Agust-2019-1-Introduction-Development of QMS

Internationally Approved Food Technology Program by IFT and IUFoST
ITP430
Food Quality Assurance
: Dr.Ir.M.Arpah, MSi Dr.Ir. Fahim M. Taqi
Dr.Ir.Adil Basuki Ahza, MSc Dr Ing. Aziz Boing S, MSc
Dr.Ir. Tjahja Muhandri
Food Technology Study Program
Department of Food Science and Technology
Bogor Agricultural University
Topic
Week Topic P1 P2 P3
1 Introduction: development of quality management Mar Tmu Abs
system, concepts of quality, definition of quality and
food quality
2 Intrinsic & Extrinsic key quality characteristics of Mar Tmu Abs
food
3 Standard and specification Mar Tmu Aba
4 Quality tools for controlling variations and Mar Fmt Aba
fluctuations
5 Quality tools for collecting, organizing, analyzing Mar Fmt Aba
data
6 Variable Control Charts & Process capability Mar Fmt Mar
7 Attribute Control Charts Mar Fmt Mar
UTS TIM
Topic
Week Topic P1 P2 P3
8 Acceptance Sampling Tmu Fmt Abs
9 Quality inspection, examination, measurement, Tmu Fmt Abs

analysis, and control
10 Quality management systems and their principles Fmt Tmu Aba
11 Quality management systems and their certification Fmt Tmu Aba

scheme
12 Food quality assurance scheme and Legal aspect of Fmt Tmu Aba
food quality assurance in Indonesia
13 Quality Audit Mar Tmu Mar
14 Quality Cost Mar Fmt Mar
UAS

Topic 1. Introduction: Development of Quality
Management System, Concepts of Quality, Definition of
Quality and Food Quality
1.1 Development of quality
management system
1.2 Definition of quality and food

quality
1.3 Concepts of quality
1.4. Juran Trilogy

Course Learning Outcomes :
After completing this course, students will be able to
 Describe quality concept development and use terms
in quality management system, describe Juran
trilogy.
 Explain definitions of quality, quality concepts and
food quality

Quality : Sometimes Beyond
Safety: Mandatory, Safety, Delighting
Well regulated, Consumers/Satisfaction,
Controlled by Gov. Mostly voluntary, Compromise
Uncompromise (price)
Quality &
E.Coli, Toxin &
Micotoxin, toxic Safety Limit Comply with
standards used Int or Ext
metal, pathogenic
microbes (might be industrial
Limitless, level, national or
detection limit International standard).
Could
Internationally Approved Food Technology Program by IFT and IUFoST be designed.
Quality design
Raw material quality
Quality Process Quality
Food Packaging quality
Final product quality
There is no Food Safety Design
Safety of raw materials
Safety Safety during Process Production
Safety of Final Products
Safety of Packaging
< 10 cfu,
Both have
parameters
121oC 30 minutes,
Protein > 3.5 %;
ALL PARAMETERS : Will vary naturally,
1 unnaturally, fluctuation, How much tolerable
variation ?, How to find the source of variations ?
VARIATIONS : Natural (standard error) systematic

2 error (human error, equipment error,
measurement error)
LIMITS : What is the target value, how to define

3 the target value ?, Upper control limit, lower
control limit, Upper & Lower Specification limits

1 Deals with Parameters : their variations and limits
Technical activities, Their tools are Lab analysis equipments,

2
measurements and laboratory instruments
Establish the limit values and standardized the values or fixed

3
the values on a given standard
4 Continuously control and correct quality and safety

parameters at their target value, detect fluctuation
Continuously record the measurement results and parameters

5 analysis results to be further analyzed in quality assurance
activities
1 Deals with Parameters : their variations and limits
Find the source of variations, Solve the problem of variations,

2 control the target value. Their tools are 7 Quality Tools and
Auditing activities
Establish the limit values (Ucl, Lcl, Usl, Lsl), control the limit
3 values
Continuously planning, controlimg and developping quality

