Monitoring and Measurement of Product - ISO 9001 - 8.2.4 "Evidence of Conformity"

[G.L.H.]

Hi,

I have just read your problem related to the go no go gages. Indeed your colleague is corrent when she says evidences must be kept for proving the check was done.
But there are olso other ways to do it. One way I've been using was to mention the verification with the acceptance criteria and reaction in case of Nok in the Operator work instruction for the specific work station, and in addition put one list of oerator registration on the work station. This way the operator is signing only once, when he comes to work, and by signing this list he confirms he is aware of all the checks he has to do and assumes responsability for it. These lists you can scann afterwards and keep them for 3 months (unless the check is done for a special characteristic).

 

[jbyrd_1976]

In our company we use similar methods of checking holes with a go / no-go gauge. The approach we have taken, for instance with a piston bore Internal Diameter : the operator inspects every 10th part and then initials the part to indicate it passed inspection. This satisfies the ISO standard for us becuase the inspection record is maintained until the next process. If the 10th part is good and the 20th part is bad, the operator would check the parts prior to #20 and work backward to the last good part.

Hope this helps

 

[Zenzi09]

If you think the yes/no is not important, why don't you just put a catch all on your paperwork, your work instructions saying that recording the inspection is not necessary unless a non-conformity has arisen, then propery document the non-conformity.

 

[statdoug]

This is the kind of problem that gives credence to the emotional post of jackweed13, "ISO9001:2008 - What a complete joke!." Too often, the drive to comply with ISO requirements superceeds the dictates of common sense. There are situations where this kind of thing is critical, and there are situations where the operator's desire to keep the process running trouble-free may suffice to insure the checks. ISO tends to cause these to be painted with the same broad brush, often, to the detriment of cost-effectiveness, and even the operator's pride in their job.

And, to his point also, the enforcement and policing of these guidelines has taken many people, with real training, who could be contributors to improvement, and given them years of busy-work, writing and re-writing sytems, that are great on paper, but often totally impractical in the real world of manufacturing.

 

[Helmut Jilling]

Hi,

I have just read your problem related to the go no go gages. Indeed your colleague is corrent when she says evidences must be kept for proving the check was done.
But there are olso other ways to do it. One way I've been using was to mention the verification with the acceptance criteria and reaction in case of Nok in the Operator work instruction for the specific work station, and in addition put one list of oerator registration on the work station. This way the operator is signing only once, when he comes to work, and by signing this list he confirms he is aware of all the checks he has to do and assumes responsability for it. These lists you can scann afterwards and keep them for 3 months (unless the check is done for a special characteristic).

This is an interesting idea, but I don't see any indication how it would meet ISO requirements to evidence inspections were performed.

It is interesting to me, if you check one part with a mic every 2 hours, it is commonplace that the inspection would be jotted down on an inspection report with an iniital or something. No big deal. But, if the same check is done with a go-nogo gage, it is suddenly a huge imposition? Why? What is so difficult about a checkmark in a column with an initial or clock number?

 

[Helmut Jilling]

...Well, I think there is this gray area, and before making any decision I would have to talk to our external auditor in his next visit ... which is next week.
He is kind of a customer in this case.

Better to think of the auditor as a assessor or referee, but we are not a "customer" in any sense of the word as used by ISO.

 

[ogghall]

I thought looking through this post would be helpful, but not really. A lot of repeating of the standard's wording. (Don't know if jafri feels the same way.) have the same question regarding the methods of providing evidence of conformity when inspections during the processing of various sub-assmeblies are being conducted. Regardless if they are go/no go or any type of attribute inspection like visual inspections or whether they measurements taken does evidence of conformity have to be some type of record? Because I don't write the result of somehthing down, pass/fail or measurement, does not mean the inspection is not important. (To those who ask why are you doing it then.) The need to collect and record the data is not important.

So my question then is for eveyone who maintains and has stated that evidence of conformity requires that a written notation, entry into a database, filled in form, etc, take place, do you really have that done in your company? Everytime a person completes an inspection?

Can evidence of conformity be the processing of the part onto the next operation, putting the part in bin identified with Acceptable status, keeping it on the conveyor,, etc? Again regardless of how the inspection takes place?

 

[whitey115]

Our company is currently recording measurement data on inspection sheets per our plan.

What is the opinion of fellow "covers" about using an authorization of product release such as a statement like:
"This Product Has Been Inspected In Accordance To Our Planned Arrangements And Meets With Our Customer Specified Requirements"

Signed____________ Date____________
In your opinion would that satisfy 8.2.4 requirement of evidence of conformity and authorization of release?

Please feel free to weigh in. Thanks in advance to everyone who participated..
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