slide 3 v6

9K2K-LAD-E-IG-D3 Ver 6 1©Robere & Associates (Thailand) 2000

PERFORMING THE AUDITPERFORMING THE AUDITPERFORMING THE AUDITPERFORMING THE AUDIT

““Using all the ‘Planning for the Audit’ Using all the ‘Planning for the Audit’ that we did yesterday”that we did yesterday”

““A fool may ask more A fool may ask more questions in an hour than a questions in an hour than a wise man can answer in wise man can answer in

seven years.”seven years.” -- English -- English ProverbProverb

©Robere & Associates (Thailand) 2000 9K2K-LAD-E-IG-D3 Ver 6 2

Day 3 – Audit ActivitiesDay 3 – Audit Activities

1.1. Review of previous dayReview of previous day

2.2. ChecklistsChecklists

3.3. Opening MeetingOpening Meeting

4.4. Conducting the AuditConducting the Audit

1.1. Review of previous dayReview of previous day

2.2. ChecklistsChecklists

3.3. Opening MeetingOpening Meeting

4.4. Conducting the AuditConducting the Audit

““It is only through the eyes of others, can It is only through the eyes of others, can one truly know one truly know

oneself.”oneself.”- Confucius


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

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


CHECKLISTSCHECKLISTS


Checklist BenefitsChecklist Benefits

• Ensures sample is balancedEnsures sample is balanced

• Assists in preparing audit teamAssists in preparing audit team

• Helps maintain correct paceHelps maintain correct pace

• Provides a record of the audit for future Provides a record of the audit for future referencereference

• Ensures sample is balancedEnsures sample is balanced

• Assists in preparing audit teamAssists in preparing audit team

• Helps maintain correct paceHelps maintain correct pace

• Provides a record of the audit for future Provides a record of the audit for future referencereference


Preparing a Checklist (1)Preparing a Checklist (1)

• General guidelinesGeneral guidelines

be conversant with the documented be conversant with the documented quality management systemquality management system

prepare separate lists for each prepare separate lists for each function/areafunction/area

consider time allocated and key elements consider time allocated and key elements to be assessedto be assessed

use the checklist as a tooluse the checklist as a tool the auditor determines the style and detailthe auditor determines the style and detail

• General guidelinesGeneral guidelines

be conversant with the documented be conversant with the documented quality management systemquality management system

prepare separate lists for each prepare separate lists for each function/areafunction/area

consider time allocated and key elements consider time allocated and key elements to be assessedto be assessed

use the checklist as a tooluse the checklist as a tool the auditor determines the style and detailthe auditor determines the style and detail


Preparing A Checklist (2)Preparing A Checklist (2)

• ReferencesReferences

use the documented systemuse the documented system

use the Standardsuse the Standards

use the auditors guideuse the auditors guide

use your experienceuse your experience

• ReferencesReferences

use the documented systemuse the documented system

use the Standardsuse the Standards

use the auditors guideuse the auditors guide

use your experienceuse your experience


Preparing A Checklist (3)Preparing A Checklist (3)

• Types of checklistTypes of checklist

criteriacriteria

specific questionsspecific questions

Standard Checklist (Internal Standard Checklist (Internal Auditing)Auditing)

bullet pointsbullet points

• Types of checklistTypes of checklist

criteriacriteria

specific questionsspecific questions

Standard Checklist (Internal Standard Checklist (Internal Auditing)Auditing)

bullet pointsbullet points


Criteria ChecklistCriteria Checklist

• Be Structured in accordance with Be Structured in accordance with QMS Standard QMS Standard

• Can be use for any auditCan be use for any audit

• Be Structured in accordance with Be Structured in accordance with QMS Standard QMS Standard

• Can be use for any auditCan be use for any audit


Criteria checklist example :Criteria checklist example :

8.3 Control Of Nonconforming Product

Company X ensures that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.

The controls and related responsibilities and authorities for dealing with nonconforming are defined in a documented procedure.