4 parameters and correct quality and safety parameters at their
target value, detect fluctuation
Manage the quality and safety (mostly by applying) QMS to
5 assure the final products comply with standards and
regulations
• Level 1: Application of GMP
• Level 2: Application of GMP and HACCP
Safe Quality • Lavel 3: Application of HACCP and QMS (ISO 9001-2015), FSSC 22000
Food
•Lowest Level : Inspect Quality (Inspect final products)

•2nd Level: Control Quality (raw material, production process, final product)
•3 rd Level: Quality Assurance (entire production)
•4th Level: Manage Quality & Certification (apply QMS: ISO 9001, MBNQW, Six
Quality Sigma, Deming Prize, EFQM): a TQM
Management •5th Level: Continuous Improvement : apply 2 or more QMS, Sustain, Adapt to
change, Excellent Organization
• Product & Process Characteristics: Key Quality Parameters & Characteristics

• Quality tools: Statistical quality & process control tools, management tools
Elements of
QA & QM • Government Regulation: regarding standards and specifications

Management
Regulations,
Characteristics
Processing
Standard,
resources
methods
Product
QMS
Quality Assurance Principles
ZERO DEFECT
Consumer Satisfaction
Topic 1: Development Of Quality Management System –
Concept of Quality
A. QMS IN HISTORY: THEORY AND ITS APPLICATION (EVOLUSI

SISTEM MANAJEMEN MUTU :TEORI DAN PENERAPAN)
B. DEFINITION OF QUALITY (PENGERTIAN MUTU)
C. QUALITY CONCEPT (KONSEP MUTU)

D. DEFINITION OF FOOD QUALITY (PENGERTIAN MUTU
PANGAN)

A. QMS IN HISTORY: THEORY AND ITS APPLICATION
Early Human Life (ANCIENT TIME)

 Each individual / family to meet their own lives
 Inefficient because each individual might has excess food
 Quality issues ? Not considered ?
BREAD
BAKING
DRY CORN OVER ROLLING
BATTER STONE
HAND
MILLED

 Mutually beneficial cooperation (barter)

 Commodities (goods) >< commodities
 goods >< services
 Early economic transactions
 Qualities was an agreement tools among
individuals to trade goods or services without the
exchange of money at this time of bartering
1. Early Development of Quality Management System
  5000 years ago
 Historical evidence
 Nebuchadnezzar of Babylon (602-502 BC)
 Specifications: construction food,
etc.
 In China (1644 BC) Specification of
ceramics
 Quality expressed qualitative Specifications
 1700 M, custom labeling became popular
(several manufacturers for one kind of
product)
1800s, Fraud prevention law

Until the End of the 19th Century, concept of Quality

Management System, Not Much Changed
PRINCIPLES :
 Quality inspection by consumers
 Worker skill is related to Quality
(Craftsmanship)
 Labeling (branding, reputation)
 Limited niche, narrow market
The first trade show, 1851 di Crystal Palace,London

2. Early Development of Quality Management System
 Development of the quality management
system is influenced by the following factors:
 Increase in production scale
 complexity of the production process
 development of customer requirements
 Advancement of technology

Second Trade Show, 1889 , Eiffel Third Trade Show 1893 di Chicago, Fourth Trade Show 1900,
Tower Illinois Paris
Progressing, mainly due to the early trade fairs in time of industrial

revolution
 Significant changes in the development of the quality
management system implementation, happens
almost every 20 years during the 20th century.
Evolution TQM
Quality
Assurance
Inspection
Foremen OFIQT
Operator
1900 1918 1937 1960 1980

Operator (Peralatan dan Mutu)

