Welcome to Sustaining Edge Solutions Performance Improvement Newsletter

Unprotected systems are vulnerable to all kinds of threats, such as computer-assisted fraud, sabotage and viruses. These threats can be internal or external, and both accidental or malicious. Breaches in information security can allow vital information to be accessed, stolen, corrupted or lost. How confident are you that your company has the appropriate controls and procedures in place to avoid such incidents?

ISO 27001 Information Security Management System (ISMS) is a standard for the management of Information Security. It is applicable to all sectors of industry and commerce and is not confined to information just held on computers or servers. It addresses the security of information. The information may be printed or written on paper, stored electronically, transmitted by email, shown or spoken in conversation. Whatever form the information takes, or means by which it is shared or stored, ISO 27001 helps an organization ensure it is always appropriately protected.

Information is now globally accepted as being a vital asset for most organizations and businesses. As such, the confidentiality, integrity, and availability of vital corporate and customer information is essential to maintain competitive edge, cash-flow, profitability, legal compliance and commercial image.

Developing an ISMS that satisfies the requirements of ISO 27001 involves three major steps:

(1). A management framework for information. This sets the direction, aims, and objectives of information security and defines a policy which has management commitment.
(2). Identification and assessment of security risks. Security requirements are identified by a methodical assessment of security risks. The results of this assessment will help guide and determine the appropriate management action and priorities for managing information security risks.
(3). Selection and implementation of controls. Once security requirements have been identified, controls should be selected and implemented. The controls need to ensure that risks are reduced to an acceptable level and meet an organization’s specific security objectives. Controls can be in the form of policies, practices, procedures, organizational structures and software functions.

Documented benefits of an ISO 27001 ISMS include:

Contact Us for more detailed information on 27001 ISMS and for all your ISMS training, documentation development, and internal auditing needs.

QuEST Forum unveiled its second report in a series on the state of the communications technologies industry quality at the 2010 Americas Best Practices Conference, Sept. 21-22 in Atlanta. The study, which covered a two-year period from 2008 to 2009, utilized TL 9000 sustained performance data and focused on the “number of problem reports” (NPR) and “fix response time” (FRT) for the “switching” product family.

The TL 9000 QMS has provided this environment and as shown by the data presented in this study, certified
companies that have adopted and are using the
TL 9000 Measurements and Performance Data
Reports have demonstrated improvement.

There was significant improvement across the product family in reducing the number of critical and major problem reports over the two-year period. The number of critical problem reports decreased by more than 33 percent, and the industry average for the number of major problem reports improved by just over 32 percent.

This report was compiled using the data from
certified TL 9000 companies. While the team
surmises that the overall industry has improved,
the data only substantiates that the companies
using the TL 9000 QMS improved. Regardless,
being able to provide objective evidence of
substantive quality improvement during a period
where suppliers were forced to aggressively
reduce their costs underscores the value of
TL 9000. As customers become more aware of
the improvements driven by TL 9000, it is expected
that they will seek to purchase products and
services only from TL 9000 certified organizations.

The best-in-class trend for the number of critical problem reports shows that the top performers continued to improve. Three of the six reporting product categories displayed perfect performance or zero critical problem reports reported throughout the two-year period.

Click here to obtain a complete PDF copy of the report and contact us for your TL9000 needs.

In a global economy where success depends on quality, innovation, and sustainability, World Quality Day on Nov. 11 offers an ideal opportunity to focus on the importance of quality and reinforce these concepts as the foundations of your business. Organizations from all over the world will be holding activities as part of World Quality Day, which was introduced by the United Nations in 1990 to increase worldwide awareness of the important contribution that quality makes toward a nation’s and an organization’s growth and prosperity.

This year’s theme, “Out of the Crisis,” will focus on what a fit organization looks like and the role that quality management professionals play in facilitating fitness, from aligning the organization’s processes to its strategic goals, to ensuring that the organization and its people consistently understand and can deliver on stakeholder needs, to helping the organization look at processes, and prioritize and deliver improvement.

