materi 3a - ti3201 - qc- smm-iso9000-2013

8/13/2019 MATERI 3a - TI3201 - QC- SMM-ISO9000-2013

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MATERI 3a:SISTEM MANAJEMEN KUALITAS

Dradjad IriantoManufacturing Systems Research Group [email protected]

LEARNING OBJECTIVES

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Sistem Penjaminan KualitasSistem Manajemen Kualitas ISO9000


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EVOLUSI MANAJEMEN KUALITAS

Catatan:A = InspeksiB = Pengendalian KualitasC = Sistem Penjamin/Manajemen KualitasD = 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 qualityimprovement.

The person offered to pay whatever priceDeming required.

This led to what has become one Demings mostfamous quotes: There is no instant pudding .

Learn & change

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FRAMEWORK MANAJEMEN KUALITAS

Earlier frameworks: Demings 14 points of quality management. Jurans 10 steps for quality improvement. Crosbys 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 Demings 14 points of quality management.

Create constancy of purpose for continuous improvement. Set fortomorrow, 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.

Note that the 14 points are about change 6


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EARLIER FRAMEWORK

Deadly diseases1. Lack of constancy of purpose2. Emphasis on short-term profits3. Performance evaluation, merit rating, annual

reviews4. Mobility of management5. Running a company on visible figures alone6. Excessive medical costs for employee health care

7. Excessive costs of warrantees

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EARLIER FRAMEWORKObstacle to success

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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 sectionsMore compatible to ISO 14000

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QMS ISO9000

ISO 9000 series:First version 1987: Quality Assurance SystemRevised (minor) version 1994: Quality Assurance SystemRevised (major) version 2000: Quality Management SystemRevised (minor) version 2008: Quality Management System

Management ResponsibilityResource ManagementProduct RealizationMeasurement, Evaluation, and Improvement

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QMS ISO9000

ISO 9000 series:

Perubahan terminologi berartiperhatian yang lebih besar pada: Fokus pelanggan Pendekatan berdasar proses Peningkatan berkelanjutan Peningkatan kualitas manusia

More on ISO9000:2000 compared to ISO9000:1994

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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 notcontain new requirements ISO 9001:2008 onlyintroduces clarifications tothe requirements of ISO9001:2000 based on eightyears of experience ofimplementing the standardworld wide with about onemillion certificates issued in

170 countries existing todate. It also introduces changesintended to improveconsistency withISO14001:2000

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QMS ISO9000

NO PRINSIP PENJELASAN

1. Fokus padapelanggan

Organizations rely on customers. Organizations must understand customer needs.Organizations must meet customer requirements.Organizations must exceed customer expectations.

2. Bentukkepemimpina

n

Organizations rely on leaders. Leaders must establish a unity of purpose and set thedirection the organization should take.

Leaders must create an environment that encouragespeople to achieve the organization's objectives.

3. Libatkansemua orang

Organizations rely on people. Organizations must encourage the involvement of people at alllevels.Organizations must help people to develop and use their abilities.

4. Gunakanpendekatanproses

Organizations are more efficient and when they use a processapproach.

Organizations must use a process approach to manage activitiesand related resources.

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QMS ISO9000

NO PRINSIP PENJELASAN5. Terapkan

pendekatansistem

Organizations are more efficient and effective when they use asystems approach.

Organizations must identify interrelated processes and treatthem as a system.Organizations must use a systems approach to manage theirtheir interrelated processes.

6. Dukungpeningkatanberkelanjutan

Organizations are more efficient and effective when theycontinually try to improve.

Organizations must make a permanent commitment tocontinually improve their overall performance.

7. Gunakan faktasebelum

memutuskan

Organizations perform better when their decisions are basedon facts.

Organizations must base decisions on the analysis of factualinformation and data.

8. Kerjasamadenganpemasok

Organizations depend on their suppliers to help them createvalue.

Organiz1ations must maintain a mutually beneficial relationshipwith their suppliers.

