Page 1 OMNEX Navigator SEMICONDUCTOR AND ELECTRONICS ISSUE SUMMER 2001 SemiconductorInside QS-9000 Killer! Article based on TS 16949 2nd edition draft and Electronics Quality Systems3 by Chad Kymal, CEO-Omnex by Chad Kymal, CEO-Omnex The International Automotive Task Document Pro Software Force (IATF) appears to be on track Most of the electronics assemblers to release the second edition of and semiconductor manufacturersDescription ISO/TS 16949 with ISO 9001:2000 like Motorola, Philips, Delphi, Visteon, AMD and National have 4 in 2002 as planned. In fact, indications are that they may even adopted QS-9000. Some of the be ahead of schedule. The next corporate offices, sales and design Omnex News & AQuA planned event is an IATF vote in functions are still ISO 9001:1994. Paris, France in June, 2001 for the All of these companies and offices Software Description final approval of the draft. Little or will have to evaluate their current situation and before too long,5 no change is anticipated from the draft at this time. After the vote in adopt a strategy to covert to ISO June, the document will make its 9001:2000 or ISO/TS 16949, 2nd Semiconductor Training way to the ISO/TC 176 for a 75% edition. (See article on TS 16949, 2nd edition at http://www.omnex.com/ approval vote from member bodies. news/ts_16949_qs_9000.html.)Schedule The Industry Eagerly Awaits QS-9000 registered companies are Some Options? eagerly awaiting the second edition In our opinion these companies of TS-16949. Very soon there will 7 have many options to choose from be an avalanche of companies when electing the strategy they are implementing going to pursue. These strategies Ann Arbor Training and registering to this new include asking the following standard. We believe that the questions – What area of the Schedule registration, company is not currently certified? “The second edition training and What products should be included implementation of TS 16949 will activity will be in the certification? Should we include ISO 9004 or SAC probably lead to the similar to when QS-9000 was certification in our plans? What documentation strategy should we slow demise of the first adopted. pursue? And lastly, what should However, most QS-9000 Standard.”9 the goals of the next registration companies are be? now a little Audit Pro wiser---- having been through a Processes to Include in ISO registration process already. 9001:2000 and TS 16949,& BOSS Software Continued on page 3 Second EditionDescriptions Some areas of the company were excluded from ISO 9001:1994 or QS-9000 certification. Continued on page 3
Page 2 • Faster way to download or upload documents between client and server. •Document Pro Enforces security of documents by assigning different levels of rights for users.Document Pro is a web-based program designed to • Prevents unauthorized access to documents.manage all kinds of documents in your company. • The administrator controls the entire system.The package would be of special help in managingdocuments related to quality standards such as ISO9001:2000, QS 9000 and ISO/TS 16949. Itdocuments an organizes Quality ManagementSystem (QMS) including quality manuals,procedures, work instructions and forms, andchecklists. The program monitors employee access,document revisions, change requests and approvals,all online.How does it work?Document Pro Organization • Keeps track of the revision history ofDocument Pro helps users manage their documents in documents.an effective and easy manner. The program monitors • Acts as a dynamic repository of documents.employee access, document revisions, change • Online helprequests and approvals, all online. The system enables • Easily deployable and portable database.security of documents by providing only users with • Simple to install and customizable package.the right to view documents to do so. If a document isto be changed, then users can fill out the changerequest form and make a request to this effect. Anyuser having the right for approvals can approve/rejectthe change requests made.Key Features: • Easy to navigate, user-friendly input screens, flexibility in arranging or sorting the documents in a customized way. • The link between related documents makes it easy to retrieve or sort related documents. • Easy to download or edit documents without compromising the security or authenticity of the documents.
