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INTERNAL AUDITfor ISO 9001:2008

Presented by : Robere & Associates (Thailand) Ltd.

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AGENDADay 1Introduction to

the auditRoles &

responsibilities Auditor skillsConflict handling

Audit cycleISO 9001conformanceaudit

Day 2Review of day 1ISO 9001conformance audit(continue)

Developing checklistPerforming mockauditPresentation of themock audit result

Question & Answer

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Objective

To ensure that the QMScomplies with ISO9001requirements

To ensure that theorganization complies withthe defined QMS andmeets the objectiveTo make sure that theQMS is effective in meetingthe objectives

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Objective

To identify non-conformityand areas of improvementfor the QMS

To provide managementinformation about the stateof the businessTo improve qualityawareness and involvementof employees

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What is an Audit A systematic independentand documented

examination

A determination of whether quality activitiesand related results :

comply with plannedarrangementsare implementedeffectively

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Relevant terminology Auditor Auditee Audit Team Audit program Audit criteria

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Definition Audit finding Audit conclusion

Objective evidenceNon-conformity (NC)Corrective actionPreventive action

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Types of AuditFirst Party Auditcarried out within an organization

by its own personnel with a primaryfocus on QMSSecond Party Audit

performed by or on behalf of acustomer with a primary focus oncontractThird Party Audit

performed by a Certification Bodywith a primary focus on ISO

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Audit Party

Internalauditing

Auditor Team(Lead Auditor &Teammembers)

Member of top management(QMR)

CompanysAuditees(Client)

Obser vers

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Responsibilitiesmaintain the integrity of the audit functioncommunicate audit requirementsplan and conduct the assigned auditdocument the observationsreport resultsverify corrective action effectivenessmaintain confidentiality

support the team leader and other team members

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Responsibilitiessame as other auditor in theteammanage the team

assist in team selectionquality control over theteam's work

interfacing with auditeemanagementpreparation/submission of audit report

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Auditor Rolesaudit conformity of actual practices against thedefine QMS against ISO9001obtain and audit objective evidence fairlytreat concerned personnel in a way that will

best achieve the audit purposeremain true to the purpose of the audit withoutfear or favor react effectively in stressful situationsperform the audit process without deviatingdue to distractions

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Auditor Rolescommit full attention andsupport to the audit processarrive at generally acceptableconclusions based on auditevidencesidentify opportunity for improvement

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Attributeshas the qualifications to perform a qualityauditis assigned and authorized to perform any or all portions of a QMS audit

be mature and open mindeduse facts and documented evidence, nothearsay has strong communication and analytical skills

is independent of the work being audited

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Responsibilitiesinform employeesco-operate with auditorsprovide logistical resourcescorrective action

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Auditor Skill Ladder Knowledge

Audit skillsPreparation

MeetingsReporting

SamplingGeneral Skill

Knowledge Audit skillsPreparation

MeetingsReporting

SamplingGeneral SkillCommunicationsInterpersonalDecisionmaking

Timemanagement

NCReport

AuditReport

TechnologyISOStandards

Audit

PrinciplesSchedule Checklist

Auditor meeting

Auditmeeting

DepthWidth

Understandsituation

AnalyseevidenceIdentify NC

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Conflict is not always avoidable. Thefive most common types of conflict anauditor might encounter include:Conflict between audit team members.Conflict between auditor and auditee.Conflict between auditor and auditeesmanagement.Conflict between auditor and auditorsmanagement.Conflict between auditee and auditeesmanagement

Occur

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Exercise (20 minutes)

During the audit process,you are facing conflict (asgiven in the attachment).You are required to analyzewhat type the conflict is andas an auditor how you willhandle it.

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Audit Cycle

1. Audit Planing

2. Audit Preparation 3. Conduct theAudit

4. Report theAudit

5. Corrective Action &Follow-up

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1. Audit Planning

1.1) Determine the AuditScopeconsider :

Reason for the audit Activities or processes in theaudit scopeConcerned product andrequirements

Auditees and areas will beaudited

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1.2) Team sizing & Selectionconsider : Auditor personal attributes Auditors skills

Required knowledgeIndependence

Assign lead auditor andauditors

1. Audit Planning

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2. Audit Preparation2.1) Audit scheduleshould include :

Date and time of the auditName of auditors

Processes, activities, locationsand areas to be auditedRelated documents, e.g. qualitymanual, procedure, work instructionRelated requirementsName of Auditee or arearesponsibilities

Approval of the audit schedule

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2.1 Audit scheduleSuggestion in preparing theaudit schedule is

analysing relationship betweenthe definedprocess and requirements or

documentsutilizing Audit Planning Matrix.

