27/08/2013
MATERI 3a: SISTEM MANAJEMEN KUALITAS Dradjad Irianto Manufacturing Systems Research Group ITB
[email protected]
LEARNING OBJECTIVES Sistem Penjaminan Kualitas Sistem Manajemen Kualitas ISO9000
2
1
27/08/2013
EVOLUSI MANAJEMEN KUALITAS
A
B
C
Catatan: A = Inspeksi B = Pengendalian Kualitas C = Sistem Penjamin/Manajemen D = Manajemen Kualitas Terpadu
D
Kualitas 3
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 famous quotes: “There is no instant pudding.” Learn & change
4
2
27/08/2013
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
5
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.
Note that the 14 points are about change
6
3
27/08/2013
EARLIER FRAMEWORK Deadly diseases 1. 2. 3.
4. 5. 6. 7.
Lack of constancy of purpose Emphasis on short-term profits Performance evaluation, merit rating, annual reviews Mobility of management Running a company on visible figures alone Excessive medical costs for employee health care Excessive costs of warrantees
7
EARLIER FRAMEWORK Obstacle to success
8
4
27/08/2013
EARLIER FRAMEWORK Obstacle to success
9
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 More compatible to ISO 14000
10
5
27/08/2013
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
11
QMS – ISO9000 ISO 9000 series: More on ISO9000:2000 compared to ISO9000:1994
Perubahan terminologi berarti perhatian yang lebih besar pada: • Fokus pelanggan • Pendekatan berdasar proses • Peningkatan berkelanjutan • Peningkatan kualitas manusia
12
6
27/08/2013
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.
14
7
27/08/2013
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 them as a system. Organizations must use a systems approach to manage their their interrelated processes.
6.
Dukung peningkatan berkelanjutan
Organizations are more efficient and effective when they continually try to improve. Organizations must make a permanent commitment to continually improve their overall performance.
7.
Gunakan fakta sebelum memutuskan
Organizations perform better when their decisions are based on facts. Organizations must base decisions on the analysis of factual information and data.
8.
Kerjasama dengan pemasok
Organizations depend on their suppliers to help them create value. Organiz1ations must maintain a mutually beneficial relationship with their suppliers. 15
PROCESS BASED APPROACH
16
8
27/08/2013
PROCESS BASED APPROACH
17
FOUR TIERS
18
9
27/08/2013
KLAUSUL ISO9000 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
19
KLAUSUL ISO9000 6. Resource management • Provision of resources • Human resource: General, competence training & awareness, • Infrastructure • Work environment
20
10
27/08/2013
KLAUSUL ISO9000 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
21
KLAUSUL ISO9000 7. Product realization (lanjutan)
• Production & service provision:
Control, Validation, Identification & traceability, Customer property, Preservation of product
• Control of monitoring & measurement equipment
22
11
27/08/2013
KLAUSUL ISO9000 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.
23
KLAUSUL ISO9000
CV. CSM
• QA FRAMEWORK: tiga SUB-SISTEM
Proses kritis 24
12
27/08/2013
LAMPIRAN: ISO9000 AT CSM
25
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.
26
13
27/08/2013
CASE CIPTA SINERGI Mfg.
27
CASE CIPTA SINERGI Mfg. • Contoh produk:
28
14
27/08/2013
CASE CIPTA SINERGI Mfg. • Contoh proses bisnis
29
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. • Proses bisnis perusahaan perlu diubah.
30
15
27/08/2013
CASE CIPTA SINERGI Mfg.
31
CASE CIPTA SINERGI Mfg.
