Semiconductor newsletter8 01

OMNEX

Navigator SEMICONDUCTOR AND
ELECTRONICS ISSUE
SUMMER 2001
Semiconductor
Inside QS-9000 Killer!
Article based on TS 16949
2nd edition draft
and Electronics
Quality Systems

3
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 manufacturers
Description 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 Edition
Descriptions Some areas of the company were
excluded from ISO 9001:1994 or
QS-9000 certification.
Continued on page 3

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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 edition

Semiconductor Supplement
The AEC task force has once again convened to align
the Semiconductor Supplement to the TS 16949,
Second Edition. The transition from the old to the new
will be more than just moving the additional
requirements to the Second Edition final draft. Expect
some 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 4.1.1.2
Objectives in the first edition are inserted into the
analogous areas of ISO 9001:2000 (5.4.1.1). In the new
standard, ISO 17025 will not be required for internal
laboratories (7.6.4.1). Furthermore, external labs might
satisfy requirements of acceptability to the customer
(7.6.4.2) 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 (7.4.1.3)". 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

disciplined problem solving method to have the following at requirements” . Many companies excluded R&D from
a minimum Œ problem identification, containment, root their initial implementations. If innovation and product
cause 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 of
www.omnex.com. Matrix on how TS 16949 and ISO 9001:2000 integrate with
each other is now available at www.omnex.com Check out the TS 16949 2nd What Products are to be included in ISO 9001:2000
Edition Overview Course on page 5! and TS 16949, Second Edition Implementation?
Email Omnex at info@omnex for a series of articles published by
Chad 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 and
Semiconductor Quality semiconductor companies have included only hardware
in their ISO and QS implementations. Oftentimes,
(continued) software processes are not defined and are most often
The 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 the
administrative offices. value-added market in electronics and semiconductor.
Both ISO 9001:2000 and TS 16949, Second Edition
In the current implementation, the implementation provide an organization with the opportunity to put
champions need to consider all areas that were once disciplines and processes where they are spending
excluded. 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’s
the organization to “provide product that meets customer Semiconductor Assembly Council conference. (See
and regulatory” needs and expectations. http://www.omnex.com/training/presentations.html to
read this presentation.) We announced then that SAC
In other words, if any area of the company is excluded had adopted ISO 9004:2000 as the base system instead
from the ISO 9001:2000 or TS 16949, Second Edition of ISO 9001:2000. ISO 9004:2000 provides the
scope, then the company would have to justify how that opportunity for companies to reach for a higher goal than
area 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 7

Omnex 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 the
fabricating house in 2001, realizing their elements and clauses made this topic Comments on Auditing Book
new product development process for much easier to understand and Hans Van Beek, Senior Management
Packaging and Test. Omnex currently is comprehend. The examples provided by Consultant for Philips and head of the
providing training for this class in this the instructor were very helpful.” Philips Business Excellence program
organization. • “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 ISO
Omnex completed a three day TS 16949 How to Audit ISO 9001:2000-An Auditor's Guide
Semiconductor course for another large Learn the best techniques for value-added implementation, interpretation, and
chip 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 registrar
specialists, 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 info@omnex.com
the overall program.
understand it. Excellent direction with 9001:2000—A Handbook for Auditors”,
High Marks!
respect for auditing techniques.” which is currently available: “I received
Omnex has just completed a six month
curriculum 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! I
Philips Semiconductor in San Jose,
Omnex is in the final stages of a QS-9000 read through it with great interest. It is one
California. Representatives from Atmel,
implementation for a large chip maker. of the best publications about ISO
Honeywell, 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 and
comments from the participants:
DVP&R. Omnex helped implement MSA

What is AQuA?
AQuA is an integrated database management system that stores and organizes your APQP document information. When
you view or print a document, AQuA extracts the required information and formats it for you. As a direct result of this
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• CONSISTENCY - Because AQuA stores information in a database, when you change information in one
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Training Schedule is subject to course load requirements; dates may vary. Please contact Omnex for
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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
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Dates: October 1-2, 2001 will be discussed.
Global 8D/Team Problem
This Ford-approved course teaches a methodology to help
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and 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 business
systems 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 have
Course description: Course description: learned.
This two day course discusses how to create process flow, These courses provide top management with a look at the
FMEAs, 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, TEXAS
can benefit from the process review methodology. FMEAs
help with small group improvement and in satisfying the
role in the implementation. ISO 9001:2000 Understanding
requirements of 8.2.3 for corrective action. The control plan
Lead Auditor Training with and Implementation
discusses what is being measured and how they are
Dates: October 8-9, 2001
measured. (8.2.3) ISO/TS 16949 Second Edition See course description above
ISO/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, 2001
Dates: 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 manufacturing
This is a course based on the final draft of TS 16949, Second Semiconductor Supplement requirements throughout the examples. This course provides and understanding of how
Edition, which includes ISO 9001:2000. This course will entire five day seminar. Presentation materials are to audit ISO 9001:2000, along with audit trails and
teach 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 final
Second Edition will be covered. Key differences between approval.. exam in the end of the course.
QS-9000 and TS 16949, Second Edition and the
implementation 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 evidence
Course description: required to implement the ISO 9001:2000 standard. The
Best-in-Class implementation methodology for each clause

