Post on 03-Jun-2020
After the Audit After the Audit
WhatWhat’’s Next??s Next??Corrective ActionCorrective Action
Theresa McCarthyTheresa McCarthyASQASQ--Granite State Granite State 18 November 200918 November 2009
AgendaAgenda
ISO19011:2002ISO19011:2002
ISO 9001:2000 ISO 9001:2000
Corrective Action Systems (IA input)Corrective Action Systems (IA input)–– CAPA PlansCAPA Plans–– Follow UpFollow Up–– EffectivenessEffectiveness
Consider other Requirements Consider other Requirements –– ISO 13485:2002ISO 13485:2002–– AS9100BAS9100B–– TS16949:2002TS16949:2002–– ISO17025:2005 ISO17025:2005
External AuditsExternal Audits
Quality Management SystemQuality Management System
Customers Customers
Requirements
Satisfaction
Management Responsibility
Product Realization
Measurement, analysis and improvement
Productinput output
Resource Management
Internal AuditInternal Audit
ISO 19011:2002 ISO 19011:2002 –– The audit is completed when all activities The audit is completed when all activities
described in the audit plan have been carried described in the audit plan have been carried out and the approved audit report has been out and the approved audit report has been distributed.distributed.
Conducting Audit Follow UpConducting Audit Follow Up
ISO 19011:2002ISO 19011:2002–– The conclusions of the audit may indicate the The conclusions of the audit may indicate the
need for corrective, preventive or improvement need for corrective, preventive or improvement actions, as applicable.actions, as applicable.
–– The completion and effectiveness of corrective The completion and effectiveness of corrective action should be verified.action should be verified.
»» Part subsequent auditPart subsequent audit
ISO9001:2008ISO9001:2008
Updated to emphasize the need for a Updated to emphasize the need for a documented proceduredocumented procedure–– A documented procedure shall be establishedA documented procedure shall be established……–– ““Establishing recordsEstablishing records”” was moved ahead of was moved ahead of
““reporting resultsreporting results”” in the list of topics in the in the list of topics in the procedure.procedure.
–– Created new sentence for Created new sentence for ““Records of audits Records of audits and their results shall be maintained.and their results shall be maintained.””
Audit ProcessAudit Process
ISO 9001:2000 ISO 9001:2000 –– 8.2.2 Internal Audit8.2.2 Internal Audit–– Management responsible for area shall Management responsible for area shall
»» Ensure that actions are taken without undue delay to Ensure that actions are taken without undue delay to eliminate detected nonconformities and their causeseliminate detected nonconformities and their causes
–– FollowFollow--up activities shall include verification up activities shall include verification of the actions taken and the reporting of of the actions taken and the reporting of verification results.verification results.
After the AuditAfter the Audit
Do you use the Corrective Action System?Do you use the Corrective Action System?
Do you have another commitment tracking Do you have another commitment tracking mechanism?mechanism? Need for Doc. Control (external,
QMS, tool Dwg or customer cad file
Customer cad?
Tool Dwg?
No
Perform review forward to QA for
distribution (approved if QMS doc.)
No
QA makes copies, updates list or database, stamps
controlled and distributes, destroys old copies or stamps them obsolete.
Dist to engineering?
Document is controlled
No
YesEngineering receives new doc from qa. Engineering distributes, destroys old copies or stamps them
obsolete, only for doc's in engineering area
Engineering reviews Dwg and updates master file
Cad file is forwarded to
Engineering who maintains file
Yes
Yes
Control of Documents
FindingsFindings
Internal AuditsInternal Audits–– Who categorizesWho categorizes
»» MajorMajor»» MinorMinor
–– Do auditees respond differently?Do auditees respond differently?
Informing the Informing the AuditeeAuditee
Closing MeetingClosing Meeting
Discuss Corrective Action PlanDiscuss Corrective Action Plan
Follow Up?????Follow Up?????
Corrective Action PlanCorrective Action Plan
How long do you get to respond?How long do you get to respond?–– Two weeks? Two weeks?
»» Is that for the Draft or Final CAPA plan?Is that for the Draft or Final CAPA plan?»» Are people late delivering their plan?Are people late delivering their plan?»» Anyone ever disagree with the need to take Anyone ever disagree with the need to take
corrective action?corrective action?»» How do you handle the Repeat finding? How do you handle the Repeat finding?
Not againNot again………………
Corrective Action PlanCorrective Action Plan
How longHow long…….does it take to .does it take to approveapprove the the corrective action plan?corrective action plan?
»» Hours, daysHours, days–– It Depends on..It Depends on..
»» How many levels of management sign off??How many levels of management sign off??
Corrective Action PlanCorrective Action Plan
What do you do if What do you do if more than onemore than one department is affected?department is affected?
