During Dr. D’s weekly visit to FDA’s enforcement page, the doctor came upon a warning letter that mentioned a seldom-cited observation—the rework of nonconforming product. Rework is a necessary evil for medical device establishments. As finished devices become increasingly more complex and the cost of assembly operations increase significantly, it is imperative that device establishments have the ability to successfully rework nonconforming product. However, being in a highly regulated industry, the FDA has its thumb in the proverbial pie, and that is not necessarily a bad thing. In the case of rework, our friends at the agency have delineated requirements associated with rework within 21 CFR, Part 820.90(b) (2). Dr. D is guessing that you will probably not find a Chief Jailable Officer (CJO) pursing a thrasonical (look-it-up) brag after receiving an agency warning letter that identifies a common-sense (not rocket science) area such as “rework” receiving a Form 483 observation. Enjoy!
Warning Letter – 10 April 2015
When an establishment receives a total of seven Form 483 observations and an equal number of either (a) “your response cannot be assessed at this time or (b) “your response is not adequate”, bad things are going to happen. In fact, you can take it to the proverbial bank, as the agency is about to unleash some serious regulatory pain. Frequent readers of DG and experienced industry quality and regulatory professionals clearly understand the ramifications associated with a warning letter, which ranges from “no Certificates to Foreign Governments (CFGs) being signed” to “no new product approvals”. In fact, the applications for CFGs, 510(k)s, and PMAs, end up in an agency in-basket collecting dust, which is a lesson that the winner of this prized warning letter is about to learn.
Warning Letter Excerpt
Observation Two (2) – “Failure to document rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, in the device history record, as required by 21 CFR 820.90(b) (2). Specifically, Rework and reevaluation activities performed on the printed circuit boards (components of the MRI coils) during manufacturing using your SMT (surface mount technology) process are not documented.
Your response dated March 26, 2015 cannot be assessed at this time. The response states that you have revised your “SMT Line – Instructions for Use”, MP050, to require all rework and reevaluation activities be documented in the device history record. Additionally, you have revised the “DDM Component Production” procedure, MP014, to require all rework and reevaluation activities be documented in the device history record; and training is ongoing. Effectiveness checks will also be performed. Please provide an update on the status of these corrective actions.”
Subpart I – Nonconforming Product
Section 820.90 – Nonconforming Product
“(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
Dr. D frequently uses the phrase “not rocket science” to describe how relatively simple it is to comply with most sections of the agency’s quality system regulation. Rework falls into the same category. Simply stated, if rework is performed on a nonconforming product, the FDA wants to ensure that the reworked product is just as robust as the product that is not reworked. You see, there is always the potential for rework to adversely influence the safety and efficacy of a finished medical device. The agency wants to ensure this never occurs. Trust the doctor when I say, “when the agency shows up on your establishment’s doorstep for a cup of coffee and an inspection, the investigator(s) will eventually get around to reviewing Device History Records (DHR)”. If the rework activities are not properly documented, the CJO will have some explaining to do.
Remember, the underlying question that establishments need to be asking themselves is, “as a manufacturer, how can I manage rework to ensure finished medical devices are not adversely impacted?” This is a fabulous Dr. D question followed by, hopefully, a fabulous Dr. D response.
1. Device establishments are required to develop written procedures for rework. The doctor recommends scripting a high-level SOP or ensuring that the “rework” requirement finds its way into the “Control of Nonconforming Products” SOP. Can you say documented evidence of compliance?
2. There will be times when rework is relatively benign (e.g., a cold solder joint on a printed circuit board). The rework instructions can be quickly generated and approved by a quality engineer and manufacturing engineer, and the rework instruction attached to the lot traveler.
3. However, there are going to be cases when the rework is much more complex. If the rework is occurring frequently and is a byproduct of the manufacturing process, then a permanent rework instruction (that can be affixed to the traveler) should be created.
4. Additionally, the agency expects that all rework (regardless of how benign) be adequately assessed to ensure that the outcome of the rework meets specification. If the rework has the potential to affect product form, fit, function, or safety and efficacy of a finished medical device, then Houston we have a problem! Remember, the potential for rework to adversely impact a finished medical device shall always be assessed and the activities appropriately documented.
5. Furthermore, all rework should require the same quality oversight as non-reworked product. If inspection is routinely performed in a non-reworked environment, then inspection should be performed as part of the rework process.
6. Finally, if you have not already figured it out, FDA requires that all rework activities be appropriately documented. Why? If rework activities are not documented in writing, in the eyes of the FDA, they never occurred. Can you guess where the documented evidence of rework resides? If you said the DHR, you would be correct. It’s written into the regulation.
For this week’s guidance the doctor will leave the readers with three takeaways. One – the FDA requires that device establishments develop written procedures and instructions for the rework of nonconforming products. Two – the agency also requires that the potential for the rework to adversely impact the product being reworked, including the potential impact to a finished medical device, be assessed. Three – all rework activities shall be documented and retained in the DHR. Remember, if an activity or event is not documented in writing, in the eyes of the FDA, it never happened. 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.
1. Code of Federal Regulation. (2014, 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. (2015, April). FDA.gov Website. Retrieved April 26, 2015, from