T.C.

MARMARA UNIVERSITY
INSTITUTE FOR GRADUATE STUDIES IN
PURE AND APPLIED SCIENCES

FAILURE MODE AND EFFECTS ANALYSIS (FMEA)

AND AN IMPLEMENTATION STUDY IN A
PACKAGING COMPANY

Ali DIRA
Industrial Engineer

THESIS
FOR THE DEGREE OF MASTER OF SCIENCE
IN
INDUSTRIAL ENGINEERING PROGRAMME
SUPERVISOR
Prof. Dr. S. mit Oktay Frat

STANBUL 2008

T.C.
MARMARA UNIVERSITY
INSTITUTE FOR GRADUATE STUDIES IN
PURE AND APPLIED SCIENCES

FAILURE MODE AND EFFECTS ANALYSIS (FMEA)

AND AN IMPLEMENTATION STUDY IN A
PACKAGING COMPANY

Ali DIRA
(141100920040321)

THESIS
FOR THE DEGREE OF MASTER OF SCIENCE
IN
INDUSTRIAL ENGINEERING PROGRAMME
SUPERVISOR
Prof. Dr. S. mit Oktay Frat

STANBUL 2008

ACKNOWLEDGEMENTS

I would like to express my gratitude to my supervisor Prof.Dr. S.mit Oktay

Frat for her invaluable comments, her supports by providing valuable sources of her
library, her advices and help during this study.
I am grateful to thank to all my friends working together in SUNJUT A..,
especially to my manager Gnl Aslan for the implementation part of this study.
I would also like to thank my brother Fatih Dra, my friends Selin Takent,
and Alihan Erolu for their support, help and patience during this study.

stanbul, 2008

Ali DIRA

3i

CONTENTS

PAGE

ACKNOWLEDGEMENTS........................................... ........ I
CONTENTS........................................................................................................II
ZET ...................................................................................................IV
ABSTRACT ........................................................................................................ V
CLAIM FOR ORIGINALITY .................................................................... VI
ABBREVIATIONS........................................................................................ VII
LIST OF FIGURES ...................................................................................... VIII
LIST OF TABLES..............................................................................IX
PART I INTRODUCTION AND AIM...........................................112
1
I.1. INTRODUCTION....................................................................................12

PART II FAILURE MODE AND EFFECTS ANALYSIS............314

3
II.1. RELIABILITY CONCEPT....................................................................14
3
II.1.1. General Overview ...........................................................................14
5
II.1.2. Reliability Requirements.................................................................16
6
II.1.3. Reliability Analysis Procedures.......................................................17
7
II.2. FAILURE MODE and EFFECTS ANALYSIS (FMEA).......................18
7
II.2.1. General Overview ...........................................................................18
9
II.2.2. Objectives of FMEA .......................................................................20
10
II.2.3. Historical Perspective of FMEA......................................................21
II.2.4. Importance of FMEA in Quality Management and Improvement
11
Systems ................................................................................................22
11
II.2.4.1. FMEA and ISO 9000 Quality Management System...............22
12
II.2.4.2. FMEA and Total Quality Management ..................................23
13
II.2.4.3. FMEA and Six Sigma............................................................24
14
II.2.5. Advantages and Disadvantages of FMEA .......................................25
17
II.2.6. Types of FMEA ..............................................................................28
18
II.2.6.1. Design FMEA .......................................................................29
19
II.2.6.2. Process FMEA ......................................................................30
4ii

II.2.7. Stages of FMEA..............................................................................3120

II.2.7.1. Forming the FMEA Team .....................................................3323
II.2.7.2. Determining the Potential Failure Modes...............................3423
II.2.7.3. Determining the Effects of Potential Failure Modes...............3524
II.2.7.4. Determining the Potential Cause(s) of Failure .......................3525
II.2.7.5. Defining the Current Process Controls...................................3625
II.2.7.6. Evaluation .............................................................................3625
II.2.7.7. Calculating the Risk Priority Number (RPN) .........................3928
II.2.7.8. Corrective Actions ................................................................4029

PART III A PROCESS FMEA IMPLEMENTATION STUDY IN

A PACKAGING COMPANY ......................................................... 4231
III.1. OBJECTIVES of the IMPLEMENTATION .......................................42
31
III.2. SCOPE of the IMPLEMENTATION ...................................................42
31
III.3. STEPS of the IMPLEMENTATION STUDY ......................................46
35
III.3.1. Analyzing the Process....................................................................46
35
III.3.2. Forming the FMEA Team..............................................................48
37
III.3.3. Determining the Potential Failure Modes .......................................48
37
III.3.4. Determining the Effects of Failure Modes......................................50
39
III.3.5. Determining the Causes of Failures................................................55
44
III.3.6. Defining the Current Process Controls ...........................................58
47
III.3.7. Calculating the RPN ......................................................................60
49
III.3.8. Recommending the Corrective Actions ..........................................65
54
III.3.9. Improvements................................................................................69
58

