法国THORN LIGHTING 品质验厂.doc

1a Is there a quality manual and documented procedures that describe the quality assurance activities being applied?1bIs there a management representative who is responsible for the achievement of quality?1c What records are available to demonstrate that inspection and testing has been performed? 1d By following an audit trail,is it possible to verify the interrelationship between departments?2a What information is available to communicate quality requirements to all people involved in the process?2bDo work instructions specify requirements for the operation,inspection,testing,gauging and recording results,including processes with special characteristics? 2c Are instructions/control plans available at the workstations? Can it be demonstrated that they are at the latest revision?2dCan it be demonstrated that employees perform operations in accordance with work instructions and other relevant requirements?3a Are personnel performing specific assigned tasks qualified on the basis of appropriate education,training and/or experience?3b Have adequate resources been provided to ensure customer satisfaction? Number of Quality Assurance/Control staff and support? 3c Has a system been established to identify training needs?3d Can it be proven that training of all personnel performing activities quality has been carried out? 3e.Does the management representative have responsibility and authority of promoting awareness of customer requirements throughout the organisation?4aHas the organization implemented controls for the identification,collection,indexing,filing,storage,and disposition of all records affecting product and system quality? 4bAre obsolete documents and samples withdrawn for all points of use?4cAre retention times for records established and recorded?4dIs it possible to identify the current status of all documents and samples?(sample drawings,forms in use,care points etc back to masters)5aCan it be demonstrated that machines and processes are capable of producing consistent output?Capability studies/SPC 5bAre the re quality records available to support the claims of satisfactory production?5c Are there proven methods of inspection and testing in use to demonstrate that the needs and expectations of the customer are being met? 5dIn the absence of customer specified inspection instructions can it be demonstrated that the expertise and knowledge of the supplier is satisfactorily applied?6a Is calibration of gauges,measuring and testing devices carried out in accordance with a written plan? 6bAre adequate measuring and testing devices provided for process control?6cAre measuring and testing devices individually identified?6dAre calibration records complete and up to date?6eIs calibrated equipment trace able to international standards/national standards?7a Is there a Planned maintenance system which defines maintenance criteria,assigned responsibilities and records to be retained?7b Is maintenance conducted at the prescribed frequencies of all equipment? 7cAre maintenance records analysed for trends and improvement purposes?7dAre replacement parts held as available for key manufacturing equipment?8a Does the company have an in-house design capability?8b Do the supplier use a CAD system? If yes, which system and which software release?8c Does the product/process comply with international standards?Can external test certificates be provided? 8d What is the current level of customer returns?e.g.PPM/Percentage rejection level.9a Is there a system to identify product at all stages from receipt to dispatch?9b Is there a traceability system applied to all raw material,components and parts?9cAre appropriate systems in place to ensure that materials are properly stored at all stages Suitable methods of storage? 9dHow is stock rotation controlled?Example FIFO systems where appropriate?10a Can the company demonstrate controls which ensures that non-conforming material is identified and segregated from conforming material-At incoming goods location?10b At all in-process stages?10c At finished goods/outgoing audit location?11aAre corrective actions taken to eliminate the causes of non-conformances?Example non-conformance reports,product audit results,deviations,quality records etc.11b Does the organization use a disciplined problem solving method?(E.g.8-D-report)11c Is the effectiveness of corrective actions verified?11d Are non-conformances addressed in a timely manner?11e What is the current level of customer returns?(PPM,Percentage of rejected deliveries)11f Is there a system for failure analysis and failure prevention in place(e.g.FMEA)12a Does the supplier operate a documented customer returns procedure? If so,how does it operate?12bCan the supplier provide after-sales-service support to customer?12c Is technical support offered in the event of faulty material/goods being discovered?12d What is the company policy on warranty terms?12eHow is the dispo。