Page 3 QS- 9000 Killer (continued) The Demise of QS-9000? QS-9000 is not being upgraded to ISO 9001:2000, as clearly indicated by the IATF. QS-9000 has integrated ISO 9001:1994 into its body. TC 176 has given all ISO companies until 2003 to upgrade to the new release of ISO 9001:2000. After 2003, QS-9000 registrations will cease to have international standing with the ISO body. QS-9000 companies really do not have a choice but to upgrade to TS 16949 with ISO 9001:2000. The second edition of TS 16949 will probably lead to the slow demise of the QS-9000 Standard. Any Surprises? As expected, the structure of TS 16949, second editionSemiconductor SupplementThe AEC task force has once again convened to alignthe Semiconductor Supplement to the TS 16949,Second Edition. The transition from the old to the newwill be more than just moving the additionalrequirements to the Second Edition final draft. Expectsome changes and additions to the supplement. is based on ISO 9001:2000. The entire ISO 9001:2000, including the introduction section, is a part of TS-16949, second edition. TS 16949 additions like 18.104.22.168 Objectives in the first edition are inserted into the analogous areas of ISO 9001:2000 (22.214.171.124). In the new standard, ISO 17025 will not be required for internal laboratories (126.96.36.199). Furthermore, external labs might satisfy requirements of acceptability to the customer (188.8.131.52) in lieu of 17025 registration. The change to the standard will impact many internal and external labs who have completed or are working on the 17025 certification. At a minimum the second edition says- "the supplier shall be compliant with ISO 9001:2000 (184.108.40.206)". The ramifications of this addition are immense; it impacts all suppliers to the organization including service suppliers that have an impact on "subsequent product realization or the final product". (7.4.1). There are many other small to medium changes that require mention-no requirement for 100% on-time delivery, no mention of APQP, and no mention of linearity, bias, discrimination or stability with MSA. The second edition has all but abandoned the sanctioned interpretations that were added to QS-9000, 3 rd edition. For example, one of the sanctioned interpretations examined whether control plans needed to include anything more than special characteristics. The answer was that any controls used in the plant needed to be included in the control plan. This showed up in the first edition of TS 16949 as "...list on the control plan the controls used for process control". Now it is missing in the second edition. Also missing are a few important words about problem solving that required the
Page 4disciplined problem solving method to have the following at requirements” . Many companies excluded R&D froma minimum Œ problem identification, containment, root their initial implementations. If innovation and productcause identification, and verification of corrective action. technology are prime requirements of this sector’s customers, then exclusion must be reconsidered.For the unabridged version of this article, go to the News section ofwww.omnex.com. Matrix on how TS 16949 and ISO 9001:2000 integrate witheach other is now available at www.omnex.com Check out the TS 16949 2nd What Products are to be included in ISO 9001:2000Edition Overview Course on page 5! and TS 16949, Second Edition Implementation? Email Omnex at info@omnex for a series of articles published byChad Kymal and Dave Watkins in the Informed Outlook on TS 16949:2002 Products are defined as Hardware, Software, Processed(Second Edition). Materials, and Services. Typically, electronics andSemiconductor Quality semiconductor companies have included only hardware in their ISO and QS implementations. Oftentimes,(continued) software processes are not defined and are most oftenThe older standards were not process-oriented, and they excluded from the implementation. In the final product,allowed exclusions in the areas of labs, R&D, and some Software is starting to represent 30 to 60 percent of theadministrative offices. value-added market in electronics and semiconductor. Both ISO 9001:2000 and TS 16949, Second EditionIn the current implementation, the implementation provide an organization with the opportunity to putchampions need to consider all areas that were once disciplines and processes where they are spendingexcluded. They need to ask the following questions as money.required by ISO 