Design of Documentation

Sustaining Edge Solutions, Inc. Newsletter )
Performance Improvement Solutions for Your Business Needs March 2011
In this issue

  • Design of Documentation
  • Creating Customer Value
  • Manufacturing Technology Consumption Up 85% in 2010
  • In The News
  • Training Courses
  • Greetings!

    Welcome to Sustaining Edge Solutions Performance Improvement Newsletter.

    Our newsletters provide information on Business Management Systems ISO 9001, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental, and others. This includes process auditing techniques and process improvement methods Six Sigma, Lean Enterprise, and other topics of interest to our readers.

    Have a topic of interest for a 2011 future newsletter? Please let us know.

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    Design of Documentation

    A critical question that many organizations face when starting a documented operational management system or improving a current one is “How much documentation is required?”

    If you’re a quality improvement veteran, you remember the ISO 9001, 1987 and 1994 versions required a number of ‘documented procedures’ as part of the standard’s 20 requirements. Such an approach did lead to an organization putting effort into creating documentation which doesn’t add much value. This was reduced with the ISO 9001:2000 revision, specifying just 6 documented procedures, although implementers are given the latitude to define more as they see fit.

    We find today in many cases that lessons learned from past year’s experiences is driving a “less is more” when it comes to management systems documentation. If we cannot rely on the ISO standard telling us where and how much documentation to write, what can we base our decision on?

    Do we base it on:

  • our friends documentation given to us to copy from another organization?
  • a canned template software program “ISO kits” found on the Internet?
  • a 2 page Quality Manual (or is that 4 pages) external firms are presenting to you?
  • The answer is in the risk associated with needing to control your business processes. What is the risk of a certain system or process not being controlled? Many factors come into play: personnel experience, competencies, turnover, task complexity, customer and regulatory requirements are just some to be considered.

    The Standard also asks that the organization document to ensure the planning, operation and control of the Management System processes is effective. An embedded guidance note further states that the extent of documentation is going to depend on:

    • the size of organization and type of activities
    • the complexity of processes and their interactions, and
    • the competence of personnel.

    No two management systems are quite the same. Documentation will look different; exclusions are taken for requirements that don’t apply. The number and diversity of procedures, work instructions, and forms, will always vary. The standard’s structure should be a guide for the kinds of documents the organization should consider including within their system. We have seen too many cases where the requirements themselves are only used for guidance (example: verbatim standard language for policies) rather than a sequenced and integrated documentation focus for improving our company competitiveness and profitability.

    Use a risk management process applicable to your internal and external requirements, products and processes when developing documentation and the amount required. Remember, a healthy appreciation of the value of process control documentation is the difference between a certification hanging on the wall, or a sustained organization that always satisfies its customer needs.

    Interested in extended risk management information and/or developing a custom approach to your documented operational and quality management system?
    Contact us

    Creating Customer Value
    Cust Sat

    It appears from our vantage point and the experts that the manufacturing segment is coming back. Many of us are thinking of what is the best way to shape our company’s economic recovery into the most profitable form possible. The answer is to deliver more than your share of customer value. Keep in mind your competition won’t be standing idle while you innovate and grow during the improving economy. To stay ahead of your competition, you should keep a laser focus on what sets your company apart within your industry.

    You could have a number of marketable differences from your competition. Spending more on R&D? Acquiring capital equipment beyond your current capacities? Is what you’re doing focused on internal needs, or are you implementing your customers ideas?

    1. Conduct face-to-face interviews. Of all the ways to learn about customer needs-telephone, e-mail survey, Internet, nothing comes close in effectiveness to face-to-face customer interviews. Many of us use customer surveys to determine satisfaction levels. We use a Likert Scale method (1-5) based on questions we have determined are important. The reality, though, is that most questions asked are actually customer-reactive, not market-customer proactive interviews. Get out and visit your customers and find out what’s important to them.

    2. Develop a Voice of the Customer mentality. Voice of the Customer studies typically consist of both qualitative and quantitative steps. They are generally conducted at the start or finish of a new product, process, or service design in order to better understand the customer’s wants and needs. That e-mail survey with the 3-5% average return, is it handing you a report of “what the customer wants?” This is a flawed model. Train your people to be VOC experts.