ISO 9001 REQUIREMENTS STATUS ACTION/COMMENTSSTATUS ACTION/COMMENTS


Criteria Checklist• Advantage

– Provides ready assessment with QMS Standard.– Focuses auditor’s mind on measures– Can be used time and time again

• Disadvantage – Requires experienced auditor– Does not identify to an inexperienced auditor what

to look for


Specific Questions ChecklistSpecific Questions Checklist

• Be structured around a discrete Be structured around a discrete department, contract,project,proceduredepartment, contract,project,procedure

• Can be used for every type of audit.Can be used for every type of audit.

• Be structured around a discrete Be structured around a discrete department, contract,project,proceduredepartment, contract,project,procedure

• Can be used for every type of audit.Can be used for every type of audit.


Specific Question Specific Question checklists Example: checklists Example: Calibration Department Calibration Department

1) What method are available to control the calibration of inspection measuring and test equipment?

2) Does the calibration method process identify all pieces of measuring, inspection and test equipment being used?

3) Is provision made for equipment whose calibration results are unsatisfactory?a. How is it evaluated?b. How is it segregated?

Checklist Question

Comment


Specific Question ChecklistSpecific Question Checklist

Advantage convenient flexible good for training auditors tell auditor what you want

Disadvantage Disadvantage

Not provide assessment with QMS standard Reflex preconceived idea of person stereotyped audits. Lot of work

Advantage convenient flexible good for training auditors tell auditor what you want


Not provide assessment with QMS standard Reflex preconceived idea of person stereotyped audits. Lot of work


Standard ChecklistStandard Checklist

• Used as part of internal audit

• Could take the form of either of theprevious checklists

• Used as part of internal audit

• Could take the form of either of theprevious checklists


Standard ChecklistStandard Checklist

Advantage Uniform practice Helps train auditors Economic and quick to create


May not be suitable for all circumstances Inflexible Blinkered Stereotyped’ audits Does not handle changes to audit type or audit basis

very well

Advantage Uniform practice Helps train auditors Economic and quick to create


May not be suitable for all circumstances Inflexible Blinkered Stereotyped’ audits Does not handle changes to audit type or audit basis

very well


Standard Checklist ExampleStandard Checklist Examplefor Training companyfor Training company

1.1. How are marketing activities initiated, and what resources are used?

2.2. Who are responsible for developing, reviewing and approving the Public Event?

3.3. Why would the Public Event Plan be resubmitted?

4.4. What should marketing material includes as a minimum?

5.5. When would you use a Registration/ Confirmation forms?

6.6. How long are Registration/Confirmation slips kept for, and by whom?


Bullet Point ChecklistBullet Point Checklist

• Only name suggest point

• Can be deployed equally as well during meeting and auditing alike

• Only name suggest point

• Can be deployed equally as well during meeting and auditing alike


Bullet Point ChecklistBullet Point Checklist

Advantage Quick and easy to prepare Very flexible


Does not provide ready assessment Only used by experienced auditors Does not define what to look for How to record comments to objective

Advantage Quick and easy to prepare Very flexible


Does not provide ready assessment Only used by experienced auditors Does not define what to look for How to record comments to objective


Bullet point Checklist ExampleBullet point Checklist Example

• Document ControlDocument Control

Establish documentation procedureEstablish documentation procedure Approve DocumentApprove Document UpdatedUpdated Identified ChangesIdentified Changes VersionsVersions Legible and readilyLegible and readily Control External DocumentControl External Document Obsolete documentObsolete document

• Document ControlDocument Control

Establish documentation procedureEstablish documentation procedure Approve DocumentApprove Document UpdatedUpdated Identified ChangesIdentified Changes VersionsVersions Legible and readilyLegible and readily Control External DocumentControl External Document Obsolete documentObsolete document


““LOOK-AT” – “LOOK-FOR” LOOK-AT” – “LOOK-FOR” Example: Design Control (1)Example: Design Control (1)• Development planDevelopment plan

• Progress controlProgress control

• Input to product development phasesInput to product development phases

• Output from product development Output from product development phasesphases

• Verification of each phaseVerification of each phase

• Development planDevelopment plan

• Progress controlProgress control

• Input to product development phasesInput to product development phases

• Output from product development Output from product development phasesphases

• Verification of each phaseVerification of each phase


Example: Design Control (2)Example: Design Control (2)Development planDevelopment plan