Organizations that will come out of the crisis are those that focus on current and potential customers, and have the flexibility to innovate and change to meet their requirements. They are determined to look at the ways they can improve their business processes to maximize use of resources, increase efficiency, and reduce redundancy and waste.

For quality to become an important focus of business, it must be valued by the whole organization. Make employees aware of what quality means to your organization and show them how they can contribute!

For more information, visit CQI’s World Quality Day web page.

Sustaining Edge Solutions is a proud Sponsor and Exhibitor of the 2010 Southern California Quality Conference, October 23, 2010 at Cal Poly University, Pomona CA. Conference theme is “Current State of Quality in American Industry.” The Keynote speaker is David Spong, President of the American Society of Quality and sits on the Board of the Baldrige Foundation. See the Conference Website for more detail and program plan. See you there!

Manufacturing Technology Consumption Up 58.9% in 2010. U.S. manufacturing technology consumption totaled $266.08 million, according to the American Machine Tool Distributors’ Association (AMTDA) and The Association for Manufacturing Technology (AMT). This total, as reported by companies participating in the USMTC program, was up 10.1 percent from June and up 72.6 percent from the total of $154.13 million reported for July 2009. With a year-to-date total of $1.4 billion, 2010 is up 58.9 percent compared with 2009. U.S. manufacturing technology consumption is also reported on a regional basis for five geographic breakdowns of the United States. For more information see the AMT website.

22nd Annual National Forum on Quality Improvement in Health Care. The National Forum on Quality Improvement in Health Care, Dec. 5-8, at the World Center Marriott in Orlando, Florida, is the premier “meeting place” for people committed to the mission of providing safe, effective patient care at a reasonable cost. This annual event draws approximately 5,500 health care leaders from around the world in person and thousands more via satellite broadcast. There are more than 200 sessions offered at the National Forum. See the National Forum brochure in PDF for complete conference information.

To see the course description, schedule, and
on-line
registration click on the course title below. We do provide onsite and custom training.

View Our Web Based E-Training Courses

Understanding and Implementing
ISO9001:2008
ISO
9001:2008 Process Based Internal Auditor

Documenting Your Quality Management System

Understanding and Implementing AS9100C:2009
Aerospace-NEW

AS9100C:2009 Process Based Internal Auditor-
NEW


Documenting Your Quality Management System

Understanding and Implementing
ISO/TS16949:2009 Automotive


ISO/TS16949:2009 Process Based Internal
Auditor

Documenting Your Quality Management System

Understanding and Implementing
ISO14001:2004 Environmental

ISO14001:2004 Process Based Internal Auditor

The Five Pillars of a Lean Workplace
Organization

Continuous Process
Improvement
Lean Six Sigma
8 Disciplines (8D) of
Problem Solving

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

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

The current economic downturn has created an enhanced awareness on how an organization creates the value needed by its products, markets and customers. Becoming more efficient and effective is much more than eliminating process waste. Internal waste reduction may not be the primary need for an organizations markets or customers, thus waste reduction may not ensure continued sustainability of the organization.

The following questions is a good place to start:

Let us not forget that the “economic value” or rationale is particularly important. Identifying the critical processes that need to be either created or improved to provide the needed strategic capabilities should drive the overall improvement effort and economic value. This is the essence of process management (effectiveness of process = ability to achieve desired results, and efficiency of process = results achieved versus resources used).

Identifying the missing gaps and implementing the missing processes can be the quickest way to improve a system. The organization must ensure that process improvements are linked to strategy and core process execution. To be a success, an organization must continuously improve all its essential core processes to provide value and to always satisfy customer requirements.

According to a survey conducted by Newsweek Magazine, companies continue to cut a higher-than-expected jobs, you can’t blame the American worker for seething. Wages remain stagnant and unemployment is at 9.5 percent, even as employee productivity is at levels not seen since 2002. Much of the workforce has endured pay cuts, furloughs, and a loss of benefits. During the same time frame, corporate profits have rebounded, according to the Standard & Poor’s 500 Index.

