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requirements are still not available from each original equipment manufacturer (OEM) that accepts and may soon require supplier registration to ISO/TS 16949:2002. In fact, the changes that took place between the balloting draft and published edition of ISO/TS 16949:2002 warranted a reevaluation of the challenges table. We have identified changes in the published TS in customer-owned processes, the Octopus model, process characteristics, customer satisfaction supplemental indicators and the auditing process requirements that caused us to rethink our approach to TS 16949:2002. You will find that, in Table 1 on the next page, there are several challenges where new text appears in italics, which reflects additions as a result of our reevaluation. It does not eliminate what was already required, but it does in several instances expand the challenges of some clauses and subclauses of the TS. In April 2002, we revisited the 3 challenges that we explored in November 2001 to discuss what has changed, although the changes made do not affect the guidance offered in November (see What QS-9000 Registered Suppliers Need to Prepare For, THE OUTLOOK, April 2002). To help you continue in your organizations preparations for the transition, we will explore 3 more of the 15 challenges in this articleSubclause 5.4.1, Clause 5.6 and Subclause 8.2.1 that not only will require a change in your organizations QMS, but demon-
Omnex, Inc.
734-761-4940 www.omnex.com
ISO 9001:2000 ISO 9001:2000 and TS 16949:1999 ISO 9001:2000 ISO 9001:2000 and TS16949:1999 ISO 9001:2000 ISO 9001:2000 and TS 16949:1999 ISO 9001:2000 New (actually Fords Q1 2002) New New ISO 9001:2000
8.2.2, Internal Audit 8.2.3, Monitoring and Measurement of Processes 8.4, Analysis of Data
Reprinted with permission from THE INFORMED OUTLOOK July 2002 issues
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Volume 7, Number 7
processes within their operations. Our organization recommends that your organization study four types of processes for inclusion in the process map: TS 16949 Processes Product Realization Processes Support Processes Business Processes. In addition to defining those four types of processes, we indicated that there is overlap among the four, although Product Realization Processes and Support Processes are either one or the other, not both. After studying these different processes, your organization can create a process map that identifies the most important processes to it. The
process map also can show the sequence and interaction of these processes. However, in discussing the process approach embodied in Clause 4.1, the QSA Checklist indicates that auditing of a TS 16949:2002-conforming QMS requires the auditing of Customer Owned Processes (COP), which Chapter 1, Process Oriented Auditing, of the QSA Checklist defines as follows: The COP is a model that was introduced by ISO 9001:2000 and refers to the fact that any organization needs customer input to comply to specified and expected needs of the customer (output). This is accomplished by value adding processes of product realization and appropriate support processes, both enabled by management activities and provided resources. Chapter 1 also indicates that the auditor shall audit all applicable requirements to an identified COP. Figure 1 at left provides a representation of a COP as described by the IATF and the Checklist. Only organizational processes that repeat continuously can meet customer requirements, so a series of processes, subprocesses and support processes need to be defined by the organization and audited by the auditor. Figure 2 at left presents a series of such processes that we refer to as the Octopus Model, which has been discussed at an ISO/TS 16949:2002 Rollout Meeting in April 2002 and in IATF registrar training sessions. Although not included in the Checklist or the IATF Guidance manuals, the IATF has provided examples of COPs at the ISO/TS 16949:2002 Rollout Meeting in April, which include the following processes: Market Analysis Bid/Tender Order/Request Product and Process Verification/ Validation Product Production Delivery Payment Warranty/Service Post-Sale/Customer Feedback. At the Rollout Meeting, the IATF also identified six unique, but consis 2002 by INFORM & ASQ
Product Quality
No Incoming Inspections GM
Result Measurables
Key Processes
Process Engineering
Quality Assurance
Procurement
Potential Causes
Process Measureables
Volume 7, Number 7
product quality. And not only do these objectives need to be measurable, but they must be deployed to relevant functions and levels within an organization. This means that these measurable objectives cannot just be high-level targets to be pursued and reviewed only by top management. The organization will then need a deployment process to carefully assign responsibilities throughout the organization. Finally, these objectives need to be in the business plan of the organization, as noted above, which means that management throughout the organization must treat the quality objectives as part and parcel of the organizations business objectives. In effect, there are three differences between the TS 16949:2002 and QS9000 requirements as far as what is required by Subclause 5.4.1, which corresponds to what is covered in Subclauses 4.1.1, Quality Policy (in part), and 4.1.4, Business Plan (in whole), of QS-9000. Although both require comprehensive objectives that need to be included in the business plan, TS 16949:2002 also requires that they be: 1. Measurable 2. Deployed to relevant functions and levels within the organization 3. Aligned with customer expectations.