Look at Look for

1. Project Schedule

2. Activity Assignment

3. Organisation Interfaces

Schedule is Complete

Assigned staff are qualified

Sub-team interfaces work


Example: Design Control (3)Example: Design Control (3)Progress ControlProgress Control

Look at Look for

1. Progress Report

2. Project Schedule

Work in progress matches with Reports and records

Project Schedule reflects actual progress


Example: Design Control (4)Example: Design Control (4)Input to product development phasesInput to product development phases

Look at Look for

1. Requirement Specification

2. Test criteria

Clear definition of Requirements

Authorization by issuing organization


Example: Design Control (5)Example: Design Control (5)Output from product development phasesOutput from product development phases

Look at Look for

1. Requirement Specification

2. Outputs/deliverables

3. Prototypes of product

traceability to input

Requirements

conformance with standards


Example: Design Control (6)Example: Design Control (6)Verification of each phaseVerification of each phase

Look at Look for

1. Design reviews

2. Checkpoint review

Detailed records of reviews

Follow-up action on problems


SummarySummary

• Be conversant with the quality system Be conversant with the quality system

• Relate the checklist to the department or quality Relate the checklist to the department or quality system area to be audited system area to be audited

• Checklists assist the auditor in sticking to the Checklists assist the auditor in sticking to the plan plan

• They can be used for subsequent auditsThey can be used for subsequent audits

Checklists are optional–Checklists are optional–

but strongly encouraged !but strongly encouraged !

• Be conversant with the quality system Be conversant with the quality system

• Relate the checklist to the department or quality Relate the checklist to the department or quality system area to be audited system area to be audited

• Checklists assist the auditor in sticking to the Checklists assist the auditor in sticking to the plan plan

• They can be used for subsequent auditsThey can be used for subsequent audits

Checklists are optional–Checklists are optional–

but strongly encouraged !but strongly encouraged !


E N DE N DE N DE N D


Team ExerciseTeam ExerciseD3-E01:“Checklists”D3-E01:“Checklists”Time: 60 MinutesTime: 60 MinutesFeedback: 30 MinutesFeedback: 30 Minutes


Stage Three: Stage Three: Conduct the AuditConduct the Audit

• Opening MeetingOpening Meeting• Conduct the auditConduct the audit• Opening MeetingOpening Meeting• Conduct the auditConduct the audit


OPENING MEETINGOPENING MEETING


Opening Meeting PurposeOpening Meeting Purpose

• Confirm the scope and Confirm the scope and method of the auditmethod of the audit

• Put the company at easePut the company at ease

• Create the "right" Create the "right" atmosphereatmosphere

• Give the auditors an insight Give the auditors an insight to the management's to the management's commitment to qualitycommitment to quality

• Confirm the scope and Confirm the scope and method of the auditmethod of the audit

• Put the company at easePut the company at ease

• Create the "right" Create the "right" atmosphereatmosphere

• Give the auditors an insight Give the auditors an insight to the management's to the management's commitment to qualitycommitment to quality


Opening Meeting Agenda - 1Opening Meeting Agenda - 1

1.1. Thanks auditee for invitingThanks auditee for inviting

2.2. Introduce assessment teamIntroduce assessment team

3.3. Note attendanceNote attendance

4.4. Confirm the full scopeConfirm the full scope

5.5. Review the audit schedule and Review the audit schedule and responsibilities of the audit teamresponsibilities of the audit team

6.6. Arrange for escorts/guidesArrange for escorts/guides

7.7. Explain how to assessmentExplain how to assessment

1.1. Thanks auditee for invitingThanks auditee for inviting

2.2. Introduce assessment teamIntroduce assessment team

3.3. Note attendanceNote attendance

4.4. Confirm the full scopeConfirm the full scope

5.5. Review the audit schedule and Review the audit schedule and responsibilities of the audit teamresponsibilities of the audit team

6.6. Arrange for escorts/guidesArrange for escorts/guides

7.7. Explain how to assessmentExplain how to assessment



8.8. Define the types of Define the types of non-conformance, recommendationnon-conformance, recommendation

9.9. Explain the output of the auditExplain the output of the audit10.10. Confirm of confidentiality of audit Confirm of confidentiality of audit

activitiesactivities11.11. Confirm and record issue status of Confirm and record issue status of

documentation documentation 12.12. Arrange for use of office, equipment, Arrange for use of office, equipment,

