Corrective & Preventive Action

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Corrective & Preventive Action CONTENTS INTRODUCTION DEFINITION & EXPLANATION “CORRECTIVE & PREVENTIVE ACTION” Procedure Requirements RAISING CPA REPORTING INVESTIGATION ACTION FOLLOW UP CLOSE OUT BENEFITS OF CPA INTERACTIVE QUIZ / DISCUSSION

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INTRODUCTION One of the most important requirements of ISO 9001 standard Serves as the Basis of QMS Improvement More emphasis given in 9001:2000 standard than the previous versions of 9001 series Tool for continual improvement DEFINITION “Corrective Action” is the “action to eliminate the causes of a detected nonconformity or other undesirable situation in order to prevent recurrence.” “Preventive Action” is the “action to eliminate the causes of a potential nonconformity or other undesirable potential situation in order to prevent its occurrence.” 1987-1994-2000

CPA PROCEDURE REQUIREMENTS : 

CPA PROCEDURE REQUIREMENTS Corrective Action Reviewing Nonconformities Determining the causes of non conformities Evaluating the need for action to ensure that nonconformities do not recur Determining and implementing the action needed Records of the results of action taken Reviewing corrective action taken

CPA PROCEDURE REQUIREMENTS : 

CPA PROCEDURE REQUIREMENTS Preventive Action Determining Potential non conformities and their causes Evaluating the need for action to prevent occurrence of nonconformities Determining and implementing the action needed Records of results of action taken Reviewing preventive action taken

CPA PROCEDURE REQUIREMENTS : 

CPA PROCEDURE REQUIREMENTS Responsibilities & Authorities Who can initiate and under what circumstances? Who verifies? Who assign responsibility & target completion date? Who verifies the effectiveness?

RAISING CPA : 

RAISING CPA Reporting Anyone in the organisation can raise a C/P Action There should be a format for it accessible to everyone There should be no punishment for issuing the request Request should be raised without bias

RAISING CPA : 

RAISING CPA Investigation Most important part of C& P Action C & P Action effectiveness depends upon proper investigation An authority must be assigned to investigate the root causes of the nonconformity Statistical techniques can be used for investigation A good traceability system will allow effective root cause investigation

RAISING CPA : 

RAISING CPA Root Causes Lack of Training Inadequate working condition Improper design & specification Inadequate Machinery and Equipment Missing procedure & documentation Inadequate procedures Non compliance with procedures Inadequate process control

RAISING CPA : 

RAISING CPA Action “Any Corrective or Preventive Action taken to eliminate the causes of actual or potential non-conformance shall be to a degree appropriate to the magnitude of problems & commensurate with the risks encountered.”

RAISING CPA : 

RAISING CPA Verification checks in CPA Is it a valid CPA request? Is this a valid root cause? Is this the right action? Have we done enough to prevent recurrence?

RAISING CPA : 

RAISING CPA Corrective Action Q.C. Tool Taken to prevent recurrence Taken after the non-conformity Preventive Action Q.A. Tool Taken to prevent occurrence Taken before the non-conformity

BENEFITS OF CPA : 

BENEFITS OF CPA Promote bottom up approach Personnel involvement More heads are better than one Continuous improvement

DANGERS IN HANDLING CPA : 

DANGERS IN HANDLING CPA Action taken when it was not required No Action taken when it was required Handling CPA without adequate professional judgement Using CPA as a tool for setting interdepartmental /personal disputes