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9K2K-LAD-E-IG-D4 Ver 6 1©Robere & Associates (Thailand) 2000

Post-Audit ActivitiesPost-Audit ActivitiesPost-Audit ActivitiesPost-Audit Activities

““The Job’s not done until the The Job’s not done until the paperwork is done”…paperwork is done”…

©Robere & Associates (Thailand) 2000 9K2K-LAD-E-IG-D4 Ver 6 2

Day 4 – Post-Audit ActivitiesDay 4 – Post-Audit Activities

1.1. Review of previous Review of previous dayday

2.2. Recording the auditRecording the audit

3.3. Grading NCR’sGrading NCR’s

4.4. Closing MeetingClosing Meeting

5.5. Corrective Action & Corrective Action & follow-upfollow-up

1.1. Review of previous Review of previous dayday

2.2. Recording the auditRecording the audit

3.3. Grading NCR’sGrading NCR’s

4.4. Closing MeetingClosing Meeting

5.5. Corrective Action & Corrective Action & follow-upfollow-up

Did I Pass?Did I Pass?


REVIEW OF DAY-THREE: REVIEW OF DAY-THREE: 10 minutes review10 minutes review

It is important that we begin each day with a review of It is important that we begin each day with a review of the previous day’s activities. Each day lays the the previous day’s activities. Each day lays the foundation for the upcoming subject topics.foundation for the upcoming subject topics.

1.1. Review HomeworkReview Homework2. What are the areas that were unclear?hat are the areas that were unclear?3.3. Identify topic areas that you want Identify topic areas that you want

reviewed from yesterday’s activities.reviewed from yesterday’s activities.


Stage Four: Report The AuditStage Four: Report The Audit

• Recording the Audit

• Grading NCR’s

• Closing Meeting


RECORDING THE AUDITRECORDING THE AUDIT


Positive ReportingPositive Reporting

• Say what was doneSay what was done

• Say what was seenSay what was seen

• Say what was good:Say what was good:• use of well designed methodsuse of well designed methods• well run production teamwell run production team• advanced manufacturing techniquesadvanced manufacturing techniques• ownership of qualityownership of quality


Report ‘Who, What and Where’Report ‘Who, What and Where’

• Report referenceReport reference

• Auditee/location/datesAuditee/location/dates

• Purpose/scopePurpose/scope

• Reference documentsReference documents

• Audit teamAudit team


Key ItemsKey Items

• Non-conformitiesNon-conformities

• Summary Summary

statement/Recommendationsstatement/Recommendations

• Signature of Audit Team LeaderSignature of Audit Team Leader

• Signature of the AuditeeSignature of the Auditee

• Further action requiredFurther action required


Other important detailsOther important details

• Distribution listDistribution list

• Attendees at opening and closing Attendees at opening and closing meetingsmeetings

• Auditee representativesAuditee representatives

• Audit programAudit program


Audit ReportAudit Report

• Communication toolCommunication tool– It stays with the Auditee long after the It stays with the Auditee long after the

audit team have gone homeaudit team have gone home– Should be legibleShould be legible– Contain information appropriate to the Contain information appropriate to the

audit (Relevant to the activity)audit (Relevant to the activity)


Audit RecordsAudit Records

– Audit PlanAudit Plan– Audit ScheduleAudit Schedule– Audit ReportAudit Report– Correct Action ProgramCorrect Action Program– Non-Conformance AnalysisNon-Conformance Analysis– Auditor NotesAuditor Notes


E N DE N D


Team Exercise:Team Exercise:D4-E01: Recording D4-E01: Recording Non-conformitiesNon-conformities


GRADING GRADING NCR’sNCR’s


Non-conformity: A DefinitionNon-conformity: A Definition

““The non-fulfillment of a The non-fulfillment of a requirement”requirement”

(ISO 9000 : 2000 – 3.6.2)(ISO 9000 : 2000 – 3.6.2)


Non-conformity: Other TermsNon-conformity: Other Terms

• Non-conformanceNon-conformance

• DeficiencyDeficiency

• DiscrepancyDiscrepancy

• FindingFinding

• Non-ConformityNon-Conformity

• Corrective Action Request Corrective Action Request (CAR)(CAR)

