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te article
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C I A L R E P R I N T …your source for the latest information on international management system standards ® © 2001 by INFORM & ASQ A Look at the Efforts of a Small Gage Manufacturer… Gaging the Challenges of Applying the TE Supplement By Melissa Syerson and Gary Phillips Publisher’s Note: This article has been reprinted with permission from THE INFORMED OUTLOOK Newsletter, April 2001 issue. C ompleted in July 1996, the Quality System Requirements: Tooling & Equipment Supple- ment (TE Supplement) provided “an interpretation of the QS-9000 require- ments as they apply to Tooling and Equipment related manufacturers”. A second edition of the supplement for tooling and equipment (TE) suppli- ers to the automotive original equip- ment manufacturers (OEMs) was issued in June 1998. A significant change in the revised edition was the removal of a prohibition against allowing TE suppli- ers to “register” to QS-9000 by using the TE Supplement. The second edition of the TE Supplement was designed to allow TE suppliers to implement and register a modified quality system that conformed to all the requirements of ISO 9001/ 2:1994 and most of QS-9000’s require- ments but eliminated or replaced re- quirements particular to production and service parts supplier operations. The expectation that the TE Supplement would be revised in 1998 so as to permit a modified QS-9000 regis- tration resulted in announcements by some OEMs in 1997 that select groups of TE suppliers would need to meet registration requirements linked to the TE Supplement. Indeed, while General Motors has no registration requirements for its TE suppliers and relies on their self-declared compliance, Ford sent letters to 600 “key” TE suppliers in 1997 establishing requirements for ISO 9001/2:1994 registration with demonstrated con- formance to the TE Supplement by one of two deadlines (December 31, 1998, for the first 125 and December 31, 1999, for the 475 others). DaimlerChrysler Corporation of Auburn Hills, MI, sent a series of letters beginning in 1997 to approximately 1,400 TE suppliers (later refined and reduced to approximately 570) estab- lishing a TE Supplement registration deadline of July 31, 2000. Thus, of the estimated 50,000 TE suppliers to the automotive sector, 1,200 or so are required by the Big Three to pursue some form of quality system registration that involves con- formance to the TE Supplement. The challenge for TE suppliers is both determining what is required to demonstrate quality system conform- ance to the OEMs and the reality that most TE suppliers are fairly small orga- nizations (less than 50 employees). Yet, the quality systems of these suppliers— which provide the tooling and equip- ment used in the facilities of the OEMs and their parts suppliers—are important to the processes and overall quality control in the sector. One group of TE suppliers that has been significantly affected by the TE Supplement are gage manufacturers. Gages are manufactured to inspect and/ or test and thus they “accept/reject” the various components that are manufac- tured for and assembled into automo- tive vehicles. A large percentage of gages are required to be manufactured within very tight specification tolerances due to the important role that they play. Many gage companies that supply directly and/or indirectly to the automo- tive OEMs have been required to address and become registered to the require- ments of QS-9000 as modified by the TE Supplement. At this time, there aren’t any new registration requirements for gage manufacturers, but those TE suppli- ers that are not yet in compliance with the DaimlerChrysler and Ford letters are starting to see the consequences—re- moval from their bid lists. To help both gage manufacturers still implementing quality systems in conformance to the TE Supplement and organizations that need to understand the situation faced by gage manufactur- ers, we will explore some of the difficult issues faced by gage manufacturers and some implementation options. The Difficulties Faced by Gage Manufacturers The TE Supplement was developed by the DaimlerChrysler/Ford/General Motors Supplier Quality Requirements Task Force (SQRTF) to provide a means to demonstrate quality system conform- ance to QS-9000 for those companies in the tooling and equipment industry that supply machinery and other equipment used by the Big Three—and some of their major Tier 1 suppliers—in the manufacture of automotive parts and the assembly of vehicles. This was a very smart move by the OEMs, since the equipment used to manufacture production and service parts and to assemble those parts into the end-product is critical to the perfor- mance of these processes and the con- formance of the product. Unfortunately, when you read the TE Supplement, it
