Edisi VIII-2020

04
Modul ke:

Manajemen Kualitas
Quality System
Fakultas
Teknik Dr. Ir. H. Chevy Herli Sumerli A., MT. IPM. AsKom.

Program Studi
Teknik Industri
Tujuan Pembelajaran
1.Memberikan pengetahuan dan pemahaman
tentang Perbaikan Kualitas agar dapat
menggunakan dan mengaplikasikan dalam
merancang dan memperbaiki sistem industri.
2.Memberikan kemampuan mengidentifikasi,
memformulasikan, dan mencari solusi
masalah-masalah Perbaikan Kualitas.
3.Membekali sikap dan perilaku etikal dan
profesional dalam menangani Perbaikan
Kualitas
Referensi
• Dale, Barrie G., 1994, Managing Quality
• Goetsch, David L., 2010, Quality Management for Organizational Excellent
• Evans, James R., and William M. Lindsay, 1993, The Management and Control of
Quality
• Juran, J.M., and Frank M. Gryna, 1993, Quality Planning and Analysis
• Moen, Ronald D., Thomas W. Nolan, and Lloyd P. Provost, 1991, Improving Quality
through Planned Experimentation
• Clements, Richard Barrett, 1993, Quality Manager’s Complete Guide to ISO 9000
• Peace, Glen Stuart, 1993, Taguchi Methods
• Ross, Phillip j., 1989, Taguchi Techniques for Quality Engineering
• Taguchi, Genichi, Elsayed A. Elsayed, and Thomas Hsiang, 1989, Quality
Engineering in Production System

• Beberapa web, artikel dan makalah, baik elektronik dan media cetak,
berhubungan dengan Manajemen Kualitas
Penilaian
⚫ Kehadiran di Kelas Minimal 80% Tatap Muka = Syarat Mutlak
⚫ Quiz dan/atau Keaktifan dalam Proses Pembelajaran = 20%
⚫ Tugas = 30%
⚫ Ujian Tengah Semester = 25%
⚫ Ujian Akhir Semester = 25%
Rencana Pembelajaran
PERKULIAHAN-1
Pertemuan-1 Konsep Kualitas
Pertemuan-2 Evolusi Manajemen Kualitas
Pertemuan-3 Total Quality Management
Pertemuan-4 Six Sigma
Pertemuan-5 Design For Six Sigma
Pertemuan-6 Quality System ISO 9000 Series
Pertemuan-7 Continuous Improvement

UTS

PERKULIAHAN-2
Pertemuan-8 Quality Management Tools
Pertemuan-9 Statistical Quality Control (Product Control)
Pertemuan-10 Perancangan Kualitas – QFD
Pertemuan-11 Perancangan Kualitas – FMEA
Pertemuan-12 Perancangan Kualitas – Taguchi Technique
Pertemuan-13 Quality Management Strategy
Pertemuan-14 Quality Cost

UAS
Ensuring Consistent Quality in
Mass Production: Evolution

• Standardization
• Quality control
• Quality assurance
• Quality systems
• Quality management
Quality System

A Quality Plan should be an instance of an organization’s Quality System

Quality Assurance Certification

Quality System influences Quality Standards

(ISO 9001, CMM)
Quality Manual
audit
Standards & External Body
feedback &
Procedures improve
certification
instantiates request
Project Plan x Accreditation
Quality plan x Body

Customers may require an externally reviewed quality system

ESE 11.7
Quality Systems

• Write what you do

• Do what you write
• Prove it
• Improve it
Write what you do

Identify Customers
State Vision and Purpose
Define Quality
Define Quality Attributes
Define Process
Do what you write

• Quality Attributes
Specifications
Standards
Quality control
• Process management
Define process
Standardize
Track
Control process
Prove it

• Customer satisfaction

• Quality attributes level--trend analysis and

metrics

• Process level--Audits and evaluation

Improve it

• “Corrective and Preventive Actions

• Feedback and training
• Organizational learning
Quality Program and System

• Quality Control → basic quality program

• Quality Assurance
• Quality Management

The food quality and food safety requirements

Quality Program

• In modern food manufacturing environments,

quality control systems are the supporting
programs that are outcrops of the hazard
analysis critical control point (HACCP) program.
Quality System
• An integrated set of documented food quality and
food safety activities, with clearly established inter-
relationships among the various activities.

• The objective of a quality system is to provide a food

company with the capability to produce a food that
fulfills all quality and safety requirements.
Continual Improvement
• Continuous Improvement of product quality is
a key objective of the quality system,
irrespective of the stage of the lifecycle.
• Four specific elements of the quality system
support achieving continuous improvement:
– Process performance and product quality monitoring
– Corrective action and preventative action
– Change management
– Management review of process
performance and product quality
QSM

• A quality management system (QMS) is a system that

defines operations to achieve consistency and creditability
with customers

• QMS refers to what the organization does to manage its

processes, or activities in order that the products or
services that it produces meet the objectives it has set
itself (ISO, 2004)
– ISO 9000 series (International Standards Organization
standard on quality management)
ISO 9000

• ISO 9000 is a generic standard - means that the standard can

be applied to any organization, large or small, whatever its
product in any sector of activity

• ISO is an auditable system – organization may be certified to a

market standard by outside agency (Weigers, 2001)

• ISO 9000 predominant QMS today – adopted by 149

countries/economies (ISO, 2004)
Growth of ISO 9000

• CURRENT: 1M ISO certs.

