MATERI 3a: SISTEM MANAJEMEN KUALITAS. Dradjad Irianto Manufacturing Systems Research Group ITB LEARNING OBJECTIVES

MATERI 3a:

SISTEM MANAJEMEN KUALITAS

Dradjad Irianto

Manufacturing Systems Research Group ITB

dradjad@mail.ti.itb.ac.id

LEARNING OBJECTIVES

Sistem Penjaminan Kualitas

EVOLUSI MANAJEMEN KUALITAS

Catatan: A = Inspeksi

B = Pengendalian Kualitas

C = Sistem Penjamin/Manajemen Kualitas

D = Manajemen Kualitas Terpadu

A

B

C

D

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SISTEM MANAJEMEN KUALITAS

• A PERSON once wrote a letter to W. Edwards Deming and asked for the formula to quality improvement.

• The person offered to pay whatever price Deming required.

• This led to what has become one Deming’s most

FRAMEWORK MANAJEMEN KUALITAS

• Earlier frameworks:

– Deming’s 14 points of quality management. – Juran’s 10 steps for quality improvement.

– Crosby’s 4 absolutes and 14 steps for improvement.

• Quality Management System model

– Process, system, tools, and teams – Standardization

• Total Quality Management Excellence model

– Deming prize, MBNQA, EFQM

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EARLIER FRAMEWORK

• Deming’s 14 points of quality management.

– Create constancy of purpose for continuous improvement. Set for tomorrow, not only for short term, but also for long term need. – Adopt and learn the new philosophy for economic stability.

– Reduce and eliminate dependence on inspection to achieve quality. – End the practice of awarding business on price tag alone.

– Improve constantly and for ever. – Institute on the job training.

– Adopt and institute modern methods of supervision and leadership. – Drive out fear, burden responsibility.

– Break down barriers between departments and individuals. – Eliminate the use of slogans, posters and exhortations. – Eliminate work standards and numerical quotas.

– Remove barriers that rob the hourly worker of the right to pride in workmanship.

– Institute a vigorous program of education and retraining.

– Define top management's permanent commitment to ever-improving quality and productivity.

EARLIER FRAMEWORK

Deadly diseases

1. Lack of constancy of purpose 2. Emphasis on short-term profits

3. Performance evaluation, merit rating, annual

reviews

4. Mobility of management

5. Running a company on visible figures alone 6. Excessive medical costs for employee health care 7. Excessive costs of warrantees

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EARLIER FRAMEWORK

Obstacle to success

EARLIER FRAMEWORK

Obstacle to success

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QMS – ISO9000

ISO 9000 series:

• ISO 9000: a set of quality management system standards.

• Tujuan: to facilitate international trade by providing a single set of standards that people everywhere would recognize and respect.

• Struktur:

Has 5 sections

QMS – ISO9000

ISO 9000 series:

First version 1987: Quality Assurance System

Revised (minor) version 1994: Quality Assurance System Revised (major) version 2000: Quality Management System Revised (minor) version 2008: Quality Management System

Management Responsibility Resource Management Product Realization

Measurement, Evaluation, and Improvement

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QMS – ISO9000

ISO 9000 series:

Perubahan terminologi berarti perhatian yang lebih besar pada: • Fokus pelanggan

• Pendekatan berdasar proses • Peningkatan berkelanjutan • Peningkatan kualitas manusia

QMS – ISO9000

ISO 9000 series:

• Delapan prinsip manajemen kualitas

1. Fokus pada pelanggan 2. Bentuk kepemimpinan 3. Libatkan semua orang 4. Gunakan pendekatan proses 5. Terapkan pendekatan sistem 6. Dukung peningkatan berkelanjutan 7. Gunakan fakta sebelum memutuskan 8. Kerjasama dengan pemasok

ISO 9001:2008 does not contain new requirements •ISO 9001:2008 only introduces clarifications to the requirements of ISO 9001:2000 based on eight years of experience of implementing the standard world wide with about one million certificates issued in 170 countries existing to date.

•It also introduces changes intended to improve consistency with ISO14001:2000 13

QMS – ISO9000

NO PRINSIP PENJELASAN 1. Fokus pada pelanggan

Organizations rely on customers.

 Organizations must understand customer needs.  Organizations must meet customer requirements.  Organizations must exceed customer expectations.

2. Bentuk kepemimpina n

Organizations rely on leaders.

 Leaders must establish a unity of purpose and set the

direction the organization should take.

 Leaders must create an environment that encourages

people to achieve the organization's objectives.

3. Libatkan semua orang

Organizations rely on people.

