AS9101D: Are You Ready?

If your company is certified to AS9100B, you should already know that the transition to AS9100C Aviation, Space, and Defense Standard starts July 1, 2011. If your surveillance or re-certification audit is going to take place after this date, you must have completed the transition to the new requirements, and have the correct documentation and objective evidence to demonstrate effectiveness. AS9101D Audit Requirements for Aviation, Space, and Defense is the new, completely rewritten standard that defines the requirements for Certification Bodies (CBs) to audit your system. This standard creates common auditing methods and document formats (seven appendices) that the CB auditor will use, and can be used by your organization in support of your internal audits, and external audits at your suppliers. Key differences to the audit requirements and CB audit process include: Expanded scope of what and when a Major nonconformity will be written. Major nonconformity situation example, a nonconformity where the effect is judged to be detrimental to the integrity of the product. A new nonconformity report (NCR) used by the auditor. Example, when nonconformity found requires immediate containment action meaning fix now to contain the nonconforming condition, it will be done. Immediate containment and correction can be reviewed by the audit team during the audit. Each audited Product Realization Process level of effectiveness will be recorded on the Process Effectiveness Assessment Report (PEAR). The PEAR identifies 4 effectiveness levels. If the auditor classifies the effectiveness level as a 1 or 2 it will result in a nonconformity being issued. No more soft grading or scoring. If the auditor found evidence of non-fulfillment of a requirement, the auditor determines the nonconformity classification (major/minor). The observations and opportunities for improvement grade no longer exists for borderline correction actions. Audit results will be posted on the Online Aerospace Supplier Information System (OASIS) for approved parties to view (i.e., your customers)! This transparency alone only emphasis the need to seriously examine your current documented system and its conformity and effectiveness. With the development of the AS9100C and AS9101D standards, you can count on performance-based, process-oriented audit methods and techniques facing your company future. It is now May, and the clock is ticking. Life was good when the auditor would ask for thus and so and you could show thus and so and get a check mark. Those days are changing fast!

V Forum SideBar Thread Tools Search this Thread Rate Thread Content

New Threads Feeds

Display Modes

Sponsor Links

#1 17th January 2011, 10:47 PM

Sidney Vianna
Post responsibly Registration Date: Oct 2001 Location: Long Beach, CA - USofA

Posts: 6,830 Thanks Given to Others: 1,269 Thanked 3,679 Times in 1,962 Po Karma Power: 709 Karma: 26618

The impact of AS9101D - Definition of Major nonconformity and NC Management

One of the topics I cover in the 2-day AS9100B2C course we run is the impact of AS9101D onto registrants.

Most organizations are unaware of the fact that AS auditors, having been through the AATT sessions w have to apply new requirements during ICOP audits. For example: Major Nonconformity: A non-fulfillment of a requirement which is likely to result in the failure of the quality management system or reduce its ability to assure controlled processes or compliant products/services; it can be one or more of the following situations:

a nonconformity where the effect is judged to be detrimental to the integrity of the product or service; the absence of or total breakdown of a system to meet a 9100-series standard requirement, an organization procedure, or customer quality management system requirement; any nonconformity that would result in the probable shipment of nonconforming product; and/ a condition that could result in the failure or reduce the usability of the product or service and intended purpose.

As for the timeliness requirements of nonconformities, AS9101D states After issuance of a nonconformity the CB shall:

when the nature of the nonconformity needs immediate containment action, require the organization to determine and report the specific containment actions, including correction with calendar days after the audit and reach agreement with the audit team leader within the

next 14 calendar days; require the organization to analyze and report on the NCR the root cause and specific correctio and corrective actions taken, or planned to be taken, to eliminate the detected nonconformities within a defined time; agree with the organization on corrective action(s) and corrective action plans within a maxim of 30 days from the end of the on-site audit. document details of evidence supporting the closure of nonconformities; and report to the organization after verification of corrective actions is complete. Evaluation and closing of the corrective action plan and associated corrective actions relating to nonconformity shall not be performed during the audit in which the nonconformity was issued

__________________ Sustainable conformity assessment adds value to all stakeholders.

Last edited by Sidney Vianna; 18th January 2011 at 12:52 AM.