• Top 10 countries for
registrations:
– China (approx. 27%)
– Italy
– UK
– Japan
– Spain
– USA (approx. 9%)
– Germany
– Australia
– France
– South Korea

19
ISO 9000 REQUIRES :
PLAN, DO, CHECK & ACT
with CONSISTENCY :

• CUSTOMER SATISFACTION
• MANAGEMENT SUPPORTS
• RESOURCES MANAGEMENT
• PROCESS MANAGEMENT
• RESULTS ANALYSIS
• CONTINUOUS IMPROVEMENT
 Quality Plan

Quality Manual
Quality Procedures
Working Instruction
Reference Document
ISO 9000 - 20 Elements

4.1 Management Responsibility

4.2 Quality System
4.3 Contract Review
4.4 Design Control
4.5 Document & Data Control
4.6 Purchasing
ISO 9000 - 20 Elements

4.7 Control of Customer Supplied

Product
4.8 Product Identification and
Traceability
4.9 Process Control
4.10 Inspection and Test Status
4.11 Control of Inspection, Measuring and
Test Equipment.
ISO 9000 - 20 Elements
4.12 Inspection and Test Status
4.13 Control of Nonconforming
Product
4.14 Corrective & Preventive Action
4.15 Handling , Storage, Packaging,
Preservation and Delivery
4.16 Control of Quality Records
4.17 Quality Audits
ISO 9000 - 20 Elements

4.18 Training
4.19 Servicing
4.20 Statistical Techniques

26
Stages
⚫ Setting up Steering Committee
⚫ Design of Management System
⚫ Training all Staff
⚫ Setting up documentation
system
⚫ Implementation
⚫ Monitoring & Evaluation
Stages
⚫ Internal Audit & Pre-assessment audit
⚫ Certification Audit
⚫ Registration
⚫ Maintenance of the system
⚫ Internal Quality Audit
⚫ Surveillance Visit
Key Aspects of ISO Participation
• Timely – prompt response to enquiries within the accepted
timeline

• Consensus – all points of view are accepted in forming the TAG

position, majority support for the position

• Transparent – activities of the committee are open and may be

inspected by all interested parties

• Traceable – all items must be accompanied by a voting record

Timeline for Standard Development
New Work Item
1 PROPOSAL
NWIP

2 PREPARATORY Working Draft

WD
Committee Draft
3 COMMITTEE
CD

Draft International Standard

4 ENQUIRY
DIS

Final Draft International Standard

5 APPROVAL
FDIS

6 PUBLICATION Publication-International Standard

IS
34
 UNDANG-UNDANG NOMOR 20 TAHUN 2014
- STANDARDISASI DAN PENILAIAN KESESUAIAN -

Sucofindo
5 MEI 2015
 TUJUAN STANDARDISASI DAN
PENILAIAN KESESUAIAN
a) meningkatkan jaminan mutu, efisiensi produksi, daya saing
nasional, persaingan usaha yang sehat dan transparan
dalam perdagangan, kepastian usaha, dan kemampuan
pelaku usaha, serta kemampuan inovasi teknologi;
b) meningkatkan perlindungan kepada konsumen, pelaku
usaha, tenaga kerja, dan masyarakat lainnya, serta negara,
baik dari aspek keselamatan, keamanan, kesehatan,
maupun pelestarian fungsi lingkungan hidup; dan
c) meningkatkan kepastian, kelancaran, dan efisiensi transaksi
perdagangan barang dan/atau jasa di dalam negeri dan luar
negeri
(UU 20 tahun 2014: pasal 3)

36
 Contoh standar SNI
SNI produk :
- TPH : bakpia, yangko, geplak, sale pisang,
keripik sukun, rempeyek kacang dsb.
- Nak : bakso, abon, susu pasturisasi, dsb.
SNI sistem :
- SNI HACCP : 01-4852:1999
- SNI Pangan Organik : 01-6729:2002
- SNI Manajemen Laboratorium Penguji/Kalibrasi :
01-17025:2005
- SNI Sistem Manajemen Mutu : 19-9000:2000
- SNI Lembaga Inspeksi : 19-17020:1999

37
 Standar Mutu
contoh: Bakpia kacang hijau
(SNI 01-4291-1996)
• Keadaan (warna, bau, rasa)
• Air (maks 30 %)
• Jumlah gula/sakarosa (min 25 %)
• Lemak (maks 10 %)
• Protein (min 8 %)
• BTM (pemanis buatan tidak boleh ada)
• BTM (pengawet sesuai Permenkes RI)

38
 Lanjutan standar mutu bakpia…….

• Cemaran logam (Timbal=Pb, Tembaga=Cu,

Seng=Zn, Raksa=Hg)
• Arsen (maks 0,5 mg/kg)
• Cemaran mikroba (angka lempeng total,
kapang maks … koloni/g, E.coli negatif)

• Dsb (cara uji, cara pengemasan, syarat

penandaan).

39
Tugas-4 :
Buat jadwal rencana aktivitas Anda dalam 1 minggu!
(Senin-Jum’at, pagi-malam, Time Frame)

1. Buat catatan mana yang dikerjakan sesuai rencana!

2. Buat catatan mana meleset dari jadwal/bahkan tidak dikerjakan!
3. Buat catatan alasan mengapa nomor 2 terjadi!

Di-email ke: chevy.herlys@unpas.ac.id

Dengan judul : MK(kls)_Tugas4_Nama
MK(kls)_Mandiri4_Nama
 Terima Kasih
“Ya, Allah sesungguhnya kutitipkan pada-Mu
apa yang Engkau ajarkan padaku,
maka kembalikanlah kepadaku
ketika aku membutuhkan,
dan janganlah Engkau lupakan.
Ya Allah Tuhan yang menguasai sekalian alam”