Corrective and Preventative Action Process

8162019 Corrective and Preventative Action Process

httpslidepdfcomreaderfullcorrective-and-preventative-action-process 111

Title and Document ID Corrective andPreventative Action Process QP852+3Revision 11Issue Date 03222012

of 11 UNCONTROLLED WHEN PRINTED or Transmitted Electronically

983111983109 983120983151983159983141983154 983109983148983141983139983156983154983151983150983145983139983155983084 983113983150983139983086 ndash Proprietary Information

Author Alessandro Cervone

Technical Manager Component amp ReliabilityEngineering

601 Shiloh RoadPlano Texas 75074

Reviewers NamesTitle

Reviewer Address

Contributors NamesTitle

Contributor Address

GE Power Electronics BusinessCorrective and Preventative Action Process






Page 3 of 11 UNCONTROLLED WHEN PRINTED or Transmitted Electronically


10 PurposeThis document defines action to take for effective Corrective and Preventative Action It should beused to guide compliance with GEEQMS85 (Continuous Improvement) as it pertains to GE PowerElectronics

The Corrective Action Process is based on the industry standard KepnerTregoe concepts and theFord Motor Company TOPS (Team Oriented Problem Solving) process ndash which is frequentlyreferred to as the ldquo8-Drdquo Process

The Preventative Action Process is based on the Six Sigma DMAIC (Define Measure AnalyzeImprove and Control) model

20 Scope

The Corrective Action Process is a reactive problem solving process which is intended to describeanalyze and subsequently determine the root cause(s) of a problem It is used to solve ldquopastrdquoactions than have caused unwanted effects Generally it takes more time energy and resources tocorrect a problem than to prevent a problem This process is most effective when utilized by asmall team that is assigned by management to resolve a known problem or nonconformance

This process should be used when

bull There is a gap between the current state and the documented standard

bull The product does not meet the requirements of the print or the specifications

bull The process is out of control

bull Customers require evidence of the resolution of a problem

The Preventative Action Process is a proactive process which utilizes the DMAIC approach toachieve continuous improvement or breakthrough improvement This process can also beundertaken to implement plans to prevent the problem from occurring

Refer to Figure 1






Figure 1

30 Definitions and Acronyms

Terminology or Acronyms Definition

Corrective Action Process that prevents recurrence of a known problem ornonconformance

Corrective Action Process A A reactionary effort that prevents anonconformance from reaching a customer andimplements a plan that assures and verifiespermanent corrective action

B The steps in this process are

1 Define the concern organize and plan

2 Describe the opportunity problem

3 Contain the nonconformance to preventescapes to the customer

4 Identify and verify the root cause

5 Develop the corrective action plan

6 Implement and verify the corrective action

7 Prevent recurrence

8 Celebrate and communicate success

Preventative Action

An improvement plan action that modifies systems






processes or products

A To prevent recurrence of a root cause thatproduced a nonconformance problem in onearea within another product or process

B Through analysis of historical data implementinga plan to prevent a potential problem from

Nonconformance A product or process that does not meet establishedrequirements

Root Cause The true (original) cause of the nonconformance as verifiedthrough quantifiable data

Customer The recipient of a product or service This could be the nextoperation in the sequence (internal customer) orthe external

customer Containment Action Action taken before permanent corrective action is implemented to

assure that a nonconformance does not escape to the customer

40 Reference Documents

Document ID Document Title

GEEQMS 85 Continuous Improvement

EEDI-268 Technical Analysis Instruction

SRCWI 85 Continuous Improvement (Sourcing)

50 Roles and ResponsibilitiesRole Responsibility

Corrective Action A Individual identifying Nonconformance

This individual has the responsibility for reporting thenonconformance and providing the data related to thenonconformance in a documented format Allcharacteristics found to be nonconforming shall bereported so appropriate problem description isunderstood

B Individual Responsible for Corrective Action

1 This individual assumes ownership or is assigned theresponsibility of resolving the nonconformance This personshall analyze the problem or concern and organize thenecessary resources to as a minimum implement action tocontain the nonconformance (if necessary) determine andverify root cause (when applicable) and implement and verifypermanent corrective action The effort shall be appropriately






documented

2 When the nonconformance involves a chronic recurrencethat compromises business goals the responsible individualshall organize a corrective action team comprised ofindividuals with the knowledge to as a minimum implementaction to contain the nonconformance (if necessary)determine and verify root cause and implement and verifypermanent corrective action The effort shall be appropriatelydocumented

Preventive ActionTo ensure preventive actions are addressed the following

applies

A Action taken to prevent a potential nonconformanceof a product or process is the responsibility of thefunction benefiting from prevention of thenonconformance

