Quality Management Orientation

1. People Integration
2. Supplier and Customer Relation
3. Corporate Environment
4. People Capability-Controable
Process
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I. QUALITY MANAGEMENT
Scope Quality Management
1. Build Quality System for Everyone
2. Simple Process not short cut
3. Quality Management Activities :
a. Quality Assurance
b. Quality Planning
c. Quality Control
Quality Management Project Management
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Quality Characteristic
1. Agenda Manajemen
2. Rencana Bisnis
3. Customer Focuss-Competition-Target
4. Socialized-Training Target to
Everybody
5. Regular View
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Quality Compromise
1. Pemastian pelaksaan SOP Quality
Management
2. Melaksanakan validasi dan menetapkan
spesifikasi
3. Menjadikan spesifikasi suatu frame work
demi terwujudnya Quality Culture
4. Training dan supervisi individu agar taat
pada spesifikasi yang ditetapkan.

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Kualitas
Langkah langkah pengendalian kualitas :
1. Definisikan dan Set Up Standard
2. Kualifikasi
3. Mengambil Database
4. Risk Management
5. Monitoring
6. Review
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Quality Management Process
1. Quality Management Responsibility
2. Trainer-Improvement-Revolutionary
3. Quality Planning Control
4. Quality Improvement
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Penyimpangan Mutu
Klasifikasi penyimpangan mutu :
Alert
Incident
Significant quality incident
Jika 2 kali alert quality incident
Kategori jumlah produk defect :
1. % variable defect bisa diukur (assay)
2. % attribute defect bisa dilihat (warna)
Perbaikan dan tracking penyimpangan mutu

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Studi Kasus 1:
Ada sebuah industri farmasi memiliki 5 buah mesin
tablet dengan kapasitas masing-masing 1.000.000
tablet perhari. Jadi industri farmasi tersebut dalam
sehari memproduksi 5 juta tablet, dalam seminggu
dihasilkan 25 juta tablet (5 x 5 juta), sebulan = 100 juta
tablet, setahun 12 x 100 juta = 1,2 milyar tablet.
Pertanyaannya :
1. Apakah ke-1,2 milyar tablet tersebut SEMUA-nya
dapat dijamin kualitasnya?
2. Berapa persenkah dari 1,2 milyar tablet tadi yang
boleh tidak memenuhi syarat yang telah ditetapkan?
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Jawaban :
1. 0% (NOL PERSEN) alias tidak boleh ada SATU
tablet-pun yang tidak memenuhi syarat. Konsep
ini yang disebut dengan Zero Defect Concept.
2. Konsep ini tidak mungkin berjalan kalau masih
menggunakan konsep Pengawasan Mutu
karena konsep ini hanya mencari kesalahan.
Penjaminan hanya bisa dilaksanakan jika ada
sistem yang mengatur seluruh komponen
(unsur) dalam industri farmasi tadi agar tujuan
mutu dapat tercapai. Sistem inilah yang sering
disebut dengan Sistem Manajemen Mutu
(Quality Management System).

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Definisi :
merupakan suatu sistem yang dirancang untuk
melancarkan jalannya suatu proses/pekerjaan dengan
ukuran tertentu yang dapat memenuhi kebutuhan
customer.
Tujuan :
Mempertahankan hasil pekerjaan selalu baik, konsisten
dan mengembangkan rasa memiliki.
Pendelegasian :
Harus jelas pada masing-masing departemen dan ada
standar penilaian untuk evaluasi pelaksanaan.
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II. PROCESS OWNERSHIP
Sasaran :
75% total karyawan memiliki proses ownership atau
individu own many processes.
Manfaat :
Terbentuk sistem yang efektif efisien
SDM dapat mengembangkan diri
Identifikasi permasalahan dengan cepat
Tantangan :
Mau belajar dan mengembangkan ilmu
Mau selalu memikirkan strategi agar sistem dapat
berjalan baik
Tidak semua individu mau keluar dari comfort zone

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Hal-hal yang dapat mensukseskan process ownership :
Fokus pada inti proses
Pribadi yang proaktif
Mau berubah secara bertahap untuk meninggalkan
kebiasaan lama.
Perubahan transisi pribasi mengubah transisi
keseluruhan shg terbentuk organisasi yang efektif.
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CIRI-CIRI LEADER yang BAIK
1. Envision
Support visi perusahaan dan visi pribadi
2. Enable
Membuat orang bisa mengerjakan tugas dan
tanggungjawabnya dengan baik
3. Energize
Menyemangati orang agar dapat bersinergi untuk
mencapai tujuan bersama
4. Empower
Memberdayakan, mengajak dan mempengaruhi
orang agar ikut sistem yang ada
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III. LEADERSHIP
Roles & Responsibilities of Leadership
Personal Leadership
Dimulai dari diri sendiri dan dapat menjadi contoh
Define requirements and targets
Tetapkan kebutuhan dan target
Standard Setting
Membuat standard untuk pribadi dan perusahaan
Understanding of quality principles
Memahami prinsip kualitas dan membangun kualitas
Development of quality culture
Menciptakan kondisi dimana tiap orang paham kualitas dan
menjadi budaya sehari-hari




