Verifikasi Dan Validasi Metode Pengujian - Isran Asnawi

Mata Kuliah : Statistika dan Pengawasan Mutu Verifikasi dan Validasi Metode Pengujian Isran Asnawi S.Si, M.T.

Teknik Kimia Mineral Politeknik ATI Makassar

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Quality of Product Machine

Man

calibrated

qualified

robust skilled

Motivation

Methods

qualified

characterised documented suitable

Quality of the Reference standards

Vibrations Tempe

Irradiations

Tim e

 Analysts´ support

products

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Quality in Analytical Laboratory Analis Akomodasi & Lingkungan Pendidikan Pelatihan

Baku Pembanding, Reagensia

Pengalaman

Hasil Valid & Terpercaya

Preparasi sampel Presisi

Verifikasi Kinerja

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VALID & TERPERCAYA

Safety Pengelola & Analis

Sampel

Dokumen sistem Mutu

Sarana & Prasarana

Bahan Kimia & SRM

Metode Analisis Alat/ Instrumen

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Quality of Analytical Data Hirarki Komponen Mutu Data Analisis Internal QA (Sampel kontrol masuk rentang)

Sistem (memenuhi uji SST)

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Prosedur Analisis

Quality Assurance: ISO 17025/GLP

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Prosedur tetap metode analisis •

PROTAP tersebut bisa disusun oleh Bagian QC atau oleh Bagian R&D. Apabila PROTAP-nya belum tersedia maka harus dibuat terlebih

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Contoh metode analisis resmi (kompendium) •

•

 ASTM ( American  American Standard Testing Testing Material ) – untuk prosedur pengujian bahan material  AOAC ( Association  Association Of Of Official Analytical Chemist  Chemist ) – untuk

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 ASTM ( American  American Standard Standard Testing Testing Material ) •

 ASTM ( American  American Standard Testing Material  Material ) – adalah badan standarisasi (berpusat di amerika serikat) untuk standar teknis pengujian bahan

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Section dan Volume dalam ASTM •

Section Section 1 - Iron and Steel Steel Products Products

•

Volume 01.01 01.01 - Steel - Piping Piping,, Tubing, Fittings Fittings

•

Volume 01.02 01.02 - Ferrous Ferrous Castings; Ferroalloys Ferroalloys

•

Volume 01.03 01.03 - Steel - Plate, Sheet, Sheet, Strip, Wire; Wire; Stainless Stainless Steel Bar

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•

Section 3 - Metals Test Methods and Analytical Procedures

•

Volume 03.01 - Metals - Mechanical Testing; Elevated and Low-Temperature Tests; Metallography

•

Volume 03.02 03.02 - Wear and Erosion; Metal Metal Corrosion

•

Volume 03.03 03.03 - Nondestructiv Nondestructive e Testing

•

Volume 03.04 03.04 - Magnetic Magnetic Properties Properties

•

Volume 03.05 - Analytical Chemistry for Metals, Ores, and Related Materials (I): (I): E 32 to E 1724

•

Volume 03.06 - Analytical Chemistry for Metals, Ores, and Related Materials (II): (II): E356 to latest; Molecular Spectroscopy; Surface Analysis Section Section 4 - Construction Construction

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•

Section 5 - Petroleum Products, Products, Lubricants, and Fossil Fuels

Volume Volume 05.01 - Petroleum Petroleum Products Products and Lubricants Lubricants (I): (I): D 56 - D 2596

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•

Sectio Section n 9 - Rub Rubber ber

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•

Section 13 13 - Medical Devices Devices and Services

•

Volume Volume 13.01 - Medical Medical Devices; Emergency Emergency Medical Services Services

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