Archive for May, 2012

AS9100C Lessons Learned and Updates

Monday, May 7th, 2012

We recently attended a workshop sponsored by DNV, a leading certification body (CB) titled “Updates and Impacts.” An agenda item for the workshop that spiked our interest was AS9100C Lessons Learned and Updates.

The following is information we noted and want to share with our AS9100C Aviation, Space and Defense interested readers.

(1) If your organization is not certified to AS9100C by the July 1, 2012 deadline, you can be given an additional six months to 1/4/13 to be certified. However, your organization will be put on “Suspension” status. If you do not become certified by the extended date your certification will be withdrawn.

(2) CB audit results are showing a ”Failure to follow a Process Approach.”  Examples given:

  • Processes comprising the QMS not identified
  • Process owners not assigned
  • Interaction and interfaces of processes not defined
  • Process effectiveness unknown (too often doing only manufacturing processes – what about purchasing, sales, design and development)?
  • Process improvement not emphasized
  • PEAR forms compromised (CB auditors are responsible for completing PEARs.)

(3) Customers can e-mail a CB through OASIS of supplier problems. A customer complaint can drive a “special audit” where the supplier may be charged by the CB for its special audit conducted.

(4) You must inform your customer of a “work transfer.” For example, moving your production line to another location – e.g., Mexico.

(5) A customer can request to see a suppliers CB audit results through OASIS.

(6) Reductions of observations are being cited due to no more “soft grading.”

(7) If a similar nonconformance is found in two consecutive audits, a major nonconformance will be written (this can be as simple as two document control issues found).

(8) ”There are still CB auditors out there doing inconsistencies regarding application and interpretation of the AS9100C requirements.” For example, telling clients that a risk management process/file must be documented for all products produced.   All AS9100C CB auditors took the same four day course and was provided the same material. However, interpretation of the new AS9100C requirements was Not part of the training.

(9) If you believe your CB auditor is wrong from a standard requirement or business perspective, “push back professionally.”

(10)  Requirement weaknesses: (a) 5.5.2 Management Representative, must have unrestricted access to top management personnel, (b) 7.5.1.1 Product and/or process re-verification, and (c) Sampling inspection-need method defined for critical products.

Have any AS9100C audit “Lessons Learned” you would like to share with us and our readers?  Please let us know and we will share them with our blog readers.  As always, we will not print the name of the submitting individual and/or company.

 

Creating a Culture of Quality

Wednesday, May 2nd, 2012

 


 Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business                              May 2012

 


This Month
* Creating a Culture of Quality
* AS9100C Standard Lessons Learned
* Baldrige 25th Anniversary
* In the News
* Training Courses

 May 21-23, 2012
Anaheim, CA
See You There!
AZ Bio

The 2012 AZBio Expo 

May 17, 2012

Phoenix, AZ

 
 
Quick Links…

Join Our Newsletter List!

 
Connect With Us

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.  

                                    

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

  

 Creating a Culture of Quality

For years, companies have used a variety of tools to try to improve the quality of their products and services. This has produced some success, but unfortunately not enough.  Quality certifications, statistical calculations, employees earning various colored belt designations, problem solving techniques and the like are all fine, but are they adequate?

A recent article written by Dave Schultz and Wayne Kost states that these methods never have been and never will be adequate.  They argue that’s because tools targeted on improving quality are usually only effective when there is a culture supported by management that insists on and encourages their use.  It’s this culture of quality that is often missing.

Many senior managers aren’t really interested in quality tools and techniques. However they are interested in improving performance and that’s what a culture of quality delivers.

So, what is a culture of quality?  It’s comprised of three components:

  • Common thoughts – everyone wants the right work to be done right;
  • Common language – everyone understands quality in the same way;
  • Common actions – there is a well-defined process that ensures customers, both internal and external, receive just what they expected.

 Common Thoughts

An organization must come to understand that little will improve in the organization until everyone takes product and service requirements seriously. “Close enough”; “it will do”; and accepting waivers and deviations are not tolerated in an organization that commits to having a quality culture. Having common thoughts means ensuring there are clear requirements and capable processes that can produce the desired outcome in a consistent, efficient manner.

