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Greetings! Welcome to Sustaining Edge Solutions E- Newsletter Our newsletters provide guidance on operational and quality systems ISO 9001, AS9100, ISO/TS 16949, TL 9000, ISO 13485, ISO 14001, and others. This includes process improvement methods Six Sigma, Lean Enterprise, and other topics of interest to our readers. If you have any questions about the articles appearing in this issue, or you want to suggest topics for future issues, please let us know. HAPPY HOLIDAYS!
A “cheat sheet” is a concise set of notes used for quick reference. In the academic world, cheat sheets are so named because they may be used by students without the instructor’s knowledge to cheat on a test.
In the business world, so called “cheat sheets or reference document” are popular in any setting where a quick reference is useful. New employees often make notes on how to perform their job, especially if written instructions aren’t available, supplied instructions are incomplete or complex, or the job training was inadequate. These personal job notes may be also referred to as cheat sheets. On the surface, use of cheat sheets would seem to be helpful and may even be encouraged. However, these job notes may not accurately describe the tasks, may be in conflict with written instructions, or be unapproved by management. ISO 9001:2000, clause 4.2.3 states that “Documents required by the quality management system shall be controlled.” So, if cheat sheets are needed by employees to carry out their activities, these cheat sheets would be viewed as documents that must be controlled. To control a document means it must be approved prior to use, updated as necessary and re-approved, and identified with the current revision status. Cheat sheets become authorized documents if they are controlled. If not, auditors will write them up as nonconformities. Employees do not like their cheat sheets being called nonconformities, especially if the corrective action is to just discard the cheat sheets. The existence of cheat sheets may indicate they are needed, so simply removing them might be a mistake. Instead, find out why some employees need the cheat sheets/reference document and take the appropriate action, e.g., improve training, provide mentoring, add the cheat sheets as controlled documents, or include the reference information in existing documents. Audits correctly spot the use of these reference items. Make sure your response supports the employees by providing alternative support.
A checklist is used to compensate for the weakness of our human memory when we want to ensure consistency and completeness in carrying out a task. For example, we use checklists to remind us of important actions or to even plan a trip to the grocery store.
As auditors, we use checklists to remind us of the audit criteria against which we are to compare the audit evidence. In other words, we compare evidence (statements, observations, documents, and records) to the applicable requirements (customer, organization, standard, and legal). To guide novice auditors, a typical checklist contains a suggested set of questions to determine if an area is conforming to the requirements. Unfortunately, the auditors often rigidly adhere to the list of questions and are unlikely to develop their own questions based upon the evidence. And, when they hear reasonable answers to the canned questions, they may accept the responses and not recognize nonconforming situations. The typical checklist gives them the questions to ask, but does not provide the expected answers. If you are an instructor giving an exam, you need the answer key to grade the responses. Likewise, an audit checklist should provide the expected answers to judge conformity. So, rather than listing only questions, we should use audit checklists with no questions, only the requirements and the expected evidence. Auditors, even new auditors, can develop the basic questions on the fly to ask regarding the applicable requirements. By not providing the questions, each audit is unique and does a better job of sampling the area under audit. Identifying the expected evidence on the checklist helps the auditor decide if the statements made, operations observed, documents reviewed, and records examined are conforming. As an example of a traditional checklist for the document control process, it would contain a question like, “Are the documents approved before they are issued?” The response might be, “Yes, I receive an email note from the document owner approving the document before I make it available.” That might sound like a reasonable response, especially if the auditee shows you records matching that practice. However, with the proposed checklist, there would be no questions. Instead, under the Requirement column would be: “Approve documents before they are issued.” Under the Evidence column might be something like: “Document owner and quality manager must sign approval form, DC-01.1.” Based upon the requirement listed, the auditor might ask, “How are documents approved?” If the same response was received, the auditor would see from the expected evidence that approval from the quality manager was missing and that the required form was not being used. An audit checklist is a memory aid and confidence builder for an auditor. It helps the auditor stay focused on the audit objectives and scope. It helps ensure the audit criteria have been addressed. And, it is a repository for the auditor notes and becomes a record of the investigated areas.
More than 175 leaders and experts from healthcare and automotive industries met November 15-16 in Troy, Mich., at AIAG’s AutoMed 2007 to discuss critical work being done by AIAG’s Health Focus Group and its collaborative partners. The group’s driving mission is to improve quality, value and efficiency by eradicating root causes and employing proven automotive processes within the healthcare industry. AutoMed serves as the partnership’s in-gathering venue and communication tool to industry leaders. Keynote speaker, Dr. Vinod Sahney, Sr., vice president and chief strategy officer, Blue Cross Blue Shield of Massachusetts, detailed several root causes for the growing healthcare cost crisis, including an aging demographic and chronic disease prevalence. “By global comparison, the U.S. aging demographic is most expensive, due to poor health and the consequential expense paid through retiree benefits,” noted Sahney. Confirming that reality, Ford Motor Company’s medical director, Dr. Walt Talamonti, showed that a shocking 58 percent of the $3.1 billion spent in 2006 by Ford on healthcare was post-retirement cost. In response to hospital and provider process inadequacies, solutions are sought in proven quality practices. Mickey Christensen, president of TQM Systems and Dan Reid, purchasing manager for GM Powertrain, presented the Business Operating System (BOS) for Health Care organizations. BOS combines the Malcolm Baldrige Health Care Criteria for Performance Excellence (MBNQA) modifications and ISO, as well as AIAG-owned content. Christensen says BOS is ideal for “application to healthcare because it is process focused and system dependent.” He also highlighted DNV Healthcare’s early initiative in U.S. hospital accreditation as a potential solution to standard practice issues. Empowering AutoMed attendees to be the driving force behind long-term solutions, Reid stated, “The people in this room can make a difference in healthcare delivery – within this state, this region, even this nation.” The January 2008 unveiling of AIAG’s Health Care Steering Committee is an answer to that call and shows an increased dedication to building solutions for massive cost-inefficiencies throughout the healthcare industry.