ALL
• Identifikasi klausul ISO9000 No
Nama
Input
Output
Ukuran/ Kriteria
Penanggung Jawab
KELOMPOK PROSES SISTEM MANAJEMEN MUTU Dokumen Manfaat bagi Wakil perusahaan perusahaan Manaje yang sah Feasibilitas men Dokumen perusahaan Mutu perusahaan mengimplementas yang terbaru ikan dokumen Efektivitas dan efisiensi dokumen yang mendukung visi misi perusahaan Rekaman Pemenuhan peraturan Wakil mutu tertulis dalam prosedur Manaje men Mutu
Sumberdaya/ Prosedur
Pasal ISO 9001:200 8
1 Pengendal ian dokumen -
Rancangan dokumen Rancangan perubahan dokumen
Prosedur 4.1 Pengendalia 4.2.1 n Dokumen 4.2.2 4.2.3
2 Pembuata n Rekaman Mutu
Formulir kosong yang sah
Prosedur 4.2.1 Pengendalia 4.2.4 n Rekaman
32
16
27/08/2013
CASE CIPTA SINERGI Mfg. • Identifikasi dokumen existing
4
DOKUMEN SISTEM MANAJEMEN MUTU CV. CIPTA SINERGI MANUFACTURING Persyaratan ISO 9001:2008 PROSEDUR MUTU PR) INSTRUKSI KERJA FORMULIR (FM) DOKUMEN Klausul 4,5 dan 6 (IK) PENDUKUNG (DP) Klausul Judul ID.Dok Judul ID.Dok Judul ID.Dok Judul ID.Dok Judul Sistem Manajemen Mutu 4.1 Persyaratan CSMProses Umum DP4.1.-01 Bisnis 4.2 Persyaratan Dokumentasi 4.2 Umum .1 4.2 Pedoman Mutu .2 4.2 Pengendalian CSM-PR4.2.3- Prosedur CSMFormulir .3 Dokumen 01 Pengendalian FM4.2.3-01 Daftar Induk Dokumen Dokumen CSMFormulir FM4.2.3-02 Tanda Bukti Penerimaan Dokumen dan Rekaman CSMFormulir FM4.2.3-03 Tanda Bukti Penarikan Dokumen dan Rekaman CSMFormulir FM4.2.3-04 Usulan Revisi Dokumen
33
CASE CIPTA SINERGI Mfg. • Proses pengendalian dokumen: Quality Assurance & IT Specialist Start
1
Menerima rancangan dokumen yang dibuat manajer departemen
2
Mengesahkan, menerbitkan, menggandakan dan mendistribusikan dokumen kepada penerima
Tanda Bukti Pemusnahan Dokumen & Rekaman
3
Tanda Bukti Penerimaan Dokumen & Rekaman Tanda Bukti Penarikan Dokumen & Rekaman
3
Menerima usulan perubahan dokumen
4
Melakukan proses revisi dokumen
5
Mengendalikan rekaman perusahaan
Usulan Revisi Dokumen
Memusnahkan dokumen dan rekaman kadaluarsa
End
Audit Mutu Internal
Laporan Audit
34
17
27/08/2013
CASE CIPTA SINERGI Mfg. • Tinjauan manajemen Customer
Quality Assurance & IT Specialist
Audit Mutu Internal
Human Resources Development & General Affairs
Laporan Audit
Menerima Dan Mengolah Hasil Penilaian Karyawan Secara Berkala Jadwal Rapat Tinjauan Manajemen 1
Menyelenggarakan Rapat Tinjauan Manajement
Karyawan perusahaan mengimplementasikan rencana perbaikan hasil rapat tinjauan manajemen
2
Risalah Tinjauan Manajemen Temuan Rapat Tinjauan Manajemen
Memantau tindakan perbaikan
3
Mengisi Formulir Umpan Balik Pelanggan Formulir Umpan Balik Pelanggan
Melakukan tindakan perbaikan dan pencegahan
35
CASE CIPTA SINERGI Mfg. Struktur prosedur: • Tujuan • Ruang lingkup • Referensi • Definisi dan Istilah • Prosedur dan Tanggung Jawab • Dokumen Terkait • Lampiran (jika ada)
36
18
27/08/2013
CASE CIPTA SINERGI Mfg. • Contoh statement “tujuan”:
37
CASE CIPTA SINERGI Mfg. • Contoh statement “ruang lingkup”
38
19
27/08/2013
CASE CIPTA SINERGI Mfg. • Contoh statement “referensi”
39
CASE CIPTA SINERGI Mfg. • Contoh statement “definisi & istilah”
40
20
27/08/2013
CASE CIPTA SINERGI Mfg. • Contoh statement butir “prosedur” 5.1
Penggunaan mesin CNC-CAD-CAM secara aman 5Manajer departemen Manufacturing Team Leader CNCCAD-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.
41
CASE CIPTA SINERGI Mfg. • Contoh statement “dokumen terkait” No. 1
Nomor Dokumen CSM-DP6.4-01
2
CSM-DP6.4-02
3
CSM-DP6.4-03
Judul Peraturan Penggunaan Mesin CNC-CADCAM Peraturan Penggunaan Mesin Konvensional Klasifikasi Api dan Alat Pemadam Kebakaran yang Sesuai
42
21
27/08/2013
CASE CIPTA SINERGI Mfg. • • • • •
Contoh Contoh Contoh Contoh Contoh
pedoman mutu prosedur lengkap: formulir instruksi kerja dokumen pendukung
RETURN 43
LEARNING OBJECTIVES Sistem Penjaminan Kualitas Sistem Manajemen Kualitas ISO9000
44
22
