It simply does not matter what industry you might be working in to understand the importance of handling nonconforming product. It could be automotive, aerospace, defense, pharma, and of course Dr. D’s favorite industry, medical devices; and the need to quickly quarantine and disposition nonconforming product are the same. Waiting eight months to scrap nonconforming product and deciding to execute the disposition during an agency inspection, is just not smart.

Ladies and gentlemen, it’s football season so the doctor will employ a football metaphor to kick off this week’s guidance. The control of nonconforming product should be considered a basic element needed to support an effective Quality Management System (QMS), not unlike the need to get the basic fundamentals right in football, blocking and tackling. Unfortunately, some Chief Jailable Officers (CJO) are either not qualified or just too “fainéant” (look-it-up) to change. Regardless, failure to properly control nonconforming product, including the execution of final disposition, within a reasonable amount of time, is always going to result in a Form 483 observation from FDA. Not wanting to state the obvious but obliged to do so; “a device establishment that racks up FDA Form 483 observations during an inspection, is destined to receive one of the agency’s prized regulatory enforcement tools, the warning letter.

Enjoy! Warning Letter – 17 September 2014

This week’s grand prize winner of the FDA’s win a warning letter contest was awarded six Form 483 observations during a June inspection. Now granted, every device establishment is bound to have an occasional hiccup resulting in one or two inspectional observations. Typically, no big deal and the observations are quickly remediated. However, when something as basic as the processing of nonconforming product hits the radar screen, bad things are bound to happen. Waiting until FDA shows up for a cup of coffee and an inspection and then deciding to start tossing out nonconforming product, well that is just plain dumb!

Warning letter excerpt – Observation 4

Failure to establish adequate procedures that define the responsibility for review and the authority for the disposition of non-conforming product, which is required by 21 CFR 820.90(b)(1). Specifically, section 6.7 of Control of Nonconforming Material, SOP8.3002, Rev. 02, states that when the disposition has been completed, the NCR is routed to the Director of QA/RA for close-out. That process was not followed in the following cases:

a. Non-conformances 13-518 and 13-521 were initiated on October 10, 2013, to quarantine finished product within the warehouse due to identified THC strip issues with lot number (b)(4). Non-conformances 13-518 and 13-521 were approved for closure on October 25, 2013, and May 2, 2014, respectively. The lot of quarantined THC strips was not scrapped until June 17, 2014 (during this inspection), approximately eight months after the closure of non-conformance 13-518 and one month after the closure of 13-521.

b. Non-conformance 13-279 was initiated on June 6, 2013, due to BUP failure in negative control. A disposition of “Accept as is” was marked. However, there was no signature approval, and the product has since been used.

FDA 483 Response: Your response states that CAPAR 14-024 was opened to address the findings. Root cause was identified and a revised SOP8.3002 (Control of Nonconforming Material) will be put into place. Relevant personnel will be retrained. FDA will need to conduct a follow-up inspection to evaluate the adequacy of those reported corrections.

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

Hopefully by now, the readers of DG understand the term establish, if not read last week’s guidance. FDA expects a reasonable attempt at scripting a control of nonconforming product SOP, supported by evidence of adequate training and implementation. Additionally, the quarantine area should be a restricted access area, preferably under lock and key.

Quick story, years ago, the doctor was working at a facility where the former Director of Quality crossed over to the dark side and moved into sales and marketing. One evening, in this individual’s zest to obtain some sample catheters from the quarantine location, this individual climbed up, over, and into the locked MRB cage to retrieve nonconforming product. Needless to say, a roof was quickly added to the MRB cage.”

The moral of the story is simple; the quarantine location needs to be secure. Additionally, the procedure really does need to have clear and concise directions for handling nonconforming product. For example, the procedure should contain (as appropriate):

• The process for identifying nonconforming product (tags, labels, forms, etc.);
• The segregation/quarantine process for nonconforming product;
• The investigation/evaluation process for nonconforming product;
• The actual disposition process: (a) scrap; (b) rework; (c) return-to-vendor; (d) no problem found; and (e) use-as-is (note please use concessions with great caution as a use-as-is disposition can quickly be equated to a design change);
• Notification to personnel responsible for the nonconforming product, including a linkage to CAPA and Supplier Corrective Actions;
• Sharing the information with quality personnel, especially inspectors;
• Disposition responsibilities (who has the authority to accept on concession, etc.);
• If a Material Review Board (MRB) is used for dispositioning material, fully describe the process (including MRB members);
• The rework process, including the determination of potential adverse effects associated with rework; and
• Record retention.

Once final disposition has been made, execute the disposition. There is no good excuse for waiting several months to toss out scrap material. If it is a supplier-related problem, good luck returning nonconforming product after 30-days.

Takeaways

For this week’s guidance, the doctor will leave the readers with three takeaways. One – if all of the elements Dr. D depicted in this week’s guidance are included in the SOP for the control of nonconforming product, then as long as the SOP is followed, your organization should be in good shape. Two – never take for granted that the security of the quarantine location. Secure means under lock and key. Three – once disposition is made for nonconforming product, execute the disposition. Do not wait! Why? Read this week’s warning letter excerpt again.

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. (2013, 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’s enforcement page. (2014, September). FDA.gov Website. Retrieved September 30, 2014, From: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm415733.htm.