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

[Jafri]

Our company uses go/no plug gages at several locations. As per control plan, the operators are required to measure product at least 3 times a shift using these gages.
Our Quality System Coordinator thinks that it is necessary to keep record of operators using go/no gages at required intervals. And that is why every operation has a form to fill in the "ok/ not ok" field for the use of plug gage.

I talked to her today and told her that it doesn't look right to me that the operators fill out forms only for plug gages. An ok/not-ok field in a form does not give us any information about process, and only gives an opportunity for auditor to find nonconformance when these forms are not filled in 100%.

She told me that it is a requirement of ISO 9001, and she cited 8.2.4 for it:
"Evidence of conformity with the acceptance criteria shall be maintained."
So she said if we don't record use of plug gage in forms then what evidence would we have for conformity with our control plan?

I had no answer to this. But it still sounds weird to me. I see no use of keeping so much data. I always thought that ISO system is very logical and uses common-sense. So I don't what to make of this interpretation.
I also remember the last company I was working it, where control plan did call for inspections using plug gages, yet they were not recording the use of plug gage anywhere. It was a given.

Please help me understand it, friends. We are accumulating loads of paperwork due to this, and to me it is for no reason.

 

[Stijloor]

Re: 8.2.4 "Evidence of conformity"

Welcome to The Cove Forums!

The standards requires what you quoted in your post. It does not require that you record all the inspections. But you must show that the product meets the acceptance criteria. It can be a simple initial on a the router. What do you currently do?

Stijloor.

 

[Jafri]

Re: 8.2.4 "Evidence of conformity"

Stijloor:

It does not require that you record all the inspections.

Where does standard says that we don't need to record ALL inspections?
If I could convince her that we really don't need to keep record of EVERY inspection then I think the problem will be solved.

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We don't use travelers/ routers.

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We have a 100% final inspection station (awful), and the inspector there typically uses all plug gages which are used in in-process inspection. So that's how we can confirm that part is good before sending it to customer.

 

[Stijloor]

Re: 8.2.4 "Evidence of conformity"

Stijloor:

Where does standard says that we don't need to record ALL inspections?
If I could convince her that we really don't need to keep record of EVERY inspection then I think the problem will be solved.

----

We don't use travelers/ routers.

----

We have a 100% final inspection station (awful), and the inspector there typically uses all plug gages which are used in in-process inspection. So that's how we can confirm that part is good before sending it to customer.

The standard only spells out the requirement. It does not provide you with implementation guidelines. Your organization needs to determine in what manner the evidence will be provided.

I only used the router as a possible example.

It looks to me a battle of the minds. You need to come to an internal agreement about what would work best for your organization and at the same time meet the Standard requirement.

A search in the "Post Attachments List" on the word "inspection" revealed this.

More on "Evidence of Conformity."

Search, click, and take your pick.

Stijloor.

 

[Marc]

Re: 8.2.4 "Evidence of conformity"

<snip> It does not require that you record all the inspections. But you must show that the product meets the acceptance criteria. It can be a simple initial on a the router. What do you currently do?

Stijloor.

This is stretching it. If an inspection is made, my expectation would be evidence of it. If a variable, I would expect the measurement as well. ISO 9001 may not specifically call it out, but I would call it on 8.2.4 as well. The results of the inspection must be recorded somewhere on some document/record.

If there is no *evidence* that something as important as an inspection was done (and if it isn't 'important', why is there an inspection?), then I would have to assume it wasn't done. And that doesn't begin to address the issue of what is the company doing with inspection data? If inspections are being done the results should be available for analysis. If they are not, the value of an inspection is virtually useless.

Improvement is based upon analysis of data. EOS

 

[Jafri]

Hello Marc. Like I said earlier, the previous automotive company I was working at did not keep record of the use of plug gages at any machining operation. And yet they were ISO certified.

(and if it isn't 'important', why is there an inspection?)

My p.o.v was that inspection is important, but keeping a yes/no record is not. If inspection is not done then it would be caught at final inspection.

About keeping record of every inspection, what if this inspection with plug gage is filled out just once in first-piece-inspection sheet? In this case the operator may not have to fill out any form every time there is need for inspection. Thus the first-piece sheet will give the evidence of inspection of that feature.
However, one can make argument that inspection of feature may have been recorded but inspection done by the operator is not!

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.

 

[Marc]

They can do that, but in my opinion it is a very bad (as in stupid) business practice unrelated to a specific ISO 9001 requirement. If an inspection is identified (whether it is attribute data or discrete {aka 'variables'} data), it should be recorded and used in analysis (ultimately as a Management Review Input).

Think about the phrases: "Analysis of Data" and "Improvement".

Edit add: OK - Let's say it is a setup sheet. Are you doing 'Last Piece' for comparison?

Whether or not you do a lot of inspections and whether you record them is dependent upon the importance of the inspection(s). If you're making plastic duckies for kids in the bath tub (injection molding process), the importance of various checks will be different than if you're manufacturing High-Rel electronics equipment for the military.

 

[Jafri]

Ok. I think I am going to maintain the status quo ... except if the external auditor has no objection.
Many thanks.

 

[JuneFoo]

Wonder could we just fill up inspection form or reject data only once we found reject issue? (If control plan spell clearly this is the organization control). Hope some one can explain further.

 

[David Hartman]

Can the parts or their container be stamped with a QC stamp upon acceptance?