ISO has begun the development of ISO 21500, an international standard on project management. BSI British Standards recently hosted the inaugural meeting in London of the new project committee, ISO/PC 236, Project management, established to develop ISO 21500. Over 50 delegates from around the world attended to begin work on the international standard, which is intended to provide generic guidance, explaining the core principles and what constitutes good practice in project management. ISO 21500 will build on existing standards and work at the national level. It is intended to be applicable to organizations of all sizes and sectors and will be designed for relative newcomers to project management, or as an aide-mémoire for more experienced practitioners. So far, delegations of experts selected by the national standards institutes of 20 countries are participating in the work, with another three countries having observer status. ISO/PC 236 includes three working groups, respectively addressing terminology, processes and informative guidance. The secretariat of ISO/PC 236 is held by the American National Standards Institute (ANSI), and it is chaired by Dr. Jim Gordon, of the United Kingdom, who commented: “The development of an international standard will be welcomed by many countries and will have broad relevance to projects in many industries and the public sector.”
Our 2008 1st Quarter course schedule is now posted on our website.
To see the course description, schedule, and on-line registration click on the course title below. Courses are awarded Continuing Education Units. Understanding & Implementing ISO9001:2000 Understanding & Implementing AS9100B:2004 Understanding and Implementing ISO/TS16949:2002 Understanding and Implementing ISO14001:2004 The Five Pillars of a Lean Workplace Organization All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?
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Archive for 2007
Instruction or Quick Reference?
Saturday, December 1st, 2007Posted in Newsletter | No Comments »
"Buy American“? How about “Buy Quality” and then live up to expectations?
Tuesday, November 6th, 2007From: Quality Digest Magazine, Nov 2007
Written by Dirk Dusharme, Editor
“Made in the USA.” What does it mean? What should it mean? To tell the truth, I’ve never thought all that much about it. My inclination has always been to buy the best product, with the features that I want, at a price that I can afford. Frankly, I’ve gotten used to those products being foreign-made, to the point that I just automatically gravitate toward Honda or Bosch or Zeiss.
But this month’s cover story by Nathalie Mitard (“Made in the USA,” beginning on page 26) made me think about it. I even posed the question to my wife. I asked her, “Everything else being equal, if you had the choice to buy a U.S.-made product or a foreign product of the same quality, which would you choose?”
Without hesitation, she said, “The U.S.-made product, because it supports our economy.”
“What if the foreign product was of slightly better quality?” I asked.
“Still U.S.,” she replied.
“Is there a point at which the better quality of a foreign product would persuade you to buy foreign rather than U.S?”
She had to think about that for a bit, but then acknowledged that, sure, at some point the quality of a product wins out over origin.
So, again, what should it mean to only buy products that are “Made in the USA”? Should I buy a U.S. product out of a sort of patriotism, or should I buy a U.S. product only if it’s better? I think it’s the latter. There’s just a little bit of hypocrisy tied up with how some U.S. manufacturers want me to blindly buy domestic. They want me to “Buy American,” but they definitely don’t want their Japanese customers to “Buy Japanese” or their Mexican customers to only buy products with a “Heche en Mexico” label.
I live in the rice-growing region of Northern California. This relatively small area exports more than 40 percent of its annual rice production to Asian countries; in fact, half of Japan’s total rice imports come from here. The total value of California’s 2002 rice exports was around $183 million. The industry creates more than 5,000 rural jobs.
Can you imagine what would happen to this area if Japan decided to embark on a “Buy Japanese Rice” campaign? “Buy [country here]” sounds good except when the shoe is on your customer’s foot.
Even with all that said, Mitard is right. There’s a trade deficit and it’s partially up to us as consumers to do something about it—but we shouldn’t do it blindly. We should buy from those U.S. producers, like Mitard’s, that put out a quality product—and, I would argue, only those. The others will learn the hard way, like our consumer electronics industry did as it crumbled beneath the onslaught of better and less-expensive Japanese-made products. Some industries, like the auto industry, learned, barely, and are now producing comparable products at comparable prices.
So I agree that maybe its time that we… I… take another look at U.S. products. The next time I get ready to make a purchase, I’ll evaluate whether the U.S. product (if it exists) is of comparable quality to the foreign. If it is, well, why not “Buy American”?
This isn’t just a blind allegiance to U.S. products, but rather an allegiance to quality U.S. products. So how about this? Let’s change the slogan from “Buy American” to “Buy Quality.” If we do that, eventually the “Made in the USA” label will mean more than just the place of manufacture.
QUALITY GURU IS ASKING FOR YOUR OPINION
We all know that many U.S. consumer products are made in other countries (example – no such thing as a Made in America automobile anymore). Does “Made in the USA” determine your buying experience or do you purchase solely on the best quality and price available?
Share your thoughts and purchasing decision process!
Posted in Articles | 1 Comment »
How Do We Audit Analysis of Data?