“There’s more of a divide in terms of compensation between senior executives and the average worker now,” says Thomas Kochan, a professor of management at MIT. “This will have a lasting effect and lead to lower trust and lower confidence in management.” If this environment lingers, it could lead to a profound cultural change in the way Americans view work.

As the recession drags on, academics and executive coaches say workers have become disconnected from companies. Eighteen percent of large companies recently surveyed by Towers Watson said they had cut or eliminated the matching money they contributed to employees’ retirement plans, starting in September 2008. Even when profits came back, those benefits often have not.

Nearly 48 percent of Americans say they planned to look for a new job once the economy stabilizes. Roughly half of those surveyed say they no longer trust their companies or feel like they treat workers fairly, according to Deloitte’s 2010 Ethics & Workplace Survey. “When you consider this, it has huge implication for companies’ bottom lines,” says Sharon Allen, chairman of Deloitte. “It costs money to replace workers, and it’s very costly in terms of the loss of institutional knowledge.”

But will asking for more actually get employees anywhere? The recession has irrevocably shifted the labor market. While top performers and those in hot industries such as tech or finance may still be able to negotiate generous compensation packages, ordinary workers may not see the cash. Employees may change jobs, only to find out that the same problems exist at new offices. Worse, workers will simply become accustomed to this new reality and feel a dampening of ambition: a sense of gratitude for any job. “It just becomes a way of life,” says Robert Sutton, a professor of organizational behavior at the Stanford Graduate School of Business. For employees to really gain the upper hand again, they may need to wait until unemployment drops back to the 5 to 7 percent range. Unfortunately for everyone, that isn’t expected any time soon.

Click here to read the Newsweek Survey.

The International Aerospace Quality Group (IAQG) has released the AS9101D standard. Its theme for this current release is “Conformity joins performance and effectiveness, resulting in a satisfied customer.”

The intent is to give the current ISO-based auditing process a stronger emphasis on QMS and process effectiveness, in addition to conformity to the AS91XX requirements. This represents a transition from clause-based auditing to a process-based approach for QMS assessment.

This is not just a new checklist, but rather an “enhanced audit approach for evaluating process-based management systems.” According to the IAQG, these principles provide the foundation of AS9101D:

(1) AS9101D takes a process-based approach to auditing. Auditing and certification comprise a process. Also, the organization is to be audited in terms of processes, not discrete compartments. Auditing plans and audit trails are to be based on processes.

(2) AS9101 focuses on organization performance. An audit should identify process, input, and performance, and should include process performance measurement and monitoring, performance targeting, improvement measurement, and fulfillment of customer expectations. This information is to be used in planning the audit, when analyzing effectiveness, and in reporting the audit results relative to the performance effectiveness of the QMS, its processes, and improvement actions.

(3) AS9101D recommends audit methodology to include the following areas:

• Customer focus
• Organizational leadership
• QMS performance and effectiveness
• Process management
• Process performance and effectiveness
• Continual improvement

(4) AS9101D is for evaluating QMS effectiveness in addition to conformity. As part of evaluating conformity to requirements, audits are to evaluate the effectiveness of the QMS and associated processes. How well is the organization fulfilling customer expectations? Is it delivering quality products, and delivering them on time? Is the organization continually improving? The auditors are to use the Process Effectiveness Assessment Report (PEAR).

(5) AS9101D improves reporting of audit results. The methods and forms for reporting audit results are standardized. Variation has been reduced to enable more consistent interpretation of audit results. The forms are easier for all stakeholders to understand, including customers and assessors. Surveillance of suppliers is more effective and efficient. The forms should enable the audited organization to better focus its improvement efforts. There are several new forms; in addition to the PEAR, auditors will now be using a Nonconformity Report, an Objective Evidence Record (which replaces the old checklist), and a QMS Process Matrix Report. AS9101D eliminates scoring and the use of a questionnaire.