9001:2000 and TS 16949, 2nd edition –1)Are the exclusions related to 7.0 only? 2)Will the Systems to pursue?exclusion of these areas (processes) affect the ability of Omnex made a presentation with Philips at last year’sthe organization to “provide product that meets customer Semiconductor Assembly Council conference. (Seeand regulatory” needs and expectations. http://www.omnex.com/training/presentations.html to read this presentation.) We announced then that SACIn other words, if any area of the company is excluded had adopted ISO 9004:2000 as the base system insteadfrom the ISO 9001:2000 or TS 16949, Second Edition of ISO 9001:2000. ISO 9004:2000 provides thescope, then the company would have to justify how that opportunity for companies to reach for a higher goal thanarea really does not impact the ability of the company to they would with ISO 9001:2000.meet the customer’s “quality (need and expectation) Continued on page 7Omnex Semiconductor News • “Excellent class. (The instructor) is and 8-D problem solving processes for this thoroughly enjoyable, and unbelievably organization.APQP Process and Class knowledgeable.”Omnex worked with a large design and • “The modules and breakdown of all thefabricating house in 2001, realizing their elements and clauses made this topic Comments on Auditing Booknew product development process for much easier to understand and Hans Van Beek, Senior ManagementPackaging and Test. Omnex currently is comprehend. The examples provided by Consultant for Philips and head of theproviding training for this class in this the instructor were very helpful.” Philips Business Excellence programorganization. • “Great class that motivated me to want to (PBE), gave a special thanks about Chad implement the standard now that I Kymal’s book “How to Audit ISOOmnex completed a three day TS 16949 How to Audit ISO 9001:2000-An Auditors GuideSemiconductor course for another large Learn the best techniques for value-added implementation, interpretation, andchip producer. The course, which was documentation of ISO 9001:2000. in a new book, authored by Chad Kymal,part of the training provided to the quality President of Omnex and founder of registrarspecialists, received a rating of 6.78 out of AQSR. Contact us today to order at a cost of $50.7. One of the highest ratings received in 734.761.4940 email@example.com overall program. understand it. Excellent direction with 9001:2000—A Handbook for Auditors”,High Marks! respect for auditing techniques.” which is currently available: “I receivedOmnex has just completed a six monthcurriculum of courses open to the public at the book How to Audit ISO 9001:2000 very QS-9000 Implementation quickly after we ordered it. Good job! IPhilips Semiconductor in San Jose, Omnex is in the final stages of a QS-9000 read through it with great interest. It is oneCalifornia. Representatives from Atmel, implementation for a large chip maker. of the best publications about ISOHoneywell, Texas Instruments and Omnex reengineered their New Product 9001:2000 that I have seen to date.Advanced Micro Systems attended these Development Process. We helped their SEE DESCRIPTION BELOW.courses. The following were some of the product team complete DFMEAs andcomments from the participants: DVP&R. Omnex helped implement MSA
Page 5What is AQuA?AQuA is an integrated database management system that stores and organizes your APQP document information. Whenyou view or print a document, AQuA extracts the required information and formats it for you. As a direct result of thisdesign, AQuA gives you: • CONSISTENCY - Because AQuA stores information in a database, when you change information in one document, all other documents that use the information are updated automatically. • FLEXIBILITY - AQuA also allows you to modify formats to meet your own needs. You can add, delete, or modify columns, control column headings and widths, add or change document headers and footers, etc. • EFFICIENCY - Because AQuA links the information from document to document, when you complete one document you will already have entered much of the information for the next document.Key Features • Characteristics Matrix • Distribute released • Design FMEAs • PPAP Forms documents to managers • DVP & Rs • Operator Instructions and sales people • Process Flows • APQP Checklists and • Archive obsolete versions • Process FMEAs Action Plan of documents for historical • Place documents on the reference • Control Plans • Dynamic Control Plans plant floor
