Tooling
& Equipment and Semiconductor Supplements to Expire
with QS-9000
As most automotive suppliers
are now aware, QS-9000 will expire on Dec. 14, 2006. Along
with its expiration go the QS-9000 Tooling & Equipment
Supplement and the QS-9000 Semiconductor Supplement. This
leaves many suppliers in these two industries wondering
what comes next.
The Big Three’s QS-9000 Supplier Quality Requirements
Task Force recently published a letter addressing supplier
organizations utilizing the QS-9000 Tooling & Equipment
and Semiconductor supplements.
Regarding ISO/TS 16949 registration, the International
Automotive Task Force will not develop a semiconductor supplement
or guidance document, or a tooling and equipment supplement
or guidance document.
Addressing semiconductor manufacturing supply organizations,
the letter states: “Certification to ISO/TS 16949
is available utilizing the existing ISO/TS 16949 requirements
document. Refer to General Motors, Ford Motor Co. and DaimlerChrysler
ISO/TS 16949 customer specifics for inclusion of the QS-9000
Semiconductor Supplement as a reference manual.”
To tooling and equipment suppliers, the letter states:
“Certification to ISO/TS is not available. Contact
your customer for tooling and equipment requirements.”
So, what does this mean for the organizations in these
two industries? Many may consider switching to ISO 9001:2000
to conform to ISO/TS 16949 as closely as possible. However,
Jim Mroz, senior editor of The Informed Outlook, warns that
there are potential setbacks to that plan of action. “Each
OEM has its own requirements for registration and/or compliance
with the TE or Semiconductor Supplement, so suppliers may
not be able to just drop their QS-9000 supplement registrations
and switch to ISO 9001:2000, even if they have other customers
outside the automotive industry that want ISO 9001:2000
registration,” he notes.
Another option is to upgrade to ISO 9001:2000 and maintain
conformance to QS-9000 supplements while they’re still
in effect, Mroz says. “Many suppliers in these two
industries have customers outside the automotive sector
that already require the transition to ISO 9001:2000,”
he explains. “There’s nothing to prevent a TE
or semiconductor supplier from upgrading its quality management
system to satisfy ISO 9001:2000 while maintaining QMS elements
required by QS-9000. It would simply require the supplier
to have its registrar cover both sets of requirements during
an audit and to issue an ISO 9001:2000 registration certificate
while keeping up its TE or semiconductor supplement certificate.”
To read the Big Three’s letter, visit the Automotive
Industry Action Group’s Web site at www.aiag.org.
Federal Agencies Hope to Improve Manufacturing
Research and Development
Six federal agencies involved
in manufacturing research and development have launched
a major effort to improve the exchange of information on
their technical programs and collaborate to enhance the
payoffs from federal investments in this area.
The Government Agencies Technology Exchange in Manufacturing
will comprehensively address manufacturing R&D across
the federal government. Agencies involved include the Department
of Commerce, represented by the National Institute of Standards
and Technology; the Department of Defense; the Department
of Energy, represented by the National Nuclear Security
Administration and the Office of Energy Efficiency and Renewable
Energy; the National Aeronautics and Space Administration;
and the National Science Foundation
Two topics have been identified as initial priority areas
in which all six GATE-M agencies have activities underway
or could benefit from new activity. These areas are:
Intelligence in manufacturing--a cross-cutting technology
area that could transform how manufacturing is carried out
in the future. Activities in this area could have a major
impact on supply chain cost, quality and reliability. In
addition, agencies with product-oriented missions might
be able to apply technology developed at other agencies
to specific manufacturing problems.
Nanoscale and microscale systems and technologies--this
area presents many manufacturing and systems issues related
to electrical and mechanical applications, assembly, and
measuring techniques and tools. GATE-M activities in this
area will be coordinated with the work of the National Nanotechnology
Initiative.