PART IV RESULTS AND DISCUSSION...................................... 7463

PART V CONCLUDING REMARKS AND
RECOMMENDATIONS................................................................. 7766
REFERENCES ................................................................................ 7968
APPENDIXES ................................................................................. 8271
CURRICULUM VITAE

iii5

ZET
HATA TR VE ETKLER ANALZ (HTEA) VE BR
AMBALAJ FRMASINDA UYGULANMASI

rn gvenilirlii bugn iletmeler iin rekabette, mteri tatmininde ve

maliyetlerde yapt etki asndan ok nemli hale gelmitir. Gvenilirliin dk
olmasna neden olan ise rn yaam evriminin farkl aamalarnda yaplan
hatalardr. Hata Tr ve Etkileri Analizi (HTEA) bu hatalar sistematik bir ekilde
analiz ederek nceden tespit etmeyi ve nlemeyi amalayan bir yntemdir. Bu
almann amac HTEA ynteminin teorik ve deneye dayal zelliklerini detayl bir
ekilde inceleyerek bir uygulama almas gerekletirmek ve bylece yntemin
kalite iyiletirmesi almalarna olan katksn ortaya koymaktr.
HTEA, bir sistemin yaam evrimi boyunca olabilecek potansiyel hatalar ve
onlarn riskini tahmin etmeye, deerlendirmeye ve bu riski drmeye yardm eden
sistematik bir yaklamdr. Burada risk, her bir hatann iddet, oluma olasl ve
tespit edilebilirlik takdirine gre hesaplanan Risk ncelik Says(RS) ile llr.
Daha sonra Bu sayya gre hatalar bykten ke doru sralanr ve belirlenen
ncelik srasna gre de her bir hatann RS sini azaltc dzeltici faaliyetler
planlanr ve uygulanr.
Bu alma sonunda uygulama aamasnn gerekletirildii srete hatalar
snflandrlm, yksek riskli hatalar belirlenmi ve risklerini drmek iin gerekli,
byk bir ksmn alanlar iin bir eitim sistemi ve diki makineleri iin bir
kontrol sistemi kurulmasnda oluan dzeltici faaliyetler belirlenmitir.

Nisan, 2008

Ali DIRA

iv6

ABSTRACT
FAILURE MODE and EFFECTS ANALYSIS (FMEA) and an
IMPLEMENTATION STUDY in a PACKAGING COMPANY

Product reliability becomes very crucial for the companies because of its effect
on competition, customer satisfaction and costs. The failures occurring in different
stages of product life cycle decrease reliability. SUNJUT A.. faces the same
problem. The failure rate of the sewing process is quite high and causes customer
complaints. The objective of this study is to reduce this failure rate through an
analysis of the theoretical and empirical features of Failure Mode and Effect
Analysis (FMEA).
FMEA is a systematic approach to help anticipate, evaluate, and reduce risk of
failures in that may occur during the lifetime of a system. .Risk is measured in terms
of Risk Priority Number (RPN) which is calculated for every cause of failure
considered and is a function of the following three ratings, severity, occurrence and
detectability of a failure. Then all the failures are prioritized according to these RPN
values and corrective actions to reduce these numbers are planned and applied.
For the said company process, failures are classified and those with high risks
have been identified. Also the order of precedence for the corrective actions which
are mainly composed of training system for labors and a controlling system for
sewing machines is presented.

April, 2008

Ali DIRA

v7

CLAIM FOR ORIGINALITY

FAILURE MODE and EFFECTS ANALYSIS (FMEA) and an
IMPLEMENTATION STUDY in a PACKAGING COMPANY

Process FMEA method is commonly used for processes which are not
realized yet to prevent failures before they occur. In this study it was tried to show
that this method can be also useful for a present process which is in operating
conditions.

stanbul, 2008

Prof.Dr.S.mit Oktay FIRAT

vi8

Ali DIRA

ABBREVIATIONS

AIAG

: Automotive Industry Action Group

AMDEC

: Analyse des modes de dfaillance, de leurs effets et de leur criticit

(Failure Mode and Effects Criticality Analysis)

