文件制修订申纠正和预防措施程序

文件类型

Document Type

应用范围

Application

Scope

品质管理体系程序

QMS PROCEDURE

通用

GENERAL

修订记录

REVISION HISTORY

版本

Rev.

A

B

修改内容

Revised Contents

Initial releasing with ISO/TS16949 requirements

Change the title from “

改正和预防行动程序

Corrective

and Preventive Action Procedure” to “

纠正和预防措施

程序

Procedure for Corrective & Preventive Action”

Revised the procedure to meet ISO13485 regulations (China)

& CFR21 FDA 21 CFR QSR(Quality System Regulation) 820

(USA) requirements

作者

Author

XXX

XXX

生效日期

EFF. Date

Nov.07,2006

Jan.10th, 2009

C

XXX

15-07-2014

文件审批

APPROVAL

本文件须经相关部门工程师（或主管）签批，请作者指定。

This document shall be reviewed by ISO Coordinator and. The author shall determine.

部门名称

DEPT. TITLE

编写部门

ORIGINATE DEPT.

相关部门

RELEVANT DEPT.

Manufacturing

Ditto

Machining

Engineering

PE

QA

工程师姓名

NAME OF ENGINEER

工程师签署

SIGNATURE

经理姓名

NAME OF MANAGER

经理签署

SIGNATURE

管理者代表签署

SIGNATURE OF M.R.

拒签理由

Reason of reject:

总经理签署

SIGNATURE OF GM.

文件分发

DISTRIBUTION

部门

DEPT.

Engineering

QA

HR

Maintenance

数量

Q’TY

1

部门

DEPT.

Assembly

Plating

Stamping

Molding

数量

Q’TY

部门

DEPT.

OFF

Sourcing

数量

Q’TY

Finance

1

目的

Purpose

本程序规范了为消除 存在或潜在的不合格而采取纠正预防措施的流程，以确保类似不

合格不再发生或潜在不合格的发生，促进质量管理体系的持续改进。

This procedure define the process of taking corrective and or preventive actions to

Eliminate existing or potential non- conformity, to prevent similar non-conformity from

Reoccurring or occurring of potential non-conformity. Promote continuous

Improvement of quality systems.

2

范围

Scope

本程序适用于公司质量管理体系范围内纠正和预防措 施的制定、实施与验证。

This procedure is applicable to the formulation, implementation and verification of

Corrective action and preventive action in the company quality management systems

3

定义

Definition

3.1

不合格：未满足指定要求 。“要求”是指明示的、通常隐含的或必须履行的需求或期

望，如法规、行业标准要求，公司文件要求等

Non-conformity: Non- fulfillment of a specified requirement.

“requirement” refers to the explic

it, usually implicit, Or the need or expectation is a must to fulfill. Such as regulation,industry

requirement,company documents etc.

3.2

关键不符合

：违反法定工艺、超出内 控质量标准或违反生产相关法规规定，将会造

成产品整批报废、产品召回、重大客户投诉

.

不符合关系到安全、企业的品牌形象和产品的市场影响。

Critical non-conformity : Violate legal process, beyond standard of internal control or

violation of related regulation requirement , which will cause scrap of

the whole batch products, recall of product,major customer complains,

The non-conformity related to safety , brand image of enterprise and

negative market impact of product.

3.3

纠正：存在不合格的处置包括修理，返工或调整。

Correction: repair, rework, or adjustment relates to the disposition of an existing

nonconformity.

3.4

纠正 措施：消除已发生的不符合或者其他不期望的情况的原因的措施。

Corrective action: the action taken to eliminate the causes of an existing nonconformity, defect

or other undesirable situation in order to prevent recurrence.

3.5

预防措施： 消除潜在不符合或者其他不期望的情况的原因的措施。

Preventive action: action taken to eliminate the cause of a potential nonconformity, defect, or

other undesirable situation in order to prevent occurrence.

一个不符合或者潜在不符合可能有多个原因。

There

can

be

more

than

one

cause

for

non- conformity

or

a

potential

non-

conformity.

备注

1)

纠 正和纠正措施是有区别的，纠正是针对不符合的，而纠正措施是针对不符

合的原因的。< /p>

Correction and corrective actions are different

. Correction is against non-

conformity whereas corrective action is against the cause of non conformity.

备注

2)

纠正措施用于防止不符合再发生，而预防措施用于防止不符合发生。

Corrective

action

is

taken

to

prevent

recurrence

of

non

conformity

whereas

preventive action is taken to prevent occurrence of non-conformity.

3.6

趋势分析

-

一种数据分析，是指通过对

CAPA

的 输入以及输入之间交叉关系分析，根

据趋势分析潜在质量问题

.

Trend analysis

–

One type of data analysis, through cross relationship analysis

Between CAPA inputs, Identify the potential quality issues based on

The trend analysis.

3.7

风险控制–在特定的水平内

,

经过讨论采取保护措施以降低或控制对人、财产或环境

的风险的过程。

Risk control- In the specific level, per discussion the process taken protective actions

To reduce or control risk on human, property or environment

3.8

纠正预防措施

负责人：负责协调某一 特定纠正预防措施报告的决定和实施的个人。

CAPA Responsibility: the person who is responsible for coordination of the specific

CAPA report decision and implementation

4.

职责和权限

RESPONSIBILITY AND AUTHORITY

4.1

问题产生的主管部门负责主导对不合格执 行分析、制定、执行相应的纠正措施，对潜

在不合格负责实施预防措施。

The department in which Issues arising from

is responsible for leading of analyzing,

Formulating and implementing corresponding corrective actions for the existing

Nonconformities, and take preventive actions for the potential nonconformities

.

4.2

质量管理部门全面负责纠正措施与预防措施的运行：

QA is responsible for the centralized management of

《

CAPA report

》

品质文员负责《纠正措施与预防措施报告》编号

,

归档管理

QA clerk is responsible for the coding, registration and archive management

.

QA

工程师确定不符合是否需要有

CAPA

流程，纠正与预防措施计划的审批及定期的统

计分析

,

跟踪纠正预防措施的实施过程并验证其有效性。

QA engineer is responsible for the determination if CAPA is needed,

periodical

Statistical analysis, follow up the implementation of corrective & preventive actions and

Verify the effectiveness

品质经理负责所有

CAPA

纠正预防 措施计划及

CAPA

关闭的审核。

Quality manager is responsible for review of all corrective & preventive plan and

Closure of CAPA.

4.4

公司总经理负责

CAPA

纠正预防措 施计划及

CAPA

关闭的的最终审批。

Site leader is responsible for the final approval of all corrective&preventive plan and

Closure of CAPA

4.5

公司管理层负责对纠正预防措施进行年度评审

Company management team is responsible for the annual review of corrective

Actions and preventive actions.

工作流程

WORKING FLOW CHART

流程图

Flow Chart

接收活动

Inspection

< br>activity

市场情况

Market

situation

质量审核

Quality

管理评审

Management

安全问题

Safety

issues

其他过程分析数据

Data analysis from

other processes

责任单位

Owner

各责任部门

Each department

QA

工程师分析不良问题来

源，影响程度和 趋势分析

以确定是否产生

CAPA

QE analyze sources of

quality data ,impact and

trend analysis to determine

if CAPA needed

不需要产生

CAPA

No neeD CAPA

QE/SQE/

System coord inator

程序结束

End

CAPA

需要

CAPA needed

不需要< /p>

No

质量工程师产生

CAPA