RH-MSP-09 - NCR CPAR - 2009-05-28 v1-0.doc

Document No.RH-MSP-09Issue:1Amendment:APage:23 of 15Date:22/7/2009 PROCEDURE TITLE:CONTROL OF NONCONFORMING PRODUCT& CORRECTIVE AND PREVENTIVE ACTION 程序标题：不合格产品的控制以及纠正与预防措施 PROCEDURE NUMBER:RH-MSP-09程序编号：RH-MSP-09 AMENDMENT修订DATE日期DESCRIPTION说明REVIEWED复核APPROVED批准A22/7/2009New Issue新签发G. Trainor G. Allen 1.PURPOSE目的To establish and maintain a system for ensuring that product or services that do not conform to specified requirements or have an undesirable impact on the environment / health and safety are identified and segregated to prevent inadvertent use or delivery, and reported to ensure appropriate corrective actions and preventive actions are implemented to prevent a recurrence and/or protect the environment, health and safety.建立和维护一个系统，以确保对不符合特定要求的、或对环境/健康与安全具有不良影响的产品或服务进行标识和隔离，防止无意使用或交付，并予以报告，确保采取适当的纠正和预防措施，从而防止其再次发生并/或保护环境、健康与安全。2.SCOPE范围This procedure applies to nonconforming product or services generated by RYCO or its suppliers and the actions necessary to resolve non-conformances and implement corrective action and preventive action.本程序适用于由莱科或其供应商产生的不合格产品或服务，以及为解决不相符问题并实施纠正和预防措施所需的行动。3.REFERENCES参考资料RH-MSP-12:Internal AuditsRH-MSP-12:内部审查4.DEFINITIONS定义4.1NONCONFORMANCE不相符A deficiency in characteristics, documentation or process implementation which renders the quality of an item indeterminate or outside that required by the relevant specification, contract or regulation, or failure to meet internal or external requirements.一种在特性、文件或过程实施上的缺陷，它导致质量不确定、或未达到相关规程、合同或规定的要求、或未能符合内部或外部要求。4.2ROOT CAUSE根本原因The true (original) cause of the non-conformance as verified through quantifiable data.通过可量化数据证实的的不合格的真正(原始)原因。 4.3DISPOSITION处置Action to be taken concerning material, components or product about which a decision has been made.对已就其做出决定的材料、部件或产品所采取的行动。4.4SCRAP废品Nonconforming items, material or products that cannot be reworked to an acceptable condition.不能通过返工达到合格状态的不合格物件、材料或产品。4.5USE AS IS照原样使用Items, material or products that are found to be nonconforming in a minor way but are still suitable for their intended purpose and acceptable to the customer.发现有微小不符，但仍适合其拟定用途并可为客户接受的物件、材料或产品。4.6QUICK-FIX ACTION快速解决措施Action taken by Territory Manager / Sales Reps or Mobile Connector Specialist to quickly respond to and fix customers concerns regarding any minor customer complaints.针对任何客户微小投诉，区域经理/销售代表或流动接头专员为了迅速地对客户顾虑做出反映和进行解决所采取的措施。4.7CONTAINMENT ACTION控制措施Action taken before permanent corrective action is implemented to assure that a non-conformance does not escape to the customer.为确保不合格产品不跑到客户那里去，在采取永久纠正行动前所采取的行动。 4.8CORRECTIVE ACTION纠正措施The action to eliminate the cause of a detected nonconformity or other undesirable situation. 为杜绝出现引起不相符或其它不良情况的原因所采取的措施。4.9PREVENTIVE ACTION预防措施An improvement plan / action that modifies systems, processes or products: 改变系统、过程或产品的改进计划/措施：A. To prevent recurrence of a root cause that produced a non-conformance / problem in one area within another product or process. 以防止在一个区域中产生不符合/问题的根源在另一个产品或过程内再次出现。B. Through analysis of historical data, implementing a plan to prevent a potential problem from occurring. 通过分析历史数据，实施某个计划以防止潜在问题发生。4.108-D Method8-D法8 Discipline (8D) method is a formal, documented step by step process which, when implemented appropriately in a team-work approach, will lead to permanent corrective and preventive action and effective problem solving.8原则(8D)法是一种正式的、成文的按部就班的过程，若通过团队合作方式实施得当，将会成为永久的纠正和预防措施并有效解决问题。