IMSP-05-纠正措施控制程序-CA-control-procedure-R02V008页

1、 Prepared: Apex He Verified: DepartmentVerifiedDepartmentVerifiedQualityFacility & EHS Approved: Date:Sandvik Mining and Construction (China)Co.,Ltd.Assembly Center (Jiading)纠正措施控制程序CA Control ProcedureIMSP-05Modification RecordRev.&Mod. No.Issue.DateDescriptionPreparedVerifiedApprovedCommentR00V002

2、013.6.8New ReleaseFrank ZhuSee main pageDaniel J Sun/R01V002014-4-28ModificationFrank ZhuGordon GeGordon Ge/R02V002016-4-22Completely rewrite according 2015 QMSApex HeSee main pageGordon Ge/1. Purpose目的To identify the detected or potential nonconformities, determine property corrective and preventiv

3、e actions to eliminate the root cause of nonconformities, and to prevent their occurrence. 对已经发生或潜在的事故、事件、不符合进行识别、分析和改进，查明不合格或不符合的根本原因，采取适当的纠正及预防措施，防止类似事故、事件及不符合重复发生。2. Scope范围Be suitable to corrective the detected or potential nonconformities occurred in integrate management system.本程序适用于山特维克矿山工程机械

4、（中国）有限公司嘉定装配中心矿山机械产品的整合管理体系中已发生或潜在的不符合的改进。3. Definition定义3.1 Correction: action to eliminate a detected nonconformity;纠正：为消除已发现的不合格所采取的措施；3.2 Corrective action: action to eliminate the cause of a nonconformity (3.4.3) and to prevent recurrence；纠正措施：用来消除不合格的原因并防止再次发生的措施；3.3 CA: Corrective action;纠正措施

5、：缩写为CA；4. Responsibility职责4.1 Quality Dept. is responsible for the establish and the update of the document control procedure;质量部负责本程序的建立和更新；4.2 Each department is responsible for the execute of CA of their own.各部门负责各自部门纠正措施的执行；4.3 Quality Dept. and Facility & EHS Dept. is responsible for the archiv

6、e and management of CA documents and records.质量部和设备及环境健康安全部负责CA文件和记录的保存和管理；4.4 Other responsible person for detail can see ”5.3”;过程中的确认、验证以及批准的责任人详见“5.3”5. Procedure流程5.1 The resource of detected of potential nonconformity could be:已发生或潜在不符合的来源主要有以下几方面：5.1.1 Audit finding: the nonconformity identifi

7、ed during audit;审核发现：审核中的发现的不符合项；5.1.2 Non-audit finding, including customer feedback and internal improvement, such as:非审核发现，包括客户反馈和内部改进，具体有：1） Interested parties complain and feedback;相关方的抱怨及反馈意见；2） Result of management review;管理评审的结果；3） Monitoring and measurement of in-process;产品实现过程的监视和测量结果；4） C

8、heck result of related institute;有关部门的检查结果；5） Nonconformity caused by the change of laws, regulations and standards;法律、法规、标准变更引起的不符合；6） Nonconformity found during the survey of some accident;事故、事件调查时发现的不符合；7） Self-assessment of IMS and production quality;8） 管理体系以及产品质量自我评价的结果；Changes in internal and

9、external issues.内外部因素的变化。5.2 Nonconformity grade judgment:不符合项严重程度的判定：Nonconformity can be divided into 3 gradesobservation, minor and major:不符合项可分为观察项、轻微以及严重三个等级：5.2.1 Observation: nonconformity report and corrective action is not required, only oral or written attention is enough. But should pay a

10、ttention to its trend;观察项：可不开列不合格报告，不要求采取纠正措施，只做口头或书面的提示，但应注意其发展趋势；5.2.2 Minor: happened accidently, the result is not so serious and easy to be corrective;轻微：指偶发、孤立，后果不严重，易于纠正的不符合项；5.2.3 Major: lose effectiveness in some area, and the result is serious;严重：指系统性以及区域性失效，造成的后果严重；5.3 The type of root-ca

11、use/CAPA analysis and related responsible person各类不符合原因分析形式及相关责任人：不符合的影响程度原因分析及纠正措施制定的形式原因分析及纠正措施的确认人跟踪验证批准关闭非审核过程中发现或潜在的轻微不符合由各部门管理人员在其职权 范围内，召集有关人员，分析不合格或不符合原因，制定CA相关主管或部门经理质量部或设备及环境健康安全部，相关主管或部门经理部门经理非审核过程中发现的或潜在的严重不符合由质量部或设备及环境健康安全部经理、相关负责人以及问题发生部门经理共同分析原因并制定CA质量部或设备及环境健康安全部经理及问题发生部门经理质量部或设备及环境健

12、康安全部管理者代表审核过程中发现的不符合项由质量部和设备及环境健康安全部、审核小组成员（内审时）以及被审核部门经理或指定人员共同分析原因并制定CA部门经理质量部和设备及环境健康安全部或审核小组成员（内审时）管理者代表The type of root-cause analysis and related responsible personEffect degree of nonconformityThe type of root-cause/CA analysisRoot-cause /CA confirmFollow and result confirmApproved to be clos

13、ed byDetected or potential minor NC which is not found in non-auditDept. leader and related person to analyze root cause together and determine CAPARelated supervisor or dept. managerQuality Dept. or Facility & EHS Dept., related supervisor or dept. manager Dept. managerDetected or potential major N

14、C which is not found in non-audit Quality or Facility & EHS Dept. Manager and detected dept. leader to analyze root cause together and determine CAPAQuality or Facility & EHS Dept. manager and detected dept. managerQuality or Facility & EHS Dept.Management RepresentativeNC found in auditQuality Dept

15、. or Facility & EHS Dept., audit team member(internal audit), audited dept. manager or appointed person to analyze root cause together and determine CAPADept. managerQuality Dept. or Facility & EHS Dept. or audit team members(internal audit)Management Representative5.4 Content and requirements for s

16、hort-term correction and long-term CA:短期纠正方案以及长期纠正措施的内容和要求：5.4.1 The content should including:其内容应包括：1） How to handle current production(replace, rework, repair scrap) and incident;针对现有产品（换货、返工、返修、报废）和事件的处理；2） The long-term CAPA should be determined to eliminate the root cause of each findings;长期措施应

17、针对所列出的问题产生的各项原因采取相应的纠正及预防措施；3） The documents which need to be added/changed according to CA;因纠正预防措施要求需新增/更改的文件；4） Education and training;教育培训；5.4.2 Requirements要求：1） Actions should be specific and accurate. Quantitative index should be used to describe action. 措施应具体、明确、用可量化的指标来描述； 2） Actions should including: why, when, who, where, what, how(5W1H);措施应列明以下内容：谁在什么时候，什么地方，采取什么措施？怎么做？（5W1H）；3） Each action should appointed responsible person and