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PROCESS BASED APPROACH

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PROCESS BASED APPROACH

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FOUR TIERS

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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, Reviewoutput

KLAUSUL ISO9000

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6. Resource management Provision of resources Human resource: General, competence

training & awareness, Infrastructure Work environment

KLAUSUL ISO9000

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7. Product realization Planning of product realization Customer-related processes:

Determination of requirement, Review ofrequirement, Customer communication

Design & development: Planning, Inputs,Outputs, Review, Verification, Validation, Control ofchange

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

KLAUSUL ISO9000

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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

Proseskritis

CV. CSM

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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 dariInkubator Bisnis Teknik Industri ITB.

CV. CSM mendirikan pabrik di di Jl. KamarungNo. 88B Cimahi Jawa Barat pada tahun 2001.

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CASE CIPTA SINERGI Mfg

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CASE CIPTA SINERGI Mfg Contoh produk:

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Contoh proses bisnis

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CASE CIPTA SINERGI Mfg Sistem manajemen mutu ISO 9001:2008

mengintegrasikan seluruh proses bisnisperusahaan sehingga proses-proses tersebutdapat saling mendukung satu sama lain.

Proses-proses yang ada dalam skema prosesbisnis perusahaan belum mencakup seluruhproses yang diatur dalam sistem manajemenmutu perusahaan.

Proses bisnis perusahaan perlu diubah.

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CASE CIPTA SINERGI Mfg Identifikasi klausul ISO9000

No Nama Input Output Ukuran/ Kriteria Penanggung

Jawab Sumberdaya/

Prosedur

Pasal ISO9001:200

8 KELOMPOK PROSES SISTEM MANAJEMEN MUTU

1 Pengendaliandokumen

- Rancangandokumen

- Rancangan perubahandokumen

- Dokumen perusahaanyang sah

- Dokumen perusahaanyang terbaru

- Manfaat bagi perusahaan

- Feasibilitas perusahaanmengimplementasikan dokumen

- Efekt ivit as danefisiensi dokumenyang mendukungvisi misi

perusahaan

- WakilManajemenMutu

- ProsedurPengendalian Dokumen

4.14.2.14.2.24.2.3

2 PembuatanRekamanMutu

- Formulirkosongyang sah

- Rekamanmutu

Pemenuhan peraturantertulis dalam prosedur

- WakilManajemenMutu

- ProsedurPengendalian Rekaman

4.2.14.2.4

ALL

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http://localhost/var/www/apps/conversion/tmp/scratch_9/Pengelompokan%20proses%20bisnis%20CV%20CSM.xlsxhttp://localhost/var/www/apps/conversion/tmp/scratch_9/Pengelompokan%20proses%20bisnis%20CV%20CSM.xlsx


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Identifikasi dokumen existingDOKUMEN SISTEM MANAJEMEN MUTU CV. CIPTA SINERGI MANUFACTURING

Persyaratan ISO 9001:2008Klausul 4,5 dan 6

PROSEDUR MUTU PR) INSTRUKSI KERJA(IK)

FORMULIR (FM) DOKUMENPENDUKUNG (DP)

Klausul Judul ID.Dok Judul ID.Dok Judul ID.Dok Judul ID.Dok Judul 4 Sistem

Manajemen Mutu4.1 Persyaratan

UmumCSM-DP4.1.-01

ProsesBisnis

4.2 PersyaratanDokumentasi

4.2.1

Umum

4.2.2

Pedoman Mutu

4.2.3

PengendalianDokumen

CSM-PR4.2.3-01

ProsedurPengendalianDokumen

CSM-FM4.2.3-01

FormulirDaftar IndukDokumen

CSM-FM4.2.3-02

FormulirTanda BuktiPenerimaanDokumendan Rekaman

CSM-FM4.2.3-03

FormulirTanda BuktiPenarikanDokumendan Rekaman

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CASE CIPTA SINERGI Mfg Proses pengendalian dokumen:

Menerima rancangan dokumen yangdibuat manajer departemen

Mengesahkan, menerbitkan,menggandakan dan mendistribusikan

dokumen kepada penerima

Melakukan proses revisi dokumen

Audit Mutu Internal

Start

Menerima usulan perubahandokumen

Mengendalikan rekaman perusahaan

Memusnahkan dokumen dan rekamankadaluarsa

End

1

2

3

3

4

5

Usulan RevisiDokumen

Laporan Audit

Tanda Bukti PenerimaanDokumen & Rekaman

Tanda Bukti PenarikanDokumen & Rekaman

Tanda Bukti PemusnahanDokumen & Rekaman

Quality Assurance & IT Specialist

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Tinjauan manajemen

Menerima Dan Mengolah HasilPenilaian Karyawan Secara Berkala

Menyelenggarakan Rapat TinjauanManajement

Audit Mutu Internal

Karyawan perusahaanmengimplementasikan rencana perbaikan hasil rapat tinjauan

manajemen

Memantau tindakan perbaikan

Jadwal RapatTinjauan Manajemen

Risalah TinjauanManajemen

Temuan RapatTinjauan Manajemen

Mengisi Formulir Umpan BalikPelanggan

Melakukan tindakan perbaikan dan pencegahanFormulir Umpan Balik

Pelanggan

Laporan Audit

1

2

3

Quality Assurance & IT SpecialistCustomerHuman Resources

Development &General Affairs

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CASE CIPTA SINERGI MfgStruktur prosedur: Tujuan Ruang lingkup Referensi Definisi dan Istilah Prosedur dan Tanggung Jawab Dokumen Terkait Lampiran (jika ada)

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Contoh statement tujuan:

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CASE CIPTA SINERGI Mfg Contoh statement ruang lingkup

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2


Contoh statement referensi

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CASE CIPTA SINERGI Mfg Contoh statement definisi & istilah

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2


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 mengenaipenggunaan mesin CNC-CAD-CAM secara aman.

5Setiap operator yang menggunakan mesin CNC-CAD-CAM harusmengetahui peraturan penggunaan mesin secara aman yang telahdibuat oleh manajer departemen.

5Dokumen yang memuat informasi mengenai peraturan penggunaanmesin CNC-CAD-CAM adalah CSM-DP6.4-01 Peraturan PenggunaanMesin 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 Kebakaranyang Sesuai

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Contoh pedoman mutu Contoh prosedur lengkap : Contoh formulir Contoh instruksi kerja Contoh dokumen pendukung

RETURN

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LEARNING OBJECTIVES

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Sistem Penjaminan KualitasSistem Manajemen Kualitas ISO9000
http://localhost/var/www/apps/conversion/tmp/scratch_9/Lampiran%201%20-%20Pedoman%20Mutu.pdfhttp://localhost/var/www/apps/conversion/tmp/scratch_9/Lampiran%203%20-%20Prosedur%20Mutu.pdfhttp://localhost/var/www/apps/conversion/tmp/scratch_9/Lampiran%204%20-%20Formulir%20Dalam%20Format%20Hardcopy.pdfhttp://localhost/var/www/apps/conversion/tmp/scratch_9/Lampiran%206%20-%20Instruksi%20Kerja.pdfhttp://localhost/var/www/apps/conversion/tmp/scratch_9/Lampiran%207%20-%20Dokumen%20Pendukung.pdfhttp://localhost/var/www/apps/conversion/tmp/scratch_9/Lampiran%207%20-%20Dokumen%20Pendukung.pdfhttp://localhost/var/www/apps/conversion/tmp/scratch_9/Lampiran%206%20-%20Instruksi%20Kerja.pdfhttp://localhost/var/www/apps/conversion/tmp/scratch_9/Lampiran%204%20-%20Formulir%20Dalam%20Format%20Hardcopy.pdfhttp://localhost/var/www/apps/conversion/tmp/scratch_9/Lampiran%203%20-%20Prosedur%20Mutu.pdfhttp://localhost/var/www/apps/conversion/tmp/scratch_9/Lampiran%201%20-%20Pedoman%20Mutu.pdf

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