Manufacturer's handling of Distributor's Historical Complaint Records

[michael Cejnar]

We, a small foreign manufacturer, and recently started to receive 'notification' of complaints from our distributors in the USA. It's mostly routine service calls of various ages (some months old) and in various stages of the process.

But now, how to handle the data?

Is a 'notification of a complaint' being handled by our giant distributor contracted to handle initial complaints, a 'complaint' requiring us to process it through our complaint handling system - and thus laboriously shadow their complaint process after the fact to fill up our record
OR
can we use it as post-market data for individual and statistical analysis, held in a separate Xcel file from our CC database and use it as direct input into our CAPA system, but not have to chase up and document their analysis, resolution and closure for each service call / complaint - for little gain.

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

[Ronen E]

In Reply to Parent Post by michael Cejnar

We, a small foreign manufacturer, and recently started to receive 'notification' of complaints from our distributors in the USA. It's mostly routine service calls of various ages (some months old) and in various stages of the process.

But now, how to handle the data?

Is a 'notification of a complaint' being handled by our giant distributor contracted to handle initial complaints, a 'complaint' requiring us to process it through our complaint handling system - and thus laboriously shadow their complaint process after the fact to fill up our record
OR
can we use it as post-market data for individual and statistical analysis, held in a separate Xcel file from our CC database and use it as direct input into our CAPA system, but not have to chase up and document their analysis, resolution and closure for each service call / complaint - for little gain.

Sorry mate, but I can't see how you can avoid handling these as complaints and stay compliant with part 820:

Sec. 820.3 Definitions.
...
(b)Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.

(emphasis added)

The only escape route I see is formally and fully delegating (subcontracting) complaint handling to a distributor. In that case I'd make sure to have a detailed contract addressing all applicable provisions of 820.198, and pay special attention to sections (f) & (g):

Sec. 820.198 Complaint files.
(a) Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure that:

(1) All complaints are processed in a uniform and timely manner;

(2) Oral complaints are documented upon receipt; and

(3) Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 of this chapter, Medical Device Reporting.

(b) Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate.

(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.

(d) Any complaint that represents an event which must be reported to FDA under part 803 of this chapter shall be promptly reviewed, evaluated, and investigated by a designated individual(s) and shall be maintained in a separate portion of the complaint files or otherwise clearly identified. In addition to the information required by 820.198(e), records of investigation under this paragraph shall include a determination of:

(1) Whether the device failed to meet specifications;

(2) Whether the device was being used for treatment or diagnosis; and

(3) The relationship, if any, of the device to the reported incident or adverse event.

(e) When an investigation is made under this section, a record of the investigation shall be maintained by the formally designated unit identified in paragraph (a) of this section. The record of investigation shall include:

(1) The name of the device;

(2) The date the complaint was received;

(3) Any device identification(s) and control number(s) used;

(4) The name, address, and phone number of the complainant;

(5) The nature and details of the complaint;

(6) The dates and results of the investigation;

(7) Any corrective action taken; and

(8) Any reply to the complainant.

(f) When the manufacturer's formally designated complaint unit is located at a site separate from the manufacturing establishment, the investigated complaint(s) and the record(s) of investigation shall be reasonably accessible to the manufacturing establishment.

(g) If a manufacturer's formally designated complaint unit is located outside of the United States, records required by this section shall be reasonably accessible in the United States at either:

(1) A location in the United States where the manufacturer's records are regularly kept; or

(2) The location of the initial distributor.

All the wonderful extras you've described may follow the basic complaint handling, but I wouldn't consider them as a substitute.

Cheers,
Ronen.

[MIREGMGR]

Unless you have a provision in your contractural relationship that specifically calls for this new information flow from them, my guess would be that their action is motivated by the FDA's evolving aggressiveness in regard to Adverse Event reporting.

Their regulatory management probably has recognized that if they "pass through" the full flow of complaints in a prompt manner, they can avoid possible FDA assignment of a share of responsibility if one or more of those complaints involves a reportable Adverse Event and you do not file such a report(s).

The only escape route I see is formally and fully delegating (subcontracting) complaint handling to a distributor.

You can delegate the work, but not the responsibility...particularly not the responsibility for Adverse Event reporting.

My view is that you should establish a documented process for qualified analysis of each complaint or other similar report as to whether it may qualify as reportable. If it does, elevate it to a rigorously managed system for that responsibility. Hopefully you won't have many of those.

If on the other hand a given complaint is insignificant and is so documented via your qualified analysis, you can subsequently process it per your proposed second path.

[Ronen E]

In Reply to Parent Post by MIREGMGR

You can delegate the work, but not the responsibility...particularly not the responsibility for Adverse Event reporting.

I agree. I did mean delegate the work - the detailed, 820.198-aligned contract would be required because the responsibility would stay with the manufacturer. I also only related to "complaints handling" per se; adverse event reporting (MDR) is a separate -- though related -- topic (part 803). I do agree that even if complaint handling is outsourced, the manufacturer would have to stay alert and report as appropriate. I think section (f) in 820.198 provides the necessary basis for the manufacturer to stay informed, though it may need some elaboration in the contract.

[michael Cejnar]

Thanks Ronen and MIREGMGR. Apologies for my sloppy sentence above.

Actually, Ronen, the distributor's contract does indeed make them commercially 'responsible' for initial customer complaint handling, with assistance from us, the manufacturer, where required, with both obliged to report known incidents. It also has had provision for routine passing on of complaints history periodically (which they are only sending now after years) always intended (but not defined as) just for statistical analysis. They must indeed be 'sharing' the responsibility for escalating and reporting.

MIREGMGR: My view is that you should establish a documented process for qualified analysis of each complaint or other similar report as to whether it may qualify as reportable.

Given above and the fact that our FDA auditor's interest has always been in looking for reportable incidents rather than customer satisfaction with, say, timely replacement of routine spare parts, I will go the qualified (and documented) analysis.

Thank you again.