I have just joined a company that has been working on ISO9002:1994 and wants this certification before ISO9001:2000. What things could I do to make the transition from 1994 to 2000 version easier.
I agree with the most recent post. If you could not produce a record demonstrating that you inspected the 10% and found that the inspected parts are/are not in conformance then the CAR is justified. I would have preferred to see the auditor examine your inpection records for other randomly selected parts as opposed to pulling individual pieces from stock to examine, however, to reveal is this instance is systematic or not.
At our company, we don't even inspect 10% - we would go out of business and have to reinvent ourselves as an inspection company! We go through a very basic part approval process - once approved, its dock to stock until we have a problem - then there are processes in place to ensure future conformance, etc.
I think the lesson here is BEWARE - you still have to do what you say you do!!! You should probably examine your inpsection process as a whole to determine what really makes sense...does 10% inspection really tell you anything? Do you have the resources to statistically sample all incoming product? Is it critical to do so? Maybe a part approval system could work for your company as well - put the work on the suppliers not your QA group. Hope this helps...
CJ,
8.2.4 clearly states, “ Evidence of conformity with acceptance criteria shall be maintainedâ€.
This is for appropriate stages of Product Realization. Incoming Inspection can be included in these stages.
On the other hand, on 7.4.3 Verification of purchased product there is no mention of record keeping. In order for you to prove, that you did establish and implement a system that ensures purchased product meets specified purchase requirements, you need objective evidence. Hence is understood that you need records.
Your auditor’s CAR statement did not imply that you have to measure and record everything. He/She is clearly stating your rules “Verify diameters 10% per sizeâ€.
You could not prove compliance to your own internal requirement. Hence the CAR.
Note#1: 10% Sampling rules are not statistically sound and they lack protection to both producer and Consumer. They are also expensive to administer. Try ANSI/ASQC Z1.4, Sampling Procedures and Tables for Inspection by Attributes.
Note#2: It is interesting to note, your CAR extends saying, “Observation of the measurement of the diameter of 3 pieces pulled randomly from finished stock found that 1 of the 3 pieces was out of specificationâ€.
I do not know your objective and type of the audit, for a systems audit, this is not typical. This go beyond System audit into a product audit!
Your auditor said you must measure and document everything. That is not according to the standard!
You must have records of what you measure, but if you don't think it's necessary to make formal measurements to your product, and your customer (intern or extern) can live with that, I don't find any N/C in that.
Anyway only being in the factory to have a more precise idea...
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Comments
sbickley 10/12/2004
I agree with the most recent post. If you could not produce a record demonstrating that you inspected the 10% and found that the inspected parts are/are not in conformance then the CAR is justified. I would have preferred to see the auditor examine your inpection records for other randomly selected parts as opposed to pulling individual pieces from stock to examine, however, to reveal is this instance is systematic or not.
At our company, we don't even inspect 10% - we would go out of business and have to reinvent ourselves as an inspection company! We go through a very basic part approval process - once approved, its dock to stock until we have a problem - then there are processes in place to ensure future conformance, etc.
I think the lesson here is BEWARE - you still have to do what you say you do!!! You should probably examine your inpsection process as a whole to determine what really makes sense...does 10% inspection really tell you anything? Do you have the resources to statistically sample all incoming product? Is it critical to do so? Maybe a part approval system could work for your company as well - put the work on the suppliers not your QA group. Hope this helps...
gramu 10/9/2004
CJ,
8.2.4 clearly states, “ Evidence of conformity with acceptance criteria shall be maintainedâ€.
This is for appropriate stages of Product Realization. Incoming Inspection can be included in these stages.
On the other hand, on 7.4.3 Verification of purchased product there is no mention of record keeping. In order for you to prove, that you did establish and implement a system that ensures purchased product meets specified purchase requirements, you need objective evidence. Hence is understood that you need records.
Your auditor’s CAR statement did not imply that you have to measure and record everything. He/She is clearly stating your rules “Verify diameters 10% per sizeâ€.
You could not prove compliance to your own internal requirement. Hence the CAR.
Note#1: 10% Sampling rules are not statistically sound and they lack protection to both producer and Consumer. They are also expensive to administer. Try ANSI/ASQC Z1.4, Sampling Procedures and Tables for Inspection by Attributes.
Note#2: It is interesting to note, your CAR extends saying, “Observation of the measurement of the diameter of 3 pieces pulled randomly from finished stock found that 1 of the 3 pieces was out of specificationâ€.
I do not know your objective and type of the audit, for a systems audit, this is not typical. This go beyond System audit into a product audit!
Regards,
GR.
teodoro 9/16/2004
Your auditor said you must measure and document everything. That is not according to the standard!
You must have records of what you measure, but if you don't think it's necessary to make formal measurements to your product, and your customer (intern or extern) can live with that, I don't find any N/C in that.
Anyway only being in the factory to have a more precise idea...