Common Language


Everyone is usually in favor of quality; they just don’t know what it is. Everyone has their own definition – goodness, perfection, excellence, etc. None of these are binary – we don’t know when we have them and when we don’t. Management must define quality as conformance to requirements, then provide work processes that will prevent problems, expect an attitude of error free work, and escalate the importance of quality by measuring it in financial terms. 

 

Common Actions

It’s not enough to want things to improve and have a language of quality. We can’t just expect people to take broken work processes and produce better outcomes. People work in the process; management works on the process, so management must be determined to enable people to do what is desired, needed, and expected to help the organization flourish.  Management must realize it’s not enough to just say the right-sounding words.

 

They have to change their actions and behaviors. A culture of quality is initiated when senior management decides they will no longer tolerate the continual inefficiencies that slow cycle times, increase scrap and rework, and destroy customer satisfaction and loyalty. The question is: How is a culture of quality created?

There are three relatively simple steps:

  • Get determined
  • Get educated
  • Get going/implement

Determination

Determination is often established by calculating the Opportunity Costs (the money lost when work processes don’t function ideally) and the Price of Non-conformance (the financial impact of the right things not being done right- Often refereed to as “The Cost of Poor Quality”). Identifying these opportunities in an organization shows management that their company-like most average, well-run organizations-is likely wasting 25 – 35 percent of their operating budget. This makes it easy to decide that action is necessary.

Education

People can only do what they know how to do. Therefore, executives and managers must acquire the knowledge and skills that enable them to plan, guide, and direct the process for creating a culture of quality.  Management must research, investigate and learn proven and specific step-by-step roadmap for creating a culture of quality. Select individuals can be are trained to educate all others in the organization.

 

Implementation

Training only works when it’s put to work. It’s not enough to look determined and act determined by talking the talk. Deployment of learned concepts helps to make it clear that management is serious about creating a culture of quality. But only when the “thought leaders” clearly understand what has to happen, and they take the required actions to make it so, does anything really change. 

 

Start creating a culture of quality in your organization! 

      AS9100C Aviation, Space & Defense Standard

 

We recently attended a workshop sponsored by DNV, a leading certification body titled “Updates and Impacts.” An agenda item for the workshop that spiked our interest was AS9100C Lessons Learned and Updates.

 

The following is information we noted and want to share with our AS9100C Aviation, Space and Defense clients and newsletter readers.

(1) If your organization is not certified to AS9100C by the July 1, 2012 deadline, you can be given an additional six months to 1/4/13 to be certified. However, your organization will be put on “Suspension” status. If you do not become certified by the extended date your certification will be withdrawn.

(2) CB audit results are showing a “Failure to follow a Process Approach.”  Examples given:

  • Processes comprising the QMS not identified
  • Process owners not assigned

  • Interaction and interfaces of processes not defined

  • Process effectiveness unknown (too often doing only manufacturing processes – what about purchasing, sales, design and development)?

  • Process improvement not emphasized

  • PEAR forms compromised (CB auditors are responsible for completing PEARs.)

(3) Customers can e-mail a CB through OASIS of supplier problems. A customer complaint can drive a “special audit” where the supplier may be charged by the CB for its special audit conducted.

(4) You must inform your customer of a “work transfer.” For example, moving your production line to another location – e.g., Mexico.

(5) A customer can request to see a suppliers CB audit results through OASIS.

(6) Reductions of observations are being cited due to no more “soft grading.”

(7) If a similar nonconformance is found in two consecutive audits, a major nonconformance will be written (this can be as simple as two document control issues found).

(8) “There are still CB auditors out there doing inconsistencies regarding application and interpretation of the AS9100C requirements.” For example, telling clients that a risk management process/file must be documented for all products produced.   All AS9100C CB auditors took the same four day course and was provided the same material. However, interpretation of the new AS9100C requirements was Not part of the training. 

 

(9) If you believe your CB auditor is wrong from a standard requirement or business perspective, “push back professionally.”

 

(10)  Requirement weaknesses: (a) 5.5.2 Management Representative, must have unrestricted access to top management personnel, (b) 7.5.1.1 Product and/or process re-verification, and (c) Sampling inspection-need method defined for critical products.

Have any AS9100C audit “Lessons Learned” you would like to share with us and our readers?  Please email us and we will share them in our June Newsletter.  As always, we will not print the name of the submitting individual and/or company.     

