Acceptance Criteria - ISO 9001:2008 Clause 8.2.4 - Questionable Audit Finding?

[AshleyE]

Good Morning Cove,

We are an ISO 9001:2008 registered contract manufacturer that primarily serves the commercial sector. At our last surveillance audit our CB auditor raised a minor nonconformity in 8.2.4, Monitoring and Measuring of Product; however we're not sure this is an appropriate nonconformity for a 9001 audit. This is exactly what we were given:

Requirement: ISO 9001:2008, 8.2.4 required evidence of conformity with acceptance criteria.
Nonconformity: 1st pc inspection not showing evidence of inspection with inspection criteria.
Evidence: All 1st pc inspection is evident only by initials and date on the traveler and does not show what characteristics and tolerances dimensions were actually inspected.

The 1st pc inspection being referred to verifying the 1st pc of the manufacturing operation (not first article, which is very different). The first pc of every manufacturing operation is signed off by an authorized employee to indicate the part conforms to customer specifications (blue prints). If the customer requires a higher level of inspection, this will be done by Quality Control. If the customer requires us to document the results, QC will do an inspection report. Our procedures show we plan to check the 1st pc of every manufacturing operation and sign/date to show the part conforms to the customer blue prints.

The standard states

8.2.4 Monitoring and measurement of product
The organization shall monitor and measure the characteristics of the product to verify that product
requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1). Evidence of conformity with the acceptance criteria shall be maintained.

To me, it seems he is applying AS9100 requirements to our 9001 system. Several times in audit he starts digging for AS9100 and gives us a hard time when we can't show evidence we're meeting an aerospace requirement.

We are considering upgrading our process to AS9100 and the auditor is aware of it, but again, this is an ISO 9001 audit.

We have no problem improving our process if there is a deficiency to the standard we are registered to but it really seems we've been written up to aerospace requirements.

Am I looking at this the wrong way? Any insight would be appreciated.

 

[Jim Wynne]

Re: Questionable audit finding?

First of all, thank you for providing details.

I think the finding is probably misguided, although not necessarily wrong. Are the acceptance criteria specified for each product? Is actual measurement done?

 

[Randy]

Re: Questionable audit finding?

Looks kinda weak to me. You guys or you customer state how and what you are to inspect and how it's to be recorded. If you state that inspection is to be against blue print specs and the inspector verifys it being done, and it's acceptable to all concerned then the auditor may have erred, if the requirement is that all the data must be documented and you didn't do it you erred.

Now with the question of Standard...If your auditor references something no applicable to you and trys to inject it into your audit ask him to stop or just stop the audit if he refuses and kick his a&& out and make a call to his company.

 

[Bonhomme]

Re: Questionable audit finding?

I'm no expert but I'd tend to agree with you.

That's how I understood the standards too :
- 9001 requires verification(s) of products as appropriate, and to record who made such verifications (what you already do with initials)
- 9100 specifies that details (criteria, ...) about said verification must be documented too

I'll happily wait for additions/corrections from the experts though

 

[qusys]

Re: Questionable audit finding?

Good Morning Cove,

We are an ISO 9001:2008 registered contract manufacturer that primarily serves the commercial sector. At our last surveillance audit our CB auditor raised a minor nonconformity in 8.2.4, Monitoring and Measuring of Product; however we're not sure this is an appropriate nonconformity for a 9001 audit. This is exactly what we were given:

Requirement: ISO 9001:2008, 8.2.4 required evidence of conformity with acceptance criteria.
Nonconformity: 1st pc inspection not showing evidence of inspection with inspection criteria.
Evidence: All 1st pc inspection is evident only by initials and date on the traveler and does not show what characteristics and tolerances dimensions were actually inspected.

The 1st pc inspection being referred to verifying the 1st pc of the manufacturing operation (not first article, which is very different). The first pc of every manufacturing operation is signed off by an authorized employee to indicate the part conforms to customer specifications (blue prints). If the customer requires a higher level of inspection, this will be done by Quality Control. If the customer requires us to document the results, QC will do an inspection report. Our procedures show we plan to check the 1st pc of every manufacturing operation and sign/date to show the part conforms to the customer blue prints.

The standard states

8.2.4 Monitoring and measurement of product
The organization shall monitor and measure the characteristics of the product to verify that product
requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1). Evidence of conformity with the acceptance criteria shall be maintained.

To me, it seems he is applying AS9100 requirements to our 9001 system. Several times in audit he starts digging for AS9100 and gives us a hard time when we can't show evidence we're meeting an aerospace requirement.
We are considering upgrading our process to AS9100 and the auditor is aware of it, but again, this is an ISO 9001 audit.