OFIQT
 Quantity of production is relatively small
 One worker (small groups of worker) to make the
products
 Controlling the entire process (purchase of
materials, measuring, etc.)
 Inspecting raw materials as well as final products
 Often called craftsmanship, craftsmen
Foremen
OFIQT
 Total production began to increase
 Workers are grouped, and directed by a
foreman
 The foreman did not “really” work (He is not
an operator)
 Foreman paid higher than workers
 The beginning of the concept of large-scale
manufacturing
Inspection Quality Control
OFIQT
 During World War I, increasingly complex
manufacturing systems
 Larger-scale production needed
 Inconsistancy in product quality, problem of
"variation“ in products
 "Full Time Inspector" required
 inspection (examination) more ordered,
systematized and organized and separated
from the “production”
Use of quality tool : Statistics (Quality
Control) to overcome variations
OFIQT
 In World War II, a mass production inevitable
 Full time inspector is not enough
 inspecting all products one by one (100% impossible)
 Use sampling techniques
 "Sampling" and "Control Chart" introduced and
initiated by Walter A. SHEWART in the 1930s and further
developed by Deming
Progressing to :
Quality Assurance
 In the 1960s, a progress from quality control to a
system of quality assurance (new paradigm) From
to “Control” progressing to for “assuring”
 Old concept (paradigm) control only apply at the
production department, but “to ensure” required
the involvement of all departments
 Introduction (Use) of management tools
 At the start a concept called "Total Quality Control"
emerging, but ultimately TQM more appropriate
(incorporation of managerial theories and
application in to quality theory)
Total Quality Management ( TQM )

OFIQT
 the initial concept of TQC, developed by Armand V.
Feigenbaum (General Electric) in the 1960s
 Expanding the responsibilities of quality from merely
"production department" to all departments within
the company
 Applied in Japan: shared responsibility by all
employees (formation of quality control circle GKM),
then Company Wide Quality Control (CWQC), 1968
 The final form is a “standardized” TQM: ISO-9001
(starting in1987). Currently it has been revised 4
times, ISO 9001  2008  2015
Iso 1987

3. Quality Management System Development in Japan
 After World War II, Japan's products have low-quality,
eventually low prices
 During 1950s Deming helped Japanese applying Statistical
Proces Control (SPC) and problem solving techniques
(PDCA Cycle)
 1954, J.M. Juran trained chief executive officer (CEO) of
Japanese companies
 1956: radio series (13 weeks) to train supervisors, 1959: a
weekly TV series for Foremen prepared by ISHIKAWA,
1962: the Gemba to Quality Qontrol magazine published.
May, the first application of QCC (Gugus Kendali Mutu)
 In 20 yrs (1982), there are 148,106 QCC (GKM) with
1,305,780 members
 1968, CWQC formed
Internationally byTechnology
Approved Food ISHIKAWAProgram by IFT and IUFoST
QCC or GKM ? Need Further
explanation ?
A small group of employees (usually work in the same areas, and
voluntarily meet on a regular basis to identify, analyze and solve their
problems) come together to discuss with the management, issues
related to either quality control or improvement in production
methods forming a Quality Control Circle (QCC).
It is said that 95% of the problems in workshops can be solved
through quality control tools. The quality control tools use for QCCs
are Pareto Diagrams, Cause-and-Effect Diagrams, Check Sheets,
Histograms, Scatter Diagrams, Graphs and Control Charts. Also,
logical thinking and experience for solving problems.

Benefits of introducing a QCC program in the work place
1. Heightened quality awareness reveals faults in the system,
It improves the quality products and services.
2. The people who are part of the quality control feel a sense
of ownership
3. Higher yields and lower rejection rates as a result of
enhanced job satisfaction for workers, which in turn drives
them to contribute more.
4. A quality control circle program also brings about improved
two-way communication between the staff and the
management.
5. The financial benefits exceed the costs of implementing the
program. Internationally Approved Food Technology Program by IFT and IUFoST
3. Quality management System Development in Korea
 Korea emulate (imitate) Japan’s development model
 Starting promoon the importance of quality in 1962
 Activities on a regular basis quality: Government agencies,
education / training, development / coaching QCC-GKM,
magazines, congresses, workshops
 In 1978, the Korean Standards Association (KSA) has
trained 300,000 workers, 110,000 QCC, 572 certificates
given to the industrial companies.
 Since 1978, the promotion of quality has shifted from
government agencies to the private company. November
established as the month of Q
4. Quality Management System Development in USA
 Initially, USA follows the European (trade skills 
craftsmanship  craftsmen
 Then First Step: The Industrial Revolution in Europe  created
a fabrication system  artisan  factory workers ; final product
inspection, Secondly: Taylor System  late 19th century,
separating the concepts of planning and implementation
(Scientific Management)
 productivity increases
 negative impact on quality (not all products inspected)
 centralized Q inspection department (Chief Inspector), use of
Statistics tools

