internal audit jun05.ppt

8/17/2019 Internal Audit jun05.ppt

1/58

Internal Audit

05/02/16(C)Copyrights - Yadav Measureents !"daipur


2/58

I#$"%

(C)Copyrights - Yadav Measureents ! "daipur 05/02/16

LABORATORY

DATA

DECISION

HEALTH, SAFETY

ENVIRONMENT

COMMERCE


3/58

M&%'* + &,A"A%I#. %'&CM$&%C&

+ A AA%Y

On the spot assessmentof by the technical

experts


Performance inPT program


4/58


SPECTRUM OF LABORATORY ACCREDITATION

PROCEDURES RULES

EXAMINATION

OF QM

ASSESSMENT SURVEILLANCE

LABORATORY

ACCREDITATION

ACTIVITIES

ACCREDITATIN

CERTIFICATE SCOPE

T

C

NABL

NABL – NEWS

COMPENDIUM

ASSESSOR’S

TRAINING

MONITORING

NIST

NVLAP

NAMAS

NATA

------

PROFICIENCY

TESTING

PROGRAMME

STANDARD REF.

MATERIAL

WECC

WELAC

ILAC

APLAC

INTERNATIONAL

LINKAGESEAL U.K. ACCREDITATION

SERVICES


5/58

'A% I* "AI%Y3

• eing

.ood 4uality does not neessarily ean high 4uality Instead iteans a predia7le degree o8 uni8ority and dependa7ility at lo9

ost 9ith a 4uality suited to the ar:et

• I* ;><

%he totality o8 harateristis o8 an entity that 7ear on its a7ility to

satis8y stated and iplied needs

• ?uran

uality is @8itness 8or purpose

– uality is a produt that eets the ustoers re4uireents

or eBpetations

– A 4uality produt does the o7 at an eonoi prie

– *uppliers o8 a produt do not deide upon its 4uality! their

ustoers deide



6/58

uality

Performance

• Quality = -----------------

Expectation



7/58

QUALITY MANAGEMENT SYSTEMuality Manageent

*yste


Manuals

$roedurese8erene

*tandards

eords

ther

douents

Identi8y ustoere4uireents

Control operations

and ativities

eord all relevant

in8orationMeet ustoer

e4uireents


8/58

Cost o8 $oor ualityNot doing right first time


e-testing

Processing !omplaints

"ost Producti#ity

"ost $usiness

ecall reports % Products

&irect financial loss

"oss of staff morale


9/58

uality CostPre#ention !ost

'(irst Time ight)


*ppraisal !ost'!hec+ing for first time right),Planning for system

Training

&ocumentation

Euipment .gt/

e#ie0s

1nternal and

External PT

1nternal and

External

*udits


10/58

Degradation of quality with time


Innovation

Innovation

Time


11/58

Continuously improved Quality


Innovation

Innovation

Time


12/58

QUALITY ASSURANCE

2*ll the planned and systematic acti#ities implemented0ithin the uality system and demonstrated3 as needed3

to pro#ide adeuate confidence that an entity 0ill fulfil the

reuirements for uality4


To ensure that

PerformanceQuality = ----------------- 5 6

Expectation


13/58

"AI%YA**"A#C&= =

• All ativities assoiated 9ith the attainent o8 4uality – rganiDational struture! responsi7ilities and authorities

– *ta88 reruitent! indution! training! 9or: alloation!developent

– eadership! otivation and supervision

– ouentation o8 proedures

– %est ethod seletion! developent and validation

– &4uipent seletion! anageent and ali7ration – Control o8 aoodation and environent

– Control o8 onsua7le supplies and re8erene standards

– Internal and eBternal 4uality ontrol

– eeption! la7eling! proessing and storage o8 saples

– Addressing oplaints and other orretive ations – eording and reporting test results