The 8-D process is illustrated in figure 1 and figure 2.8-D过程说明见图1和图2。4.11 INCIDENT事件An incident is any undesired event that causes, or has the potential to cause injury, illness, property damage, harm to the environment, loss to production or impact on the community. This includes a near miss.事件是可以导致或潜在导致伤害、疾病、财产损失、环境损害、生产损失或社区影响的任何不良事项。其中包括侥幸脱险的情况。4.12 EHSEnvironment, Health and Safety.环境、健康与安全。4.13 Hazard危险A hazard is any situation with the potential to cause harm to the safety and health of people, to processes, to equipment, to the environment or the community.危险是可对人员安全与健康、过程、设备、社区环境潜在造成损害的任何情况。4.14 Risk Assessment风险评估A risk assessment is the process of ensuring that the risks associated with hazards identified within work areas are adequately assessed to determine priorities for action. The magnitude of the risk is determined by considering the likelihood or probability of the hazard causing damage/injury and the likely severity of the consequences should the damage/injury occur.风险评估是一个过程，通过该过程确保与工作区域内确认的危险相关的风险可得到充分评估，从而确定行动的先后次序。风险程度是通过考虑危险导致损坏/伤害的可能性或几率以及如果损坏/伤害发生，后果可能具有的严重性加以确定的。 5.RESPONSIBILITIES责任5.1DEPARTMENT MANAGER / BRANCH MANAGER / SUPERVISOR部门经理/分公司经理/主管The department Manager / Branch Manager / Supervisor shall be responsible for:部门经理/分公司经理/主管负责内容：(a)Raising and actioning Field Investigation/Non-conformance reports (NCR) and/or Corrective/Preventive Action Request where applicable.提出并完成现场调查/不符合项报告(NCR)和/或在适用时，提出并完成纠正、预防措施请求。(b)Deciding the disposition of non-conformances (minimising any environmental impact) in conjunction with the Group Quality Manager or the relevant Department Manager.与集团质量经理或相关部门经理一道决定不相符处的处置方式(尽可能减少任何环境冲击)。(c)Identifying and isolating (where practical) non-conforming product and attaching an appropriate inspection status tag such as reject tags, hold for inspection tags, quarantine tag or a documented report. 鉴别并隔离(在可行时)不合格产品，并附着适当的检验状态标牌(例如：拒收标牌)、停放待检标牌、隔离标牌或书面报告。(d)Arranging for a CPAR form to be raised in relation to faulty incoming material from the supplier and immediately advising the purchasing department.就来自供应商的有缺陷进厂材料，安排提出纠正、预防措施请求表格，并立即通知采购部门。(e)Advising all Departments / Personnel concerned of the non-conformance.将不相符情况通知所有相关部门/人员。(f)Monitoring the progress and resolution of the non-conformance.监控不相符情况的进展和解决情况。(g)Ceasing production in the event of any non-conformances until the matter is resolved.在任何不相符情况出现时暂停生产，直到问题得到解决。(h)Mitigating the initial impacts caused by incident.减轻事件所导致的初始冲击。(i)Undertaking corrective actions to address the direct cause of incidents in a timely manner.采取纠正行动及时解决事件的直接起因。(j)Encouraging employees and contractors to report EHS incidents鼓励员工和承包商报告环境、健康与安全事件。(k)If applicable, assisting the Group Quality Manager in communicating and updating progress of non-conformance investigations with the customer 在适用时，协助集团质量经理传达和更新与客户一起进行的不相符情况调查的进展情况。 5.2GROUP QUALITY MANAGER 集团质量经理 The Group Quality Manager or nominee shall be responsible for:集团质量经理或被指定人员负责：(a)Maintaining a non-conformance / incident report file and / or a CPAR / 8D file for each RYCO branch location.为每个莱科分公司地点保存不符合项/事件报告文件和/或纠正、预防措施请求/8D法文件。