4. Quality Management System
Development in USA
 World War II (1940) Mass production quality decreased

(Delivery Time  priority)
 1960 TQC concept (Feigenbaum), but "scientific
management approache" is difficult to remove
 1970 Japan better (in terms of what?) In electronic products,
automobiles, machinery, etc..
 1980  Starting to implement Japanese quality practices
(GKM, KAIZEN, Just in Time, House of Quality)
 1987  1987 NIST introduced Malcolm Balridge Quality
Award at about the same time with ISO (International)
5. Quality Management System
Development in Indonesia
 Lack of information on the early development stages of
those countries.
 As if directly to International stages: TQM/ISO-9001
 Emphasis on dev of government agencies (Korean model)
 Create standards, up to 1983 has formulated 1500
standards (SII, SP, SPI)
 1984 establish DSN, but its position, main tasks, functions
and compositions, later on 1989, KAN for accreditation and
certification.
 Main activities : SII
SP SNI
SPI
 1998: DSN  BSN
 1992: KAN (Komite Akreditasi Nasional)
 part of BSN
 Certification (quality systems, environmental
management, products, HACCP, training) accreditation
for Certification body
 The number of the Certification Body (2002)
 quality systems : 14 buah
 personnel : 5 buah
 environmental management : 3 buah
 HACCP : 2 buah
 November: as the month of Q (since 1992)
 2001 : - ISO-9001 Certification : 384 perusahaan
- ISO-14000 Certification : 21 perusahaan
B. Definition of quality and food quality
J. M. Juran (1974)
(“Quality is conformance to requirements not goodness”)
Kualitas atau mutu adalah kesesuaian dengan keperluan
(kegunaan) bukan kebagusan.
Phillip B. Crosby (1979)

(Quality is conformance with expectations of the consumer)
Kualitas atau mutu adalah kesesuaian dengan keinginan

H. D. Seghezzi (1979)
(“The degree to which a product or service is fit for the specified
use”) Derajat kesesuaian suatu produk atau jasa dengan
penggunaanya yang bersifat spesifik.
A.V. Feigenbaum (1983)

(“The total composite product and service characteristics of
marketing engineering, manufacture, and maintenance through
which the product and service meet the expectation by the
customer”). Gabungan dari semua faktor pada produk dan jasa,
baik pada pemasaran, peralatan yang digunakan , proses
pengolahan dan pemeliharaan, yang diharapkan dapat memenuhi
keinginan konsumen.
International Standard ISO

(“The totality of features and characteristics of a product that
bear on its ability to satisfy stated or implied needs”)
Keseluruhan sifat atau karakteristik pada suatu produk yang
menunjukkan kemampuan produk tersebut untuk memuaskan
kebutuhan yang sesuai dengan tujuan produk.
Menurut Kamus Webster’s

 A usually high level of merit or superiority Synonyms: caliber,
merit, stature, value, virtue, worth
 Degree of excellence
Synonyms caliber, class, grade
Gov Decree No. 28, 2004: Regardimg Safety, Quality and Nutrition of
Food. Quality of food is “the value” determined on the basis of
“safety criteria”, “nutrional contents” and conformance with
“trade regulation and standards” for raw foods, foods and drink.
Key values: safety, nutritinal contents, trade regulation/standards
PP NOMOR 28 TAHUN 2004 TENTANG KEAMANAN, MUTU DAN GIZI

PANGAN Mutu pangan adalah nilai yang ditentukan atas dasar
kriteria Keamanan pangan, kandungan gizi, dan standar
perdagangan terhadap bahan makanan, makanan dan minuman.
Key Word: Keamanan pangan, Kandungan gizi, Standar
perdagangan
C. Quality Concept
Green (1994): 6 Konsep

