【正文】 ce to requirements ? Have written customer approval or waiver on design changes ? Have customer review proprietary design changes Product Process Management ? Element Purchasing ? Requirements: ? Evaluate, select, and control subcontractors ? Maintain records of acceptable subcontractors ? Ensure purchasing documents clearly describe the product ordered ? Review and approve purchasing documents ? Verify product at subcontractor or by customer Product Process Management ? Element Purchasing (cont.) ? Additional: ? Use customer approved subcontractors ? Satisfy governmental and safety requirements for production materials ? Develop subcontractors using QS9000 ? Require 100% ontime delivery performance from subcontractors (supplier provides appropriate planning information and purchase mitments) ? Implement a system to monitor delivery performance of subcontractors Product Process Management ? Element Control of Customer Supplied Product ? Requirements: ? Establish methods to verify, store, and maintain customer supplied products ? Record and report lost, damaged, or unsuitable product to the customer ? Additional: ? Includes customer owned tooling and returnable packaging Product Process Management ? Element Product Identification and Traceability ? Requirements: ? Where appropriate, identify product by suitable means from receipt and during all stages of production and delivery ? Where traceability is a specified requirement, provide for unique identification of product and record identification Product Process Management ? Element Process Control ? Requirements: ? Document procedures defining manner of production ? Use suitable equipment and in a suitable working environment ? Comply with standards, control plans, procedures ? Monitor and control key process parameters and product characteristics ? Approve processes and equipment ? Stipulate criteria for workmanship ? Provide suitable maintenance of equipment ? Qualify special processes Product Process Management ? Element Process Control (cont.) ? Additional: ? Have a process to ensure pliance with government safety and environmental regulations ? Comply with customer requirements for special characteristics ? Provide an effective total preventive maintenance system ? Document process monitoring and operator instructions ? Perform preliminary process capability studies and meet customer targets ? Meet ongoing process performance requirements defined by customer Product Process Management ? Element Process Control (cont.) ? Additional (cont.): ? Verify job setups ? Notify the customer and record effective dates for process changes ? For appearance items, provide: ? Appropriate lighting for evaluation ? Masters for color, grain and texture, as appropriate ? Qualified personnel to make appearance evaluations Product Process Management ? Element Inspection and Testing ? Requirements: ? Verify ining product before use according to plan ? In determining the approach, consider: ? Amount of control at subcontractor ? Recorded evidence of conformance provided ? If product is released prior to verification: ? Positively identify and record ? Recall or replace if found nonconforming ? Inspect and test inprocess product according to plan ? Hold product until verification is pleted Product Process Management ? Element Inspection and Testing (cont.) ? Requirements (cont.): ? Inspect and test final product according to plan ? Complete all specified activities and meet requirements ? Dispatch no product unless all planned activities are pleted ? Establish records which show the inspection status and inspection authority Product Process Management ? Element Inspection and Testing (cont.) ? Additional: ? Use zero defects for attribute data sampling plans ? Document acceptance criteria for other situations ? Use accredited laboratories when required by the customer ? Use one or more of the following in the ining quality system: ? Receipt of statistical data ? Receiving inspection and/or testing ? Second or thirdparty assessments ? Use an accredited laboratory for part evaluation ? Use subcontractor warrants or certifications (include test results and use one of the other methods) ? Perform layout inspection and functional verification at customer prescribed frequency Product Process Management ? Element Control of Inspection, Measuring, and Test Equipment ? Requirements: ? Determine measurements and accuracy required ? Select capable equipment ? Calibrate equipment ? Identify equipment with a calibration status indicator ? Maintain calibration records ? Evaluate previous results when outofcalibration is found ? Ensure suitable handling and environmental conditions ? Safeguard equipment from unauthorized adjustments Product Process Management ? Element Control of Inspection, Measuring, and Test Equipment (cont.) ? Additional: ? Include in calibration records: ? Revisions following engineering changes ? Gage conditions and actual readings as received for calibration ? Notification to customer if suspect material shipped ? Analyze variation of measurement and test equipment with statistical studies Product Process Management ? Element Inspection and Test Status ? Requirements: ? Identify the inspection and test status of product by suitable means and maintain throughout the production process to ensure that only verified product is used ? Additional: ? L