质量内审检查表－品质部.docx

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1、质量管理体系内部审核检查表INTERNAL QUALITY AUDIT CHECK LIST受审核部门Department tobe auditedQC受审核部门负责人Head ofdepartment to beauditedSkyLihong页码page审核组长Audit groupleaderSky审核员auditorGobby/Max/Victor审核时间Audittime2020/8/11过程要素Processelements审核要点Audit points审核记录Audit records评价evaluation1.1、 文件要求Documentationrequirements1

2、.2、 文件控制Documentationcontrol1.3、 记录控制Record control1、是否得到了适用的有效的文件？Do they get the applicable effective files?2、部门使用的文件是否有效？Are the documents used by the department effective?1、记录的填写是否真实、及时、清楚、正确？Is the record filled in true, timely, clear, correct way?2、部门的记录是否按规定进行整理、保管，保管是否适宜？Are the department r

3、ecords sorted out and keptaccording to provisions. Is the custody proper?均为有效版本经批准发放，均为有效版本符合规范并进确认符合要求合格2.2、职责和权限Responsibilityand authority2.3、内部沟通Internalcommunication1、部门的职责、权限是否得到规定？Are the responsibility and authority of the departmentruled?2、部门的相关人员对职责、权限是否进行了有效地沟通？Do the relevant personnel o

4、f the department have aeffective communication about responsibility andauthority?1、沟通方式是否得到规定？Is the communication way ruled?2、沟通的有效性如何？How is the effectiveness of communication?制定了清晰的岗位责任制.组织架构图和职责分配等电话沟通，邮件确认，会议跟踪合格3.1、资源提供Provision ofresources部门的人力资源、基础设施、工作环境等是否充分，能否保证正常工作的需要Are the human resour

5、ces, infrastructure, workingenvironment full? Can they guarantee the normal work?达到了规定的要求合格3.2、人力资源Humanresources1、抽查重要岗位的工作人员2 5人，确定是否能满足岗位职责的要求？Have a selective examination to 2-5 staffs in theimportant positions, to determine whether they can meetthe requirements of “the post responsibility ”？2、同

6、重要岗位的人员2-3人交谈，审查其能力能否胜任工作。有无因人员能力不足而影响工作的情况？Talk to 2-3 staffs in the important positions, to根据现场抽查结果满足了规定的要求合格examine whether their abilities can be competent for thejob. Is there any case that a staff is so lack of ability toeffect work?4.1、过程的监视和测量Processmonitoring andmeasuring1、责任部门是否按规定方法对主管QMS

7、过程进行监视和测量？Whether the responsibility department monitors andmeasures the main QMS process according to theprescribed method?2、在监视和测量中发现的问题是否采取了纠正或纠正措施，以使其符合要求？Whether they take corrective action for the problemsfounded in the monitoring and measuring to meet therequirements?进行了原料,半成品，成品的检验并记录.对不良品进行

8、了隔离，标示.对发现的问题进行了改进并记录跟进.合格4.2、数据分析Data analysis1、询问部门领导，审查部门领导是否清楚应收集的数据？Ask the department head to check if he is clear aboutthe data should be collected?2、查阅记录，审查部门是否按规定的范围、内容收集、传递或分析利用相关数据？Look up the records to check if the departmentcollects, transports, analyzes the relevant data accordingto t

9、he prescribed scope and content?清楚各类报表与分析符合规范并由部门经理确认合格4.3、持续改进Continuousimprovement1、同部门领导交谈了解改进的意识和打算。Talk with the department head to know theconsciousness and plan of improvement.2、部门是否利用质量方针、目标实施、内外审结果、数据分析结论、纠正和预防措施制定实施和管理评审确定的措施，对部门工作持续改进并核查其有效性。Does the department take measures aboutimplemen

10、ting and managing audit confining accordingto the quality policy, objectives, results of internal andexternal implementation, conclusions of data analysis,corrective or preventive actions, to improve the workcontinuously and check the effectiveness?部门领导对需要改进的配件，产品及其配合分开存放，标示并寻求改良的方案.暂无让步接受的心态.根据质量方针

11、、目标实施、内外审结果、数据分析结论、纠正和预防措施制定实施和管理，对部门工作持续改进并核查其有效性.合格4.4纠正措施correctiveaction1、向部门负责人和相关人员了解或者查询相关记录收集出现的不合格情况。Ask or inquire the department head or relatedpersonnel to collect the unqualified.2、对已出现不合格的部门是否在评审基础上针对严重的问题按规定制定和实施纠正措施？As for the unqualified department, whether take andimplement correct

12、ive action for serious problems basedon the audit according to rules?记录符合要求已出现不合格的部门针对严重的问题按规定制定和实施纠正措施合格4.5、预防措施Preventionmeasures1、向部门负责人或相关人员了解或查询相关数据分析趋势，确定部门是否有潜在不合格存在？Ask or inquire the department head or relatedpersonnel about data analysis trends to ensure if there is apotential unqualified?

13、2、针对潜在的不合格部门相关人员是否按其严重程度对潜在不合格的产品进行了评估.并按其严重程度和预防措施要求制定和实施预防措施合格和预防措施要求制定和实施预防措施？Whether take and implement prevention measuresaimed at the relevant personnel of potential unqualieddepartment according to the severity and preventiverequirements?5.1、产品实现的策划Planning ofproductrealization1、是否确定了产品实现的主要过

14、程，是否能提供满足产品要求的能力和责任2、了解产品实现的策划过程，是否将质量目标分解到相关职能和层次.3、对于产品实现过程所需的文件、资源、记录是否确定。4、是否策划过程所需的验证、确认、监视、检验和试验活动，明确产品/过程产品的验收/接收准则。已确定每一种产品的主要过程.满足已将质量目标分解到相关职能和层次.经审核并确定.制定关键工序，关键质量点,以及检验标准.通过试生产来提前解决生产过程出现的问题.合格5.2.1、与产品有关要求的确定Determinationof requirementsrelatedtoproducts1、对顾客的要求(包括交付和交付后活动的要求)是否得到充分识别并予以确定。Are the requirements (including delivery andrequirements for activities after delivery) for customersidentified fully and determined?2、与产品有关的法律、法规及要求是否充分确定？Are the laws, regulations and requirements related toproducts determined fully?客人要求确定后发放给相关人员.进行测试检验，有计划地安排生产