(b)Monitoring the progress and resolution of field investigation non-conformances, in-process non-conformances, incidents and corrective / preventive actions.监控现场调查不符合项、过程中不符合项、事件和纠正/预防措施的进展和解决情况。(c)Periodically analysing data relating to non-conformance and CPAR reports to identify the cause of nonconforming conditions and implementing system improvements where possible.定期分析与不符合项以及纠正、预防措施请求报告相关的资料，以确定导致不合格状态的原因，并在可能时实施系统改进。 (d)Signing off and closing out non-conformance and CPAR reports.签署和完结不符合项以及纠正、预防措施请求报告。(e)Liaising with customers regarding customer complaints and nonconforming product.针对客户投诉和不合格产品与客户联系。(f) Ceasing production in the event of any non-conformances.在任何不符情况发生时暂停生产。(g) Reporting to CEO / Operations Manager on the progress of resolution of major non-conformance or significant incident, and forwarding recommendations for process / procedure amendments if necessary.向首席执行官/运营经理报告重大不符合项或重大事件解决的进展情况，并在必要时，转交过程/程序修订建议。5.3WAREHOUSE PERSONNEL 仓库人员Warehouse personnel shall be responsible for advising the relevant department manager/supervisor of any nonconforming product, so that appropriate corrective actions can be taken and an In Process NCR or CPAR / 8D report is raised if required.仓库人员负责将任何不合格产品情况通知相关部门经理/主管，以便采取适当的纠正措施，并在需要时，提出过程中不符合项报告或纠正、预防措施请求/8D法报告。 5.4RYCO HOSE CONNECTOR SPECIALIST / SALES STAFF / TERRITORY MANAGER莱科软管接头专员/销售人员/区域经理Where a non-conformance has occurred with any RYCO product after installation by a RYCO Hose connector specialist or customer, the connector specialist or applicable RYCO sales representative or territory manager shall determine if the problem falls within the scope of a Quick Fix. If so, they shall immediately fix the problem with the customer to maintain customer satisfaction. Any minor product discrepancies shall be logged on a register and reported monthly to the QA Department.如果在莱科软管接头专员或客户安装后，任何莱科产品出现不符合项，接头专员或适当的莱科销售代表或区域经理须确定问题是否处在“迅速解决”范围内。如果是，他们须立即与客户一起解决问题，以维持客户满意度。须在登记簿上记录任何微小的产品不符合项，并每月向质保经理报告。If the problem arising falls outside the scope of Quick Fix, the RYCO representative shall complete in as much detail as possible a Field Investigation/Non-conformance Report and submit this to the RYCO Product Manager for review and appropriate actioning.如果问题出现在“迅速解决”范围外，莱科代表须尽可能详细地填写现场调查/不符合项报告，并将其提交给莱科产品经理进行复核并采取适当措施。5.5PRODUCT MANAGER产品经理The Product Manager or nominee shall review the FI/NCR to ensure that all required information in the report has been completed correctly, review the application & specification details for compliance with RYCO technical specifications and confirm if the FI/NCR warrants further action prior to submitting it to the QA department.产品经理或被指定人员须复审现场调查/不符合项报告，以确保在报告中所有要求信息均正确填写，并复核应用和规格详情是否符合莱科的技术规程，并确认在将现场调查/不符合项报告提交给质保部门前，它是否为进一步措施提供了正当理由。 5.6EHS REPRESENTATIVE 环境、健康与安全代表The EHS Representative shall be responsible for:环境、健康与安全代表须负责： (a)Providing advice for incident corrective action and preventative action.为事件纠正和预防措施提供建议。(b) Participating in incident investigation.参与事件调查。(c) Undertaking risk assessment on proposed corrective action / preventative action.对提出的纠正/预防措施进行风险评估。5.7 All EMPLOYESS and CONTRACTORS所有员工和承包商All Employees and Contractors shall be responsible for:所有员工和承包商须负责：(a) Reporting any safety or environmental incident to their Leader.向自己的领导报告任何安全或环境事件。(b) Reporting incidents in the correct manner. 以正确方式报告事件。(c) Identifying and managing hazards in the workplace确定和管理工作场所存在的危险。