• DeviationDeviation


Categories of NonconformitiesCategories of Nonconformities

MAJOR nonconformity:MAJOR nonconformity: The absence of a required procedure or total

breakdown of a procedure or process. Significant failure to conform with

requirement Breakdown of a key aspect of the quality

management system A number of minor nonconformities listed

against the same requirement

MAJOR nonconformity:MAJOR nonconformity: The absence of a required procedure or total

breakdown of a procedure or process. Significant failure to conform with

requirement Breakdown of a key aspect of the quality

management system A number of minor nonconformities listed

against the same requirement


Categories of Non-conformitiesCategories of Non-conformities

• MINOR non-conformity:MINOR non-conformity:

A single observed lapse in a procedureA single observed lapse in a procedure isolated non-fulfillment of specified isolated non-fulfillment of specified

requirementrequirement negligible effect on qualitynegligible effect on quality


ObservationsObservations

In some circumstances it may add value to also In some circumstances it may add value to also include ‘Observations’ which:include ‘Observations’ which:

““relate to existing conditions and which, in an relate to existing conditions and which, in an assessor’s judgement, warrant clarification or assessor’s judgement, warrant clarification or investigation so as to improve the overall status investigation so as to improve the overall status and effectiveness of the quality system”and effectiveness of the quality system”


Reasons for NonconformitiesReasons for Nonconformities

• Process not in Process not in

conformanceconformance with quality with quality manualmanual

• Written procedures not Written procedures not implemented in the implemented in the processprocess

• Process is ineffectiveProcess is ineffective

• Process not in Process not in

conformanceconformance with quality with quality manualmanual

• Written procedures not Written procedures not implemented in the implemented in the processprocess

• Process is ineffectiveProcess is ineffective


Always RememberAlways Remember

Auditing is looking for Auditing is looking for conformance conformance

BUT……BUT……you should not shy away if you should not shy away if there is something to find! there is something to find!


Non-conformity StatementsNon-conformity Statements

• The facts:The facts:• wherewhere• whatwhat• why - nature of the non-conformity why - nature of the non-conformity • ISO 9001 clauseISO 9001 clause• Documented Quality Management Documented Quality Management

System referenceSystem reference


Recording Non-conformitiesRecording Non-conformities

• The findings:The findings:• the factsthe facts• acknowledged by auditeeacknowledged by auditee• at the time they are foundat the time they are found

• Non-conformity statements must Non-conformity statements must be:be:

• accurateaccurate• completecomplete• helpfulhelpful• briefbrief


Handling Possible MAJOR Non-Handling Possible MAJOR Non-conformitiesconformities

• Major non-conformities - always:Major non-conformities - always:

– inform the Lead Auditor at the earliest opportunityinform the Lead Auditor at the earliest opportunity– do not alarm the auditee or intervieweedo not alarm the auditee or interviewee– follow the certification body’s proceduresfollow the certification body’s procedures

Remember:Remember: a MAJOR is defined as the absence of ora MAJOR is defined as the absence of or

breakdown of a required Quality Management breakdown of a required Quality Management

System ElementSystem Element


Example Non-conformity FormExample Non-conformity FormROBERE QUALITY AUDIT

NONCONFORMITY REPORT

Company under Audit: XYZ plc Nonconformity Number ...................

Area under review: ISO 9001 Clause Number .............................................................................................

Category MAJOR* MINOR* * delete one

Nonconformity

Auditor


SummarySummary

• The Audit Report is the formal record of the The Audit Report is the formal record of the audit and:audit and:

• contains all information about the auditcontains all information about the audit• will be read by people not involved in the auditwill be read by people not involved in the audit

• Non-conformity statements must:Non-conformity statements must:• cover the facts, clearly and specificallycover the facts, clearly and specifically• be acknowledged by auditee at the time they are found be acknowledged by auditee at the time they are found

and be:and be:» accurateaccurate» completecomplete» helpfulhelpful» briefbrief


E N DE N D


Team ExerciseTeam ExerciseD4-E02: Grading NCR’sD4-E02: Grading NCR’sTeam ExerciseTeam ExerciseD4-E02: Grading NCR’sD4-E02: Grading NCR’s


