ISO 9000-3 Digest Thursday, 14 March 1996 Volume 01 : Number 012 In this issue: Need help defining input/output requirements [none] FYI: Results of ASQC CQA Cyber-survey (fwd) Changing from Waterfall to Spiral Process What does "ticket" stand for Non-member submission from ["Wikramanayake, Nihal"] (fwd) RE: Non-member submission from ["Wikramanayake, Nihal" ] (fwd) Opportunities in SW Quality at Bell Atlantic in Silver Spring MD Cyber-Q's Dinner during Annual Quality Congress, Chicago, 5/14 Question: Control of Development Tools Announcement: Measurement Quality conference ---------------------------------------------------------------------- From: "Melanie Hopwood" Date: Tue, 5 Mar 1996 11:22:43 CST6CDT Subject: Need help defining input/output requirements Hello I work for a medical device software organization. We are certified to ISO-9000 and TickIT. We are in the process of changing our software development process from a traditional Waterfall model to a more Spiral Process. With the traditional Waterfall model it was easy to define our input/output requirements for each software development phase. Our development phases were for example: Research/Feasibility, Requirements, Design, Implementation/Integration and Alpha. Now we are going to be combining the Requirements, Design, and Implementation/Integration Phases. I am looking for some suggestions on setting up requirements for our development process and how to define steps when to perform development audits. Any help with this would be greatly appreciated. Have a great day!! You can e-mail me at hopwoodm@cms-stl.com. Melanie Hopwood Software Quality Assurance Engineer Computerized Medical Systems 1195 Corporate Lake Dr. St. Louis, MO 63132 phone: (314)993-0003 fax: (314)993-0075 ------------------------------ From: raychel@bns101.bng.ge.com (Rick Raychel ph2109) Date: Fri, 8 Mar 96 08:32:37 EST Subject: [none] subscribe iso9000-3-digest raychel@bng.ge.com ___________________________________________________________________________ Rick Raychel E-Mail: raychel@bng.ge.com Lockheed Martin Control Systems Phone Number: 607-770-2109 600 Main Street FAX: 607-770-2954 / 8*255-2954 Johnson City, NY 13790-1888 ___________________________________________________________________________ ------------------------------ From: "Bill Casti, CQA (Moderator)" Date: Sat, 9 Mar 1996 00:57:23 -0500 (EST) Subject: FYI: Results of ASQC CQA Cyber-survey (fwd) NOTE: Mr. Arter's survey was distributed to all of the QUALITY.ORG email discussion lists last month. These are the results of his informal cyber-survey. We both thank those of you who responded for your participation. If you are subscribed to more than one list, you will receive duplicates of this message, one for each list you're on. My apology for the unavoidable duplication. Regards. Bill - ---------- Forwarded message ---------- In February of 1996, I asked participants in the several internet discussion lists whether the ASQC's Certified Quality Auditor should be changed. I estimate that about 5,000 people read the message. In order to provide data for discussion of the issue in Kansas City, I asked the participants to vote for one of three choices: A. The CQA should not be changed B. The CQA should include knowledge of ISO 9001/2/3 C. The CQA should become equivalent to the ISO 9000 Lead Assessor Course final exam I must have touched something dear to many of you, as the responses came within two hours of posting on a Friday afternoon! Many were well thought-out and presented good information. Date A B C Unknown 2/2 14 5 1 6 2/3 1 4 3 1 2/4 3 3 - 1 2/5 9 4 5 5 2/6 4 2 1 1 2/7 4 2 1 1 2/8 4 4 1 - 2/9 3 3 1 - 2/10 2 2 - 1 2/12 2 5 1 - 2/13 1 - - - 2/14 3 2 1 - 2/15 3 - - - Total 54 36 15 16 Cyber Summary: The A respondents generally felt the CQA exam should cover the principles of good auditing which would be applicable to any Standard. B's respondents were concerned with doing business internationally, affirming that ISO Standards hold a lot of sway in that arena. The C respondents seemed to feel the CQA exam could use more tooth, which they do feel is present in the ISO 9000 Lead Assessor exam. The Unknown column represents responses that were more complicated than the clear choices offered in the other three columns. ASQC Quality Audit Division Recommendation (Kansas City, February 24) Similar to the internet discussions, the members of the Quality Audit Division expressed passion in their CQA and its exam. After a round of discussion, five voted to "include more specific information from quality management system standards, including ISO 9001/2/3, but only in a situational context." Thirty voted to "keep the CQA exam independent of specific knowledge of any particular quality standard." We have passed this information on to the ASQC's Certification Committee. Thank you all for your participation! - -------------------------------------------------------- Dennis R. Arter, "The Audit Guy" ->NEW ADDRESS<- Columbia Audit, 6951 W. Grandridge Blvd, Kennewick, WA 99336 509/783-0377, fax/783-1115, internet: darter@mcimail.com - ------------- End of Forwarded Message --------------------- ============================================================================== Bill Casti, CQA Email: help@quality.org - Domain Owner, QUALITY.ORG Pager: +1 800 604 6149 - List Moderator, "TQM in Manufacturing and Service Industries" - Chairman, Electronic Media ASQC Section 0511 (Northern VA) Section Email: E-media@quality.org - Senior Internet Systems Administrator, Federal Emergency Management Agency - ------------------------------------------------------------------------------ We support open standards and First Amendment rights. We oppose the censorship provisions of the 1996 Communications Decency Act. See http://www.aclu.org for details about how you can help defend free speech. - ------------------------------------------------------------------------------ QUALITY RESOURCES ONLINE at: http://www.quality.org/qc ============================================================================== ------------------------------ From: calafut@epix.net (George J. Calafut) Date: Sun, 10 Mar 96 13:44:50 PST Subject: Changing from Waterfall to Spiral Process Melanie, RE: Changing from a waterfall to a spiral development process, looking for help on setting up requirements, defining steps, and performing audits(posted March 5, 1996) My impression is that your spiral process is home grown rather than an existing process('off the shelf"). The easiest way to define requirements & steps is to map your process to an existing spiral process model. This mapping should ensure that your process is complete & addresses all TickIT requirements, e.g. planning, validation, verification, etc. I'll fax you an example of a spiral model that should be useful. This model was taken from a TickIT Auditor's training course I attended.. For many years, I worked at an ISO/TickIT certified programming laboratory at IBM. Initially, we used the waterfall model exclusively but later began experimenting spiral/rapid prototyping methods. Before rolling out the new process to the whole organization, we piloted it on specific projects. The pilots helped expose glitches, allowed time for refinements, and provided an opportunity to train development staff(important for TickIT). You might try piloting your process before using it consistently. Regarding development audits, your audit schedule will depend on your specific situation, e.g. do you have specific problem areas that need attention, or do you want to cover all phases of the development process evenly. If I can be of further assistance, my email address is calafut@epix.net. Regards, George Calafut, CQA. ------------------------------ From: "Wikramanayake, Nihal" Date: Mon, 11 Mar 96 17:46:51 MST Subject: What does "ticket" stand for What does 'Ticket' stand for in relation to iso9000-3 (Software) certification issued in Europe? Thanks ------------------------------ From: "Bill Casti, CQA (Moderator)" Date: Mon, 11 Mar 1996 21:04:03 -0500 (EST) Subject: Non-member submission from ["Wikramanayake, Nihal" ] (fwd) NOTE: Respond ONLY to the poster (below) and/or to the list, not to me. Bill - ---------- Forwarded message ---------- Date: Mon, 11 Mar 1996 19:48:12 -0500 From: "Wikramanayake, Nihal" To: iso9000-3@quality.org Subject: What does "ticket" stand for What does 'Ticket' stand for in relation to iso9000-3 (Software) certification issued in Europe? Thanks ------------------------------ From: calafut@epix.net (George J. Calafut) Date: Tue, 12 Mar 96 12:03:54 PST Subject: RE: Non-member submission from ["Wikramanayake, Nihal" ] (fwd) Nihal, Heres a definition of TickIT from ISO Easy(online). Q: What is TickIT? A: The TickIT program was created by the government of the United Kingdom to provide a method for registering software development systems based on the ISO 9000-3 standard. (Note, that's dash 3, not 9003.) The scheme was jointly developed by the United Kingdom Department of Trade and Industry (DTI) and the British Computer Society. TickIT is fully explained in the Guide to Software Quality Management System Construction and Certification Using EN 29001. The Guide is available from DISC TickIT Office / 2 Park Street / London W1A 2BS / England. Phone 44-71-602-836, Fax 44-71-602-8912. The ISO 9000-3 Standard is named "Quality management and quality assurance standards - Part 3: Guidelines for the application of ISO 9001 to the development, supply and maintenance of software." It was originally written as a "guidance standard." The TickIT program turns it into a compliance standard. TickIT auditors must several years experience as software developers, giving them the specialized knowledge and experience required to audit under the scheme. They then must take the TickIT lead auditor course and pass required exams. In summary, TickIT is a UK certification scheme for software that sets professional requirements for software auditors & provides special guidance for software audits. Regards, George J. Calafut, CQA - ---------------Original Message--------------- NOTE: Respond ONLY to the poster (below) and/or to the list, not to me. Bill - ---------- Forwarded message ---------- Date: Mon, 11 Mar 1996 19:48:12 -0500 From: "Wikramanayake, Nihal" To: iso9000-3@quality.org Subject: What does "ticket" stand for What does 'Ticket' stand for in relation to iso9000-3 (Software) certification issued in Europe? Thanks ------------------------------ From: ASQC Section 0511 Date: Wed, 13 Mar 1996 12:39:03 -0500 (EST) Subject: Opportunities in SW Quality at Bell Atlantic in Silver Spring MD I've just received some new position postings from Bell Atlantic, specifically for SW Quality professionals. Positions will be at their Silver Spring MD facility. They are online under the "Telecom Opportunities" section at the top of the QUALITY.ORG homepage, as well as in the "Employment Opportunities" section. If you cannot access the homepage and want a copy of the postings, let me know. Regards. Bill ============================================================================== Bill Casti, CQA Pager: +1 800 604 6149 Chairman, Electronic Media, Section Email: asqc0511@quality.org ASQC Section 0511 (Northern VA) General Email: e-media@quality.org - ------------------------------------------------------------------------------ E-media Mailing Address: PO Box 1412 Herndon VA 22070-1412 - ------------------------------------------------------------------------------ Section 0511's PGP public key is available by fingering asqc0511@quality.org - ------------------------------------------------------------------------------ Online Quality Resources at http://www.quality.org/qc ============================================================================== ------------------------------ From: "Bill Casti, CQA (Moderator)" Date: Thu, 14 Mar 1996 01:13:26 -0500 (EST) Subject: Cyber-Q's Dinner during Annual Quality Congress, Chicago, 5/14 Here's the announcement and current list of those who've RSVP'd so far. If any of you are going to be in Chicago for the ASQC Annual Quality Congress and would like to join us for some informal socializing and conversation with some of the foremost Quality folks and the rest of us, at our 2nd Annual Offsite Cyber-Q's Dinner Gathering, email your RSVP directly to me, at: help@quality.org, *not* to this list's posting address. NOTE: This message is being distributed to a number of Quality lists, so you may get duplicates, if you're subscribed to more than one list. My apology for the unavoidable duplications. Thanks. Bill - ------------ [Please send your dinner RSVPs only to: help@quality.org, and NOT to the list. Thanks!] !!!!! The Cyber-Q's' Eat Again !!!!! Who: THE CYBER-Q's 2ND ANNUAL AQC OFFSITE DINNER GATHERING When: Tuesday, May 14th Time: Cocktails from 5:45-6:45pm Start Ordering Dinner at 6:45pm Where: Giordano's Pizza 236 S. Wabash (at Jackson) Chicago, IL (312) 