In addition, with AS9101D there is now a single audit standard that replaces all existing versions of 9100, 9110, and 9120. According to an IAQG media release, “Both QMS Certification auditors and Certified organizations will notice a significant change in how future audits are conducted, including the reporting of process effectiveness and audit conclusions. These changes will lead to a determination of an organization’s ultimate measure of QMS effectiveness – customer satisfaction.”

For more information on the full roster of our aerospace offerings, visit our website or contact us.

Sustaining Edge Solutions is a proud Sponsor and Exhibitor of the 2010 Southern California Quality Conference, October 23, 2010 at Cal Poly University, Pomona CA. The Keynote speaker is David Spong, President of the American Society of Quality and sits on the Board of the Baldrige Foundation. Early Bird Pricing is $65 only until Sep 24th, 2010. See the Conference Website for more detail and program plan. See you there!

AMT Urges Congress to Strengthen, Rebuild U.S. Manufacturing. In an open letter, Douglas K. Woods, president of The Association For Manufacturing Technology (AMT) urges Congress and the administration to help rebuild the U.S. manufacturing sector.

AMT is urging Congress and the administration to implement policies consistent with AMT’s “Manufacturing Mandate,” a national manufacturing strategy to help rebuild and strengthen this country’s manufacturing sector.

A solid economic recovery has been slow to take hold, and that has been especially true in the manufacturing sector where credit remains tight and uncertainty concerning the future has prevented companies from retooling, diversifying, and investing in R&D. AMT believes its national manufacturing mandate is necessary to cement this recovery and create a strong foundation for sustained economic growth.

This document supplements the 9100 standard requirements for deliverable software and contains quality management system requirements for organizations that design, develop, and/or produce deliverable software for the aviation, space, and defense industry. This includes, as required, support software that is used in the development and maintenance of deliverable software. The deliverable software may be stand-alone, embedded, or loadable into a target computer.

AS9115 can be purchased at SAE International.

To see the course description, schedule, and
on-line
registration click on the course title below. We do provide onsite and custom training.

Understanding and Implementing
ISO9001:2008
ISO
9001:2008 Process Based Internal Auditor


Documenting Your Quality Management System

Understanding and Implementing AS9100C:2009
Aerospace-NEW

AS9100C:2009 Process Based Internal Auditor-
NEW

Documenting Your Quality Management System

Understanding and Implementing
ISO/TS16949:2009 Automotive


ISO/TS16949:2009 Process Based Internal
Auditor

Documenting Your Quality Management System

Understanding and Implementing
ISO14001:2004 Environmental

ISO14001:2004 Process Based Internal Auditor

The Five Pillars of a Lean Workplace
Organization

Continuous Process
Improvement
Lean Six Sigma
8 Disciplines (8D) of
Problem Solving

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

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

Layered Process Audits (LPAs) have become quite popular and in many cases mandatory for suppliers in the automotive industry. The effects of properly conducted layered process audits can be substantially positive. Because layered process auditing reduces the number of operator errors they have spread to industries outside of automotive.

A layered process audit is an ongoing chain of simple verification checks that ensure a defined process is
followed correctly. It is a powerful management tool that can improve safety, quality and cost savings by
amplifying problem solving systems and making continuous improvement almost routine. Through observation,
evaluation and conversations on the manufacturing floor, these checks ensure key work steps are performed
properly. LPA interactions are also an excellent way for managers to show respect for frontline workers.

Let’s identify some essential components of a Layered Process Audit Program

Survey data shows excessive process input variation is the single largest cause manufacturing quality problem. This often results from a failure to reinforce process corrective actions. Or, can be attributed to a failure to follow the required steps and methods. Layered process audits reduce this variation along the manufacturing line up through the ranks of plant management. This helps ensure that operators are following the process steps.

Keep in mind that a layered process audit system must have a documented audit structure (just as quality system standards require) that schedules auditors at pre-determined levels and frequency of audits. These audits focus on process operations and error-proofing, not on finished product inspections.

