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LEARNING OBJECTIVES
Sistem Penjaminan Kualitas Sistem Manajemen Kualitas ISO9000
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Kualitas
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EARLIER FRAMEWORK
Demings 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.
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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
EARLIER FRAMEWORK
Obstacle to success
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EARLIER FRAMEWORK
Obstacle to success
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
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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:
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
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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 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
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QMS ISO9000
NO PRINSIP PENJELASAN
Organizations rely on customers. Organizations must understand customer needs. Organizations must meet customer requirements. Organizations must exceed customer expectations. 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. Organizations rely on people. Organizations must encourage the involvement of people at all levels. Organizations must help people to develop and use their abilities. Organizations are more efficient and when they use a process approach. Organizations must use a process approach to manage activities and related resources.
1.
Fokus pada pelanggan Bentuk kepemimpina n Libatkan semua orang Gunakan pendekatan proses
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3.
4.
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QMS ISO9000
NO 5. PRINSIP PENJELASAN 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. Organizations are more efficient and effective when they continually try to improve. Organizations must make a permanent commitment to continually improve their overall performance. Organizations perform better when their decisions are based on facts. Organizations must base decisions on the analysis of factual information and data. Organizations depend on their suppliers to help them create value. Organiz1ations must maintain a mutually beneficial relationship with their suppliers. 15
6.
Dukung peningkatan berkelanjutan Gunakan fakta sebelum memutuskan Kerjasama dengan pemasok
7.
8.
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FOUR TIERS
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KLAUSUL ISO9000
5. Management responsibility
Management committment Customer focus Quality policy Planning: Quality objectives, Quality management
system planning, Responsibility & authority, Management representative, Internal communication. Management review: General, Review input, Review output
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KLAUSUL ISO9000
6. Resource management Provision of resources Human resource: General, competence training & awareness, Infrastructure Work environment
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7. Product realization
Determination of requirement, Review of requirement, Customer communication Outputs, Review, Verification, Validation, Control of change Verification of purchased product
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KLAUSUL ISO9000
7. Product realization (lanjutan)
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8. Measurement, analysis and improvement
KLAUSUL ISO9000
QA FRAMEWORK: tiga SUB-SISTEM
CV. CSM
Proses kritis
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ALL
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
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Tanda Bukti Penerimaan Dokumen & Rekaman Tanda Bukti Penarikan Dokumen & Rekaman
End
Laporan Audit
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Laporan Audit
Menerima Dan Mengolah Hasil Penilaian Karyawan Secara Berkala Jadwal Rapat Tinjauan Manajemen
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Mengisi Formulir Umpan Balik Pelanggan Formulir Umpan Balik Pelanggan Melakukan tindakan perbaikan dan pencegahan
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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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RETURN
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LEARNING OBJECTIVES
Sistem Penjaminan Kualitas Sistem Manajemen Kualitas ISO9000
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