939-4646 Type of Food: Pizza, Italian Vegetarian Available? Yes. Handicapped Acessible? Yes. Prices: Average cost of a dinner entree: less than $15-20 ***** Here's who has committed to being there, as of posting date: Bill Casti, CQA help@quality.org Dan O'Leary doleary@mr.picker.com Cindy Visscher Cvisscher@aol.com Sam Friedman FriedSH@aol.com Boyce Grier Boyce.H.Grier__Jr@att.com Chuck Messall Messall.Chuck.MM7@MacMail1.nb.rockwell.com Mr. & Mrs. Tom Slaughter us022066@interramp.com Chris Seow cseow@pmc1.pmc.port.ac.uk Hal Popplewell GaltJohn22@aol.com Dave Miller djm@ihgp.ih.att.com Robert Matthews rfmatth@sandia.gov John Hankwitz JHANKWITZ@qtiworld.com Tess Ailshire Tbailsh@aol.com John Shoemaker Administrator@qof.com Dennis & Mary Lynn Arter darter@mcimail.com Becky Knight BKnightB@aol.com Lew Atkinson atkinsol@vitro.com Thanks. I hope to see all of you on the 14th of May! Bill ============================================================================== Bill Casti, CQA Email: help@quality.org - - Domain Owner, QUALITY.ORG Pager: +1 800 604 6149 - - List Moderator, "TQM in Manufacturing and Service Industries" - - Chairman, Electronic Media ASQC Section 0511 (Northern VA) Section Email: E-media@quality.org - - Senior Administrator, Internet Systems - Federal Emergency Management Agency - ------------------------------------------------------------------------------ We support open standards and First Amendment rights. We oppose the censorship provisions of the 1996 Communications Decency Act. See http://www.aclu.org for details about how you can help defend free speech. - ------------------------------------------------------------------------------ QUALITY RESOURCES ONLINE at: http://www.quality.org/qc ============================================================================== ------------------------------ From: gdaczkow@telesciences.com (Greta H Daczkowski) Date: Thu, 14 Mar 96 15:15 EST Subject: Question: Control of Development Tools Hello all! We are performing our first internal audits and ran across a good question: If Engineering uses software on a TECELEK (data generation) which is provided by Tekelec (however you spell it), should this software be under some "control process" whereby the original software assigned a control number and archived in a location where it will not be damaged by environment or just lost. We also have some firmware that falls into this category. The key here is, the items are used in the development process. They do not become a part of the final product, but they will be used to troubleshoot problems or to assist in future software development. Let me know your opinions on where we draw the line. It's the hardware guys operating in the lab who are effected. They do not want to have to archive their tools. =================================================================== _/_/_/_/_/ _/_/_/_/ Greta Daczkowski _/ _/ _/ System Test Engineer _/ _/_/_/ _/ _/ Securicor Telesciences _/ _/ _/ _/ (609) 866-1000 _/_/_/_/_/ _/_/_/_/ email:g.daczkowski@telesciences.com ================================================================== ------------------------------ From: Philip Stein Date: Thu, 14 Mar 1996 19:55:24 -0500 Subject: Announcement: Measurement Quality conference Final Announcement Measurement Quality Conference The Fourth Annual National Conference of the ASQC Measurement Quality Division April 23-25, 1996 Rockville, MD Preceded by a One-Day Tutorial: Basics of Measurement Science for Industry and Business April 22, 1996. The tutorial and the conference are open to the public and are not restricted to ASQC members. The annual Measurement Quality Conference has been established to provide a forum for topics where the interests of metrology and quality professionals intersect, i.e., the quality aspects of good measurement and the measurement aspects of effective quality management. There will be a mix of panel discussions and individual presentations. The Measurement Quality Conference devotes ample time for informal discussion with the speakers and other participants, both during and between the sessions. This year's theme is on assuring and maintaining measurement traceability and uncertainty. Sponsored by: American Society for Quality Control (ASQC) Measurement Quality Division and the National Institute of