ASA-100 Revision 3.6 Released

Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business                              March 2012


This Month
* ASA-100 Revsion 3.6 Released
* New Employee Orientation
* Medical Devices Safety Aspects
* In the News
* Training Courses

 

 

May 21-23, 2012
Anaheim, CA

 

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

 

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ASA-100 Revision 3.6 Released

The Aviation Suppliers Association (ASA), based in Washington, D.C., represents global member companies that are positively shaping the aviation industry. Collectively, they lead critical logistics programs, purchasing efforts, and distribution of aircraft parts world-wide. Member companies include: distributors, suppliers, surplus sales organizations, repair stations, manufacturers, airlines, operators, and other companies that provide services to the aviation parts supply industry.

Current ASA-100 Accredited Companies:


September 1, 2012 – Implementation Deadline
– All companies must have the 3.6 revision implemented by the September 1st deadline. All audits conducted starting on that date will be to the 3.6 revision. Should you implement the 3.6 revision prior to the implementation deadline, and you have an audit conducted, the auditor will audit you to the revision implemented in your quality system.

 

New ASA-100 Companies:


Companies that are new to the program and have an audit already scheduled, or have begun the accreditation process, will be audited to the 3.5 revision. These companies will be required to have the 3.6 revision fully implemented by the September 1st deadline. Any companies joining the program after March 1, 2012, that have not already begun the process or scheduled an audit, will be audited to the 3.6 revision. Any questions can be directed to ASA to determine your implementation deadline or the revision that you will be required to meet.

 

Quality Manual Changes:


Revisions to your quality manual can be submitted through email. If you prefer to send a hard copy, please contact ASA for the address. Changes should be accompanied by a revision to the List of Effective Pages, Record of Revision Page, and change markers or documentation noting the changes. You may send a revised manual in full or the revised pages to be inserted into the quality manual on file. If submitting the quality manual in full, it must be submitted as one document and not a .zip file to be put together. If submitting revised pages to be inserted into the quality manual on file, directions for the exact page and location to be removed and/or inserted must be given along with the revision.

 

 

Documents referenced in the revision, which can be found on the ASA Website are

  • LI 100-009 rev. 3/2012
  • ASA Best Practice – Disposition of Unsalvageable Aircraft Parts
  • Revised ASA Self-Audit Checklist (revision available on March 2nd)

Looking for help with your ASA-100 revision upgrade? Contact us.

 

New Employee Orientation

If your company does not have a new employee orientation program, should it?  Yes, employee orientation has proven to be a critical element with making new employees comfortable and in retaining employees. Let’s take a look at some key reasons for orientation which are:

1. Shorten the time to get employees up to speed.
2. Lessen the anxiety when entering a new situation.
3. Reduce employee turnover with tools to succeed.
4. Convey job expectations and positive attitudes.

5.  Introduction to fellow coworkers.

 

An effective orientation program can make a significant difference in how quickly a new employee becomes oriented and becomes highly productive.

As part of new employee orientation, you should want to answer these quality related questions for them:

  • Why are quality products and services so important?
  • Why are we certified to this quality standard?
  • What is my role in the quality management system?

Also, explain what is process related and how to perform:

  • What are the key performance measures for my area?
  • What are my required inputs and who provides them?
  • What are my outputs and how do I measure effectiveness?
  • What documents will be used and where are they located?
  • What records are created and what to do with them?
  • What are my required procedures and work instructions?
  • Who do you see if a problem arises?

As a good quality professional, you should also be documenting training and ensuring a method of training effectiveness is applied. It is very important to convey your organizations commitment to quality, improvement, and continual process learning.

Medical Devices Safety Aspects

 

ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission) have just published a new, improved guide to help standards writers address safety aspects in medical device standards even more thoroughly.

 

ISO/IEC Guide 63:2012, Guide to the development and inclusion of safety aspects in International Standards for medical devices, improves on and replaces a 1999 edition. Notably, it responds to the risk-based framework set out in ISO 14971: 2007,Medical devices – Application of risk management to medical devices.

 

ISO/IEC Guide 63 is designed to improve the interface between the standards-developing committees and the stakeholders they serve, as well as to make the optimal use of resources by only developing medical device safety standards for which there is a clear market requirement.

 

Alfred M. Dolan, Convenor of the team that updated the guidelines, described the benefits which the new guide is expected to bring to users and the improvements made compared to the 1999 edition it replaces:

 

“ISO/IEC Guide 63:2012 identifies common elements of all medical device safety standards and recommends a specific logical order to address these within a risk management framework as specified in ISO 14971. It provides a very helpful context in developing consistent standards.

 

“Compared to the 1999 version, the new guide accentuates the concept of risk and emphasizes the need to consider the relationship between hazards and the associated harms which may result. The resultant risk is what standards need to control through establishing technical or process requirements in those standards.”

 

ISO/IEC Guide 63 was prepared jointly by ISO/TC 210, Quality management and corresponding general aspects for medical devices, and IEC/SC 62A, Common aspects of electrical equipment used in medical practice, in a Joint Working Group, Application of risk management to medical devices.

 

Purchase ISO/IEC Guide 63 at the ANSI Standards Store.

In the News

 

Key Note Speakers at ASQ World Conference

 

Executives from The Boeing Co. and The Coca-Cola Co. are among four keynote speakers featured at the American Society for Quality (ASQ) 2012 World Conference on Quality and Improvement, scheduled for May 21-23, 2012, at the Anaheim Convention Center in Anaheim, California.

The theme for this year’s WCQI is “Producing Results: Proven Solutions in Today’s Challenging World,” focusing on basic quality, globalization, best practices in supply chain management, managing risk, and changing technology.

There are more than 100 sessions scheduled for the annual event, focusing on changing technology, managing risk, globalization, best practices in supply-chain management, and basic quality. Sessions will cover topics critical to a variety of industries, including traditional manufacturing, health care, government, financial services, and more.

 

For detailed information see the World Conference Website.

 


NADCAP Survey Results Announced From Aerospace Suppliers

In response to the question “Do you agree that quality has improved because of your Nadcap accreditation?” 85 percent agreed, while 7 percent neither agreed nor disagreed. This shows a continual improvement from previous surveys; in 2007, 76 percent of respondents agreed, rising to 83 percent in 2009.

 

The aspects of globalization that have the most impact on the Nadcap audit are language and culture. Most survey respondents reported that they had never expected any challenges with Nadcap related to language and culture. The availability of auditors or staff who speak different languages and the availability of checklists and other online resources in different languages were the most common issues reported in the survey. Meanwhile, only 1 percent of respondents noted that resources were not available due to time zone differences.

 

This fifth biennial survey was conducted in 2011 and received more than 1,500 responses, which were analyzed by an independent consultant, and supported by a global team of aerospace prime-contractor and supplier representatives.

 

Training Courses

To see the course description, schedule, and on-line registration click on the course title below. We deliver onsite training for 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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