CLOSING CLOSING MEETINGMEETING


Pre-Closing MeetingPre-Closing Meeting• Review findingsReview findings

• Agree non-conformitiesAgree non-conformities

• Write non-conformity statementsWrite non-conformity statements

• Write summary statementWrite summary statement

• Prepare agendaPrepare agenda

• Team form an agreement on assessment outcomeTeam form an agreement on assessment outcome

• Review findingsReview findings

• Agree non-conformitiesAgree non-conformities

• Write non-conformity statementsWrite non-conformity statements

• Write summary statementWrite summary statement

• Prepare agendaPrepare agenda

• Team form an agreement on assessment outcomeTeam form an agreement on assessment outcome


Closing Meeting : AgendaClosing Meeting : Agenda• Thank youThank you• PurposePurpose• Confirmation of scopeConfirmation of scope• SampleSample• FindingsFindings• SummarySummary• Follow-up activityFollow-up activity• ClarifyClarify• Report availabilityReport availability• GoGo

• Thank youThank you• PurposePurpose• Confirmation of scopeConfirmation of scope• SampleSample• FindingsFindings• SummarySummary• Follow-up activityFollow-up activity• ClarifyClarify• Report availabilityReport availability• GoGo


Closing Meeting ConductClosing Meeting Conduct

• Lead Auditor's meetingLead Auditor's meeting

• Keep to the agendaKeep to the agenda

• Keep it shortKeep it short

• Keep a record Keep a record (attendees)(attendees)

• End on a positive noteEnd on a positive note

• Lead Auditor's meetingLead Auditor's meeting

• Keep to the agendaKeep to the agenda

• Keep it shortKeep it short

• Keep a record Keep a record (attendees)(attendees)

• End on a positive noteEnd on a positive note


Summary Statement–Summary Statement–Version 1 Version 1

This Company has a Quality Management System which is well documented and generally in conformance with the requirements of ISO 9001:2000. However,the systems and procedures have not been fullyimplemented in the contract, project management and product shipment areas.

The audit found 33 non-conformities and particular concern is felt for:• Lack of application of the system for review of the quality requirements of contracts.• Evidence of a lack of disciplined control toward customer complaints and related follow-up actions.• Lack of quality awareness on the part of project and senior management personnel.


Summary Statement–Summary Statement–Version 1Version 1• No significant problems were found in the activities of either the

Design or pre-sales teams.

• There is a need for more frequent review of the Quality Manual and project management procedures.

• It will therefore be necessary for the company to undertake corrective action on the deficiencies raised and for a further audit to be carried out to verify that it has been taken before the company can be awarded a certificate. Corrective action should be effected within three months from today.


Summary Statement–Summary Statement–Version 2Version 2

There are important omissions in the Quality Management System operatedThere are important omissions in the Quality Management System operatedby the company, although what exists is mostly in line with the requirementsby the company, although what exists is mostly in line with the requirementsof ISO 9001:2000. It has also been found that the systems and procedures, of ISO 9001:2000. It has also been found that the systems and procedures, which do exist, have not been universally implemented, particularly relatedwhich do exist, have not been universally implemented, particularly relatedTo the review of contracts, project planning and customer-relations areas.To the review of contracts, project planning and customer-relations areas.The audit found 33 deficiencies of which 4 were considered to be major.The audit found 33 deficiencies of which 4 were considered to be major.

Particular concern is felt for:Particular concern is felt for:

• Lack of a system for reviewing the requirements of contracts.Lack of a system for reviewing the requirements of contracts.

•The absence of planning and progress control on work not directlyThe absence of planning and progress control on work not directly related to customer contracts.related to customer contracts.

•The effect that the current lack of control of customer complaints and The effect that the current lack of control of customer complaints and follow-up actions may cause.follow-up actions may cause.


Summary Statement–Summary Statement–Version 2Version 2

No significant problems were found in the activities of either the Design orPre-sales teams. There is a need for more frequent review of the QualityManual and software development procedures.

