Audit Requirements-methods.ppt

7/23/2019 Audit Requirements-methods.ppt

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Attributes of a Good Auditor

Ethical (Sincere, honest and discreet) Open-minded (Receptive to others)

Diplomatic (actful in dealin! "ith people)

Observant (Activel# a"are of surroundin!)

$erceptive (%nstinctivel# a"are of andunderstand)

&ersatile (Ad'usts readil# to different situations)

enacious (ocused on achievin! ob'ectives)

Decisive (oncludes in time, based on lo!icalreasonin!)

Self-reliant (Acts independent "hile interactin!effective)


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Specific Knowledge of QMS auditors*

+ualit# related method and techniues

+S principles and applications

+ tools and their application (S$,

EA etc.,) $rocesses and products*

Sector-specific terminolo!#

echnical characteristics of processes andproducts, and

Sector-specific processes and practices.


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Skills and GK for Auditors* Management system and reference documents include* Applications of ana!ement s#stem to different

or!ani/ations

%nteraction bet"een components of ana!ement s#stems +S audit criteria Abilit# to prioriti/e bet"een various reference documents Application of reference documents to audit situations %nformation s#stems, control of documents, data and records

Organization context auditors should know* Or!ani/ational structure, si/e, functions and

interrelationships General business processes and related terminolo!ies ultural and social customs of auditees.

Auditors should also knowapplicable la"s andre!ulations* 0ocal, re!ional, national codes. 0a"s andre!ulations.

ontracts and a!reements %nternational treaties and conventions Other reuirements to "hich or!ani/ation subscribes.


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Auditin!

%ndependence

%mpartialit# of the audit and ob'ectivit#

of the audit conclusions.

Evidence based approach

he rational method for reachin!

reliable and reproducible audit

conclusions in a s#stematic audit

approach.


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Audit S#stematic, independent and documented

process for obtainin! Audit evidence and

ob'ectivel# evaluatin! to determine the

e1tent to "hich the audit criteria are fulfilled. +ualit# s#stems audit

S#stematic investi!ations of the intent, the

implementation and the effectiveness ofselected aspects of the +ualit# s#stem of

an or!ani/ation.


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Audit evidence

2ased on actual observation.

3ninfluenced b# emotion or pre'udice

Stated or documented +ualitative or uantitative

&erifiable


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Audit criteria Set of policies, procedures or reuirements used as a

reference

Reuirements are* Stated needs of the customer %mplied needs Obli!ator# needs

Audit criteria ma# include* $olicies, $rocedures Reuirements Ob'ectives

+ualit# plans Governin! specifications Statutor# and re!ulator# reuirements ontractual needs.


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Audit scope*

E1tent and boundaries of an audit* ph#sical locations andor!ani/ational units, activities and time period covered.

Audit client* Or!ani/ation or person reuestin! an audit. Auditee* Or!ani/ation bein! audited.

$urpose of Audit* o determine the e1tent of fulfillin! the audit criteria. o evaluate stren!ths and "ea4nesses of the +S. A mana!ement tool for assessment of an# desi!nated

process or activit#. A mana!ement tool for identification of improvement actions

b# the auditee. Evaluation of effectiveness and efficienc# of the +S b# the

auditor and to ma4e informed 'ud!ment on the s#stem. A tool for obtainin! evidence that e1istin! reuirements of

product or contract have been met.


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5o" +S are Audited6

Are processes identified alon! "ith their interactions "ithother processes6

Are processes adeuatel# established for effective andefficient reali/ation of processes and continual improvement6

Are the on!oin! control of processes at the lin4a!e areadeuatel# established6 Are resources used effectivel# and efficientl#6 Are product and process performance measures adeuate6 Are their trends monitored and trac4ed for improvement6 5o" anal#sis of data is used for improvement6 Are improvement processes established6


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ate!ories of audit

S#stems Audit Assessin! the +S $roduct Audit Assessin! the ualit# of

the product

$rocess Audit Assessin! the businessprocesses of an or!ani/ation

ombined audit 7hen a +S and ESare audited to!ether.