1 Mutu sebagai kebagusan (goodness). This concept
emphasises highlevel standards
Mutu sebagai kesesuaian dengan kegunaan (fitness
2
for use), This concept emphasises achievement of the
planned objectives )
3 Mutu sebagai suatu batasan minimal (meet minimum
specifications), This concept emphasises meet
standards)

C. Quality Concept
6 Konsep Mutu
4 Mutu sebagai nilai tambah (added value). This concept
emphasises the value
Mutu sebagai suatu nilai uang (Quality as value for
5
money), focus on efficiency. It measures outputs against
inputs
6
Mutu sebagai kepuasan konsumen (Satisfaction of the
client), quality is described as: "something has quality
when it meets the expectations of the consumer; quality
is the satisfaction of the client".
C. Juran Trilogy

C. Juran Trilogy
Quality planning Quality control Quality improvement
Establish quality Evaluate actual Prove the need

goals performance
Identify who the Compare actual Establish the
customers are performance with infrastructure
quality goals
Determine the needs Act on the Identify the
of the customers difference improvement projects
Develop product Establish project

features that teams
respond to customers’
needs

C. Juran Trilogy
Quality planning Quality control Quality improvement
Develop processes Provide the teams

able to produce the with resources,
product features training, and
motivation to:
Establish process Diagnose the causes
controls; transfer Stimulate remedies
the plans to the Establish controls to
operating forces hold the gains

Stages of Quality Movement
Small Q versus Inspection Quality Quality Strategic Competitive
Big Q Control Assurance Quality Continuous
(SPC) Management Improvement
1. Scope
2. Action
3. Primary Concern
4. Focus
5. Orientation
6. What to Measure
7. Target
8. Key Responsibilities
9. Operating Philosophy
10. Methods & Concepts

C
h
a Scope Product Process Total Quality Excellent-
sustainable
r Quality Quality
organisation
a
c Action Reactive to quality problems Proactive or preventing Flexible,
t quality failure Responsive,
Adapt
e
quickly to
r changes
i
s Primary Inspection Detection Coordination Strategic Continuous
t Concern impact Improvement
i Focus Conformance Conformance Total customer Customer Continuously
C to to customer satisfaction: comes first: add value to
s specification requirements/e product, process, strategic and organization's
system assurance stakeholders
ngineering management
description
C
h
a Orientation "Inspect" "Control" "Build in" "Manage" "CI in"
r quality quality quality quality quality
a
c Measure Finished In-process Entire Quality Stakeholder
t goods measureme production managemen satisfaction
e nt chain t
r System
i Target Specificatio Achieve AQL Zero Defect
s n
t
i Key Inspector Quality Active involvement of entire
C Respon department organization
s sibilities
Operating Craftsman mass flexible specialization
Philosophy mass customizati
C Methods & Gauging and Statistics: SPC Management CQI by Self
h Concepts measurement Sampling Plan practice: integrating assessment
a Process QCC, TQC, management (MBNQA,
r Improvement TQM practice EFQM, Deming
a Reduce waste (Kaizen) with process prize,
c & cost Control Plan improvement Balanced
t JIT Capability ISO9000 Scorecard)
e Do It Right study series
Benchmarking
r the First DOE, MSA, Six Sigma
Product
i Time FMEA Re-
&process
s design
Engineering (QFD, Design
t Lean for six sigma-
i production DFSS)
C Advanced
s statistics

