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Records Management Program <[log in to unmask]>
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Mon, 23 Jul 2007 17:28:39 -0700
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Records Management Program <[log in to unmask]>
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Nolene Sherman <[log in to unmask]>
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Caveat: We are not a product manufacturer and I have never had to use these citations for our company.

When I read these two sections, my interpretation is that 2.5.4 only relates to records that proves that quality checks have been performed, but not necessarily to the content of the checks; 2.11 refers to the quality tests themselves and the documentation for the outcome of the tests.

"Permanent" would be life of company. 

What Larry indicated for "Suitable period" ... Last manufacture date of product + warranty period ... Sounds reasonable to me. I'm presuming that once you sell it to a retailer, you don't know when it has actually been sold to the consumer so you'd have no way of knowing when each product in a QC batch actually made it into the hands (or another part of the anatomy!) of the ultimate user. However, if you DO have some way of knowing when the last item in the QC batch was ultimately sold, you could use that date + the warranty period.

Nolene
Nolene Sherman | Director of Records Management | Standard Pacific Homes | 949-727-9360 | FAX 949-789-3379 | [log in to unmask]

-----Original Message-----
Subject: [RM] Quality Certification Records

2.5.4 Records of checks and tests
The manufacturer must draw up and keep permanently records that prove that the products have undergone checks and/or tests according to the defined acceptance criteria (see 2.11).
 
2.11 Records relating to the quality of the finished product
The manufacturer must update the appropriate records of checks and tests to prove compliance with the specified requirements. Records relating to the quality of the finished product must be legible and identifiable vis-à-vis the relevant product. Records relating to quality, which justify compliance with the specified requirements must be kept for a suitable period and be available on request.
 

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