On multiple occasions, Dr. D has written about customer complaints and how, although never a pleasant experience, they can result in significant product improvement opportunities, if the data collected is appropriately investigated, analyzed and used. However, documenting complaints and then failing to take appropriate investigative action (deep subject, the doctor knows) is always going to end badly for an offending establishment. In fact, when our dear friends from FDA appear in the lobby for that friendly cup of coffee and an inspection, bad things are going to happen if the complaint management system is not ship-shape. The Chief Jailable Officer (CJO) does not need a crystal ball, Tarot cards, Irish tea leaves or any other type of clairvoyant instrument to peer into the future. In fact, he or she can just take it to the bank that a form 483 observation is in the establishment’s future or even worse—that prized agency warning letter. Obviously, having a great complaint management system is not a panacea(look-it-up) for all that ails a less than compliant quality management system (QMS). However, effective complaint management is clearly a step in the right direction. Enjoy!
Warning Letter – April 21, 2017
Read enough warning letters as the years cascade by, and finding a letter with six form 483 observations cited is pretty typical. However, on that rare occasion when a warning letter has an event or citation that really jumps off the agency’s warning letter page, the doctor is obliged to inform the readers about the issue so they can learn from the offending establishment’s pain. When the FDA comes across 1,385 complaints, with no documented evidence of investigations being performed, it is going to become a long day indeed for the CJO of the offending establishment. Make no mistake, the FDA is almost always going to find its way into a device establishment’s complaint system.
Warning Letter Excerpt
Observation Three (3) – “Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). For example:
Your firm has not analyzed any of your 1385 open complaints received since January 2016 to identify any existing or potential causes of nonconforming product, or other quality problems.
Your firm failed to investigate and identify any actions needed to evaluate the impact of the (b)(4), ID # C5003 after a calibration service provider reported it “failed as found”. This flow meter was used in routine device acceptance activities to calibrate the (b)(4) adjustments of your Criticare patient monitors.”
“During the inspection we observed that your firm had not yet taken any actions to address your only CAPA, CTI CA1000, initiated on August 1, 2016.”
21 CFR, Part 820.100 – Corrective and Preventive Action
“(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:
(1) Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;
(2) Investigating the cause of nonconformities relating to product, processes, and the quality system;
(3) Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
(4) Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;
(5) Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
(6) Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and
(7) Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.
(b) All activities required under this section, and their results, shall be documented.”
Compliance for Dummies
Now Dr. D is not really sure why the investigator chose to site CAPA versus §820.198 (complaint files) for the observation three. The doctor’s guess is that the investigator wanted to make the link to CAPA for failing to investigate complaints and pursue appropriate corrective action. Regardless, the point being made by FDA was that failing to investigate complaints was a serious compliance failure.
There is no requirement to investigate every single complaint. However, the decision not to pursue an investigation needs to be documented. Can you say written rationale? There are times when a minor problem is inherent in a medical device or family of devices. The manufacturer may have already completed the investigation and is diligently working on the fix. If subsequent complaints are for the exact same problem, it makes no sense to perform a new full-blown investigation. All an establishment is required to do is to document the rationale for not performing an investigation and move on. However, failing to do anything is considered a compliance failure in the eyes of FDA, and the offending establishment will be appropriately rewarded—either with a form 483 observation or worse, a prized agency warning letter.
As mentioned in the beginning of this week’s guidance, although never pleasant, complaints are free advice coming from a device establishment’s customer base. If there are 1,385 complaints, the customers are sending a message (loud and clear) but it appears the message recipient may not be listening. Now, the doctor is not going to bore you with all of the regulatory requirements associated with complaint management or CAPA. The quality system regulation (QSR) spells out the regulatory requirements in black and white. In fact, §820.198 is one of the more prescriptive sections of the QSR (Dr. D’s humble opinion). However, managing complaints is not rocket science, so repeat after the doctor (broken record time):
- Complaints shall be logged
- Complaints shall be investigated
- Written rationale shall be provided if a complaint investigation is not performed
- Appropriate corrective action shall be pursued
- Records associated with each complaint shall be retained
- Complaints shall be reported as a medical device report (MDR) in accordance with Part 803, when an adverse event deemed to be reportable is identified
- The customer shall be notified of the results of an investigation, if requested by the customer
For this week’s guidance, the doctor will leave the readers with just one takeaway. There is more to managing a complaint then just logging the event. Complaints shall be investigated and the results of the investigation documented. If a decision is made not to investigate a complaint, written rationale that supports the decision shall be retained in the complaint file. It does not get any simpler than that, my dear readers. 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.
- Code of Federal Regulation. (April 2016). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
- Code of Federal Regulation. (April 2016). Title 21 Part 807: Establishment registration and device listing for manufacturers and initial importers of devices. Washington, D.C.: U.S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
- FDA. (April 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. Criticare Technologies, Inc. Accessed May 7, 2017. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm554586.htm.