AS9100D clause 8.6 - Documentation required to show evidence of conformity

[perezf]

Good morning everyone.



I currently work as a Quality Engineer in a manufacturing business (build-to-print) of aerospace parts certified to AS9100D (excluding design). We supply to both military and civil programs. The topic I am bringing up today is regarding clause 8.6 of AS9100D.



8.6 Release of Products and Services
The organization shall implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met.
The release of products and services to the customer shall not proceed until the planned arrangements have been
satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer.
The organization shall retain documented information on the release of products and services. The documented information shall include:
a. evidence of conformity with the acceptance criteria;
b. traceability to the person(s) authorizing the release.

When required to demonstrate product qualification, the organization shall ensure that retained documented information provides evidence that the products and services meet the defined requirements.
The organization shall ensure that all documented information required to accompany the products and services are present at delivery.

My organization performs final inspection of the parts, but no test reports are compiled or retained to evidence conformity with the design data (unless inspection is performed with a CMM machine, in which case the CMM report is retained electronically for each part inspected). For parts that can be qualified using less sophisticated methods such as the use of a micrometre, vernier, thread gauges, etc. all we produce is a certificate of conformity making a statement that the parts comply with the applicable drawing and/or specifications and the individual authorising the release.

I do not believe this meets the requirement stipulated in clause 8.6 of AS9100D above in showing "evidence of conformity with the acceptance criteria" as we have no records (test reports) to demonstrate that the dimensions measured at final inspection met the drawing.

The only thing that is making me doubt is the fact that our company has obviously passed AS9100D audits by accreditation agencies (BSI), so they must have assessed this as an acceptable practice to the standard. However, I cannot see how that is the case when we cannot demonstrate through inspection records the measurements that we took on the parts… All we have is the word of the inspector and his signed statement that the parts comply to the design data.

Could I get your thoughts on this please?

Best regards.

 

[Tagin]

This is yet another badly worded 9001:2015 requirement. In actuality, 8.6 is not asking for evidence in the sense you are thinking ("...test reports are compiled or retained to evidence conformity with the design data..."); instead, the 'evidence' can be just the release itself.

In our system, the release occurs by electronically moving an order from a production stage to a released stage, and an electronic audit trail event is automatically created, and that entry is the evidence we show in 9001:2015 audits. (The audit trail entry also of course shows who performed that release, thereby also satisfying 8.6b.) We also have security set on the order stage change function so that only authorized users can actually perform that release.

Of course, this release process is documented in our QMS, and says that the authorized person can perform the release ONLY if the order has passed all Q/C tests, etc. So, the release carries an implied verification of conformity.

We also have signed Q/C sheets that accompany each product, so these do demonstrate that we indeed tested this product and it passed, but these are not records of release per se in our QMS process flow.

 

[John Predmore]

I agree, a record containing quantitative results is always preferred over a pass/fail determination. However, a company is allowed to use economic common sense in regards to practicality of detailed records. It is a risk/benefit tradeoff, subject to scrutiny against common industry practices.

All we have is the word of the inspector and his signed statement

I assume the statement says more than that the parts were good, it says something to the effect, I inspected these parts on such-and-such date, and they passed such-and-such criteria. Most QMS's require records contain a date and traceability to the person making the approval decision, so this is more than someone's recollection, it is a contemporaneous record. If the auditor is following an audit trail, he might ask how you know this part was properly inspected, and you should point to work instructions or part-number-specific criteria. He might ask how you know this employee was competent to inspect the part and make the decision, which would lead to a review of his/her training/competence.

accreditation agenc[y]... must have assessed this as an acceptable practice to the standard

There are usually disclaimers on behalf of the CB that outside auditor(s) have limited time in an on-site audit to conduct a sampling of identified aspects of your operations. Failure to discover any gaps or non-conformances that might have been present but not discovered on the day of the audit is not a carte blanche to conclude that every aspect of your QMS is in top-shape.

 

[Enghabashy]

* I see that the generated QC reports are representing declaration & a final decision of products release ; it's only as total conclusion for reaching the conformance / achieving acceptance criteria ;
*the requirement doesn't completely fulfilled ; the audit results aren't enough evidence to proof the effective complying of the product or process conformity
*the results of measuring ,inspection & testing which evidenced that each product acceptance criteria is met are essential ;it's a system preventive measures also to prevent potential deviation as well ;
* measuring ,inspection & testing results of each batch should ready to be provided as the client request ; regardless audit results or notified body release " if existed "
*if there's appeal happened in future ' you can find innocent evidence also

 

[Sidney Vianna]

I do not believe this meets the requirement stipulated in clause 8.6 of AS9100D above in showing "evidence of conformity with the acceptance criteria" as we have no records (test reports) to demonstrate that the dimensions measured at final inspection met the drawing.

I agree with your assessment. May you never have to undergo an NTSB investigation following an aircraft accident and have NO EVIDENCE to show the quantitative inspection and test results to demonstrate product conformity to requirements. That, in my opinion, would be a huge liability exposure to the organization.

Using Boeing Commercial Aircraft X31764 document as an example, they clearly estipulate

​

Obviously, you might not have BCA in your customer chain, but I believe the need for such data to be available to be the general expectation of all aero OEM's and it is the intent of the AS9100 paragraph you brought up.

I agree, a record containing quantitative results is always preferred over a pass/fail determination. However, a company is allowed to use economic common sense in regards to practicality of detailed records. It is a risk/benefit tradeoff, subject to scrutiny against common industry practices.

Not when you are dealing with high-risk regulated products. Context of the organization is key. When you, as an organization, decide to become a participant in regulated supply chains, the expectations for evidence of conformity become more laborious and onerous. One of the reasons you can charge premium fees for the products.


Good luck.

 

[Tagin]

I don't have a copy of AS9100D, but...I suspect there is some conflation between the evidence which supports the release of product vs. the evidence for the authorization of release.

From searching, I see there is a requirement 8.5.1n, which requires as records "the availability of evidence that all production and inspection/verification operations have been completed as planned, or as otherwise documented and authorized".

So, we already have the records of monitoring/measurements of product required by the standard before we even get to release.

This would be the evidence which supports the decision to release (8.6). It is not clear to me why 8.6 would ask for the same evidence in a less precise way.

Here I think we have to distinguish between measurements of product for verification/inspection (8.5.1n) and acceptance criteria (8.6a: "evidence of conformity with the acceptance criteria"). The two may overlap but are not synonymous.

Could it be that for 8.6 you perhaps need to show (e.g., as part of a release checklist) that 8.5.1n was completed successfully, and similarly with other requirements (8.5.1q, etc.)? I think this depends on the company's precise definition of acceptance criteria for that product.