Auditing 144

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Auditing:QMS Bajaj's 1

AUDITING

QUALITY MANAGEMENTSYSTEMS

ISO-9000-2000 AD

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DEFINITION OF QUALITY AUDITING

A systematic and independent examination to determine

whether the quality activities and related results comply

with planned arrangements and whether the arrangementsare implemented effectively and is suitable to achieve

objectives

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THREE ASPECTS OF QUALITY

MANUALIS THE SYSTEM: -

Adequatelydefined

Is it beingfollowed

Is it effective

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CHARACTERISTICSCarried out by persons or groups from outside the

Departments/ Company avoiding any biases

Random checks of the system, therefore the

necessity of choosing critical audit samples.

Audits are objective checks and not subjectiveimpressions. i.e., demonstrable factual evidence.

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ESSENTIALSSTAGES

First Stage. Study of

Quality Manual, to check

compliance with standards

Second Stage. Company visit to

evaluate adequacy-also called

adequacy audit

Third Stage. Reporting andfollow-up.

TYPES

Internal Also called 1st Party, and

carried out by the Company Staff

External Classified as 2nd Party forSuppliers/ Vendors, or of the Org by

Customer; and 3rd Party by External

Professional Registrars for Certification/

periodic surveillance.

FREQUENCYUsually Annually

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PROCESS Existence is the system

defined?

Operation is the

documented system

implemented?

Effectiveness is it thepractice

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NON-CONFORMITIESMINOR

An isolated case or a minorirregularity.

MAJOR

Frequent case of minorirregularities, or a major gap

in Quality Systems

resulting in failure of thesystem

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CORRECT AUDIT PRACTICES

Speak to the right people, generally the owner of theprocess being audited.

Focus at the work place where the action is.

Avoid desk audit. Avoid personal identity, particularly during externalaudits.

Be familiar, but not friendly.

Avoid the issue of competence, being a delicate issue. Avoid hearsay.

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AUDIT PLANNING

Examine whether all the elements are adequately addressed, ifrequired initiate corrective actions.

Lead Auditor makes himself familiar with the organisation andascertains the time frame required depending upon No. of factors

Ascertain the logistic requirement, eg. Transport andaccommodation., protective gear required.

Prepare audit programme based on the pre audit visit. Prepare checklist. Department/ element wise.

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EVALUATING IMPLEMENTATION

POLICY

Commitment to quality'.

Understanding of thequality policy by the

employees involved.

Implementation of the

policy

DOCUMENTS

Whether approved prior to

the issue?Are approving authoritiesiden?

Are correct/ revised

documents being used?Are obsolete docu.removed?

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EVALUATION AND CONTROL OF

SUPPLIERSSelection. Record of

approved sub-

contractors.

Evaluation of sub-contractors.

Previous performancerecords.

Effective controls.

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SerNo.

Check for Points Dept./ Area

1 QUALITYMANUAL,

Procedures,

WIs

AvailabilityCurrencyApproving

authority

Amendmentscarried out and

their approval

Nature ofchanges

identified.

Inspection

Deptt./ Main

Office/ Deptt.

Office.

2 Specificationsissued bystandardorganisation

AvailabilityCurrency understandi

ng

EXAMPLES OF ASSESSMENT CHECKLISTS

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CONDUCT OF AUDIT Define the purpose and scope. Work out the quantum of work.

Finalise the team and the Team Leader. Prepare audit log. Finalise schedule with the auditee. Prepare criteria checklist for adequacy/ system

audit.

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Conduct adequacy/ system audit based on

Quality Manual. Points observed should be fed to the auditee for

corrective actions.

Prepare audit checklist. Conduct opening meeting.

CONDUCT OF AUDIT

(CONTD)

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CONDUCT OF AUDIT (CONTD) Conduct audit- in that check product/ process/ system/

procedures.

Give feedback to the auditee for corrective action.

In case of minor NC, get these removed. In case ofmajor NC decide on date for re-audit.

Prepare report.

Hold Closing Meeting.

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OPENING MEETING

Introduction to the Team Members and itscomposition.

Scope of Audit. Guide for Auditors. Arrangement for Special Safety Kits.

Any other points.

