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Standard (EN?, prEN?,ISO?) that deals with Certificate of Analysis?

M

Monica Lewis

#1
#1
Marc,

Have you or anybody else heard about a Standard (EN?, prEN?,ISO?) that deals with
certificate of analysis for raw material or final product (content, who should sign it etc.)
 
QMS for Medical Device Companies
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Marc

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
#2
I haven't heard of a documented standard, however the 'normal' minimums are:

Test performed
Units of measure
Upper and lower limits
The actual reading obtained
Signature of responsible company official
 
T

Texasrussian

#3
#3
Ugh, my boss is going to freak, the customer is wanting a new COA to list individual part measurements, five per part on the COA, which would have 100 parts or about a ten page COA. I read the customer's specification and their requirement "implies" lot averages which will keep the COA to one page and no mention of indiviual values on their COA section. Textile rolled good is the part.

We already input the inspection into a spreadsheet, but I fear formatting the COA the customer wants will be another two hours of work. I've mention to the customer quality engineer, but he still pushing back that he wants the long version of the COA. How to handle?
 
Jim Wynne

Jim Wynne

Staff member
Admin
#4
#4
Texasrussian said:
Ugh, my boss is going to freak, the customer is wanting a new COA to list individual part measurements, five per part on the COA, which would have 100 parts or about a ten page COA. I read the customer's specification and their requirement "implies" lot averages which will keep the COA to one page and no mention of indiviual values on their COA section. Textile rolled good is the part.

We already input the inspection into a spreadsheet, but I fear formatting the COA the customer wants will be another two hours of work. I've mention to the customer quality engineer, but he still pushing back that he wants the long version of the COA. How to handle?
Click to expand...
Tell your customer you'll be happy to revise your pricing just as soon as you receive documented requirements.
 
Wes Bucey

Wes Bucey

Quite Involved in Discussions
#6
#6
Jim Wynne said:
Tell your customer you'll be happy to revise your pricing just as soon as you receive documented requirements.
Click to expand...
Yes! Add-on requirements after the contract is agreed can easily push a profitable contract into red ink unless the supplier has the intestinal fortitude [guts] to face the customer and say "Whoa! Let's revisit our pricing."

Note, though, that if it was already in the contract and the supplier just missed it by lack of diligence - there's a different worry.
 
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