APQP

: Advanced Product Quality Planning

ASQC

: America Society of Quality Control

BS

: British Standard

DIN

: Deutsches Institut fr Normung

DMADV

: Define-Measure-Analyze-Design-Verify

DMAIC

: Define-Measure-Analyze-Improve-Control

FIBC

: Flexible Intermediate Bulk Container

FMEA

: Failure Mode and Effects Analysis

FMECA

: Failure Mode and Effects Criticality Analysis

IEC

: International Electrotechnical Commission

ISO

: International Standard Organization

NASA

: National Aeronautics and Space Administration

QMS

: Quality Management System

QS

: Quality System

PP

: Polypropylene

PE

: Polyethylene

RPN

: Risk Priority Number

SAE

: Society of Automotive Engineers

SPC

: Statistical Process Control

TQM

: Total Quality Management

USA

: United States of America

vii9

LIST OF FIGURES

Page No:
Figure II.1. Pressures Leading to overall perception of risks......7
5
Figure II.2. Inductive and Deductive Procedures....8
6
Figure II.3. Reliability Analysis Procedures.......9
7
Figure II.4. Relationship Between Cost and Failure... 18
15
Figure II.5. The FMEA Procedure.....24
21
Figure III.1. Drawing of a Bigbag.....38
33
Figure III.2. The Whole Production Process of a Bigbag.....40
34
Figure III.3. Bigbag Sewing Process.42
36
Figure III.4. Failures Frequency of Process Steps...45
39
Figure III.5. Average Severity Rating of Process Steps48
42
Figure III.6. Maine Root Causes of Sewing Process Failures...51
45
Figure III.7. Average Occurence Ratings of Process Steps..53
47
Figure III.8. Average Detectability Rating of Process Steps5549
Figure III.9. Total RPN Percentage of Each Interval57
51
Figure III.10. Pareto Chart of RPN Values According to Basic Intervals5852
Figure III.11. Average RPN Values of Each Process Step...60
54
Figure III.12. Scree Plot of RPN Values ..62
56
Figure III.13. Graphical Notation of Improvements at Average Occurence and
Detectability Ratings...68
62

viii
10

LIST OF TABLES

PAGE NO:
Table II.1. The Dimensions of Quality...............4
4
Table II.2. Overview of DMAIC......16
14
Table II.3. Overview of DMADV............16
14
Table II.4. FMEA Occurrence Rating Guideline .....29
26
Table II.5. Severity Rating Table .........30
27
Table II.6. Detectability Rating Table..32
28
Table III.1. Frequency of Failures at Each Process Step...44
38
Table III.2. Multiple Failures in the Sewing Process....45
39
Table III.3. Severity Rating Table Used in Implementation Study ......46
40
Table III.4. Total Severity Rating of Each Process Step...47
41
Table III.5. Serious and Fatal Failures......49
43
Table III.6. Occurrence Rating Table Used in Implementation Study..50
44
Table III.7. Main Root Causes of Failures51
45
Table III.8. Total and Average Occurrence Ratings of the Process Steps.52
46
Table III.9. Total and Average Detectability Ratings of Process and Its Steps54
48
Table III.10 First 8 Failure Modes According to Their RPN...................................5150
Table III.11. Failure Data According to RPN Value Intervals..57
51
Table III.12. Total and Average RPN Value of the Process and Its steps.59
53
Table III.13. Corrective Actions of the Failures Which Have Higher RPNs............58
57
Table III.14. Improvements at RPNs Before and After Corrective Actions.64
59
Table III.15. Improvements at Occurrence Ratings Before and After Corrective
Actions....65
60
Table III.16. Improvements at Detectability Ratings Before and After Corrective
Actions...61

ix11

PART I INTRODUCTION AND AIM

INTRODUCTION and AIM

I.1. INTRODUCTION
This study is carried out in SUNJUT A.., and the objective is to give detailed
information about FMEA methodology and to integrate it into a real case study, with
an aim of reducing high customer complaints and failure rates of the sewing process.
This study consists of five main parts. This introduction and aim part is composing
the first one. Second, a general information about reliability subject, and FMEA in
terms of history, purposes, advantages and disadvantages, two types of FMEA
(design and process FMEA), and the application process are given in Part II. Then
the application details including the general information about the firm and the
problem description are explained in Part III. While the results of the application
study are presented and discussed in Part IV, finally this study ends with concluding
remarks and recommendations given in Part V.
The empirical part is constituted of a Process FMEA study. Another main
objective of this study is to show the contributions of Process FMEA to a process
which is in operating conditions contrary to general applications. Before starting the
application, the problem description, the purposes and the scope of the study are
determined. The application starts with an analysis of the process. A flowchart is
organized in order to demonstrate each step of the sewing process.
The second step is the formation of the FMEA team. A cross functional team is
composed of six members who are in relation with the sewing process directly but
working in different functions.
Determination of the failure modes is the third step of the process FMEA. All
possible failures are presented, analyzed and classified at this stage. Different steps
of the sewing process are compared to each other with respect to frequency of
failures.
The fourth step is to determine the effects of failures on the customers. Then
the severity evaluation is done for each effect by a 1 to 10 scale. Comparison of the

112

sewing process steps, pointing out the most severe steps and an analysis of the
severity level of the whole process are presented.
Determination of the causes of failure modes is the fifth step of this study. All
the potential causes are defined for each failure mode. Then their occurrences are
evaluated by the team based on a 1 to 10 scale. The sewing process and its steps are
analyzed in terms of occurrence rating evaluation.
The sixth step is to determine the current process controls. At this stage the
detectability power of the process is evaluated for each failure mode with the
assistance of a 1 to 10 scale again. An analysis of the sewing process and its steps are
presented in terms of detectability.
Following the preceding three steps, Risk Priority Numbers (RPN) are
calculated for each failure mode as the seventh step. Then the failures are prioritized
with respect to their RPN values. The process and its steps are also analyzed in terms
of their average RPNs.
The eighth step consists of some recommendations about the corrective actions
for the failures. As a result of high failure frequencies, three approaches are used in
order to choose the failures for which the corrective actions should start. All the
corrective actions determined by the team are presented at this stage.
The last step of the Process FMEA study is the improvement phase. After
corrective actions are completed, the RPNs are recalculated by the team. The
improvements gained from these corrective actions are explained at this step.
This study ends with last two separate chapters. The first one is the Results and
Discussion Part, where all the results obtained from the application study and
comparisons before and after the corrective actions, are presented in Part IV. The
second one is the Concluding Remarks and Recommendations Part, where the
difficulties and obstacles such as the motivation decreases caused by the long
application time, and some suggestions about future works on another Process
FMEA study are given in Part V.
FMEA is a very powerful tool to analyze and improve the processes which
have high failure rate. By using this methodology and following successive steps, the
problems of the firm about high customer complaints and failure rates are improved.