Page 6OMNEX Semiconductor Training For Silicon Valley & Texas2001 Schedule 734.761.4940 www.omnex.com Training Schedule is subject to course load requirements; dates may vary. Please contact Omnex for the most current information and a copy of our catalog, outlining our full course offering. This two day class will describe the most current changes to of the standard is covered. The class covers the standard SAN JOSE, CA TS 16949, Second Edition as it moves from its QS-9000 toward ISO 9001:2000. It will provide a comprehensive and introduces two methodologies that can be used with ISO 9001: QOS, and Process Review. QOS starts with customer QOS for ISO 9001:2000 - approach to auditing each element of the ISO/TS 16949 and expectations, goals and objectives, and then drives toward SAC standards, and addresses the concept of audit trails and key processes and process measurables. Process Review is Business Operation collecting objective evidence. This is a great upgrade course the methodology that conducts a process flow, PFMEA, and for internal auditors. Key differences between QS-9000 and Control Plan for administrative processes. Methodology (BOM) TS 16949, Second Edition and the implementation processDates: October 1-2, 2001 will be discussed. Global 8D/Team ProblemThis Ford-approved course teaches a methodology to helpcompanies become customer-focused. It shows how to link ISO 9001:2000--The Role of SolvingCustomer Expectations (5.2), Mission Statement (5.3),Goals and Objectives (5.4), Key Processes (7.0), Process Executive Management Dates: December 19-21, 2001and Result Measurables (8.4) and Continuous Improvement (optional 3rd day for your company’s issues)(8.5). Companies implementing ISO 9001:2000 have an & Course description:opportunity to tightly link and integrate their businesssystems using the QOS methodology. ISO/TS 16949, Second This three-day seminar covers all phases of the team Edition--The Role of approach to identifying and solving problems, based on the eight-discipline methodology. The Global 8-D Process is Process Review for ISO Executive Management taught using a real life case study. The seven statistical tools, cause and effect diagrams, decision analysis, Is/Is Not, 9001:2000 Date: November 14, 2001 and brainstorming are some of the tools taught in this class.Dates: October 3-4, 2001 (Two ½ day seminars in one) The last day of the course focuses on solving your own company problems and using the teachings you haveCourse description: Course description: learned.This two day course discusses how to create process flow, These courses provide top management with a look at theFMEAs, and Control Plans for documenting key processes strategic implications and ramifications of the standard in(service or administrative processes) identified in the QOS.Also, the product realization, support and QMS processes their organizations. The group will discuss how the standard affects their organization, the business implications and their AUSTIN, TEXAScan benefit from the process review methodology. FMEAshelp with small group improvement and in satisfying the role in the implementation. ISO 9001:2000 Understandingrequirements of 8.2.3 for corrective action. The control plan Lead Auditor Training with and Implementationdiscusses what is being measured and how they are Dates: October 8-9, 2001measured. (8.2.3) ISO/TS 16949 Second Edition See course description aboveISO/TS 16949, Second Edition and the Semiconductor with the new Semiconductor Supplement ISO 9001:2000 Internal Supplement Dates: December 10-14, 2001 Auditing Course description: Dates: October 10-12, 2001Dates: November 8-9, 2001 This seminar is ANSI-RAB NAP accredited Lead Auditor Course description:Course description: training and fully integrates ISO/TS 16949:2002 and This course teaches both service and manufacturingThis is a course based on the final draft of TS 16949, Second Semiconductor Supplement requirements throughout the examples. This course provides and understanding of howEdition, which includes ISO 9001:2000. This course will entire five day seminar. Presentation materials are to audit ISO 9001:2000, along with audit trails andteach the TS 16949 along with ISO 9001:2000. The intent, supported with real-world semiconductor examples and sampling. Conducting an audit, writing non conformance,content, and objective evidence required for TS 16949, exercises. This training is also provided under SAC’s and