What if your finding is not the part of the What if your finding is not the part of the core process and is a core process and is a supporting processsupporting process??–– Where do you conduct follow up?Where do you conduct follow up?–– Who prepares capa plan?Who prepares capa plan?
ResourcesResources
ISO 9001:2000 6.1 Provision of ResourcesISO 9001:2000 6.1 Provision of Resources–– Determine and provide resources to implement Determine and provide resources to implement
and and maintain maintain the qms and continually improve the qms and continually improve the effectiveness.the effectiveness.
»» Do you have adequate resources to manage theDo you have adequate resources to manage theCAPA plan and CAPA plan and follow up?follow up?
Follow Up ActivitiesFollow Up Activities
When do you do this?When do you do this?–– It dependsIt depends…………
Time Interval???Time Interval???
SeveritySeverity
Next AuditNext Audit
Follow Up ActivitiesFollow Up Activities
Is this a checkbox on the CAR?Is this a checkbox on the CAR?
Correction:Correction:
Root Cause:Root Cause:Corrective Action:Corrective Action:Preventive Action:Preventive Action:
Effectiveness Check Yes NoEffectiveness Check Yes No
Form use: (4.14 CA Form use: (4.14 CA --INTERNAL), (VENDOR CAR), (PREVENTIVE ACTION), (4.17 INTERAL INTERNAL), (VENDOR CAR), (PREVENTIVE ACTION), (4.17 INTERAL AUDITING CA) (CIRCLE ONE)Action Number: (4.17) Audit Report NumAUDITING CA) (CIRCLE ONE)Action Number: (4.17) Audit Report Number: (4.17)ber: (4.17)
Minor or Major: Minor or Major: CONCERN AND EXTENT: CONCERN AND EXTENT: Auditor: __________ Assigned to: Auditor: __________ Assigned to: ___________________ Date: ______________________________________ Date: ___________________
2.0 CONTAINMENT AND SHORT TERM CORRECTIVE ACTION:2.0 CONTAINMENT AND SHORT TERM CORRECTIVE ACTION:
Due Date;__________ Date Implemented: __________ Due Date;__________ Date Implemented: __________
Person Responsible: __________Person Responsible: __________
3.0 DEFINE AND VERIFY ROOT CAUSE:3.0 DEFINE AND VERIFY ROOT CAUSE:
4.0 PERMANENT CORRECTIVE ACTION TAKEN (must indicate a planned 4.0 PERMANENT CORRECTIVE ACTION TAKEN (must indicate a planned implementation date) : implementation date) :
Due Date;__________ Date Implemented:____________ Due Date;__________ Date Implemented:____________
Person Responsible:___________Person Responsible:___________
5.0 VALIDATION OF CORRECTIVE ACTION: (BOTH IMPLEMENTATION AND 5.0 VALIDATION OF CORRECTIVE ACTION: (BOTH IMPLEMENTATION AND EFFECTIVENESS)EFFECTIVENESS)
Auditor Sign Off:__________________ Date:__________________Auditor Sign Off:__________________ Date:__________________
Quality Manager Sign Off::_________________ Date:______________Quality Manager Sign Off::_________________ Date:______________
Is training required?Is training required? Documents require updatingDocuments require updating
Read OnlyRead Only NoNo
Read and Document Read and Document Yes ______________ Yes ______________
Follow Up ActivitiesFollow Up Activities
Is this a general statement in next years Is this a general statement in next years report?report?
––
Verification of status of previous completed Verification of status of previous completed commitments was performed concluding commitments was performed concluding that corrective actions implemented are in that corrective actions implemented are in place and appear to be effective.place and appear to be effective.
Is there detailed analysis?Is there detailed analysis?CAPA#CAPA# ISO ISO
13485:200313485:2003Observation Observation and Actionand Action
EffectiveEffective
11131113 5.6.25.6.2 Mgt Review Mgt Review Minutes do not Minutes do not include specific include specific reference to reference to continued continued compliance to compliance to CMDR.CMDR.
Yes Verified Yes Verified Minutes from Minutes from 17 March 17 March 2008.2008.
EffectivenessEffectiveness
How do you know?How do you know?
EffectivenessEffectiveness
WhoWho decides if a corrective action is decides if a corrective action is effective effective –– Same auditor?Same auditor?
What if you approved the plan and one year What if you approved the plan and one year later??later??–– YouYou ask who approved this?ask who approved this?
What else do you look for?What else do you look for?–– EffectivenessEffectiveness…………
EffectivenessEffectiveness Is KPI related to Quality ObjectivesIs KPI related to Quality Objectives??