213

PART II FAILURE MODE and EFFECTS ANALYSIS

FAILURE MODE and EFFECTS ANALYSIS

II.1. RELIABILITY CONCEPT

II.1.1. General Overview
Reliability is one of the most important characteristics of any product,
regardless of its practices. When dealing with customer satisfaction, whether the
customer is internal or external and in the decision to give the next order by
customers, reliability is also an important aspect [1]. Customers require a product
that will have a relatively long service life and long times between failures [2].
The reduction of failure costs attributable to scrap, rework, warranty claims,
product liability and product recall, being one of the fundamental ways of improving
business competitiveness [3]. All these failure costs are the results of companies
reliability performances.
Improving the products reliability is a part of the larger picture of improving
quality. It is accepted that, quality has nine different dimensions, and then reliability
is one of the as seen in Table II.1.

3
14

Table II.1. The Dimensions of Quality [2]

No

Dimension

Meaning and Example

Performance

Features

Conformance

Reliability

Durability

Useful life, includes repair.

Service

Resolution of problems and complaints, ease of repair.

Response

Aesthetics

Reputation

Primary product characteristics, such as brightness of

the picture.
Secondary characteristics, added features, such as
remote control.
Meeting specification or industry standards,
workmanship.
Consistency of performance over time, average time
for the unit to fail.

Human to human interface, such as the courtesy of the

dealer.
Sensory characteristics, such as exterior finish.
Past performance and other intangibles, such as being
ranked first.

A momentous quality characteristic, reliability is concerned with the

performance of the products function over a stated period of time. Therefore,
whereas quality is defined as conformance to requirements, on the other hand
reliability is defined as a failure or fault free performance in all products provided to
customers. Compared with quality which embraces the whole organization,
reliability has a more product specific definition and therefore should be the main
impetus to continuously improving reliability performance of the product.
There is also an overall belief that higher reliability will result in lower
product life-cycle costs which give allowances for shorter manufacturing time
leading to shorter delivery time, price reduction, and more importantly lower failure
fields [1].
The propensity of managers and engineers to minimize the risk in a particular
system, design, process, and/or service has forced an examination of reliability
engineering, not only to minimize the risk, but also to define the risk whenever
possible. Some of the forces for defining risks were shown in Figure II.1.

415

Safety
Competition

Market Pressure

Others

Management
Emphasis
Perceived
Risks
Development of
Technical Skills

Legal, Statutory
Requirements
Warranty and
Service Costs

Customer
Requirements

Public
Liability

Figure II.1. Pressures Leading to Overall Perception of Risks [4]

These risks can be measured by reliability engineering and/or statistical

analysis [4].
II.1.2. Reliability Requirements
In all cases, the acceptance of a process or a certain product is subject to
meeting certain set of given requirements for reliability of the process or product. It
is, however, important to realize that although the definition for reliability is
relatively simple, the customer and the supplier may have different descriptions of
what constitutes failure. This common agreement on what constitutes reliability
should be defined in terms of influence on other related systems, the complexity of
the failure, the reliability of past similar systems, and finally the relative criticality of
the failure [2].
Quality and reliability of products and manufacturing processes are absolutely
critical to the manufacturing outcome-the functional performance of the end
products. To ensure good product quality, a comprehensive and as well as an
effective quality system must be established in the very early stages of product
design. All engineers involved in the project should consider product/process quality
and reliability while performing their tasks [5].

5
16

II.1.3. Reliability Analysis Procedures

Reliability analysis procedures are diverged into two classes. These are
inductive and deductive procedures. These procedures analyze the failures that can
occur in the system in different ways. Inductive procedures examine failures from
component to system, whereas those of deductive do this the other way around.

Picking Upper Level

Failure in Component
Top Down
Causes

Summarizing
bottom up

Determine Failure Modes of Lower

Level Components

Figure II.2. Inductive and Deductive Procedures [6]

There are many different specific procedures or methods that can be under
inductive and deductive headings. Some of them can be seen in Figure II.3.

