Archive for 2012

Investing in Process Improvement

Wednesday, February 1st, 2012

Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business                              February 2012


This Month
* Investing in Process Improvement
* Study Shows Positive Baldrige Results
* Audit Definitions- ISO 19011
* In the News
* Training Courses

 

Healthcare Systems Process Improvement

February 18-21, 2012

Las Vegas, NV

 

 

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.

 

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

 

Investing in Process Improvement

 

During these challenging economic times, many companies are under pressure to cut costs in response to lower revenues and decreased margins. Many are cutting costs haphazardly, for example letting people go (and the institutional knowledge with it) when they should be streamlining their business processes to become more efficient, enhance results, and achieve sustainable success.

 

When times are good, many companies create a “surplus to  process requirements” based on immediate needs.  More inspection and non-value-added steps that result from high volume needs may not work in a reduced economy.  There is no room for redundancy and cost cutting must be focused on waste reduction.  Organizations need to streamline costs yet still provide optimal value through exceptional product or service quality.

 

Investing in process improvement while cutting costs may seem counterintuitive, however by studying how the process is producing the desired output you can scale back and still meet your requirements and the customers needs. A well designed and executed improvement effort will always identify non-value-added activities for elimination, where those dollars saved can be used for other purposes and positively impact customer satisfaction. On the flip side, rash decision making and cost cutting can produce a detrimental effect on your business disappointing customers and reducing your revenues.

 

How can your organization improve processes to face the economic downturn?
  1. Identify the critical processes that produce the most value to your customers.
  2. Communicate with your customers and involve them with defining (or redefining) their needs and wants and adjust your outputs accordingly.
  3. Understand how your processes work.  Dissect your processes and identify the critical variables, inputs into outputs.  For example, people, material, methods, environment, hardware, software.
  4. Establish and/or review the criteria used for the operation of your processes For example, performance metrics related to process outputs, key variables, documentation used, or not used effectively, training effectiveness or lack of training validation.
  5. Use Lean tools and methods to aggressively eliminate waste in these processes.  For example, 5S, value steam mapping, error proofing, kaizen, visual management or kanban.
  6. Follow-up with Six Sigma tools to minimize process variation and improve the accuracy and predictability of your processes.  For example, process mapping, QFD, FMEA, control charts and SPC methods.
  7. Make process improvement a constant within your organization.  Reward people for their ideas and ensure they provide the highest quality product and service. This requires leadership determination and organizational commitment.
In the proactive mode, the organization that recognizes the need to continually improve its processes to meet the challenges of the future, even in poor economic times is successful.  Successful organizations understand this – let it work for you and your organization.
We can help your organization produce tangible improvement results, Contact us.

 

 

Study Finds Baldrige Criteria Results in Cost Savings

During the years 2007 through 2010, there were 322 applications for the Malcolm Baldrige National Quality Award. These 322 applications were from 273 firms and organizations; the 49 additional applications were repeat applications from some of the 273 firms and organizations. The 273 firms and organizations that applied for the Award from 2007 through 2010 were asked by the Program Office to participate in a study of the benefits they received through the Award application process.

 

Specifically, each firm or organization was asked to complete a Web-based survey instrument. A total of 45 firms and organizations responded to the survey request-a response rate of 16.5%-and the results from an evaluation analysis based on those responses are discussed in this report.

 

Using a counterfactual evaluation method, three categories of social benefits have been quantified from the responses of 45 Award applicants to a Web-based survey.  These categories
are:

  • the counterfactual cost savings of the applicants because it was not necessary for them to incur the investment costs to achieve on their own the same level of benefits from their performance excellence strategies as they realized from the availability of the publicly funded Baldrige Performance Excellence Program,
  • the gains to consumers from greater satisfaction from higher quality products because the Baldrige Criteria were available and used,
  • the gains to the economy from saving scarce resources (because successful performance excellence strategies not only enable higher quality products or services but also lower the costs of providing them) because the Baldrige Criteria were available and used.

The benefit-to-cost ratio of 820-to-1-using only the benefits for the surveyed group of applicants for the National Quality Award since 2006 but using all of the social costs of the Baldrige Program-certainly supports the belief that the Baldrige Program creates great value for the U.S. economy.

 

The Baldrige Performance Excellence Program, with the imprimatur of national leadership and a prominent national award presented by the President, creates great value that could not be
replicated by private sector actions alone.

 

The entire report is available in PDF at the NIST website.

 

 

Audit Defintitions According to ISO 19011:2011

 

The ISO 19011:2011 audit guidance standard has revised audit definitions, expanded related notes, and added new definitions. Some examples of these changes are described below.

 

The definition of audit: a systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled. Its revised note clarifies that the purpose of an internal audit may be to confirm the effectiveness of the management system or to obtain information for the improvement of the management system. The note adds that in a small organization, independence can be shown by freedom from responsibility for the activity being audited or freedom from bias and conflict of interest.