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ISO 9001:2000 ISO 9001:2000 Internal curriculum of
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Implementation Dates: October 19-21, 2001
Dates: September 17-18, 2001 Course description: courses.
This course teaches both service and manufacturing
Course description: examples. This course provides and understanding of
This class teaches the intent, content, and objective
evidence 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, Second
standard. The Best-in-Class implementation
methodology 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 Semiconductor
two methodologies that can be used with ISO 9001:
QOS, and Process Review. QOS starts with customer QOS for ISO 9001:2000 - Supplement
expectations, goals and objectives, and then drives
toward key processes and process measurables. Process
Business Operation Dates: November 26-27, 2001
Review 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 administrative
processes. 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). Companies

Course description:
implementing ISO 9001:2000 have an opportunity to ISO/TS 16949, Second
tightly link and integrate their business systems using
This class will teach the TS 16949, Second Edition and the QOS methodology. Edition Transition Training
the Semiconductor Supplement. The task force
members will be editing the current requirements and for Auditors
aligning the Semiconductor Supplement with TS Process Review for ISO Dates: December 6-7, 2001
16949, second edition.
9001:2000 Course description:
Dates: November 12-13, 2001 This two day class will describe the most current
ISO 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 with
These courses provide top management with a look at ISO/TS 16949 and
the strategic implications and ramifications of the

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

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ISO/TS 16949
NEW! 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 Omnex's review of Understanding How to Audit ISO/TS 16949
Edition 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, 2001
July 24, 2001 overview which is integrated July 30, 2001 July 31, 2001
September 14, 2001 with ISO 9001:2000. If you are September 24, 2001 September 25, 2001
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Semiconductor Quality Ford Q1
(continued) The New Ford Q1 Requirements were rolled
The main benefit of ISO 9001:2000 is the ease with out on May 2, 2001 to the top 30 Ford
which excellence standards integrate, and implementers Suppliers. The new Q1 Requirements contain
have the choices of ISO 9004:2000, SAC standards, four parts: Capable Systems, High
Malcolm Baldridge and the Semiconductor Supplement Performance, Manufacturing Assessment, and
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certification have shown that SAC Level I companies are Ford gets high marks for this well thought-out
the best benchmark companies in the world. The SAC approach. This has what QS-9000 or
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TS-16949 does not – performance
measurable results apparently provides the results that
organizations are
requirements.
looking for.

Companies pursuing
software registration the goal of the implementers. Not only is this
could consider achieveable, but many other industries operate like this.
integrating ISO Why not semiconductors?
9001:2000 and CMM
Standard (Computer Getting Results from the Implementation
maturity model). The Another left over notion from the defense industry is the
processes required by view that ISO 9001 or TS 16949 is a customer
CMM level III specification—something that needs to be done
companies can now expediently but with very little cost or impact on the
nicely integrate with business. This view of top management causes great
the process model in harm. And if ISO or QS implementation is added as
the ISO 9001:2000 standard. another layer of requirements on top of other
requirements, then this ends up costing semiconductor
Omnex teaches a class several times a year on how to companies more money.
integrate these standards. Write to info@omnex to
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Edition. These standards should be adopted by top
Documentation.. Too Much Documentation!!! management with the view of providing measurable
Perhaps due to their defense heritage, semiconductor returns. Some goals that Omnex has recommended
companies 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 work
instructions and 150 forms and checklists or should be

Let us move forward and get the most out of our
implementations!

How Does it Work? Key Features
BOSS takes the worry out of data management by putting • Customer Expectations Tracking
forth solutions for profit and loss, production numbers, other • Linking of Expectations to Key Processes and to
business measurables, and most importantly, the process Improvement Action
metrics supporting QOS (Quality Operating • Standardized Tools and
System) and Score Card reporting efforts. It Methodologies like:
ensures that the measurement of variables • Trend charts
for processes in your business and the • Pareto diagrams
QOS result measurements are all where • 8D Summaries
they should be. • Action Plan
BOSS is capable of automatically storing
• Improvement Plan
data gathered from a variety of sources. The
• Drill Down from Corporate to
data is stored so that companies can map
Departments for each
trends and make comparisons for
measurable
illustrating problems or inconsistencies.
These problems are highlighted in a ‘drill • Visual Data Analysis and
down’ process, whereby the data stored in • Status Monitoring Practices
different categories serves a detailed analysis of these • Management Review and Improvement Meeting
problems. • Documentation
• Meeting Minutes, Agenda, Charts & Graphs, and
• Action Plan

What is Audit Pro 2000? Key Features
Audit Pro is a web-based application designed to help an • The administrator can easily add audit programs, audit
organization, manage, schedule, assign, and monitor the status types, forms, auditors, organizations, and assign forms
of 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 for
The Use of Audit Pro •
a particular organization.
Clients can log on to the site to download audit and
The power of Audit Pro is in the user-defined
customization of audit forms and checklists. This corrective action forms which can later be completed and
package 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 see
9000, ISO 14000, QS-9000 and ISO/TS-16949 and supplier their audit and corrective action status from anywhere in
audits. It can handle multiple audit programs simultaneously. the world at any point in time.

• Facilitates sending mails automatically to the
administrator, auditors, and clients in the course of an
audit.

Semiconductor newsletter8 01

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