LogisticLogistic

8.8. Define the types of Define the types of non-conformance, recommendationnon-conformance, recommendation

9.9. Explain the output of the auditExplain the output of the audit10.10. Confirm of confidentiality of audit Confirm of confidentiality of audit

activitiesactivities11.11. Confirm and record issue status of Confirm and record issue status of

documentation documentation 12.12. Arrange for use of office, equipment, Arrange for use of office, equipment,

LogisticLogistic



13.13. Invite questions Invite questions

14.14. Thank auditee organization for Thank auditee organization for time and commitmenttime and commitment

13.13. Invite questions Invite questions

14.14. Thank auditee organization for Thank auditee organization for time and commitmenttime and commitment


Additional Key PointsAdditional Key Points

• As appropriateAs appropriate– Explain the purpose of any review meetingExplain the purpose of any review meeting– Are there any specific health and safety?Are there any specific health and safety?– If the required, organize a brief familiarization If the required, organize a brief familiarization

tour of the facilitytour of the facility– Define start/stop times for the remainder of Define start/stop times for the remainder of

the auditthe audit– Is everyone aware of the audits (i.e. Unions)Is everyone aware of the audits (i.e. Unions)

• As appropriateAs appropriate– Explain the purpose of any review meetingExplain the purpose of any review meeting– Are there any specific health and safety?Are there any specific health and safety?– If the required, organize a brief familiarization If the required, organize a brief familiarization

tour of the facilitytour of the facility– Define start/stop times for the remainder of Define start/stop times for the remainder of

the auditthe audit– Is everyone aware of the audits (i.e. Unions)Is everyone aware of the audits (i.e. Unions)


Opening Meeting ConductOpening Meeting Conduct

• Keep it shortKeep it short

• Be well preparedBe well prepared

• Conduct meeting in a Conduct meeting in a business like mannerbusiness like manner

• Keep a recordKeep a record

• Keep it shortKeep it short

• Be well preparedBe well prepared

• Conduct meeting in a Conduct meeting in a business like mannerbusiness like manner

• Keep a recordKeep a record


SummarySummary

• Cover the details:Cover the details:– confirm the scope and method of the confirm the scope and method of the

auditaudit

– confirm logistical details / confirm logistical details / arrangementsarrangements

• Set the tone:Set the tone:– be prepared and professionalbe prepared and professional

– get off on ‘the right foot’get off on ‘the right foot’

• Cover the details:Cover the details:– confirm the scope and method of the confirm the scope and method of the

auditaudit

– confirm logistical details / confirm logistical details / arrangementsarrangements

• Set the tone:Set the tone:– be prepared and professionalbe prepared and professional

– get off on ‘the right foot’get off on ‘the right foot’


E N DE N DE N DE N D


Team ExerciseTeam ExerciseD3-E02:“Opening Meeting”D3-E02:“Opening Meeting”


CONDUCTING THE AUDITCONDUCTING THE AUDIT

A “Process” ApproachA “Process” Approach


Process RelationshipsProcess Relationships

• We are auditing a “system” that is We are auditing a “system” that is made up of “processes”.made up of “processes”.

• Look for some “process map” that Look for some “process map” that indicates the relationship and indicates the relationship and interaction of each activityinteraction of each activity

• We are auditing a “system” that is We are auditing a “system” that is made up of “processes”.made up of “processes”.

• Look for some “process map” that Look for some “process map” that indicates the relationship and indicates the relationship and interaction of each activityinteraction of each activity

PROCESS

PROCEDURETODO

WORK

PROCEDURETO

CHECKWORK

STANDARDS

TOOLBOX

PRODUCT(S)

IN

+

ENTRY

CRITERIA

PRODUCT(S)

OUT

+

EXIT CRITERIA

REWORK

PROCESS

PROCEDURETODO

WORK

PROCEDURETO

CHECKWORK

STANDARDS

TOOLBOX

PRODUCT(S)

IN

+

ENTRY

CRITERIA

PRODUCT(S)

OUT

+

EXIT CRITERIA

REWORK

PROCESS

PROCEDURETODO

WORK

PROCEDURETO

CHECKWORK

STANDARDS

TOOLBOX

PRODUCT(S)

IN

+

ENTRY

CRITERIA

PRODUCT(S)

OUT

+

EXIT CRITERIA

REWORK

• Examine the “interface” between Examine the “interface” between each process. Look for a logical each process. Look for a logical approachapproach

• Does the “output” of one process Does the “output” of one process lead to the “input” of another?lead to the “input” of another?