 Organizations must encourage the involvement of people at all

levels.

 Organizations must help people to develop and use their abilities.

4. Gunakan pendekatan proses

Organizations are more efficient and when they use a process approach.

 Organizations must use a process approach to manage activities and related resources.

QMS – ISO9000

NO PRINSIP PENJELASAN 5. _Terapkan

pendekatan sistem

Organizations are more efficient and effective when they use a systems approach.

 Organizations must identify interrelated processes and treat

themasasystem.

 Organizations must use a systems approach to manage their

theirinterrelatedprocesses.

6. _Dukung peningkatan berkelanjutan

Organizations are more efficient and effective when they continually try to improve.

 Organizations must make a permanent commitment to

continuallyimprove theiroverallperformance.

7. _{Gunakan fakta} sebelum memutuskan

Organizations perform better when their decisions are based on facts.

 Organizations must base decisions on the analysis of factual

informationanddata.

8. _Kerjasama dengan pemasok

Organizations depend on their suppliers to help them create value.

 Organiz1ations must maintain a mutually beneficial relationship

withtheir suppliers.

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PROCESS BASED APPROACH

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5. Management responsibility

• Management committment • Customer focus

• Quality policy

• Planning: Quality objectives, Quality management system planning,

• Responsibility, authority & communication: Responsibility & authority, Management representative, Internal communication.

• Management review: General, Review input, Review output

KLAUSUL ISO9000

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6. Resource management

• Provision of resources

• Human resource: General, competence training & awareness,

• Infrastructure • Work environment

7. Product realization

• Planning of product realization

• Customer-related processes:

Determination of requirement, Review of requirement, Customer communication

• Design & development:

Planning, Inputs,

Outputs, Review, Verification, Validation, Control of change

• Purchasing:

Purchasing process, Information,

Verification of purchased product

KLAUSUL ISO9000

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7. Product realization

(lanjutan)

• Production & service provision:

Control, Validation, Identification & traceability, Customer property, Preservation of product

• Control of monitoring &

measurement equipment

8. Measurement, analysis and improvement

• General

• Monitoring & measurement:

Customer

satisfaction, Internal audit, Monitoring & measurement of processes, Monitoring & measurement of product

• Control of non-conforming product

• Analysis of data

• Improvement:

Continuous improvement,

Corrective action, Preventive action.

KLAUSUL ISO9000

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KLAUSUL ISO9000

• QA FRAMEWORK: tiga SUB-SISTEM

LAMPIRAN:

ISO9000 AT CSM

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CASE CIPTA SINERGI Mfg.

• CV. Cipta Sinergi Manufacturing adalah industri logam yang berdiri sejak 1997 sbg bagian dari Inkubator Bisnis Teknik Industri ITB.

• CV. CSM mendirikan pabrik di di Jl. Kamarung No. 88B Cimahi Jawa Barat pada tahun 2001.

CASE CIPTA SINERGI Mfg.

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CASE CIPTA SINERGI Mfg.

CASE CIPTA SINERGI Mfg.

• Contoh proses bisnis

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CASE CIPTA SINERGI Mfg.

• Sistem manajemen mutu ISO 9001:2008 mengintegrasikan seluruh proses bisnis

perusahaan sehingga proses-proses tersebut dapat saling mendukung satu sama lain. • Proses-proses yang ada dalam skema proses

bisnis perusahaan belum mencakup seluruh proses yang diatur dalam sistem manajemen mutu perusahaan.

CASE CIPTA SINERGI Mfg.

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CASE CIPTA SINERGI Mfg.

• Identifikasi klausul ISO9000

No Nama Input Output Ukuran/ Kriteria Penanggung Jawab Sumberdaya/ Prosedur Pasal ISO 9001:200 8 KELOMPOK PROSES SISTEM MANAJEMEN MUTU

1 Pengendal ian dokumen - Rancangan dokumen - Rancangan perubahan dokumen - Dokumen perusahaan yang sah - Dokumen perusahaan yang terbaru - Manfaat bagi perusahaan - Feasibilitas perusahaan mengimplementas ikan dokumen - Efektivitas dan efisiensi dokumen yang mendukung visi misi - Wakil Manaje men Mutu - Prosedur Pengendalia n Dokumen 4.1 4.2.1 4.2.2 4.2.3 ALL

CASE CIPTA SINERGI Mfg.