– Aounting and adinistrative 8untions

– Audits and Manageent evie9 and 8ollo9-up iproveents



14/58

QUALITY CONTROL

perational ativities aied at onitoring the 4uality o8

produts and servies throughout the testing proess! and at

identi8ying unsatis8atory per8orane

&Baples =

• "se o8 re8erene standards or ites

• epliate testing

• %rend analysis

• Inter-la7oratory oparison trials



15/58

QUALITY IMPROVEMENT

Quality impro#ement is li+e a race 0ithout a finish line17O%1E! 689:; and *ccreditation are


16/58

I&C 1E025=2005 F #e9 Clause

•


17/58

uality 7etive


S.M.A.R.T

STRATEGIC

ACEI!A"#E

RE#E!A$T%EAS&RA"#

E

TARGETE

D


18/58

Iproveent


The organization shall continually improve

the effectiveness of the quality

management system through the use of Quality policy, Quality objectives, Auit results Analysis of ata, !orrective an preventive actions Management revie".


19/58


20/58

I#%&#A A"I%*

• %his is a re4uireent o8 I*/I&C 1E025

• Manageent 9ants to disover any 9ea:ness inthe la7oratoryHs systes as soon as possi7le

• Managers use the as a poliing 8untion

• Internal audits are a po9er8ul anageent tool toaid 4uality iproveent

• Internal audits veri8y the e88etiveness o8 orretiveations



21/58

.eneral $riniples o8 Auditing

The general principles of auditing include the follo0ing

a) *udits are an effecti#e management tool to examine acti#itiesand processes/ The result of an audit is information on 0hichmanagement can act>

b) Obc) *udits are authori?ed3 and authority may result from the decision

of management3 company policy3 pro#isions of contract3 theaudit client3 legislation or regulation>

d) *udit programmes and audits are planned and managed toensure that they are conducted in an effecti#e and consistentmanner and that the audit conclusions are credible>

e) *udits are conducted using established methods and techniuesto ensure that audit e#idence and audit findings are rele#ant3reliable and sufficient3 such that audit teams 0or+ingindependently from one another 0ill reach similar audit

conclusions>(C)Copyrights - Yadav Measureents ! "daipur

05/02/16


22/58

.eneral priniples o8 auditing

f ) %he sope! o7etives and audit riteria o8 eah audit are

learly de8ined and agreed prior to oening the auditg) Audit tea e7ers and audit prograe anagers are

opetent 8or the tas:s they per8or

h) Audit tea e7ers at 9ith due pro8essional are andadhere to a ode o8 ethis 9hih presri7es 8or eBaple!

auditor 7ehavior! integrity! on8identiality and otherattri7utes Audit tea e7ers are 8ree 8ro 7ias andon8lit o8 interest throughout their ativities

i) %he relationship 7et9een the audit tea! auditee and theaudit lient is one o8 on8identiality and disretion "nlessre4uired to do so 7y la9! the audit tea does not dislose

the ontents o8 douents! the nature o8 any otherin8oration o7tained during the audit! or the 8inal report! toany third party! 9ithout the eBpliit approval o8 the auditlient and! 9here appropriate! the approval o8 the auditee



23/58

e4uireents 8or Internal Audits

a) %he la7oratory has planned 8or audits in its 4uality syste

7) %he la7oratory has noinated a person! or persons! to 7eresponsi7le 8or onduting audits

) %he proedures 8or auditing are douented

d) %he audits are atually arried out

e) %he audits are onduted in aordane 9ith a preplannedprograe

8) %he results o8 audits are reorded

g) eedial ation is initiated iediately 7y the la7oratory toorret all non-oplianes identi8ied in its 4uality syste9ithin a reasona7le tie saleand

h) %he reedial ation is e88etive and opleted proptly



24/58

Audit yle

2

&Beution

8 Audit

1$lanning and

preparation

<+ollo9 up J

CA

G

eporting

results

05/02/16(C)Copyrights - Yadav Measureents !"daipur

The audit is considered to be complete only

0hen correcti#e actions ha#e been ta+en @ auditor has #erified/


25/58

Audit J ole o8 uality Manager

• Quality .anager is the responsible person for – Planning of audit

– ecords of audit

– 1n#ol#ement of other experts to complete the audit



26/58

A"I% $A##I#.

