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Oleh:

Wahono Sumaryono

Mata Kuliah Manajemen Mutu PSPA


Fakultas Farmasi Universitas Pancasila
MANAJEMEN FARMASI

Manajemen Manaj.Proses Manajemen Manajemen


Manajemen
Sumberdaya Produksi Distribusi Pelayanan
(manufaktur) Pemasaran
Jasa

• SDM • GMP • PBF • Ethical • Kepuasan


• Sarpras • CPOB • Apotik • Non-ethical • Kualitas
• Dana • COPTB • Toko Obat • OTC • Kuantitas
• Bahan Baku • CPKB • Infrastruktur • Daya Saing • Kontinuitas
• Persediaan • Dll pendukung • Produk Inovatif • kecepatan
(inventory) (transportasi, • Produk Follower
• dll pergudangan, • Wilayah
dll) • Kelompok
Sasarn

Good Corporate Governance


2
Good Corporate Governance
Fairness Accountability Responsibility
Transparency Independence

Business
Performance Risk
Management
Process
Management
Management

Integrated Management System &


Enterprises Resource Planning

3
CORPORATE IMAGE
Unsur Pembangun Dimensi

NO DIMENSI ATRIBUT PENGUKURAN


• Perhatian tinggi terhadap konsumen
• Produk barang/jasa berkualitas tinggi
1 Quality • Perusahaan yang dapat dipercaya/
diandalkan
• Perusahaan yang inovatif
• Perusahaan yang memiliki peluang tumbuh
2 Performance dan berkembang.
• Perusahaan yagn dikelola dengan baik
• Perusahaan yang peduli lingkungan
3 Responsibility • Perusahaan yang memiliki tanggung jawab
sosial
• Perusahaan merupakan tempat kerja
idaman
4 Attractiveness
• Perusahaan memiliki karyawan berkualitas
baik/tinggi
4
Strategi Bisnis
● Cost Leadership (whole process)

● Product differentiation/innovation

● Quality Assurance (process, product,


services)

5
Operasi Sebagai Sistem Yang Produktif
Lingkungan

Manajemen Operasi
INPUT OUTPUT
PROSES

• Tenaga kerja
• Modal PROSES TRANSFORMASI
• Material NILAI TAMBAH
•Operation management PRODUK
• Energi
•System Design (Barang dan Jasa)
• Tanah
• Informasi •Operation Planning & Control
• Manajerial

Umpan Ballik untuk


Pengendalian Input,
Proses, dan Teknologi

Skema Sistem Produksi 6


Tanggung Jawab Manajemen Produksi

1. Proses (Process) :
Keputusan tentang aliran proses, type peralatan dan
teknologi, penyusunan fasilitas, dan aspek-aspek lain terkait
peralatan secara fisik atau fasilitas jasa.
2. Kapasitas (Capacity)
~ Keputusan untuk menghasilkan produk yang tepat.
~ Untuk jangka panjang, kapasitas ditentukan dari ukuran
fisik yang dipakai.
~ Untuk jangka pendek, kapasitas dapat diperbanyak
melalui subkontrak, tambahan gilir kerja (shift), atau
menyewa tempat produksi tambahan.

7
Tanggung Jawab …... lanjutan

3. Persediaan (inventory) :
~ Keputusan menyangkut apa yang dipesan, berapa banyak,
dan kapan memesan.
~ Sistem pengendalian persediaan dipakai untuk mengatur
bahan baku (mulai dari pembelian bahan baku s/d menjadi
barang jadi).
~ Manajer persediaan perlu memutuskan jumlah barang yang
akan disimpan sebagai persediaan, tempat/lokasi
penyimpanan, dan hal-hal terkait lainnya (a.l. kondisi
ruang, dsb.)
4. Kualitas (Quality)
~ Keputusan untuk manajemen kualitas produk final terkait
erat dengan seluruh rangkaian proses; mulai dari
kualitas bahan baku, penetapan standar-standar,
disain peralatan, SDM yang kompeten, serta
pengawasan produk/jasa yang dihasilkan.
8
1. Model Strategi Operasi

