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ISO 9001:2000
ISO 9001:2000 & TS 16949:1999 ISO 9001:2000 ISO 9001:2000 & TS16949:1999 ISO 9001:2000 ISO 9001:2000 & TS 16949:1999 ISO 9001:2000 New (actually Fords Q1 2002) New
7.4, Purchasing*
New
ISO 9001:2000
8.2.2, Internal Audit 8.2.3, Monitoring and Measurement of Processes 8.4, Analysis of Data
*Clauses/Subclauses examined in the third article in series (November 2001). Clauses/Subclauses examined in the fifth article in series (July 2002). Clauses/Subclauses examined in the sixth article in series (September 2002). Clauses/Subclauses examined in the seventh article in series (December 2002).
Reprinted with permission from THE INFORMED OUTLOOK June 2003 issues
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Volume 8, Number 6
need to be evaluated and verified by the organization. The customer should be apprised of any change as defined in the related PPAP reference manual, including changes to the customers proprietary designs. If a PPAP is required, then it needs to be conducted in order to validate that the change had no impact on the ability of the product and/or process to meet customer specifications. Of course, PPAP is only a customerspecific requirement of Chrysler Group, Ford Motor Company and General Motors. The customer-specific requirements of your organizations individual customer(s) need to be considered when conforming with Change Control. Although Subclause 7.1.4 is a new requirement in ISO/TS 16949:2002, it is not really new to the US automotive industry. This requirement was included by most organizations during QS-9000 implementation either because of PPAP or Q-101. The biggest impact of 7.1.4 could be found in the statement: For proprietary designs, impact on form, fit or functionshall be reviewed with the customer. This requirement differs slightly from QS-9000:1998, where 4.4.9.1, Design ChangesSupplemental, required the impact on form, fit, function, performance, and/or durability shall be determined with the customer so that all effects can be properly evaluated. The expectation is that the organization now has responsibility to consider the impact of changes not just on customer-owned design, but also on the designs that it owns.. This approach to Change Control involving proprietary designs was not implemented in many of the large Tier 1 automotive suppliers with QS-9000. Now, even though the design is proprietary, changes impacting form, fit or function need to be evaluated with the customer. This may enhance the partnership nature of customer-supplier relations in some cases. At present, one of us is working with a large Tier 1 that has hundreds of factories worldwide. It is rolling out a Manage the Change process across its several business units. The reason for the rollout is that changes in products and/or processes are causing severe problems for its OEM customer. The organization promised the customer that it would roll out a worldwide program and is now in the process of doing just that, spending a considerable amount of resources and time. Reviewing the existing change process has clarified several factors that this organization needs to consider, including: What types of changes need to be included in the process? Should all changes go through this process, including a document change? How centralized or decentralized should this process be? (Centralization provides for more control, but it results in less speed in making changes.) How many people should be involved in the change process? (More
people may mean less risk but may result in less speed and more cost.) This implementation effort clarified the importance of managing the change process in regard to the customer, the quality of the product and the organization. Most organizations would be wise to study and implement this process carefully as they revise their QMSs to fully satisfy Subclause 7.1.4.
2003 by INFORM
Volume 8, Number 6
audit products at appropriate stages of production and delivery to verify conformity to all specified requirements,. Measurement and monitoring of processes related to the organization is required in Clause 4.1 and Subclause 8.2.3. Our organization recommends that its clients again use their BMS control plans described earlier to plan and assign overall responsibilities for the measurement and monitoring of processes. Except for key processes (e.g., product realization, design and development or manufacturing) that may be monitored by Top Management, all others are probably measured locally by departments. Therefore, the organization has to assign responsibility for the analysis of data. This responsibility may be decentralized or centralized, but the result should be information that identifies potential opportunities for improvement, as described earlier. In effect, Clause 8.4 requires an organization to establish data management plans. Your organization will need to determine who will collect the data and to what aggregation level. The aggregation of the data has a direct impact on data analysis. Aggregation levels should correspond to the level of detail required for conducting data analysis. For example, delivery data gathered by the customer would identify how well your organization is meeting customer delivery requirements, but it would not tell you what productsand which of your departmentswere late. If this type of data analysis is required, then your organization needs to gather sufficient data by customer and department as well as by product. This sort of data aggregation would allow analysis by department and product as well as by customer. Finally, for data management and aggregation, you have to consider where the data is available, who will collect it, who will analyze it and what type of information is required for problem-solving and continual improvement. Most organizations will obtain large savings through the use of good data management plans and automated data collection. In most organizations, a variety of employees gather the same type of data in several different ways.
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Worse yet, this data often is not in agreement. If this data can be collected once in an effective and efficient way, made available to everyone who needs it and acted on by all in the same way, it will lead to immense savings and real benefits for the organization. So far, we have been discussing the ISO 9001:2000 requirements for analysis of data. ISO/TS 16949:2002 adds Subclause 8.4.1, Analysis and Use of Data. What Subclause 8.4.1 does is add requirements, as stated in its title, for the use of data and states: Trends in quality and operational performance shall be compared with progress towards objectives and then lead to action. Quality and operational performance data can be thought of as measurements related to the product realization process as required in Clause 4.1 and Subclauses 5.1.1, Process Efficiency, and 8.2.3. However, 8.4.1 requires this data to be compared with progress toward objectives. The overall objectives are to be set by Top Management (per Subclause 5.4.1) and then deployed into the manufacturing plants, where specific quality and operational performance data can then be tracked. Subclause 8.4.1 also relates this data analysis to addressing overall customerrelated problems and trends. The operational and quality data analyzed needs to be compared with progress toward objectives and then lead to actions for improvement as required, including the provision of prompt solutions to customer-related problems and determination of trends affecting the customer. Determining trends must contribute to status review, decision-making and longer term planning so as to identify issues to be addressed and processes and practices that have positive impacts and need to be maintained and enhanced. 8.4.1 requires linkages between data analysis and customer needs and expectations (per Clause 5.2, Customer Focus) as well as customer satisfaction (per Subclause 8.2.1). Finally, data analysis relating to the customer also needs to be linked to longer term planning (i.e., Subclause 5.4.2, Quality Management System Planning). What is important to take away from ISO 9001:2000s Clause 8.4 and
the TSs Subclause 8.4.1 is that your organization is required not just to collect data. Your organization must collect data that is relevant to measuring the effectiveness of the QMS and its processes and the satisfaction of your customer(s) and then act on this data. ISO 9001:1994 required a great deal of documentation, including of procedures, that made for a nice paper trail but did not always lead to improvement and responsiveness to customer needs. While QS-9000 was more attuned to the pursuit of improvement and customer satisfaction, ISO/TS 16949:2002 represents a more proactive approach to quality management.
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