Standards and Technology U.S. Department of Commerce Location: The DoubleTree Hotel 1750 Rockville Pike Rockville, MD (301) 468-1100, FAX: 301-468-0163 Rate of $114 single, or $125 double, includes tax. Transportation: BWI Super Shuttle, (301) 369-0009 Suburban Airport Shuttle, (301) 279-2222 Washington Metro Red Line train towards "Shady Grove" to the Twinbrook station. The hotel is immediately across the street from the Twinbrook station. Technical Information: Carroll S. Brickenkamp, NIST Telephone: (301) 975-4291 Fax: (301) 926-0416 e-mail: Carroll.Brickenkamp@nist.gov Registration Fees: The April 23-25 Conference Registration fee is $290 per person, and includes continental breakfasts, coffee breaks, lunches, a reception, and the proceedings. The Basics of Measurement Science for Industry and Business Tutorialon April 22 Fee is $225 per person, and includes materials, workbook, and two coffee breaks. Both Master and Visa credit cards are accepted. TO REGISTER: Send your name, company affiliation, address, telephone, fax, and e-mail address to: Dan Harper, Treasurer 822 NW Murray Blvd., Suite 238 Portland, OR 97229 Telephone: (503) 646-1380 Fax: (503) 646-1380 THE PROGRAM: Tutorial: Basics of Measurement Science for Industry and Business April 22, 1996 Preceding the Conference. Doubletree Hotel, Rockville, MD 8 a.m. to 5 p.m. The tutorial, taught by Philip Stein and Woody Eicke, will cover the following topics: Principles of standardization Calibration and traceability Industrial and business measurements Metrology requirements of ISO 9000 and QS 9000 Fundamentals of dimensional measurement Fundamentals of DC and low frequency electrical measurements Overviews of temperature, time, mass, and color measurements - --------------------------------------------------------------- Conference: - ----------- Tuesday, April 23 8:30 a.m. Registration and continental breakfast 9:00 a.m. Welcome & Overview of the Measurement Quality Division Future of the Measurement Quality Conference Dan Carlson, MQD Chair 9:30 a.m. to 5:00 p.m. Workshop on Quality in the Measurement Laboratory Organized by M. Carroll Croarkin, NIST Statistical Engineering Division, and presented by her and others on the NIST staff. Specific topics will include: Uncertainty Analysis and Guidelines. This tutorial will describe how to evaluate and report uncertainties in terms of the ISO guidelines. Control (Check) Standards and Their Use in Measurement Process Monitoring and Uncertainty Analysis. This tutorial explores incorporating "known" measurement values into routine measurement processes in order to quantify your own measurement uncertainty, and to track (and control) drift and shift. Case Studies for Uncertainty Analysis. Simple and advanced techniques for estimating measurement uncertainty and for using test reports in calculating your own measurement uncertainty will be provided. 5:30 p.m. Reception Measurement Quality Division Council Meeting Open to all attendees - ------------------------ Wednesday, April 24, 1996 8:30 a.m. Measurement Aspects of Quality Standards This session focuses on specific areas of written standards and guides that deal with measurements primarily from a management perspective. ISO 9000, ISO Guide 25, and ANSI Z540-1 are the primary standards under discussion. The relationships among various quality standards, concepts, and philosophies such as TQM and the Malcolm Baldrige National Quality Award and their implications for measurement practitioners will also be discussed. Ted Doiron, Dimensional Metrologist at NIST, and Dennis Sanchez, Lockheed Martin will speak. 10:30 a.m. There's More to Quality Than Standards There seems to be an insidious belief that adherence to quality standards is quality. While written standards give basic elements of quality systems, attainment of the highest quality levels requires motivated, educated, and well-assigned staff. This panel discussion will offer a look at motivational needs and tools for fulfilling them. Panelists include Linda Doherty, Director of the Navy's Total Quality Leadership Office, Carl Thor of Jarretthor International, Tom Kimbrell from the Community College of Aurora, Colorado, Jack Pekar, Kennemetal,Inc. and noted author. 