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INFORMED Outlook Reprint: April 2001 © 2001 by INFORM & ASQ Web Site: HTTP://WWW.INFORMINTL.COM appears as if it was almost an after- thought to have gage manufacturers develop, implement and maintain quality systems that conform with and could become registered to the TE Supplement. In applying QS-9000 as modified by the TE Supplement to gage manufac- turers, both small and large firms have been challenged by some of the specific requirements of QS-9000 and the supplemental requirements that TE suppliers are to follow. The TE Supple- ment basically directs TE suppliers to ignore some QS-9000 requirements that do not apply to TE processes and, in some instances, to meet other require- ments that are meant to be more appro- priate—and effective—for many types of TE operations. Keep in mind that QS-9000 is designed to suit processes involving the mass production of parts, while many TE suppliers produce small quantities of tooling and/or equipment that must be manufactured to perform precise func- tions (e.g., die manufacturers). The requirements in QS-9000 itself are very generic so as to be able to be applied to the processes that output the various products that are assembled into the final product—the vehicles that roll off the assembly line of an OEM. The TE Supplement is very specific to TE manufacturers that manufacture the machinery, tools, equipment, fixtures and dies that produce the parts for and are used in the assembly of these vehicles. However, gages are not used to produce the parts that make up a vehicle or to assemble the vehicle; gages are used to measure or test the parts that tooling or equipment purchased from a TE supplier produces. In a sense, gages are tier 2 tools. Neither the require- ments of QS-9000 itself nor of QS- 9000 as modified by the TE Supplement apply entirely to the pro- cesses covered by gage manufacturer quality systems. This makes it difficult both for individual gage companies that attempt to implement a quality system to obtain TE Supplement registration and for any auditor that must assess the conformity of these quality systems. Not only is applying the TE Supplement to a gage manufacturing organization a difficulty, but finding a registrar that has auditors who under- stand the unique circumstances of gage manufacturers is challenging. We have found that there are few auditors with the field expertise necessary to effec- tively assess the conformance of gage industry quality systems with the TE Supplement. Thus, it is a necessity for gage manufacturers to obtain their regis- tration assessments from a registrar that has auditors with industry experience in the manufacture of gages. Learning the Hard Way at Dependable Gage and Tool We learned firsthand at Depend- able Gage and Tool Company in Oak Park, MI, that if an auditor with little field experience with gage manufacturers attempts to conduct a TE Supplement assessment of a gage company’s quality system, the result is likely to be dissatis- faction for all parties involved. Depend- able Gage and Tool Company has 20 employees and designs and manufac- tures a wide variety of gaging, design and build, from fixture gages to semi- automatic gages for automotive parts. Approximately 80% of Dependable’s business is automotive, and most gages manufactured are on a custom basis. Dependable supplies to all tiers of the automotive industry and achieved registration to QS-9000 with compliance to the TE supplement in December 2000. This was accomplished in approximately a one-year timeframe. One issue that we faced at Depend- able Gage and Tool in having an inexpe- rienced auditor assigned to conduct the TE Supplement registration assessment was the misconception—of the audi- tor—that Clause 4.2.4, Machinery Qualification Runoff Requirements, in the TE Supplement should—or could— be applied to gages. Anyone familiar with the gage industry also would know that it is impossible to apply these machinery qualification requirements of the TE Supplement to gage manufacturing. The TE Supplement’s runoff require- ments are a replacement of the QS-9000 production part approval process (PPAP) requirements. Clause 4.2.4 of the TE Supplement has been developed to assure that all identifiable problems are elimi- nated before machinery, tooling or equip- ment is integrated into a larger system or installed at the manufacturer’s site of operation. But it is impossible to apply these runoff requirements to a gage. The basics of the runoff