Corporate and
business strategy

Internal
Mission Functional strategies
analysis
in marketing,
finance, engineering,
Distinctive Competence
human resources,
Objectives and information
External systems.
(cost, quality, flexibility,
analysis delivery)
Policies
(process, quality, system,
capacity, and inventory)

Consistent pattern
of decisions

Results 9
PENGERTIAN DAN DIMENSI MANAJEMEN
KUALITAS TOTAL

Kualitas adalah ukuran seberapa dekat suatu barang


atau jasa sesuai dengan standar tertentu. Standar
mungkin berkaitan dengan waktu, bahan, kinerja,
keandalan, atau karakteristik (objektif dan dapat diukur)
yang dapat dikuantifikasikan.
Dewasa ini orang selalu mendasarkan diri pada sistem
yang menjamin kualitas, yaitu sistem yang terdiri atas
kebijaksanaan, prosedur dan pedoman yang
membentuk dan memelihara standar tertentu kualitas
produk.

10
Adapun unsur sistem penjamin kualitas adalah :
1.Unsur pendukung dari lingkungan dunia usaha
(ekstern)
a. Prioritas pelanggan
b. Pemasok
c. Langganan pada umumnya
d. Produk yang diproses
2.Kegiatan pengawasan kualitas
a. Tujuan manajemen kualitas
b. Spesifikasi kualitas
c. Masukan, proses, dan keluaran (pengawasan
kualitas)
3. Unsur pendukung organisasi (intern)
a. Kemampuan berproduksi
b. Penunjang teknis
c. Tugas lapangan

11
Total Quality Management merupakan sistem
manajemen yang mengikutsertakan seluruh anggota
organisasi dalam menerapkan konsep dan teknik
kendali mutu untuk mendapatkan kepuasan pelanggan
dan orang yang mengerjakannya.
Dari pengertian tersebut, dapat dijabarkan bahwa TQM
memiliki ciri sebagai berikut :
a.Melibatkan seluruh karyawan dari semua tingkatan
yang dikenal dengan manajemen partisipatif.
b.Menerapkan konsep pengendalian mutu, dengan
memutar daur PDCA (plan, do, check, action) yang
dikenal kemudian sebagai delapan langkah pemecahan
masalah.
c.Menerapkan metoda statistik, sebagai salah satu alat
pemecahan masalah.
12
Sasaran yang ingin dicapai TQM adalah kepuasan
pelanggan, memastikan mutu kepada pelanggan,
menumbuhkan kerjasama yang baik dari seluruh
karyawan dari semua tingkatan serta kelangsungan
hidup dan perkembangan perusahaan.
Konsep TQM memformulasikan hubungan antara
manajemen perusahaan, sistem, karyawan, serta
konsumen sebagai sasaran akhir produk, yaitu dengan
menciptakan iklim perbaikan secara terus menerus
melalui pemanfaatan teknik statistik guna mengambil
keputusan.

13
Mengukur kualitas perlu memperhatikan dimensi
kuantitatif dan kualitatif. Pada umumnya kualitas barang
atau jasa dapat dilihat dari 6 dimensi yaitu :
1.Operasi atau fungsi barang/jasa.
2.Keandalan dan keawetan.
3.Kesesuaian dengan spesifikasi.
4.Mudahnya dirawat atau diservis.
5.Penampilan.
6.Kualitas yang dipersepsikan pengguna.
14
TECHNOLOGY CAN IMPACT ANY ASPECT
OF THE VALUE-CHAIN

Materials Process Maintenance

Operations Competitiv
Logistics and Distribution Marketing Services e
Manufacturing Advantage

Materials
Package Media
Handling

• Testing
• Information systems
• Transportation
• Communications
• Quality
• Product/Process Development 15
Ref. : SRI - International
Technology strategy must support and shape business
strategy. Achieving this link usually requiress a specific
program or process.