• Examine the “interface” between Examine the “interface” between each process. Look for a logical each process. Look for a logical approachapproach

• Does the “output” of one process Does the “output” of one process lead to the “input” of another?lead to the “input” of another?


Process Auditing for ISO9000:2000Process Auditing for ISO9000:2000 starts at the topstarts at the top

• More focus on Top More focus on Top ManagementManagement

• Start with Quality Start with Quality PolicyPolicy– Does it reflect a Does it reflect a

customer focuscustomer focus– Provide for setting and Provide for setting and

reviewing objectivesreviewing objectives– Is there a commitment Is there a commitment

to continual to continual improvementimprovement

• More focus on Top More focus on Top ManagementManagement

• Start with Quality Start with Quality PolicyPolicy– Does it reflect a Does it reflect a

customer focuscustomer focus– Provide for setting and Provide for setting and

reviewing objectivesreviewing objectives– Is there a commitment Is there a commitment

to continual to continual improvementimprovement


Management CommitmentManagement Commitment

• Must show commitment to policy, objectivesMust show commitment to policy, objectives

• Must “focus” on the customerMust “focus” on the customer

• Must have a policy that “makes sense” Must have a policy that “makes sense” (strategic planning used)(strategic planning used)

• Must “Plan” for resources to accomplish the Must “Plan” for resources to accomplish the goals and objectivesgoals and objectives

• Must be able to show that the responsibility, Must be able to show that the responsibility, authority and authority and communication communication (internal/external) is in place for everyone.(internal/external) is in place for everyone.

• Must have a “management review” that Must have a “management review” that shows results.shows results.

• Must show commitment to policy, objectivesMust show commitment to policy, objectives

• Must “focus” on the customerMust “focus” on the customer

• Must have a policy that “makes sense” Must have a policy that “makes sense” (strategic planning used)(strategic planning used)

• Must “Plan” for resources to accomplish the Must “Plan” for resources to accomplish the goals and objectivesgoals and objectives

• Must be able to show that the responsibility, Must be able to show that the responsibility, authority and authority and communication communication (internal/external) is in place for everyone.(internal/external) is in place for everyone.

• Must have a “management review” that Must have a “management review” that shows results.shows results.

Version 2.0


ObjectivesObjectivesObjectivesObjectivesObjectivesObjectivesObjectivesObjectivesObjectivesObjectivesObjectivesObjectivesObjectivesObjectives



A Different Audit FocusA Different Audit Focus

• Everything starts with the Everything starts with the “Quality Policy”“Quality Policy”

• The corporate “goals” The corporate “goals” must reflect the need must reflect the need stated in the Policystated in the Policy

• Departmental Departmental “objectives” fulfill the “objectives” fulfill the goals..goals..

• Everything starts with the Everything starts with the “Quality Policy”“Quality Policy”

• The corporate “goals” The corporate “goals” must reflect the need must reflect the need stated in the Policystated in the Policy

• Departmental Departmental “objectives” fulfill the “objectives” fulfill the goals..goals..

QualityQualityPolicyPolicy

GoalGoalGoalGoal GoalGoal

Version 2.0


Objectives are the “key” to Objectives are the “key” to Continuous ImprovementContinuous Improvement• Must be evident at all levels Must be evident at all levels

throughout the organization. They throughout the organization. They must be:must be:– MeasurableMeasurable– Useful (not just easy to measure)Useful (not just easy to measure)– Contributes toward the Quality PolicyContributes toward the Quality Policy– Suitable to demonstrate effectivenessSuitable to demonstrate effectiveness– Monitored for trends and acted upon by Monitored for trends and acted upon by

top managementtop management

• Must be evident at all levels Must be evident at all levels throughout the organization. They throughout the organization. They must be:must be:– MeasurableMeasurable– Useful (not just easy to measure)Useful (not just easy to measure)– Contributes toward the Quality PolicyContributes toward the Quality Policy– Suitable to demonstrate effectivenessSuitable to demonstrate effectiveness– Monitored for trends and acted upon by Monitored for trends and acted upon by

top managementtop management


Conducting Process AuditConducting Process AuditThe following items are considerationThe following items are consideration

