Executive Team Involved with Your QMS?

Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business                              January 2012

This Month
* Your Executive Team Involved in QMS?
* Economy Chief Concern in 2012
* Global Impact of ISO Standards
* In the News
* Training Courses



January 25-26, 2012 Phoenix Convention Center Phoenix, AZ

February 27-28, 2012
Phoenix, AZ


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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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Celebrating our 10th Year (2002-2012) Improving Performance!

We are very proud in celebrating our 10th anniversary of business improving operational and quality management systems performance.  It has been an extremely rewarding experience for us and we look forward to this New Year and Beyond.  Our sincere thanks to all our clients and newsletter readers.



Executive Management Team Involved with Your Quality System?


Note: Though this article references 21 CFR Part 820, it is applicable to any company that is striving for more quality-system input and involvement from management.

Many of us heard of the recent FDA decision to increase the focus of inspections on management with executive responsibility. There have been at least two warning letters issued this year with observations targeted in this area.


According to an article written by Christine Park, published in GxP Lifeline while there are 26 references to the role of executive management within the Quality System Regulations (QSR 21 CFR820) these warning letters address two very basic requirements of quality systems:

  • “Failure of management with executive responsibility to adequately ensure that the quality policy is understood, implemented, and maintained at all levels of the organization, as required by 21 CFR 820.20(a). For example, the Quality Policy has not been established by any member of executive management…”
  • Failure to establish and maintain procedures for management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of 21 CFR Part 820 and the manufacturer’s established quality policy and objectives as required by 21 CFR 820.20(c).”

These examples are obviously blatant and send a strong message: Now is the time to step back and re-evaluate the role your executive management team is playing in your own quality system.

21 CFR 820 defines management with executive responsibility as “those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer’s quality policy and quality system.” What does this really mean and how can you as a Quality Professional help your executive management team meet these requirements in the course of every-day business practice?

In most organizations, the company quality policy is derived by the executive management team. The quality policy is then widely distributed to all employees with appropriate explanation to understand the intent and purpose of the policy. Additionally, the quality policy must be measurable and reviewed for adequacy as part of the management review.

The responsibilities for management with executive responsibility can be distributed into four key areas of focus:


  • Core competencies.  The executive management team is responsible and accountable for providing clear direction and a definition of the business structure and its related vision. The documentation of core competencies and skill sets should be integrated into the overall business plan and managed by the executive team. The quality manual can effectively achieve this task when written and implemented as a roadmap to compliance.
  • Internal Audits. We live in a world of matrixed organizations and operations. The silo approach to business process and quality system management is not an effective means of achieving the overall business and quality plan.  The internal auditors must look at the interfaces between processes as well as the individual function or process. The data from internal audits should be presented to executive management in a format that demonstrates the effectiveness of the quality system structure and business process.

Just because the number of non-conformances decreases from audit to audit does not mean the internal audit program is good or the quality system is effective. The data analysis should look across the core competencies, functions, and processes to determine any potential systemic issues.  Question:  Is your organization quantifying the postive results (your investment return) of your internal audits to show executive management the payback?

  • Meaningful Metrics. The most common approach to keeping executive management involved is through the Quality Management System Review.  These management reviews are regularly scheduled with the executive management team based on the organization’s needs and requirements. While the primary focus of these reviews is to review quality performance, it is most effective to present the information based on its overall impact to the business.

This equates to moving beyond the minimum required inputs based on the standard your company is registered. The value of this meeting is to present information that has the biggest impact on the business from a quality and/or financial perspective. Each chart presented should tell a story and speak for itself. This approach sets a stronger foundation for risk based decisions.


  • Risk Management Process.The executive management team makes risk-based decisions as a part of their routine business activities. Risk management extends beyond the product risk preparations and analyses as required by the regulations.

Risk management also covers process and project risk. In most companies, resources are limited and priorities must be evaluated and set to drive the business to success and high customer satisfaction. There are many tools available to evaluate risk, prioritize activities, and reduce the potential for failure. These tools should be included in the everyday decision making process for the management team.

When the quality management system and the business plan are integrated at the executive level there is a strong foundation for the organization to make good decisions-business decisions as well as product quality decisions.

Further points to consider:

  • How effective is your management review process? Do you provide data for data’s sake or are you providing appropriate analysis to help the executives be more aware of product and process quality so that they can make better business decisions?
  • How does your organization use your quality manual? Is it a roadmap providing guidance for compliance to regulation and business process? Or is it just another book on the shelf?
  • Are you sure that you could provide adequate evidence that the executive management team is actively involved with the quality system?

Take a few minutes and evaluate your own system now. It may save you the agony of a warning letter in the future. Quality is not hard-it’s just good business.


Economy Chief Concern in 2012 for Manufacturers

While 66 percent of manufacturers expect to experience revenue growth in 2012, many say the recovering economy will remain a major hurdle to operations, according to a recent ASQ survey.


Nearly 1,600 manufacturing professionals from around the world responded to ASQ’s 2012 Manufacturing Outlook Survey, which was conducted online from Oct. 17 through Nov. 4. Respondents represent the aerospace, automotive, food, medical device, pharmaceutical and utility industries, among others.


