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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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CASE CIPTA SINERGI Mfg
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
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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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CASE CIPTA SINERGI Mfg
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
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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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CASE CIPTA SINERGI Mfg
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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CASE CIPTA SINERGI Mfg
Contoh statement referensi
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CASE CIPTA SINERGI Mfg Contoh statement definisi & istilah
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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 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