We have no problem improving our process if there is a deficiency to the standard we are registered to but it really seems we've been written up to aerospace requirements.

Am I looking at this the wrong way? Any insight would be appreciated.

If the acceptance criteria that you have agreed with the customer are for attributes ( pass/ no pass), you should be ok if you showed the record and so I do not think the nc could have been raised up. In the case the request is to record data of the first pc inspection ( with measurement check and related values) and you did not do it, the nc is valid.
It depends .

 

[Mikishots]

Re: ISO 9001:2008, 8.2.4 - Acceptance Criteria - Questionable Audit Finding?

Good Morning Cove,

We are an ISO 9001:2008 registered contract manufacturer that primarily serves the commercial sector. At our last surveillance audit our CB auditor raised a minor nonconformity in 8.2.4, Monitoring and Measuring of Product; however we're not sure this is an appropriate nonconformity for a 9001 audit. This is exactly what we were given:

Requirement: ISO 9001:2008, 8.2.4 required evidence of conformity with acceptance criteria.
Nonconformity: 1st pc inspection not showing evidence of inspection with inspection criteria.
Evidence: All 1st pc inspection is evident only by initials and date on the traveler and does not show what characteristics and tolerances dimensions were actually inspected.

The 1st pc inspection being referred to verifying the 1st pc of the manufacturing operation (not first article, which is very different). The first pc of every manufacturing operation is signed off by an authorized employee to indicate the part conforms to customer specifications (blue prints). If the customer requires a higher level of inspection, this will be done by Quality Control. If the customer requires us to document the results, QC will do an inspection report. Our procedures show we plan to check the 1st pc of every manufacturing operation and sign/date to show the part conforms to the customer blue prints.

The standard states

8.2.4 Monitoring and measurement of product
The organization shall monitor and measure the characteristics of the product to verify that product
requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1). Evidence of conformity with the acceptance criteria shall be maintained.

To me, it seems he is applying AS9100 requirements to our 9001 system. Several times in audit he starts digging for AS9100 and gives us a hard time when we can't show evidence we're meeting an aerospace requirement.

We are considering upgrading our process to AS9100 and the auditor is aware of it, but again, this is an ISO 9001 audit.

We have no problem improving our process if there is a deficiency to the standard we are registered to but it really seems we've been written up to aerospace requirements.

Am I looking at this the wrong way? Any insight would be appreciated.

My take on this is that the finding is valid if you haven't been able to show evidence of conformity. You've shown records that have the release authorization on them, but it seems that the auditor did not see any acceptance criteria.

 

[Randy]

Re: ISO 9001:2008, 8.2.4 - Acceptance Criteria - Questionable Audit Finding?

My take on this is that the finding is valid if you haven't been able to show evidence of conformity. You've shown records that have the release authorization on them, but it seems that the auditor did not see any acceptance criteria.

The criteria was in the blueprints and instruction used by the inspector

 

[AndyN]

What's missing here is that if an inspection is performed and, if there's variables data obtained, that should be recorded! Just a set of initials to say a feature is inspected is (relatively) meaningless! DATA is necessary to give evidence that the result meets the blueprint. A signature doesn't show anything meets the blueprint.

Practically, if a feature is measured and the result is not recorded, but in fact is right at the limit, what if the customer's measurement shows it's out of tolerance - how is anyone going to have a meaningful discussion about what result was achieved and how? Showing them a set of initials doesn't show conformity!

 

[AshleyE]

Thank you all for your take on this.

The majority of our customers only care about getting their parts on time, and the parts match the customer specifications. Very few of our customers require we keep results of inspection on file. The first time we make a part for any customer, it gets a full inspection report that spells out each dimension from the print, the acceptance critera and the actual measurement. Anytime a customer requires inspection reports for a job, that becomes a requirement on the job traveler and it goes through full inspection with reports.

We keep evidence of conformity based on what our customer requires. If the customer does not require evidence of conformity, we use our standard sign/date procedure.

I guess it all boils down to how does one define "evidence of conformity" and what "evidence" acceptable.

 

[AshleyE]

What's missing here is that if an inspection is performed and, if there's variables data obtained, that should be recorded! Just a set of initials to say a feature is inspected is (relatively) meaningless! DATA is necessary to give evidence that the result meets the blueprint. A signature doesn't show anything meets the blueprint.

Practically, if a feature is measured and the result is not recorded, but in fact is right at the limit, what if the customer's measurement shows it's out of tolerance - how is anyone going to have a meaningful discussion about what result was achieved and how? Showing them a set of initials doesn't show conformity!

Andy, I just missed your post when I put up my reply. I do see your point.