 

Baldrige Begins Its 25th Anniversary    

Last month we informed our readers about the 25th anniversary of the ISO 9001 standard.  Now, we are celebrating the same silver anniversary of the Baldrige Performance Excellence Program!

 

Did you know?

The Baldrige Performance Excellence Program is building an even better future as a national steward of validated management practices; even better operations, systems, and processes for the thousands of manufacturers, service organizations, small businesses, health care organizations, education organizations, and nonprofit organizations that have adopted Baldrige; and even better partnerships for the Enterprise of Baldrige-based state and sector programs, (for example, the Arizona Quality Alliance, our state award program) the Baldrige FoundationASQ, and the stakeholders who believe in the Baldrige roadmap to success and sustainability.

As the Baldrige Performance Excellence Program celebrates its 25th anniversary, it looks forward to continuing its journey to performance excellence in partnership with its Enterprise partners and its international network of Baldrige Criteria users and supporters, including

  • the Baldrige Board of Examiners, a volunteer workforce of more than 500 members per year (more than 6,600 trained at the national level since 1987 and 2,397 trained by state programs in 2011 alone), who contribute the equivalent of more than $8 million in services each year
  • an informal network of private consultants, who use the Baldrige Criteria to help their client organizations improve
  • Baldrige-Award-winning organizations, who share role-model practices and strategies nationally and internationally

  • thousands of other organizations that rely on the Baldrige model and framework as an improvement methodology, management model, and/or certification/accreditation standard

Ways that Baldrige Adds Value 

  1. Jobs Created
  2. Lives saved
  3. Increased sales, profits, and market share
  4. Rising reading and mathematics proficiency
  5. Benefit-to-cost ratio of 820-1. 

On April 15, 2012, U.S. Commerce Department Secretary John Bryson presented the 2011 U.S. organizations with the Malcolm Baldrige National Quality Award, the nation’s highest honor for organizational innovation and performance excellence.

The winners include:

It’s obvious that health care organizations are making considerable progress with quality improvement and being recognized for their success.  Congratulations!


The Baldrige Award and the Baldrige Performance Excellence Program are managed by the Commerce Department’s National Institute of Standards and Technology (NIST) in conjunction with the private sector. For more information, http://www.nist.gov/baldrige

  

In the News

Manufacturing Orders Continue to Rise in 2012 – ‘Best start since 1988,’ says AMT president.

 

According to AMT, The Association for Manufacturing Technology. This total, as reported by companies participating in the United States Manufacturing Technology Orders (USMTO) program, was up 9.3 percent from January and up 35.2 percent when compared with the total of $328.44 million reported for February 2011.

“Manufacturing technology orders are off to their best start since 1998,” says AMT President Douglas K. Woods. “U.S. manufacturers continue to seek increases in productivity through automation and innovative technologies to increase their global competitiveness.”

Visit the AMT website for more details and geographic locations.

 

ASTM Supplier’s Declaration of Conformity

 

Responding to increasing requests from suppliers and their customers, ASTM International has developed a new program, the Supplier’s Declaration of Conformity. Launched in April 2012, this latest offering is an outgrowth of ASTM International’s certification programs.

 

Supplier’s Declaration of Conformity provides manufacturers, purchasers, and consumers with the evidence that products in fact conform to ASTM test methods. Product test results will be registered with ASTM International, and supporting documentation will show the supplier’s registration and acceptance by an independent third party.

 

Visit the Supplier’s Declaration of Conformity web page.

 

 FDA-ISPE CGMP Conference

   

The International Society for Pharmaceutical Engineering (ISPE), which provides an educational forum for the pharmaceutical industry, has brought together a substantial lineup of global regulatory officials and pharmaceutical industry leaders to be plenary speakers at the Food and Drug Administration (FDA) conference in Baltimore on June 4-5, 2012. 

 

Attendees will receive a rare opportunity to hear directly from the policy makers and influencers affecting business and manufacturing. The plenary sessions will consist of presentations focused on global quality, worldwide compliance, and the future vision of the pharmaceutical industry.

More information on the conference, including complete speaker bios, education details, and registration information is available at the ISPE web page. 

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?

Contact Us

 

 

 

Phone: 888-572-9642 toll free