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AUDITING

QUALITY MANAGEMENT
SYSTEMS
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 arrangements
are implemented effectively and is suitable to achieve
objectives
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THREE ASPECTS OF QUALITY
MANUAL
IS THE SYSTEM: -
-Adequately
defined
-Is it being
followed
-Is it effective

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CHARACTERISTICS
Carried 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 subjective
impressions. i.e., demonstrable factual evidence.
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ESSENTIALS
STAGES
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 and
follow-up.
TYPES
Internal Also called 1
st
Party, and
carried out by the Company Staff
External Classified as 2
nd
Party for
Suppliers/ Vendors, or of the Org by
Customer; and 3
rd
Party by External
Professional Registrars for Certification/
periodic surveillance.
FREQUENCY
Usually Annually
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PROCESS
Existence is the system
defined?
Operation is the
documented system
implemented?
Effectiveness is it the
practice
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NON-CONFORMITIES
MINOR
An isolated case or a minor
irregularity.
MAJOR
Frequent case of minor
irregularities, or a major gap
in Quality Systems
resulting in failure of the
system
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CORRECT AUDIT PRACTICES
- Speak to the right people, generally the owner of the
process being audited.
- Focus at the work place where the action is.
- Avoid desk audit.
- Avoid personal identity, particularly during external
audits.
- 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, if
required initiate corrective actions.
Lead Auditor makes himself familiar with the organisation and
ascertains the time frame required depending upon No. of factors
Ascertain the logistic requirement, eg. Transport and
accommodation., 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 the
quality policy by the
employees involved.
Implementation of the
policy
DOCUMENTS
Whether approved prior to
the issue?
Are approving authorities
iden?
Are correct/ revised
documents being used?
Are obsolete docu.
removed?
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EVALUATION AND CONTROL OF
SUPPLIERS
Selection. Record of
approved sub-
contractors.
Evaluation of sub-
contractors.
Previous performance
records.
Effective controls.

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Ser
No.
Check for Points

Dept./ Area
1

QUALITY
MANUAL,
Procedures,
WIs

Availability
Currency
Approving
authority
Amendments
carried out and
their approval
Nature of
changes
identified.

Inspection
Deptt./ Main
Office/ Deptt.
Office.

2

Specifications
issued by
standard
organisation

Availability
Currency
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 of
major NC decide on date for re-audit.
Prepare report.
Hold Closing Meeting.
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OPENING MEETING
Introduction to the Team Members and its
composition.
Scope of Audit.
Guide for Auditors.
Arrangement for Special Safety Kits.
Any other points.

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AUDIT PROCEDURE
Prepare tentative schedule and get the same
approved by the auditeee MR..
After finalising the time and date with the
auditee, and inform team members accordingly.
Arrange meeting of the auditors for preparation
and finalisation of checklist.
On arrival at the organisation arrange Opening
Meeting.
Conduct of the organisation in accordance with
the prepared schedule.
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AUDIT PROCEDURE (CONTD)
-Recording of objective evidences, and
taking the consent of the auditee
-Meeting of the Audit Team is held for
discussing 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 Department
with copy to the MR

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CLOSING MEETING
_ The audit report is
handed over to the
Departmental Heads.
_ The NCs are discussed.
_ If required the date of
follow-up audit is
decided.
_ Final report is
prepared and handed
over, followed by
briefing 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 audit
findings.
- The MR reviews the audit report. He prepares a report
on the Non conformities.
- The suitability of the quality systems shall and the
report of the audit is thereafter reviewed by the CEO/
MD.
- Corrective actions are initiated at the level of Senior
Management.
- Implementation of corrective actions is monitored by
the MR.

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Methods
Advantages & Disadvantages
Trace Forward
-Shows 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 case
certain employees are not available.
-Inflexible.
-Not practical for partial audits.
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Methods(Contd)
Advantages & Disadvantages
Trace Backward
- Easy for training.
- Aids preplanning.
- NCs can be determined as clearly.
- Results of a department seen ab-initio, as
such 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 & Disadvantages
Random Checking
-Flexible.
-Minimum disruptions due to non-
availability of employees in a particular
department. Shows broad scenario fairly
easily.
-Suitable for pre award surveys, in case
of 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 and
determined.
Fair and friendly.
Have excellent, clear and
verbal and written
communication.
Have language skills.
Suggest solutions.
Be human and neglect
human failings.
Be an adept listener.
Avoid getting into any
arguments with the
employees/ auditee.

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CONDUCT OF AUDITEES
-Wasting time.
-Precautions.
-Special case logics.
-Absentees.
-Trial by strength of
arguments.
-Insincerity. Please by
bribe or otherwise.

- Amnesia (auditor
may forget).
- Language barrier-
used as an excuse.
- Showing impatience/
desperation.
- Ugly and unsought
display 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 the
sample, 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 the
QMS.
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 has
been put into practice.
Extent the system in practice effective
Is a particular area (s) of the Organisation
significantly weak.
Is there significant weakness in the particular
area (s) of the Management System.
The area of the organisation where greatest
risk of non-compliance lies in the QMS
implemented.
Type of failures, their relative frequency and
sensitiveness 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