2. Audit Preparation

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ElementProcess / Department

5.15.25.35.45.55.66.16.26.36.47.1

Management commitmentCustomer focus

Quality policyPlanningResponsibility, Authority andCommunicationManagement reviewProvision of resourceHuman resourcesInfrastructureWork environmentPlanning of realization processes

Control of measuring and monitoring devicesPlanningMeasurement and monitoringControl of nonconformity

Analysis of dataImprovement

Customer related-processes

PurchasingProduction and service provision

7.2

7.37.47.5

4.14.2

General RequirementDocumentation Requirement

7.68.18.28.38.48.5

M G T

S a l e

Q C

P U R

M / A

W / H

X X X X X XXXX X X X X XX X X X X XX X X X X XXX

X X X X XX X X X XX X X X X

X X XX

X XX X X

XX

X XX X

X X X X X XX X X X X X

2. Audit PreparationSample of an audit planning matrix - requirements

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Sample of an audit planning matrix - documents


Process/ Department

Document (QM, Procedure,WI) M a n a g e

m e n t

S y s t e m

Q C

P u r c h a s i

n g M / A

W / H

QM- 001 XQP 423 X X

X X X XQP 424

X X XX X X

QP 560X

QP 622, WI 630, WI 640 X X XX X

QP 720X

WI 743X

QP 824X

WI 840, WI 851X X X X

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Factor to be consideredTime & activities, required by theaudit team

Preparation

MeetingThe audit criteria / requirementsComplexity of the auditNumber & competency of theaudit team membersLimit of available time

Availability of auditees


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When the audit schedule is

changed, the concerned parties shall make known as

soon as possible

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minutes)

Each group is assigned to plan tconduct an internal audit in your organization.

1. Define scope of the audit2. Prepare Audit Planning Matr 3. Prepare Audit Schedule

Then, present your audit plan tothe class.

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2.2 Team Meeting and Assignment Assure every auditor has the sameunderstanding.

Assign the role of lead auditor andauditors.Confirm responsibility of the teammember.Discuss the audit requirements anddocumentation.Review relevant documents.Prepare checklist.


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2.2 Review of QMSdocumentation such asQuality Manual

Quality Policy and ObjectiveProcedure and Work InstructionOther working documents

Customer specific documentsForms and RecordRegulatory Requirement


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2.2 Preparing audit checklistBenefitEnsure sample is balanced

Assure coverage of the auditsubject Assists in sequencing the

process auditProvides a record of the audifor future reference


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2.2 Types of checklistCriteria checklistBullet-point checklistspecific question checkliststandard question checklist


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Criteria checklistBe structured in accordancewith QMS standard

Example :


he internal audit has been conducted atlanne d intervalshe audit has been planned in considerationf the status and importance of the processesnd area to be audited, as well as the resultsf previous audits

Item Yes No Comment

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Bullet-point checklistOnly title or brief suggestpoint

Example :


Vender selection and evaluation methodSelection and evaluation criteria

Evaluation record

Item Yes No Comment

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Specific question checklistBe structured around adiscrete process, departmenor procedureExample :


Has the calibration plan been prepared?s there a list of equipments requiredcalibration?Have the equipments been calibrated twicea year?

Item Yes No Comment

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Standard question checklistCould the form of either of previous checklistBe uniform practice withinorganizationExample :


What method does each department usein pu rchasing?

Item Yes NoComment

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Product a checklist for theaudit of assigned process

minutes)

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3. Conduct the Audit

3.1) Opening Meetingintroduction of auditorsinform audit scopeexplain audit methodexplain audit criteria

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3.2) Audit Trail

Detail of activities withinprocesses.

