8.2.4 Monitoring and measurement of product - Do I need to record every serial number

[johnnybegood]

How do I comply to 8.2.4?.... Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product

Our process is such that Production will pass the product for QA to buy-off. The lot will not be acceptable if it fails the acceptance criteria plan. Question is do I need to write down every single product's serial number as an evidence of conformity?

[sal881vw]

Hello johnnybegood,
IMHO, it all depends on what traceability method you have in in place.
Are you able to back track your components/products right through the chain of supply?
Is the seriel number on the product itself?
Do your work orders co relate with materials used, methods applied, manpower used, machinery/tools used?

Record what is essential and of need, duplication of data is a waste, unless as a back up.

[Mike S.]

Johnny,

Sal makes some good points. How do you identify your products? How do you know product meets requirements?

Let's say each product has a sequential serial number, for example, and you do an AQL sampling of 125 samples for a 3000 piece lot. IMO you do not need to record 3000 serial numbers, or even 125 serial numbers, but I would say I sampled 125 pieces from a group with serial number 12000 - 15000 and record the results of the sampling, who did the sampling and authorized the release, etc.

If this does not answer your question please write back with more details.

[Al Dyer]

JBG,

No

Al...

[bpritts]

I will second Al's opinion ... with the follow-up note:

We have 2 kinds of situations:
1. 100% inspections
2. Sampling inspections

We record 1 report stating the number of pieces checked, number found
acceptable/unacceptable, and the size of the lot involved. No need to
track individuals unless your own system (or customer) demand this.

Brad