The purpose, input, output, control and resources applicable The purpose, input, output, control and resources applicable to each process are clearto each process are clear

Links are established between process, and high level and Links are established between process, and high level and local quality objectiveslocal quality objectives

The outputs of the process are compared with desired The outputs of the process are compared with desired

outcomes, purpose of the process and any specific quality outcomes, purpose of the process and any specific quality objectivesobjectives

The steps in the process and responsibilities are The steps in the process and responsibilities are determineddetermined

Process measures are identifiedProcess measures are identified

Evidence of continual improvement is soughtEvidence of continual improvement is sought

Need of internal and external customers are clearNeed of internal and external customers are clear

The following items are considerationThe following items are consideration

The purpose, input, output, control and resources applicable The purpose, input, output, control and resources applicable to each process are clearto each process are clear

Links are established between process, and high level and Links are established between process, and high level and local quality objectiveslocal quality objectives

The outputs of the process are compared with desired The outputs of the process are compared with desired

outcomes, purpose of the process and any specific quality outcomes, purpose of the process and any specific quality objectivesobjectives

The steps in the process and responsibilities are The steps in the process and responsibilities are determineddetermined

Process measures are identifiedProcess measures are identified

Evidence of continual improvement is soughtEvidence of continual improvement is sought

Need of internal and external customers are clearNeed of internal and external customers are clear


Control of the AuditControl of the Audit

• The auditor must keep controlThe auditor must keep control

• The auditor must manage his/her timeThe auditor must manage his/her time

• Use prepared checklistsUse prepared checklists

• Judgement - What is the result of the Judgement - What is the result of the processprocess

• The audit team must keep in touchThe audit team must keep in touch

• The auditor must keep controlThe auditor must keep control

• The auditor must manage his/her timeThe auditor must manage his/her time

• Use prepared checklistsUse prepared checklists

• Judgement - What is the result of the Judgement - What is the result of the processprocess

• The audit team must keep in touchThe audit team must keep in touch


Audit ObjectiveAudit Objective

• To gather objective evidence To gather objective evidence through…through…

• interviewinginterviewing

• observationobservation

• To gather objective evidence To gather objective evidence through…through…

• interviewinginterviewing

• observationobservation


Objective Evidence (1)Objective Evidence (1)

• Found in the form of:Found in the form of:

–documentsdocuments

–statementsstatements

–observationsobservations

–recordsrecords

• Found in the form of:Found in the form of:

–documentsdocuments

–statementsstatements

–observationsobservations

–recordsrecords


Objective Evidence (2)Objective Evidence (2)

• The evidence MUST The evidence MUST be:be:

– factual and existfactual and exist– accurateaccurate– relevant to the non-relevant to the non-

conformity identifiedconformity identified– significantsignificant

• The evidence MUST The evidence MUST be:be:

– factual and existfactual and exist– accurateaccurate– relevant to the non-relevant to the non-

conformity identifiedconformity identified– significantsignificant


Recording EvidenceRecording Evidence

• A factual statement that can be verifiedA factual statement that can be verified not based on opinion or preferencenot based on opinion or preference not based on emotionnot based on emotion based on actual observations and based on actual observations and

statementsstatements

• A factual statement that can be verifiedA factual statement that can be verified not based on opinion or preferencenot based on opinion or preference not based on emotionnot based on emotion based on actual observations and based on actual observations and

statementsstatements


Evidence of DocumentationEvidence of Documentation• Quality Policy for the OrganizationQuality Policy for the Organization