B Documented process reviews andmanufacturing equipment maintenanceactivities should routinely be performed bysuppliers

C The review and analysis of customer recordssatisfaction surveys the quality system andprocess and product assessment results are theresponsibility of the suppliers quality function

Team Action It is the responsibility of each member of the team to contributeto an effective resolution of the nonconformance or potentialnonconformance The team consists of individuals with theskills associated with completing the appropriate steps of thecorrective action preventive action process

60

61 Procedure - Requirements for Corrective Action611 Corrective actions taken to eliminate the root causes of actual nonconformance(s) shall be to

a degree appropriate to the magnitude of problems and consistent with the risks encountered Any corrective action process is an exercise in problem solving An industry standard forconducting corrective action adopted at GE Power Electronics involves the 8 Discipline (8D)method This method is a formal documented step by step process which when implementedappropriately will cause permanent corrective and preventive action






612 The 8D Reactive Problem Solving Process Figure diagrams the 8D process

Figure 2

613 The minimum requirements of the 8D reactive problem solving process are summarizedbelow

A All steps of the 8D reactive problem solving process shall be addressed when processing acomplaint or rejection received from GE Power Electronics

B The results of corrective actions shall be documented and maintained as a quality record

614 GE Power Electronics Reactive Problem Solving Process (8D)






Problem SolvingProcess Step Desired Outcome

1 Define ConcernOrganize and Plan

bull Concernproblem identified

bull Project Plan in place for eliminating the problem and improving theprocess including scope key activities boundaries responsibilitiestimeliness resources etc

2 Describe theOpportunityProblem

bull Problem statement written in terms of gap between ldquoas isrdquo and ldquodesiredstaterdquo

bull Define the nonconformance in term of ldquowhat is wrongrdquo (the defect) withldquowhatrdquo (the object

bull Determine the quantity size volume magnitude of the nonconformance3 Contain the Problem bull Implement interim actions to shield the customer from the problem

4 Identify and Verify

Root Cause

bull Selected root cause to work on

bull Revised problem statement if requiredbull Produce list of as many ways as possible to solve the problem

5 Develop CorrectiveAction Plan

bull Decide on optimum corrective ationsolution and plan its implementation

6 bull Perform pilot test

bull Evaluate effectiveness of corrective actionsolution

bull Document improvements

bull Address open issues

bull Remove the interim actions and the problem does not re-occur

7 Prevent Recurrence bull Apply permanent ldquofixrdquo

bull Identify what system practice or procedure allowed the root cause tooccur

bull Modify and monitor to prevent recurrence of problem

8 Celebrate andCommunicateSuccess

bull Contributions of everyone involved recognized

bull Change or improvements communicated to all individuals who areaffected

62 REQUIREMENTS FOR PREVENTIVE ACTION

621 Preventive action is a proactive effort taken to identify a potential nonconforming product or processThe preventive action process applies to development of new product or processes to preventpotential nonconformance or to create breakthrough improvements

622 Preventive actions resulting from actual nonconformance root cause analysis should be performedas part of the correctivepreventive action process by the 8D team

623 The results of preventive actions shall be documented and maintained as a quality record

624 The DMAIC Process

A The DMAIC (Define Measure Analyze Improve Control) process is a structured approach forleading continual and breakthrough improvement initiatives This structuremodel is based onthe Plan Do Check Act cycle






B The GE Power Electronics Six Sigma Operational Excellence initiative utilizes the DMAICprocess lead by a Black Belt or Green Belt to launch and manage breakthrough improvement

C Continual improvement initiatives should follow this same methodology however these project teamsare not usually lead by a Black Belt and there may be a less rigorous application of the statistical tools








63 Record Retention

Document Record

Retentionperiod

Storage location Responsible(if applicable)

8D or Failure Analysis Report

7 years Windchill in MaterialContext under comcode

ComponentEngineering











20 Scope








Refer to Figure 1






Figure 1














Preventative Action






























documented



applies





60









Figure 2



















Root Cause




































63 Record Retention

Document Record

Retentionperiod










Figure 1














Preventative Action






























documented



applies





60









Figure 2



















Root Cause




































63 Record Retention

Document Record

Retentionperiod

































documented



applies





60









Figure 2



















Root Cause




































63 Record Retention

Document Record

Retentionperiod











Figure 2



















Root Cause




































63 Record Retention

Document Record

Retentionperiod



















Root Cause




































63 Record Retention

Document Record

Retentionperiod



















63 Record Retention

Document Record

Retentionperiod





Corrective and Preventative Action Process

Documents

Transcript of Corrective and Preventative Action Process