One of the most common questions we hear with 5S (and Lean for that matter) is how do you sustain? Sustaining 5S can be very difficult without the use of a formal process. A layered audit program can be used successfully to ensure that your company’s 5S efforts continue.

Layered Audits are tied directly into the fifth S – Sustain – and they are the means used in Lean Improvement Systems to avoid “backsliding” into old habits, creating sustainable culture change. Layered Process Audits require that multiple operational levels within an organization review the same key operational controls to ensure sustainability. Simply stated, they are an ongoing chain of simple verification checks, which through observation, evaluation and conversations on the line; assure that the process is being properly performed.

The key is everyone is an “auditor”. This starts with the operator personally checking their process for compliance. Then the first line supervisor checks key processes, where feedback is immediate as are any agreed-upon corrective actions. The next level supervisor would then make the same checks, and so forth.

The essential part of the Layered Audit is the creation of a standard checklist You must identify and ask the right questions on the checklist. This is where Standard work at all levels of the organization is critical. Layered Audits is a formalization of “management by walking the Gemba”.

Layered Process Audits can be compared to a pilot’s preflight checklist. Is my operation ready for take-off? Am I confident that everything is in place to build and ship conforming product to my customer? When the day goes smoothly, management and operators can use the time saved to work on improvements. The beauty of LPAs is that managers often can learn much about the manufacturing processes from operators, and operators can learn much about what is important to customers from managers.

Contact us for more information and training about LPAs, 5S, and a Free Layered Audit Checklist.

The International Organization for Standardization (ISO) has developed a new technical specification, ISO/TS 10004:2010, which provides guidance to organizations in establishing effective processes for monitoring and measuring customer satisfaction.

Customer satisfaction is one of the key elements for the success of an organization, whether it’s in public or private sector. The information obtained from monitoring and measuring customer satisfaction can help identify opportunities for improvement of the organization’s strategies, products, processes, and characteristics that are valued by customers, and which serve the organization’s objectives. Such improvements can strengthen customer confidence and result in commercial and other benefits.

ISO/TS 10004-”Quality management-Customer satisfaction-Guidelines for monitoring and measuring” deals with:

• Concept of customer satisfaction and guiding principles
• Framework for monitoring and measuring customer satisfaction
• Planning for monitoring and measuring customer satisfaction
• Processes for monitoring and measuring customer satisfaction
• Maintenance and improvement of monitoring and measurement processes

This technical specification is intended for use by organizations regardless of type, size, or product provided. Its focus is on customers external to the organization. It is not intended for certification or contractual purposes, nor is it intended to alter any rights or obligations under applicable statutory or regulatory requirements.

ISO/TS 10004 belongs to the ISO 10000 series of standards on customer satisfaction. ISO 10001:2007, ISO 10002:2004, and ISO 10003:2007 provide guidance on codes of conduct, complaints handling, and dispute resolution. ISO/TS10004 complements these standards by providing guidance on monitoring and measuring customer satisfaction. Collectively, their guidance can assist the organization to take actions that can help to sustain or enhance customer satisfaction.

By providing guidance on monitoring and measuring customer satisfaction, ISO/TS 10004 supports the objectives, and is compatible with, ISO 9001:2008-”Quality management systems-Requirements,” and with ISO 9004:2009-”Managing for the sustained success of an organization-A quality management approach.”

ISO/TS 10004 can be purchased through the ISO Store.

TL 9000 is the globally recognized quality management system standard for the telecommunications industry. It was developed by the QuEST Forum-a consortium of international telecommunications service providers and suppliers. It includes all of the requirements of ISO 9001, supplemented with industry-specific requirements for hardware, software, and services. It is unique in that it also includes a comprehensive set of product- and service-related reliability and quality measurements that can be used to evaluate the effectiveness of an organization’s quality management system.

TL 9000 requirements were revised in 2009 with Release 5.0 of the Requirements Handbook. These requirements must be implemented by TL 9000-registered companies for assessment in certification body audits conducted after November 10, 2010. The latest revisions to the TL 9000 measurements has been published.