• Quality Manual referring to proceduresQuality Manual referring to procedures

• Procedures covering ISO 9001Procedures covering ISO 9001

• Procedures covering processes company’sProcedures covering processes company’s

• InstructionsInstructions

• Quality objectivesQuality objectives

• Responsibilities and authoritiesResponsibilities and authorities

• Quality Policy for the OrganizationQuality Policy for the Organization

• Quality Manual referring to proceduresQuality Manual referring to procedures

• Procedures covering ISO 9001Procedures covering ISO 9001

• Procedures covering processes company’sProcedures covering processes company’s

• InstructionsInstructions

• Quality objectivesQuality objectives

• Responsibilities and authoritiesResponsibilities and authorities


Evidence of ImplementationEvidence of Implementation

• RecordsRecords

• ActivitiesActivities

• InterviewsInterviews

• ObjectsObjects

• UnderstandingUnderstanding

• RecordsRecords

• ActivitiesActivities

• InterviewsInterviews

• ObjectsObjects



Evidence of EffectivenessEvidence of Effectiveness

• Records/resultsRecords/results

• MeasurementsMeasurements

• MilestonesMilestones

• Management reviewManagement review

• Customer feedbackCustomer feedback

• Timely corrective actionTimely corrective action

• Right versions of documents in useRight versions of documents in use

• Records/resultsRecords/results

• MeasurementsMeasurements

• MilestonesMilestones

• Management reviewManagement review

• Customer feedbackCustomer feedback

• Timely corrective actionTimely corrective action

• Right versions of documents in useRight versions of documents in use


Interviewing (1)Interviewing (1)

• ElaborationElaboration

• ExplanationExplanation

• Work statusWork status

• Basis for evidenceBasis for evidence


• Dialogue/rapportDialogue/rapport

• PerspectivePerspective

• ElaborationElaboration

• ExplanationExplanation

• Work statusWork status

• Basis for evidenceBasis for evidence


• Dialogue/rapportDialogue/rapport

• PerspectivePerspective



• Open Questions:Open Questions:• where?where?• who?who?• when?when?• why?why?• how?how?• what?what?

• ListenListen

• Closed questionClosed question

• Please show mePlease show me

• Open Questions:Open Questions:• where?where?• who?who?• when?when?• why?why?• how?how?• what?what?

• ListenListen

• Closed questionClosed question

• Please show mePlease show me



• Questions:Questions:

– supposesuppose– repeat, rephraserepeat, rephrase– ‘‘silly’ questions may have to be askedsilly’ questions may have to be asked– silence can be usefulsilence can be useful– remain neutralremain neutral– confirm your understanding with closed confirm your understanding with closed

questionsquestions

• Questions:Questions:

– supposesuppose– repeat, rephraserepeat, rephrase– ‘‘silly’ questions may have to be askedsilly’ questions may have to be asked– silence can be usefulsilence can be useful– remain neutralremain neutral– confirm your understanding with closed confirm your understanding with closed

questionsquestions



• Remember to ask:Remember to ask:

– the right questionsthe right questions

– at their workplace at their workplace

– in their languagein their language

• Remember to ask:Remember to ask:

– the right questionsthe right questions

– at their workplace at their workplace

– in their languagein their language


Investigating Actions (1)Investigating Actions (1)

• ReviewsReviews• re-workre-work• re-planre-plan• re-reviewre-review

• MinutesMinutes• action takenaction taken• action recordedaction recorded

• ReviewsReviews• re-workre-work• re-planre-plan• re-reviewre-review

• MinutesMinutes• action takenaction taken• action recordedaction recorded


Investigating Actions (2)Investigating Actions (2)

• InspectionsInspections

• design changesdesign changes

• change approvalchange approval

• EstablishEstablish traceability from origin traceability from origin through decision and execution to through decision and execution to resultresult

• InspectionsInspections

• design changesdesign changes

• change approvalchange approval

• EstablishEstablish traceability from origin traceability from origin through decision and execution to through decision and execution to resultresult


Investigating PlansInvestigating Plans

• Determine whether:Determine whether:

– they are being followedthey are being followed

– they are being achievedthey are being achieved

– they are at riskthey are at risk

– they are up to datethey are up to date

• Determine whether:Determine whether:

– they are being followedthey are being followed

– they are being achievedthey are being achieved

– they are at riskthey are at risk

– they are up to datethey are up to date


Recording the Audit TrailRecording the Audit Trail

• Document referencesDocument references

• Item identificationItem identification

• Job titlesJob titles

• Quotations / drawings referencesQuotations / drawings references

• Suspected problems for further Suspected problems for further investigation in other areasinvestigation in other areas