closing out non-conformance are taught. There is a finalSecond Edition will be covered. Key differences between approval.. exam in the end of the course.QS-9000 and TS 16949, Second Edition and theimplementation process will be discussed. ISO 9001:2000 -ISO/TS 16949, Second Edition Understanding and Please email Omnex for Transition Training for Implementation our entire curriculum of Auditors Dates: December 17-18, 2001 Semiconductor courses.Dates: November 12-13, 2001 Course description: This class teaches the intent, content, and objective evidenceCourse description: required to implement the ISO 9001:2000 standard. The Best-in-Class implementation methodology for each clause
Page 7OMNEX Semiconductor Training For Thailand2001 Schedule 734.761.4940 www.omnex.com Training Schedule is subject to course load requirements; dates may vary. Please contact Omnex for the most current information and a copy of our catalog, outlining our full course offering. standard in their organizations. The group will discuss BANGKOK, how the standard affects their organization, the business implications and their role in the Please email Omnex THAILAND implementation. for our entire ISO 9001:2000 ISO 9001:2000 Internal curriculum of Understanding and Auditing Semiconductor Implementation Dates: October 19-21, 2001Dates: September 17-18, 2001 Course description: courses. This course teaches both service and manufacturingCourse description: examples. This course provides and understanding ofThis class teaches the intent, content, and objectiveevidence required to implement the ISO 9001:2000 how to audit ISO 9001:2000, along with audit trails and sampling. Conducting an audit, writing non ISO/TS 16949, Secondstandard. The Best-in-Class implementationmethodology for each clause of the standard is conformance, and closing out non-conformance are Edition with the new taught. There is a final exam in the end of the course.covered. The class covers the standard and introduces Semiconductortwo methodologies that can be used with ISO 9001:QOS, and Process Review. QOS starts with customer QOS for ISO 9001:2000 - Supplementexpectations, goals and objectives, and then drivestoward key processes and process measurables. Process Business Operation Dates: November 26-27, 2001Review is the methodology that conducts a process Methodology (BOM) Course description: This is a course based on the final draft of TS 16949,flow, PFMEA, and Control Plan for administrativeprocesses. Dates: November 6-7, 2001 Second Edition, which includes ISO 9001:2000. This Course description: course will teach the TS 16949 along with ISO 9001:2000. The intent, content, and objective evidence TS-16949, Second Edition This Ford-approved course teaches a methodology to help companies become customer-focused. It shows required for TS 16949, Second Edition will be covered. Understanding and how to link Customer Expectations (5.2), Mission Key differences between QS-9000 and TS 16949, Second Edition and the implementation process will be Statement (5.3), Goals and Objectives (5.4), Key Implementing Processes (7.0), Process and Result Measurables (8.4) discussed.Dates: October 15-16, 2001 and Continuous Improvement (8.5). CompaniesCourse description: implementing ISO 9001:2000 have an opportunity to ISO/TS 16949, Second tightly link and integrate their business systems usingThis class will teach the TS 16949, Second Edition and the QOS methodology. Edition Transition Trainingthe Semiconductor Supplement. The task forcemembers will be editing the current requirements and for Auditorsaligning the Semiconductor Supplement with TS Process Review for ISO Dates: December 6-7, 200116949, second edition. 9001:2000 Course description: Dates: November 12-13, 2001 This two day class will describe the most currentISO 9001:2000--The Role of changes to TS 16949, Second Edition as it moves from Course description: Executive Management This two day course discusses how to create process its QS-9000 toward ISO 9001:2000. It will provide a comprehensive approach to auditing each element of & flow, FMEAs, and Control Plans for documenting key processes (service or administrative processes) the ISO/TS 16949 and SAC standards, and addresses the concept of audit trails and collecting objective ISO/TS 16949, Second identified in the QOS. Also, the product realization, evidence. This is a great upgrade course for internal support and QMS processes can benefit from the Edition--The Role of process review methodology. FMEAs help with small auditors. Key differences between QS-9000 and TS 16949, Second Edition and the implementation process group improvement and in satisfying the requirements Executive Management of 8.2.3 for corrective action. The control plan will be discussed.Date: October 17, 2001 discusses what is being measured and how they are measured. (8.2.3) ISO 9001:2000 Lead (Two ½ day seminars in one)Course description: Auditor Training withThese courses provide top management with a look at ISO/TS 16949 andthe strategic implications and ramifications of the
