers completely ignore establishing high-level procedures for Identification and Traceability and attempt to nestle the requirements into a variety of material handling, production control procedures, and work instructions. Guess what, this approach is absolutely driving FDA investigators and notified body auditors completely bonkers.
Now please hear the old doctor out, I am not saying it is not okay to place granularity specific to identification and traceability into procedures and work instructions. Dr. D is saying to take the time and create a high-level SOP to address the requirement from a regulatory vantage point. At the end of the day, you will be thanking Dr. D as this approach facilitates smooth inspections and audits. Remember the doctor has never been accused of being quiet or “demure” (look-it-up), so when Dr. D strongly recommends that a procedure should be scripted specifically for Identification and Traceability, just do it!
Subpart F – Identification & Traceability
Each manufacturer shall establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mix-ups.
Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components. The procedures shall facilitate corrective action. Such identification shall be documented in the DHR.
ID & Traceability
So what in the heck does an Identification and Traceability procedure need to contain? Let’s start with the identification of a process for assigning lot/batch (note: lot and batch are typically considered to have the same meaning) numbers upon material receipt. The good news is that most MRP systems have the capability of doing this upon receipt. Make sure that the Bill of Materials (BOMs) employed for assembling kits needed for production are accurate and contain actual material lot numbers. When shop floor paper work is created for finished medical devices (i.e., production travelers or routers) ensure that this documentation also has a unique lot number. Remember the expectation is that traceability for finished medical devices be maintained from the finished device back to raw materials employed in the manufacture of the device. This is specifically true for implantable devices. For manufacturers of capital equipment, e.g., radiotherapy systems, a serial number is usual employed as the system identifier. However, traceability for critical components is required back to the lot number.
Another important aspect of a functioning identification and traceability system is the identification of conforming/acceptable materials, lots, and systems versus nonconforming materials, lots, and systems. It is never a good idea to have accepted and rejected materials in the same general location. Dr. D recommends have a quarantine location (preferably locked) for all nonconforming location. Another valuable tool is line clearance. It is imperative that effective line clearance practices be employed through all aspects of production. Remember, mixing parts and lots is always a bad thing. Guess what? Without effective line clearance, it is just a matter of time when the wrong components, adhesives, or even expired adhesives will be used. It happens and without effective line clearance practices it will continue to happen.
So why is Identification and Traceability so darned important? Well if one has to ask the question, one has not been in industry for too terribly long. Can you say Recall (Dr. D’s favorite 6-letter word)? You see, Dr. D’s old Irish pal Mr. Murphy is alive and well, living in the medical device industry. Mr. Murphy’s ongoing presence ensures that there will be occasional issues with medical device that make them less safe and effective. If a medical device starts hurting patients and/or users, the manufacturers must quickly act to remove suspect product from the market place. If the problem can be traced to a specific device lot or a specific component lot, the recall activities and subsequent recovery of product can be very specific, which results in reduced exposure for the device manufacturer. However, if product identification and traceability has been poor, then it’s game over. The device manufacturer will need to recall all products. The fiscal impact and pending loss of market share can be devastating to an organizations bottom line, while resulting in a windfall for their competitors.
For this week’s guidance, Dr. D will leave the readers with one takeaway. Instead of attempting to rationalize why your current approach to identification and traceability is acceptable, just bite the bullet and script a high-level SOP. For those of you that have invested the time and generated such a procedure, you can pass go and collect your $200. For those of you that are still discussing the finer points of identification and traceability, what are you waiting for? It is time to stop talking and start typing. In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success.
- Code of Federal Regulation. (2012, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.