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Quality Management Orientation
1. People Integration2. Supplier and Customer Relation
3. Corporate Environment
4. People Capability-ControableProcess
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I. QUALITY MANAGEMENT
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Scope Quality Management
1. Build Quality System for Everyone2. Simple Process not short cut
3. Quality Management Activities :
a. Quality Assuranceb. 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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Kualitas
Langkahlangkah pengendalian kualitas :1. Definisikan dan Set Up Standard
2. Kualifikasi
3. Mengambil Database4. 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 mesintablet 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 yangboleh 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 adasistem yang mengatur seluruh komponen
(unsur) dalam industri farmasi tadi agar tujuan
mutu dapat tercapai. Sistem inilah yang sering
disebut dengan Sistem Manajemen Mutu(Qual i ty Management Sys tem).
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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
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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 dapatberjalan 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 dantanggungjawabnya dengan baik
3. Energize
Menyemangati orang agar dapat bersinergi untuk
mencapai tujuan bersama4. Empower
Memberdayakan, mengajak dan mempengaruhi
orang agar ikut sistem yang ada
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III. LEADERSHIP
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Roles & Responsibilities of Leadership
Personal LeadershipDimulai dari diri sendiri dan dapat menjadi contoh
Define requirements and targets
Tetapkan kebutuhan dan target
Standard SettingMembuat 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 danmenjadi budaya sehari-hari
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Roles & Responsibilities of Leadership
Right first time operationMemikirkan 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 goalsPerusahaan harus konsisten terhadap kualitas
Quality policy communicated and in place
communication process
Performance and behavior
Terkait dengan pengaturan kedisiplinan
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Objectives1. 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
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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 informationneccessary for release
Provide audit trail
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Documents should be
Designed Prepared
Reviewed
Distribution with care
Design documentation
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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
personsNo document should be changed without authorization
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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
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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
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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 bepacked
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 ProceduresWho is responsible for SOPs ?
Where should SOPs be stored ?
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Standard Operating ProceduresWhich 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 RecordsWhat 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