Tag: Buddy Cressionnie

AS9100 7.1.5.2 Measurement Traceability

Airplane, aerospace, AS9100

Question

Can a manufacturer use “reference only” M&M equipment to accomplish in-process checks as long as these items are verified later on by “Inspection” using calibrated and/or verified equipment?

Would all of the measurements have to be verified by properly calibrated equipment?

Answer

The practice of using “reference-only” devices for in-process measures is not noncompliant with the standard.  The formal inspections to accept product would require use of calibrated equipment.

In clause 7.1.5.1, the standard clearly states “the organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements.”  And in clause 7.1.5.2, “hen measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results…”

Users and auditors should look at formal inspections steps and final buy-off to determine if any nonconformities were escapes from in-process measurements being conducted without calibrated devices.  Customer complaints can also be analyzed to see if any escapes were a result of failed in-process inspections.  If so, then the organization did not properly determine and provide the appropriate resources.

Buddy Cressionnie

For more information on this topic, please visit ASQ’s website.

7.1.5.2 AS9100 D

Airplane, aerospace, AS9100

Question

Section 7.1.5.2 of AS9100D States that “the organization shall establish, implement, and maintain a process for the recall of monitoring and measuring equipment requiring calibration or verification.”

Are calibration and verification both referring to the checking of equipment to make sure that it is suitable for it’s purpose, or is verification referring to the measurements taken on product? More specifically, does this require the organization to be able to identify which piece of measurement equipment made which measurements? In other words, if I have two micrometers that are both in a system that recalls them periodically for calibration, have I satisfied the requirements of 7.1.5.2 even if I don’t record which micrometer makes which measurements during it’s daily use?

Answer

The calibration or verification both refer to the monitoring and measurement equipment.  The AS9100D additional text is consistent with the ISO 9001:2015 by referring to calibration or verification.  The monitoring and measurement equipment could require verification as meeting requirements instead of a calibration.  If monitoring and measurement equipment is found to be out-of-tolerance and there is a product conformity impact, then it is very helpful if the organization has identified which instrument was used for which job.  Otherwise, the recall of product or alerting customers is much broader since the impact is not understood.  There is not specifically an AS9100D requirement to record which monitoring and measuring equipment was used but it is a good practice.

Buddy Cressionnie

To learn more about this topic, visit ASQ’s website.

AS9100 D and ISO 9001: 2015

Airplane, aerospace, AS9100

Question

Is there a document that compares the requirements of AS9100 D against the requirements of ISO 9001:2015?

I am looking to update our system to AS9100 D, and have the standard, however it would be helpful to have a document to help identify the gap between the two.

Answer

ISO 9001:2015 is embedded in AS9100D as the baseline.  If you look at AS9100D text…the regular text is ISO 9001:2015 text and the bold-italics text are the additional Aviation, Space & Defense text.  So what you are looking for regarding the additional requirements is the bold-italics text.

I hope this is helpful.

Buddy Cressionnie
9100 Americas Leader

For more information on this topic, please visit ASQ’s website.

Aerospace Surveillance Audits

Airplane, aerospace, AS9100

Question

In reference to AS9104/1 clause 8.2.2.f “Auditing of the entire AQMS standard on all shifts is required for initial and recertification audits. For surveillance audits, the planning shall include coverage of multiple shifts, when the audit plan activities occur across multiple shifts.”

The identified process is “Production” but shift one conducts assembly and shift two kits parts for assembly. Since “Production” spans both shifts but “activities” are distinct on each shift, do you have to audit both shifts during every surveillance audit?

Answer

It would be required that production be audited on both shifts when it is planned for surveillance audits.  For example, if the acquire business, design & development, and procure parts/materials were audited in Annual Surveillance #1 and production and procure parts/materials were audited in Surveillance #2, then second shift would only require to be audited during Surveillance #2.

Buddy Cressionnie

For more on this topic, please visit ASQ’s website.

AS9100C: Scoring the Aerospace QMS

Airplane, aerospace, AS9100

Q: I’m reviewing the scoring method used for auditing AS9100C  – Requirements for Aviation, Space and Defense Organizations, and I don’t see any verbiage to show what would be considered an acceptable overall score. I’m curious to know if the score is more subjective to the discretion of the auditor or if the threshold for “acceptable” or “not acceptable” exists somewhere as a guideline. Thank you to anyone able to offer insight.

A: The AS9101D auditing standard (currently not sold by ASQ) has scoring to provide an indicator of how robust your quality management system is operating (QMS), which is based upon the findings identified during your audit.  There is not a required score to “pass” the audit and receive certification.  The AS9101D score is recorded in the OASIS database, which your current and potential customers may review.

AS9100C requires the use of the AS9101D auditing standard, which has eliminated scoring.

Buddy Cressionnie
International Aerospace Quality Group Americas AS9100 Lead
Voting member of the U.S. TAG to ISO/TC 176
Southlake, TX

For more on this topic, please visit ASQ’s website.
 

AS9100 Production Rough Card

Aerospace, AS9100, Requirements, Standard

Question

According to our customer requirement, our quality inspectors are signing each step in production rough card in the following way: they apply their personal stamp (which includes their first and last name and personal number), add a manual signature and date. I tried to convince our customer to give us permission to eliminate the manual signature (as the personal stamp and date are enough), but he doesn’t agree with me.

Is there any official standard for this procedure? I was not able to find any special requirement for this in AS9100 Rev. C  – Requirements for Aviation, Space and Defense Organizations.

Answer

The AS9100 standard does not dictate any specific method of recording that a production step (clause 7.5.1) or verification step (clause 8.2.4) is complete. AS9100 does require the organization to comply with customer requirements. So this is a requirement which you need to discuss with your customer.

Buddy Cressionnie
International Aerospace Quality Group Americas AS9100 Lead
Voting member of the U.S. TAG to ISO/TC 176
Southlake, TX

For more on this topic, please visit ASQ’s website.

AS9100 Rev. C Document References

Airplane, aerospace, AS9100

Q: My organization is getting ready for our registration audit to AS9100 C– Requirements for Aviation, Space and Defense Organizations.  There is a debate regarding procedures and the document references with those procedures.  If the procedure does not mentioned a document within the body of the document we normally do not include it in the reference section of the procedure.  Our internal auditor says that we should reference all documents that show linkage in the process approach.

For example, the auditing procedure references corrective action, preventive action, etc., but does not have any of the document mentioned in the body of the procedure.

Can you settle this matter? Our auditor says that we will get a finding if this is not done.

A: The process approach is more than including references to documents, especially with AS9100 C requirements to identify your product realization processes.  I would encourage you to examine some guidance materials available on the ISO website:
Introduction and support package: Guidance on the concept and use of the process approach for management systems action procedures, but the narrative of the procedure does not include how these procedures tie into the auditing practice?  It would seem that the auditing procedures body should support the referenced procedures and explain how they are applicable within the auditing process.  If I was your auditor, I would issue an observation or opportunity for improvement for that condition.

Your first paragraph seems to indicate the reverse scenario.  If a document is not referenced within the body of the document, then it is not a referenced procedure.  Yes, that appears reasonable.

It is a good practice to show the interrelationship of documents to include parent-child relationships and referenced documents when appropriate.

Buddy Cressionnie
International Aerospace Quality Group Americas AS9100 Lead
Voting member of the U.S. TAG to ISO/TC 176
Southlake, TX

For more on this topic, please visit ASQ’s website.