This document discusses sampling procedures for inspection by attribute as outlined in ANSI/ASQC Z1.4. It provides background on why sampling is needed for quality inspection given that no producer can achieve 100% perfection. ANSI/ASQC Z1.4 is introduced as the most widely used acceptance sampling plan worldwide for lot-by-lot inspection using attributes. Key aspects of ANSI/ASQC Z1.4 covered include its use for end products, components, materials, operations and more. Acceptable Quality Level (AQL) and inspection levels are also discussed as important parameters for determining sampling size and acceptance criteria.

1. SHARING
ANSI/ASQC Z1.4
Sampling Procedure for Inspection By Attribute
By :
Muhammad Agung Sumantri
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2. By: M. Agung S.
TUJUAN
Adanya standard yang terdokumentasi dan
disusun secara sistematik


Pengambilan keputusan yang cepat dan terukur

Reduksi Subjektivitas

Sebagai parameter kualitas yang terukur
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3. By: M. Agung S.
INTRODUCTION
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4. By: M. Agung S.
Introduction
Produksi secara massal di industri telah dimulai
sejak awal abad ke-19 sejak ditemukannya mesin
uap:
1. Harga turun → demand naik
2. Dibutuhkan “new measures” untuk menetapkan
kualitas
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5. By: M. Agung S.
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
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6. By: M. Agung S.
Statistik
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7. By: M. Agung S.
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
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8. By: M. Agung S.
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
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9. By: M. Agung S.
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
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10. By: M. Agung S.
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. Besterfield
Engineering Statistics Handbook; http://www.itl.nist.gov
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11. By: M. Agung S.
Sequential SP
Cited from :
Engineering Statistics Handbook; http://www.itl.nist.gov
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12. By: M. Agung S.
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
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13. By: M. Agung S.
ANSI/ASQC z1.4
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14. By: M. Agung S.
ANSI/ASQC z1.4
Sampling plan for lot-by-lot inspection by
attributes
Accaptance Sampling Plan yang paling banyak
digunakan di dunia
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
Cited from : Quality Control, 1998, Prof. Besterfield
- Acceptance Sampling in Quality Control, 2008, Schilling and Neubaue
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15. By: M. Agung S.
ANSI/ASQC ?
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16. By: M. Agung S.
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
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17. By: M. Agung S.
Sampling Plan dalam ANSI/ASQC z1.4
1)Single
2)Double
3)Multiple ( 7)
Standar ini tidak menyediakan Sequential Sampling Plan
Cited from : Quality Control, 1998, Prof. Besterfield
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18. By: M. Agung S.
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
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19. By: M. Agung S.
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
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20. By: M. Agung S.
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
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21. By: M. Agung S.
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
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22. By: M. Agung S.
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.
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23. By: M. Agung S.
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 Prices
Cited from : - Quality Control, 1998, Prof. Besterfield
- Acceptance Sampling in Quality Control, 2008, Schilling and Neubauer
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24. By: M. Agung S.
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
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25. By: M. Agung S.
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
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26. By: M. Agung S.
PENTING
Penjaminan Kualitas Mulai dari Bahan Baku dan
pada tiap step produksi,
bukan hanya testing saat End Product
KONSEP QUALITY ASSURANCE
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27. By: M. Agung S.
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
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28. By: M. Agung S.
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)
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29. By: M. Agung S.
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
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30. By: M. Agung S.
TERIMA KASIH