The most important conclusion is that there is a need for more seniormanagement involvement in and support for implementation of thedocumented system. Until this is established and the declared QualitySystem is applied consistently and effectively throughout the company, itwill not be possible to grant certification.

It is recommended that the company takes appropriate corrective actionand re-applies for assessment when all of the above concerns anddeficiencies have been addressed.


SummarySummary

• Be prepared before meetingBe prepared before meeting

• Ensure there are NO surprises for the Ensure there are NO surprises for the auditeeauditee

• Stick to the prepared agendaStick to the prepared agenda

• Don’t be drawn into discussionDon’t be drawn into discussion

• Ensure the auditee is clear as to the next Ensure the auditee is clear as to the next stepstep

• Be prepared before meetingBe prepared before meeting

• Ensure there are NO surprises for the Ensure there are NO surprises for the auditeeauditee

• Stick to the prepared agendaStick to the prepared agenda

• Don’t be drawn into discussionDon’t be drawn into discussion

• Ensure the auditee is clear as to the next Ensure the auditee is clear as to the next stepstep


ENDEND


Team Exercise:Team Exercise:D4-E03: Role-Play: D4-E03: Role-Play: Closing MeetingClosing Meeting


Stage Five:Stage Five:Stage Five:Stage Five:

CORRECTIVE ACTIONS & CORRECTIVE ACTIONS & FOLLOW UPFOLLOW UP


ACCEPT

Corrective Actions ProcessCorrective Actions ProcessCorrective Actions ProcessCorrective Actions ProcessInitiation of Non-conformity

Provide Programme of CA

Submit CA Programme to Auditor

Analysis of CA Programme

Monitoring,Reviewing,Auditing

Verify and closing

Auditor

Auditee

Auditee

Auditee

Auditor

Auditor

Stage 1

Stage 5

Stage 2

Stage 6

Stage 3

Stage 4


Stage 1–Initiation of Stage 1–Initiation of Non-conformityNon-conformity

• The Auditor raises the problem:The Auditor raises the problem:

• the factsthe facts

• the non-conformitythe non-conformity

• the department responsiblethe department responsible


Stage 2–Provide Program of Stage 2–Provide Program of Corrective ActionCorrective Action

• The Auditee ResponseThe Auditee Response– Root cause analysisRoot cause analysis– Corrective actionCorrective action– Preventive actionPreventive action– ApprovalApproval– The organization's Quality The organization's Quality

Assurance function provides advice Assurance function provides advice to the responsible managerto the responsible manager


Stage 3 – Submit Corrective Stage 3 – Submit Corrective Action Program to AuditorAction Program to Auditor

• The auditee responds:The auditee responds:– with proposed corrective actionwith proposed corrective action– and identifies root cause of non-and identifies root cause of non-

conformityconformity– and initiates action to prevent and initiates action to prevent

recurrencerecurrence– with target date for completionwith target date for completion


Stage 4 – Analysis of Stage 4 – Analysis of Corrective Action ProgramCorrective Action Program

• The auditor responds:The auditor responds:– analysis of the Corrective Action analysis of the Corrective Action

Program against the original NC Program against the original NC StatementStatement


Stage 5 - Monitoring, Stage 5 - Monitoring, Reviewing, AuditingReviewing, Auditing• The auditee responds:The auditee responds:

– Procedures requiredProcedures required

– Use of status logUse of status log

– Corrective action review meetingsCorrective action review meetings

– The auditee notifies the auditorThe auditee notifies the auditorwhen the actions are completewhen the actions are complete


Stage 6 - Verify and ClosingStage 6 - Verify and Closing

• The auditor responds:The auditor responds:

– Verify the implementation of some Verify the implementation of some actions prior to the report closeactions prior to the report close

– If Corrective Action is satisfactory, If Corrective Action is satisfactory, close out the reportclose out the report


Example:Example:Corrective Action Status LogCorrective Action Status Log

CARNos.

DateIssued

Subject of Report

Initiator CARSent To

ResponseDue Date

Approval ofResponse(Name & Date)

Verifiedby (Name)

Closed(Date)


Auditee RepresentativeAuditee Representative AuditorAuditor

Date:Date: Report Nos.Report Nos.