Key revisions involved in Measurements Handbook Release 4.5 include:

• A new network support service outage measurement, which will be applicable for outages attributed to installation, engineering, field maintenance, and network operations centers. This replaces the EIO measurement.
• Changes to counting rules and counting exclusions for the problem report (NPR and FRT) measurements, on-time delivery measurements, system outages, return rates, and defective software fix measurements.
• Changes to the concept of customer base and measurements sources that require measurement reporting for all customers, so as to enable an organization to gather the required data from its own internal monitoring systems.
• Reduced problem report resolution threshold timeframes for service provider product categories.
• Clarification of the treatment of firmware for software measurement reporting purposes.

Purchase Measurements Handbook 4.5 at the Quest Forum Website.

Policymakers Must Address Manufacturing Challenges-Now. As U.S. manufacturers struggle to recover from the recession, a new report finds that manufacturing fuels economic prosperity but requires pro-growth policies to create jobs and remain globally competitive. The report, released by the National Association of Manufacturers (NAM) and the Council of Manufacturing Associations (CMA), was written by economists Joel Popkin and Kathryn Kobe, noted experts on issues related to prices, wages, productivity and technology.

Manufacturing industries perform almost two-thirds of the private sector research and development (R&D), driving America’s leading edge in innovation and break-through technologies. But manufacturers in America face serious challenges that threaten to undermine their contributions to U.S. prosperity.”

The new report, “Manufacturing Resurgence – A Must for U.S. Prosperity,” is available online.

4th Edition of MSA. The Measurement Systems Analysis (MSA) Reference Manual, 4th Edition is now available. It was jointly developed by Chrysler Group LLC, Ford Motor Company, and General Motors Company to provide guidance to their automotive suppliers.

The purpose of the document is to present guidelines for assessing the quality of a measurement system. The manual is not intended to be a compendium of analyses for all measurement systems. Its primary focus is measurement systems where the readings can be replicated on each part. Customer approval is required for measurement systems analysis methods not covered in this manual.

You can begin using the 4th Edition of the MSA reference manual now. The document can be ordered at the AIAG web site.

19th Annual ASQ Service Quality Conference Sept 13-14, 2010, Las Vegas, NV.

Medical device manufacturers may gain a one-year exemption from Food and Drug Administration (FDA) inspections if their establishment has been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) founding members using ISO 13485.

Manufacturers must submit the audit results to the FDA voluntarily. From the audit results, the FDA determines whether to inspect that establishment for one year.

In a draft guidance issued on May 20, 2010 the “Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program,” the FDA describes how its Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research are implementing section 228 of the Food and Drug Administration Amendments Act of 2007.

According to provision F of section 228, “For the purpose of setting risk-based inspectional priorities, the Secretary shall accept voluntary submissions of reports of audits assessing conformance with appropriate quality system standards set by the International Organization for Standardization (ISO) and identified by the Secretary in public notice.” It further specifies that if the owner or operator of an establishment chooses to submit audit reports, the owner/operator “shall submit all such audit reports with respect to the establishment during the preceding 2-year periods.”

Audit reports must provide “a degree of assurance of compliance with basic and fundamental quality management system requirements for medical devices.” If the FDA determines there is minimal probability that the establishment will produce nonconforming and/or defective finished devices based on “the relationship between the quality system deficiencies observed and the particular device and manufacturing processes involved,” then it will use the audit results in determining whether to remove that establishment from its routine work plan for one year. However, inspections conducted “for cause” will not be affected.

This draft guidance can be downloaded from the FDA website.

Contact Us for all your ISO 13485:2003 Medical Devices training and implementation needs.

To see the course description, schedule, and
on-line
registration click on the course title below. We do provide onsite and custom training.