617

Reliability
Analysis
Procedures
Inductive
Procedures

Hardware
Failures

Failure Mode
and Effects
Analysis

Deductive
Procedures

Human
Interaction
Errors
Reliability
Analysis

Human and
Hardware Errors

Human Factors
Analysis

Fault Tree
Analysis

Event Tree
Analysis

Probabilistic
Risk Assessment

Figure II.3. Reliability Analysis Procedures [6]

FMEA which is under Inductive Procedures in Figure II.3 is a systematic way
of determining the possible failures related with product, process or system for
establishing a reliability system.
In order to meet requirements of product reliability, reliability analysis must
contain both product design and process operations. FMEA is a popular tool for
reliability. It is common and critical to conduct reliability analysis at the earliest
stage of the product life cycle. Design and product engineers need to work with a
project team that at least includes customers, manufacturing engineers and reliability
engineers to identify the potential quality and reliability failures in the design
process. Hence, the problems can be eliminated as early as possible to avoid
complicated and costly correction processes [5].
II.2. FAILURE MODE and EFFECTS ANALYSIS (FMEA)
II.2.1. General Overview
Failure Mode and Effects Analysis (FMEA) is equally a major term in the
reliability literature. The aim of this technique is to identify the sources of the
process problems by breaking the process into its sub-components. FMEA tends to

718

relate the costs to material, manpower, method, and machine problems. This has
great impact and highlights the inability of achieving process capability [7].
Specifically, an FMEA can find the weaknesses in product designs and
manufacturing processes before the design and process are realized, either in
prototype or mass production [8].
FMEA is essentially a systematic brainstorming session aimed at finding out
what can go wrong with a system or process [9].
FMEA is a technique used by engineers to ensure all the potential problems
have been considered and addressed. FMEA identifies potential product-related
failure modes, the potential effects of the failures on customers, the potential
manufacturing or assembly causes, methodologies to reduce the failure modes
occurrence frequency, and current detectability considerations. In other words,
FMEA is a systematic method of identifying, prioritizing and acting on potential
failure modes before they occur [10].
The primary outputs of this analysis are:
i.

records of failure modes found in different stages of the design cycle

ii.

evidence of the actions required

iii.

evidence of actions taken

iv.

record of the action success or failure

v.

evidence of risk reduction

vi.

relative measure of risk reduction for individual failure modes [11].

In the stage of product development and design, the predictive analysis of

reliability is always carried out through FMEA which analyses all potential modes of
failures of individual items of product and thus it can be used as a good tool to
predict a behavior of product during a warranty period [12].
FMEA applies Risk Priority Number (RPN) by using occurrence, severity and
detectability ratings to be decided which failures are having priority for corrective
action.
Criteria used in the FMEA can be list in order:
i. Occurrence which shows the frequency of failure
ii. Severity which shows the seriousness of the failure
iii. Detectability which shows noticing of the failure before it arrives to customer
RPN which is calculated by multiplying of these three ratings provides
determining the problems priorities [4].
819

The conditions that forces the companies to use FMEA are:

i. Intent of doing a job at first time and reduction of re-processing, warranty, and
cost of wastes.
ii. Intent to correspond the customer requests which changes rapidly and providing
more customer satisfaction.
iii. Obligatory to increasing ethical and legal regulations,
iv. Intent of integrating the high quality with low cost at one product or service.
II.2.2. Objectives of FMEA
One of the most powerful methods available for measuring reliability of the
process, product or service is FMEA. FMEA is an analytical technique that combines
the experience of people and technology in identifying foreseeable failure modes of a
product or process and planning for its elimination. This method can be implemented
in both the design and the process areas and basically involves the identification of
the potential failure modes and the effect of those on both the internal and external
customer.
The use of FMEA in both the product-design and process areas of
manufacturing is more important today than it has ever been. Current products are
more complicated than ever, and this requires more organization and precaution. It
will take far more planning to produce current products with the same reliability as
prior products. Consumers today also are far more particular than they have been in
the past, demanding products of the highest quality for the lowest possible cost.
FMEA also allows the engineer to keep a record of all actions and thoughts taken to
ensure a safe and reliable product. This becomes extremely important with the
customers current mode of thinking-needing to assign blame whenever something is
not exactly as expected. The most important aspect of this discussion is to follow up
on any and all concerns that seem critical and to document the changes and concerns
made, continuously updating the FMEA. All changes and concerns between the
design stage and the delivery of the product to the consumer should be noted in a
through, precise, and organized manner [2].
The main objectives of this method can be counted as provided below:
i.

To compare the design characteristics relative to the planned manufacturing or

assembly methods to make certain that the product meets the requirements of
customers.

920

ii.

To provide justification for setting up a process in a certain manner.

iii.

To prevent the failures that can be at product or process by determining them

before.

iv.

To take corrective precautions to eliminate them or reduce the probability of

occurrence, when the potential failure modes are determined,

v.

