Manufacturing Site Assessment Questionnaire英文资料.docVIP

The Planning Process Audit Notes Result (/Obs/( Planning Procedures What process does the supplier use to understand customer requirements? How are significant product and process characteristics identified? How are project risks identified, documented and communicated to the customer? Are remediation plans identified, documented and effectively implemented to address project risks? Organisational Structure Is planning process based on a cross-functional approach? Is the involvement of all relevant functions documented in supplier’s documents? Is Quality involved in project planning? Is adequate structure and resource in place to coordinate and support EDI Rail requirements? Resources Are resources reviewed and adequate to support current and new EDI Rail projects? What resource assessment methods are used? How supplier assesses the requirement for key skills and specialised workforce? Is adequate resource allocated to prepare quality planning documents for EDI Rail (Process Flow, ITP, WI, First article inspection)? Historical Quality Information Are previous and current quality issues analysed and used as input for the identification of effective countermeasures for new products? Is evidence that information on past product non conformances, warranty, plant rejections is used as input into the planning process? Traceability Are product traceability requirements clearly understood for new projects? What current traceability methods the supplier is working to? Are these methods compatible with EDI Rail traceability requirements for the project? 1.6 FMEA Is there evidence of the effective use of DFMEA’s and PFMEA’s or other risk assessment methods for all new and modified products to assess and to quantify product risks? If yes -are actions taken to reduce RPN’s? 1.7 Inspection and Test Plans Are ITP’s developed during the planning process and prior to First Article Inspection? Is there clear link between DFMEA, PFMEA, PCP and safety