ansi asqc application in pharma plant
DESCRIPTION
ANSI ASQC Application in Pharma Industry is useful especially for determining the decision pertaining to product failure. By using this tool, we can standardized our decision scientificallyTRANSCRIPT
SHARING
ANSI/ASQC Z1.4Sampling Procedure for Inspection By Attribute
By :Muhammad Agung Sumantri
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TUJUAN
Adanya standard yang terdokumentasi dan disusun secara sistematik
Pengambilan keputusan yang cepat dan terukur
Reduksi Subjektivitas
Sebagai parameter kualitas yang terukur
By: M. Agung S.
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INTRODUCTION
By: M. Agung S.
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Introduction
Produksi secara massal di industri telah dimulai sejak awal abad ke-19 sejak ditemukannya mesin uap:
1. Harga turun → demand naik2. Dibutuhkan “new measures” untuk menetapkan kualitas
By: M. Agung S.
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Kenapa butuh sampling?
Tidak ada satu pun produsen yang menghasilkan 100% hasil sempurna
Kendala : Destructive test → uji amunisi oleh militer AS pada PD II → MIL-STD-105D
By: M. Agung S.
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Statistik
By: M. Agung S.
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Definisi statistik
Pengumpulan data kuantitatif (secara sistematik) mengenai suatu hal/kelompok
Ilmu yang berhubungan dengan teknik pengumpulan, tabulasi, analisis, dan interpretasi serta penampilan data kuantitatif
Cited from : Quality Control, 1998, Prof. Besterfield
By: M. Agung S.
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Statistik Analisis dapat melibatkan pengujian sekilas atau
perhitungan yang mendalam
Dua Fase dalam statistik:
1. Deductive (descriptive) : berusaha menggambarkan suatu kelompok secara utuh
2. Inductive : berusaha menggambarkannya melalui limited amount of data (sample) --> tidak ada kesimpulan absolut, istilah probability lebih pantas
Cited from : Quality Control, 1998, Prof. Besterfield
By: M. Agung S.
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Pengumpulan Data
Variables Attributes
Data diperoleh dengan pengukuran aktual pada kareakterisitik
Data yang diperoleh dengan menghitung atau konversi menjadi proporsi
30 N, 50 N, 150 N
Tablet 30-50 N, jumlah vial pecah
Cited from : Quality Control, 1998, Prof. Besterfield
By: M. Agung S.
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Types of Sampling Plan
1) Single
2) Double
3) Multiple (ANSI/ASQC z1.4 menggunakan 7 sampel)
4)Sequential : Berbeda dari ketiga sampling plan sebelumnya
Keputusan diambil setelah bukti kumulatif mencukupi
Proses sampling : item-by-item sequential sampling
Cited from : Quality Control, 1998, Prof. BesterfieldEngineering Statistics Handbook; http://www.itl.nist.gov
By: M. Agung S.
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Sequential SP
Cited from : Engineering Statistics Handbook; http://www.itl.nist.gov
By: M. Agung S.
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Sampling Plan mana yang dipilih? Tingkat tantangan bagi keempat SP tersebut
sama --> secara teori, memberikan hasil yang sama --> efektifitas sama
5 Faktor :
1. Simplicity (single vs sequential)
2. Biaya administrasi (single vs sequential)
3. Quality information in each lot (single vs sequential)
4. Number of units inspected (single vs sequential)
5. Psikologis Cited from : Quality Control, 1998, Prof. Besterfield
By: M. Agung S.
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ANSI/ASQC z1.4
By: M. Agung S.
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ANSI/ASQC z1.4
Sejarah : Dimulai oleh Bell Telephone Laboratories Awalnya, JAN-STD-105 Revisi ke-5 : MIL-STD-105E, diadopsi oleh ISO 1993 Dikembangkan sebagai draft resmi oleh USA
(ASQC) --> ANSI/ASQC z1.4
Sampling plan for lot-by-lot inspection by attributes
Accaptance Sampling Plan yang paling banyak digunakan di dunia
Cited from : Quality Control, 1998, Prof. Besterfield - Acceptance Sampling in Quality Control, 2008, Schilling and Neubaue
By: M. Agung S.
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ANSI/ASQC ?
By: M. Agung S.
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Penggunaan ANSI/ASQC z1.4
End Product Components and raw materials Operations
Materials in process --> WIP Supplies in storage Maintenance operations Data or records Administrative procedures
Cited from : Quality Control, 1998, Prof. Besterfield
By: M. Agung S.
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Sampling Plan dalam ANSI/ASQC z1.4
1)Single2)Double3)Multiple ( 7)
Standar ini tidak menyediakan Sequential Sampling Plan
Cited from : Quality Control, 1998, Prof. Besterfield
By: M. Agung S.
