Obviously, no one wants to hear complaining. Be it a spouse, children, in-laws, grandkids, siblings, bosses, politicians that have lost an election, etc. Need the doctor say more? Unfortunately, complaining dates back to the beginning mankind when Adam complained to Eve about something like eating that damned apple. However, complaints can also be a valuable tool. For example, when customers begin complaining about product quality issues, there is no time like the present to address those issues. In the medical device industry, frequent product complaints will usually end up manifesting themselves as medical device reports (MDRs), especially if patients and users are getting hurt. If an establishment racks up enough MDRs, they can expect an eventual visit from our dear friends at FDA for that cup of coffee and an inspection. Even when complaints are not translating into MDRs, the agency expects device establishments to investigate complaints received from customers, and the documenting of the results (in writing, please). When establishments fail to execute their responsibilities in accordance with the 21 CFR, Part 820.198 (the Quality System Regulation requirements for managing the complaint process), bad things are going to happen. For example, when the FDA does arrive for the facility inspection, the odds are pretty darn good that the investigator will eventually dive headfirst into the complaint files. If there are problems with the complaint process, the investigator will reward the offending establishment with a Form 483 observation. There will be no amount of effrontery (look-it-up) from the chief jailable officer (CJO) that will prevent that inevitable outcome. In fact, rack up enough Form 483 observations, and the reward increases to the awarding of the highly prized agency warning letter. Enjoy!
Warning Letter – December 15, 2016
At first glance, the six Form 483 observations noted in the warning letter reviewed this week are frequently cited observations made by investigators, with the exception of management review and acceptance activities. Observation one documents issues with the management of complaints. Because of the importance of complaints in the eyes of FDA, although compliance with the entire QSR is important, Dr. D will focus on complaint management in this edition of Devine Guidance (DG). One of the biggest mistakes any device establishment can make is down-playing the importance of customer complaints. Essentially, customer complaints, although a few can be pretty nasty, contain the best free advice any establishment can ask for; but more important, the FDA expects device establishments to actually investigate the complaints received from customers.
Warning Letter Excerpt
Observation One (1) – “Complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary, as required by 21 CFR 820.198(c).”
A. You failed to review, evaluate, and investigate quality complaints involving a class II device (Pink and Green FlatPacks: a container for soft, gas permeable and hard contact lenses case used during chemical disinfection and storage) bleeding into contact lenses (discoloring the contact lenses).
B. Customer Relationship Manager (CRM) (b)(4) quality complaint reports for Class II devices are not reviewed by your Quality Department.”
21 CFR, Part 820.198 – Complaint Files
“(c) Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.”
Compliance for Dummies
One thing to keep in mind is that when the customer service phones are ringing 24/7 and the messages are all bad, a device establishment really needs to figure out why and do so quickly. You see, irritated customers tend to react with their feet. The doctor guarantees that if a device establishment or supplier has a quality problem, pretty soon their competitors will know about the problem. The awareness quickly surfaces when orders begin to dry up while your competitors are bombarded with new requests for quotation. The good news is that an establishment’s customer base and the FDA can be placated if all of the complaints are recorded (including verbal complaints), investigated, documented, and the appropriate mitigation activities pursued. Simply stated, what do you do when that shiny new car you purchased breaks down? Hopefully, you have a good warranty and take it back to the dealership to have it repaired. If you have enough problems, chances are you purchased what is called a lemon. When it comes time to purchase that next new car, Dr. D guarantees that you will take a long-hard look at the make of car you purchased with all of the problems before buying another one. The same concept holds true for medical devices and medical device suppliers.
So what does the FDA expect to see in regard to compliance with §820.198? For starters,
“any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.” This simple statement of fact is so important the doctor felt the need to repeat it in this DG. Additionally, the following bullet points, in some fashion, shall be addressed and established through the scripting of a clear and concise procedure:
- The processing of complaints in a timely manner (note: 12-months is not considered timely
- The requirement for including, documenting, and processing of oral complaints as an actual complaint (as previously mentioned)
- The assessing of complaints for the potential to report as an MDR in accordance with Part 803 requirements
- Ensuring the requirements for complaints reported as MDRs to be clearly identified as such (recommend making a separate complaint folder for MDR reportable events—using a different color folder is a reasonable practice)
- Ensuring relevant information is collected and documented during the investigative process
When it comes to performing the investigation, the FDA requires the following information be collected and documented in the complaint file:
- Documenting if a device failed to meet specification (i.e., the product specification)
- Documenting if the device failed during its intended use (potential adverse/reportable event)
- Documenting the relationship between the suspect device and the adverse event
- Device name
- Date complaint received
- Unique Device Identifier (UDI), Universal Product Code (UPC), batch/lot/ or serial number
- Name, address, and telephone number of complainant
- Relevant complaint information (details)
- Date(s) and result(s) of complaint investigation activities
- Corrective action pursued to preclude a recurrence of the complaint
- Reply to the complainant (if applicable)
- Any other information relevant to the complaint investigation process
For this week’s guidance, the doctor will leave the readers with just one takeaway. Customer complaints, although never considered pleasant, is free advice for a device establishment. Customers really do not want to move their business and hope the complaint(s) will be quickly resolved. However, failing to take action on customer complaints is tempting fate. Not only will the customer be angered, but even worse, the regulatory gods at FDA will not be amused. As Dr. D. has stated on many occasions, a CJO might as well grab a sharp stick, walk into a cave, and poke a sleeping bear in the eye. The results will be the same, very painful. In closing, thank you again for joining Dr. D., and I hope you found value 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 803: Medical device reporting. 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. (December 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Nomax, Inc. Accessed January 16, 2017. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm534145.htm