    Best of all, you’ll develop a reputation among customers as “that supplier who really does listen to us.”

    3. Become a quantitative organization. After you conduct good qualitative customer interviews, you can target specific customer ideas you could work on. Which ideas do you target in your product design? Which ideas do you target in your product realization processes? At this point get quantitative. Being quantitative helps you to understand which customer outcomes are most important and least satisfied.

    The key to taking advantage of the recovering economy is in changing the way your company approaches your current and future customers. Start now, with a new approach and you’ll shape a true recovery at your company.

    Manufacturing Technology Consumption Up 85% in 2010

    December U.S. manufacturing technology consumption totaled $446.76 million, according to The Association For Manufacturing Technology (AMT) and the American Machine Tool Distributors’ Association (AMTDA). This total, as reported by companies participating in the U. S. Manufacturing Technology Consumption (USMTC) program, was up 40.9 percent from November and up 104.8 percent when compared with the total of $218.16 million reported for December 2009. With a year-to-date total of more than $3.2 billion, 2010 is up 85.3 percent compared with 2009.

    “For the first time in USMTC history, we experienced four months of consecutive growth following IMTS [the International Manufacturing Technology Show], ending the year on a solid upswing,” says Douglas K. Woods, president of AMT. “2010 orders closed strong, up 85 percent over 2009, and December’s orders were 40.9-percent higher than the previous month. With backlogs firming and quotation levels accelerating, we are very optimistic that the industry will see strong results in 2011.”

    The USMTC report, jointly compiled by the two trade associations representing the production and distribution of manufacturing technology, provides regional and national U.S. consumption data of domestic and imported machine tools and related equipment. Analysis of manufacturing technology consumption provides a reliable leading economic indicator as manufacturing industries invest in capital metalworking equipment to increase capacity and improve productivity.

    U.S. manufacturing technology consumption is also reported on a regional basis for five geographic breakdowns of the United States.

    To view the five geographic areas visit the AMT website.

    In The News

    New ISO/IEC 17021 Raises Level of Management System Certification. The International Organization for Standardization’s (ISO) just-published second edition of ISO/IEC 17021 sets new requirements for auditing management systems and for auditor competence in order to increase the value of management system certification to public and private-sector organizations worldwide. The certification bodies that carry out management system certification (independently of ISO), are being given a two-year period to bring their operations in line with the new edition.

    Certification bodies that use the new edition will be able to ensure competent audit teams, with adequate resources, following a consistent process and reporting audit results in a consistent manner. ISO/IEC 17021:2011 was developed by the ISO Committee on Conformity Assessment and is available from ISO national member institutes.

    Manufacturing for Growth. Four leading associations of small- and medium-sized manufacturing companies announced that they are combining resources to host the inaugural Manufacturing for Growth (MFG) meeting, a gathering of hundreds of manufacturing leaders, March 3-6, 2011, in Chandler, AZ. For more event information read press release.

    U.S. to Celebrate World Standards Day 2011. This year, the U.S. Celebration of World Standards Day-Advancing Safety and Sustainability Standards Worldwide-will recognize the crucial role of standards, codes, and conformity assessment in ensuring the health and safety of people and the environment, today and for future generations. Standardization speeds innovation, facilitates harmonized trade, and boosts consumer and government confidence in products, services, systems, and processes. But above all, standardization provides an adaptive framework for developing the most effective solutions to critical global challenges.

    Since the initial celebration in 1970, World Standards Day is now recognized in nations around the globe. U.S. activities are organized annually by a planning committee consisting of representatives from across the standards and conformity assessment community.

    For more information or to register, please visit ANSI website.

    Training Courses

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

    View all our Courses

    View Our Web Based E-Training Courses

    Understanding and Implementing ISO9001:2008
    ISO 9001:2008 Process Based Internal Auditor
    Documenting Your Management System

    Understanding and Implementing AS9100C (9110 &9120) Aviation, Space and Defense
    AS9100C:2009 Process Based Internal Auditor
    Documenting Your Management System

    Understanding and Implementing ISO/TS16949:2009 Automotive
    ISO/TS16949:2009 Process Based Internal Auditor
    Documenting Your Management System

    Understanding and Implementing ISO14001:2004 Environmental
    ISO14001:2004 Process Based Internal Auditor

    5S 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?

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