8oint Audit 7hen t"o or moreor!ani/ations cooperate to audit a sin!leauditee


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#pes of Audit

%nternal

or

%st $art# * or!ani/ation E1ternal

or

9nd$art#* Audit on suppliers

:rd$art#* Re!istration 2od#


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2enefits of Audits irst part#*

$o"erful tool for aidin! continual

improvements ontrol mechanism utili/ed b#

mana!ement.

+S standard reuires them. orrect non compliances beforee1ternal bodies find them.


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Second part# audit* +S standard;s implied need

$rovides input to selection andevaluation of suppliers

5elps to improve supplier;s ualit#s#stems

%ncreases mutual understandin! of

ualit# 0eads to


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hird $art# audit* Reduce avoidable costs to customers and

or!ani/ation.

0ess need for 9ndpart# audits.

Establish minimum standards met b#

companies.

Reco!nition of compliance "ith an

international standard

Aid to compan#;s mar4et competitiveness.


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Adeuac# audit>Documentationaudit*

o chec4 the completeness of

documentation. ompliance audit*

o chec4 the de!ree of compliance,

the effectiveness and efficienc# ofthe +S (improvements)


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Scope definition is important in an audit.

Does scope call for audit of total inte!ratedmana!ement s#stem6

Does the scope calls for audit of one elements ofthe inte!rated mana!ement s#stem6

Once scope is clear, the process of audit "ill be*

Document revie"

ompliance audit? $re audit activities

? Audit activities? $ost audit activities

%nte!ration of ualit# mana!ement s#stem ma# bepartial or total.


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onductin! an audit - Overvie" of the processsteps

@. Sources of information

9. ollectin! b# appropriate samplin!

:. &erification of audit evidence

. Evaluatin! a!ainst audit criteria

B. Audit findin!sC. Revie"in!

. Audit conclusions

a4e a procedure and as4 uestions 7ho, 7hat,5o", 7hen and 7h#6

%n respect to 7%, as4 5o" in Detail6 7ho inspecific6 7hich in specific6


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or compliance use the concept of 0oo4 at and 0oo4 for.

7e loo4 at a product, document, record or euipment. or e1ample in the case of procedures* 0oo4 for * ompliance, effective date, controlled, approved,

understandable, readable omponent* %D, %nspection>test status

$urchase order* omplete data, authori/ed, accurac#,approved vendor Records* 0e!ible, authori/ed, retention period, inde1ed,

stored, accessible Operator* understandable "or4 instruction, follo"in!

procedure, s4ill, ualit# polic#, safet#.

%nstrument* %dentification, calibration status, stored, handled Environment* 0i!htin!, noise, vibration, pollution, lines


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act indin!*

3se chec4lists

Select samples #ourself

0oo4 for audit evidence b# readin!,observation and communication.

a4e notes

o and fro chec4in!.


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onductin! %ntervie"s*

Durin! normal "or4in! hours and "or4-places $ut the person at ease E1plain the reason for intervie" and ta4e notes As4 them first to describe the 'ob Adopt !ood uestionin! techniues (an #ou

e1plain, please) hec4 facts and record findin!s Avoid uestions that bias ans"ers and leadin!

uestions

Summari/e and revie" results "ith personsintrvie"ed han4 persons intervie"ed for participation and

co-operation.


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7hat should Auditor do6

0isten attentivel# "hile ta4in! notes 0isten "ithout #our o"n 'ud!ment and conclusions reate a "arm climate b# active listenin! 2e a"are of the learnin! happenin! "hile listenin! Do not pressuri/e auditees to ans"er or behave in #our

prescribed manner. As4 "hat "ould #ou li4e to do6 %nstead of our prescriptions sothat auditee understands his conte1t better.

Sho" fle1ibilit# to the follo"in!* han!in! situations

ana!ement st#les ana!ement levels Reasonin! about nonconformities Evaluation of corrective action


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Audit Evidence*

Admissible statements Document no and issue %dentifiers Departments

$ositions (and names if necessar#)

&erification* Random basis hosen b# auditor $ermission sou!ht Establish and a!ree facts Remain disinterested and polite


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ature of the Audit* Audit must be positive Audit should help to improve s#stem onconformities are opportunities Don;t loo4 for blame 0oo4 for solutions

Revie" meetin!s* Revie" non-conformities Resolve uestions or problems onitor pro!ress

larif# misunderstandin!s %f appropriate, a!ree for corrective actions. A !ood auditor "ill never !et involved in an ar!ument or ta4e

sides if internal conflicts develop durin! the audit.


