Does Sampling Plan Revision need Customer Approval?

D

Dottie123

#1
[FONT=&quot]1) W[/FONT]hen I look at the finished product specification provided by the customer for their disposable medical devices, it provides the sampling plan and inspection for release of finished product. It then lists the critical, major and minor areas of the product to be tested along with the attributes that need to be tested to ensure we are releasing a ?quality? product. Do we have to test every aspect listed on this sampling plan or can I pick and choose as long as we can justify why we are not testing some area and documenting the results. Also, there may be several inspection levels listed int eh sampling plan which means that the QC Tech has to keep up with which sampling plan and which AQL to use for each attribute of the medical device. I would like to implement an internal inspection plan where we choose the highest inspection level and AQL and inspect rather than going back and forth. If I revise this, do I need the customer?s approval to change and use my plan.
 
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NikkiQSM

Quite Involved in Discussions
#2
Re: Sampling Plan Revision

If you agreed to produce a product to the customer's specification, then you have to do what the spec says.

If you feel some testing is not needed, or some information is not needed, then contact the customer and voice your concerns. Ask that they update their specification if they agree the testing is not needed either and get the new revision in your system.
 
I

isoalchemist

#3
Re: Sampling Plan Revision

The Customer may not always be right, but they are the customer and if you have agreed to meet their specifications, you need to perform the testing as they have defined it.

If their testing is a problem, you need to have a discussion. You will find one of two things either they have a valid reason for why they chose the testing scheme the did or you will get blank stares. It's worth the discussion if you can have it, but don't change anything without their approval or technically you will be in breach of contract which is a lot worse than extra testing.
 
A

amit_rd

#4
[FONT=&quot]1) W[/FONT]hen I look at the finished product specification provided by the customer for their disposable medical devices, it provides the sampling plan and inspection for release of finished product. It then lists the critical, major and minor areas of the product to be tested along with the attributes that need to be tested to ensure we are releasing a ?quality? product. Do we have to test every aspect listed on this sampling plan or can I pick and choose as long as we can justify why we are not testing some area and documenting the results. Also, there may be several inspection levels listed int eh sampling plan which means that the QC Tech has to keep up with which sampling plan and which AQL to use for each attribute of the medical device. I would like to implement an internal inspection plan where we choose the highest inspection level and AQL and inspect rather than going back and forth. If I revise this, do I need the customer?s approval to change and use my plan.
It is wise to have the revised plan signed off with the Customer. You may need to demonstrate that the quality targets can be achieved with the revised plan.

You may initiate this as a continual improvement project, during the process involve your customer and get the "not necessary" inspection points parked for a test run. Once this test run proves that quality can be assured without these identified points you may revise your plan.

This way you will also win the confidence of the customer.
 
J

Jon Nonns

#5
[FONT=&quot]1) W[/FONT]hen I look at the finished product specification provided by the customer for their disposable medical devices, it provides the sampling plan and inspection for release of finished product. It then lists the critical, major and minor areas of the product to be tested along with the attributes that need to be tested to ensure we are releasing a ?quality? product. Do we have to test every aspect listed on this sampling plan or can I pick and choose as long as we can justify why we are not testing some area and documenting the results. Also, there may be several inspection levels listed int eh sampling plan which means that the QC Tech has to keep up with which sampling plan and which AQL to use for each attribute of the medical device. I would like to implement an internal inspection plan where we choose the highest inspection level and AQL and inspect rather than going back and forth. If I revise this, do I need the customer?s approval to change and use my plan.
As the other responses have said you need to be very cautious not to breach contract so customer approval is a definite (I would require them send a revised specification or sign off on yours prior to implemenetation). One additional twist is since this is a medical device, the quality control plan, including tests and testing frequency, may have been reviewed and approved by a regulatory agency or body and therefore this might not be a simple change to be made. Of course this highly depends on the class of medical device and where it is distributed. Good luck!

Jon
 
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