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

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

I am not a FDA guru, but I would guess that there would be one procedure for Corrective Action, and another one for Recalling Product. You could even join them as one, in my opinion. Maybe some FDA gurus can add some insight here.

It's like the Aerospace Requirement to have both Corrective and Preventive Action procedures.

Kurt, when you mention "corrections", are you referring to corrective action or corrections as in rework activities? Some companies refer to rework as corrections.

As for a recall procedure, this is typically a separate procedure, however, depending on the size and needs of your company, it may well be combined with other related procedures, as Coury suggested. For example, for complex Class III medical devices, a company may need to have a detailed procedure for how the recall of such devices is handled. On the other hand, if the product (device) is a minimal risk Class I device, the recall procedure may be combined with another procedure for corrective action and/or rework or whatever the case may be. The bottom line is that you should do what works for your company, as long as it meets the requirements of the applicable standards/regulations.

BTW, welcome to the Cove! :bigwave: Good first post!

I'm sure others will join in with more advice, as well...

Are we discussing FDA rules?

The FDA uses "Correction" and "Removal" to describe specific actions that are not Recalls, but affect product in the marketplace. See 21 CFR 7 for Recalls, and 21 CFR 806 for Corrections and Removals.

For something a little more easily understood than the 21 CFR legalisms, see http://www.fda.gov/ora/compliance_ref/recalls/ggp_recall.htm, "Guidance for Industry--Product Recalls, Including Removals and Corrections".

Or for the easiest-to-understand Executive Summary, see this FDA Powerpoint presentation:
http://www.fda.gov/cdrh/oivd/meetings/041806/bernier.ppt

You would want to have a procedure, unitary or split as you see fit, that provides for both recalls when the circumstances warrant, and removals and/or corrections when those are the effective way to proceed. You need all of those capabilities in order to effectively respond to the full range of possible circumstances.

In addition to great response from MIREGMGR, few more inputs -

Since this question is posted in the FDA section, the FDA definition for "correction" is slightly different from the ISO terminology when used in conjuction with Corrective Actions and Preventive Actions.

A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA).

As per FDA definitions,

Correction means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location.

Removal means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.

Therefore in Recall, the marketed products are either corrected (no location change) or removed (location change).

There could be a single procedure listing the methodology.

Thank you all for the insight.

Regards,
Kurt

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