require- ments are for the machinery to function and produce product for either 50/20 hours of dry run (50 hours for robots and 20 hours for all other machinery). The machinery, tooling and equipment must continuously operate without failure or intervention at the customer- specified cycle speed to comply. This is impossible with gages, because it is not possible to run a gage for 50 or 20 hours at a continuous cycle speed. This TE Supplement requirement is therefore inapplicable to the gage industry. It is difficult for most organizations in specialized industries to apply the “benchmarking requirements” of QS- 9000 and the TE Supplement to many aspects of their operations. QS-9000 throughout mentions the need to benchmark and specifically requires benchmarking-related activities in Sub- clause 4.1.4, Management Responsibil- ity, Business Plan. Subclause 4.1.4 states that, as part of the business plan, “The goals and plans should be based on analysis of competitive products and on benchmarking inside and outside the automotive industry and the supplier’s commodity.” Remember that QS-9000 states in its Approach: “The word ‘should’ indi- cates a mandatory requirement with Reprinted with permission from THE INFORMED OUTLOOK April 2001 issues THE INFORMED OUTLOOK 4 15913 Edgewood Drive 4 Montclair, VA 22026 Tel: (703) 680-1436 4 Fax: (703) 680-1356 E-Mail: INFORMINTL@EROLS.COM 4 Web Site: HTTP: WWW.INFORMINTL.COM Contact us TODAY for a FREE sample issue …and a SPECIAL subscription offer (code FS-0104)!
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4 THE INFORMED Outlook 4 3 INFORM: (703) 680-1436; ASQ: (800) 248-1946 © 2001 by INFORM & ASQ some flexibility allowed in compliance methodology.” And although the content of the business plan is not subject to a third-party (registrar) audit, an auditor can verify if the organization has ad- dressed the Subclause 4.1.4 requirements. Many businesses inside the auto- motive sector are highly competitive and conceal information that would be considered of great value for competi- tors to benchmark against. Like many specialty manufacturers, Dependable Gage and Tool produces specialized gages that it supplies to a range of cus- tomers in a number of sectors, not just automotive, making it difficult to sup- ply information for benchmarking pur- poses because of the confidentiality requirements of other customers and the company itself. In this case, we used information gathered by a tooling association in which Dependable Gage and Tool par- ticipated as a part of its benchmarking process. Such information can be used to benchmark a company against the industry sector for compliance with QS- 9000’s requirement for analysis of com- petitive products and benchmarking, including outside the automotive sector. Despite the clear benefits for almost any organization, obtaining registration to ISO 9001/2, QS-9000 and/or the TE Supplement is usually a more challenging and difficult feat for small organizations than for larger ones. This is often because smaller organizations lack the resources and access to the expertise needed to implement an effective and conforming quality system. A large amount of man- power is needed to develop, implement and maintain a quality system that con- forms to the TE Supplement or any other set of requirements. Implementation Options and Tools for Gage Manufacturers Like a majority of TE suppliers, many gage manufacturers are small orga- nizations with limited resources, so most place the management representative’s responsibilities in the hands of the plant or quality manager. The problem is that saddling the plant or quality manager with the management rep’s responsibili- ties makes it difficult to also manage the organization’s day-to-day operations. Clearly, the management of these organi- zations can apply the TE Supplement to their quality systems, but often a higher level of expertise is needed. This is also true for the responsibilities of the internal auditing function. There is an alternative implementa- tion approach that would provide the organization with an effective, TE Supplement-conforming quality system without burdening the plant or quality manager. Many TE companies in this situation find it beneficial, more efficient and cost-effective to hire a consultant with industry experience and expertise. This individual can handle the management representative’s function during the implementation phase (handing this responsibility back to an internal management rep after registra- tion is achieved), can lead the internal auditing function or perform both func- tions until the quality system is imple- mented, effective and registered. In addition, a gage manufacturer