To document the reasons and principles of the system based on, for assembly
and production process [4].
II.2.3. Historical Perspective of FMEA
FMEA was applied first time at USA army named as Procedures for

Performing a Failure Mode, Effects and Criticality (FMECA), with MIL-P-1629

code, as a reliability evaluation technique to determine the effects of system and
equipment failures [13].
FMECA is a qualitative method which lists the failures order according to
theirs importance priorities. This listing is done according to failures occurrence and
their effects to criticality. International Electrotechnical defines FMECA, a
qualitative method of reliability analysis which involves fault modes and effects
analysis together with a consideration of the probability of their occurrence and of
the seriousness ratings of the faults [11].
Today FMEA harmonizes to FMECA because of including this criticality
analysis. FMEA was used by NASA from 1965 to 1969 for Apollo project which
lands on moon with men. The product of this project was unique and its cost was
quite high. It was not wanted to break down any system or component. To not to
undergo the cost of backing up of system, FMEA was implemented.
FMEAs first industrial implementation was realized by Japanese company
NEC and then it became widespread in the world.
In many industries, specifically in automotive, FMEA is a mandatory
deliverable of product development process documentation [11].
It was started to use by automotive industry by FORD in 1980. But the
complex military application was simplified. FMEA was denominated as AMDEC
(L'Analyse des Modes de Dfaillance, de leurs Effets et de leur Criticit) in Renault
and Citroen companies. In 1985, it was started to be used by FIAT company as same
as the FORD application.

10
21

In 1988, International Standard Organization published the ISO 9000 series.

This series force organizations to focus the quality management systems format
according to customer expectations and requirements. In automotive industry ISO
9000 system was denominated as QS 9000. FMEA takes place in that standard under
the quality planning title [14].
AIAG (The Automotive Industry Action Group) and ASQC (American Society
of Quality Control) published the FMEA standards which covers the other sectors
and corresponds to SAE J-1739 standard of Automotive Engineers Association in
February 1993. The same procedure was defined as BS 5760 in England, DIN 25448
in Germany [15]. The name of British Standard 5760 is Reliability of Constructed or
Manufactured Products, System, Equipments and Components; Part 5, Procedure for
Failure Modes, Effects and Criticality Analysis (FMEA and FMECA).
Some more standards can be used to perform FMEA, but each standard is
geared to a specific market or application. Some examples:
i.

MIL STD 785 which is a reference of the reliability tasks that widely used in
aerospace and defense industry [16].

ii.

SAE ARP5580 is generally used by Aerospace and defense companies.

iii.

Most other industries such as Telecommunications have adopted MIL-P-1629A

as their FMEA guideline [17].

iv.

IEC 61508, an international norm for the functional safety of electronic safetyrelated systems [18].
II.2.4. Importance of FMEA in Quality Management and Improvement
Systems
II.2.4.1. FMEA and ISO 9000 Quality Management System
The ISO 9000 is a series of standards which can be tailored to fit any

organizations needs, whether it is large or small, a manufacturer or a service

organization. In very simplified terms, the standards require an organization to say
what it is doing to ensure quality, then do what it says, and, finally document or
prove that it has done what it said.
There are various reasons for implementing a quality system conforms to an
ISO standard. The primary reason is that customers and marketing are suggesting or

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22

demanding compliance to a quality system. Other reasons are needed improvement

in processes or systems and desire for global deployment of products and services.
The three standards of the series are described briefly in the following
paragraphs:
i.

ISO 9000:2000 Quality Management Systems (QMS) fundamentals and

vocabulary discusses the fundamental concepts related to the QMS and
provides the terminology used in other two standards

ii.

ISO 9000:2001 Quality Management Systems (QMS) requirements is the

standard used for registration by demonstrating conformity of the QMS to the
customers, regulatory, and organizations own requirements.

iii.

ISO 9004:2000 Quality Management Systems (QMS) guidelines for

performance improvement provides guidelines that an organization can use to
establish a QMS focused on improving performance.
We can see FMEA directly or indirectly in several parts of these standards.
Clause 7.1.1.3 of ISO 9004:2000 is about product and process validation and

changes. It states Risk assessment should be undertaken to asses the potential for,
and the effect of, possible failures or faults in processes. The results should be used
to define and implement preventive actions to mitigate identified risks. FMEA is
taking place as one of the tools for risk assessment.
At the 7.3. clause of ISO 9004:2000, design fault mode and effect analysis is
submitted as a tool for risk assessment of design and development.
It is said that at the 8.5.3 clause of the standard, fault mode and effect analysis
can be used for generating data to provide a systematic way for loss prevention [19].
II.2.4.2. FMEA and Total Quality Management
Total Quality Management (TQM) is an enhancement to the traditional way of
doing business. It is a proven technique to guarantee survival in world class
competition. Only by changing the actions of management will the culture and
actions of an entire organization be transformed.
TQM is defined as both a philosophy and a set of guiding principles that
represent the foundation of a continuously improving organization. It is the
application of quantitative methods and human resources to improve all the processes
within an organization and exceed customer needs now and in the future. TQM

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23

integrates fundamental management techniques, existing improvement efforts, and

technical tools under a disciplined approach.
Total Quality Management requires six basic concepts:
1.

A committed and involved management to provide long-term top-to-bottom

organizational support.

2.

An unwavering focus on the customer, both internally and externally.

3.

Effective involvement and utilization of the entire work force.

4.

Continuous improvement of the business and production process.