Thursday, November 1st, 2007
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Greetings! Welcome to Sustaining Edge Solutions E- Newsletter Our newsletters provide guidance on operational and quality systems ISO 9001, AS9100, ISO/TS 16949, TL 9000, ISO 13485, ISO 14001, and others. This includes process improvement methods Six Sigma, Lean Enterprise, and other topics of interest to our readers. If you have any questions about the articles appearing in this issue, or you want to suggest topics for future issues, please let us know. Thanks for your Support!
Analyzing data is an essential activity for improving your system and its processes, as well as, your products and services. Data collection has no purpose if the data isn’t examined, evaluated, analyzed, and converted into proposals for decision making. The Guidance on Terminology resource at the ISO web site defines the term “analysis” as the breaking up of something complex into its various simple elements. The reason to separate something into its elements is to determine either their nature (qualitative analysis) or their proportions (quantitative analysis). Therefore, we analyze the data to show the quality management system is effective (achieving planned results) and to spot where improvements can be made. It is not enough to just collect the data, we must analyze it and reach some conclusions. As a result of the monitoring and measurement activities called for by ISO 9001:2000, Clauses 8.2.3 and 8.2.4, you will have collected a lot of data, which can be analyzed to indicate trends. Any trends you may find could suggest where there are problems in your quality management system and indicate areas where improvements are needed. Analysis of data can help to determine the root cause of existing or potential problems, and thereby guide decisions about corrective and preventive actions need for improvement. For an effective evaluation by management of the total performance of an organization, data from all parts of the organization should be integrated and analyzed. The overall performance should be presented in a format that is suitable for different levels of the organization. The results of this analysis can be used to determine:
So, How do we audit the analysis of data? Well, it can be hard to assess because ISO 9001:2000 doesn’t say what data should be collected or how to analyze the data. The requirement calls for analysis of the “appropriate” data. Begin by looking at the results of the data analysis implied by other clauses:
If any of this information is missing or incomplete, see if the data is being collected and not analyzed, or if the data is just not being gathered. Writing a more specific finding will help the organization focus on the appropriate data and its analysis.
ISO 9001:2000 recognizes the importance of communication by stating in clause 5.5.3 that the appropriate communication processes must be established within the organization. And, in clause 7.2.3, the standard adds that the organization must determine and implement effective arrangements for communicating with customers.
According to the HR Daily Advisor, a study by Sirota Survey Intelligence shows that the lack of communication is a key reason why initially enthusiastic employees become unmotivated in as little as 6 months after joining their organizations. The survey also shows that a company’s performance at communicating lags far behind any other facet of organizational performance. Lack of communication is obviously a serious shortcoming. Without communication, teams can’t work together. And, customers are misunderstood. Leaders may try to lead, but without effective communication, employees may not know how to follow. To improve communication, an article in the HR Daily Advisor suggests these strategies: Communication begins before conversation. Studies show that 40 percent of what is communicated comes through body language and tone of voice. Both should match the message being delivered. For example, if you say a mistake is not really a big deal, don’t send a different signal by rolling your eyes and wincing. Communication starts with a name. Nothing establishes rapport better than acknowledging others by their name. But in today’s transient world, names are easy to forget or confuse. Use a memory technique such as connecting the person’s name with someone famous. If you meet George, mentally connect him to George Washington. Start with small talk. Chatting amiably opens the door to more substantial messages, but, monitor the person’s reaction so you don’t go on too long … and never talk about workplace confidences or gossip. Tailor conversation to your audience. Talks with a boss, co-worker, or customer require different styles. With bosses, pick the right time and ask honestly for what you need and what they can reasonably deliver. For co-workers, be humble, reliable, and discreet. If customers call with problems, listen, apologize, and offer a solution. And a natural smile, when appropriate, applies in all cases, even on the phone. Consider your audience when writing. Develop your message for the intended audience and use the appropriate media for communication. Remember that others beyond the intended recipient, and perhaps into the future, may read your written words. Never write what you wouldn’t want to be openly read. Conduct more effective meetings. Nothing in business seems to irritate people more than useless meetings. So, meet only when necessary, with only the required participants, and always with an agenda. End the meeting by summarizing the decisions and actions. Thank everyone for their involvement. Send them off on a positive note.
When you audit a process, you can look for evidence by observing the process, reviewing its documents, and examining its records. However, an important source of evidence is the information gained through interviews. A quick overview of the interview process is shown below:
Reasons for interviews
Want more? Interested in improving your audit system results from boring to brilliant? Click on link and course descriptions Process Based Internal Auditor Courses
Industry Week recently published the results of their 2007 IW/MPI Census of Manufacturers. Response summaries are shown below for improvement methodologies in use, strategic practices, and focus of market strategies. Please note that multiple responses were allowed.
Improvement Methodologies in Use
Strategic Practices
Focus of Market Strategy
For more information about the survey results, see the Industry Week Article.
Our October-December course schedule is now posted on our website
To see the course description, schedule, and on-line registration click on the course title below. Courses are awarded Continuing Education Units. Understanding & Implementing ISO9001:2000 Understanding & Implementing AS9100B:2004 Understanding and Implementing ISO/TS16949:2002 Understanding and Implementing ISO14001:2004 The Five Pillars of a Lean Workplace Organization All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?
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email: wtighe@sustainingedge.com
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ISO 9001:2000 and Quality Plans
Monday, October 1st, 2007![]()
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Greetings! Welcome to Sustaining Edge Solutions E- Newsletter Our newsletters provide guidance on operational and quality systems ISO 9001, AS9100, ISO/TS 16949, TL 9000, ISO 13485, ISO 14001, and others. This includes process improvement methods Six Sigma, Lean Enterprise, and other topics of interest to our readers. If you have any questions about the articles appearing in this issue, or you want to suggest topics for future issues, please let us know. Thanks for your Support!