Control activities and interface of these processes.Follows the Plan / Do / Check /

Act cycle

3. Conduct the Audit A P

C D

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Begin at Quality policy andobjectives

understand the organizationalquality polityensure the departmentalobjectives are real,measurable, and monitoredfor effectivenessobjectives are the key tocontinuous improvement


ObjectivesObjectivesObjectivesObjectivesObjectivesObjectivesObjectivesObjectivesObjectivesObjectivesObjectivesObjectives



Quality

Policy

GoalGoal Goal

2) Conducting process audit

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3. Conduct the AuditExample

Purchasing processPurchasing

requisition

S u p p o r t p r oc e ss e s

Related Process

Planning

Receipt of purchased product

Inventory control

P l a n n

i n g

C o m m u n i c a t i o n

C o n t r o l o f d o c u m e n t s & R e c o r d s

R e s o u r c e

M a n a g e m

e n t P

r o c e

s s

m o n i t o

r i n g

A n a l y s i s o f d a t a

A u t h o r i t y & r e s p o n s i b i l i t y

a s s i g n m e n t

I m p r o v e m e n t

Orderplacemen

t

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3.3) CollectingEvidenceInterviews

Examination of documents

Observation of activities


P r o c e d u re

u are looking for facts not mistakes

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InterviewingTalk to the right person Ask proper question

Listen carefully to theanswer Remain on the purpose

Analyze and controlsituations


Be aware that Auditor should be a good listener, while having Auditee explains his processes

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Questioning TechniqueOpen ended questions - toallow explanation

Close-ended questions - to limitscope of answer Leading questions - to lead thesubjectClarify questions - tosummarize the point


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3.2) Conducting process auditConsider :The purpose, input, output, control and resourcesapplicable to each processLinks between process and quality objectivesThe steps in the process and responsibilitiesProcess measurementEvidence of continual improvementNeed of internal and external customers


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minutes

In group, establish 2questions of each type of question ( total 8 ) which issuitable for an audit

...?

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3.4) Identify & record theaudit evidencesDocuments

Quality Policy & ObjectivesQuality ManualProcedure &Work Instructio


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3.4) Identify & record the auditevidencesObservation of implementation

Records of activities

Actual practiceUnderstanding & AwarenessResult of effectiveness

Minute of management reviewResult of data analysisRecord of corrective and Preventivaction


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4. Report the Audit

Auditor judges the level of NCReasonable & realistic, supported with

objective evidence.Not bias by auditors personal opinion.Auditor reports the NC to themanagement of audited areaTeam auditor reports the result of the

audit to the top management

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Grading Non-ConformityMajor Non-Conformitysignificant failure to conform withrequirements

jeopardize certificationMinor Non-Conformityisolated non-fulfillment of specificrequirementnegligible effect on quality

Observationfor improvement

4. Report the Audit

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Example of Non-ConformityProcedure for control of document are notdocumentedThere are no evidence of authorized approval

for the delivered products which had notbeen inspected as planned

A purchased item has been purchased from asupplier who is not listed in the approvedvendor listThere are uncontrolled drawings; 2 at the

Assembly Department, 5 at ProductionDepartment and 2 at Engineering Department

4. Report the Audit

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Non-Conformity reportdetail of NCaudit evidences & reference

documentsname of auditors and auditeesothers as necessarybe clear and understandable

4. Report the Audit

Be remind that ou are auditing the system, not the perso

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Example of NC report writingThere is no evidence of follow-up activitieswithin suitable timeframe for manycorrective actions, e.g. the record no.201, 208, 231, 245 and 263 (NC to clause8.2.2) At sales department, the quality objectiveshave been established but there is noaction plan to ensure that the objectiveswill be achieved. (NC to clause 5.4.2)

4. Report the Audit

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Example of NC & Corrective Action Request From

4. Report the Audit

CORRECTIVE ACTION REQUEST (CAR) CARNo.________

To: _____________________ Result of Int ernal AuditFrom: __________________ Result of Manae ment ReviewAudit Date : ______________ Other

ProblemN C:

NCfounderDate :

Root cause

Correcti veP reventive action

Due date : Reso nsible e rson: Ar oved b M R :

Follow-u a ctivit : Result of acti onSatisfiedNot sati sfiedissued newCARno.

Follow-u b : QMR:

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Reporting the auditactivityState the non-conformitysupported with the auditevidencesPoint-out the goodProvide a complete,concise and clear recordof the audit

4. Report the Audit

Be ensure that the report is easyto understand by readers who

might not involved in the audit

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Suggested content in an auditreportThe audit objectiveThe audit scope, time period and place

Audit team members and auditeesThe audit criteriaThe audit finding

(NC, observation andrecommendation)

The audit conclusionsThe distribution list of the audit report

4. Report the Audit

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. Follow-up

Summarize status of the pro

Investigatethe root

cause

Propose corrective action

Implement the corrective ac

Follow-up result of actio

Identify theproblem

1

Approve theproposed

action

1Corrective Action Processorrective Action Process

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Auditee takes action on thenonconformity

Auditor follows up correctiveactioneffective on the agreed

timebound.supported with evidenceshowing:

the cause of problem iseliminated.