5.

Treating suppliers as partners.

6.

Establish performance measures for the processes.

These concepts outline an excellent way to run an organization.
We see FMEA in the fourth concept. TQM stipulates a continual striving to

improve all business and production processes. Quality improvement projects, such
as on time delivery, order entry efficiency, billing error rate, customer satisfaction,
cycle time, scrap reduction, and supplier management, are good places to begin. And
statistical process control (SPC), benchmarking, quality function deployment, ISO
9000, designed of experiments and FMEA are excellent techniques for problem
solving [2].
II.2.4.3. FMEA and Six Sigma
The simplest definition for Six Sigma is to eliminate waste and to mistake
proof the processes that create value for customer. The elimination of waste led to
yield improvement and production quality; higher yield increased customer
satisfaction. The Six Sigma methodology of measuring and monitoring performance
issue deals with a variety of statistical applications.
Six Sigma is a rigorous, focused and highly effective implementation of proven
quality principles and techniques. It aims for virtually error free business
performance.
Six Sigma implementation projects are conducted by two different
methodologies depending on the scope. First one is known as Define-MeasureAnalyze-Improve-Control, or DMAIC. It is used when a projects goal can be
accomplished by improving an existing product, process, or service. Another
approach, used when the goal is the development of a new or radically redesigned
product, process or service, is Define-Measure-Analyze-Design-Verify, or DMADV.

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24

DMAIC and DMADV are composed of basic steps provided in Table II.2. and Table
II.3. successively below.

Table II.2. Overview of DMAIC [15]

D Define the goals of the improvement activity.
M Measure the existing system.
A Analyze the system to identify ways to eliminate the gap between the
current performance of the system or process and the desired goal.
I

Improve the system.

C Control the new system.

Table II.3. Overview of DMADV [15]

D Define the goals of the design activity.
M Measure. Determine critical to stakeholder metrics.
A Analyze the options available for meeting the goals.
D Design the new product, service or process.
V Verify the designs effectiveness in the real world.

FMEA takes places especially in analyze and control steps of DMAIC and in
design phase of DMADV projects involving improvement of processes or complex
systems [15].
II.2.5. Advantages and Disadvantages of FMEA
The main advantages that can be gained after the use of FMEA are:
i.

All the failure modes are determined systematically to prevent the lowest cost
of failure that can happen at product or process.

ii.

The effects of each failure that can affect the product, process, or service are
defined.

iii.

The critical failures which have the biggest effect on product, process or
service are defined.

iv.

The probabilities of failures occurrence and their reasons are defined.

v.

Inspection programs are established to test the reliability.

vi.

Effects of modifications on product can be determined before.

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25

vii.

It is a visibility tool that can easily be understood and used.

viii.

It identifies weaknesses in the system design, focusing attention on a few

components rather than on many;

ix.

It is useful in design comparison [20].

x.

The image of the company and their competitive power improves.

xi.

Customer satisfaction increases.

xii.

Time and cost of the product development decrease.

xiii.

The development is encouraged. It helps develop an organization culture

because it needs team work.

xiv.

Less risk is taken at product liability.

xv.

The actions and researches which leads to development are documented [15].

xvi.

Providing training for new employees.

xvii.

Helping uncover misjudgments, oversights, and errors that may have been
made.
Figure III.1. shows how the systems cost is directly proportional to how early

the system failure is identified.

Cost

Avoiding
Potential
Failure

Design
FMEA

Detectability and
Screening of
Internal Failures

Process
FMEA

SPC

Discovery &
Resolution of
External Failures
Customer
Incoming
Failures

Incoming
Inspection
Outgoing
Inspection

Field
Failures

Developm. Product
Engineering

Procurement

Manufacturing
USER

PLANNING
Manufacturer

Customer

Figure II.4. Relationship Between Cost and Failure [21]

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26

Time

A good use of the FMEA technique can provide a manufacturing company

benefits such as high product reliability, less design modification, better quality
planning, continuous improvement in product and process design, and lower
manufacturing cost. A company must fully utilize FMEA to improve the reliability of
the products and processes to obtain the benefits mentioned above. If a companys
main purpose of developing the FMEA report is to fulfill demand of customers, then
the benefits of performing FMEA will be reduced, and the cost for the FMEA
process may not be compensated by the benefits of performing the analysis except
that it satisfies customers demand to have the report [5].
The FMEA document, however, cannot solve all design and manufacturing
problems and failures. The document, by itself, will not fix the identified problems or
define the action that needs to be taken. Another misconception is that FMEA will
replace the basic problem-solving process [2].
The deficiencies of FMEA as a reliability tool are very few, but not
negligible. Some of those deficiencies are as follows:
i.

When each of the components and their failure modes are addressed, FMEA
cannot produce credible information on product reliability. FMEA treats each
failure mode as independent. The dependency, when known by the analyst
must be modeled with the help of another reliability method such as Markov
Analysis, Event Tree Analysis, or Fault Tree Analysis with the dynamic event
modeling. Most of FMEA are limited to the single independent failure modes,
thus the unreliability or probability of product failure due to their interaction is
often not accounted for.

ii.