Page 8 requirements throughout the entire five day seminar. Semiconductor Course description: Presentation materials are supported with real-world This seminar is ANSI-RAB NAP accredited Lead semiconductor examples and exercises. This training is Auditor training and fully integrates ISO/TS also provided under SAC’s approval.Dates: December 19-21, 2001 16949:2002 and Semiconductor Supplement
Page 9OMNEX2001 Schedule Training 734.761.4940 Ann Arbor, MI www.omnex.com Training Schedule is subject to course load requirements; dates may vary. Please contact Omnex for the most current information and a copy of our catalog, outlining our full course offering. ISO/TS 16949NEW! Exclusively from Omnex! ISO/TS 16949 reflects worldwide efforts within the automotive industry to harmonize supplier quality system requirements.ISO/TS 16949 Second Based upon Omnexs review of Understanding How to Audit ISO/TS 16949Edition Overview the second draft of TS 16949, ISO/TS 16949 May 31, 2001(includes ISO 9001:2000) this one day course teaches an June 28, 2001 June 29, 2001July 24, 2001 overview which is integrated July 30, 2001 July 31, 2001September 14, 2001 with ISO 9001:2000. If you are September 24, 2001 September 25, 2001October 23, 2001 currently registered or planning October 29, 2001 October 30, 2001November 19, 2001 to be registered to an November 19, 2001 November 20, 2001December 11, 2001 automotive Quality System December 17, 2001 December 18, 2001 standard, then you will need to attend this course.New Ford Q1 Internal and Lead Auditor AQuA Guidelines Training for AutomotiveNEW! Exclusively (QS-9000/TS 16949)from Omnex!Ford Q1 Overview Our ANSI-RAB NAP Participants with "average" experience and knowledge will be Omnex Systems offersJune 20, 2001 accredited Internal Auditor training in its popular APQP training courses transformed into confidentJuly 25, 2001 auditors with a clear process management andSeptember 13, 2001 comprehensively integrate quality documentation understanding of documentation automotive requirements andOctober 24, 2001 reviews, elements, and audit software. give participants an in-depth trails. We utilize a practical AQuA 3 Basic TrainingNovember 19, 2001 understanding of requirements, approach by incorporating real- June 4 & 18, 2001December 19, 2001 audit systems, and instruments. world examples. Automotive July 9 & 23, 2001 Hands on exercises will guide classes are ANSI-RAB NAP August 6 & 20, 2001This one day course for you through conducting audits, accredited courses. September 10 & 24, 2001Ford suppliers will writing audit reports, and October 8 & 22, 2001provide a three hour taking corrective actions. Internal Auditor for November 5 & 12, 2001 December 3 & 10, 2001overview of the new Ford AutomotiveQ1 and an in-depth 4 hour May 7-9, 2001 Lead Auditor for AQuA 3 Workshop June 11-13, 2001look at the 15 part Automotive July 16-18, 2001 May 22-23, 2001Manufacturing Assessment May 21-25, 2001 June 19-20, 2001 September 12-14,2001 June 4-8, 2001 July 24-25, 2001Tool. October 10-12, 2001 August 21-22, 2001 September 17-21, 2001 November 12-14, 2001 October 15-19, 2001 September 25-26, 2001 December 5-7, 2001 December 17-21, 2001 October 23-24, 2001 November 13-14, 2001 December 11-12, 2001
