A Cultural Transition

What Is Quality?
Degree to which a set of inherent characteristics
fulfils requirements
QUALITY
Fitness for Use
Conformance to Customer Requirements
Meeting Customer Expectations
Customer Satisfaction
JM Juran
!" Cros#y
$% Feigen#aum
& Ishi'a(a
What is a Quality Management System?

Policies,

Processes

Procedures
What is a Quality Management System?
)
Required for planning and executing
business processes
)
To meet customer requirements
)
Accredited to International
Standards by a Registrar
ISO 9001:2008 is an example
What Is A Quality Management System?
!eople
!rocesses
Materials
Equipment
Resources
!lanne*
In*i+i*ually
,ystem
-"est !ractice.
Implemente*
Collecti+ely
/ocumente*
,ystem
/escri#es ho( this
happens
QMS (SISTEM MANAJEMEN MUTU)
DEI!ISI SISTE" "A!A#E"E!
"$T$
-Management system to *irect an* control an organi0ation (ith
regar* to quality .
-,istem mana1emen untu' mengarah'an *an mengen*ali'an suatu
organisasi *alam 'aitannya *engan mutu.
A PHILOSOPHY
Change
It Requires ..
1. Leadership
2. Determination
3. Resilience
4. Commitment
5. Engagement
Hierarchy of Quality
Advanced Auditing covers
QA and QM more
effectively
Basic conformance
auditing covers QC
level
Quality
Management
Quality Assurance
Quality Control
Quality Techniques QMS Stan!a"!s
%uality
Control
%uality
Assurance
%uality
"anagement
&Detection' &(re)ention' &Direction'
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Quality management
)
IS* +,,- is for quality management.
)
Quality refers to all those features of a
product &or ser)ice' which are required by the
customer.
)
Quality management means what the
organi/ation does to0
)
ensure that its products or ser)ices satisfy the
customer1s quality requirements, and
)
comply with any regulations applicable to
those products or ser)ices.
Quality management (cont.)
)
%uality management also means what
the organi/ation does to0
)
enhance customer satisfaction2 and
)
achie)e continual improvement of its
performance.
Internal factors External factors
Initial an* perio*ic
status re+ie(
!olicy
$u*it 9rganising
!lanning an*
implementing
Measuring
performance
Information lin'
C9=>R9? ?I=&
lowchart of
a generic
management
system
Eight %uality "anagement (rinciples
-3
-. Customer ocus
4. 5eadership
6. In)ol)ement of (eople
7. (rocess approach
8. Systems approach to management
9. Continual Impro)ement
:. actual approach to decision ma;ing
3. "utually beneficial supplier relationships
!ro*uct
Continual impro+ement of the quality management system
Customers
@an* other
intereste*
partiesA
Requirements
Management
responsi#ility
Resource
management
MeasurementB
analysis an*
impro+ement
!ro*uct
realisation
9utput
,atisfaction
Input
Source0 <S E! IS*
+,,-04,,,
&eyC
%alue a**ing acti+ity
information flo(
Customers
@an* other
intereste*
partiesA
Top Management
rocess !"ners
!perators
Top Management
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#ffective policy
deployment
through
measurement is
required $y all
%&! '(() $ased
standards*
Policy
Management
System (Business)
Objectives
Process Objectives
Project / Product / Sub-rocess objectives
Typical %"S Structure
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QU$?I>D M$=U$?
!olicyB o#1ecti+esB organi0ationB
outline of quality system
!R9CE,, /9CUME=>,
$=/ !R9CE/URE,
I=,>RUC>I9=,
F9RM,
!rocessesB practicesB
responsi#ilitiesB
interfaces
/etaile* instructions
on ho( to carry out
specific tas's
Quality
recor*s
/esign I> ,upport Installation >raining
Clic; to edit "aster text styles
Second le)el

Third le)el

ourth le)el

ifth le)el
)* +A,- .esign or revise $usiness process
components to improve results
/* .!- %mplement the plan and measure its
performance
0* CH#C1 2 &T3.4- Assess the measurements
and report the results to decision ma5ers
6* ACT- .ecide on changes needed to improve
the process
#very organi7ation8s
management systems are
comprised of various
processes, each "ith
their o"n set of metrics,
goals, targets and
initiatives*
The 5ey is to align each
process8 .CA cycle "ith
the overall strategic effort
of the organi7ation*
As your Management &ystems mature, effective use
of the .eming Cycle "ill ensure continual
improvement
Clic; to edit "aster text styles
Second le)el

