Managing Clause 9.1.1. for Documenting Inspection Results

We recently had our ISO/IATF recertification audit in November of last year, and came away with a minor finding regarding not fully documenting operator inspection results. (ISO portion) In years past, we did away with our operator checksheets for recording manual gaging because all they were doing was checking that they did them. They weren't recording actual results. The majority of our measurements have automatic gaging with feedback. However, there are still some cells that rely on the operator to take the measurements. We perform 4-hour checks within the QC Lab and perform production interruption audits if there are any issues. We did appeal the finding siting that it would hinder our initiative to convert to a paperless system. (Appeal was denied) I know there are software programs available that our operators could use and other ways to record inspection information electronically but you run the risk of it being labor intensive and causing operators to fall behind and not make rate. Obviously, rate means nothing if they aren't good parts, but at the same time we feel we have checks and balances in place to capture any issues, which we provided supporting documentation for in our appeal request. To implement automatic gaging plantwide is not feasible at the moment. That would definitely be a long-term solution but to get us through responding to this finding, I wanted to put my feelers out there to see what other companies have been doing that is not cumbersome and non-value added, but still meets the requirements. Any help you can provide would be greatly appreciated. I will say, I'm still awaiting a formalized letter from our registrar to document WHY they rejected our appeal because all I have at the moment is an email stating they stand by the auditor's original finding!

 

Yes, they are.

 

No, our process flows aren't that specific but I can say for certain one of the checks originated from a corrective action response to a customer complaint that was documented in our PFMEA.

 

Agreed, but like I mentioned before not all parts we run have the automated gaging, so we would need to implement something to document the checks that are manual until such time we can replace the manual checks with automated gaging.

 

9.1.1. is (as the title suggests), a generalization and not specific to operational product measuring and certainly is not specific to "Documenting Inspection Results. Indeed, sticking specifically with the 9001 standard, 8.6 is the (only?) place that speaks to verifying at planned stages.

9.1.1 leaves it to to the "organization shall determine"....what is measured (this could be specific to product, services, or simply aspects of the organization that would be a good barometer as to the effectiveness (or not) of the management system....which is specifically what the clause refers to. Generally this is considered the key metrics that are part of 9.3 (remember, we're in clause 9 here (performance evaluation) and not clause 8 (operational control), which speaks frequently about "verification", implying/stating the confirmation that products/services meet their intended output.
In fact, the only places the standard (9001) speaks to verification is in clauses 8 (product/service verification) and clause 7 (control of the measuring devices to be used).

If we are going to discuss the OP stated subject "inspection results" I counsel that we focus on clause 8 since that is how the standard (9001) is structured in that context.

Hope this helps.
Be well.

 

If I understand your process, the operators are doing checks but not recording them? Then the quality lab is doing a four hour check and recording it? If so, what’s the purpose of the operator check and why would it need to be recorded? We frequently have an operator check a part, but only to make sure it’s good before giving to QA who does the documented check.

 

9.1.1 begins by saying "The organization shall determine..." Therefore, the organization, not the CB auditors, is the one who will determine what/how/when monitoring and measurement are to be done, including what information is appropriate to be retained. There's no categorical statement that requires "operators to document their inspection". If the organization deems that automatic gaging with feedback, 4-hour checks by QC lab and production interruption audits are the what/how/when of an organization in monitoring and measurement, then there's no violation of the requirements of the standard.

If the CB finding will hinder the organization to a more efficient system, then there's no value in getting certification from them.

 

It will depend on what their control plan documentation says. You can inadvertently get caught up in a lot of nonsense between what a control plan says and what you actually do that works for you.

 

But their issue was the 4-hour checks don't capture the operator checks....Our control plan calls out these same checks.

 

Right. So fix the glitch and remove the formal requirement for an operator check on the CP. You can still do them, just don’t “require” them. And thus the absurdity of the standard.

 

Noted! Thank you....we're going to structure our procedure to break down the different checks that we have listed on the control plan and specify how they are documented, if at all and if not what is used to ensure parts are still good.

 

Your statement here has been running through my head on repeat for a while now.

My organisation is having this issue (Thought is certified ISO 9001 and not related to this thread).

There is no data derived from our inspections other than Job Number and who 'completed' the inspection. All that results is the operator commencing in pencil whipping. I'd like them to some how start recording actual outputs of inspections, i.e dimensional analysis. But I come to the same conclusion, that the operators will just make up the results to a degree & the fact that most of our drawings (thousands) don't have ballooned dimensions to reference on inspection sheets.

I also don't have any shop floor QC so they're responsible for inspecting & recording the out puts of their own work, and due to the massive size of our organisation it's impossible to confidently say these inspections are being done.