Archive for April, 2014

AS9101E QMS Audit Requirements Published

Monday, 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.

Future AS9100 Aviation, Space and Defense Changes

Friday, April 4th, 2014

 Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business                                 April 2014

 

 
This Month
* AS9100 Future Changes
* Streamlining Your QMS
* Why Great Managers Are So Rare
* In the News
* Training Courses

 

 
Events…
ASQ Chapter Tucson, AZ General Session June 10, 2014 – Cost of Poor Quality, Presenter Walter Tighe, SES President

 

 

 
Helpful Links…

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Our newsletters provide information on business management systems and process improvement methods.  These systems include ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental Management Standard, and others.  Subjects include performance improvement methods such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

If you have any questions regarding content, or have a subject of interest for a future newsletter, please let us know.   

Future AS9100 Aviation, Space and Defense Changes            

We recently attended the National Quality Assurance (NQA) Auditors and Consultants Conference.  NQA is one of the largest and most respected ISO registrars in the world.  We always look forward to this two-day event due to the great information that is distributed to all attendees, including the opportunity of sharing this valuable information with our readers.

The following is information heard regarding the International Aerospace Quality Group (IAQG) and future AS9100 series documentation changes and future 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.

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.

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

AS9104/1 Requirements for Aviation, Space, and Defense Quality Management System Certification Programs.  This document contains requirements for certification bodies and requirements for certified organizations. 

  • Must ensure that clients have established an OASIS DB administrator
  • For recertification of a multiple site certification, audits shall be conducted at the central function and each site to the complete AQMS standard(s) requirements at each site.
  • Eight (8) hours is the minimum on-site audit time from opening to the closing meeting
  • When auditing organizations with an existing ISO 9001 certificate that are upgrading to an AQMS standard, a full initial audit of all requirements for the applicable AQMS standard must be completed.

In our next newsletter we will provide information from a question and answer, Q&A format on AS9100 interpretation.   

Looking for more information, contact us

 Streamlining Your Quality Management System                  

  


An article published in the NQA, January 2014 Newsletter discusses how your QMS for ISO9001, AS9100 as well for other standards does not have to be complicated. Why create ten pages (or more) of wordy procedures for which 1), nobody will read and 2), if they do read it, may not understand it?

We see many procedures written by various companies that are long, wordy and contain a vocabulary that only the writer understands. Most of these procedures and/or work instructions are not just for your management team but also are for the many other folks working in your production areas, engineering, buyers in your purchasing group, and other groups within your organization. They need to read, understand and follow these process procedures on an ongoing, daily basis. So why not simplify them and create user friendly documentation while still maintaining the requirements of the standard that you are certified to? 

You can help eliminate a lot of nonconforming issues by doing this. How many times have you written or seen corrective actions stating “Retrained the Operator”, “Buyer was not aware of the requirement in the procedure – ‘Retrained'”, “Retrained so and so of the procedure.” Retrain, retrain, RETRAIN! In the Aerospace industry, you may be in the “rocket science” world but you don’t need to make your procedures difficult for your employees to read and understand. You may just be asking for problems if you do!

Another proactive measure for your company is to make your management system “visible” to build buy-in while raising the awareness of your management system in every employee. The payoff comes when employees gain a deeper understanding of the system – even the processes which do not touch their job specifically – which can elevate awareness throughout the company and even contribute to better performance. 

Start off on the right foot – Sometime within the worker’s first week on the job with your company, provide them with an orientation of your system – and it shouldn’t matter if the job is in accounting, customer service, executive management or the factory floor – they should all attend orientation. Explain the “why’s” of the management system, use a slide show and don’t forget to toss in some humor to keep things interesting while your employees learn the “what’s”, such as where procedures are kept and how to go about making a change to a procedure. Leave plenty of time for questions and answers after the session. That way, employees can get more details. Provide them with a “Management System Awareness Certificate” and add a copy to their training file as well. Whatever you do – don’t be boring!

Any time you write (or rewrite) a procedure or document, it’s helpful to consider several things –

  • Who are the intended users of the document, and what level of competence do they have?
  • What is the intended outcome of the process the document is controlling?
  • Do you understand the process enough to be able to draw a flow diagram of it?  (If not, don’t even attempt it until you get the understanding, or maybe have a process owner write the document.)
  • What information doesn’t need to be in the document?
  • How can you give the user the information they need as quickly as possible so they can get back to work?

By implementing some “simple” ideas, you are likely to find that everyone in your organization will speak the same “quality language” and will better understand your organizations’ dedication to your operational and quality management system. 

   

Why Great Managers Are So Rare              

  

Gallup has found that one of the most important decisions companies make is simply whom they name manager. Yet our analytics suggest they usually get it wrong. In fact, Gallup finds that companies fail to choose the candidate with the right talent for the job 82% of the time.

Bad managers cost businesses billions of dollars each year, and having too many of them can bring down a company. The only defense against this problem is a good offense, because when companies get these decisions wrong, nothing fixes it. Businesses that get it right, however, and hire managers based on talent will thrive and gain a significant competitive advantage.