To foster information exchange, GATE-M participants plan
to conduct detailed interagency reviews of programs in the
aforementioned areas. They are also considering co-sponsoring
workshops, promoting and sponsoring the development of “roadmaps”
in specific technical areas, and conducting multi-agency
brainstorming sessions.
GATE-M’s intent is to involve the nation’s
manufacturing community of industry, government, academia
and manufacturing associations in an integrated effort.
Other technical areas of interest to the GATE-M agencies
include environmentally focused technologies and processes,
homeland and national security, manufacturing education,
manufacturing process development, manufacturing quality
and reliability, and supply chain/systems integration and
interoperability.
GATE-M also plans to issue joint white papers that represent
interagency positions. Other possible strategies include
issuing joint “challenges” to the research community
to tackle and solve difficult technical obstacles, developing
joint small business innovative research topics and awards
and supporting studies by authoritative third parties to
address technical issues. For more information, visit www.mel.nist.gov.
Manufacturing “Nobel Prize”
Recognizes Lean Organizations
A record number of organizations
applied for the 2003 Shingo Prize for Excellence in Manufacturing;
in fact, there’s been a 133-percent increase in applicants
since 2000. As a result, administrators of the coveted “Nobel
Prize” of manufacturing have recognized a record number
or organizations: 15 winners and 25 finalists.
“We’re very impressed with the lean manufacturing
achievements of this year’s recipients,” says
Ross Robson, the Shingo Prize’s executive director.
“In an economic recession, it’s a comfort to
see plants that are prepared to weather economic uncertainty
by not wasting precious manufacturing and business resources.”
The Shingo Prize program is the only industrial excellence
award that focuses on lean manufacturing. First implemented
in the Toyota Production System, lean manufacturing has
become a widely used quality improvement tool, focusing
on waste reduction and increased workflow.
The Large Business category yielded the most winners--14
in all--several of which were sectors of a shared parent
company. Two divisions of Autoliv ASP were winners: Airbag
Module Facility of Ogden, Utah, and Inflator Facilities
of Ogden and Brigham City, Utah. Two TI Automotive sites--in
Caro and New Haven, Michigan--were separately recognized.
Delphi Corp. saw similar results, as four of its operations
received the Shingo Prize: Delco Electronics de Mexico,
Delnosa 1–4 Operations in Reynosa, Mexico; Energy
& Chassis Systems, Sistemas Electricos y Conmutadores
of Juarez, Mexico; Flint Operations in Flint, Michigan;
and Packard Electric Systems, Plant 19 of Warren, Ohio.
Large businesses that rounded out the category were Lockheed
Martin Aeronautics Co., F-117 of Palmdale, California; Medtronic
Xomed of Jacksonville, Florida; Merillat Industries in Atkins,
Virginia; Symbol Technologies Inc. in New York, Texas and
Mexico; The HON Co. of Cedartown, Georgia; and Vibracoustic
North America, MCU Products Lead Center in Manchester, New
Hampshire.
The Small Business Category generated one winner: Affordable
Interior Systems Inc. of Hudson, Massachusetts. In addition,
25 finalists were recognized.
The Shingo Prize for manufacturers in the United States,
Canada and Mexico is administered by the College of Business
at Utah State University. Awards will be presented at the
15th Annual Shingo Prize Conference and Awards Ceremony
on May 14 in Detroit.
To learn more about the winners and finalists, visit www.shingoprize.org.
ANSI-RAB Responds to NAPA Report Recommendations
In its report “Third-Party
Auditing of Environmental Management Systems: U.S. Registration
Practices for ISO 14001,” the National Academy of
Public Administration detailed a number of recommendations
to strengthen U.S. environmental management system registration
practices. The American National Standards Institute-Registrar
Accreditation Board’s National Accreditation Program,
the U.S. accreditation body for management systems, has
answered by indicating improvements that have been made
in response to the report and other stakeholder input.