According to the survey results, more than 70 percent of respondents say they experienced revenue growth in 2011. In ASQ’s 2011 Manufacturing Outlook Survey conducted in late 2010, 67 percent had hoped to experience revenue growth in 2011.


Despite the outlook regarding revenue, manufacturers continue to be wary of the global economy, citing the housing market and fears of a double-dip recession.


In addition to fears of the world economy, manufacturers say the lack of a qualified workforce is inhibiting their ability to grow. According to the survey results, 44 percent of respondents say finding qualified applicants is the biggest hurdle to filling vacant positions, while 27 percent say budget is a biggest hurdle to filling open positions. Twenty-three percent claim time-and the lack thereof-is the biggest hiring hurdle.


Retiring employees pose minimal effect.


Survey results show few manufacturers think their company will be adversely affected by retirements in 2012. On a scale of one to 10, where one is “very unlikely” and 10 is “very likely,” nearly 68 percent of respondents said retirements were “unlikely” to affect their business, including 26 percent who said retirements were “very unlikely” to affect the organization. Only 9 percent said retirements were “very likely” to affect the business.


“While many manufacturers are showing improvement and experiencing revenue growth, there remains clear hurdles facing these businesses,” said ASQ CEO Paul Borawski. “Even though companies say retiring baby boomers aren’t adversely affecting their businesses, finding qualified employees is still a concern-one that can affect businesses in this global economy-as retiring employees often leave with a wealth of knowledge not easily replaced.”

Global Impact of ISO Standards Application


Beginning with the first publication of ISO 9000 in 1987, the impact of ISO on organizational practices and world trade has been tremendous. The development of management system approaches to many specific sectors has happened as well. Some of these you may not be aware of include:

ISO 10002:2004 Quality management – Customer Satisfaction – Guidelines for complaints handling in organizations.  ISO 10002 provides guidance on the process of complaints handling related to products within an organization, including planning, design, operation, maintenance, and improvement.


ISO 10003:2007 Quality Management – Customer Satisfaction Guidelines for Dispute Resolution External to Organizations.  ISO 10003 provides guidance for an organization to plan, design, develop, operate, maintain, and improve an effective and efficient dispute-resolution process. It is applicable to complaints relating to the organization’s products intended for, or required by, customers, the complaints-handling process, or dispute-resolution process


ISO/TS 10004:2010 Quality management – Customer satisfaction – Guidelines for monitoring and measuring.  ISO/TS 10004 provides guidance in defining and implementing processes to monitor and measure customer satisfaction. It is intended for use by organizations regardless of type, size, or product provided.


ISO 50001:2011 Energy Management (planned).  ISO 50001 will help organizations to improve their energy performance, increase energy efficiency, and reduce climate change impacts. It will establish a framework for industrial plants, commercial facilities or entire organizations to manage energy.

ISO 22000:2005 Food safety management systems. ISO 22000 specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption.

IWA 1:2005 Health Care quality management systems — Guidelines for process improvements in health service organizations.  IWA 1 provides additional guidance for any health service organization involved in the management, delivery, or administration of health service products or services, including training and/or research, in the life continuum process for human beings, regardless of type, size and the product or service provided.


ISO 31000:2009 Risk management.  ISO 31000 provides principles and generic guidelines on risk management. The standard can be applied to any type of risk, whether having positive or negative consequences.


ISO 20000-1:2011 Service management system requirements.  ISO 20000-1 is a service management system (SMS) standard. It specifies requirements for the service provider to plan, establish, implement, operate, monitor, review, maintain, and improve an SMS.


ISO has developed over 18,500 International Standards on a variety of subjects and some 1,100 new ISO standards are published every year. The full range of technical fields can be seen from the listing International Standards. Users can browse that listing to find bibliographic information on each standard and, in many cases, a brief abstract.

Click here to browse all ISO Standards.


In the News

Become a Baldrige Examiner

Deadline Friday, Jan 13th. Each year, the Baldrige Performance Excellence Program seeks applicants for its Board of Examiners. The board supports and evaluates the performance improvement of all types of organizations-businesses, schools, hospitals, and nonprofit organizations, including government agencies-that are striving to serve as role models by applying for the Baldrige Award.

By becoming an examiner, you can make a major contribution to your own organization and to the national effort to recognize and promote performance excellence.


Click here for more information.


ISO Survey – Certifications Up Six Percent

The global market relevance of ISO’s management system standards for quality, environment, medical devices, food safety and information security reveals an increase in certificates of 6.23 %, a worldwide total of 1,457,912 certificates and users of one or more of the standards in 178 countries. The biggest increases in certification are to the sector-specific ISO 22000:2005 food safety management system standard which is up by 34 %and to the issue-specific ISO/IEC 27001:2005 information security management system standard which has risen by 21 %.


ISO Secretary-General Rob Steele comments, “Indicating nearly a million and a half users, these figures illustrate the continuing attraction of the ISO management system model pioneered by ISO 9001 for quality management and since extended to meet other challenges faced by public and private sector organizations.”


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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