5-auditsandassessments.ppt

8/11/2019 5-AuditsandAssessments.ppt

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Audits and Assessments


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OutlineWhat is an audit ?

Types of Audits

How to meet standard requirements

Effective auditing

Preparing for an auditConducting an audit


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Internal Audits Required:By ISO 9000

clause 4.17

By ISO/IEC 17025clause 4.13 (management requirements)


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What is an Audit ?Systematic and independent examination ofthe quality management system (QMS)

What are you doing?

Does it comply with the standard you havechosen to follow?

Can be by someone within the organisationor from someone outside


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The Audit ProcessScheduled Audits

programme managed by Quality Manager orauditors

examine documents, results, processesidentify problems

improve

Unscheduled Auditsinvestigate problem

improve


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Why Audit?Is QMS implemented exactly as intended ?

To investigate a problem

why did it occur ?how can it be resolved ?

how can it be prevented in future ?

Identify opportunities to improveTo see if the QMS meets the requirements ofstandards ?


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Types of AuditsHorizontal

all departments audited against oneelement of standard or procedure

Verticalone department audited against all

elements of standard or procedure

Internal and External


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Standard Requirements:

ISO 9001 and 17025Audit program

Documented procedures

Auditors independent of activity

Audit results documented and reported

to managementPrompt action after problems identified

Follow up activities


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Managements Responsibility Define [internal] auditing policy

Assign responsibility of internalaudit programQuality Manager

Must be advised of internal auditoutcomes

discussed at management review


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Quality Managers

ResponsibilityEstablish & maintain internal auditsystemDevelop scheduleCoordinate auditsManage corrective action systemAdvise management auditoutcomes


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Who Audits ?Trained & qualified auditors

Quality Manager selects and trains

internal auditorsobserver on Quality Managers audits

fist audit under supervision of qualified

auditor

Person independent of the activityto be audited


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Audit ScheduleAnnual

Address all elements of the qualitysystem

not all departments

Frequency ?critical areas


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Documents used in Auditing

ChecklistsCorrective action request forms

Audit report forms


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Documenting the Audit Program (1)

Quality Manual

quality policy on internal auditing

responsibility for internal audits


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Documenting the Audit

Program (2)Internal audit procedure(s)selection and training of auditors

scheduling audits

responsibilities of auditors

preparation, conducting and reporting on

auditsidentifying, resolving and following upcorrective actions

reporting audit results to management


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Effective Auditing (1)

Gather evidence about

compliance with qualitysystem or standard


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Effective Auditing (2)

Gather information about:process, operating procedures

staff, equipment, test methods

environment, handling of samplesquality control, verification activities

recording and reporting practices.

Compare with documented system

Identify breakdown in system ordeparture from procedures


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What to AuditSystems audit

adherence to documented procedures

Technical auditTechnical correctness

adherence to documentedprocedures/test methods

auditor must have technical knowledge of

test

Combinationvertical audit


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What to Audit - Technical Audit

StaffMethods

EquipmentTesting EnvironmentSamples and Test Items

Quality ControlComputersRecords and Reports


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Audit PreparationQuality Manager determines

audit teamlead auditor

audit detailsscope of audit

time, date, duration

Contact auditeedate, time, type & duration


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2. Developing Checklists

Guidelines

Review documentsidentify important aspects of the activity

list in logical order

set of questions


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Audit Follow-up Activities

I t may be necessary for a fol low-up audi t to be

per formed to ver i fy the e ffec t iveness of any

co rrect ive act ion carr ied ou t . Correct ive act ion, and

su bsequent fo l low-up audi t s , sh ould be com ple tedwithin a t ime per iod agreed to by the audi tee , in

co nsu l tat ion w i th the audi tor.

The Qual i ty Manager sh ou ld sc hedu le the fol low -upaudi t and enter detai ls on th e A ud i t Schedule and th e

Au di t Status Lo g .


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3. Opening MeetingWho ?

auditor/audit team

auditeeany staff from area to be audited that maybe interviewed

What ?Scope

expected duration


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4.1 Gather Evidence about Compliance

Interviewsask questions about system and its

implementationwho, what, when, how, where, why ?

other questions

directhypothetical

clarifying


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4.3 Gather Evidence about Compliance

Observe activitieswhat is said or written may not reflect practiceshow me

Examine facilitiesas travel through laboratory/officesexamine:

equipment

standard of housekeepingsize and layout of working areaenvironment eg. temperature in lab


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5. Recording Results

Record on checklistsactivities which do not adhere to qualitysystem

may be classified

major non-conformance

minor non-conformance

areas for improvement


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6. Closing Meeting(s)

Audit team meetingdiscuss audit results

Closing meetingdiscuss corrective actions

determine resolution dates

Identify corrective actionsuse corrective action forms


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7. Audit Report

Audit details

Summary of findingscorrective actionsnumberedobjective evidencereference the document

observations

Distribute


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Corrective and Preventive Action


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Outline

What is a corrective action ?

What is a preventive action ?

Corrective and preventive actionprogram

Corrective and preventive actionprocess


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Corrective & Preventive Action Required:

By ISO 9000clause 4.14

By ISO/IEC 17025clause 4.10 corrective action

clause 4.11 preventive action


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Corrective Action

An action taken to correct a

problem

incorrect result

departure from procedure


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Preventive Action

A proactive process to identifyimprovement opportunities

potential sources of non-

conformance


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Corrective & Preventive Action Program

Corrective and preventive actionmanaged by one programmeClosely linked to the internal auditprogrammeManaged by the Quality Manager

Process managed using correctiveaction form


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1.CARRaised

2.CARlogged

3.Investigate rootcause of problem

and identify CA

ManagementReview

Majorchange ?

5.CA

effective?

4.ImplementCA, Updatedocumentation

End

ProblemSolving Team

Corrective andPreventive

Action Process

No Yes


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1. Raising a Corrective or PreventiveAction

Audits (internal and external)Observations by staffManagement reviewClient feedback


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2. Recording the CAR

Initiate CAR formRecord corrective or preventive

actioncategoriseQuality Manager to

log in CAR

allocate unique CAR identificationnumber


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3.1 Investigating the Corrective Action

Investigate root cause of theproblem

why did the problem occur ?

Potential causes:samples

methods and proceduresstaff skills and training

equipment and calibration

Record CAR


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3.2 Identify Possible Corrective Action

Identify potential corrective actionwhat would prevent the problem fromhappening again ?

Problem solving team

if many staff or departments affectedif major non-conformance

Record on CAR


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4. Implement Corrective Action

Implement the action/s

make changes to the system

Record

Update documentation


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5. Was Corrective Action Effective ?

Verify and record effectiveness has it prevented the problem fromoccurring again ?follow up

additional audits