1:30 p.m. Preparing the Calibration Laboratory for Accreditation. Presentations will be made by representatives from the two accreditation bodies in the U.S. dealing with calibration laboratories -- the American Association for Laboratory Accreditation (A2LA) and the NIST National Voluntary Laboratory Accreditation Program (NVLAP) -- and from two recently accredited laboratories, one laboratory maintaining its accreditation for nearly 10 years, and one now preparing for accreditation. Among the issues dealt with will be the meaning of accreditation and the body of knowledge of the measurement process required for successful auditing. Panelists include Jim Cigler, Chief of the National Voluntary Laboratory Accreditation Program Pete Unger from A2LA Bud Stott, Fluke Corp Lynne Neuman, Entela Inc Tom Wiandt, Hart Scientific, and Peter Crisp, Wavetek. This panel session will provide guidance by your peers on the preparations and considerations necessary to become and stay accredited. 3:30 p.m. Introduction to Statistical Thinking Statistical Thinking is a philosophy of learning and action based on recognition that (1) all work is a system of interconnected processes; (2) variation exists in all processes; and (3) understanding and reducing variation will lead to success Lynne Hare, Chief of the NIST Statistical Engineering Division will introduce the participants to the philosophy and application of statistical thinking in the three major levels of an organization: strategic, managerial and operational. By using an experiential learning exercise emphasizing a diversity of learning styles, he will show how to implement Statistical Thinking in an organization. Also provided will be a demonstration illustrating the advantages of reducing of variation. - ---------------------- Thursday, April 25 8:30 a.m. What's New? This is a new kind of session, one in which participants explain their tools and techniques for improved measurement quality. New training and educational information will be highlighted. There will be opportunities for announcements and new industry area briefings. 10:30 a.m. Traceability: SI Units to Accuracy Ratios This session will cover the concept of traceability in all of its aspects: from the establishment and maintenance of national measurement standards to assuring proper performance of instrumentation on the production floor. Companies using, manufacturing, providing, importing, or exporting measurement-sensitive goods take the measurement infrastructure for granted until they perceive themselves as a part of it. This session will provide insight as to where a company or its laboratory fits into this infrastructure and what questions must be answered to maintain confidence in the measurements being made. Norm Belecki, Group Leader for NIST Electrical Calibrations will describe how NIST realizes the SI Units and translates these standards into calibration services. Bill Sorrells from Hewlett-Packard will describe how HP sets their equipment specifications. 1:30 p.m. Measurement as a Process Technical aspects of the measurement process will be covered in this session. Some of the specific topics are: * Proficiency Testing Using Reference Materials by Roger Johnson, Eastman Kodak * Using Interlaboratory Comparisons for Process Improvement by Georgia Harris, NIST Office of Weights and Measures * Test Accuracy Ratios, Tolerance Testing, and the Concerns of the Shop Floor 3:30 p.m. Standards for Measurements Traceability and uncertainty of the result of a measurement are critical whether the stated reference is to national or international artifact standards such as the International Prototype Kilogram or whether the reference is to an industry-wide measurement, such as moisture content of industrial scrap aluminum. This session will provide participants with a perspective on the evolution of a measurement process to a national or international standard from former Chairman of ASTM, Nancy Trahey, NIST Standard Reference Materials Program. In addition, you will have a unique opportunity to have your questions answered by members of a panel of experts on training, physical measurements, and sources for consensus standards. Philip Stein O- Consultants in the Physical Sciences, Measurements, and Quality Chair-elect, ASQC Measurement Quality Division ------------------------------ End of ISO 9000-3 Digest V1 #12 *******************************