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Related Topic Tags
complaint handling process, incidents and incident reports, service calls, customer complaints and customer found nonconformance
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  #1  
Old 24th March 2009, 12:55 AM
Valli Valli is offline
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Please Help! 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 ,

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Valli
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Old 24th March 2009, 01:05 AM
MIREGMGR MIREGMGR is offline
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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.
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  #3  
Old 24th March 2009, 01:52 AM
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Re: Difference between Customer Complaint and Service Call as in ISO 13485

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.

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  #4  
Old 24th March 2009, 03:21 AM
Valli Valli is offline
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Re: Difference between Customer Complaint and Service Call as in ISO 13485

Thanks for the reply.

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

Regards,
Valli
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Old 25th March 2009, 12:12 PM
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Re: Difference between Customer Complaint and Service Call as in ISO 13485

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

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  #6  
Old 25th March 2009, 12:24 PM
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Re: Difference between Customer Complaint and Service Call as in ISO 13485

Quote:
In Reply to Parent Post by Randy View Post

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

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  #7  
Old 25th March 2009, 01:02 PM
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Re: Difference between Customer Complaint and Service Call as in ISO 13485

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

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  #8  
Old 25th March 2009, 04:08 PM
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Re: Difference between Customer Complaint and Service Call as in ISO 13485

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
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