• Document referencesDocument references

• Item identificationItem identification

• Job titlesJob titles

• Quotations / drawings referencesQuotations / drawings references

• Suspected problems for further Suspected problems for further investigation in other areasinvestigation in other areas


Behaviour AwarenessBehaviour Awareness

• Personal spacePersonal space

• National conventions / cultureNational conventions / culture

• Disabilities / nervousnessDisabilities / nervousness

• DistractionsDistractions

• FamiliarityFamiliarity

• Personal spacePersonal space

• National conventions / cultureNational conventions / culture

• Disabilities / nervousnessDisabilities / nervousness

• DistractionsDistractions

• FamiliarityFamiliarity


Auditee ReactionsAuditee Reactions

• AuthorityAuthority

• AntagonismAntagonism

• HostilityHostility

• Diversionary tacticsDiversionary tactics

• Volunteered informationVolunteered information

• Internal conflictsInternal conflicts

• DeceptionDeception

• StressStress

• AuthorityAuthority

• AntagonismAntagonism

• HostilityHostility

• Diversionary tacticsDiversionary tactics

• Volunteered informationVolunteered information

• Internal conflictsInternal conflicts

• DeceptionDeception

• StressStress


Diversionary TacticsDiversionary Tactics

• Some tactics:Some tactics:• long lunch and other breakslong lunch and other breaks• detours between interviewsdetours between interviews• introducing other ‘interesting’ topicsintroducing other ‘interesting’ topics• asking for your advice/opinion on an issueasking for your advice/opinion on an issue• searching for records, documents etcsearching for records, documents etc

• Problem!Problem!• unable to see sufficient evidence of unable to see sufficient evidence of conformanceconformance!!

• ResolutionResolution• politely insist on keeping to the schedulepolitely insist on keeping to the schedule• report to Lead Auditor or Quality Managerreport to Lead Auditor or Quality Manager

• Some tactics:Some tactics:• long lunch and other breakslong lunch and other breaks• detours between interviewsdetours between interviews• introducing other ‘interesting’ topicsintroducing other ‘interesting’ topics• asking for your advice/opinion on an issueasking for your advice/opinion on an issue• searching for records, documents etcsearching for records, documents etc

• Problem!Problem!• unable to see sufficient evidence of unable to see sufficient evidence of conformanceconformance!!

• ResolutionResolution• politely insist on keeping to the schedulepolitely insist on keeping to the schedule• report to Lead Auditor or Quality Managerreport to Lead Auditor or Quality Manager


SummarySummary• The Lead Auditor is responsible for overall The Lead Auditor is responsible for overall

control of the audit but the auditor must control of the audit but the auditor must control their activitiescontrol their activities

• Interviewing Is the principle toolInterviewing Is the principle tool

• Use effective questioning techniquesUse effective questioning techniques

• Record the audit trail Record the audit trail

• Verify details of non-conformitiesVerify details of non-conformities

• Opinions and preferences should be Opinions and preferences should be suppressed suppressed

• Be aware of auditee reactions and Be aware of auditee reactions and diversionary tacticsdiversionary tactics

• The Lead Auditor is responsible for overall The Lead Auditor is responsible for overall control of the audit but the auditor must control of the audit but the auditor must control their activitiescontrol their activities

• Interviewing Is the principle toolInterviewing Is the principle tool

• Use effective questioning techniquesUse effective questioning techniques

• Record the audit trail Record the audit trail

• Verify details of non-conformitiesVerify details of non-conformities

• Opinions and preferences should be Opinions and preferences should be suppressed suppressed

• Be aware of auditee reactions and Be aware of auditee reactions and diversionary tacticsdiversionary tactics


E N DE N D


Team Exercise:Team Exercise:D3-E03: Mock AuditD3-E03: Mock Audit


Team HomeworkTeam Homework

slide 3 v6

Automotive

d3 ver

robere associates thailand

audit 9k2klad

equipment 9k2klad

alike 9k2klad

confucius 9k2klad

previous checklists

future reference 9k2klad