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

[Jen Kirley]

I don't like the finding's wording because it is so specific and implies the auditor is stating actual requirements of your system that aren't in the standard.

That said, I appreciate Andy's position: without seeing your record of inspection I am left to wonder if it even states which customer specification the part was checked to? What revision? Which tool was used?

What does your procedure say?

Without marking the actual measurement, how would anyone know that, for example the part is nesr one or other limit and the smallest process drift would render out of tolerance conditions. Without recording results of an inspection (your description was only recording that an inspection took place) there is questionable value in being able to go back to that point later and learn from it.

 

[AshleyE]

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?

We do actually measure the part to make sure the part conforms to customer specifications. The sign off indicates "I did the inspection and the measured dimension meets the customer criteria".

 

[AndyN]

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

Actually, the scenario could be even worse! Let's for discussion, say that the 1st item was right at the limit on some feature or other - how many could be made before the feature goes out of limit and is subsequently rejected? You could be 'responsible' for approving a part which - with data - you'd have had the operator reset the cut to nominal and given a chance to run more (depending upon the capability of the machine, of course). Right now, the very next parts could be run, all out of spec for as long as it took for the next inspector to 'find' it and reject it - then who sorts and at what cost?

Without this data, any frequency/timing etc of follow up line inspections is going to be a "cr*p-shoot" because no-one knows how long it will be before the tool wears (or other factors) to affect the feature dimensions. Think of it as CYA - use data to justify the approvals, and then any part inspection later, to ensure no non-conforming parts a re processed...

 

[AshleyE]

Actually, the scenario could be even worse! Let's for discussion, say that the 1st item was right at the limit on some feature or other - how many could be made before the feature goes out of limit and is subsequently rejected? You could be 'responsible' for approving a part which - with data - you'd have had the operator reset the cut to nominal and given a chance to run more (depending upon the capability of the machine, of course). Right now, the very next parts could be run, all out of spec for as long as it took for the next inspector to 'find' it and reject it - then who sorts and at what cost?

Without this data, any frequency/timing etc of follow up line inspections is going to be a "cr*p-shoot" because no-one knows how long it will be before the tool wears (or other factors) to affect the feature dimensions. Think of it as CYA - use data to justify the approvals, and then any part inspection later, to ensure no non-conforming parts a re processed...

Again - these are valid points.

Let me clarify a little bit. On each step of the job traveler, there is a space to sign off that the 1st pc of the operation was done correctly. Once the operator continues making parts on that operation, the procedure is to keep checking parts through the run and raise a hand when something does not conform to customer specs. There is not a single operator who assumes "1st pc was good, now I don't have to bother checking another part."

To your point also, while the procedure is to periodically check parts in process and alert supervisors of defects, we do not specify how often. It depends on the tolerances, customer requirements and is up to the supervisor to advise. We can absolutely tighten up our inspection procedures and specify what gets documented and when. No one in the plant is arguing that we can't improve our inspection process.

The only argument we have is are we are being written up to a requirement that is not part of ISO9001.

 

[Wes Bucey]

I don't like the finding's wording because it is so specific and implies the auditor is stating actual requirements of your system that aren't in the standard.

That said, I appreciate Andy's position: without seeing your record of inspection I am left to wonder if it even states which customer specification the part was checked to? What revision? Which tool was used?

What does your procedure say?

Without marking the actual measurement, how would anyone know that, for example the part is nesr one or other limit and the smallest process drift would render out of tolerance conditions. Without recording results of an inspection (your description was only recording that an inspection took place) there is questionable value in being able to go back to that point later and learn from it.

I agree with Jennifer the auditor's description of what he notes is weak BECAUSE he does not cite the "acceptance criteria" he/she used for a basis to declare a nonconformity.

We often use the phrase "show me the shall" here in the Cove. The auditee's responsibility is to NOT LET THE AUDITOR LEAVE unless and until every ambiguity is cleared up in the closing meeting. Too frequently, both the auditor and auditee rush through the closing meeting - the auditor to catch a plane and the auditee because he's exhausted from the stress of the audit and the preparation before the audit. This rush to get out often precipitates "What did the auditor mean?" questions here in the Cove, when an extra five minutes spent at the closing meeting could have cleared up the mystery.

In fairness, many of us here in the Cove are hardened old pros not easily intimidated by an auditor, even when there is a lot of pressure from the bosses to get it all over and done with without making waves. Newbies, however, may not be all that sure of their ground and auditors have a way of coming across as both omniscient and omnipotent, when the truth is they are merely employees doing a narrowly focused job.

Having been the owner of a contract machining company. I can attest MANY customers are not concerned with, nor do they request, detailed inspection reports. In my shop, we created such inspection plans primarily for our own benefit in maintaining a profitable operation and as a way to :ca: if something should crop up down the road. Such detailed records are also handy (whether the customer requests them or accepts them as a gift) in narrowing the scope of any recall occasioned for any reason in the future.

It sounds to me (from the flow of the thread to date) that the auditor could clear up this mystery by answering a phone call which asks, "Which specific "acceptance criteria" were you citing in making this N/C?"

If he has a viable citation, step up and correct it; if not, ask him to delete it.

 

[AndyN]

It may be a poorly worded nc statement, but it seems enough to me, given that you aren't recording the actual values inspected:-

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.