View Our Web Based E-Training Courses

Understanding and Implementing
ISO9001:2008
ISO
9001:2008 Process Based Internal Auditor

Documenting Your Quality Management System

Understanding and Implementing AS9100C:2009
Aerospace-NEW

AS9100C:2009 Process Based Internal Auditor-
NEW


Documenting Your Quality Management System

Understanding and Implementing
ISO/TS16949:2009 Automotive


ISO/TS16949:2009 Process Based Internal
Auditor

Documenting Your Quality Management System

Understanding and Implementing
ISO14001:2004 Environmental

ISO14001:2004 Process Based Internal Auditor

The Five Pillars of a Lean Workplace
Organization

Continuous Process
Improvement
Lean Six Sigma
8 Disciplines (8D) of
Problem Solving

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

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

The International Aerospace Quality Group (IAQG) recently issued a letter on transition training for aerospace auditors. This training is a key element in the transition to the AS9100C, AS9110A, and AS9120A standards, as well as, use of the common AS9101D audit requirements standard.

All Aerospace Auditors (AA) and Aerospace Experienced Auditors (AEA) must complete Aerospace Auditor Transition Training (AATT) to be authenticated for auditing the new aerospace 2009 standards.

AS9100: This IAQG-Sanctioned AATT course has online and instructor-led components. The online component consists of an online initial examination and an online module titled, “Foundations: Understanding 9100″. The instructor-led component is a 4-day course and includes an evaluation and examination.

For more information on the IAQG-sanctioned Aerospace Auditor Transition Training, go to this Plexus web page.

AS9100C Changes. Let’s look at a few of the key changes in the standard and identify important process points.

C. Configuration Management: Moved from clause 4.3 to 7.1.4. The move and expanded scope provides focus of this requirement during product realization. Added
ISO 10007 sections (a-e). Point: Have you defined what, who and how (a-e example: config ID & audit) are executed, controlled, and valid objective evidence)? Configuration management is aimed to know at any time the “as designed” and the “as built”
configuration of products in order to ensure fit for use of these products.

D. Project Management: Project management has been added to the standard outlining requirements on
planning and managing product realization risks, resources and schedule. Point: Most
aviation, space and defense products are complex and involve multi-tier partners and suppliers and project management provides additional focus on upfront planning and the management of project plans throughout product realization.

E. Customer Satisfaction: This requirement defines mandatory measures (e.g. customer performance indicators) that all organizations of all sizes and complexity must monitor), analyze and review to assess if improvement is needed. If action is needed, improvements must be planned and
implemented and the results of the action must be evaluated to check their effectiveness. Point: A formal improvement process (example- PDCA) can ensure method, evidence, and evaluation of effectiveness.

F. Monitoring and Measurement of Processes: The Achilles’ heal – poorest evidence requirement we witness in documentation and measurable business performance improvement evidence. “Demonstrate the ability of processes to achieve planned results” (look beyond Management Review Inputs). Point: A note has been added to provide guidance on how an organization may go about determining appropriate process monitoring and measurement methods. It requires that the organization determine if the process nonconformity is limited or if it has affected other processes or products.

SES is currently working with a number of aerospace firms to achieve a successful and measurable transition. Contact Us for all your AS9100 training, documentation assistance, process improvement and internal auditing needs.

It would not be an exaggeration to say that the ISO 9001 standard from the International Organization for Standardization (ISO) brought about a revolution in the field of quality assurance. Some efforts have been made in the past to analyze the effectiveness of certification in countries such as Brazil and India. Encouraged by such studies and realizing a need for a more broad-based study, especially in developing economies A Joint study by IAF, UNIDO, and ISO to measure effect of management system certification is taking place.

The project, titled “Implementation of ISO 9001 Quality Management System in Asian Developing Countries: Survey Covering System Development, Certification, Accreditation and Economic Benefits,” is to be carried out in about 10 economies.

The objective of phase 1 of the project-a survey of customer satisfaction-is to evaluate the effect of ISO 9001 certification on the satisfaction of customers of certified organizations, and their perceptions about the performance of their suppliers (i.e., the certified organizations). A survey questionnaire has been developed for this part of the project and has been validated by large institutional purchasers in other parts of the world.