• Identifikasi dokumen existing

DOKUMEN SISTEM MANAJEMEN MUTU CV. CIPTA SINERGI MANUFACTURING Persyaratan ISO 9001:2008

Klausul 4,5 dan 6

PROSEDUR MUTU PR) INSTRUKSI KERJA (IK)

FORMULIR (FM) DOKUMEN PENDUKUNG (DP) Klausul Judul ID.Dok Judul ID.Dok Judul ID.Dok Judul ID.Dok Judul

4 Sistem Manajemen Mutu 4.1 Persyaratan Umum CSM-DP4.1.-01 Proses Bisnis 4.2 Persyaratan Dokumentasi 4.2 .1 Umum 4.2 .2 Pedoman Mutu 4.2 .3 Pengendalian Dokumen CSM-PR4.2.3-01 Prosedur Pengendalian Dokumen CSM-FM4.2.3-01 Formulir Daftar Induk Dokumen CSM-FM4.2.3-02 Formulir Tanda Bukti Penerimaan Dokumen dan Rekaman CSM-FM4.2.3-03 Formulir Tanda Bukti Penarikan Dokumen dan Rekaman CSM-FM4.2.3-04 Formulir Usulan Revisi Dokumen 33

CASE CIPTA SINERGI Mfg.

• Proses pengendalian dokumen:

Menerima rancangan dokumen yang dibuat manajer departemen Mengesahkan, menerbitkan, menggandakan dan mendistribusikan

dokumen kepada penerima

Melakukan proses revisi dokumen Start

Menerima usulan perubahan dokumen

Mengendalikan rekaman perusahaan Memusnahkan dokumen dan rekaman

kadaluarsa 1 2 3 3 4 5 Usulan Revisi Dokumen Laporan Audit Tanda Bukti Penerimaan

Dokumen & Rekaman Tanda Bukti Penarikan Dokumen & Rekaman

Tanda Bukti Pemusnahan Dokumen & Rekaman

CASE CIPTA SINERGI Mfg.

• Tinjauan manajemen

Menerima Dan Mengolah Hasil Penilaian Karyawan Secara Berkala Menyelenggarakan Rapat Tinjauan

Manajement Audit Mutu Internal

Karyawan perusahaan mengimplementasikan rencana

perbaikan hasil rapat tinjauan manajemen Memantau tindakan perbaikan

Jadwal Rapat Tinjauan Manajemen Risalah Tinjauan Manajemen Temuan Rapat Tinjauan Manajemen

Mengisi Formulir Umpan Balik Pelanggan

Melakukan tindakan perbaikan dan pencegahan Formulir Umpan Balik

Pelanggan

Laporan Audit

1 2 3

Quality Assurance & IT Specialist Customer

Human Resources Development & General Affairs

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CASE CIPTA SINERGI Mfg.

Struktur prosedur:

• Tujuan

• Ruang lingkup • Referensi

• Definisi dan Istilah

• Prosedur dan Tanggung Jawab • Dokumen Terkait

CASE CIPTA SINERGI Mfg.

• Contoh statement “tujuan”:

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CASE CIPTA SINERGI Mfg.

CASE CIPTA SINERGI Mfg.

• Contoh statement “referensi”

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CASE CIPTA SINERGI Mfg.

CASE CIPTA SINERGI Mfg.

• Contoh statement butir “prosedur”

5.1 Penggunaan mesin CNC-CAD-CAM secara aman

5Manajer departemen Manufacturing Team Leader CNC-CAD-CAM berkewajiban untuk membuat, menetapkan, menerapkan dan mengembangkan peraturan mengenai penggunaan mesin CNC-CAD-CAM secara aman.

5Setiap operator yang menggunakan mesin CNC-CAD-CAM harus mengetahui peraturan penggunaan mesin secara aman yang telah dibuat oleh manajer departemen.

5Dokumen yang memuat informasi mengenai peraturan penggunaan mesin CNC-CAD-CAM adalah CSM-DP6.4-01 Peraturan Penggunaan Mesin CNC-CAD-CAM.

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CASE CIPTA SINERGI Mfg.

• Contoh statement “dokumen terkait”

No. Nomor Dokumen Judul

1 CSM-DP6.4-01 Peraturan Penggunaan Mesin CNC-CAD-CAM

2 CSM-DP6.4-02 Peraturan Penggunaan Mesin Konvensional 3 CSM-DP6.4-03 Klasifikasi Api dan Alat Pemadam Kebakaran

CASE CIPTA SINERGI Mfg.

• Contoh pedoman mutu

• Contoh prosedur lengkap:

• Contoh formulir

• Contoh instruksi kerja

• Contoh dokumen pendukung

RETURN

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LEARNING OBJECTIVES

Sistem Penjaminan Kualitas