Brief Summary:
1. Rapid progress in quality theory after the Industrial Revolution, Taylor
systems on division of labor, trade show
2. Rapid progress in application after world war II (mass production),
after incorporation of the statistical method (as tools), Sampling
techniques
3. Japan and Korea were “the arena” or place to test these applications
4. Paradigms change and Internationalization since 1987, System
Certification (after incorporation of management elements and tools)
5. Indonesia clearly joined the effort for applic after Internationalization
6. Clearly defined in text books since 1974 (definition of quality)
7. Summarized by Green (1994), with 6 Concepts of quality
8. Food Quality is value: Key values are safety, nutritional contents,
trade regulation/standards
9. Juran Trilogy: Quality Planning, Quality Control, Quality Improvement
Bibliography
Feigenbaum, A. V. 1983. Total Quality Control, Third Edition. McGraw-
Hill, Inc.
Juran, J.M. 1998. Juran’s Quality Control Hand Book. Fourth Edition.
McGraw-Hill International
Tenner, A. R dan I. J. Detoro. 1992. Total Quality Management.
Addison-Wesley Publishing Company.
________. 2000. ISO-9000. Quality Management System –
Fundamental and Vocabulary. ISO Copyright Office.

Thank You
Terima Kasih

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Internationally Approved Food Technology Program by IFT and IUFoST

9 Quality inspection, examination, measurement, Tmu Fmt Abs

11 Quality management systems and their certification Fmt Tmu Aba

14 Quality Cost Mar Fmt Mar

Internationally Approved Food Technology Program by IFT and IUFoST

1.2 Definition of quality and food

1.3 Concepts of quality

1.4. Juran Trilogy

Internationally Approved Food Technology Program by IFT and IUFoST

Internationally Approved Food Technology Program by IFT and IUFoST

VARIATIONS : Natural (standard error) systematic

LIMITS : What is the target value, how to define

Internationally Approved Food Technology Program by IFT and IUFoST

Technical activities, Their tools are Lab analysis equipments,

Establish the limit values and standardized the values or fixed

4 Continuously control and correct quality and safety

Continuously record the measurement results and parameters

Find the source of variations, Solve the problem of variations,

Continuously planning, controlimg and developping quality

•Lowest Level : Inspect Quality (Inspect final products)

• Product & Process Characteristics: Key Quality Parameters & Characteristics

Internationally Approved Food Technology Program by IFT and IUFoST

A. QMS IN HISTORY: THEORY AND ITS APPLICATION (EVOLUSI

B. DEFINITION OF QUALITY (PENGERTIAN MUTU)

C. QUALITY CONCEPT (KONSEP MUTU)

Internationally Approved Food Technology Program by IFT and IUFoST

Early Human Life (ANCIENT TIME)

Internationally Approved Food Technology Program by IFT and IUFoST

 Mutually beneficial cooperation (barter)

Internationally Approved Food Technology Program by IFT and IUFoST

Until the End of the 19th Century, concept of Quality

The first trade show, 1851 di Crystal Palace,London

Internationally Approved Food Technology Program by IFT and IUFoST

Internationally Approved Food Technology Program by IFT and IUFoST

Progressing, mainly due to the early trade fairs in time of industrial

1900 1918 1937 1960 1980

Internationally Approved Food Technology Program by IFT and IUFoST

Operator (Peralatan dan Mutu)

Total Quality Management ( TQM )

Internationally Approved Food Technology Program by IFT and IUFoST

Internationally Approved Food Technology Program by IFT and IUFoST

Internationally Approved Food Technology Program by IFT and IUFoST

 World War II (1940) Mass production quality decreased

Phillip B. Crosby (1979)

Internationally Approved Food Technology Program by IFT and IUFoST

A.V. Feigenbaum (1983)

International Standard ISO

Menurut Kamus Webster’s

PP NOMOR 28 TAHUN 2004 TENTANG KEAMANAN, MUTU DAN GIZI

Green (1994): 6 Konsep

Internationally Approved Food Technology Program by IFT and IUFoST

Internationally Approved Food Technology Program by IFT and IUFoST

Establish quality Evaluate actual Prove the need

Develop product Establish project

Internationally Approved Food Technology Program by IFT and IUFoST

Develop processes Provide the teams

Internationally Approved Food Technology Program by IFT and IUFoST

Internationally Approved Food Technology Program by IFT and IUFoST

Internationally Approved Food Technology Program by IFT and IUFoST

Internationally Approved Food Technology Program by IFT and IUFoST

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