Quality ObjectivesQuality Objectives
Process Efficiency
Strategic
New product investment and capital efficiency
Engineering, research & development spending
Engineering productivity
Resource utilization
Tactical
OperationalOperational
Product EffectivenessProduct Effectiveness
Sales growth
Market share
ROI
Product lifecycle throughput
Product profitability
Sales growth
Market share
ROI
Product lifecycle throughput
Product profitability
Total development cost
Applied time
Elapsed time (cycle time)
Price realization
Product value/cost
Warranty cost
Price realization
Product value/cost
Warranty cost
Design cost
Budget performance
Schedule performance
Design cost
Budget performance
Schedule performance
Design-to-cost
Quality
Functional performance
Design-to-cost
Quality
Functional performance
Monitoring for EffectivenessMonitoring for Effectiveness
How do you monitor effectiveness?How do you monitor effectiveness?–– Time based Time based –– Closed on timeClosed on time–– Anyone use $$$$$$$Anyone use $$$$$$$–– Is it QA or shared responsibility??Is it QA or shared responsibility??
How do you use results of audit findings to How do you use results of audit findings to continually improve effectiveness of qms.continually improve effectiveness of qms.–– Is this data important?Is this data important?
Analysis of DataAnalysis of Data
At Management ReviewAt Management Review–– How or Do you analyze activity of Internal How or Do you analyze activity of Internal
Audit System?Audit System?–– Process Process –– RequirementRequirement–– Time IntervalsTime Intervals–– SeveritySeverity
0102030405060708090
1stQtr
2ndQtr
3rdQtr
4thQtr
EastWestNorth
Requirements to ConsiderRequirements to Consider
AS9100BAS9100B
ISO13485:2003ISO13485:2003
ISO17025:2005ISO17025:2005
TS16949:2002TS16949:2002
Does your procedure allow for an Does your procedure allow for an extension?extension?
AS9100B AS9100B –– Corrective Action 8.5.2 h.Corrective Action 8.5.2 h.–– Specific actions where timely and/or effective Specific actions where timely and/or effective
corrective actions are not achieved. corrective actions are not achieved.
Do you have this built into your procedure?Do you have this built into your procedure?–– ExtensionsExtensions–– How many??How many??
ISO13485:2003ISO13485:2003
Determining and implementing action Determining and implementing action needed, including, if appropriate, needed, including, if appropriate, updating updating documentationdocumentation
Recording of the results of any Recording of the results of any investigationsinvestigations and of action takenand of action taken
Reviewing the corrective action taken and Reviewing the corrective action taken and its its effectivenesseffectiveness
ISO 17025: 2005ISO 17025: 2005
The procedure for corrective action shall The procedure for corrective action shall start with an investigation to determine..start with an investigation to determine..
The laboratory shall monitor the results to The laboratory shall monitor the results to ensure the corrective actions have been ensure the corrective actions have been effectiveeffective
Additional Audits 4.11.15Additional Audits 4.11.15–– When doubt on labs compliance the lab shall When doubt on labs compliance the lab shall
ensure that area are audited as soon as possible.ensure that area are audited as soon as possible.
TS16949:2002TS16949:2002
8.5.2 Corrective Action8.5.2 Corrective Action
Problem SolvingProblem Solving
Error ProofingError Proofing
Corrective Action ImpactCorrective Action Impact
Rejected Product Test AnalysisRejected Product Test Analysis
Internal versus ExternalInternal versus External
How do you handle audits of your How do you handle audits of your suppliers?suppliers?
Do they get more time to respond?Do they get more time to respond?
What if they do not respond?What if they do not respond?–– Change status?Change status?
»» Conditionally qualifiedConditionally qualified»» DisqualifyDisqualify
Customer AuditsCustomer Audits
What do your customerWhat do your customer’’s expect in a s expect in a corrective action response?corrective action response?
What if you do not agree with your What if you do not agree with your customercustomer’’s finding?s finding?
Any customerAny customer’’s require you to comply with s require you to comply with their requirementstheir requirements–– 21 CFR 210, 21121 CFR 210, 211–– TS16949TS16949
Corporate AuditsCorporate Audits
Who is audited by Corporate Office?Who is audited by Corporate Office?
Is the audit response procedure differentIs the audit response procedure different–– than your internal procedure?than your internal procedure?
Do they use the same classificationDo they use the same classification–– Major? Major? –– Minor?Minor?
SummarySummaryQuality Management SystemQuality Management System
QualityQuality ManualManualQuality Quality
ProceduresProcedures
Work InstructionsWork Instructions
Records Records
Management Review
Corrective andPreventive Action
Internal Audit
Thank YouThank You
For attending ASQFor attending ASQ--Granite State Section.Granite State Section.
Meetings are posted on the web site.Meetings are posted on the web site.
Third Wednesday of the MonthThird Wednesday of the Month
TheresaTheresa..McCarthy@comcast.netMcCarthy@comcast.net