 

[Chance]

IMHO, I think this is an easy fix. The proper inspection is done by inspectors following the customer requirements (blue prints). No problem. Is there enough evidence that results are within the acceptance criteria? No. Can't you just make a simple checklist with a drop down choices for inspectors to choose while performing the inspection?
This could benefit you also, in case the customer will return any part that is out of spec. You can just easily show your records, that everything was checked on this date with no such issue, with readings within spec.

 

[Jen Kirley]

Again - these are valid points.

Let me clarify a little bit. On each step of the job traveler, there is a space to sign off that the 1st pc of the operation was done correctly. Once the operator continues making parts on that operation, the procedure is to keep checking parts through the run and raise a hand when something does not conform to customer specs. There is not a single operator who assumes "1st pc was good, now I don't have to bother checking another part."

To your point also, while the procedure is to periodically check parts in process and alert supervisors of defects, we do not specify how often. It depends on the tolerances, customer requirements and is up to the supervisor to advise. We can absolutely tighten up our inspection procedures and specify what gets documented and when. No one in the plant is arguing that we can't improve our inspection process.

The only argument we have is are we are being written up to a requirement that is not part of ISO9001.

Ok, now I think I am making some progress in understanding you.

8.2.4 says, in part "Evidence of conformity with the acceptance criteria shall be maintained."

So, the initials on a line by a step are evidence of what? It seems the auditor believed the initials were evidence the inspection took place. An activity.

Does the initial also mean acceptance, or would the inspector also identify him/herself if a part was rejected?

The issue here is evidence of conformity with acceptance criteria. Since evidence means "A thing or things helpful in forming a conclusion or judgment" and criteria means "A standard, rule, or test on which a judgment or decision can be based" (Dictionary.com) the requirement of 8.2.4 raises the bar: from indicating an inspection was performed and accepted, to a description of the basis of acceptance, both of the found characteristics and the instrument(s) used to measure them.

 

[AshleyE]

Ok, now I think I am making some progress in understanding you.

8.2.4 says, in part "Evidence of conformity with the acceptance criteria shall be maintained."

So, the initials on a line by a step are evidence of what? It seems the auditor believed the initials were evidence the inspection took place. An activity.

Does the initial also mean acceptance, or would the inspector also identify him/herself if a part was rejected?

The issue here is evidence of conformity with acceptance criteria. Since evidence means "A thing or things helpful in forming a conclusion or judgment" and criteria means "A standard, rule, or test on which a judgment or decision can be based" (Dictionary.com) the requirement of 8.2.4 raises the bar: from indicating an inspection was performed and accepted, to a description of the basis of acceptance, both of the found characteristics and the instrument(s) used to measure them.

The Initial/Date is evidence 1.) that the part was inspected to the customer specification and 2.) it meets specifications.

Had the part not met specifications, it would have been segregated from production and handled through the nonconforming material process.

The standard requires: Evidence of conformity with the acceptance criteria shall be maintained.

We are maintaining the Initial/Date as evidence of conformity, and the customer requirements (blue prints) as acceptance criteria.

I do not see in 9001 where it requires documentation of specific characteristics, tolerances and specific measuring instruments used. However, in AS9100, those requirements and the need for documentation are blatantly spelled out with a "shall".

Am I missing something?

 

[Wes Bucey]

It may be a poorly worded nc statement, but it seems enough to me, given that you aren't recording the actual values inspected:-

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.

Ok, now I think I am making some progress in understanding you.

8.2.4 says, in part "Evidence of conformity with the acceptance criteria shall be maintained."

So, the initials on a line by a step are evidence of what? It seems the auditor believed the initials were evidence the inspection took place. An activity.

Does the initial also mean acceptance, or would the inspector also identify him/herself if a part was rejected?

The issue here is evidence of conformity with acceptance criteria. Since evidence means "A thing or things helpful in forming a conclusion or judgment" and criteria means "A standard, rule, or test on which a judgment or decision can be based" (Dictionary.com) the requirement of 8.2.4 raises the bar: from indicating an inspection was performed and accepted, to a description of the basis of acceptance, both of the found characteristics and the instrument(s) used to measure them.

Sorry to say, in the world of job shops and contract manufacturing, folks make a distinction between "first piece" and "first article." First Article is usually done very similarly to Aerospace ideal - each characteristic is measured and noted; each attribute is declared "pass-fail." This First Article is then typically passed to customer for approval before production continues.

In less rigorous shops, "first piece" is usually the rule where SPC is not a regular activity In essence, the first piece of the day or of the shift when a new operator comes on duty is examined for certain criteria, usually set by the supplier, not the customer, and if it passes this minimal inspection, production continues. Rarely do the shops keep a record of this

It is a practice contrary to most modern concepts of quality professionals, but it usually serves a purpose, especially in situations where tolerances are pretty loose and customer expectations are not very demanding, especially regarding paperwork records. (think of buying a box of screws at the local hardware - no buyer I ever heard of ever asks to see a copy of the manufacturer's SPC charts for that lot.)

My shop was VERY high tech, with demanding customers - I liked it that way because I could charge more for generating and providing the records and traceability those customers craved! My internal efficiencies allowed me to make additional profit on the records, not just the products.
Just because many shops are like mine was (in generating detailed records) does NOT make a shop that does not maintain such record keeping a schlock outfit.