IMSP-05-糾正措施控制程序-CA-control-procedure-R02V008頁(yè)

1、 Prepared: Apex He Verified: DepartmentVerifiedDepartmentVerifiedQualityFacility & EHS Approved: Date:Sandvik Mining and Construction (China)Co.,Ltd.Assembly Center (Jiading)糾正措施控制程序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. 對(duì)已經(jīng)發(fā)生或潛在的事故、事件、不符合進(jìn)行識(shí)別、分析和改進(jìn)，查明不合格或不符合的根本原因，采取適當(dāng)?shù)募m正及預(yù)防措施，防止類似事故、事件及不符合重復(fù)發(fā)生。2. Scope范圍Be suitable to corrective the detected or potential nonconformities occurred in integrate management system.本程序適用于山特維克礦山工程機(jī)械

4、（中國(guó)）有限公司嘉定裝配中心礦山機(jī)械產(chǎn)品的整合管理體系中已發(fā)生或潛在的不符合的改進(jìn)。3. Definition定義3.1 Correction: action to eliminate a detected nonconformity;糾正：為消除已發(fā)現(xiàn)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；糾正措施：用來(lái)消除不合格的原因并防止再次發(fā)生的措施；3.3 CA: Corrective action;糾正措施

5、：縮寫為CA；4. Responsibility職責(zé)4.1 Quality Dept. is responsible for the establish and the update of the document control procedure;質(zhì)量部負(fù)責(zé)本程序的建立和更新；4.2 Each department is responsible for the execute of CA of their own.各部門負(fù)責(zé)各自部門糾正措施的執(zhí)行；4.3 Quality Dept. and Facility & EHS Dept. is responsible for the archiv

6、e and management of CA documents and records.質(zhì)量部和設(shè)備及環(huán)境健康安全部負(fù)責(zé)CA文件和記錄的保存和管理；4.4 Other responsible person for detail can see ”5.3”;過程中的確認(rèn)、驗(yàn)證以及批準(zhǔn)的責(zé)任人詳見“5.3”5. Procedure流程5.1 The resource of detected of potential nonconformity could be:已發(fā)生或潛在不符合的來(lái)源主要有以下幾方面：5.1.1 Audit finding: the nonconformity identifi

7、ed during audit;審核發(fā)現(xiàn)：審核中的發(fā)現(xiàn)的不符合項(xiàng)；5.1.2 Non-audit finding, including customer feedback and internal improvement, such as:非審核發(fā)現(xiàn)，包括客戶反饋和內(nèi)部改進(jìn)，具體有：1） Interested parties complain and feedback;相關(guān)方的抱怨及反饋意見；2） Result of management review;管理評(píng)審的結(jié)果；3） Monitoring and measurement of in-process;產(chǎn)品實(shí)現(xiàn)過程的監(jiān)視和測(cè)量結(jié)果；4） C

8、heck result of related institute;有關(guān)部門的檢查結(jié)果；5） Nonconformity caused by the change of laws, regulations and standards;法律、法規(guī)、標(biāo)準(zhǔn)變更引起的不符合；6） Nonconformity found during the survey of some accident;事故、事件調(diào)查時(shí)發(fā)現(xiàn)的不符合；7） Self-assessment of IMS and production quality;8） 管理體系以及產(chǎn)品質(zhì)量自我評(píng)價(jià)的結(jié)果；Changes in internal and

9、external issues.內(nèi)外部因素的變化。5.2 Nonconformity grade judgment:不符合項(xiàng)嚴(yán)重程度的判定：Nonconformity can be divided into 3 gradesobservation, minor and major:不符合項(xiàng)可分為觀察項(xiàng)、輕微以及嚴(yán)重三個(gè)等級(jí)：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;觀察項(xiàng)：可不開列不合格報(bào)告，不要求采取糾正措施，只做口頭或書面的提示，但應(yīng)注意其發(fā)展趨勢(shì)；5.2.2 Minor: happened accidently, the result is not so serious and easy to be corrective;輕微：指偶發(fā)、孤立，后果不嚴(yán)重，易于糾正的不符合項(xiàng)；5.2.3 Major: lose effectiveness in some area, and the result is serious;嚴(yán)重：指系統(tǒng)性以及區(qū)域性失效，造成的后果嚴(yán)重；5.3 The type of root-ca

11、use/CAPA analysis and related responsible person各類不符合原因分析形式及相關(guān)責(zé)任人：不符合的影響程度原因分析及糾正措施制定的形式原因分析及糾正措施的確認(rèn)人跟蹤驗(yàn)證批準(zhǔn)關(guān)閉非審核過程中發(fā)現(xiàn)或潛在的輕微不符合由各部門管理人員在其職權(quán) 范圍內(nèi)，召集有關(guān)人員，分析不合格或不符合原因，制定CA相關(guān)主管或部門經(jīng)理質(zhì)量部或設(shè)備及環(huán)境健康安全部，相關(guān)主管或部門經(jīng)理部門經(jīng)理非審核過程中發(fā)現(xiàn)的或潛在的嚴(yán)重不符合由質(zhì)量部或設(shè)備及環(huán)境健康安全部經(jīng)理、相關(guān)負(fù)責(zé)人以及問題發(fā)生部門經(jīng)理共同分析原因并制定CA質(zhì)量部或設(shè)備及環(huán)境健康安全部經(jīng)理及問題發(fā)生部門經(jīng)理質(zhì)量部或設(shè)備及環(huán)境健

12、康安全部管理者代表審核過程中發(fā)現(xiàn)的不符合項(xiàng)由質(zhì)量部和設(shè)備及環(huán)境健康安全部、審核小組成員（內(nèi)審時(shí)）以及被審核部門經(jīng)理或指定人員共同分析原因并制定CA部門經(jīng)理質(zhì)量部和設(shè)備及環(huán)境健康安全部或?qū)徍诵〗M成員（內(nèi)審時(shí)）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:短期糾正方案以及長(zhǎng)期糾正措施的內(nèi)容和要求：5.4.1 The content should including:其內(nèi)容應(yīng)包括：1） How to handle current production(replace, rework, repair scrap) and incident;針對(duì)現(xiàn)有產(chǎn)品（換貨、返工、返修、報(bào)廢）和事件的處理；2） The long-term CAPA should be determined to eliminate the root cause of each findings;長(zhǎng)期措施應(yīng)

17、針對(duì)所列出的問題產(chǎn)生的各項(xiàng)原因采取相應(yīng)的糾正及預(yù)防措施；3） The documents which need to be added/changed according to CA;因糾正預(yù)防措施要求需新增/更改的文件；4） Education and training;教育培訓(xùn)；5.4.2 Requirements要求：1） Actions should be specific and accurate. Quantitative index should be used to describe action. 措施應(yīng)具體、明確、用可量化的指標(biāo)來(lái)描述； 2） Actions should including: why, when, who, where, what, how(5W1H);措施應(yīng)列明以下內(nèi)容：誰(shuí)在什么時(shí)候，什么地方，采取什么措施？怎么做？（5W1H）；3） Each action should appointed responsible person and