 

Gallup has studied performance at hundreds of organizations and measured the engagement of 27 million employees and more than 2.5 million work units over the past two decades. No matter the industry, size, or location, we find executives struggling to unlock the mystery of why performance varies from one workgroup to the next. Performance metrics fluctuate widely and unnecessarily in most companies, in no small part from the lack of consistency in how people are managed. This “noise” frustrates leaders because unpredictability causes great inefficiencies in execution.

 

Most companies promote workers into managerial positions because they seemingly deserve it, rather than have the talent for it. This practice doesn’t work. Experience and skills are important, but people’s talents — the naturally recurring patterns in the ways they think, feel, and behave — predict where they’ll perform at their best. Talents are innate and are the building blocks of great performance. Knowledge, experience, and skills develop our talents, but unless we possess the right innate talents for our job, no amount of training or experience will matter.

Gallup finds that great managers have the following talents:

  • They motivate every single employee to take action and engage employees with a compelling mission and vision.
  • They have the assertiveness to drive outcomes and the ability to overcome adversity and resistance.
  • They create a culture of clear accountability.
  • They build relationships that create trust, open dialogue, and full transparency.
  • They make decisions based on productivity, not politics.

Very few people can pull off all five of these requirements of good management. Most managers end up with team members who, at best, are indifferent toward their work — or, at worst, are hell-bent on spreading their negativity to colleagues and customers. However, when companies can increase their number of talented managers and double the rate of engaged employees, they achieve, on average, 147% higher earnings per share than their competition. 

 

More information can be found on this study at the Gallup Business Journal Website.

 

  
In the News      
   

Destech Corporation Achieves ISO 9001 Certification

  

We are proud to announce that our client, Destech Corporation has achieve ISO 9001:2008 certification!  Destech Corporation is a manufacturing company creating precision displacement materials used in molding and casting metals. Destech Corporation employs the latest technology in molding silica into precision parts as well as researching new innovations in casting and molding processes. 

Destech had a very successful certification audit conducted by The British Standards Institute (BSI) with a client base in over 150 countries.  For more information on Destech Corporation, contact Bruce Davidson, President at 520-290-2859.  

World’s Largest Automakers Reach Guidelines Agreement  

Guidelines cover working conditions, environment responsibility and business ethics.

 

Two leading corporate responsibility business associations, Automotive Industry Action Group (AIAG) and CSR Europe, facilitator of the European Automotive Working Group on Supply Chain Sustainability, announced an unprecedented agreement has been reached among 14 global automakers on a set of standards outlining expectations for suppliers on key responsibility issues including human rights, environment, working conditions and business ethics.

For more information, see the AIAG PDF Announcement.

 

Top-100 List Again Demonstrates Baldrige Impact in U.S. Health Care

 In March 2014, Truven Health Analytics released its annual study identifying the 100 top hospitals (PDF) based on their overall organizational performance. 

As in previous years, health care organizations using the Baldrige Health Care Criteria for Performance Excellence as a management framework were well represented. Some of these organizations have been formally recognized by the national Malcolm Baldrige National Quality Award or state and sector-specific Baldrige-based awards of Alliance for Performance Excellence programs across the country. Other organizations on the list have applied for Baldrige feedback/recognition at the national or state levels but cannot be publicly named as applicants due to confidentiality policies of the award programs.

According to Truven, the health care organizations on its list have achieved performance excellence and are leading their peer hospitals in demonstrating high-quality patient outcomes while improving efficiency. Truven states that based on the results of this year’s study, if all Medicare inpatients received the same level of care as those treated in the award-winning facilities, the following would be possible:

  • More than 165,000 additional lives could be saved.
  • Nearly 90,000 additional patients could be complication-free.
  • $5.4 billion could be saved.
  • The average patient stay would decrease by nearly half a day.

For more information visit the Baldrige Website.

Training Courses

To see the course description, schedule, and on-line registration click on the course title below. We deliver onsite training for all these courses and customized training to fit your specific needs.  We offer group discounts.  

 

View all our Courses

View Our Web Based E-Training Courses   

ISO 9001 Quality Management

Understanding and Implementing ISO9001:2008

ISO 9001:2008 Process Based Internal Auditor 

Documenting Your Management System

AS9100 Aviation, Space and Defense

Understanding and Implementing AS9100C (9110 &9120) Aviation, Space and Defense

AS9100C:2009 Process Based Internal Auditor

Documenting Your Management System 

ISO/TS 16949 Automotive

Understanding and Implementing ISO/TS16949:2009 Automotive

ISO/TS16949:2009 Process Based Internal Auditor
Documenting Your Management System 

ISO 14001 Environmental

Understanding and Implementing ISO14001:2004 Environmental
ISO14001:2004 Process Based Internal Auditor

Lean Enterprise and CI 

5S Five Pillars of a Lean Workplace Organization
Continuous Process Improvement
Lean Six Sigma
8 Disciplines (8D) of Problem Solving

ISO 13485 Medical Devices

Understanding and Implementing ISO 13485:2003 Medical Devices
ISO 13485 Process Based Internal Auditor 

ISO 27001 Information Security

Understanding and Implementing ISO 27001:2005 Information Security
ISO 27001 Process Based Internal Auditor 

All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

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