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劳氏验厂一定不可出现下列问题,否则就会重验 品质FC Major 6.2 Are personnel qualified based upon appropriate education, training requirements, and/or experience? 基于适当的教育,培训,技能和经验,从事产品要求符合性工作的人员是否能够胜任?.sampling 6.7 Does the vendor formally indicate inspection status of finished goods?(成品的检验标识状态) 6.12 Does the factory have bar code scanners and perform sampling scans of barcodes on all sizes of packaging?(条码扫描仪)对各种型号的包装箱扫描 10.3 Is the calibration date of a gage or a test / inspection equipment documented?对测量仪器校验并文件化 10.4 Is the expire date of a gage or a test / inspection equipment documented?测量设备的文件上注明有效期 10.6 Are gages and test / inspection equipment controlled by a documented system and are calibration records maintained?对测量仪器文件化和点检记录要有文件系统控制 10.7 Does calibration frequency for equipment and reference standards meet PRC National Standard or other National Standard?按照国家或当地法规进行定期校验 10.8 Are controls in place to ensure that all appropriate equipment is calibrated?保证适用的设备已经校验是受控的 11.1 Does vendor have provisions for safety / reliability testing?有安全和可靠性测试 11.2 Does the vendor evaluate warranty failure data and modify the reliability test program accordingly?评估失败数据和可靠性测试程序 11.4 Are samples from current production used in the reliability test program?样品 11.5 Is there a recording system for failures?对失败数据有记录 11.6 Is there a formal system for investigating and correcting failures?有纠正预防措施执行吗 品质QMS Major 5.1 Is the question Is the QMS system effective? asked... and the answer reacted upon if needed? 是否对质量体系的有效性询问…必要性得到答复? 5.6 Are the above items discussed/documented/addressed (annually, at a minimum) at a Management Review?管理评审至少每年进行并且是否对以上问题进行讨论/形成文件/得到解决? L7.1.3 Is there evidence of an implemented Advanced Product Quality Planning process? 是否有先期质量计划过程实施的证据?control plan, process? L7.1.6 Do Failure Mode Effects Analysis (FMEA) consider all Key Product/Process/Safety Characteristics? 对于所有关键的产品/过程/安全性能是否进行失效模式分析(FMEA)? 1~10 L7.1.8 Do Control Plans (CP) follow the same process f
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