ISO/TS 16949 checklist about monitoring and measurement
ISO/TS 16949 checklist about monitoring and measurement
Clause 8.2
8.2.1 CUSTOMER SATISFACTION
8.2.1 Does the organization monitor information relating to customer perception as to whether the organization has met customer requirements as one of the performance of the quality management system?
8.2.2 Has the organization determined the methods for obtaining information relating to customer perception as the whether the organization has met customer requirements?
8.2.1.1 CUSTOMER SATISFACTION – SUPPLEMENTAL
8.2.3 Does the organization monitor customer satisfaction through continual evaluation of performance of the realization process?
8.2.4 Are the organization’s performance indicators for customer satisfaction based on objective data and include, but not limited to:
- delivered part quality performance?
- Customer disruptions including field returns?
- Delivery schedule performance (including incidents of premium freight)?
- Customer notifications related to quality or delivery issues?
8.2.5 Does the organization monitor manufacturing processes performance to demonstrate compliance with customer requirements for product quality and efficiency of the process?
8.2.2 INTERNAL AUDIT
8.2.6 Does the organization conduct internal audits at planned intervals to determine whether the quality management system:
a) conforms to the planned arrangements (see 7.1) to the requirements of ISO/TS16949:2002 and to the quality management system requirements established by the organization?
b) Is effectively implemented and maintained?
c) (8.2.2)
8.2.7 Has the organization planned for an audit program that takes into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits?
8.2.8 Has the organization defined the internal audit criteria, scope, frequency and methods?
8.2.9 Does the organization ensure objectivity and impartiality of the audit process in the selection of auditors and conduct of internal audits?
8.2.10 Has the organization defined the responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records in a documented procedure?
8.2.11 Does the management responsible for the area being audited ensure that actions are taken without undue delay to eliminate detected non-conformities and their causes?
8.2.12 Does the organization’s internal audit follow up activities include the verification of the actions taken and the reporting of verification results (see element 8.5.2 of ISO/TS16949:2002)??
8.2.2.1 QUALITY MANAGEMENT SYSTEM AUDIT
8.2.13 Does the organization audit its quality management system to verify compliance with ISO/TS16949:2002 and any additional quality management system requirements?
8.2.2.2 MANUFACTURING PROCESS AUDIT
8.2.14 Does the organization audit each manufacturing process to determine its effectiveness
8.2.2.3 PRODUCT AUDIT
8.2.15 Does the organization audit products at appropriate stages of production and delivery to verify conformance to all specified requirements at a defined frequency?
8.2.2.4 INTERNAL AUDIT PLANS
8.2.16 Does the organization’s internal audits cover all quality management related processes, activities and shifts, and scheduled according to an annual plan?
8.2.17 Does the organization increase its audit frequency appropriately when internal/external non-conformities or customer complaints occur?
8.2.2.5 INTERNAL AUDITOR QUALIFICATION
8.2.18 Are the organization’s internal auditors qualified to audit the requirements of ISO/TS16949:2002 (see element 6.2.2.2)?
8.2.3 MONITORING AND MEASUREMENT OF PROCESSES
8.2.19 Does the organization apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes?
8.2.20 Does the organization’s methods for monitoring and measurement of processes demonstrate the ability of the processes to achieve planned results?
8.2.21 When planned results are not achieved by the organization’s processes, does the organization take correction and corrective action to ensure conformity of the product?
8.2.3.1 MONITORING AND MEASUREMENT OF MANUFACTURING PROCESSES
8.2.22 Does the organization perform process studies on all new manufacturing processes to verify process capability and to provide additional input for process control?
8.2.23 Does the organization document the results of process studies with specifications where applicable for means of production, measurement and test, and maintenance instructions?
8.2.24 Does the organization’s documents for monitoring and measurement of manufacturing processes include objectives for manufacturing process capability, reliability, maintainability and availability as well as acceptance criteria?
8.2.25 Does the organization maintain manufacturing process capability or performance as specified by the customer part approval process requirements?
8.2.26 Does the organization ensure that the control plan and process flow diagram are implemented, including adherence to the specified:
- measurement techniques?
- sampling plans?
- Acceptance criteria?
- Reactions plans when acceptance criteria are not met?
8.2.27 Does the organization note significant process events on the control charts?
8.2.28 Does the organization initiate the appropriate reaction plan from the control plan for characteristics that are either unstable or non-capable?
8.2.29 Does the organization’s reaction plans for characteristics that are either unstable or non-capable include containment of product and 100% inspection as appropriate?
8.2.30 Does the organization establish a corrective action following the initiation of reaction plans, indicating specific timing and assigned responsibilities to assure that the process becomes stable and capable?
8.2.31 Are the organization’s corrective action plans reviewed with and approved by the customer when so required?
8.2.32 Does the organization maintain records of effective dates of process changes?
8.2.4 MONITORING AND MEASUREMENT OF PRODUCT
8.2.33 Does the organization monitor and measure the characteristics of the product to verify that product requirements have been met?
8.2.34 Does the organization monitor and measure the characteristics of the product at appropriate stages of the product realization process in accordance with the planned arrangements (see element 7.1 of ISO/TS16949:2002)?
8.2.35 Does the organization maintain evidence of product conformity with the acceptance criteria?
8.2.36 Does the organization’s records on monitoring and measurement of product indicate the person(s) authorizing release of product (see element 4.2.4 of ISO/TS16949:2002)?
8.2.37 Are the organization’s product releases and service delivery proceeding only after all the planned arrangements (see element 7.1 of ISO/TS16949:2002) have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable by the customer?
8.2.4.1 LAYOUT INSPECTION AND FUNCTIONAL TESTING
8.2.38 Does the organization perform a layout inspection and a functional verification to applicable customer engineering material and performance standards for all products at a sufficient frequency as specified in the control plan?
8.2.39 Does the organization have layout inspection and functional testing results available for customer review?
8.2.4.2 APPEARANCE ITEMS
8.2.40 For organizations manufacturing parts designated by the customer as “appearance items” does the organization provide:
- appropriate resources including lighting for evaluation?
- Masters for color, grain, gloss, metallic brilliance, texture, distinctness of image (DOI) as appropriate?
- Maintenance and control of appearance masters and evaluation equipment?
- Verification that personnel making appearance evaluations are qualified to do so?
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