Alternate Methods Control Procedure 替代方法管控程序-中英文

Alternate Methods Control Procedure

替代方法管控程序

1.Purpose/目的 (3)

2.Scope/范围 (3)

3.Responsibility/职责 (3)

4.Definition/定义 (4)

5.Content/内容 (4)

5.1替代方法的识别/ Identification of alternate methods. (4)

5.2替代方法的评审和批准/Review and approval of alternate methods (5)

5.3替代方法的实施/Implementation of alternate methods (6)

5.4重启验证方法/Restart validation method (8)

6.Flow Diagram/流程图 (8)

7.Reference Document/参考文件 (8)

8.Form/表格 (9)

9.Change History/修订记录 (9)

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1. Purpose/目的

对替代方法进行识别和风险管理，确保产品发运及追溯。

This procedure is to identify and manage risk of alternate methods to delivery products in right time and good quality, and keep its traceability.

2. Scope/范围

适用于公司替代方法的过程和产品

This procedure is applicable to manage the alternate methods of process and product in company.

3. Responsibility/职责

IE部对操作和防错的替代方法负责，并将替代方法定义在相应的“替代方法清单”中；

IE department is responsible for alternate method of operation and error-proofing, and put the replacement method into the related “Alternate Method List”;

质量部对检验和测量的替代方法负责，并将替代方法定义在“替代方法清单”中，并实施质量部负责的替代方法管控；

Quality department is responsible for alternate method of inspection and measurement, put the replacement method into the related “Alternate Method List”, and implement the alternate method which controlled by quality department;

工程部对其试验的替代方法负责，如未使用顾客规定的试验方法，应和客户达成一致的替代方法；Engineering department is responsible for alternate method of test, and make agreement with customer about the alternative method if not use customer defined test method;

生产部负责替代方法的实施和日常监控，有问题及时反馈给对应的负责部门

Production department is responsible for carrying out, routine monitoring the alternate methods, and give feedback to the responsible department if any problem.

4. Definition/定义

PFMEA:Process Failure Mode and Effects Analysis 过程失效模式和后果分析

CP: Control Plan 控制计划

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5. Content/内容

5.1 替代方法的识别/ Identification of alternate methods.

IE部/质量/工程部识别可替代方法，列出“替代方法清单”，包括：

IE/Quality/ENG is responsible for identifying potential alternate methods, making “Alternate Method List”. It shall contain:

—操作，如自动改手动,光滑通止规使用内径量表替代。

Operate such as: automatic changes to manual, Go/no go gauge changes to inner diameter gauge

—检验

Inspection

—测量

Measurement

—试验

Test

—防错

Error-Proofing

替代方法识别的部门分配/ Responsible department for identification of alternate methods：

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5.2 替代方法的评审和批准/Review and approval of alternate methods

5.2.1. 由质量、IE和工程组成替代方法评估小组，应在替代方法发行前以及发行后至少每半年一次对

替代方法评审，包括替代方法的接受准则；

Quality, IE and ENG form an alternate methods assessment group. Group members shall review the alternate methods every half a year at least before and after the release of alternate methods, including acceptance criteria of alternate methods;

5.2.2. 对确定纳入的替代方法应由跨职能小组在“替代方法清单“中识别替代方法的风险，进行RPN

风险评价；

The feasible alternate methods shall be identified for its risks through RPN risk assessment in FMEA by across function team members;

5.2.3. 质量部输入CP中/或使用单独的“替代方法清单”，在使用替代方法之前，替代方法应得到客

户的批准；

Quality department put it into control plan or individual “Alternate methods list”，then submit it to customer and gets customer's approval before the alternate methods using.

5.2.4. 如果客户有替代方法，质量部门沟通评审后更新“替代方法清单”及接受准则，接受准则客

户有要求时，按客户要求；

If customer have their alternate methods, quality department communicate and review the alternate methods, then update “Alternate Method List”, and follow customer requirements if customers have acceptance criterion.

5.2.5. 每年进行替代方法评审，对“替代方法清单”中的替代方法进行评审及必要的升级，使用前，

重新提交“替代方法清单”给客户批准。

In alternate method review annually, the alternate methods in the “Alternate Method List” should be reviewed and necessary upgraded, and submitted to customer for approval before using.

备注：替代方法的测量系统分析见《计量器具管控程序》。

Remark: measurement system analysis of alternate methods can refer to Measuring Device Control Procedure.

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5.3 替代方法的实施/Implementation of alternate methods

5.3.1. 使用替代方法前，应对相应的PFMEA和控制计划做修订，将替代方法加入其中；对应的替代

方法负责部门应编制替代方法的操作指导书，并培训使用者，包含以下内容：

Before using the alternate methods, the PFMEA and CP should be updated to add the alternate methods. The responsible department for the related alternate method is responsible for establishing SPI of each alternate method and train the operator including the following: —使用说明；

Instructions;

—产品序列号和生产日期记录；

Record of product serial number and production date;

—每日点检方法；

Daily tally method

—重启验证方法。

Restart verification method.

5.3.2. 操作人员应严格按照替代方法操作指导书的要求进行操作；

Operators shall strictly operate according to the requirements of alternate methods instructions.

5.3.3. 生产部应使用适用的检查表记录测量变更点，并班前会培训；

Production department should use the applicable inspection form to record the change point and train by the …… 此处隐藏：4945字，全部文档内容请下载后查看。喜欢就下载吧 ……