持续改进程序英文版

CONTINUAL IMPROVEMENT PROCEDURE

1.

Purpose: 1.1 The purpose of this procedure is to

a) Ensure that SLT continually improves the effectiveness of the QMS. b) Define the method to take corrective and preventive actions to eliminate the

actual and potential root cause of nonconformity.

c) Describe the method to analyze key data and information for continuous

improvement processes.

2. Scope: 2.1 This procedure shall apply to material, product, manufacturing process, QMS, and

personnel performing the work. 3.

Reference: 3.1 ISO 9001:2008 Clause 8.1, 8.4, 8.5 3.2 Engineering Change Control Procedure (QP0203) 3.3 Customer Satisfaction Evaluation and Complaint Handling Procedure (QP0218) 3.4 Control of Records Procedure (QP0222) 3.5 Disposition of Non-Conformity/Discrepancy Report (QCD-F07) 3.6 Data Compiled for Analysis 3.7 CAPAR

3.8 CAPAR Status Log

4. Attachment: None

5.

Definition: 5.1 Major Non-Conformity

a) A quality fault entails the rejection of the whole lot of production. b) A quality complaint by a customer as per Customer Satisfaction Evaluation and

Complaint Handling Procedure.

c) Recurring and quality system non-conformity

5.2 CAPAR (Corrective and Preventive Action Request) 5.3 NCR (non-conformity report) 5.4 PIC (Person In Charge) 5.5 PDCA (Plan, Do, Check, Action)

6.

Responsibility: 6.1 MR

a) Shall monitor the status of the corrective and preventive action. b) Shall follow-up verification through management review meeting c) Shall follow up the disclosed of CAPAR d) Shall recommend continual improvement activities to management review

meeting.

6.2 All Department

a) Shall take corrective and preventive action using CAPAR b) Shall perform relevant data analysis c) Shall take appropriate improvement activities

7.Flow Chart:

8.

Procedure: 8.1 Continual improvement activities are directed from top management or proposed by

concerned HOD.

8.2 Benchmark/target/objectives set shall be specific, measurable, attainable,

realistic/relevant, track-able/time base.

8.3 Nominated personnel shall note the action taken, progress and status at any form of

record or evident shown.

8.4 Continual improvement can be any of the following:

a) Strategic

i) Business plan by top management ii) Management review committee meeting iii) Multi disciplinary continual improvement project

b) Operational

i) Department Quality Objective Report shall be prepared by

responsible personnel and compare against Quality Objective.

ii) Analysis of data and operation performances results by respective

PIC

iii) Corrective and preventive action by respective PIC iv) Internal/external audits by auditors v) Evaluation of customer satisfaction/perception

c) Individual

i) 8.5 and improvement processes.

8.6 MR

a) methodologies

b) Shall determine those that are most appropriate and ensure that the relevant

staff is suitably trained in their use and application.

8.7 A continual improvement activity can be raised upon any repeated or major non-conformances, unless otherwise specified by customers, when the implement is

capable by SLT.

8.8 Corrective Action

a) For internal production quality problems, QC Inspector shall prepare NCR

upon discovering any significant quality problems.

b) All the NCR shall be reviewed by MR and a CAPAR shall be raised where

applicable.

c) These shall be initiated by either:

i) MR ii) Factory Director iii) HOD

d) Copies of the CAPAR shall be given to:

i) The MR ii) The HOD where the fault originated

e) The person detailed to implement the necessary corrective action. f) Details of the CAPAR will be recorded on the CAPAR Status Log. g) This log shall be maintained by the MR and updated as progress is made. h) The person detailed shall investigate the root cause of the problem and

ensure that the necessary corrective action have been determined, recorded and implemented to prevent recurrence of the fault.