The words “plan”, “planned”, and “planning” are used more than 30 times in the requirement clauses of the ISO 9001:2000 standard. A plan is simply a method you develop before doing something so you are more likely to have a successful result.
The term “quality plan” is only used once in the standard, in a Note associated with clause 7.1, Planning of Product Realization. The Note refers to a quality plan as a document specifying the processes of the quality management system, as well as, the resources to be applied for a specific product, project, or contract. According to ISO 10005:2005, quality plans provide a means of relating specific requirements of the process, product, project, or contract to work methods and practices that support product realization. The benefits of establishing a quality plan include:
Development of a Quality Plan Your organization should identify the need for a quality plan. For example, a quality plan may be needed for legal or customer reasons, to organize and manage activities, optimize the use of resources, to monitor or assess compliance, or minimize the risk of not meeting requirements. However, in some cases, an organization with a well established system may be able to meet its needs for quality planning without developing separate quality plans. After deciding to create a quality plan, it is time to identify its inputs. For example, what are the requirements for the plan, the needs of the people that will use it, the resource requirements, and any risk assessments. You must determine what is to be covered by the quality plan and what will be addressed by other documents. The scope of the plan will depend on the extent the plan will be supported by a documented quality management system, as well as, the processes and quality characteristics that are unique to the product, project, or contract being addressed. You will need to name someone as the author of the document and responsible for its preparation. Of course, multiple people may be involved in contributing to its content. Content of a Quality Plan The quality plan should indicate how the required activities will be carried out, either by including that information, or referring to other documents, for example, documented procedure, project plan, work instruction, checklist, or computer application. The quality plan should indicate how the required activities will be carried out, either by including that information, or referring to other documents, for example, documented procedure, project plan, work instruction, checklist, or computer application. A quality plan may include the topics listed below or refer to their coverage in other documents:
The quality plan may be in presented in one of several different structures. For example, it could be a simple text description, a table, a document matrix, a process map, or a work flow. ISO 10005:2005, Guidelines for Quality Plans, includes examples of quality plans in its Annex A.
Industry Week is hosting a free 12-session, 2-day online conference on Wednesday, October 10 and Thursday, October 11. The one-hour sessions start at 11:00 AM EDT and complete by 5:00 PM EDT each day.
The sessions on October 10 are:
The sessions on October 11 are:
Most of the sessions will give away a complimentary $100 gift certificate to five randomly drawn attendees. To register for one or more of the sessions, go to the Operations Excellence Online LIVE web site.
The 2Q07 issue of the TickIT software quality journal includes the final article of a three part series exploring the relationship between ISO 9001:2000 and CMMI in terms of the benefits gained by undertaking combined surveillance audits. The first article explained that a good mapping between ISO 9001 and CMMI would be essential for the combined surveillance audits to work effectively. The first two articles developed this mapping from an ISO 9001 perspective, that is, would an organization with CMMI level 3 satisfy the requirements of ISO 9001. In the final article, the mapping is examined from the perspective of CMMI, i.e., would an organization with ISO 9001 (and TickIT) satisfy the requirement of CMMI level 3. The author concludes that an organization with CMMI level 3 would stand a reasonably good chance of satisfying the requirements of ISO 9001:2000. However, the converse would not be as easy to say. There is a greatly increased reliance on exactly how an organization implements the requirements of ISO 9001 which will bear on its ability to satisfy CMMI under a SCAMPI appraisal. While the two models are very similar, the differences noted in the 2Q07 article may result from their origins and on what is perceived as their goals, or maybe at the way they aim to achieve their goals – that is, driven by customer satisfaction back into processes or driven by processes to give customer satisfaction. However, there is some evidence to suggest that organizations with ISO 9001 experience find it somewhat easier to undertake a CMMI-based improvement program and associated appraisal. This probably has little to do with the mapping, but more to do with the cultural understanding of the need for documents, records, processes and procedures, management commitment, involvement, and reviews. CMMI is very prescriptive and will invariably provide coverage of ISO 9001:2000 requirements; but ISO 9001 being very high-level and generic cannot be assured of covering all the specific requirements of CMMI. You can see the full article (pdf) and color-coded mapping at the TickIT web site.
The Environmental Protection Agency (EPA) web site has an online EMS 101 course that provides an overview of an Environmental Management System. The course also covers how an EMS program can support environmental improvements at facilities that are subject to environmental regulations. The free course takes about one hour to complete.
In addition, the course describes the EPA’s involvement in supporting EMS efforts at facilities regulated under a number of environmental statutes, e.g., the Resource Conservation and Recovery Act (RCRA). The web-based EMS training course has four modules.
Each web page contains directions that help you navigate through the course. Arrows on the bottom of each page control movement from page to page. “Main messages” pop up throughout the module to reinforce its learning objectives. And, a short quiz is included at the end of each module to test your knowledge of the materials.
Our October-December course schedule is now posted on our website To see the course description, schedule, and on-line registration click on the course title below. Courses are awarded Continuing Education Units. Understanding & Implementing ISO9001:2000 Understanding & Implementing AS9100B:2004 Understanding and Implementing ISO/TS16949:2002 Understanding and Implementing ISO14001:2004 The Five Pillars of a Lean Workplace Organization All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?