Prevention of re-occurance.

. Follow-up

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the QualityManagement System

ISO 9001:2008Requirement

( Part 2 )

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1. Scope

1.2 Application Application and exclusion is based

on the nature of an organization

and its product.Exclusion shall not affect theorganizations ability, or responsibility, to provide product that meet cus

tomer and applicable regulatory requirementsExclusion are limited torequirements within clause 7

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.RequirementDocument, implement and maintain the QMSDefine necessary processes, their application, criteriaand methodsDefine sequence and interaction of these processesProvide information and resources

Monitor, measure, analyze and take action to ensureachievement of planned resultsContinual improve the process and QMSDefine and control outsource processes

i

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. Requirement

4.2.1 GeneralQMS documentation include;

a quality policy and quality objectives

A Quality ManualDocumented procedures as required byISO 9001Documents required by an organizationto ensure;

Effective planning/operationControl of its processes

Records required by ISO 9001

R i

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. Requirement

4.2.2 Quality Manualshall be established andmaintained which includes;

The scope of the QMSIncluding details and justificationof any exclusions

Documented procedures or referenceDescription of sequence &interaction of processesincluded in the QMS.

R i

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. Requirement4.2.3 Control of documentsQMS documents shall be controlled

A documented procedure shall be established to;approve prior to usereview, update as necessary and re-approveidentify changes and the current revision statusEnsure available at points of useEnsure legible and readily identifiableidentify and control distribution of external documentsPrevent unintended use of obsolete documents

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. Requirement

4.2.4 Control of Quality Recordsestablished and maintained recordsrecords shall be legible, readilyidentifiable, retrievable

A documented procedure shalldefine;

Identification, legibility, storage,protection, retrieval, retention period,disposition.

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. Management Responsib

i

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. commitment

Top management shall provideevidence of commitment by;Communicating the importance of meeting customer, statutory, regulatoryrequirementsEstablishing the quality policyEnsuring quality objectives areestablishedConducting management reviewsEnsuring the availability of resources

5 2 C f

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5.2 Customer focus

Top management shallensure

customer requirements aredetermined and are metthereby, enhancingcustomer satisfaction

5 3 Q lit P li

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5.3 Quality Policy

Ensure that the quality policy;is appropriate to the purpose of theorganizationincludes a commitment to comply withrequirements and continual improve theeffectiveness of the QMSprovides a framework for establishingand reviewing quality objectives

is communicated and understoodis reviewed for suitability

5 4 Pl i

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5.4 Planning

5.4.1 Quality ObjectivesEnsure objectives areestablished at relevant

functions and levelsThese objectives shall be;Measurable

Consistent with the QualityPolicy

5 4 Pl i

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5.4 Planning

Planning of the QMS tomeets requirements of 4.1and the Quality Objectives.

The integrity is maintainedwhen the QMS is changes .

. ,

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. ,Communication

5.5.1 Responsibility & AuthorityDefined andcommunicated;Responsibilities

Authorities

Interrelation

. ,Authority &

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. , Authority &Communication

5.5.2 Management RepresentativeTop Management shall appoint a QMR from themember of management teamQMR is responsible for;

Ensuring the processes of the QMS areestablished, implemented and maintainedReporting to top management on the performanceof the QMS, including needs for improvementPromoting awareness of customer requirementsthroughout the organization

. Authority &

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. Authority &Communication

5.5.3 InternalCommunicationEnsure appropriate,regarding theeffectiveness of the QMS

. R i

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. Review

5.6.1 GeneralTop Management shallreview the QMS atplanned intervals toensure suitability,adequacy andeffectiveness.

Records of managementreviews shall bemaintained

. Re ie

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. Review

5.6.2 Review Inputshall include;Results of auditsCustomer feedback

Process performance and productconformityStatus of preventive and correctiveactionFollow up actions from previous

management reviewsPlanned changes that could effect theQMSRecommendations for improvement

. Review

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. Review

5.6.3 Review Outputshall include decisions andactions related to;

Improvement of theeffectiveness of the QMS andits processesImprovement of product,related to customer requirementsResource needs

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6. Resource Manageme

. resources

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. resources

Determine and provideresources

.Resources

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.Resources

6.2.1GeneralPersonnel shall becompetent on the basis of;