Standard ref.:Standard ref.: Doc. Ref.Doc. Ref.

Details of Non-conformanceDetails of Non-conformance

Non conformance Accepted ByNon conformance Accepted By

Immediate ActionImmediate Action

Preventive ActionPreventive Action

Corrective Action Verified byCorrective Action Verified by

NameNameDateDate

Example Corrective Action FormExample Corrective Action Form


Additional Key PointAdditional Key Point

The Auditee role:

– Look across the organization to identify Look across the organization to identify the other possible area where the same the other possible area where the same problem may occur but was not problem may occur but was not necessarily identified during the audit.necessarily identified during the audit.

– May provide opportunity to prevent May provide opportunity to prevent problems before they arise.problems before they arise.

– Using a structured problem solving Using a structured problem solving technique to correct the problem.technique to correct the problem.


Summary: Auditor RoleSummary: Auditor RoleSummary: Auditor RoleSummary: Auditor Role

• Communicating/explaining the audit Communicating/explaining the audit report to the auditeereport to the auditee

• Eliciting a response from the auditee Eliciting a response from the auditee as to corrective actionas to corrective action

• Evaluating the auditee's responseEvaluating the auditee's response

• Agreeing the corrective action Agreeing the corrective action proposedproposed

• Verifying that corrective action has Verifying that corrective action has been takenbeen taken

• Closing out the follow-upClosing out the follow-up


Summary: Auditee RoleSummary: Auditee RoleSummary: Auditee RoleSummary: Auditee Role

• Examines the evidenceExamines the evidence

• Identifies immediate action needs and actIdentifies immediate action needs and act

• Check corrective action effectivenessCheck corrective action effectiveness

• Establish root causeEstablish root cause

• Identify action to prevent recurrenceIdentify action to prevent recurrence

• Implement action to prevent recurrenceImplement action to prevent recurrence


ENDEND


Team Exercise:Team Exercise:D4-E04: Corrective ActionD4-E04: Corrective Action


Day-Four Summary:Day-Four Summary:We reviewed yesterdays activitiesWe reviewed yesterdays activitiesWe discussed how to record the results of the audit by

using an exercise based on previous evaluationsWe continued with our discussion about the audit and We continued with our discussion about the audit and

about the follow-up activities that we are to perform.about the follow-up activities that we are to perform.We discussed how to grade NCR: Major and Minor We discussed how to grade NCR: Major and Minor We discussed how to report the non-conformances to that We discussed how to report the non-conformances to that

our auditee can understand what type of corrective action our auditee can understand what type of corrective action needs to be taken.needs to be taken.

We discussed the format and agenda of the closing We discussed the format and agenda of the closing meeting. meeting.

We reviewed examples of summary statements that would We reviewed examples of summary statements that would give us an idea of how to structure our report.give us an idea of how to structure our report.

We discussed Corrective Actions and what we should We discussed Corrective Actions and what we should expect from our auditee if corrective action was necessary.expect from our auditee if corrective action was necessary.

We reviewed yesterdays activitiesWe reviewed yesterdays activitiesWe discussed how to record the results of the audit by

using an exercise based on previous evaluationsWe continued with our discussion about the audit and We continued with our discussion about the audit and

about the follow-up activities that we are to perform.about the follow-up activities that we are to perform.We discussed how to grade NCR: Major and Minor We discussed how to grade NCR: Major and Minor We discussed how to report the non-conformances to that We discussed how to report the non-conformances to that

our auditee can understand what type of corrective action our auditee can understand what type of corrective action needs to be taken.needs to be taken.

We discussed the format and agenda of the closing We discussed the format and agenda of the closing meeting. meeting.

We reviewed examples of summary statements that would We reviewed examples of summary statements that would give us an idea of how to structure our report.give us an idea of how to structure our report.

We discussed Corrective Actions and what we should We discussed Corrective Actions and what we should expect from our auditee if corrective action was necessary.expect from our auditee if corrective action was necessary.


End of Day FourEnd of Day Four

Only one-day left..Only one-day left..


ENDEND

Team HomeworkTeam Homework

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