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onconformit# onfulfillment of an# audit criteria is a non-conformit#. Audit criteria* $olicies $rocedures Ob'ectives

+ualit# plan Governin! specifications Statutor# or re!ulator# reuirements.

on conformit# e1ists because of

@. anual>procedures do not compl# "ith the standard9. $ractice is not in line "ith the intent

:. $ractice is not effective


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5o" nonconformities are stated6

act based>ob'ective learl# e1pressed in auditee;s lan!ua!e oncisel# stated Refer to clause number of the standard and auditee;s documents

a!reed as audit criteria

State the e1act nonconformit# ention the identifiers of the nonconformit# ate!ori/e as ma'or or minor (%n internal audits if it is a practice in the

or!ani/ation) 2e accepted and si!ned b# the auditee.

ollo"in! "ords "ill be freel# used in the audit reports* Deficienc#, discrepanc#, findin!, noncompliance, nonconformance,

nonconformit# to describe a situation "hich e1ists, but does notcompl# "ith reuirements.


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Report should contain Details of nonconformit# he observation *actual info !athered durin! audit

and substantiated b# audit evidence. he e1planation* A brief e1planation of "h# stated

observation is a nonconformit#. %t could, at times bea repetition of the procedure or standardsreuirement.

he attribution* Relevant clause of %SO F@*9

a!ainst "hich the observation is a nonconformit#and or reference to +ualit# s#stem document.

he corrective action planned orrective action completed and verified.


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#pes of nonconformit# (3sed onl# in hird-part# audits)

Minor-A failure in some part of the or!ani/ation;s documentedualit# s#stem relative to appropriate standard.

Or A sin!le observed lapse in follo"in! one item of an or!ani/ation;sualit# s#stem.

Maor-he absence or total brea4do"n of a s#stem to meet %SOF@*9 reuirement or

An# noncompliance that "ould result in the probable shipment of anonconformin! product.

2efore declarin! ma'or or minor, consider the follo"in! uestions, 7hat could !o "ron! if the nonconformit# remains uncorrected6 5o" often such nonconformit# !et repeated6

Recommendation options*

orrective actions $artial reassessment ull reassessment

O!ser"ations* ovin! to"ards a nonconformit#


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Audit report

Should include# Audit ob'ectives Audit scope, identif#in! functions, processes and time period %dentification of audit client Dates and places of onsite audits Audit criteria Audit findin!s

Audit conclusions

Should not contain# %ndividual names in nonconformit# references onfidential information Sub'ective statements

Emotive statements %nformation not raised earlier An audit is complete "hen* All activities as per audit plan have been carried out and approved audit report

distributed.


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%nternal audit reports are inputs to mana!ement revie"s. One can ma4e an anal#sis of the audit findin!s to discuss

in revie"s. Anal#sis can be made clause "ise or process "ise. Anal#sis should enable mana!ement to concentrate their

efforts on processes "here corrective action is reuired.

ormal practice "hosoever as4s #ou to conduct the auditR>+A mana!er, if the# have specific printedchec4lists>observation recordable use that. Other"iseprepare one #ourself. 7rite the final findin!s and report inthat form>or !ive it t#ped bac4 to R>+A ana!er "ith acop# to the concerned person audited for follo"-up if an#.

Hou can include #our observations>recommendations inthe report in an ob'ective "a# based on preciseobservation>info.


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+S Audits

ive audit trails are normall# used b# most of

the 0ead auditors.

@. 2usiness plannin! and mana!ement revie"

9. $rocess monitorin! and improvement

:. e" product development

. $rovision

B. Administration and resources.he related dia!rams and audit trail are !iven

belo"*


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Sample four t#pes ofprocesses* $roduct

reali/ation, business

processes, and support

processes


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5.5 Responsibility, authority and

communications

4.2 Documentation

requirements

6.2 Human Resources

6.3 Infrastructure

6.4 or! en"ironment

Sample* Each sub

element is uniue

Audit Requirements-methods.ppt

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