AS9101E QMS Audit Requirements Published

April 21st, 2014

AS9101 has changed from Revision D  to Revision E.  AS9101E is the standard for Quality Management Systems Audit Requirements for Aviation, Space, and Defense Organizations.

This standard defines requirements for the preparation and execution of the audit process. Additionally, it defines the content and composition for the audit reporting of conformity and process effectiveness to the 9100-series standards, the organization’s quality management system documentation, and customer/regulatory requirements.

Changes to the standard include:

  • Audit forms have been consolidated
  • The PEAR (Process Effectiveness Assessment Report) will capture objective evidence of conformity (planned activities) and performance (planned results). It includes both the performance and the conformity assessment results. 
  • CB Auditors will record definitions, targets and values of key performance indicators (KPI’s) related to the audited process on the PEAR
  • CB Auditors will record detailed objective evidence (e.g., audited procedures, PO’s, work orders, and documents
  • The principle of recording objective evidence still remains
  • The Objective Evidence Record (OER) has been replaced.  Objective evidence will now be captured in the super-pear (clause 7 processes).  This includes a QMS Process Evaluation Matrix (for other than clause 7 processes) and an audit report summary.

The rollout date of AS9101E has not been announced by the certification bodies. The certification bodies along with the  auditors will need to be trained on the new forms and provided a date to implement the changes.  We will keep you informed on further information. You can order AS9101E from the Society of Aerospace Engineers at www.sae.org.

IAQG and future AS9100 series

March 24th, 2014

As stated in our last post, we want to share more information we received regarding the International Aerospace Quality Group (IAQG) and future AS9100 series documentation changes/requirements.

The 9100 series of standards are scheduled for project completion in early 2016. Plan is to fix what is broken and be very cautious in adding new requirements. 3 CB representatives on AS9100 team–IAQG to provide transition plan, guidance documents.

AS9101E – Waiting on international translation. Expect release in spring. No financial impact for customer but online training course for auditors.

The International Aerospace Quality Group (IAQG) recently identified reasons for returned audit reports for:

  • Missing required objective evidence
  • Poorly written findings or acceptance of poor root cause analysis
  • Acceptance of dates from auditor for NCR’s that do not support requirements
  • Audit plans that do not meet requirements
  • PEAR’s with poorly documented blocks 9 and 11
  • Missing documentation
  • PEAR’s not meeting industry expectations
  • Audit duration not meeting requirements

Next post we will provide information on Frequently Asked Questions (FAQs) on AS9100/1 from a certification body interpretation.

NQA Auditor/Consultant Conference

February 23rd, 2014

We just attended the National Quality Assurance (NQA) Auditors and Consultants Conference in Phoenix, Arizona.  We look forward to this two-day event annually due to the great information that is distributed to all attendees.

We want to share some of the information (more to come in next post) heard regarding the International Aerospace Quality Group (IAQG) and future AS9100 series documentation changes/requirements.          

  • IAQG potential reduction of Certification Boards (CBs) certifying to AS9100.  Informed that the number may be 8 CBs.
  • Removal of CB auditors that “Don’t follow the Rules” regarding AS9101D requirements.
  • Issues about poorly written PEARS and poor root cause definition.
  • AS9101E – Expect spring 2014 release. No cost to clients, auditors will undergo online training requirement.
  • Appendix A, AS9101D being removed for AS9101E.  The OER and PEAR will become one – The New PEAR.
  • The OER will be in a newly reformatted method.
  • Auditing all shifts for AQMS required.  All audit team members must be aware of AS9104/1 requirements.
  • The same CB audit team leader can only lead two consecutive audit cycles
  • Client suspension process will take place 60 days of the NCR issuance if client cannot demonstrate conformance to the standard.
  • PEARS will be required for All product realization processes.

More information to follow soon.

Less confidence about corporate strategies

January 14th, 2014

In a Booz & Company survey conducted in December 2013, executives from around the world, 60% were not able to say affirmatively that their companies’ strategy would lead to success, as of the end of 2013.

Three years ago, 52% expressed this lack of confidence in their company strategy. The survey, overall, has involved 3,855 participants since 2010. It is not clear whether the dip in executives’ faith in their strategy is related to the external environment, or other factors. It appears that business leaders have a range of frustrations, most relating to the clarity and focus of their strategy. In fact, most leaders – 66% – said “having too many priorities” is a major point of frustration for their organizations management team.

The survey shows…

  • More than half of executives (51%) said that communicating the company’s strategy and getting buy-in for it is a significant challenge at their company.
  • 55% said ensuring day-to-day decisions are in line with the strategy is a significant challenge.
  • 56% said allocating resources in a way that really supports the strategy represents a big challenge.

And 54% said quickly translating strategic and operational decisions into action is a challenge.  With the faster pace and ever changing business climates today, this survey reflects that companies are struggling with developing and executing a winning strategy.

Risk Management Guidance

December 15th, 2013

As we have written in prior posts, the future ISO 9001:2015 standard will take a risk-based approach requirement to determine the type and extent of controls appropriate to each external provider, and all external provision of goods and services. The proposed standard addresses, for example risks which can affect conformity of goods and services as well as customer satisfaction.

Published in 2009, ISO 31000:2009, Risk management – Principles and guidelines, provides principles, framework and a process for managing risk.

Now, ISO has just published a guidance document which aims to help organizations implement the ISO 31000 risk management standard.

The new 37 page document, entitled ISO/TR 31004:2013 ‘Risk Management: Guidance for the implementation of ISO 31000′ provides:

  • A structured approach for organizations to transition their risk management arrangements in order to be consistent with ISO 31000, in a manner tailored to the characteristics of the organization;
  • An explanation of the underlying concepts of ISO 31000;
  • Guidance on aspects of the principles and risk management framework that are described in ISO 31000.

The new ISO/TR 31004:2013, Risk Management – Guidance for the implementation of ISO 31000, will help organizations smoothly align their risk management practices to ISO 31000.  ISO/TR 31004 will help you establish or align a system to detect, understand and manage risk based on ISO 31000 – an internationally-recognized generic document on managing risk in organizations of all types and sizes.

For more information and to purchase the standard, visit the ISO Store.

 

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