Difference between Customer Complaint and Service Call as in ISO 13485

Dear All,

Last week during Stage 1 Audit, auditor asked for Customer Complaint report for past 2years.

We are taking all the
1.calls (Except technical clarification) or
2.problems reported by customer about the break down of equipment or
3.errors or disrupt to the operation of equipment as customer complaint irrespective of Warrenty period.

Is this procedure correct? What is the industry followed procedure for Classifying Customer Complaints? How do you classify Complaint verses Service Call?

His version of suggestion is to log call reported during warrenty period as complaints and remaining as service calls.

Please advice ,

Regards,
Valli

Re: Diff between Customer Complaint and service Call as 13485

Lesson to be learned:

If you don't have a sufficiently detailed and accurate procedure in place for effectively documenting and categorizing such contacts as they actually occur so that you can later defend your complaint data as having been validly distinguished from your non-complaint data...

Expect your auditor to ask to see more data than you want to produce and to make assumptions about customer contact type that are "conservative" and less favorable to you than you'd like.

He's not supposed to have a version or suggestion and it looks like he has overstepped his bounds.

You're the one that defines what constitutes a complaint, not the auditor.

Normally a complaint may preceed a service call or a service call may be caused by a complaint...whichever way you see it.

Thanks for the reply.

Your response gave me more strength that my path is correct.

Regards,
Valli

Your classification should be driven by and substantiated by your risk management records

Randy said:

You're the one that defines what constitutes a complaint, not the auditor.

Click to expand...

Actually, ISO 13485 defines complaints, and depending on what regulatory requirements the organization is subjected to, they obviously have to comply with that as well. For example, the FDA defines what type of feedback must be recorded and investigated.

This issue has been exhaustively discussed here.

You mean this?

3.4 customer complaint: written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market

My meaning was "Yes" based on the way they define it

here's how FDA defines the procedures for handling complaints; you can certainly consider the reference as base and customize it as per your requirements; and the following reference may cover the associated regulatory processes which may not be relevant for your scenario.

http://www.fda.gov/cdrh/qsr/15compl.html scroll through the page and you will find an sample procedure in the later part of the page.
and as far as complaint definition is concerned...FDAs definition goes like this..
"A "complaint" is any indication of the failure of a device to meet customer or user expectations for quality or to meet performance specifications. Thus, any written, oral, or returned goods expression of dissatisfaction relative to the identity, quality, durability, reliability, safety, effectiveness, or performance of any device manufactured by this manufacturer would be considered a complaint. "

as far as the evaluation/classification is concerned...as per the above referred document..."Service or repair data shall be reviewed [820.200(b)&(e)] to identify systematic problems and problems that may qualify as complaints. When these problems are identified they should be processed as complaints according to the requirements in 820.198. "

each service call could be evaluated if it match any of the criteria mentioned for it to be considered as complaint. [refer above webpage..]
1. PRODUCT PERFORMANCE: the product in some way does not perform to user's expectation or to any level of performance conveyed to the customer by printed labeling or verbally by company employees.
2. PRODUCT SAFETY: all safety complaints are covered by this procedure.
3. PRODUCT RELIABILITY: failure rate or need for service adjustments greater than user expectation, i.e. beyond the tolerable level of expected wear or malfunction.
4. PRODUCT APPEARANCE: visual defects inconsistent with the user's expectations for a medical device.
5. GENERAL COMPLAINTS: order or shipping error, delayed or unacceptable response to problems, unfulfilled promises, etc.
6. MDR REPORTABLE COMPLAINTS: all complaints involving device-related deaths, serious injuries and malfunctions. (See Policy/Procedure No. XXX for handling of MDR reports.)

hope that helps.
valiveti

It is amazing how often when I'd like a 2nd opinion (or 10, and several polite and well reasoned dissents!) that I find a good thread here.

I'm working with a device that is very, very low risk. The primary market is the US but we are developing a quality system compliant with the QSR and ISO 13485.

Most customer contacts for service relate to a PC and off the shelf accessories, and do not impact the function of the medical device element. I intend to have the service procedure reference the "expression of dissatisfaction" element and to provide for tracking and trending of service calls. All employees who have service contact will be involved in categorizing each call, and will be aware of the procedure to follow if the customer specifically expresses one or more of the "dissatisfaction" items.

The service and complaint procedures will also provide the screening questions for MDR, so that the employees who handle all the service calls are able to appropriately code "No", or flag potentially reportable events for QA review. The MDR procedure will define QAs review and provide the details on submitting the report.

The coded service calls and items flagged for MDR review will be trended to aid in identification of "systematic" problems, whether they relate to the medical device function or not.

I have many years of shipping single use medical devices, where it was quite appropriate to treat each contact as a possible complaint. Reviewing service calls seems to match the regs precisely, but seems too easy! Can I get a sanity check?

Shelley

v9991 said:

"A "complaint" is any indication of the failure of a device to meet customer or user expectations for quality or to meet performance specifications. Thus, any written, oral, or returned goods expression of dissatisfaction relative to the identity, quality, durability, reliability, safety, effectiveness, or performance of any device manufactured by this manufacturer would be considered a complaint. "

as far as the evaluation/classification is concerned...as per the above referred document..."Service or repair data shall be reviewed [820.200(b)&(e)] to identify systematic problems and problems that may qualify as complaints. When these problems are identified they should be processed as complaints according to the requirements in 820.198. "

each service call could be evaluated if it match any of the criteria mentioned for it to be considered as complaint. [refer above webpage..]
1. PRODUCT PERFORMANCE: the product in some way does not perform to user's expectation or to any level of performance conveyed to the customer by printed labeling or verbally by company employees.
2. PRODUCT SAFETY: all safety complaints are covered by this procedure.
3. PRODUCT RELIABILITY: failure rate or need for service adjustments greater than user expectation, i.e. beyond the tolerable level of expected wear or malfunction.
4. PRODUCT APPEARANCE: visual defects inconsistent with the user's expectations for a medical device.
5. GENERAL COMPLAINTS: order or shipping error, delayed or unacceptable response to problems, unfulfilled promises, etc.
6. MDR REPORTABLE COMPLAINTS: all complaints involving device-related deaths, serious injuries and malfunctions. (See Policy/Procedure No. XXX for handling of MDR reports.)

hope that helps.
valiveti

Click to expand...

As it is not always easy to differentiate between customer complaint and "just" feedback, we have a SOP "Customer Feedback and Complaint" and a form sheet to document the customer feedbacks. The form includes a questionnarire to evaluate if a feedback is a possible complaint. If it is a possible complaint, other people (from QM) get involved. Our auditor likes our approach - all customer feedbacks are considered. Based on the risk-based approach, eedback can be anything from good (e.g. new product ideas, yeah!), neutral, or negative (e.g. complaint, f**k!)...