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

Buddy has written extensively about this standard. ASQ members have access to his articles here.

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

ASQ Members: read the latest about AS9100D here.

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

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

Learn more about the AS9100 standards here.

Using White Out on Controlled Documents

ISO documentation practices, requirements

Question

During our certification for AS9100C the auditor found some documents with correction liquid that we have used for years. We have prohibited the use of any type of correction on all processes company wide.

It is common that during the prototype stage we performed dozens of changes due to the differences between the calculating/design program (electrical) and what happens in real life. During those adjustments we change manually circuits, values, etc. from the original version, with white-out tapes (before was liquid paper) once the prototype works those changes are incorporated as “Initial release” in the package that goes out for manufacturing. Do you guys see any problem using white out tape / correction tape on the controlled copies during prototype stage? My point is that the original values are recorded on the originals that will be obsoleted and the new ones on the initial release, keeping the controlled copies marked as records of the prototype.

Response

Thanks for contacting ASQ’s Ask the Experts program.

With regard to your inquiry, changing the documented results of inspection or test activities should be avoided or at least strictly controlled.  This is of special importance if these records are intended to provide evidence of product or process conformance.

However, prototype test results which may be subject to frequent changes during preliminary inspection or test activities, doesn’t require the same level of control.  These results are usually intended for informational purposes only and not for final acceptance of a process or product.

Bill Aston
ASQ Senior Member
Managing Director of Aston Technical Consulting Services
Kingwood, TX
http://www.astontechconsult.com

AS9100 Audit

Training, completed training, competance

Question:

I have recently started work at a company that is registered to AS9100. My previous employer was registered to ISO 9001 and I was trained as an internal auditor.

What additional training is required to audit to AS9100? (other than learning the standard).

Does my previous training in internal quality auditing qualify me to audit to the AS9100 standard?

Are the standards for auditor different for AS9100 than ISO 9001?

Response:

The ISO 9001 and AS9100 requirement for internal auditors are the same; that the auditor be competent. The organization determines the competence requirements for its internal auditors. Typically, the competence includes both knowledge of the standard and internal audit methodology.

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

Additional ASQ Resources

AS9100 Keeps Bosch Communications Flying High in Aerospace Industry
by Janet Jacobsen
Abstract: In 2006, the Bosch Corporation acquired Minnesota-based Telex Communications, Inc., a supplier to the aerospace industry. This business became known as Bosch Communications Systems. Boeing, a key customer for Bosch Communications’ aviation headsets, issued a requirement for all suppliers to become certified to AS9100, the international quality management system standard for the aerospace industry. To satisfy Boeing’s requirement, Bosch Communications launched an ambitious initiative to achieve dual AS9100/ISO 9001 certification in less than one year. Bosch contracted with ASQ to provide AS9100 lead auditor and internal auditor training to educate a cross-functional team about the standard and prepare them for the auditing process. In October 2008, just 11 months after launching its certification effort, Bosch earned both AS9100 and ISO 9001 certification.

Road to Revision- The path ahead for updating the AS9100 series of standards
by Buddy Cressionnie
Abstract: The flagship aviation, space and defense quality management system (QMS) standard has started revision activities. AS9100—Quality management systems—requirements for aviation, space and defense organizations is the foundation standard of the International Aerospace Quality Group (IAQG).

The AS9100C, AS9110, and AS9120 Handbook (ebook)
by James Culliton
Abstract: AS9100, AS9110, and AS9120, the quality management system (QMS) standards for the aerospace industry, are written in the most ambiguous language possible. Indeed, they don’t outline how they should be implemented. Those decisions are left to the organization implementing their requirements or, in some cases, to a consultant.

Although some consultant firms for aerospace systems are excellent, there are many that purport to be experts yet proffer systems and processes that are either in contravention to the standards’ requirements or so unwieldy that they render the process impotent.

In an effort to simplify these issues, this book proposes practices that have been described as opportunities for improvement or best practices by registration auditors in the past. It includes a discussion of each of the three standards’ clauses, suggests best practices to comply with them, outlines common findings associated with them, and provides an overview of the changes to AS9100C from AS9100B.

AS9100 Temperature Control

Temperature control

Question:
There is a form for recording the temperature etc. of the measuring and calibrating equipment, but should there also be a requirement that the temperature be set at 20 degrees Celsius as that is the temperature in which all the calibrated equipment (gauge blocks etc.) would be accurate in?

Does an AS9100 certified company require a temperature controlled room for which to house all equipment and also in which all critical measurements are taken place?

Response:
The AS9100 states that environmental conditions shall be suitable for the calibration, inspection, measurement, and testing being carried out.  If the measuring equipment is measuring close tolerance dimensions (typically .0001 inch) then expansion coefficients of materials must be considered including temperature and humidity.

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

AS9100C

Question:

Question: The AS9100C, which is an expansion of the ISO 9001:2008, states that a “process” based system is being promoted as is shown in 0.2 of the Introduction.  Why are 3rd party auditors being required to use the AS9101 Quality Management Systems Audit Requirements for Aviation, Space and Defense Organizations checklists for their audits?  These check lists are not “process” based and go back to the old procedure systems of the 1994 standard.

Each of our core processes consists of a flow chart of the process, process turtle and PEAR.  If you were doing a true process audit you would take these documents and perform the audit and not limit the auditor to being “boxed in” by a check list.  If the QMS has been developed correctly the process approach audit will allow you to cross other processes when being performed.

Response:

Thanks for the question.  The IAQG AS9101 Team does firmly believe in promoting the process approach which you will see reflected with the next AS9101 revision.  I agree that auditors should follow the process while performing all auditing (including 3rd party audits), yet it is also important to ensure that all the AS9100 requirements are satisfied.  That is why AS9100 auditors are trained to audit the process and then complete the Objective Evidence Record to ensure all AS9100 requirements are fulfilled.

Thanks,
Buddy Cressionnie
Americas 9100 Lead

AS9100C: Scoring the Aerospace QMS

Q: I’m reviewing the scoring method used for auditing AS9100 Rev. C  – 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

Editor’s note: Looking for additional resources on AS9100 auditing? Check out AS9101D Auditing for Process Performance: Combining Conformance and Effectiveness to Meet Customer Satisfaction