Hello,
I work in QA at a small biotech company that has recently added a delivery device to our product. I'm struggling to understand the relationship between the recall process and corrections and removals. Do companies typically have two separate procedures? If you use two different procedures, I'm curious why that decision was made?
Thanks,
Kurt
Kurt,
These are two requirements that basically address the severity of the issue. The requirements and action taken will vary depending on the severity of the problem. For example, if an establishment, through it's complaint system, detects a recurring, minor defect (let's say that after six months, a plastic door falls off of a device. It's purely aesthetic and poses no risk of injury.). The establishment, following its CAPA system, initiates an investigation and redesigns the door. Based on the number of complaints it's received, the establishment decides that it will proactively replace the door in the field.
The complaint handling procedure should include provisions for determining whether entry to the CAPA system or MDR system is necessary. If the complaints are coming in on a daily basis, it would be obvious that entry to the CAPA system would be necessary, but not a MDR in a case like this. If it's not readily obvious during complaint handling, the CAPA system should catch the increased, recurring complaint. The system should include provisions for determining whether a Correction / Removal or Recall is necessary.
There are two types of C/R actions - reportable and non-reportable. In this case, this would be a non-reportable correction. If the establishment elected to notify all of its customers, and request that the device be returned for alteration, it would be a non-reportable removal. You're still required to complete all of the necessary C/R reports and collect the required data, but you won't send the report to FDA.
Recall is a specific, voluntary action that typically results from a removal or correction. Removal or correction will be considered a recall only if the FDA regards the product as involving a violation that is subject to legal action, e.g., seizure. Recalls are classified based on severity. Here's something from the FDA's website that may be helpful:
Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.
Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Market withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.
Medical device safety alert: issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.
The biggest mistake I see made in this area is that many establishments fail to connect their MDR, corrections/removals and recall procedures to their quality systems. In reviewing your complaint handling procedures, one of the first things the Agency will look for is whether you're analyzing complaints for Medical Device Reporting requirements, as well as your CAPA system. Complaint Handling, CAPA, MDR, Corrections and Removals, and Recall should all tie together. Too often I find stand alone procedures for each of these areas. None report into one another, and as the result are never used. It raises a huge red flag.
I worked for a company once that had six complaints in its complaint system when I started, but they had distributed the device for nearly three years. They didn't document complaints because they didn't really understand the definition, and were concerned that "too many complaints would raise a red flag at FDA". They showed me a C/R procedure that had never been used, because no system required that anything be analyzed for C/R requirements, and ... you guessed it... they had a MDR procedure that not only was inaccurate, they never intended to use. They felt that notifying the FDA of a problem would be the worst possible disaster, and would certainly result in an inspection. It was an uphill battle to say the least, and it took quite a bit of time to pull everything together. We were able to backtrack and find the complaints buried throughout the quality system. Some were found in design control, others in non-conforming material, some even in purchasing... In the end, we extrapolated about 1500 complaints, analyzed them, entered them into the appropriate systems and successfully closed them. Luckily, none of the complaints resulted in reportable corrections, but several internal reports were generated. Ironically, FDA scheduled a regular inspection shortly after we completed this project (as well as a complete overhaul to the quality system) - only three minor 483 violations that could have easily been a Warning Letter otherwise. The moral of the story is, it's critical that these systems not only be in place, but they be used. None of these can be after thoughts or stand-alone, side-procedures. An interaction between them is necessary to assure safety and effectiveness.
Best of luck to you!
Chris Ford
Good first post!
