Customer Returns Evaluation Ownership - Medical devices

amjadrana

Involved - Posts
#1
I am currently revising our customer returns procedure. In our current procedure customer support evaluates the product upon return and gives it to production for repairs.

Which department in best practice should be taking ownership of evaluation upon return? Should it be production, engineering (design), customer support or quality asurance?

Thanks for your input?

Amjad Rana
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Re: Customer returns evaluation ownership Medical devices

For us, Quality has nominal ownership, but Engineering quickly becomes involved, and Sales and Customer Service have overview/supervisory roles. Production may be involved if there is a discrepancy between what the customer return implies for what they now want/need, and what Production has been directed to make, or is capable of making.
 
P

paulthequalityguy - 2009

#3
It is my recommendation for the Quality Assurance department to have full ownership of the entire return process. When your customer makes first contact at this critical time regarding a potential quality issue, an immediate evaluation performed by a Quality representative begins the RMA process. All necessary tasks from logistics to final report must be performed by an experienced and unbiased quality representative. The RMA process is an important and often underrated step of Continuous Process Improvement. Failure analysis, finding root cause and driving an effective corrective action should be meticulously documented in every detail on an 8D report or similar document. Typically only a Quality representative is afforded the time and has the attention to detail necessary for completing a comprehensive 8D report. When executed properly a customer will come away from the experience with increased confidence in the quality of your product and your company’s ability to meet their needs.
 

MasterBB

Involved In Discussions
#4
Quality alone is not good enough.

Give the product to the most knowledgable person (#1) of the product & the SME for root cause analysis (possibly a quality person). Most effective technique is a team effort and owned by both Engineering/Quality (notice the order).
 

sowmya

Involved - Posts
#5
Regarding ownership of the returned part, it is quality. Normally, CFT team is required for review. But checking the AS IS condition and referring it with the reason for return is normally done by quality person. But, sales, engineering and production also involved in disposition.
 
S

SteveK

#6
Amjad,

In our company the first port of call is Quality CONTROL (QC) who actually handle/inspect the goods i.e. the same as product release. Other departments as indicated will naturally get involved, Sales (generally first point of CONTACT), Production etc e.g. if repairs are involved. The ownership is overall a QC responsibility.:2cents:

Steve
 
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