For years, it seemed to old Dr. D that rework was a gray area seldom talked about within industry. If a product was determined to be non-conforming, it was reworked if at all possible. However, questions such as how the rework potentially impacted the use of finished devices were seldom assessed. Simply stated, the entire rework process was some sort of black magic. Depending on the complexity of a finished medical device, some rework appeared to be built into the manufacturing process. It was a scary proposition when Dr. D would inquire about the rework process and received responses such as (true story): “This device is difficult to assemble and the rework at this stage is 50% of all units due to leak failures identified during in-process testing.” Seriously, if that level of rework is required, then the device in question should not have been transferred to manufacturing, without resolving the manufacturing issues. Can you say process validation? From an FDA perspective, their concerns are pretty basic: (a) script a written procedure for rework, (b) document when rework has occurred in the device history record (DHR), and (c) identify potential adverse influences the rework may have on the finished device (in writing of course). When an investigator from the agency decides to visit an establishment for that friendly cup of coffee and an inspection, it will be difficult for the Chief Jailable Officer (CJO) to sit across from the investigator and explain the rework process if there is no documented evidence (in writing) to support claims of compliance. Without the perspicuous prose necessary to define the rework process or judicious analysis to support the effectiveness of rework, the CJO is placed in a precarious (look-it-up) position when explaining the entire rework process during an agency inspection. Enjoy!

Warning Letter – July 11, 2017

The warning letter used in support of this week’s guidance contained a total of eight Form 483 observations, a number that usually results in the awarding of that prized FDA Warning Letter. Additionally, the offending establishment failed to notify the FDA of a market withdraw (a.k.a. Recall, that nasty six-letter word). Furthermore, the FDA found the establishment’s procedure for managing recalls, in accordance with Part 806, was in need of some love. Finally, when phrases such as “devices being misbranded under the Act” or “firm failed or refused to furnish material or information” are used, the future for an offending establishment is about to get extremely challenging from a regulatory perspective. A CJO does not need a crystal ball, tarot cards, Irish tea leaves, or a self-acclaimed clairvoyant to see the FDA opening up that can of regulatory whoop-ass. Ouch!

Warning Letter Excerpt

Observation Seven (7) – “Failure to document rework and reevaluation activities in the device history record, as required by 21 CFR 820.90(b)(2). Specifically,

A total of 3 of the 6 Nonconformance Reports that document rework for in-process nonconformances could not be linked to a device history record.

Your response cannot be assessed at this time. Your response states your investigation under CAPA 17-09 determined that rework is not being appropriately documented. The nonconforming product procedures and device history record procedure is being revised. The corrective action will be completed by June 30, 2017. Please provide an update on the status of these corrective actions.”

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

As mentioned in the opening section of this week’s guidance, the regulatory requirement is pretty straight forward: (a) script a written procedure for rework, (b) document when rework has occurred in the device history record (DHR), and (c) identify potential adverse influences the rework may have on the finished device. There are varying levels of rework (Dr. D’s opinion) that occur during manufacturing. There just might be that challenging process that routinely requires some level of rework. If that is the case, document it! Put it in writing because in the eyes of FDA, if an activity is not documented, it never happened. Rework that occurs frequently should be well-documented, including the potential adverse impact the rework may have on the finished device. For example, if a finished device has been validated for just 1x ethylene oxide sterilization and the manufacturer has made the decision to sterilize devices a second time, the rationale to do so better be rock solid. Can you say, repeating the sterilization validation to ensure the product performance is not compromised?

For simple rework such as replacing a defective component on a printed circuit board (PCB), the rework will probably involve some level of board or system test to ensure the rework was properly completed. However, depending upon the complexity of the circuitry or how the device is being used, an assessment of how the replaced component impacts the performance of the device or user life still needs to be assessed.

Regardless of the level of rework, all rework activities must be documented and retained in the DHR. This step is not optional. Failure to properly document rework activities and assessing the potential impact of rework on finished devices will result in the awarding of a Form 483 observation during an inspection. Receive a significant number of Form 483 observations and that prized warning letter becomes a viable FDA option.

Takeaways

For this week’s guidance, the doctor will leave the readers with three takeaways. One: Establishments are required to establish a procedure for rework. If your establishment does not have one, there is no time like the present to start banging on the keyboard of your computer and script one. Two: All rework activities shall be documented. Please ensure that rework activities find their way into the DHR. Three: Device establishments are required to identify potential adverse influences the rework may have on the finished device. In closing, thank you again for joining Dr. D, and I hope you found value (and some humor) 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. (April 2016). 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. (July 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. National Biological Corp. Accessed July 23, 2017 Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm566621.htm