Third le)el

ourth le)el

ifth le)el
-. IS* +,,- Structure
a. %uic; =istory
i. *riginal Standard in -+3:
ii. 4, clauses
iii. (rocedure>based
i). Re)ision in -++7
). A ?twea;@
)i. Re)ision in 4,,,
)ii. "aAor o)erhaul
)iii. 3 sections
ix. ocus on the Customer
x. ocus on <usiness Results
xi. Re)ision in 4,,3
xii. A ?twea;@
http0BBwww.iso.orgBisoBabout.htm
The 4,,3 ?Twea;@
)
IS* +,,-04,,3 did not introduce additional
requirements
)
!or did it change the intent of the IS*
+,,-04,,, standard.
)
IS* +,,-04,,3 was de)eloped in order to0
E
Introduce clarifications to the existing requirements
of IS* +,,-04,,, and
E
Introduce changes that are intended to impro)e
compatibility with IS* -7,,-04,,72 En)ironmental
"anagement Systems.
/o What the
Customer Wants
Manage*
Measure
$nalyse
Impro+e
#$$%
&$M'ANY
!olicy
Customer Focus
Committe*
9#1ecti+es
/etermine F Communicate
$uthority F Responsi#ilities
Re+ie(
!eople
"uil*ingsB EquipmentB
MachineryB etc
En+ironment
!lanning
!ro+i*e Resources
Customer
,atisfaction
,ystem
!rocesses
!ro*uct
=on7conforming
!ro*uct
/ata F Info
Correcti+e
$ction
!re+enti+e
$ction
Control 9ur !rocesses
Control 9ur /ocumentation
IS$
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,)*
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,),
,).
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,elling
!urchasing
/esigning
Cali#rating
!ro*uction
%&!
Clause
,um$er %&! Clause ,ame
, I!TR*D$CTI*!
,.- Ceneral
,.4 (rocess Approach
,.6 Relationship with IS* +,,7
,.7 Compatibility with *ther "anagement Systems
- SC*(E
-.- Ceneral
-.4 Application
4 !*R"ATIDE REERE!CES
6 TER"S A!D DEI!ITI*!S
7 %$A5ITE "A!ACE"E!T SESTE"
7.- Ceneral Requirements
7.4 Documentation Requirements
7.4.- Ceneral
7.4.4 %uality "anual
7.4.6 Control of Documents
7.4.7 Control of Records
8 "A!ACE"E!T RES(*!SI<I5ITE
8.- "anagement Commitment
8.4 Customer ocus
8.6 %uality (olicy
8.7 (lanning
8.7.- %uality *bAecti)es
8.7.4 %uality "anagement System (lanning
8.8 Responsibility2 Authority2 and Communication
8.8.- Responsibility and Authority
8.8.4 "anagement Representati)e
8.8.6 Internal Communications
8.9 "anagement Re)iew
8.9.- Ceneral
8.9.4 Re)iew Input
8.9.6 Re)iew *utput
9 RES*$RCE "A!ACE"E!T
9.- (ro)ision of Resources
9.4 =uman Resources
9.4.- Ceneral
9.4.4 Competence2 Training2 and Awareness
9.6 Infrastructure
9.7 For; En)ironment
%&!
Clause
,um$er %&! Clause ,ame
: (R*D$CT REA5IGATI*!
:.- (lanning of (roduct Reali/ation
:.4 Customer>related (rocesses
:.4.-
Determination of Requirements Related to the
(roduct
:.4.4 Re)iew of Requirements Related to the (roduct
:.4.6 Customer Communication
:.6 Design and De)elopment
:.6.- Design and De)elopment (lanning
:.6.4 Design and De)elopment Inputs
:.6.6 Design and De)elopment *utputs
:.6.7 Design and De)elopment Re)iew
:.6.8 Design and De)elopment Derification
:.6.9 Design and De)elopment Dalidation
:.6.: Design and De)elopment Changes
:.7 (urchasing
:.7.- (urchasing (rocess
:.7.4 (urchasing Information
:.7.6 Derification of (urchased (roduct
:.8 (roduction and Ser)ice (ro)ision
:.8.- Control of (roduction and Ser)ice (ro)ision
:.8.4
Dalidation of (rocesses for (roduction and Ser)ice
(ro)ision
:.8.6 (roduct Identification and Traceability
:.8.7 Customer (roperty
:.8.8 (reser)ation of (roduct
:.9 Control of "onitoring and "easuring Equipment
3
"EAS$RE"E!T2 A!A5ESIS A!D
I"(R*DE"E!T
3.- Ceneral
3.4 "onitoring and "easurement
3.4.- Customer Satisfaction
3.4.4 Internal Audits
3.4.6 "onitor and "easurement of (rocesses
3.4.7 "onitoring and "easurement of (roduct
3.6 Control of !onconforming (roduct
3.7 Analysis of Data
3.8 Impro)ement
3.8.- Continual Impro)ement
3.8.4 Correcti)e Actions
3.8.6 (re)enti)e Actions
%t8s not a$out the paper"or59
%t8s all a$out if it "or5s:
Course &ummary
KEBIJAKAN MUTU BADAN POM
!"
Badan POM berkomitmen untuk melindungi masyarakat dari
Obat dan Makanan yang berisiko terhada kesehatan dan se!ara
terus"menerus meningkatkan enga#asan serta memberikan
elayanan keada seluruh emangku keentingan
Kebijakan Mutu Badan POM terdapat dalam Manual Mutu yang ditetapkan melalui Keputusan
Kepala Badan POM Nomor HK.04.1.2.11.11.0!21! "a#un 2011 tentang Penerapan $istem
Manajemen Mutu %&uality Management $ystem' Badan POM
KOO$DINA%I PEN&E'O'AAN &M$ BADAN POM
Deuti Mana(emen Pun!ak
Mana(emen Pun!ak

%ekretaris Utama
Deuti Koordinator Management (epresentati)e
Ema %etya#ati
Koordinator Management (epresentati)e
Togi Juni!e )utad(ulu
Koordinator
Auditor Internal
Insektur
%ekretariat
Koordinator
Management
(epresentati)e
PEME'I)A$AAN DAN PENIN&KATAN
&M$ BADAN POM TA)UN *+,-
!!
Audit Surveilan
Audit Sertifikasi
CAPA
Sertifikasi
Persiapan Audit Mutu Internal Diseminasi/ Kaji Ulang Dokumen
Audit Mutu Internal
CAPA
Evaluasi Tinjauan Manajemen
Audit
Inspektorat
CP!
PICS
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!esar/!alaiP
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