Appropriate educationTrainingSkills

Experience

.Resources

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.Resources

6.2.2 Competence, awareness andtrainingDetermine the necessary competenceProvide training or take other actions to

satisfy these needsEvaluate the effectiveness of the actionstakenEnsure personnel are aware of their ownimpact on qualityMaintain records of education/training,

skills and experience

6 3 Infrastructure

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6.3 Infrastructure

Determine, provide, maintaininfrastructure;

Buildings, workspace andassociated utilitiesProcess equipment, bothhardware & software

Supporting services such astransport or communication

6 4 Work Environment

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6.4 Work Environment

Determine and managethe conditions of the workenvironment needed to

achieve conformity toproduct requirements

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7. Product realization

.product realization

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product realization

Plan and develop the processesDetermine the following (as appropriate)Quality objectives & requirements for the productThe need to establish processes, documents, andprovide product specific resources

Required verification, validation, monitoring, inspectionand test activities specific to the product and thecriteria for product acceptanceRecords

.Related Processes

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Related Processes7.2.1 Determination of requirementsrelated to the product

Requirements specified by customer Requirements not stated by the customer

but necessary for useStatutory and regulatory requirementsrelated to the product

Additional requirements determined bythe organization

.Related Processes

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Related Processes

7.2.2 Review of requirementsrelated to the productReview to ensure;

Product requirements are definedThe difference are resolvedThe ability to meet the definedrequirements

Maintain records of the results of the review and required actions.

Where product requirements arechanged;Documents are amendedRelevance are made aware of thechanges

.Related Processes

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Related Processes

7.2.3 Customer CommunicationDetermine and implement effectivearrangements for customer communication in relation to;

Product informationEnquiries, contracts or order handling, including amendmentsCustomer feedback, includingcustomer complaints

. Development

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Development7.3.1 Design & Development planning

Plan, control and determine;Design and development stagesThe review, verification and validation thatare appropriate to each stageResponsibilities and authoritiesManage all interfaces

Planning output shall be updated

. Development

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7.3.2 Design &Development InputsDetermined & reviewedInputs relating to productrequirementsMaintain records

Development

. Development

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7.3.3 Design & Development OutputsProvided in a suitable formMeet the input requirementsProvide appropriate information for purchasingproduction and for service provisionContain product acceptance criteriaSpecify the product characteristics

Approved prior to release

Development

. Development

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7.3.4 Design &Development reviewPerform systematic reviewsat planned appropriatestagesMaintain records of boththe results of the reviewsand actions

Development

. Development

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7.3.5 Design & DevelopmentVerificationVerify to ensure that outputs

have satisfied the inputMaintain records of theresults of the verification andnecessary actions

Development

. Development

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7.3.6 Design & DevelopmentvalidationValidate to ensure that the product iscapable of fulfilling the requirements for the specified or known intended use or applicationPerformed as planned, and completedprior to delivery or implementation of the product

Maintain records of the results of validation and necessary actions

Development

. Development

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7.3.7 Control of changesIdentify and control design anddevelopment changesEvaluate effect of the changes onconstituent parts and deliveredproductReviewed, verified and validated (asappropriate) and approved prior to

implementationMaintain records of the result of thereview of changes and necessaryactions

Development

7 4 Purchasing

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7.4 Purchasing

7.4.1 Purchasing processControl to ensure that purchasedproduct conforms to specifiedpurchase requirements

Evaluate and select suppliers basedon their abilityEstablish criteria for selection,evaluation and re-evaluation

Maintain records of the results of evaluations and necessary actions

7 4 Purchasing

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7.4 Purchasing

7.4.2 Purchasing InformationEnsure the adequacy of specifiedpurchase requirements prior to their communication to the supplier Purchasing information includes:

Detail of purchased productRequirements for approval of product ,QMS, etc.(if required)

7 4 Purchasing

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7.4 Purchasing

7.4.3 Verification of purchasedproductEstablish and implement theinspection to ensure that purchased

product conforms to specifiedrequirementsState the verification arrangementsand method of product release in

the purchasing information, Where the verification at the supplierspremises is a requirement

.Service Provision

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Service Provision7.5.1 Control of production & serviceprovisionPlan and carry out under controlled

conditions:availability of product characteristicsinformationavailability of work instructionsuse of suitable equipmentavailability and use of monitoring andmeasuring devices

implementation of monitoring andmeasurement activitiesimplementation of release, delivery andpost delivery activities

.Service Provision

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Service Provision7.5.2 Validation of processes for productand service provisionValidate processes to demonstrate the

ability to achieve planned resultsEstablish arrangements include:(asapplicable)

