Download - 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