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Records Management
Saturday, September 1st, 2007
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Greetings! Welcome to Sustaining Edge Solutions E- Newsletter Our newsletters provide guidance on operational and quality systems ISO 9001, AS9100, ISO/TS 16949, TL 9000, ISO 13485, ISO 14001, and others. This includes process improvement methods Six Sigma, Lean Enterprise, and other topics of interest to our readers. If you have any questions about the articles appearing in this issue, or you want to suggest topics for future issues, please let us know. Thanks for your Support!
The ISO 9001:2000 quality standard addresses the control of records, but only includes three sentences of requirements:
If you want to know more about records management than included in ISO 9001:2000, you should look at ISO 15489-1:2001, Information and Documentation – Records Management. Records A records management system results in a source of information about business activities that support subsequent activities and business decisions, as well as, ensure accountability to present and future stakeholders. Records Management Policy Authenticity Reliability The system that manages the records should be capable of continuous and regular operation in accordance with applicable procedures and provide ready access to all relevant records. Integrity The record system should include controls for access monitoring, user verification, authorized destruction, and security to prevent unauthorized access, destruction, alteration, or removal of records. Usability You can order ISO 15489-1:2001 at the ANSI eStandards Store.
The second edition of ISO 14971:2007, Application of Risk Management to Medical Devices, has been released. The revised version aligns better with ISO 13485:2003 requirements and provides an improved model for implementing a risk management system. ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971:2007 are applicable to all stages of the life- cycle of a medical device. ISO/TR 14969:2004 provides guidance for applying the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485. It does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. However, its guidance can be used to better understand the ISO 13485 requirements and to illustrate some of the methods and approaches available for meeting those requirements. Purchase the Standard for $160 at the ANSI Site
Have you heard about FMEA, but remain unsure of its use as a quality tool? Well, FMEA is the acronym for Failure Modes and Effects Analysis. failure Modes are the ways in which something might fail. The failures are actual or potential errors or defects, especially those affecting the customer. Effects Analysis refers to studying the consequences or effects of those failures. Failures are prioritized according to the seriousness of their consequences, the frequency of their occurrence, and likelihood of their detection. The purpose of FMEA is to take actions to eliminate or reduce failures, starting with the higher priority ones. FMEA is used during design to prevent failures. Later, it is used for control before and during operation of the process. Ideally, FMEA begins during the earliest conceptual stages of design and continues throughout the life of the product or service. It is a step- by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. To see an FMEA example, go to this ASQ web page
The CE Mark is mandatory for a wide range of products sold in the European Union. The CE Mark has been described as a “passport” that allows manufacturers to trade industrial products freely within the internal EU market. The CE Mark indicates the manufacturer has undertaken all assessment procedures required for the product. The CE Mark is not a quality mark and does not indicate conformity to a standard; it indicates conformity to the legal requirements of the EU directives. General Steps for Getting the CE Mark
Obtaining authority to attach the CE Mark is often thought to be difficult and time-consuming. However, in many cases it is not. view the CE Mark PDF brochure at the NIST web site.
Our October-December course schedule is now posted on our website To see the course description, schedule, and on-line registration click on the course title below. Courses are awarded Continuing Education Units. Understanding & Implementing ISO9001:2000 Understanding & Implementing AS9100B:2004 Understanding and Implementing ISO/TS16949:2002 Understanding and Implementing ISO14001:2004 The Five Pillars of a Lean Workplace Organization All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?
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Friday, August 3rd, 2007

Internal Auditing: A Tool for Effective Process Mapping
Internal audits are often scheduled, and therefore conducted according to the ISO 9001:2000 clause structure. Most organizational audit systems start with a formalized checklist where auditors ask questions to ensure employees know their jobs, check for available procedures, and determine if documents and records are being utilized. These audits are mostly focused on judging conformity than evaluating effectiveness. Looking clause by clause, the quality management system may appear conforming, yet be fragmented and ineffective.
Auditors must adopt the process approach and assess the quality management and operational system through its natural workflow. Of course, this requires understanding the business, its processes and the integration of linkages that drives effective auditing and process mapping. Audit planning and interviews should identify for each process:
• Inputs: What, when, and from whom?
• Resources: With what people, materials, equipment?
• Methods: How done (procedures and instructions)?
• Controls: How monitored and controlled?
• Measures: What are performance indicators?
• Outputs: What is delivered, when, and to whom?
Auditors should view the quality management system as a set of integrated processes (by understanding the interfaces and interactions). Adopt the process approach for your audits. Add value by looking at more than just conformity. Evaluate the linked processes for their “effectiveness”. Verify their controls and identify any process risks. Also, determine opportunities for improvement. Auditors can promote the process approach through their own audit methods.
Share with us and our readers what method you and your company use to identify and document the Six “Process Based” outcomes identified above.
We will post all examples and discuss best practices next month!
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U.S. Workplace in Need of Team Builders
Wednesday, August 1st, 2007
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Greetings! Welcome to Sustaining Edge Solutions E- Newsletter Our newsletters provide guidance on operational and quality systems ISO 9001, AS9100, ISO/TS 16949, TL 9000, ISO 13485, ISO 14001, and others. This includes process improvement methods Six Sigma, Lean Enterprise, and other topics of interest to our readers. If you have any questions about the articles appearing in this issue, or you want to suggest topics for future issues, please let us know. Thanks for your Support!
According to a survey conducted this year by the International Association of Administrative Professionals and Office Team, 67 percent of the professionals surveyed said they would hire an applicant with strong soft skills whose technical abilities were lacking.
