How to handle customer request for changing specifications

Q

QACen

#1
Hello,

If a customer requests for a product to be changed (deviation from requirement specifications) to meet their need. Is that acceptable? What are regulation implications to consider?

I am aware of FDA's 820.70, but I believe that speaks to internal mfg deviations.
Sec. 820.70 Production and process controls.
(a)General. Each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications...

Here is an example:
We build a product that processes in the range of 60-70mL, but the customer wants it to read 75mL.

Any guidance you can give would be great?
 
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Ajit Basrur

Staff member
Admin
#2
Re: How to handle customer request for changing specifications ?

It depends on what caused the customer to change the specifications ... if its a result of any complaints or deviaitions and that the customer wants to study the process before going in for a change, there could be a PLANNED DEVIATION document to justify the change.

But if it is an intended action, the document could be something like "Temporary Change Request" to document to new specifications.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Re: How to handle customer request for changing specifications ?

It depends on what caused the customer to change the specifications ... if its a result of any complaints or deviaitions and that the customer wants to study the process before going in for a change, there could be a PLANNED DEVIATION document to justify the change.

But if it is an intended action, the document could be something like "Temporary Change Request" to document to new specifications.
I am assuming it's a medical device.

I tend to disagree with the above. If the customer changes the requirements it's not a deviation, it's a design change. The reasons and/or process that led to the request may be important, but they don't change the nature of the situation. I'm not aware of any part 820 provisions for things like "temporary change" or "planned deviation". These are concepts from the pharma world.

IMO the relevant section is 820.30 (i):

(i) Design changes. Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.
I perceive the described situation as a change in Design Inputs, so basically the Design Control process needs to be followed through from the beginning. If you conclude that the change is trivial or insignificant some stages may be minimised, however your own procedures should be complied with - they should include provisions for categorising changes and acting accordingly.

Cheers,
Ronen.
 
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