“The ANSI-RAP NAP has taken a thorough and measured
approach in addressing the recommendations of the NAPA report
and has implemented new guidance and procedures to enhance
public confidence in the system,” says Lane Hallenbeck,
ANSI’s vice president for conformity assessment.
Auditing and registration are based on international consensus
standards: ISO 14001 for EMS and ISO 19011 for auditing
of management systems. Registrars must abide by ISO/IEC
Guide 66 and accreditation bodies by ISO/IEC Guide 61. Additionally,
related norms of practice are developed by the International
Accreditation Forum.
Issue 2 of IAF Guidance on the Application of ISO/IEC
Guide 66, released after the NAPA report was published,
responds directly to many of the report’s recommendations.
In light of the substantial changes to the IAF Guidance,
the ANSI-RAB NAP withdrew its “Criteria for Bodies
Operating Registration of Environmental Management Systems.”
Thus, ANSI-RAB NAP contends that the landscape has changed
significantly since the NAPA report was researched and published.
What follow are some of NAPA’s recommendations and
ANSI-RAB NAP’s response to each:
NAPA--The ANSI-RAB NAP should play a central role in U.S.
EMS registration and “act fairly but vigorously to
correct, sanction or suspend poorly performing registrars
and auditors.”
ANSI-RAB NAP--For initial accreditation, re-accreditation
every four years, and re-accreditation annually, ANSI-RAB
NAP auditors conduct extensive office audits of registrars
and observe registrar auditing and registration practices
at facilities seeking registration. If these audits indicate
serious nonconformances that are not addressed in a timely
manner, accreditation may be suspended or withdrawn.
NAPA--The ANSI-RAB NAP should ensure uniform implementation
of ISO 14001.
ANSI-RAB NAP--ANSI-RAB NAP monitors the interpretations
of each accredited registrar for conformance with the standard,
as well as the registrars’ conformance to IAF Guidance.
The wide variety of organizations registered to ISO 14001
demonstrates that the standard is flexible enough to be
applicable and useful for enterprises of any size and type
of business.
NAPA--Registrars and auditors should ensure substantive
conformity to ISO 14001.
ANSI-RAB NAP--An audit team with the competence required
by IAF Guidance should have no difficulty identifying that
an organization has a satisfactory process.
NAPA--Auditors should document all judgments that lead to
findings.
ANSI-RAB NAP--The need for auditor documentation is addressed
extensively in ISO 19011. Because documented evidence is
an integral component of a successful registration program,
ANSI-RAB NAP auditors examine how findings and nonconformances
are supported by documentation.
NAPA--More guidance is needed in a number of areas, including
auditor independence.
ANSI-RAB NAP--Impartiality and freedom from conflict of
interest are clear requirements of ISO/IEC Guide 66:1999,
and IAF Guidance requires that an auditor be fully independent
of the organization being assessed.
NAPA--Pre-audit planning needs more attention.
ANSI-RAB NAP--The revised IAF Guidance addresses competence
of personnel, contract review, selection of the audit team,
and what the audit team is expected to address during the
Stage 1 audit. ANSI-RAB NAP auditors routinely examine how
registrars incorporate this guidance.
NAPA--Surveillance audits and assessments of continual EMS
improvement need more attention.
ANSI-RAB NAP--The revised IAF Guidance on assessing continual
improvement, surveillance and reassessment meets this need.
Because continuity of an auditor and/or audit team is important
in assessing continual improvement, the ANSI-RAB NAP assesses
this during audits of registrars. Since the NAPA report
was published, NAP has begun assigning an executive audit
team leader to each registrar for the duration of the accreditation
cycle.
NAPA--More uniform auditor training is needed.
ANSI-RAB NAP--Auditor certification should remain voluntary.
“The latest IAF Guidance provides more specific direction
to registrars on the use and conduct of auditors,”
says Robert H. King Jr., RAB’s president and CEO.
More recommendations are outlined in the complete ANSI-RAB
NAP response, which is available online at www.rabnet.com/pub/newsletters/NAPAresponse.pdf.