The definition of audit findings: the results of the evaluation of the collected audit evidence against audit criteria. A note states audit findings indicate conformity or nonconformity. A new note under audit findings clarifies that findings can lead to the identification of opportunities for improvement or recording good practices. Another new note says if the audit criteria are selected from legal or other requirements, the audit finding is termed compliance or non-compliance (instead of conformity or nonconformity).

The definition of audit client: the organization or person requesting an audit. Its note states that in the case of an internal audit, the audit client can also be the auditee or the person managing the audit program. The note also says requests for external audit can come from sources such as regulators, contracting parties, or potential clients.

The definition of competence: the ability to apply knowledge and skills to achieve intended results. The related note states that ability implies the appropriate application of personal behavior during the audit process.

 

The new definition for guide: a person appointed by the auditee to assist the audit team. The new definition for observer is: a person who accompanies the audit team but does not audit. Its notes add that an observer is not a part of the audit team and does not influence or interfere with the conduct of the audit. It says an observer can be from the auditee, a regulator, or other interested party who witnesses the audit.

The new definition for management system: a system to establish policy and objectives and to achieve those objectives. The related note states a management system of an organization can include different management systems, such as a quality management system, a financial management system, or an environmental management system.

 

Purchase ISO 9001:2011 Guidelines for auditing management systems at the ANSI Standards Store.

 

 

In the News

 

Personal Health Data Protected by New ISO Standard

 

ISO has published a new technical specification which will increase protection of personal health information processed, stored and transferred by computer systems for subsequent use by clinicians and others in healthcare organizations. ISO/TS 14265:2011, Health informatics – Classification of purposes for processing personal health information, defines a set of high-level categories of purposes for which such personal health information can be processed.

 

ISO/TS 14265:2011, provides a framework for classifying the various specific purposes that can be defined and used by individual policy domains (e.g. healthcare organizations, regional health authorities, jurisdiction countries) as an aid to the consistent management of information in the delivery of healthcare services and for the communication of electronic health records across organizational and jurisdictional boundaries.

 

For more information see the ISO News Page.

 


AIAG PFMEA Fourth Edition – Still the Best

 

The AIAG FMEA manual defines FMEA as “an analytical methodology used to ensure that potential problems have been considered and addressed throughout the product and process development process. FMEAs are an effective tool to quantify risk so it can be analyzed, prioritized, mitigated, or eliminated.” FMEAs can be applied in all types of organizations, including manufacturing and service.

 

Risk is generally quantified by using a risk priority number (RPN), which is calculated by multiplying ratings for severity (S) of problem by likelihood of occurrence (O) by likelihood of detection (D), or S × O × D = RPN. Use of arbitrary thresholds, for example, RPN > 40, is not recommended. Organizations should be working the highest priority risks regardless of the rating criteria or values. High severity ratings should always be addressed.

 

The FMEA manual indicates that the FMEA scope “establishes the boundary of the FMEA analysis.” The scope can be system, subsystem, or component. A system consists of many subsystems, which consist of many components. The links and interactions among parts within the scope, as well as with other subsystems or systems, also must be addressed.

 

Purchase PFMEA Fourth Edition at the AIAG Store.

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

Supplier Requirements to the Aerospace and Defense Industry

Saturday, January 28th, 2012

We just attended the Aerospace and Defense Requirements Conference at the Phoenix Convention Center this week.  In our home state of Arizona, we have many suppliers providing products and services to the Aerospace and Defense industry. This conference was sponsored by many prime manufacturers such as Honeywell, Boeing, and Raytheon; including being presented by the Arizona Technology Council, where Sustaining Edge Solutions is a member company.

The primary goal of this conference was to allow those who attended the opportunity to hear firsthand what type of supplier requirements it takes to become a preferred supplier.  A common theme from BAE Systems, Northrop Grumman, Boeing and other presenters was the need, NO the Requirement that all suppliers must have an effective Quality Management System and Certification to ISO 9001/AS9100.

The following are notes we quickly wrote as the speakers presented:

  • Must have ISO/AS certification, a strong Quality Management System.
  • Just-in-time supply systems, including a 100% on-time delivery.
  • Zero parts per million – supplier expectation.
  • Cost, quality and schedule imperative for all suppliers
  • 42% of Boeing Defense, Space and Security revenue is subcontracted.
  • Deliver value and solutions – must be customer focused.
  • Have an up-to-date website.  “Let people know who you are.”
  • Register for online RFP applications
  • Know your customer and potential customers quality requirements.
  • Improve affordability and efficiency through Lean Operations.

What’s the take away here?  Supplier opportunities do exist according to all the presenters we heard.  At a minimum, if your company is not certified to the ISO 9001/AS9100 standard, you won’t be considered.  Also, having an effective lean manufacturing program focus on quality, cost, and schedule is highly desirable.

Question: Has certification to ISO 9001 or AS9100 helped your organizational growth?  Have you found it to be a prerequisite to become a supplier to major Aviation, Space and Defense customers?

Let us know!!

 

 

 

Executive Team Involved with Your QMS?

Tuesday, January 3rd, 2012

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

 

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.

 

 

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?

Contact Us

 

 

Phone: 888-572-9642 toll free