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AUDIT PROCEDUREPrepare tentative schedule and get the sameapproved by the auditeee MR..After finalising the time and date with theauditee, and inform team members accordingly.Arrange meeting of the auditors for preparationand finalisation of checklist.On arrival at the organisation arrange OpeningMeeting.Conduct of the organisation in accordance withthe prepared schedule.

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AUDIT PROCEDURE (CONTD)Recording of objective evidences, andtaking the consent of the auditeeMeeting of the Audit Team is held fordiscussing the observations.Preparation of the Audit Report.Closing Meeting is held.Final report is prepared and handed over to

the CEO or the Head of the Departmentwith copy to the MR

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CLOSING MEETING The audit report ishanded over to theDepartmental Heads. The NCs are discussed. If required the date offollow-up audit isdecided. Final report is

prepared and handedover, followed bybriefing if required.

Well done!?!

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RECORDS AND REPORT OF AUDIT

The record and reports required to be

prepared are as follows: -

Audit logs.Audit Summary Report.

Non-compliance reports.

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MANAGEMENT REVIEW

CEO/ MD is responsible to review the QMS on auditfindings.

The MR reviews the audit report. He prepares a reporton the Non conformities.

The suitability of the quality systems shall and thereport of the audit is thereafter reviewed by the CEO/MD.

Corrective actions are initiated at the level of SeniorManagement.

Implementation of corrective actions is monitored bythe MR.

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MethodsAdvantages & Disadvantages

Trace ForwardShows the logical System through the

organisation.Easy for training.Aids preplanning.Non-compliances/ otherwise can be

determined more clearly

Logical flow will be interfered with in casecertain employees are not available. Inflexible.Not practical for partial audits.

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Methods(Contd)Advantages & DisadvantagesTrace Backward

Easy for training.

Aids preplanning.

NCs can be determined as clearly.

Results of a department seen ab-initio, assuch requires less time.

Requires greater perception to discern

logical flow . Inflexible (limited flexibility)

Not practical for partial audits.

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Methods(Contd)Advantages & DisadvantagesRandom Checking Flexible.

Minimum disruptions due to non-

availability of employees in a particulardepartment. Shows broad scenario fairlyeasily.

Suitable for pre award surveys, in caseof short time frame.

Suitable for partial audits.Requires experienced auditors.Can entail detailed note taking.

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CONDUCT OF AN AUDITOR

Be calm, polite and

courteous.

Be punctual.

Be brief, and to the point.

Knowledge of processes.

Dress smartly.

Manage the available time

appropriately.

Be honest.

Sense of clarity.

Be decisive anddetermined.

Fair and friendly.

Have excellent, clear andverbal and written

communication. Have language skills. Suggest solutions. Be human and neglect

human failings. Be an adept listener. Avoid getting into any

arguments with theemployees/ auditee.

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CONDUCT OF AUDITEES

Wasting time.

Precautions.

Special case logics.

Absentees.

Trial by strength of

arguments.

Insincerity. Please bybribe or otherwise.

Amnesia (auditor

may forget).

Language barrier-

used as an excuse. Showing impatience/

desperation.

Ugly and unsoughtdisplay of knowledge/

skill.

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TECHNIQUES OF INTERVIEWING

Unit Concept Method.

Hypothetical Questioning Techniques.

Dumb Questioning Technique.Silent Questioning Technique.

Comparison Method

Lead/ Open ended Questions.

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REPORTING COMPLIANCE

Name of the person with whom the discussions were held.

Place where this happened.Reference to process/ equipment/ facility relevant to thesample, Standard Clause.

Documents examined.

Records verified.Details of the audit trails to be followed subsequently.Reference to clause of the standard.

Reference to relevant documents used or referred to in theQMS.

Reference to the NCR, as and when they are revealed.

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SYSTEM EFFECTIVENESS

Extent the documented QMS addresses the

requirements of the Standard.To what extent the documented system hasbeen put into practice.Extent the system in practice effectiveIs a particular area (s) of the Organisationsignificantly weak.Is there significant weakness in the particulararea (s) of the Management System.The area of the organisation where greatestrisk of non-compliance lies in the QMSimplemented.Type of failures, their relative frequency andsensitiveness to the process.

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APPENDICES/ ANNEXURES

Audit Scope

Audit Report Summary

Audit Schedule

NCR Log

NCR and Corrective action Report Performa

Internal Audit Plan and Execution

Auditing 144

Documents

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