or other TE supplier has available to it the core tools of QS-9000 and the TE Supplement. The QS-9000 catalogs consist of a number of quality system manuals that any automotive supplier should count among their core imple- mentation and registration tools. These core tools (and modifications of QS-9000’s definitions of the tools) are: q Reliability and Maintainability Guideline for Manufacturing Machinery and Equipment (R&M Guideline). (A guideline providing reliability and main- tainability fundamentals, including recommended R&M practices. The practices include tools and techniques for both users and suppliers of machin- ery and equipment.) q Potential Failure Mode and Effects Analysis (FMEA) manual. (A guideline providing tools and techniques for a systemized group of activities intended to: 1) recognize and evaluate the poten- tial failure of a product/process and its effects; 2) identify actions that could eliminate or reduce the chance of the potential failure occurring; and 3) docu- ment the process.) q Advanced Product Quality Planning and Control Plan (APQP) manual. (A manual providing guidelines designed to produce a product quality plan that will support the development of a product or service that will satisfy the customer.) q Statistical Process Control (SPC) manual. (A manual providing an intro- duction to SPC that is intended neither to limit evolution of statistical methods suited to particular processes or com- modities nor to be comprehensive of all SPC techniques.) q Measurement Systems Analysis (MSA) manual. (A manual providing an introduction to MSA and intended to cover normally occurring measurement systems situations.) These core tools are often over- looked by TE suppliers in terms of level of importance to quality system con- formance. In the development of a quality system to meet the requirements of QS-9000 or the TE Supplement, it is easy to mistakenly “write in” the core tools as a part of the quality policy or the procedures of the system, making them subject to auditing without ac- tively using them to implement and manage the system. This creates addi- tional difficulties in terms of system nonconformances that an auditor may report, because a QS-9000-registered or TE Supplement-compliant supplier is required by them to use these core tools to support the quality system. In other words, the manuals should be used as reference tools only—but references to be followed wherever appli- cable—without being embodied within the quality system documentation. By not using the manuals as specified, an organization may burden itself with more difficult requirements than necessary. Another technique that could assist small TE suppliers is what could be called an organizational approach to quality system implementation. In the quest to conform with and become registered to QS-9000 as modified by the TE Supplement, TE suppliers can generalize many of the requirements to the family of products produced. When developing the required documentation for a QS-9000- and/or TE Supplement- conforming quality system, a family approach may be taken. This means that, in place of the specialized Design FMEA, Process FMEA, R&M plan and control plan that are developed for each individual job or product, DFMEAs, PFMEAs, R&M plans and control plans can be developed that are generic to the com- mon processes and common aspects of the jobs/products or generic to types of products (e.g., fixture gages, automatic
4.
4 4 THE
INFORMED Outlook Reprint: April 2001 © 2001 by INFORM & ASQ Web Site: HTTP://WWW.INFORMINTL.COM gages, semi-automatic gages). If all gages are manufactured through the same processes, this makes the concept of generic or family-compli- ant documentation much easier to ap- ply. Few organizations take advantage of this approach, but it can be a very im- portant technique for smaller firms that specialize in one type of product. In general, gages, dies, tools, fix- tures and molds are manufactured to the intent of a blueprint provided by the manufacturer’s product design and development team or by the customer so as to attain the desired end result required by the customer. Organizations in industries that employ highly skilled and trained tradespeople to perform and/or manage the production processes also will not need to provide work instructions to these employees to satisfy the require- ments of the TE Supplement and QS- 9000, thereby eliminating the need for detailed work instructions in the process of manufacture and the operation of manufacturing machinery. This eliminates one more difficulty for small organizations, like Dependable Tool and Gage and other gage compa- nies, that need to obtain and maintain TE registration