5.8 QUALITY IMPROVEMENT TEAM (QIT) 质量改进小组(QIT)It is the responsibility of each member of the quality improvement team to contribute to an effective resolution of In-process and Field non-conformance or potential non-conformances. The team shall consist of individuals with the skills associated with completing the appropriate steps of the corrective action / preventive action process.质量改进小组的每个成员有责任为过程中和现场不符合项或潜在的不符合项的有效解决贡献力量。小组由具有完成纠正/预防措施过程中的相关步骤的相关技能的人员组成。6. PROCEDURE程序6.1 QUICK-FIX迅速解决Where a minor customer complaint is raised that falls within the scope of Quick Fix, the connector specialist or applicable RYCO sales representative or territory manager shall fix the problem immediately with the customer in accordance with RYCO policy. If applicable the relevant RYCO branch QA representative shall log details of any minor product discrepancies on a register and send a report monthly to the QA Department for further review and appropriate action.如果客户提出的微小投诉处在“迅速解决”范围内，接头专员或适当的莱科销售代表或区域经理须立即按莱科有关政策与客户一起解决问题。如果适用，相关莱科分公司质保代表须在记录簿上记录任何微小产品差异的详情，并每月向质保部门发送一份报告，以便进一步复核和采取适当措施。6.2 NONCONFORMANCE不符合项Non-conformances may be detected in supplier procured material, products or services or in company services and in-process manufactured items or products.不符合项可以在供应商采购的材料、产品或服务，或在公司服务和在制件或产品中发现。When nonconforming items, material or products are detected, the Manager/Supervisor responsible for that department or process shall positively identify and isolate (where practical) the nonconforming items to prevent unauthorised use, despatch or mixing with conforming products and preventing or minimising any detrimental environmental impact.在发现不相符件、材料或产品时，负责该部门或过程的经理/主管应明确鉴别和隔离(在可行时)不符合项，以防止擅自使用、发货或与符合品混合，并防止或最大减少任何有害环境冲击。The Manager or Supervisor responsible for the department or process shall:对该部门或过程负责的经理或主管应：(a)Advise the QA department of the details of the non-conformance, either verbally or via email. 将不符合项的详细情况以口头形式或通过电子邮件通知质保部门。(b)Advise all departments/personnel concerned with the non-conformance. 通知与不符合项有关联的所有部门/人员。(c)If appropriate, document the non-conformance details on a CPAR.如果适当，在纠正、预防措施请求表格上记录不符合项详细情况。6.3 CONTAINMENT ACTIONS控制措施After receiving an NCR report, the QA department shall review and if required arrange for appropriate containment action to prevent or minimise any further NCR issues. 在收到不符合项报告后，质保部门应进行复核，并在需要时，安排适当的控制措施，以防止或最大减少任何其他的不符合项报告问题。The QA department shall ensure that all the stock locations are reviewed and goods are quarantined or placed on hold pending the results of the NCR investigation. If required customers shall be advised to check their stock. 质保部门应确保对所有库存部位进行复核，并将货物隔离或搁置起来，等待不符合项报告的调查结果。如果需要，应通知客户检查其库存。6.48-D Process (8 Step Problem Solving Discipline) 8-D过程(8步问题解决原则)Depending on the severity of an NCR raised, the Group Quality Manager or nominee will establish a formal quality improvement team (QIT) and initiate the 8-D process with the aim to determine the true root cause. 根据所提出的不符合项报告的严重度，集团质量经理或被指定人员将建立一个正式的质量改进小组(QIT)，并启动8-D过程，目的在于确定真正根本原因。The QIT members shall meet periodically. A team leader shall be nominated to monitor progress until all the 8-D steps have been satisfactorily completed as close as possible to the allocated time frames for each step. Refer to figure 1 and 2 for details of the 8-D process. 