INDUSTRY NEWS
Faro Technologies Inc. has formed a strategic arrangement
with HighRES Inc., a provider of CAD/CAM integrated 3-D
digitizing software. Under the arrangement the Platinum
FaroArm, Titanium FaroArm and FARO Laser Tracker will now
ship with HighRES’s reverse-engineering software modules.
The arrangement eliminates the need for FARO customers
to import 3-D data from stand-alone platforms. FARO will
review proposals from other third-party software companies
in an effort to further broaden the digitizing options for
its CMM clients. Learn more at www.faro.com.
HighRES’s Web site is www.reverse-it.com.
JMP, a Business Unit of SAS, has partnered with Sigma Breakthrough
Technologies Inc. to promote Six Sigma training. The relationship
provides Six Sigma training curriculum that integrates JMP
statistical analysis software. The software allows users
to link statistics with graphs and visually explore data.
Customers can utilize both companies’ resources to
learn how to use JMP software for Six Sigma implementation.
Learn more at www.sbti-hq.com.
Smithers Scientific Services Inc. has reorganized after
acquiring an environmental toxicology and analytical studies
company. The reorganization encompasses three companies
structured under the name, The Smithers Group.
With worldwide headquarters in Akron, Ohio, The Smithers
Group companies include Smithers Scientific Services--a
testing, research and consulting firm for the tire, rubber,
plastics, chemical and automotive industries; Smithers Quality
Assessments--a third-party registrar; and Springborn Smithers
Laboratories--a contract research and regulatory compliance
firm in the pharmaceutical, agrochemical and chemical industries.
For more information, visit www.smithersscientific.com.
Integral Solutions and ASI DataMyte have finalized a merger
that combines ISI’s quality process and control software
with ASI DataMyte’s hardware components.
The combined companies will provide PC-based wireless
and hand-held data collection devices; software for quality
documentation, applied statistics, data analysis and reporting;
gage management and attribute data collection; and product
and methodology training. For more information about the
merger, visit www.integralsolutions.com
or www.asidatamyte.com.
Six Sigma Academy is under new ownership and leadership.
Jack Finney, a longtime member of the company’s board
of directors and one of three shareholders, has assumed
the role of owner, president and CEO.
Other leadership appointments include Jim Anderson as
finance manager; Phyllis Finney, Laura Joslin and Karen
Riding as master consultants; Steve Marra as executive consultant;
and Debby Sollenberger as vice president of breakthrough
value services. Learn more at www.6-sigma.com.
The proposed new version of DIS 13485 is in its final stage
before formal publication. FDIS 13485 is intended to update
ISO 13485:1996, a management system for medical devices.
FDIS 13485 was released for restricted circulation to
the committee members of ISO/TC 210 and the National Standards
Committees on Feb. 13. Recent estimates suggest that ISO
13485:2003 will be published between May and July 2003.
For future updates about the progress of FDIS 13485, visit
www.bsiamericas.com/MedicalDevices/Updates.
Following Brown & Sharpe’s announcement of the
closure of the Standard Gage plant in Poughkeepsie, New
York, Dorsey Metrology International, also located in Poughkeepsie,
announced their intention to manufacture and support many
of the products that were previously manufactured by Standard
Gage prior to the plant’s closure.
Dorsey acquired much of Standard Gage’s tooling
and machinery at auction and subsequently hired former Standard
Gage employees to continue manufacturing many of the core
products. To learn more, visit www.dorseymetrology.com.
IQS Inc. has donated $500,000 worth of its Business System
and API Toolkit software to Penn State University’s
Center for Manufacturing Enterprise Integration.
Funded by the Ben Franklin Technology Partnership, CMEI
focuses on research to improve e-manufacturing across enterprises,
distributed production control and distributed process control.
The donation of IQS software augments Penn State’s
efforts to provide students access to cutting-edge technologies.
Learn more at www.iqs.com.
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