Page 10OMNEX2001 Schedule Training 734.761.4940 Ann Arbor, MI www.omnex.com Training Schedule is subject to course load requirements; dates may vary. Please contact Omnex for the most current information and a copy of our catalog, outlining our full course offering.California ISO 9001:2000 Transition TrainingTraining Now RAB-Accredited! RAB- and ApprovedOmnex is offering courses ISO 9001:2000 ISO 9001:2000 An intensive two dayon the West Coast. Many Internal Auditor auditor transition Lead Auditor training course forof the courses you see here June 25-29, 2001 June 25-27, 2001 August 1-3, 2001 auditors who haveare also offered with the July 9-13, 2001 passed an internal or September 24-28, 2001 October 15-17, 2001Semiconductor Supplement December 5-7, 2001 lead auditor course. October 22-26, 2001 This two day courseincluded. Call Jody November 26-30, 2001 Understanding & will teach ISOO’Bryan at (734)761-4940 December 10-14, 2001 9001:2000 audit trails, Implementingor visit www.omnex.com to ISO 9001:2000 ISO 9001:2000 scope selection, andobtain a schedule for San Process Review audit planning. September 13-14, 2001 June 18-19, 2001Jose. July 30-31, 2001 Breakouts and graded October 18-19, 2001 exercises will test your December 19-20, 2001 October 8-9, 2001 December 3-4.2001 skills in the new ISO 9001:2000 ISO 14000 APQP requirements for ISO 14000 Lead Auditor APQP Implementation and documentation,Six Sigma Improvement management review, and Customer expectations and planning. June 7-8, 2001 July 19-20, 2001 September 20-21, 2001 October 25-26,2001 November 15-16, 2001 December 3-4, 2001Taught by a Master Black Call Omnex for more June 18-22, 2001Belt who led Allied Signal information on our Six Sigma September 24-28, 2001Safety Systems in their Six Open Enrollment and onsite November 12-16, 2001Sigma implementation. The training being offered now.Omnex Six Sigma training ISO 14000 Internalinstructor will show you the Auditorhands-on techniques used in May 23-25, 2001the successful deployment of July 16-18, 2001Six Sigma from an insiders September 17-19, 2001view. November 7-9, 2001With our Black Belt training, Understanding,youll be able to save Documenting, and$500,000 - $750,000 per Implementing ISO 14000Black Belt. July 11-13, 2001 September 10-12, 2001 November 5-7, 2001
Page 11July 9-13, 2001October 29-Nov. 2, 2001 ISO/IEC QOS – Ford 17025 This new standard replaces Automotive lessons learned from implementation of the ISO/IEC Worldwide Guide 25:1990 and EN 45001: Training 1989 and contains all the requirements that testing and QOS Implementation calibration laboratories should and Improvement for have. This training incorporates Manufacturing/Servic all the requirements of ISO 9001 e & ISO 9002 that are relevant to the scope of testing and May 21-22, 2001 calibration services covered by July 19-20, 2001 the laboratorys quality system. September 10-11, 2001 Laboratory Quality Systems November 8-9, 2001 July 26-27, 2001 September 26-28, 2001 November 5-6, 2001
Page 12Semiconductor Quality Ford Q1(continued) The New Ford Q1 Requirements were rolledThe main benefit of ISO 9001:2000 is the ease with out on May 2, 2001 to the top 30 Fordwhich excellence standards integrate, and implementers Suppliers. The new Q1 Requirements containhave the choices of ISO 9004:2000, SAC standards, four parts: Capable Systems, HighMalcolm Baldridge and the Semiconductor Supplement Performance, Manufacturing Assessment, andto include in their implementations. SAC standards and Continual Improvement-Ongoing Excellence.certification have shown that SAC Level I companies are Ford gets high marks for this well thought-outthe best benchmark companies in the world. The SAC approach. This has what QS-9000 orsecond party scheme with the requirements for TS-16949 does not – performancemeasurable results apparently provides the results thatorganizations are requirements.looking for.Companies pursuingsoftware registration the goal of the implementers. Not only is thiscould consider achieveable, but many other industries operate like this.integrating ISO Why not semiconductors?9001:2000 and CMMStandard (Computer Getting Results from the Implementationmaturity model). The Another left over notion from the defense industry is theprocesses required by view that ISO 9001 or TS 16949 is a customerCMM level III specification—something that needs to be donecompanies can now expediently but with very little cost or impact on thenicely integrate with business. This view of top management causes greatthe process model in harm. And if ISO or QS implementation is added asthe ISO 9001:2000 standard. another layer of requirements on top of other requirements, then this ends up costing semiconductorOmnex teaches a class several times a year on how to companies more money.integrate these standards. Write to info@omnex toreceive a course catalog and the Silicon Valley Course It is time that top management was trained on the value-Curriculum. added nature of ISO 9001:2000 and TS 16949, Second Edition. These standards should be adopted by topDocumentation.. Too Much Documentation!!! management