质量改进小组(QIT)成员将定期开会。须为小组指定一名组长监控进程，直到在尽可能接近为每个步骤分配的时间框架的情况下满意地完成了各8-D步骤为止。8-D过程的详细情况，见图1和图2。Appropriate QA root cause analysis tools such as “5Y”, process mapping, cause and effect diagram may be used to support the improvement project. 可以采用适当的质保根本原因分析工具支持改进计划，例如：“5Y”、过程图、因果图。6.4 NONCONFORMANCE / CPAR / 8D REPORTS不符合项/纠正、预防措施请求/8D报告The non-conformance or CPAR or 8D report shall identify the following as applicable:在适用时，不符合项或纠正、预防措施请求或8D报告应标明以下内容：(a)Non-conformance or CPAR Report No. 不符合项或纠正、预防措施请求报告编号(b)Reference No. / Part No. 参考号/零件编号(c)Description of Non-conformance不符合项说明(d)Origin of non-conformance. 不符合项来源(e)Cause of non-conformance if known. 不符合项的原因，如果知道的话(f)Action taken - including disposition and resulting rectification, re-inspection or re-testing. 所采取的行动 其中包括处置和导致的整改、重新检验或重新试验(g)Follow up details. 跟进详细情况The Group Quality Manager or nominee shall: 集团质量经理或被指定人员须：(a)Issue the report number. 发布报告编号(b)Monitor the progress and resolution of the non-conformance via the appropriate status log: FI/NCR; In-Process NCR or the CPAR/8D status log. 通过适当的状态记录：现场调查/不符合项报告、过程中不符合项报告或纠正、预防措施请求/8D状态记录，监控不符合项的进程和解决情况。(c)Document the corrective and preventive action taken. 用文件记录所采取的纠正和预防措施(d)Sign off and close out the reports. 签署并完结报告The CPAR/8D report number shall be a sequentially allocated number with a branch location prefix and controlled via the CPAR status log which is maintained by the QA department / representative.纠正、预防措施请求/8D报告编号是一个按顺序分配的、带有分公司位置前缀的编号，且通过由质保部门/代表保存的纠正、预防措施请求状态记录进行控制。The Field Investigation/Non-conformance Report number shall be a sequentially allocated number with a branch location prefix and controlled via the NCR register, which is maintained by the QA department / representative.现场调查/不符合项报告的编号是一个按顺序分配的、带有分公司位置前缀的编号，并通过由质保部门/代表保存的不符合项报告登记簿进行控制。6.5.1Re-addressing a Non-conformance重新解决不符合项When a follow up indicates that the actions taken have not been effective in correcting the non-conformance and/or preventing a recurrence, this shall be recorded in the Follow up section of the CPAR report, the report shall then be closed out. 如果跟进表明所采取的措施未能有效纠正不符合项和/或防止不符合项再次发生，应在纠正、预防措施请求报告的跟进部分对此加以记录，然后完结该报告。The continuing non-conformance shall be re-addressed by a new CPAR or if further investigation is required to determine the true root cause then a CPAR/8D report shall be raised. The number of the new report shall be cross-referenced to the old report and vice versa. Should the subsequent follow up audit indicate that the action taken is still unsatisfactory; the CPAR or 8D report shall be forwarded to the CEO / Operations Manager for further action. 须采用一份新的纠正、预防措施请求报告重新解决持续的不符合项，或者如果需要通过进一步调查确定问题的根源，则应提出一份纠正、预防措施请求/8D报告。新报告的编号应当与旧报告相互对照，反之亦然。如果后续跟进审核表明所采取的措施仍然不令人满意，应将纠正、预防措施请求或8D报告转给首席执行官/营运经理，以便采取进一步措施。6.6 DISPOSITION处置Disposition of nonconforming product shall be as follows: 须按如下所述对不合格产品进行处理：(a)Scrap, i.e. nonconforming product that cannot be reworked to an acceptable condition. 废品，即不能通过返工达到合格状态的不合格产品。(b)Rework, i.e. nonconforming product that can be reworked to an acceptable condition. 返工，即可以通过返工达到合格状态的不合格产品。(c)Quarantine, i.e. Product labelled with tag and isolated or placed in quarantine holding bay to prevent further use. 隔离，即用标牌标记和隔离或放置在隔离存放区域以防止进一步使用的产品。(d)Use as is, i.e. product that is nonconforming in a minor way, but is still suitable for its intend