Only 9 percent would hire someone who had strong technical expertise but weak interpersonal skills, and 93 percent said technical skills are easier to teach than soft skills. Soft skills are commonly considered the ability to organize, collaborate, communicate tactfully and to analyze and solve problems. Anila DeHart, human resources manager of employee and career advising for the University of Arizona, said that “soft skills” is a term she has yet to embrace. “We don’t call them soft skills” she said. “They’re critical.” While many soft skills are intuitive, ways exist to improve or acquire those skills. “Everything is learnable,” DeHart said. “Success depends on how willing (the employee) is to learn these skills. Ownership is equal: Both employee and the employer have to be invested.” Here is a list of soft skills cited as being most in demand at their companies (multiple responses were allowed).
The International Aerospace Quality Group (IAQG) is revising the IAQG 9100 family of standards. Since the IAQG 9100 standard is published as AS9100 in the USA, we will refer to it as AS9100 in the remainder of this article.
AS9100 uses ISO 9001:2000 as its foundation, with additional aerospace requirements highlighted in bold, italic type. The ISO 9001 standard is being amended with publication expected in May 2009. This revision is driving an update of AS9100. According to Buddy Cressionnie in a recent Quality Progress article, the objectives for the AS9100 revision include improving supplier performance and customer satisfaction by:
The first draft of the AS9100 revision is planned for later this year, with publication expected in mid-2009, depending on the release date of the ISO 9001 amendment. The AS9110 (Maintenance Organizations) and AS9120 (Stocklist Distributors) standards are undergoing a similar revision process. Since they use AS9100 as the baseline, they will trail the AS9100 revision by about six months and are expected to be released by the end of 2009. AS9101 is a checklist that must be completed during other-party audits. It is being revised as a more process-oriented tool and to apply to AS9100, AS9110, and AS9120. The first draft of the revised AS9101 checklist is expected later this year. It will be introduced into the audit process as organizations make the transition to the 2009 versions of AS9100, AS9110, and AS9120. AS9115 is a new international software quality standard and will be confined to “deliverable” software. It will be framed around the existing Americas standard, AS9006, and will bring in elements of European Technical Report TR9109, ISO 12207, and other standards. It is targeted for release in December 2008. AS9100 Training Understanding and Implementing AS9100
OHSAS 18001:2007 specifies the requirements for an organization to control its Occupational Health and Safety risks and improve its performance. OHSAS 18001:2007 has been issued as a British Standard and supersedes OHSAS 18001:1999, which will remain current until 2009.
There have been a number of significant changes made to the standard to reflect its widespread use in more than 80 countries and by approximately 16,000 certified organizations. The principal changes include a much greater emphasis on “health” rather than just “safety” and significantly improved alignment to ISO 14001:2004 for use of integrated management systems. The key changes between OHSAS 18001:2007 and OHSAS 18001:1999 include:
Transition Period For organizations just starting the path towards certification to OHSAS 18001 and looking for guidance, they can still use the sister standard OHSAS 18002:2000, which provides guidelines for the implementation of OHSAS 18001. While OHSAS 18002 is aligned on a clause by clause basis against OHSAS 18001:1999, it does contain valuable advice on what must be done to achieve compliance. A revised edition of OHSAS 18002 is planned for publication at the end of the 3rd quarter of 2008.
According to AIAG News, automotive manufacturers and suppliers lose millions of dollars and weeks of product development time from the lack of interoperability from proprietary quality data collection solutions. The Quality Measurement Data (QMD) Specification enables the seamless exchange of quality measurement information between disparate and proprietary gages and reporting tools, solving this data integration problem by reducing as many as 1,500 data formats to one single open reporting format.
Currently, companies are forced to integrate data to or from numerous disparate data sources. These proprietary, integrated quality data collection solutions cost manufacturers and suppliers enormous amounts of money because of the lack of interoperability among gages and reporting tools. Now, with the QMD Specification, gages will be able to exchange data used in Statistical Process Control (SPC) and Measurement Systems Analysis (MSA) studies to different reporting tools. Developed in fully extensible XML XSD with an accompanying data dictionary, this document constitutes a common language for quality measurement. It describes a non- proprietary and open standard for variable, attribute, and binary quality measurement data. The QMD Specification helps companies recover some of the costs, wasted time, and resources from data integration by enabling gages to communicate with more reporting tools and reporting tools to accept data from more sources. The publication is available in CD and electronic document formats for a list price of $78. AIAG members can purchase the QMD Specification at a discounted rate of $39. To purchase, visit the AIAG Website or call AIAG at 248-358- 3003. The QMD Specification has been tested and validated by many companies. For more information on the specification, visit the QMD Website
To see the course description, schedule, and on-line registration click on the course title below. Courses are awarded Continuing Education Units. Understanding & Implementing ISO9001:2000 Understanding & Implementing AS9100B:2004 Understanding and Implementing ISO/TS16949:2002 Understanding and Implementing ISO14001:2004 The Five Pillars of a Lean Workplace Organization All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?
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email: wtighe@sustainingedge.com
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How to Audit an Internal Audit Program
Sunday, July 1st, 2007
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Greetings! Welcome to Sustaining Edge Solutions E- Newsletter Our newsletters provide guidance on operational and quality systems ISO 9001, AS9100, ISO/TS 16949, TL 9000, ISO 13485, ISO 14001, and others. This includes process improvement methods Six Sigma, Lean Enterprise, and other topics of interest to our readers. If you have any questions about the articles appearing in this issue, or you want to suggest topics for future issues, please let us know. Thanks for your Support!