Defined criteria for review and approval of processes Approval of equipment and qualification of

personnelUse of specific methods and proceduresRequirements for recordsRe-validation

.Service Provision

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Service Provision

7.5.3 Identification & TraceabilityIdentify the product by suitablemeansIdentify monitoring and measuringstatusControl and record the uniqueidentification of the product, wheretraceability is a specifiedrequirement

.Service Provision

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Service Provision

7.5.4 Customer propertyExercise care with customer property

Identify, verify, protect andsafeguardReport and maintain records

of any lost, damaged or thefound unsuitability for use

.Service Provision

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Service Provision

7.5.5 Preservation of productIdentify, handle, pack, store

and protect to preserve theconformity of product andconstituent parts

.Monitoring andmeasuring devices

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measuring devicesDetermine the monitoring and measurement tobe taken, and needed devices/software Measuring equipment shall be:

calibrated or verified at specified intervals or prior to use, against national or international standards

record the basis, where no such standards exist

adjusted or re-adjusted as necessaryidentified calibration statussafeguarded from adjustmentsprotected form damage and deterioration

measuringdevices cont

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devices. cont

Assess and record the validityof previous measuring results,when equipment is found notto conform to specifiedrequirementsTake appropriate action on theequipment and any productaffectedMaintain records of the results

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8. Measurement,

Analysis andImprovement

8.1 General

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8.1 General

Plan and implement neededmonitoring, measurement,analysis and improvementprocessesDetermine applicablemethods, statisticaltechniques and the extent of their use

. measurement

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measurement

8.2.1 Customer satisfactionMonitor information relatingto customer perception as to

whether the organization hasfulfilled customer requirementsDetermine methods for obtaining and using thisinformation

. measurement

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measurement8.2.2 Internal Audit

Plan and conduct internal audits atplanned intervalsEstablish and implement thedocumented procedureDefine audit criteria, scope,frequency and methodsSelect and assign auditorsTake action eliminate cause of non-conformities without undue delaVerify the actions taken and reportthe results

. measurement

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measurement

8.2.3 Monitoring &Measurement of processes Apply suitable methods for

monitoring and measurementof the QMS processesTake correction andcorrective action, whenplanned results are notachieved

. measurement

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measurement8.2.4 Monitoring & measurement of product

Monitor and measure the characteristics of theproduct at appropriate stages, in accordance withplanned arrangementsMaintain evidence of conformance with theacceptance criteria and the authorize person(s)

for product releaseProduct release and service delivery withoutcompletion of all the planned arrangements shallbe approved by relevant authority or customer

.Nonconformingproduct

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productIdentify and control to prevent unintended use or

delivery in accordance with documented procedureDispose by:(one or more)By taking action to eliminate the detectednonconformity, then re-verificationBy authorizing its use, release or acceptance under concession

By taking action to preclude its original intended useor applicationMaintain records of the nature of non-conformitiesand any subsequent actions takenTake appropriate action, when nonconformingproduct is detected after delivery or use

8.4 Analysis of data

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y

Determine, collect andanalyze appropriate datarelating with:

Customer satisfactionConformance to productrequirementsCharacteristics and trends of

processes and productsincluding opportunities for preventive actionSuppliers

8.5 Improvement

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p8.5.1 Continual Improvement

continually improve theeffectiveness of the QMSthrough the use of the;

Quality PolicyQuality objectives Audit results Analysis of data

Corrective and preventive actionManagement review

8.5 Improvement

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p8.5.2 Corrective Action

Establish and implement adocumented procedure for:

Reviewing non-conformities andcustomer complaints

Determining the causesEvaluating the need for action toensure that they do not recur Determining and implementing theactions needed

Recording of results of action takenVerification of corrective action taken

8.5 Improvement

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p8.5.3 Preventive action

Establish and implement a documenteprocedure for;

Determining potential non-conformitiesEvaluating the need for action to prevenoccurrenceDetermining and implementing actionneededRecords of results of action taken

Verification of the preventive action take

Activity

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yEach team will be assigned to audit

a process:Prepare an audit checklist using theaudit matrices as guideline (45minutes)Conduct a mock audit using theprepared checklist, record the resultand NC in the provided from (60minutes)Make a presentation of the result of activities

(5 minutes/team)

Closing Activities

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g

Summary Audit Objectives Auditor responsibility

Audit processPlan, prepare, conduct,report, corrective action &

follow-up

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Question?