• ist the ativity you plan to audit• eterine the period you need to oplete the audit

• &nsure that eah ativity is overed

%a:e the help o8 he: list

• Arrive at the total duration needed to oplete theaudit

• Identi8ying the persons to 7e used 8or auditing

• &nsure their availa7ility and properly oordinate 9ith

individual(s) o8 the setion to 7e audited• eide to 9hat eBtent sapling is to 7e done isuss

it 9ith individuals or la7 sta88 to 7e used 8or audit



27/58

Ipleenting the audit prograe

a) ouenting and ouniating the audit prograe

7) Co-ordinating and sheduling ativities

) Assigning auditors and audit teas

d) $roviding re4uired resoures to the audit tea

e) Conduting audits aording to the audit prograe8) Collating reords o8 the audit ativities

g) evie9ing audit reords

h) evie9ing and distri7uting audit reports to the auditlient and other spei8ied parties

i) $er8oring audit 8ollo9-up



28/58

#A assessent $roess

• Pre-assessment team briefing

• Opening meeting

• Examination of laboratory

• (inal team meeting• !losing meeting



29/58

#A - pening eeting

• 1ntroduction

• Purpose @ scope

• Program

• *ny changes special arrangements• !onfidentiality



30/58

Audit ethods

• 1nter#ie0ing staff

• Examination of facilities

• Obser#ing acti#ities

• e#ie0ing documentation• e#ie0ing records and reports



31/58

&Baining e4uipent

• "istAA



32/58

hat are :ey lauses3



33/58

Audit F Manageent

• .anage time

• 7tay on trac+

• ecord finding

• emain impartial and ob


34/58

uestions

• *s+ open uestions

– Bho

– Bhat

– Co0

– Bhen

– Bhere

– Bhy



35/58

o not as:

• Questions

– 7elf ans0ering

– !ompound

– Tric+ uestions


Con8ir ans9ers in 7et9een


36/58

'uan aspets

• "istening s+ills

– (ocus on spea+er

– *#oid physical distraction

– eassure #erbally

– .aintain appropriate eye contact

– Pro


37/58

'uan aspets

• educe tension

– Put auditee at ease

– *ppreciate good 0or+



38/58

&**%IA* + A# A"I%

• Dno0ledge of uality manual3 laboratory proceduresand other documents

• Dno0ledge of accreditation criteria

• Dno0ledge of specific criteria

• &ont in#ol#e indi#iduals to audit their o0n 0or+



39/58

C#"C%I#. A"I%

• C#"C%I#. A"I% A# *%I & +I*

K #H% &L'II% Y" *"$&MACY

K #H% %Y % +I# "% +A"%*

• #&.&• C#"C% + A"I%

– eain al! 8riendly

– &Baine all 8ats and than onlude

–&Bplore option 8or orretion



40/58

$&*#A &A%I#* / $&*#A A%%I"%&*

• Open mindedness• .aturity

• 7ound


41/58

'oriDontal Audit

• audit plan hori?ontal/doc


http://audit%20plan%20horizontal.doc/http://audit%20plan%20horizontal.doc/


42/58

,ertial Audit

• audit plan Fertical/doc


http://audit%20plan%20vertical.doc/http://audit%20plan%20vertical.doc/


43/58

C#%%* + A"I% &$%

#ae o8 audit o88ier

ate o8 audit

Areas audited

etails o8 aspets eBained inluding saple nu7er!e4uipents 9ith identi8iation NN

Any non opliane o7served CategoriDation o8 nonopliane e. Maor/inor

Corretive ation agreed! tie period 8or orretiveation

ate o8 on8iration o8 opletion o8 orretive ation *ignature o8 4uality anager on8iring that

orretive ation has 7een opleted



44/58

I%I+YI#.