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Roles & Responsibilities of Leadership
Right first time operation
Memikirkan cara yang tepat dan menyusun strategi
sebelum mengerjakan sesuatu
Elimination of rework
Menghilangkan rework reduce cost
Establish commitment to quality for everybody
Mengetahui seberapa besar komitmen kita dalam
membangun kualitas
Empower all
Mengajak setiap orang untuk melakukan hal yang baik
demi tercapainya tujuan bersama

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Roles & Responsibilities of Leadership
Definition of site goals
Describe quality performance
Deskripsikan penurunan atau kenaikkan produk reject
dengan parameter yang jelas
Consistent with company goals
Perusahaan harus konsisten terhadap kualitas
Quality policy communicated and in place
communication process
Performance and behavior
Terkait dengan pengaturan kedisiplinan
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Studi Kasus 2 :
Ada sebuah Perusahaan Farmasi Dalam Negeri yaitu PT.
Sumber Sehat Farma, Tbk yang berencana akan
meluncurkan produk mee to pada tahun 2014 yaitu :
1. Sirup Batuk Pilek
2. Tablet Vitamin Anak
3. Dry Sirup Antibiotika
4. Tetes Telinga Antiinfeksi
5. Gel Analgesik
Buatlah sistem perencanaan produk di atas mulai dari
preformulasi sampai dengan didapatnya Nomor Izin Edar
disertai dengan quality risk assesment-nya?
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Objectives
1. To review general requirements for documents
2. To review specific requirements for each document
3. To consider current issues applicable to your countries
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Why are documents so important?
Communication
Cost
Audit trail
IV. DOCUMENTATION
General Principles-I
Documentation is an essential part of QA and relates to all
aspects of GMP.
Purpose of documentation
Ensure that there are specifitions for all materials and
methods of manufacture and control
Ensure all personnel know what to do and when to do it
Ensure that authorized persons have all information
neccessary for release
Provide audit trail
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Documents should be
Designed
Prepared
Reviewed
Distribution with care
Design documentation
General Principles-II
Inspectors should look at the Style of the document
Instructions in the imperative
Short sentences
Not long sentences
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General Principles-III
Approval of Documentation
Approved, signed and dated by appropriate authorized
persons
No document should be changed without authorization
General Principles-IV
Distribution of documentation
Electronically or photographycally recorded data
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General Principles-V
Review
System for regular revision
Completion
During the process
Typical of Documentation
Labels
Specifications and Test Procedures
Master formulae
Batch processing and batch packaging records
Standard operating procedurs
Stock control and distribution records
Water quality manual
Other types (map, flowchart, photograph)
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Labels
What must be labelled ?
What must be on the label ?
Who has responsibility for labelling ?
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Specifications and Test Procedures

Starting and packaging materials
Intermediates and bulk products
Finished products

Master Formulae

Manufacturing instructions
Name of product with product reference code
Dosage form, strength and batch size
Full list of materials including quantities, unique reference
code
Expected final yield with acceptable limits
Processing location and principle equipment
Equipment preparation methodology
Stepwise processing instructions
Details of in-process controls with instructions for sampling
and acceptance limits
Storage requirements and special precautions

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Master Formulae

Packing instructions
Name of the product
Dosage form, strength and method of administration
Pack of size (number, weight or volume of product in finished
pack)
List of all packaging materials (quantities, size and code
number)
Example of printed packaging materials, with location of
batching information
Special precautions, including area cleareance check
Description of the packaging operation
In-process control checks, with sampling instructions and
acceptance criteria


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Batch Processing Records
Name of the product, batch number
Dates and times for major steps in process
Name of person responsible for each stage of production
Name of the operators carrying out each step (check signatures)
Theoretical quantities for materials in the batch
References number and quantity of materials used in the batch
Main processing, steps and key equipment
In-process controls carried out and results obtained
Yield at each stage with comments on deviations
Expected final yield with acceptable limits
Comments on any deviations from process
Area clearance check, instructions to operators
Record of activities
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Batch Packaging Records
Name of the product, batch number and quantity to be
packed
Batch number, theoretical quantity and actual quantity of
finished product
Reconsiliation calculations, dates and times of operation
Name of person responsible for packaging, initials of
operators carrying out each step
Checks made and results obtained
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Batch Packaging Records
Details of packaging operation, including equipment and line
used
Returns to store
Specimen of printed packaging materials, with batch coding
Comments on deviations from the process and actions taken
Reconsiliation of packaging materials, including returns and
destruction
Area clearance check
Product variables
Record of activities and check signatures

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Standard Operating Procedures
Who is responsible for SOPs ?
Where should SOPs be stored ?
Standard Operating Procedures
Which activities require SOPs ?
Receipt of all material deliveries
Internal labelling, quarantine and storage of materials
Operation, maintenance and cleaning of all instruments and
equipment
Sampling of materials
Batch numbering system
Material testing at all stages of production
Batch release or rejection
Maintenance of distribution records
Equipment assembly and validation
Calibration and operation of analytical apparatus
Maintenance, cleaning and sanitation
Personnel recruitment, training, clothing and hygiene
Environmental monitoring


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Stock Control and Distribution Records
What should be recorded ?
Where should records be stored ?
Why are the records important ?

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Water Quality Manual
Full details of design of system, operation and maintenance
Details of testing, requirements