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纠正和预防措施控制程序(英文版)

5.1.3.1First piece quality confirmation.
5.1.3.2Quality confirmation after corrective actions taken.
5.1.3.3In process quality confirmation.
5.1.3.4Quality confirmation for finished goods after actions taken.
5.2.1.2 Potential conformity found by GM office in daily check.
5.2.1.3 Customer’s information on quality collected by Business Department in sales process ,and pass to QA.
Follow items should be reviewed in “Production /Quality Meeting” in month-end:
(1)Investigation, root cause analysis and result confirmation.
(2)Temporal and long term actions.
(3)Responsible department for actions.
Approved
Checked
Prepared
5.1.3 After actions taken, production, engineering and QA department should review the effectiveness of following items:
3.1Correct:to provide with corrective actions for abnormal issues and to meet product’s requirement.
3.2Corrective action :to avoid the recurrence of similar issue after root cause analysis and actions taken.
3.Customer complaint handling form
4.Proposal for improvement
5.2 Preventive actions as follows :
5.2.1Preventive action information source
5.2.1.1 QA department should statistic and analyze the quality conditions according to QA weekly report based on related inspection record.
4.2.QA Department is the direct responsible department of this procedure.
5.Procedure
5.1Corrective actions as f should be dealt according toControl of InspectionandControl of Abnormal Events.
5.1.6Customer complaint and non-conformities of internal audit should be corrected and prevented according to the requirements ofCustomer Complaint HandlingandControl of Internal Auditto assure the effectiveness.
5.4 Corrective and preventive actions and related information should be reviewed in Management Review Meeting.
5.5 Preserve of Quality Record
Refer to procedure ofControl of Quality Record
5.1.3.5Others.
5.1.4 In order to prevent the recurrence of similar quality issue, design, spec, work instruction etc should be revised to solve the quality issues thoroughly.
4.Customer complaint handling(File. No.:CC-H0-B103)
5.Control of internal audit(File. No.:CC-A0-B101)
7.Related form
1.Quality issues feedback form
2.Abnormal event report
Issued Date:1stSep.2002
Control of Corrective and Preventive Actions
Doc. No.:CC-H0-B104
Updated Date:
Rev.:A0
Page(s):3
1.Purpose
To eliminate actual or potential failure cause and to take corrective or preventive actions for product’s continuous improvement and achievement of quality target.
5.1.2Inspector should inform operators to correct and to meet quality requirement if any F G is out of spec and not meet customer requirement. Quality abnormal feedback form should be issued to responsible department for discussion and follow up.
Following items should be reviewed in “Production/Quality” weekly review meeting:
(1)Investigation, root cause analysis and result confirmation.
(2)Temporal and long term actions.
(3)Responsible department for actions.
5.2.3 After actions taken, production, engineering and QA department should review the effectiveness .
5.3 Effective corrective and preventive actions should be induced to QMS files ,GM office is responsible for updating and renewing in written.
2.Scope
Applied for all quality issues of raw material, semi-FG ,FG ,services after sales, customer complaint and non-conformities of internal audit.
3.Definition
5.2.1.4Potential nonconformity of QMS found in Management Review ,Internal Audit ,GM should determine the preventive actions.
5.2.2Analyze potential nonconformity cause ,determine preventive actions:
5.1.5 Non-conformity product disposition:QA department should work with production Department to deal with the products and issueQuality Issue Feedback Form.
3.3Preventive action :to prevent potential NG ,defect or other unexpected issues and eliminate the cause .
4.Responsibility
4.1.Supervisor of GM office is responsible for the control of this procedure.
6.Reference
1.Control of inspection(File. No.:CC-H0-B101)
2.Abnormal events handling(File. No.:CC-H0-B105)
3.Control of Quality Record(File. No.:CC-A0-B103)
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