BUSINESS STRATEGY

• Products/Processes
• Service
OPTION AND • Competitive Position COMPETITIVE
LINKAGE • Finances ADVANTAGE
• Operations
• Human Resources

TECHNOLOGY STRATEGY

Ref. : SRI - International 16


Manajemen Kualitas Farmasi
WHAT IS QUALITY?
General Definition of Quality
● ISO 9000 2005(E)
● Degree to which a set of inherent characteristics
fulfills requirements
● The ability to fulfill requirements, or to provide
satisfaction.
Quality Definition for Product to Satisfy Customer
● Fitness for Use (J.M. Juran)
● Conformance to Customer Requirements (P.B.
Crosby)
● Meeting Customer Expectations (A.V. Feigenbaun)
● Customer Satisfaction (K. Ishikawa)

Ref. : Wayan Redja 18


BIG QUALITY

Quality
Parameters of Quality Interested Parties
Types
Design, Performance, Reliability, User, Customer,
Fitness for Use, Esthetics, Price, etc. Manufacturer
Product

Effectiveness, Efficiency (speed/ Manufacturer, Owner


Process cost), Productivity, Safety

Safety (physic, health, legal) comfort All stakeholders


Environment

Speed, Cost, Delivery time, Afer-sale User


service, Friendliness, Politeness, Costumer
Service
Ethics

Ref. : Wayan Redja 19


Traditional vs Modern Paradigm on Quality

Point of View Traditional Modern


Issue Technical Business
Responsible parties QA/QC Dept. Stakeholders
Specification Stakeholders
Objective
conformance satisfaction
Final inspection Built into the
The way to achieve
product
Supplier relationship Short-term Long-term
By Inspection System and process
Quality Assurance
approach
Tight inspection & high Customer focus
Quality improvement
cost

Ref. : Wayan Redja 20


WHAT IS QUALITY MANAGEMENT?

ISO 9000 : 2005(E)


Quality Management is coodinated activities to direct and
control an organization with regard to quality.
Direction and control with regard to quality; quality policy,
quality objective, quality planning, quality control, quality
assurance, quality improvement.
Total Quality Management (TMC) is coordinated activities
in all level of operational management or processes in
each functional area for continuous performance
improvement.

Ref. : Wayan Redja 21


ISO 9001 vs GMP of Pharmaceutical Products

ISO 9001 GMP


• Quality Management Standard • Quality Management Standard
for Any Organization for Pharmaceutical Products
Manufacturing

• International Standard (ISO) • National, Regional or


International (WHO)

• Voluntary • Compulsory

Ref. : Wayan Redja 22


GMP for Pharmaceutical Products

Documented Resources & Activities (CPOB, 2008)


* Requirements/Specifications for Resources
1. Personel 2. Premises 3. Equipment
* SOPs, Wls and Forms for Processes
QS* 1. Sanitation & Hygiene 5. Claim Handling & Recall
2. Production 6. Documentation
3. Quality Control 7. Contract Manufact & Analysis
1. QM
4. Self Inspection 8. Qualification & Validation

Totality of planned QS and its consistent implementation, proven


by correct records and reports, to ensure that the products conform
with the quality standard appropriate to their intended use.
QA
Principle : “Do what is written, write what is done”

* QS provision in accordance with GMP Guidelines for Pharmaceutical Products

Ref. : Wayan Redja 23


Typical Product Realization
in Pharmaceutical Industry
MR = Marketing Request PPIC = Product
PP = Production Plan Planning &
PO = Purchase Order Inventory Control
RM = Raw Material PR = Purchase
IP = Itermediate Request
Product Pcs = Purchase
BP = Bulk Product Rcv = Receiving
FP = Finished Product Qrt = Quarantine
MR/ST IPC = In Process Control Wgh = Weighing
QC = Quality Control Mix = Mixing
PPIC ST = Stock Fill = Filling
Tab = Tableting
Pkg = Packaging
PP/PR
Pcs