##-CM$IA#C&*

Non-compliances can be

• elated to the uality system

• elated to technical acti#ities

• (ailure to do some thing reuired

• &ifference bet0een 0or+ practices and documented

instructions



45/58

CA**I+YI#.

##-CM$IA#C&*

.a


46/58

&L$&**I#. ##-CM$IA#C&*

7tatements of non-compliances

must be

• Non-blaming statements of fact

• $ased on recorded ob


47/58

Control o8 #onon8oring or:

Brong results can be found in many 0ays/

"aboratory must control this nonconforming0or+/

T0o main aims pre#ents 0rong results being sent to clients

Pro#ides opportunities for impro#ement

!orrecti#e actions must follo0-up detection of

nonconforming 0or+



48/58

Control o8 #onon8oring or:

1dentification

&ocumentation

7egregation

E#aluation e#ie0 and disposition



49/58

ouentation o8 #onon8ority

&ate nonconformity 0as detected

The uantity of nonconforming 0or+

The significance of the nonconforming 0or+ in terms ofpotential conseuences

&isposition of the nonconforming 0or+

*uthority for disposition decision



50/58

Identi8iation o8 #onon8ority

Q! procedures

!alibration results

External assessments

1nternal audits .anagement re#ie0

!ustomer feedbac+



51/58

*uary

"aboratory must ha#e procedures for dealing0ith nonconforming 0or+/

Procedure must must ensure identification3

documentation3 e#aluation and disposition/Procedures must protect the client from 0rong

results/

esponsibility for re#ie0 and authority for

disposition must be established/



52/58

Corretive and $reventive ation

!orrection .ista+e in report corrected

!orrecti#e action (ind the cause for mista+e and ensuring that it does not occur in

future

Pre#enti#e action .a+ing the fool proof procedure to ensure that the problem does

not occur/



53/58

Corretive Ation

• !orrecti#e actions focuses on fixing problemsthat already exist/

• 1mpro#ement is possible through correcti#e

action but it is costly and fragmented/• Pre#enti#e action focuses on doing something

before a problem occurs

• 1mpro#ement is less costly



54/58

C&C%I,& AC%I# $


"i+ely

!ause

1dentified

Problem1dentified

!orrecti#e

*ction

1dentified

!orrecti#e

*ction Ta+en

!orrecti#e

*ction

Effecti#eA

ecords @

&ocuments

Gpdated

HE7

NO


55/58

Corretive and $reventive ation 8or


Yadav Measureents $rivateiited! "daipur Corretive and $reventiveation

ate=#u7er=

Initiation =-Internal 7servation / Custoer Coplaints /+eed7a:/ Internal audit*pei8i ali7ration (I8 any) =-ate o8 reeipt (y Inharge) =y=- ate=-

(+or use in ase o8 internal audit)e8erene *tandard = I&C 1E025Clause #u7er=e8erene ouent=Auditor=

etails o8 7servation / oplaint =-

oot ause analysis =-Coents J aeptane 8ro onerned =-

y=- ate=-

Corretive Ation eided esp %arget ate Atual opletion1)2)

$reventive Ation eided esp %arget ate Atual opletion1)2)

Closing / +ollo9 up rear:s =-y=- ate

Monitoring e4uired =- Yes / #oAtion

C t t 8 dit t


56/58

Contents o8 audit report

Name of audit officer

&ate of audit

*reas audited

&etails of aspects examined including sample number3euipments 0ith identification II

*ny non compliance obser#ed !ategori?ation of noncompliance e/g/ .a


57/58

Manageent revie9s

The responsibility lies 0ith senior management

Quality manager is responsible to prepare the

agenda

Quality manager is responsible for action ta+ingas decided by .anagement e#ie0

• #A F ,isits

1mportance of records of 1nternal *udit @.anagement e#ie0



58/58

$eriodiity

Each lab area shall be internally audited at least once in

a year for all reuirements of 1E! 689:;

Our initial recommendation One internal audit before pre-assessment

T0o internal audit bet0een pre and final assessment

There on t0o audits per year

internal audit jun05.ppt

Documents