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1、,1,葵花寶典:品質管理系統/QMS (e.g. ISO 9001/9004:2000 , QS-9000 , ISO/IEC 17025 , ISO/TS 16949等) 之推行 Request current CSPM before the audit, perhaps in the audit plan; Review the CSPM as the first item of the audit; Include a notice to the client of the flexibility of the auditor to change the audit track or t
2、iming based on the results of the initial review of CSPM;,110,RAB supports a less rigid audit plan to handle this variability; Auditor should maintain an awareness of the applicable CSPM requirements by each OEM; Poor CSPM results should guide the auditor towards evaluations of potential source defi
3、ciencies in the QMS; If auditor is not satisfied, system deficiencies can become a documented basis for issuing non-conformance; The CSPM and revised audit trail are documented;,111,Insufficient coverage of required surveillance items - because of unplanned auditing resulting from evaluating CSPM an
4、d related system non-conformities - is not acceptable; added effort should be planned. TS-2 Rule: The organization shall provide the following documentation to the CB for review, and for use in planning the audit:,112,Quality manual (for each site to be audited) Internal audit and management review
5、planning and results from previous twelve months List of qualified internal auditors List of customer specific requirements Customer complaints status Operational performance trends for the previous 12 months, minimum. QS-9000 4.1.5 Analysis and Use of Company Level Data The supplier shall document
6、trends in quality, operational performance (productivity, efficiency , effectiveness, cost of poor quality) and current quality levels for key product and service features.,113,These should be compared with those of competitors and/or appropriate benchmarks. Trends in data and information should be
7、compared with progress toward overall business objectives and lead to action to support: Development of priorities for prompt solutions to customer-related problems, Determination of key customer-related trends and correlations to support status review, decision-making and longer-term planning.,114,
8、TS-2 8.4.1 Analysis and use of data Trends in quality and operational performance shall be compared with progress toward objectives and lead to action to support the following: Development of priorities for prompt solutions to customer-related problems; Determination of key customer-related trends a
9、nd correlation for status review, decision-making and longer term planning; An information system for the timely reporting of product information arising from usage. NOTE Data should be compared with those of competitors and/or appropriate benchmarks.,115,IATF Guidance to TS-2: 8.4.1 Analysis and us
10、e of data Operational performance may include productivity, cost of poor quality , process efficiency and effectiveness, production output, quality performance, and equipment utilization. TS-2 Rule: 2.10 The audit plan shall include evaluation of all of the organizations QMS requirements for effecti
11、ve implementation of ISO/TS 16949:2002 as well as for effectiveness in practice. Assessment shall evaluate the effectiveness of the system, its linkages, its performance and its requirements.,116,Note: Effectiveness of the system should consider how well the system is deployed, as demonstrated by th
12、e measures defined by the organization to meet customer satisfaction and company objectives. Initial certification audit activities shall be conducted according to the following rules: Review effectiveness of the implementation of the ISO/TS 16949:2002 requirements and for effectiveness in practice,
13、 related to planned and achieved quality performance.,117,The Automotive Industrys (IATF) Categorization of QMS Processes are: Customer Oriented Processes (COPs): 常見之10 COPs Market Analysis/Customer Requirements Bid/Tender Order/Request Product and Process Design Product and Process verification / v
14、alidation Product Production Delivery,118,Payment Warranty/Service Post Sales/Customer Feedback 2) Support Processes: 常見之Support Processes: Sales 或以後製程人員稽核前製程(Internal Customer之觀念),132,儘量採用精兵制或委外給專業人士來執行，而且要嚴格執行後續之“Auditor Qualification Maintenance”之規定(可參閱 ISO 10011-1,-2 或授權以Internal audit planner/s
15、cheduler責任，在每次排audit schedule/agenda時，必需review先前所開之CARs決定是否要增加稽核頻率。,141,Process oriented auditing IATF expects TS-2 auditors to audit Customer Owned Processes (COP，也有人稱為Customer Oriented Processes 或 Core Processes). The COP is a model that was introduced by ISO 9001:2000 and refers to the fact that
16、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. The audit approach of TS-2 must not be driven by an “element” or a “section” driven checklist. Instead the checklist shall be a tool to identify the completeness of the audit, which means that