How do you audit an internal audit program? Lets begin by reviewing the definition of an audit from ISO 9000:2005, Fundamentals and Vocabulary, clause 3.9.1. An audit is:
“a systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.” In other words, an audit is a planned, organized, and documented set of activities performed by impartial and objective auditors. The audit process collects evidence from an area to evaluate conformity to the applicable requirements. Audit evidence is factual, not based on opinion or hearsay. The sources of audit evidence are:
The primary audit criteria are:
According to ISO 9001:2000, clause 8.2.2, internal audits must be conducted at planned intervals to determine if the quality management system conforms to planned arrangements, requirements of the standard, and requirements of the organization. In addition, internal audits must verify that the quality management system has been “effectively” implemented and maintained. The responsibilities and requirements for planning audits, conducting audits, reporting results, and maintaining records must be defined in a documented procedure. An audit program includes all the activities needed to plan, organize, and conduct the scheduled audits. The audit program must be planned to consider the status and importance of the areas to be audited, as well as, the results of prior audits. The audit criteria, scope, frequency, and methods must be defined. Auditors must be selected to carry out impartial and objective audits. This doesn’t mean that you must show organizational independence, just that auditors can’t audit their own work. Management must ensure that corrective actions are taken without undue delay to eliminate the detected nonconformities and their causes. Follow-up activities must verify that the actions were implemented and report the results. ISO 9004:2000, Guidelines for Performance Improvements, clause 8.2.1.3, suggests that an organization:
When reporting the audit results, ISO 9004:2000 suggests you share evidence of excellent performance, provide opportunities for recognition, and motivate people. Remember, these are guidelines, not requirements. A nonconformity report can only be written against a requirement of the standard. However, the absence of a suggested audit practice may identify an opportunity for improvement to include in your audit report.
The Institute of Internal Auditors has published “Sarbanes-Oxley Section 404: A Guide for Management by Internal Control Practitioners”. The Guide incorporates guidance from the U.S. Securities and Exchange Commission, the Public Company Accounting Oversight Board, The Institute of Internal Auditors, and the real-world experience and insight of practicing internal auditors. The Guide focuses on how costs can be minimized without impairing the effectiveness of your internal controls. It also discusses the interplay between the requirements of Section 404 and those of Section 302, which requires annual and quarterly certifications by the chief executive officer and chief financial officer that include assessments of the internal controls. Internal control is broadly defined as a process designed to provide reasonable assurance regarding the achievement of objectives. The Guide notes that an internal control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance to management and the board regarding achievement of an entity’s objectives. Management has a great deal of latitude in describing the condition of its internal controls. The only formal requirement is that they don’t assess the controls as effective when there is a material weakness. The assessment should clearly describe management’s opinion. What is the true condition of the system of internal control at the end of the year? Is it sufficiently robust to provide reasonable assurance that material errors will either be prevented or detected? The investor should be able to read the assessment and understand whether the company has adequate controls to run the business and report the results.
To understand the term “process owner”, lets begin with the definition of a process. A Process is a set of interrelated or interacting activities which transforms inputs into outputs. The inputs of a process are the outputs from other processes. And, processes are planned and carried out under controlled conditions to add value.
A Process Owner is a person who is given the responsibility and authority for managing a particular process. Most organizations find it useful to appoint individual process owners and define their responsibilities as ensuring the implementation, maintenance, and improvement of their specific process and its interactions with other processes. Process owners take an organization-wide view of their processes. They may not truly “own” the process in that some of the people who are involved in carrying out the process may not report to them. Instead, the owner is responsible for the design of the process, in other words, how it is carried out, how it interacts with other processes, and how it is measured. And, this responsibility is an ongoing task. Process owners have responsibility for their specific process, end-to-end. However, as stated earlier, this does not mean that all the staff involved in a process actually report to the process owner. Process owners usually have responsibility for most steps in the process and are able to influence other key areas outside their direct organizational control. Process owners should ensure the following activities are completed:
Process owners can use the Plan-Do-Check-Act methodology to improve their processes: 1) planning what to do and how to do it, 2) doing what was planned, 3) checking the results to see if things happened according to plan, and 4) acting to improve the process the next cycle. In summary, a Process Owner is the person immediately accountable for creating, sustaining, and improving a particular process, as well as, being responsible for the outcomes of the process.
Our July-September course schedule is now posted on our website. To see the course description, schedule, and on-line registration click on the course title below. Courses are awarded Continuing Education Units.
All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?
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email: wtighe@sustainingedge.com
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Auditing Customer Feedback Processes
Friday, June 1st, 2007![]()
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Greetings! Welcome to Sustaining Edge Solutions E- Newsletter Our newsletters provide guidance on operational and quality systems ISO 9001, AS9100, ISO/TS 16949, TL 9000, ISO 13485, ISO 14001, and others. This includes process improvement methods Six Sigma, lean enterprise, and other topics of interest to our readers. If you have any questions about the articles appearing in this issue, or you want to suggest topics for future issues, please let us know. Thanks for your Support!
