Rangkuman UAS Rekul

Andi Ameera Sayaka C

14419027

ISO 9000

FRAMEWORK MANAJEMEN KUALITAS

- Deming’s 14 points of quality management
- Juran’s 10 steps for quality improvement
- crosby ‘s 4 absolute and 14 steps of improvement
- Feigenbaum’s total quality management
Quality Management System:
- Process, system, tools, and teams
- Assurance and standardisation (ISO 9000)
Total Quality Management Excellence Model :
- Deming prize, MBNQA, EFQM

Deming’s 14 Points:
- Create constancy of purpose for cont improvement (short term and long term)
- 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
- Insitte on the job training
- Adopt and institute modern method of supervision and leadership
 - Drive out fear, burden responsibility
- Break down barriers between departments and individuals
- Eliminate use of slogans, posters, and exhortations
- Eliminate work standards and numerical quota
- 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 permanents commitment to ever-improving quality and
productivity

QUALITY ASSURANCE
- Part of quality management, focused on providing confidence that quality
requirements will be fulfilled
- All planned and systematic activities implemented within quality system can be
demonstrated to provide confidence that a product or service will fulfil req for
quality
- Formalised business practice that define management responsibilities for
organisational structure, processes procedures and resources needle to fulfil
product/ service requirements, customer satisfaction, and continual improvement
- Formalised system that document processes, procedures, and responsibility for
achieving quality policies and objectives
- Help coordinate and direct an organizations activities to meet cust and regulatory
req and improve its effectiveness and efficiency on continuous basis

ISO 9000 Series

- A set of quality management system standards
 - Objective : facilitate international trade by providing a single set of standards that
people everywhere would recognize and respect

Prinsip ISO 9000

ISO 9000: 2008 ISO 9000:2015

Fokus pada pelanggan Customer focus

Bentuk kepemimpinan Leadership

Libatkan semua orang Engagement people

Gunakan pendekatan proses Process approach

Terapkan pendekatan sistem Improvement

Dukung peningkatan berkelanjutan Evidence based decision making

Gunakan fakta sebelum memutuskan Relationship management

Kerjasama dengan pemasok *Addition : risk management; knowledge

management; external/internal evaluation

Closed Loop
Write down what you do → justify what you do → do what is written → record → review →
revise → corrective loop
 ISO 90001 : 2008 ISO 9001 : 2015

Introduction Introduction

Scope Scope

Normative reference Normative reference

Terms and definition Terms and definition

Quality management system Context of organisation

Management responsibility leadership

Resource management Planning

Product realisation support

measurement , analysis, improvement Operations

Performance evaluations

Improvement

METHODOLOGY
1. Fully engage top management
2. Identify key process and interactions neede to meet quality objective
 3. Implement and manage the QMS and its processes using process management
techniques
4. Build your ISO 90001
5. Implement system, train company staff, verify effective operation of your processes
6. If necessary, seek a thor party certification

What To Design (Design States):

1. RnD and business ideas and development
2. Product design-prototyping testing
3. Process design selection
4. Plant layout design
5. Organizational and information system design
6. Optimizing all process and standardisation
7. Quality management system design

QMS - Metodolog Perancangan :

- Pemetaan proses bisnis perusahaan
- Peletakkan proses bisnis pada klausul ISO 900
- Lengkapi proses bisnis jika masih terdapat klausul yang belum terpetakan dan
jelaskan sesuai format manual kualitas
- Susun prosedur SOP untuk seluruh proses bisnis
- Lengkapi prosedur dengan instruksi kerja, formulir dan atau gambar
PROCESS ANALYSIS AND PROCEDURE

Process:
- Combination of input, actions, and output
- Set of interrelated or interacting activities that use inputs to deliver an inteded
result

Process mapping → schematic model for a process

Operating Process Chart (OPC)

- Instrument that visualize and analyze various system in organization
- Helps identify bottleneck in the different process
- Identifies unnecessary involvement of people
- Assist to make organization more efficient in operations

-
Rich Picture Diagram → picture about real word situation
Influence Diagram → Graphical representation for problem scenario used for decision
making

Causal Loop Diagram → depicts cause and effect relationship between various aspect,
entities or variables
Flowchart
International Definition (IDEF)
Value Stream Mapping (VSM) → lean tool that employs flow diagram documenting in
high detail every step of a process
Critical Path Mapping (CPM)
Supplier Input Process Output Customer (SIPOC)
APQC Process Mapping
Process Mapping ISO 9000

Steps in Process Mapping

1. Select a team
2. Select a process
3. Select a process : judging your selection
4. Map the primary process
5. Map alternative paths
6. Map inspections point
7. Improve process

Process Documents:
- Show how everything fits together
- Flow of work
 - Across procedures
- Across time

Procedure Documents:
- Direction on how to perform a task
- One taks
- Clear and accurate
- What the operator needs to do and how

STANDARD OPERATING PROCEDURES (SOP)

- Set of instructions having the force of directive
- Written in concise, step by step, easy to read format
- Information presented unambiguous and overly complicated
- Active voice and present verb tense
- “You” not be used, but implied
- Keep it simple and short
- Information conveyed clearly and explicitly
- Use flowchart to illustrate process

Cakupan SOP:
- Tujuan
- Kegiatan
- Pihak yang terlibat
- Peralatan yang digunakan
- Lokasi
- Dokumen terkait