Custom Records and Quality Systems - Products that change frequently

rlangeZMC

Starting to get Involved
#1
So we have products that change frequently, bacteria and viruses, and since we are updating our quality system to the new 2016 ISO 13485 standard, we are having issues trying to figure out what to do with them and still be compliant. :confused: Does anyone have any experience with this? What do you do? We used to use deviations explaining custom records did not have to comply with certain aspects but now that we've amped up out nonconforming material procedure, it's making it a bit harder to justify not filing hundreds and hundreds of NCM reports for what once used just a couple deviation reports. Obviously, manufacturing is not happy about hundreds of reports that they don't have time to fill out. What do we do? :bonk: Can we somehow exempt custom records from our quality manual/system?

Insert rock, me and a hard place. :lol: Thank you!
 
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John Broomfield

Staff member
Super Moderator
#2
rlange,

Exactly how do your customers specify the bacteria or viruses they require?

That may help determine the nonconformities (failures to fulfill requirements) that need to be recorded and to invoke correction and corrective action.

Normally specs are one or more of the following:

A. Product characteristics
B. Product performance
C. Method to result in the required product

B requires design of the product.

John
 

rlangeZMC

Starting to get Involved
#3
"Exactly how do your customers specify the bacteria or viruses they require?

That may help determine the nonconformities (failures to fulfill requirements) that need to be recorded and to invoke correction and corrective action.

Normally specs are one or more of the following:

A. Product characteristics
B. Product performance
C. Method to result in the required product

B requires design of the product."

Thank you for your response! Many of our bacterial and viral products aren't sold. They are then used as a raw material to make some other product that is sold. We're just trying to eliminate a lot of extra work for everyone.
 

John Broomfield

Staff member
Super Moderator
#4
"Thank you for your response! Many of our bacterial and viral products aren't sold. They are then used as a raw material to make some other product that is sold. We're just trying to eliminate a lot of extra work for everyone.
rlange,

Then you need to consult with the designers of your product.

They determine the key characteristics of the raw materials for your products.

Ask them to determine the acceptance criteria for raw material and you should then have a handle on when bacteria or viruses are nonconforming.

John
 
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