Bag it and tag it! It really does not get much easier than that when there is a need for segregating non-conforming product. Now granted, there are additional steps when it comes to the actual disposition and the need for an investigation. However, it is the doctor’s humble opinion (wait a minute, Dr. D has no humble opinions) that no device establishment should ever receive a Form 483 observation for the failure to control non-conforming product. Never, never, never! For this week’s guidance, Dr. D will provide some really simple steps that need to be taken when managing non-conforming product. However, for establishments failing to have a robust process for the handling of non-conforming material, it will serve no purpose to have your Chief Jailable Officer (CJO) fulminating (look-it-up) over the issuance of a Form 483 from your friendly FDA investigator when such transgressions occur. After all, FDA has appeared in your lobby for that friendly cup of java and an inspection. Enjoy!

Warning Letter –  November 2, 2015

There was nothing spectacular about the warning letter issued to the subject of this week’s guidance. However, the failure to control non-conforming product has always been something that kind of disturbs an already-disturbed Dr. D. Seriously, how difficult is it to place a tag on some bad product, open a non-conforming material report (NMR), place the suspect product under lock and key, and perform an investigation into how the non-conforming product actually became non-conforming? Unfortunately, the winner of this prized agency warning letter failed to recognize some these key steps, including the providing of a deficient response to the agency. Please remember, bad things always follow deficient responses to inspectional observations.

Warning Letter Excerpt

Observation Three: “You failed to adequately establish procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).”

“Our inspection has determined that your firm did not establish adequate procedures to control product that does not conform to specified requirements because your firm continues to distribute Triton FP infusion pumps with potentially (b)(4) as a result of your failure to determine the root cause for the defects. You also failed to establish procedures for proper equipment maintenance as demonstrated by the malfunctioning equipment (asset (b)(4)) used for testing the (b)(4) prior to finished product distribution.”

“Your response is inadequate to address our concerns as demonstrated by the following…”

21 CFR, Part 820.90 – Nonconforming Product

“(a) Control of nonconforming product. Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented.

(b) Nonconformity review and disposition. (1) Each manufacturer shall establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product. The procedures shall set forth the review and disposition process. Disposition of nonconforming product shall be documented. Documentation shall include the justification for use of nonconforming product and the signature of the individual(s) authorizing the use.

(2) Each manufacturer shall establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the DHR.”

Compliance for Dummies

My dear readers, not wanting to state the obvious but obliged to do so: Device establishments are required to script a procedure that captures all of the requirements delineated with §820.90. For example, FDA expects establishments to: (a) identify, (b) document, (c) evaluate, (d) segregate, and (e) disposition non-conforming product. These steps should be clearly spelled out in a procedure. In fact, these should be the titles of each section.

Additionally, the FDA expects investigations into non-conforming product to be thorough, including the identification of root cause. If the non-conformance is driven by a supplier issue, the FDA expects that the supplier is notified. Use the Supplier Corrective Action Report (SCAR) process (Dr. D loves the acronym SCAR). Furthermore, the potential dispositions should also be placed in the written procedure. For example, typical dispositions include:

• Return to Vendor (RTV)
• Rework to Specification (RWK)
• No Problem Found (NPF)
• Scrap (SCP)
• Use-As-Is (UAI), which is considered a concession

The doctor would like to warn the readers about the pitfalls associated with accepting non-conforming product by concession. Simple stated, UAI could imply a design change has occurred. For example, if dimensions are widened, this change could imply a change to the product specification. Be prepared to defend the dimensional change. To protect your establishments, please ensure regulatory affairs reviews and approves all UAI dispositions. The regulatory affairs person will decide as to whether the FDA needs to be notified (PMA supplement, special 510(k), etc.

Finally, make sure the holding cell (the doctor actually means quarantine location) is under lock and key. Years ago, the doctor remembers that a sales/marketing director (a former quality guy) climbed the walls of the quarantine cage to retrieve a catheter. Within 24 hours, a top was installed onto the cage. All kidding aside, the FDA takes the control of non-conforming product very seriously. They want to ensure non-conforming product never makes its way into distribution, including suspect components that can potentially impact the safety and efficacy of finished medical devices.

Takeaways

For this week’s guidance, the doctor will leave the readers with two takeaways. One: FDA expects establishments to: (a) identify, (b) document, (c) evaluate, (d) segregate, and (e) disposition non-conforming product. However, it is never enough to just have the procedure; the agency actually expects device establishments to adhere with the procedure they script. Two: There is nothing like an old-fashioned cage or cabinet with a really strong lock to keep non-conforming product segregated. If you have a quarantine cage, the doctor recommends placing a top on it or electrifying the surrounding fence. Well maybe not electrifying the fence (a potential OSHA issue). 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.

References

1. Code of Federal Regulation. (2015, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system   regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
3. Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
4. FDA. (November 2, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. WalkMed Infusion, LLC. Accessed December 16, 2015. Retrieved from: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm474240.htm