PO RM RM IP IP BP BP FP FP

Pcs Rcv, Qrt Wgh, Mix Qrt Fill, Tab Qrt Pkg Qrt
IPC, QC IPC QC IPC QC IPC QC

PROCESSING PACKAGING

PRODUCTION

MANUFACTURING
Ref. : Wayan Redja 24
QUALITY MANAGEMENT PRINCIPLES*

● Customer focus
● Mutually beneficial supplier relationship
● Leadership
● System approach to management
● Involvement of people
● Process approach
● Factual approah to decision making
● Continual improvement
* These principles may form a basis for establishment of a quality policy

Ref. : Wayan Redja 25


Quality Management Basic Elements
(WHO, 2007)

QM

QA QS

Ref. : Wayan Redja 26


QUALITY MANAGEMENT SYSTEM

● What is Quality Management System (QMS)


● The Elements of QMS
● QMS of ISO 9001

Ref. : Wayan Redja 27


WHAT IS QUALITY MANAGEMENT SYSTEM?

● Quality Management System (QMS) is a documented


written procedures and standard practices to fulfill
requirements
● All activities to provide confident that the QMS is
consistenly implemented is called Quality Assurance.
● “Do what is written and write what is done”
● Documented Procedures and Standards consist of :
Quality Manual, Specifications, Procedures (SOP),
Work Instructions (WI), Forms
● Quality manual is a Guidelines for Quality Management
consisting of : Vision and Mission, Quality Policy,
Organization Structure, Job Descriptions, Management
Requirements, and Technical Requirements.
Ref. : Wayan Redja 28
QUALITY ELEMENTS OF QMS ISO 9001

● Management Responsibility; Management


Commitment, Customer focus, Quality policy, Quality
planning, Adminstration, Management review
● Resource Management : Provision of resources,
Human resources, Facilities, Work environment
●Product (Good and/or Service) Realization :
Planning of realization processes, Customer related
processes, Design and development, Purchasing,
Production and service operation, Control of measuring
devices.
● Measurement, Analysis and Improvement : Planning,
Measuring/monitoring, Control of non-conformity,
Analysis of data, Improvement.

Ref. : Wayan Redja 29


QMS CONTINUAL IMPROVEMENT ISO 9001
CONTINUAL IMPROVEMENT

Manajement
Responsbility

CUSTOMER Measurement, CUSTOMER


Resource
REQUIREMENT Analysis, SATISFACTION
Manajement
Improvement

Product
Realization
IN-PUT PROCESS OUT-PUT

Information flow
Value-adding activities

Ref. : Wayan Redja 30


What is Quality Assurance?

1. A WIDE-RANGING CONCEPT
- ISO 9000:2005(E)
Part of quality management focused on providing confidence
that quality requirements will be fulfill.
- The totality of planned and systematic actions necessary
that implemented and proved to provide adequate
confidence that a product will satisfy the requirements for
quality (WHO, 2007)
2. A BROAD-BASED DEPARTMENT
Department which is concerned with quality assurance of many
quality-related activities, such as : quality system
development, quality planning, product realization, quality
control, quality audit, and continuous quality improvement
(J.M. Juran, 1988)
Ref. : Wayan Redja 31
Quality Assurance of Pharmaceutical
Products

Principle
- Quality Assurance is a wide-ranging concept, covering all
matters that individually or collectively influence the quality
of a product.
- It is the totality of organized arrangement made with the
object of ensuring that pharmaceutical products are of the
quality required for their intended use.
- It incorporates GMP and other factors, including product
design and development.
This wide-ranging concept covering integrated activities among
stakeholders government, industry, health-care
professionals and community.