with the view of providing measurablePerhaps due to their defense heritage, semiconductor returns. Some goals that Omnex has recommendedcompanies have always had a propensity to over- include –improvement in Customer Satisfaction,document. Often documents contain over 25 pages! And improvement in internal PPM, improvement in lead time,there are shelves and shelves of documentation in many reduction of paperwork, and many other things.cases. There is a great opportunity for improvement with the The new standard gives ISO 9001:2000 and TS 16949. Organizations are semiconductor encouraged to adopt these standards as their functional companies the perfect continuous improvement vehicle. What they need to time to re-evaluate their avoid is what happened in a gap analysis Omnex documentation needs. conducted last year in one of the world’s largest For many organizations semiconductor organizations. Remarking about ISO, a – “less is more.” senior manager said, “I just pull that stuff out for the Reduction of auditors, then I go back to doing my business.” A documentation will properly performed ISO or TS implementation integrates actually result in an both the business at hand with the “ISO stuff.” ISO increase in quality. 9001:2000 and accordingly TS 16949, Second Edition Then more personnel in are truly business system implementations. Isn’t this the organization would what senior management really wants to be working on-- Don’t let documentation actually read all of the providing business results? This makes “quality” a vital get the best of you! documents. part of any business plan. Quality professionals are no longer just confined to “product” quality, but to the larger With one Level I, then realm of “business” quality.approximately 100 procedures (processes), 500 workinstructions and 150 forms and checklists or should be
Page 13Let us move forward and get the most out of ourimplementations!How Does it Work? Key FeaturesBOSS takes the worry out of data management by putting • Customer Expectations Trackingforth solutions for profit and loss, production numbers, other • Linking of Expectations to Key Processes and tobusiness measurables, and most importantly, the process Improvement Actionmetrics supporting QOS (Quality Operating • Standardized Tools andSystem) and Score Card reporting efforts. It Methodologies like:ensures that the measurement of variables • Trend chartsfor processes in your business and the • Pareto diagramsQOS result measurements are all where • 8D Summariesthey should be. • Action Plan BOSS is capable of automatically storing • Improvement Plandata gathered from a variety of sources. The • Drill Down from Corporate todata is stored so that companies can map Departments for eachtrends and make comparisons for measurableillustrating problems or inconsistencies.These problems are highlighted in a ‘drill • Visual Data Analysis anddown’ process, whereby the data stored in • Status Monitoring Practicesdifferent categories serves a detailed analysis of these • Management Review and Improvement Meetingproblems. • Documentation • Meeting Minutes, Agenda, Charts & Graphs, and • Action PlanWhat is Audit Pro 2000? Key FeaturesAudit Pro is a web-based application designed to help an • The administrator can easily add audit programs, auditorganization, manage, schedule, assign, and monitor the status types, forms, auditors, organizations, and assign formsof audits and the corrective actions for internal audits under an audit type or program.including system, process, or product audits. • Auditors can log in separately and download the forms to their desktop and upload the approved forms. They can issue corrective action reports and closeout responses forThe Use of Audit Pro • a particular organization. Clients can log on to the site to download audit andThe power of Audit Pro is in the user-definedcustomization of audit forms and checklists. This corrective action forms which can later be completed andpackage can serve third party registrars as well as uploaded.organizations with single and multiple plants. It works for ISO • The administrator, auditor and client will be able to see9000, ISO 14000, QS-9000 and ISO/TS-16949 and supplier their audit and corrective action status from anywhere inaudits. It can handle multiple audit programs simultaneously. the world at any point in time.
Page 14• Facilitates sending mails automatically to the administrator, auditors, and clients in the course of an audit.