Thanks to Sidney Vianna for your informative Post and/or Attachment!

tyker

Sidney Vianna View Public Profile Find all posts by Sidney Vianna Sponsored Links

#2 20th January 2011, 08:22 PM

Sidney Vianna
Post responsibly Registration Date: Oct 2001 Location: Long Beach, CA - USofA

Posts: 6,830 Thanks Given to Others: 1,269 Thanked 3,679 Times in 1,962 Po Karma Power: 709 Karma: 26618

Re: The impact of AS9101D - Definition of Major nonconformity and NC Managem

Ladies and Gentlemen, In our continued efforts to keep you informed about the latest AS news, we would like to notify you ab the implications of the revision of the AS9101 document. The transition process for the AS91X0:2009 standard(s) (AS9100C, AS9110A and AS9120A) requires all future audits to follow AS9101, Revision D (AS9101D). AS9101D will bring some heightened expectations to the audit process, which will indirectly affect organizations that are certified to the AS standards. A summary of the changes are listed below: A heightened emphasis on a process-oriented approach, which includes the need for organizations to establish goals/objectives/metrics for all identified high-level processes that are part of the Quality

Management System. To that effect, it is highly advisable that registrants must clearly define or re-de their process/interaction maps.

CB auditors will go beyond the traditional verification of conformance by assessing process effectivene AS9101D requires auditors to document a review and assessment of the product realization processes through the PEAR (Process Effectiveness Assessment Report) form.

The audit team leader shall obtain information regarding the proportion of aviation, space, and defens business of each of the organizations customers, based on their approximate percentage of business. audit team leader shall ensure that the amount of audit time planned on auditing any one customers specific quality management system requirements, is consistent (approximately) with the proportion o aviation, space, and defense business each customer represents (e.g., customer X may only have 20% the business, so do not spend 80% of the time verifying customer X's specific quality management sy requirements). A new definition of Major nonconformity: Major Nonconformity: A non-fulfillment of a requirement which is likely to result in the failure of the quality management system or reduce its ability to assure controlled processes or compliant products/services; it can be one or more of the following situations:

a nonconformity where the effect is judged to be detrimental to the integrity of the product or service; the absence of or total breakdown of a system to meet a 9100-series standard requirement, an organization procedure, or customer quality management system requirement; any nonconformity that would result in the probable shipment of nonconforming product; and/ condition that could result in the failure or reduce the usability of the product or service and its intended purpose.

Requirements for nonconformity resolution timeliness; after issuance of a nonconformity, the CB shall

(when the nature of the nonconformity needs immediate containment action), require the organization to determine and report the specific containment actions, including correction with calendar days after the audit, and reach agreement with the audit team leader within the next calendar days; require the organization to analyze and report on the NCR the root cause and specific correctio and corrective actions taken, or planned to be taken, to eliminate the detected nonconformities within a defined time; agree with the organization on corrective action(s) and corrective action plans within a maximu of 30 days from the end of the on-site audit. document details of evidence supporting the closure of nonconformities; and report to the organization after verification of corrective actions is complete.

Evaluation and closing of the corrective action plan and associated corrective actions relating to a nonconformity shall not be performed during the audit in which the nonconformity was issued. We hope that the above information assists you in understanding some of the changes you might experience during the upcoming audits performed by DNV. While not mandatory for you, we strongly encourage you to familiarize yourself with the AS9101D document. It can be purchased from SAE @ http://standards.sae.org/as9101d.

While we always welcome your feedback, we must stress that the changes made to the audit process mandated by the IAQG, and that all AS accredited Certification Bodies must follow this enhanced proto Failure to do so would put our AS accreditation at risk. We look forward to working with you on our journey towards a mature and robust aerospace quality management system. Yours truly, Sidney Vianna Director of Aviation, Space & Defense Services DNV Business Assurance North America __________________ Sustainable conformity assessment adds value to all stakeholders.
Thanks to Sidney Vianna for your informative Post and/or Attachment!

Jeff Frost

Sidney Vianna View Public Profile Find all posts by Sidney Vianna Sponsored Links

Lower Navigation Bar The Elsmar Cove Forum > Company Specific Forum(s) > DNV Client Forum
The impact of AS9101D - Definition of Major nonconformity and NC Management

Bookmarks