纠正措施程序Corrective-Action-Procedure.doc

YANPET BENZENE MITIGATION PROJECT

CORRECTIVE ACTION PROCEDURE

11108-PI0311-Q-005

B0
20SEP
REVISED AS COMMENT
Hou YS

A
24JUL
ISSUED FOR REVIEW
Hou YS
Yao X
Cai YS
REV
DATE
DESCRIPTION
PREP'D
CHK'D
APP'D

Contents

1 SCOPE 2
2 REFERENCES 2
3 RESPONSIBILITIES 2
4 WORKING PROCEDURE 3
5 ATTACHMENT 7

1 SCOPE
1.1 This document is formulated to eliminate cause of nonconformity to prevent their recurrence and continually improve Wison’s Quality Management System on YANPET BENZENE MITIGATION PROJECT.
1.2 This document specifies the requirement of corrective action establishment, review, implementation and verification.
1.3 This document is applicable to prevent recurrence of major nonconformities and respective minor nonconformities discovered during implementing Quality Management System.

2 REFERENCES
The following normative documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, for updated references, the latest edition of the normative document referred to applies.
Project Quality Plan 11108-PI0302-Q-001
Project Quality Audit Procedure 11108-PI0311-Q-003
Nonconformance Procedure 11108-PI0311-Q-004
ITB4.7
ISO 9001:
3 RESPONSIBILITIES
3.1 QA/QC GROUP
The main responsibilities of QA/QC Group are as follows:
a) Conduct analyzing cause of major nonconformities and respective minor nonconformities discovered during implementing Quality Management System;
b) Conduct analyzing cause of major nonconformities found in Quality Special Inspection by the Project;
c) Assist determining corrective actions for nonconformities found during Quality Management System and Quality Special Inspection conducted by the Project;
d) Conduct verifying effectiveness of corrective actions taken for nonconformities found during implementing Quality Management and Quality Special Inspection conducted by the Project.
3.2 Other Group
The main responsibilities of other groups are as follows:
a) Collect nonconformities and communicate information to relevant groups;
b) Analyze cause of major nonconformities and respective minor nonconformities discovered in the group;
c) Determine Corrective actions for nonconformities which is the duty of this group and implement corrective actions;
d) Organize verifying effectiveness of corrective actions taken for nonconformities related to this group;
e) Assist relevant group to analyze cause, determine and implement corrective actions.
4 WORKING PROCEDURE
4.1 Collecting Nonconformities
4.1.1 Nonconformities discovered during implementing Quality Management System shall be disposed according to requirements of 11108-PI0311-Q-004 Nonconformance Procedure and ITB 4.7. Moreover, corrective actions shall also be taken to prevent recurrence of nonconformities for the following cases:
a) Major nonconformities;
b) Respective minor nonconformities;
c) Nonconformities discovered in management system audit activities.
4.1.2 Sources of nonconformities mainly include the following aspects:
a) Complaints from interested parties, such as clients;
b) Nonconformity report, management review report;
c) Nonconformities discovered during executing project;
d) Result from inspections and measurement activities;
e) Result from monitoring and measurement activities, such as results from all levels and all kinds of inspections and assessments.
4.1.3 Various groups shall actively collect nonconformities and communicate relevant information to responsible group. The division of responsibilities are as follows:
a) Quality group shall be responsible for collecting and communicating nonconformities during whole process of project execution;
b) Quality group shall be responsible for collecting and communicating nonconformities from audit and review of management system;
c) Other groups shall be responsible for collecting and communicating nonconformities related to this group;
d) Group which conducts inspections and assessments shall be responsible for collecting nonconformities found in all kinds of inspections and assessments, and communicating them to relevant groups.
4.1.4 All groups shall summarize and analyze nonconformities to determine the need for taking corrective actions.
4.2 Analyzing cause and determining corrective actions
4.2.1 Responsible group shall analyze cause of nonconformities with relevant group and carry out the investigation as needed when receiving nonconformities. Cause analysis can be considered from several aspects such as personnel, machinery, material, method, work environment, etc. Statistic techniques, such as cause and effect diagram, can be adopted to analyze cause as appropriate.
4.2.2 Responsible group shall put forward corrective actions corresponding to cause of nonconformities and review them with relevant groups, so as to:
a) Further determine necessity and pertinence of corrective actions proposed;
b) Evaluate adequacy, suitability and effectiveness of corrective actions proposed.
4.2.3 Corrective actions shall be appropriate to nonconformities’ severity, impact, possibility of recurrence, difficulty degree of implementation and economical efficiency. Person in charge of implementing corrective actions, responsibilities, time limit, other resources requirements, involved changes and alterations shall be made necessary arrangements.
4.2.4 Responsibilities assignment of organizing cause analysis and determining preventive actions shall refer to clause 4.1.2.
4.3 Implementing and verifying corrective actions
4.3.1 After corrective actions are determined, responsible group shall implement corrective actions with the assist of relevant group as required.
4.3.2 Quality group shall organize verifying effectiveness of corrective actions taken for nonconformities discovered during implementing Quality Management System and in Quality Special Inspection conducted by the Project after the corrective actions being completed on schedule. Responsible groups shall organize verifying effectiveness of corrective actions taken for nonconformities discovered in the group. Verification involves the following aspects:
a) Determine that corrective actions have been completed as required;
b) Demonstrate that analysis of cause is accurate;
c) Judge that corrective actions are effective and corrective actions taken can prevent recurrence of nonconformities.
4.3.3 If corrective actions can not be completed within scheduled time, responsible group shall report to group in charge and give reasonable reasons. After application is approved by group in charge, reasonable group shall reschedule implementation plan.
4.3.4 Corrective actions that haven’t achieved expected effect after verification can be divided into following to situations. If it is caused by implementation deviation, reasonable group shall implement original corrective actions; if it is caused by inappropriate actions, responsible group shall re-analyze cause, re-determine corrective actions and implement the new corrective actions. For above two situations, it is necessary to implement verification.
4.4 Other Requirements
4.4.1 Group in charge and responsible group shall keep records related to nonconformities collection, cause analysis, corrective actions determination and implementation. The forms of records can be as follows:
a) Corrective Action Record;
b) Special report / notification;
c) Inspection report / summary;
d) Meeting minutes;
e) Nonconformity report, etc.
4.4.2 Corrective actions for nonconformities discovered in internal audit shall be taken according to requirements of Project Quality Audit Procedure 11108-PI0311-Q-003 and this document. Corrective actions for improvement items determined in management review shall be taken according to requirements of Management Review and this document.
4.4.3 If corrective actions shall cause modification of management system document, Quality group shall collect feedback from relevant groups and conduct document modification according to requirements of Procedure for Document Control.
4.4.4 Various groups shall summarize corrective actions taken by the group into management review presentation materials. Quality group shall gather corrective actions taken by Project Management Teams and input them into management review. It can provide basis for continual improvement of management system.
5 ATTACHMENT
Attchment-1 Form QF0141 CORRECTIVE ACTION REPORT
Attchment-2 Form QF0142 CORRECTIVE ACTION REPORT LOG