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Tingkat Penjaminan Kualitas
Masing-masing Sampling Plan (single // multiple) dapat diarahkan pada tingkat penjaminan kualitas yang berbeda tergantung jenis prosedur inspeksinya (ingat! Bukan level inspeksi!!).
Jenis Prosedur Inspeksi:
1. Normal (biasanya pada awal inspeksi)
2. Tightened (produk punya riwayat kualitas yang jelek atau untuk tujuan penjaminan kualitas yang ketat)
3. Reduced (produk punya riwayat kualitas yang baik atau untuk tujuan penjaminan kualitas yang longgar)
Cited from : Quality Control, 1998, Prof. Besterfield
By: M. Agung S.
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Sampling Size
Yang menentukan sampling size adalah pemilihan inspection level.
Sampling Size >> Representasi Populasi >> Inspection level ditentukan oleh otoritas yang
bertanggung jawab. Inspection level :
1. general → I, II, III
2. Special → S-1, S-2, S-3, S-4
Cited from : Quality Control, 1998, Prof. Besterfield
By: M. Agung S.
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Panduan pemilihan Inspection level
Level I : less discrimination Level II : unless other specified Level III : more discrimination S1-S4 : risiko sampling dapat
diabaikan/ditolerasnsi
Cited from : - Quality Control, 1998, Prof. Besterfield - www.uk.sgs.com
By: M. Agung S.
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AQL
Acceptable Quality Level Definisi : persentase maksimum nonconforming
yang dapat dianggap cukup memuaskan sebab hanya merupakan “process average”
“cukup memuaskan” : risiko produsen Penentuan AQL dilakukan bersama oleh pihak
terkait dalam suatu perjanjian bersama atau ada keputusan dari otoritas yang lebih tinggi.
Cited from : - Quality Control, 1998, Prof. Besterfield
By: M. Agung S.
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AQL
• Acceptable Quality Level (AQL) is the maximum percent defective that is considered satisfactory as a process average by the producer and consumer. In other words, if, on average, 4% (AQL=4.0) nonconforming product is acceptable to BOTH the producer and consumer, then the producer agrees to produce, on average, 4% nonconforming product.
By: M. Agung S.
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Panduan pemilihan AQL
1. Data historis produk
2. Pengalaman empirik
3. Percobaan (ekesperimen) mengenai berapa jumlah penyimpangan dalam 100 unit suatu produk.
4. Kapabilitas produsen
5. Permintaan Konsumen
Each Customer VS PricesCited from : - Quality Control, 1998, Prof. Besterfield
- Acceptance Sampling in Quality Control, 2008, Schilling and Neubauer
By: M. Agung S.
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Frequent Practices
Dalam buku-buku standardisasi, hanya sedikit informasi mengenai AQL yang ideal. Namun, frequent practices yang digunakan oleh industri adalah sebagai berikut:
- AQL 0.10 untuk penyimpangan critical
- AQL 1.00 untuk penyimpangan major
- AQL 2.5 untuk penyimpangan minor
Cited from : - Quality Control, 1998, Prof. Besterfield
By: M. Agung S.
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PENTING
Walaupun demikian, banyak lembaga standardisasi yang masing-masing menentukan nilai AQL yang berbeda satu sama lain.
Oleh karena itu, sebaiknya kita mengacu kepada frequent practices mengenai penetapan AQL di industri serta disesuaikan dengan kapabilitas perusahaan kita
By: M. Agung S.
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PENTING
Penjaminan Kualitas Mulai dari Bahan Baku dan pada tiap step produksi,bukan hanya testing saat End Product
KONSEP QUALITY ASSURANCE
By: M. Agung S.
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Switching The Procedures
Normal --> Tightened : 2 dari 5 (atau lebih sedikit) batch berturut2 tidak accept pada normal inspection
Tightened --> normal : 5 batch berturut2 accept pada tightened
Normal --> reduced : 10 batch beruturt2 accept Reduced --> normal : 1 batch tidak accept; 1
batch sebelumnya ditemukan defect berada di atas syarat accept namun berada di bawah syarat reject, produksi menjadi jarang
By: M. Agung S.
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Menjamin Kualitas
QA : “all aspect that collectively or individually influence product quality from design concept to consumer use” (WHO, 2004)
Konsep QA : pola pikir + kerja tim + tanggung jawab tiap orang dalam perusahaan sehingga tujuan mutu tercapai (Manajemen Farmasi Industri, 2007)
By: M. Agung S.
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Produktivitas VS Kualitas
Produktivitas akan harmonis dengan Kualitas jika --> mekanisme perbaikan mutu --> CAPA yang efektif
Peningkatan produktifitas dan kualitas secara bersamaan --> menentukan efektifitas ekspansi bisnis
Usaha : mengurangi pekerjaan “menunggu” karena status yang tidak jelas --> dibutuhkan standardisasi keputusan
By: M. Agung S.
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TERIMA KASIH
By: M. Agung S.