Dr. D would like to start this week’s guidance by wishing all of the Marines that read Devine Guidance, a Happy 239th Birthday. Additionally, Dr. D would like thank all of the veterans that served this great nation and hope you had an enjoyable Veteran’s Day with your loved ones.

An old friend of mine (Frank Pokrop) sent me an email last week pointing out a particularly poignant warning letter issued by our friends at the agency. Like most warning letters, the infamous “adulterated products” claim is clearly stated. However, what really captured Dr. D’s attention were the 735,385 non-conformances identified by the offending establishment that were not evaluated. Are you kidding me? 735,385 not being evaluated is just sheer lunacy. Dr. D guesses that when FDA delivered the “trenchant” (look-it-up) truth, the Chief Jailable Officer (CJO) must have experienced an eye-opening epiphany of the bad things about to happen to his or her establishment.

Considering the handling of nonconforming products and non-conformances, as a whole, is considered one of the salient elements of any Quality Management System (QMS), something must have been seriously wrong with the offending establishment. In fact, if an organization fails to investigate non-conformances, how in the heck are they going to fix the problems? This must have been the equivalent of Nightmare on Elm Street # 735,385. Enjoy!

Warning letter – 16 September 2014

The offending establishment discussed in this week’s guidance was the recipient of seven Form 483 observations with many of the observations containing multiple sub-parts. In general, the investigator(s) sent a strong message to this establishment’s management team. That message being, all is not well in Bloomington, IN. Additionally, not wanting to read too much into the warning letter but obliged to do so; when non-conformances are not being captured and reported prior to routine inspection points, it sound like someone just might be attempting to make production yields appear palatable. That being said, the doctor would like to share a story.

Several years ago, Dr. D was visiting a supplier in an effort to bring some tough love to a poorly performing organization. When the doctor asked the production manager about yields, Dr. D was informed that the yields were currently at 90.0 percent. Prove it, was the doctor’s response. This rocket scientist of a production manager (keep a straight face please) informed the doctor that: (a) the first pass yield was 90.0 percent; (b) the second pass yield was 90 percent; and (c) the final inspection yield was 90 percent. The doctor quickly attempted to explain to this individual that the actual yield was 72.9 percent (0.90 x 0.90 x 0.90). This individual was having not understanding the basic concept of correctly calculating his yield.

Warning letter excerpt

Observation Five: “Failure to establish and maintain procedures to control product that does not conform to specified requirements as required by 21 CFR 820.90(a). For example, your firm’s nonconformance system is inadequate in that:

A. From June 1, 2012 to June 18, 2014, your firm identified 735,385 non-conformances across all device families however; you did not evaluate and, where necessary, investigate those non-conformances. Your firm’s evaluation involves associating the nonconformance with a reject definition; however, the definitions do not adequately identify the cause of the problem so that it can be addressed.

B. Non-conformances found prior to Quality Control inspections are not identified and documented, and therefore, the exact number cannot be quantified. Non-conformances found prior to Quality Control Inspections are routinely taken to the group leader, who takes them to the individual responsible for the nonconformance for reworking. Devices that are reworked in this manner are not documented as non-conformances and are therefore not quantified.”

Section 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

FDA could not make a section much easier to understand then §820.90. Establishments are expected to:

• Identify nonconforming product;
• Document nonconforming product;
• Evaluate/investigate (hopefully to root cause) the cause of nonconforming product;
• Segregate nonconforming product (stick it in a locked quarantine area if possible); and
• Disposition nonconforming product.

Dr. D likes the phrase bag it and tag it. Seriously, once nonconforming product has been identified, a tag or some sort of identified should be affixed to it that clearly identifies the material as discrepant. Every organization should have a non-conforming material report (NCMR) or a similar document that identifies relevant product information, a field for evaluating the nonconformity, a field for assigning disposition, and an area for signatures. If the nonconforming material process consist of the production manager stating “use-as-is” as a final disposition, with no quality oversight, Houston we have a problem.

Depending on the size of the establishment, a Material Review Board (MRB) may be the appropriate path for dispositioning nonconforming product. However, as a minimum, the disposition process needs to be placed into the control of nonconforming product procedure. In fact, it should be very clear, within the organization, the signatory authority for each functional group responsible in the disposition process. Additionally, disposition options should be limited to:

(a) return-to-vendor (RTV);

(b) scrap;

(c) rework;

(d) no problem found; and

(e) with proper written rationale (including the signature of the CJO) use-as-is (UAI).

However, please keep in mind a UAI disposition can be interpreted by the agency as a design change. Design changes for PMA products (Class III) need to be evaluated for the need to file a PMA supplement.

Finally, Dr. D always finds value in a locked cabinet, cage, or room, with limited access, to store all nonconforming product, until such time when disposition is carried out. Please keep in mind, nonconforming product disposition should be carried out quickly. For example, if the disposition is to RTV, if you hold onto the material for six months, your supplier is not going to take the nonconforming product back. Your establishment will end up eating the cost associated with this inefficiency.

Takeaways

For this week’s guidance, the doctor will leave the readers with three takeaways. One – when nonconforming product is identified, quickly bag it and tag it. Two – make sure the disposition process is well documented, including evidence of an investigation to support the disposition. Three – it is strongly recommended that a locked quarantine location be used.

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. Devine, C. (2013).
3. 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, November). FDA.gov Website. Retrieved November 10, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm419624.htm