to meet the needs of their automotive customers. The fact remains that, although challenging for small organizations, implementation and use of a quality system that conforms to the require- ments of QS-9000 as modified by the TE Supplement will benefit the opera- tions of TE suppliers. It is simply a matter of understand- ing how to apply the requirements in implementing and registering the system so that the intent of the requirements is satisfied and the result is a quality sys- tem that improves processes and reduces nonconforming product. These results will only come with work and an understanding of what the TE Supplement requires, especially when the organization involved is a gage manufacturer or other supplier for which the TE Supplement is not a per- fect match. ### Melissa Syerson is President of Syerson Consulting and has more than nine years of experience as well as an aca- demic background in quality, quality system standards and requirements (ISO 9001/2/3:1994, ISO 9001:2000, QS- 9000, and the TE Supplement), docu- ment control and quality engineering. She is a certified IRCA QMS Lead Auditor and is currently a Lead Auditor for ISO 9001/2/3:1994, ISO 9001:2000 and QS-9000 registration and surveillance assessments for Quality Management Institute (QMI) a division of CSA International. Mrs. Syerson can be reached by phone (810-293-1201) or e-mail (melissa@syersonconsulting.com). Gary Phillips is Shop Manager and the TE Supplement Management Represen- tative at Dependable Gage and Tool Company in Oak Park, MI. Mr. Phillips has more than 20 years of expe- rience in the automotive and related industries and has a Bachelor’s of Busi- ness Administration. CALL (703) 680-1436 OR FAX (703) 680-1356 Visit www.INFORMintl.com © INFORM & ASQ Printed on recycled paper THE INFORMED OUTLOOK…your source for the latest information on international management system standards co-published by… Inside THE OUTLOOKInside THE OUTLOOK ® March 2001 4 Volume 6, Number 3 (page 21, ISO/CD3 19011) (page 8, SPC GUIDANCE) Does Your Organization Know How to Apply SPC? ISO SPC Guidance Will Assist ISO 9001:2000-Based QMSs By John E. (Jack) West F or a number of industries, statisti- cal process control (SPC) is an activity that is critical to the effective operation of a quality manage- ment system (QMS) and to satisfying customer requirements for product quantity as well as quality. SPC is a well-established quality management tool, and some sectors have had SPC reference manuals for use in meeting QMS requirements for some time (e.g., the SPC reference manual used with QS-9000 was first issued in 1992). Yet, despite the existence of the ISO 9000 series since 1987, ISO has not had a good SPC guidance standard to support this critical QMS activity as well as the requirements of ISO 9001/2. This situation should soon be recti- fied when ISO 11642-1, which is pres- ently a Final Draft International Comment and Balloting for Draft Auditing Standard Ends US Submits Qualified “Yes” on Advancing ISO/CD3 19011 O n February 13, 2001, the joint US TAG’s Environmental Auditor/Quality Auditor Liai- son Committee (US Joint Committee) submitted 80 comments and a vote to conditionally approve the advancement of the third Committee Draft (CD3) of ISO 19011, Guidelines on quality and/or envi- ronmental management systems auditing. The US vote is based on the results of a round of comments and balloting that concluded on January 15, 2001, with 16 votes of approval, 3 votes of disapproval and no abstentions. The qualified “yes” is based on the expectation that US concerns with CD3’s criteria for auditor competency and the lack of audit management guid- ance on determining such competency will be addressed. The ballot was not a vote to advance CD3 to the Draft Inter- national Standard (DIS) stage, but rather on whether CD3 will be mature y The Arrival of ISO 9001:2000: Building a Transition Strategy y The Role of ISO 19011:2001 in EMS and QMS Auditing y QuEST Forum: TL 9000 Alignment with ISO 9001:2000 Approved y Marketplace Trends— Taking the Pulse of ISO 14001 Registrations y Legal Liability: ISO 9001:2000, A Liability Perspective on Its Impact y A Registrar Q&A! The ISO 9001:2000 Transition—Documenta- tion Requirements y Registration Issues: What Are an Organization’s Rights With Its Registrar? y Plus…Other News Items co-published by… ® Satisfaction Guaranteed co-published with the American Society for Quality (ASQ) America’s # 1 newsletter on management system standards 4 factual, timely, usable 4 one source for all standards 4 in-depth how-to guidance 4 backed by leading industry experts Ask for a free sample issue
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