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