7.3.4.1, Design and Development Measurements of design and development ReviewMonitoring (1 category) 8.2.1.1, Customer Satisfaction Supplemental Although it does not mention management review or top management, the importance of this performance evaluation to the IATF requires its review by top management. This includes delivered part quality performance, customer disruptions (including field returns), delivery schedule performance (including premium freight) and customer notifications related to quality or delivery (4 categories)
egories to be reviewed. Table 2 below identifies several subclauses and other areas that require or mention the need for the inclusion of topicsbusiness categoriesin the Management Review. While there is some overlap between categories and some are more individual measurements than full-fledged categories, they are classified as 21 categories to simplify the communication of the magnitude of the measurements required in Management Review. 2. Based on what is required in TS 16949:2002, it is not practical to conduct this review in a single meeting once a year. In fact, to treat all the categories that need to be reviewed on an equal basis will make Management Review difficult and unproductive. In reality, the top management team needs to decide the frequency with which each of the 21 categories needs to be presented to top management and subject to evaluation and decision-making based on the nature of the organization. Some categories may require review on a monthly basis, while others may only need quarterly, biannual or annual reviewing. 3. Management Review meetings must be improvement-oriented and focused on making changes required in the QMS. The inputs for Management Review are more clearly defined than in QS-9000:1998 and point to the need for the QMS to be effective, for top management to actually look at the systems performance in terms of meeting and exceeding customer requirements and for top management to proactively revise the Quality Objectives so as to aim the QMS (and thus the organization) toward improvement. 4. The output of Management Review meetings must be documented. And not just any type of output is required, but an output that records decisions and actions related to improvements in the organizations QMS, processes and products as well as resources needed to achieve those improvements. Management Review in TS 16949:2002 is no longer a fuzzy concept, but a defined business process for management to perform. This Management Review is a significant improvement over what is required in QS-9000. It is recom 2002 by INFORM & ASQ
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ture of energy, time and money and maximize the return on investment, since the upgraded system will take your organization to both a higher level of performance and a more globally accepted registration status. Speaking of registration, it is worth noting where the registration scheme for ISO/TS 16949:2002 stands. The International Automotive Oversight Bureau (IAOB) has begun offering registrar auditor training for the second edition of the TS, and registrars qualified by the IAOB to conduct ISO/TS 16949:2002 assessments and issue certificates of registration have begun to audit organizations. Whats more, auditors from a registrar not yet qualified are allowed to complete five audits before their witness audits. Based on the observation of a recent registrar audit of an organization for TS 16949:2002 conformance and a subsequent discussion with the auditors by one of us, it is not clear if all of the IATFs hot points have been communicated in the registrar training. However, an understanding of the process approach, of how to audit a process approach-based QMS and of the importance of the customerowned processes came through loud and clear in the audit. The IATF has made it clear to registrars and auditors alike that only the best registrars will be allowed to conduct ISO/TS 16949:2002 audits and that the number of registrars conducting QMS assessments in the automotive sector is expected to continue decreasing during the next few years. It is our opinion that ISO/TS 16949:2002 has a significant capability for success. However, the expectations required of the QMS auditors need to be communicated to the automotive supply base. Quality cannot be audited in. Registrars surprising organizations with seemingly new requirements for COPs and process characteristics will create a poor customer-supplier relationship. Indeed, we believe the IATF needs to more clearly identify what its expectations are for the content and results of QMS audits against TS 16949:2002 either in the guidance or rules for TS 16949:2002 or in the customer-specific requirements. Lastly, although ISO/TS 16949:2002 is published and readily available, not all the required documents for TS 16949:2002 implementation and auditing are available for immediate delivery, with several on backorder. And as noted above, the customer-specific requirements for all the OEMs are still not available. We think it is advisable that organizations that want to make the transition in the near future place orders for these guidance and rules documents now and begin to consider what the challenges of transitioning will be for their organizations. That way, when all the pieces are finally in place, the planning process will have been completed and those organizations will be able to
move forward. We will examine three more challenges in an upcoming issue of THE OUTLOOK. ### Chad Kymal is Chief Executive Officer of Omnex, Inc., an international consulting, training and software organization specializing in business quality improvement methodologies. Omnex has worked with hundreds of organizations to meet the requirements of ISO 9001/2/3, QS-9000 and ISO/TS 16949 worldwide and to obtain registration. He assists organizations worldwide in his capacity as a consultant and trainer and also serves as a Lead Auditor for AQSR, an accredited registrar that is qualified to conduct ISO/TS 16949:2002 assessments. Mr. Kymal served in the past two years on the Malcolm Baldrige National Quality Award Board of Examiners, has a BSME from General Motors Institute and has an MS in Industrial Operations Engineering and an MBA from the University of Michigan. He can be contacted by e-mail (ckymal@omnex.com). David Watkins is President of Omnex, Inc., and is a senior trainer/consultant. He has a wide range of international experience focused on enhancing the ability of organizations to create value for their customers and stockholders and integrating QMSs and other management systems to enhance performance. Mr. Watkins can be contacted by e-mail (dwatkins@omecconsultants.com).
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