Ref. : Wayan Redja 32


Quality Assurance of Pharmaceutical
Care

“Quality Assurance is that set of activities that are


carried out to monitor and improve performance so that
the health care provide is as effective and as safe as
possible”.
“all activities that contribute to defining, designing,
assessing, monitoring, and improving the quality of
health care”

Ref. : Wayan Redja 33


Core Principles of Quality Assurance In Health
Care

● Focus on the client/patient


● Focus on system and processes
● Focus on measurement
● Focus on teamwork

Ref. : Wayan Redja 34


The Philosophy of QA in Each Management Functions

1. Plant Check c. Evaluation of Engineering


a. Planning Evaluation Prototype & Trial Mass
2. Reliability Test Production
b. Prototype Evaluation SALES & SERVICE 5. Evaluation of the Process
PLANNING &
3. Merchandise Test •Service Excellence 6. Evaluation of the Product
DEVELOPMENT
4. New Product Evaluation •Serviceman in the Market
•Development e
•Research qualification d. Product Quality &
•Feasibility study •After Sales Service Productivity Satisfaction
e. Customer Satisfaction
Evaluation
a 1 6 d
QUALITY
OPERATION
DESIGN CRITERIA 5 •Purchase Control
•Layout
2
•Incoming inspection
•Design Review •Process Control
•Simulation 3 •Final Inspection
•Prototype Testing 4
b OPERATION c
PREPARATION
•Operational
Standards
•Process Design
Prototype

Ref. : Wayan Redja 35


Why Quality Assurance ?

● To assure customer satisfaction


● To increase productivity (effectiveness/efficiency)
● To increase organization competitiveness
● To enhance organization image
● To ensure the organization sustainability

Motto : Mutu atau Mati

Ref. : Wayan Redja 36


How to Implement Good QA Practice ?
● Assure to Top Management commitment
● Designate a working group and a coordinator as
Management Representation (MR)
● Establish: Vision, Mission, Quality Policy, and Objectives
● Prepare QMS documents, Procedures, WI, Forms, Record
● Sosialization and traning on the established QMS
● Implement established QMS consistently
● Perform Internal Audit
● Conduct Management Review
● Take preventive and corrective actions.
● Make records and report
“Writte what will be done, do what is written, write what is done”

Ref. : Wayan Redja 37


Quality Policy and Objectives

Quality Objectives
•Something sought, or aimed for related to quality.
•The setting is based on the organization quality policy.
•Are specified for relevant function and levels in the
organization.
•Their achievement need to be measurable.
•The results have positive impact on product quality, financial
performance, and stakeholders satisfaction.
Example :
1.CPD increase 10%
2.DRP decrease 5%
3.Customer complaints decrease 10%
4.Sale increase 15%, etc.
Ref. : Wayan Redja 38
QMS Documents
Quality Manual, Quality Plans, Specifications, Guidelines,
Procedures, Work Instructions, Drawings, Records

Quality Manual
•Provide consistent information, internally and externally
about the organization’s QMS; the scope, the documented, a
description of the interaction between the processes.
Quality Plans
Part of quality planning describing how the QMS is applied
to a specific product, project or contract.
Quality planning is part of quality management focused on
quality objectives, related processes and resources.

Ref. : Wayan Redja 39


QMS Documents
• Specifications
Documents stating requirements for particular resources.
A specification can be related to activities (procedure, process, test)
or product (service, sofware, hardware, processed materials).
• Guidelines
Documents stating recommendations or suggestions.
• Written Procedures, Work Instructions (WI) and Drawings
Documents that provide information to perform activities (WI)
and process (Procedure) consistently.
Process is set of interrelated or interacting activities which
transforms inputs into outputs.
• Records
Documents that provide objective evidence of activities
performed or result achieved.

Ref. : Wayan Redja 40


CONCLUSION
(Key Success Factor)
Make quality people prior to making quality product.
Built quality into the product.
Do it right from the first time and every time.
Write what will be done, do what is written, write
what is done.
• Top management commitment
• Mind set : Quality First, process effectiveness and
efficiency, continual improvement.
• Implementation of quality management principles.
• Establish QMS in your organization including good
practices (GLP, GCP, GMP, GDP or GPP, etc,)
• Implementation of QA concept as consistent
implementation of the QMS.
Ref. : Wayan Redja 41
Ruuaaarrr biasa
Prof….ciamiik…!

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