The customer feedback process is a critical part of the quality management system, and should therefore receive adequate attention during a third party audit. Feedback from the customer is one of the primary performance indicators that can be used to judge the overall effectiveness of the QMS. It is important, therefore, for the auditor to verify that
What should be addressed when auditing customer feedback processes? Customer feedback is a process. It needs to be audited as a process, not as a “clause of the standard”. An evaluation also needs to be performed on the way in which the process is managed (see ISO 9001:2000 clause 4.1.c), and its ability to provide meaningful information with which to judge the overall effectiveness of the QMS. The way in which the organization obtains this feedback (“the method”) is up to the organization to define. The auditor needs to be aware of the specific characteristics of the organization’s products that are likely to impact customer satisfaction. Throughout the audit the auditor should be alert for indications that may suggest customer satisfaction or dissatisfaction which could serve as input into the audit of the customer feedback process. Good sources of such information may include, for example:
These are some issues an auditor should address during an audit of the customer feedback process: What is the desired output of this process? What information is actually available on customer perceptions? How is this information used by management to drive improvements to the product, processes and the QMS? · Are all customer categories covered by this information? It is important to remember that the organization may have more than one category of customer. For example, a manufacturer may sell to wholesalers, who then sell to retailers, who in turn sell to the general public. In this case the organization may need to address all three types of customer and they may all have different perceptions. The organization could be satisfying one group and upsetting another. How is the data collected to feed the process? · There are many ways for an organization to monitor its customers’ perceptions, and the auditor should avoid preconceived ideas about how this should be done. Some examples of techniques the organization can use include:
Often complaints are the only “spontaneous feedback” received from customers, and these should be analyzed for any trends, key concerns, impacts etc. It must be stressed, however, that customer complaints can not be the only input for monitoring customer perceptions. How is the data analyzed? Simply collecting data on customer perceptions is not sufficient – the auditor must follow the process through, to check how the data is analyzed (see ISO 9001:2000 clause 8.4), and what conclusions are made with respect to the effectiveness of the QMS. Are there any trends? Is the situation stable, improving, or deteriorating? Are customer needs and expectations changing? How does the information generated by this process feedback into the QMS as a whole? The auditor should be able to recognize that the output from the customer feedback process forms an important input into other QMS process, such as data analysis, management review and continual improvement processes. An auditor who strives to add value will try to ensure that the organization recognizes the benefits a sound customer feedback process can bring, and will encourage (but can not require) the organization to think beyond simply “meeting the requirements of the standard”
Have your customers quit responding to your lengthy satisfaction surveys? Are your response rates too low for adequate analysis and action?
Fortunately, there is a simpler way of surveying your customers. A measurement tool, called Net Promoter Score (NPS), uses only one question: On a scale of 1 to 10, how likely is it that you would recommend our company to a friend or colleague? A study by Satmetrix Systems, in partnership with Fred Reichheld of Bain & Company, determined this single loyalty question can judge individual customer purchase and referral patterns across seemingly disparate industries. If customers reported they were likely to recommend a particular company to a friend or colleague, then these same customers were also likely to actually repurchase from the company, as well as, generate new business by referring the company by word-of mouth. If customers reported they were not likely to recommend a company, they were also less likely to engage in actual repurchase or referral behaviors. Ultimate Question Promoters Passives Detractors Net Promoter Score Of course, there is more to profitably growing your company than just calculating a score. A successful Net Promoter program includes 5 elements:
Business objectives and customer strategy.
Too often, a company swings from emphasizing financial metrics over customer metrics, to the other extreme of customer focus over profitability. A business approach based on the voice of the customer must not be excessive in responding to customer needs outside of the context of strategy and of analytical discipline. A growth company using must balance both financial and customer measures of success. The balanced scorecard is a great tool for doing exactly that. The balanced scorecard describes specific measures and performance commitments that track progress not only to concrete, current-year business plans, but also to the strategic three-to-five-year goals of the company. The balanced scorecard suggests that an organization be viewed from four perspectives – financial, customer, internal and growth - and that the organization develop metrics, collect data and analyze that data relative to each of these perspectives. Following is the outline of a model for developing a balanced scorecard and the next level of detail for each of the four perspectives. The model was developed for a financial institution and should act as a practical example for building a balanced scorecard.
Next, use balanced scorecard development principles by linking measurements to the company’s strategy for meeting key business goals. Consider the following three questions in regard to each of the four perspectives:
Financial Perspective:
Customer Perspective:
Growth Perspective:
Metrics must be developed based on the priorities of the strategic plan, which provide information that managers care about most and can actually take action on. The goal of the balanced scorecard is to empower managers to see their company more clearly – from many perspectives – and thus make more effective long-term decisions.
All courses are delivered at your company or at our training centers. Students are awarded Continuing Education Units.
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Effective Procedure Writing
Tuesday, May 22nd, 2007
When writing a procedure, keep in mind these questions:
• What is the objective of process? Know its purpose before starting.
• Which activities are part of scope? Agree on coverage of activities.
• Who is responsible for these activities? Identify key process players.
• What are inputs and who are suppliers? Identify inputs and providers.
• What are outputs and who are customers? Identify outputs and recipients.
• What is referenced as an information source? Identify related documents.
• What is the logical series of steps? Organize the steps in a logical sequence.
• How are the activities performed? Interview users and observe operations.
• Which departments use the process? Know readers and users of the process.
• What reports or records are generated? Identify records for the process.
• What forms are used? Don’t overlook forms used to collect information.
• When and where is the work performed? Identify timing and location
of work.
• What products are covered by the process? Define its applicability.
• What process documentation already exists? See if documents can be adapted.
• What are the requirements of the process? Know user and organization needs.
• What are the quality criteria? Identify the acceptance criteria.
• What are the related procedures? Ensure compatibility with other processes.
• Which tasks have or need instructions? Add or refer to needed instructions.
• How might the process be audited? Be able to demonstrate conformity.
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