Phase 2, a survey of certified organizations, will be conducted in 2010. The aim is to assess the effectiveness of the ISO 9001 certification process, the status of the quality management system, and perceptions regarding the effects of certification in ISO 9001-certified organizations. Independent assessors will be used for this part of the project, according to competence criteria and methodologies currently under development in collaboration with ISO and the IAF.

Expected outcomes of the project include:

We will keep you updated when the results of the study are published.

In ISO 9004:2009 managing for the sustained success of an organization – a quality management approach — Clause 9.2 – Improvement, suggests that “improvement processes should follow a structured approach such as the “Plan-Do-Check-Act” (PDCA) methodology.”

Most of us have heard, and are familiar with The Lean Six Sigma methodology to follow a structured approach, known as DMAIC: DEFINE-MEASURE-ANALYZE-IMPROVE-CONTROL. It is important to recognize that this “structured” methodology does not conflict with or negate the application of the PDCA methodology suggested in 9004. Instead, PDCA links to DMAIC from a strategic and tactical point of view.

From a strategic perspective, PDCA can be used to successfully deploy a DMAIC process improvement strategy across the organization. Examples of PDCA activities can include:

• Plan: Establish short and long-term objectives and targets for the initiative, determine resources needed to achieve them, and schedule progress reviews.
• Do: Deploy the initiative according to your plan; monitor and measure performance for comparison with planned objectives and targets.
• Check: Conduct top management reviews at planned intervals (with responsible personnel ) to ensure that the deployment is on track, and identify opportunities for improvement.
• Act: Take action to correct deficiencies and/or address improvement opportunities identified through the management review process.

From an organizational approach, PDCA can be utilized as the cornerstone that supports each DMAIC step. Let’s look at a couple of examples of how PDCA can be applied within DMAIC steps:

DEFINE Step:

• Plan: Prepare for an improvement project by establishing a project charter.
• Do: Draw a high-level process map (SIPOC) and gather Voice of the Customer (VOC) information.
• Check: Verify the SIPOC and VOC information against your goals and objectives.
• Act: Make any adjustments to the project charter and authorize the project’s continuation.

MEASURE Step:

• Plan: Identify what needs to be improved and prepare for data collection.
• Do: Collect the data to determine where we are.
• Check: Verify that data collection is effective with what was planned.
• Act: Take action where planned arrangements are not being followed, and make appropriate changes.

The same principle does apply to the ANALYZE, IMPROVE, and CONTROL steps of DMAIC. ISO 9004 provides valuable guidance related to the various elements that comprise a strategy that leads to success. The application of Lean Six Sigma is one method to support the strategy detailed in ISO 9004 to achieve measurable organizational success.

Nation’s Manufacturing Sector to Bounce Back in 2011-2012. Manufacturing will recover to prerecession levels during the next two years in states with low tax rates, a diverse collection of manufacturing industries, and strong government services, says a report from Ball State University in Muncie, Indiana.

The CBER report can be found on their web page.

U.S. Autos Improve in Initial Quality. Domestic auto brands, as a whole, have demonstrated higher initial quality than import brands for the first time, according to J.D. Power and Associates’ recently released 2010 U.S. Initial Quality Study (IQS). The study has been conducted annually for the past 24 years. The study is used extensively by manufacturers worldwide to help them design and build better vehicles, and by consumers to help them in their vehicle purchase decisions.

View the study at the J.D. Power Website.

Eighty-Three Organizations Seek the 2010 Baldrige Award.Eighty-three organizations are in the running for the 2010 Malcolm Baldrige National Quality Award, the nation’s highest recognition for organizational performance excellence through innovation and improvement. Applicants include three manufacturers, two service companies, seven small businesses, 10 educational organizations, 54 health care organizations, and seven nonprofit and governmental organizations. The number of applicants is up 20 percent over 2009 and marks the fifth consecutive year that there have been 70 or more organizations seeking the award.

To learn more about advancing your organization’s quality journey, visit the NIST Website.

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