In a perfect world, money grows on trees, good bourbon flows freely from the garden hose, Cuban cigars are legal to smoke, and the San Jose Sharks win Lord Stanley’s Cup. Unfortunately, Mr. Murphy is alive and well in the medical device industry, and as a result it is inevitable that device manufacturers will have to handle non-conforming product. If a device manufacturer has “exiguous” (look-it-up) policies and procedures for handling nonconforming product, then it will never be a question as to if FDA will pay a visit but when the FDA will pay a visit to the device manufacturer’s facility
The effective handling of nonconforming product is essential for all device manufacturers. Identifying, quarantining, investigating, and correcting are salient steps that need to be completed when dealing with nonconforming product. Trust Dr. D when I say, “the mishandling of nonconforming product can be costly, may result in product withdraws (RECALLS), and invite a surprise visit from FDA.”
Identification is only a small piece to solving the handling of nonconforming product puzzle. The best guidance Dr. D can offer to the readers is to invest in developing an effective process for managing nonconforming product. The process should include:
- Robust procedures;
- A well-designed form, e.g., Non-conforming Material Report (NCMR);
- A link to CAPA;
- A clearly-defined process for disposition;
- The creation of nonconforming-product tags;
- A segregated storage area (restricted-access quarantine location);
- Instructions for rework;
- Supplier notification or supplier corrective action request (SCAR), if warranted;
- A policy for returning nonconforming product to the supplier; and
- A Material Review Board (MRB) process.
Control of nonconforming product
The need for an investigation, root-cause analysis, and the notification (when applicable) of the appropriate organizations (internal and external) are required when nonconforming product is identified. If the nonconformance is determined to be external, a.k.a.
, supplier generated, a SCAR (please read last week’s DGII for guidance
) should be issued to prevent a recurrence of the nonconformance. Additionally, ensure all SCAR activity is closed with a verification of effectiveness step; otherwise, history will repeat itself, just ask Mr. Murphy. Furthermore, all of these activities shall be documented. Why – “because documented evidence of compliance is your best defense during a friendly visit from the agency.”
Nonconformity review and disposition
For starters, you should never have manufacturing be the sole authority for providing disposition of nonconforming product. As a minimum, the doctor recommends including (a) manufacturing, (b) purchasing, (c) quality, (d) supply chain, (e) R & D, (f) manufacturing engineering; (g) quality engineering and (h) the janitor (just kidding on the janitor)
. Extended reviewers, employed as necessary, can be (a) clinical / medical sciences, (b) marketing, (c) sales, and (d) the cafeteria staff (sorry, just kidding again on the cafeteria staff)
Additionally, all dispositions require more than just names; signatures and dates are also needed. Furthermore, Dr. D STRONGLY RECOMMENDS that use-as-is (UAI) never be used for Class III devices. A UAI disposition implies product does not meet specification and a conveyance is required to accept the product. In short, the nonconforming product now meets a different specification, probably wider. This equates to a design change. Now you can argue with the doctor until the cows come home, but you will never win this argument. Why? Because design changes made to Class III products require a PMA supplement (as a minimum) and subsequent review and approval by the agency. The doctor’s recommendation will always be to rework nonconforming product to print, scrap and remanufacture, or return the nonconforming product to the supplier (with a nasty gram of course). The regulatory risk is just too high. Finally, document the results. Why? Broken-record time; “because documented evidence of compliance is your best defense during a friendly visit from the agency.”
Rework of nonconforming product is an area where Dr. D sees device manufacturers often getting themselves into trouble. You already know Dr. D’s position on UAI. That being said, rework, which means reworking nonconforming product to established and approved specifications, is a viable option. As part of the rework process, the agency’s expectation is that the product be retested and/or reevaluated to ensure compliance to the product’s approved specification is achieved. If the current product specification is not approved or has been changed and not approved, your organization has other issues. These issues will quickly be exacerbated when the agency stops by for a cup of coffee and an inspection.
Reworked product needs to be assessed for potential long-term impact to product performance, a.k.a., product safety and efficacy. What? For example, let say a finished-device lot has been sterilized employing Ethylene Oxide (EO). While attempting to load the finished devices onto a truck for shipment to distribution, a forklift driver (true story) has managed to attack a pallet containing the product with the forks of the forklift. As part of the disposition, it has been determined the product will be inspected, repackaged, submitted to EO sterilization for a second time, and released for distribution. If the finished devices were only validated for one sterilization cycle (1X), you now have a problem. That is why all aspects of the rework need to be evaluated. Furthermore, all rework activities shall be documented and placed into the Device History Record (DHR).
Finally, Dr. D recommends the DHR be maintained in a pristine condition as accuracy counts. Trust me, FDA will look at your DHRs and use the review as one of the stepping-off point for their inspection, along with CAPA. Remember, the DHR contains the entire manufacturing history for each device or lot of finished devices. Finally, a complete and accurate DHR is extremely important; “because documented evidence of compliance is your best defense during a friendly visit from the agency.”
Dr. D cannot place enough emphasis on not taking shortcuts when it comes to the handling of nonconforming product. Managing nonconforming product effectively begins with the creation of a robust written procedure. Other important aspects associated with the control of nonconforming product are: (a) clear identification of all nonconforming product; (b) restricted-access quarantine locations; (c) a well-defined disposition policy; (d) MRB meetings; (e) the use of clearly-defined rework instructions; and (f) a link to the device manufacturer’s CAPA system (internal and supplier).
In closing, the doctor hopes you have found some value in this week’s guidance. Cheers from Dr. D. and best wishes for continued professional success.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- Devine, C. (2012). Devine guidance for complying with the European medical device directive – MDD. Charleston, SC: Amazon.