When FMEA addresses only some, but not all of the components and their
failure modes, probability quantification of the entire products failure is not
possible.

iii.

When an FMEA is done using automotive methodology, then the seemingly

linear scales numbered from 1 through 10, can not provide any information on
product reliability, whether the values were a product of exact calculations (for
occurrence) or just estimated. The occurrence numbers cannot be converted
into the fractional probability numbers because they are exact values, and not
ranges. Therefore, this method of analysis is food for comparison of potential
improvements, but not for overall product reliability estimation or for tracking
of the reliability growth. The Occurrence scale, while applicable to some
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27

product types may not be detailed enough to allow estimation of risk of failure
modes found in electronic products [11].
iv.

One of disadvantages of RPN analysis is that various sets of failure occurrence,

severity and detectability may produce an identical value, however, the risk
implication may be totally different which may result in high-risk events may
go unnoticed.

v.

The other disadvantage of the RPN rating method is that it neglects the relative
importance among occurrence, severity and detectability. The three factors are
assumed to have the same importance but in real practical applications the
relative importance among the factors exists [6].
II.2.6. Types of FMEA
Generally, it is accepted that there are four types of FMEA. These are System,

Design, Process, and Service listed in order as given:

i.

System FMEA, is a method using for optimizing the flow of systems like
production or quality assurance after completing all the equipments and
designs. A system FMEA focuses on potential failure modes between the
functions of the system caused by system deficiencies. It includes the
interactions between systems and elements of the system [4].

ii.

Design FMEA, is a procedure to identify that the right materials are being
used, to conform to customer specifications, and to ensure that government
regulations are being met, before finalizing the product design. It focuses on
failure modes caused by design deficiencies.

iii.

Process FMEA, traditionally begins when the design FMEA report is available.
It

identifies

any

potential

failures

manufacturing/assembly processes,

that

could

be

caused

by

fixtures, machines, and production

methods [5].
iv.

Service FMEA, is a method to aim developing the customer services by

coordinating production, quality assurance and marketing functions. It focuses
on failure modes (tasks, error mistakes) caused by system or process
deficiencies [4].
But all these categories are broadly combined in two categories. Design FMEA

and Process FMEA based on whether they analyze system design or the processes

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involved in manufacturing and assembling and servicing the system [4]. Detailed
information about them is given in following part.
II.2.6.1. Design FMEA
Design FMEA is a technique which is applied before starting the production of
product and finding as well as preventing the failures that can occur in production or
assembling of the products, or using by customer use [15].
The goal of the design FMEA is to define and demonstrate engineering
solutions in response to functional requirements as defined by the system FMEA and
the customer.
The information input to design FMEA consists of customer inputs and
specifications. Based on requirements of customer, the potential failure modes are
determined. All the possible functional failures in product design must be identified
and reported in the design report. Component by component evaluations are
necessary in design FMEA [22].
The situations that the design FMEA used in are provided:
i.

When a new product will be produced

ii.

When an existing product will be modified.

iii.

When existing products will be used in a new application [15].

A design FMEA usually is accomplished through a series of steps to include

component, subsystems/subassemblies, and/or systems/assemblies. The design

FMEA is an evolutionary process (dynamic as opposed to static) involving the
application of various technologies and methods to produce an effective design
output. This result will be used as an input for the process or assembly, and/or the
service FMEA.
Effective design FMEA is basically realized through the system engineering
process, product development, research and development, marketing, manufacturing,
or a combination of all these entities. The focus in this stage is to minimize failure
effects on the system, regardless of what level FMEA is being performed [4].
Design FMEA is known to be more difficult to handle than process FMEA.
Therefore the personnel selection in the design FMEA must be based on the ability to
cover all aspects of product functions. The design FMEA team checks the component
problems, the functionality problems; and then lists all the possible failures and
begins to communicate with customers and suppliers. The members of the team

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discuss the potential failure modes in design with their customers to make the
possible changes in the product specifications to improve its design. They also talk to
product engineers to improve the products manufacturability. They inform suppliers
about the potential problems in components or possible improvement required for a
better design [2, 9].
II.2.6.2. Process FMEA
Process FMEA is an analytical technique which examines and solves the
failures that can happen in production process to provide products arriving to
customer with minimum failure.
Process FMEA is defined as a method which provides analyzing the machine,
equipment, method and human used for producing perfect products in production
process. It also provides evaluating the production process and determining the weak
points of it.
The objective of process FMEA is to define, demonstrate and maximize
engineering solutions in response to quality, reliability, maintainability, cost, and
productivity as defined by the design FMEA and the customer [4].
The situations that the process FMEA is used in are below:
i.

At all new products.

ii.

Existing products which will be modified.

iii.

The products where new technologies will be used for producing them [15].

iv.

When developing an existing processes.

A process FMEA is accomplished through a series of steps to include labor,

machine, method, material, measurement, and environment considerations. It is

obvious that each of these components, which may react individually, in tandem, or
as an interaction to create failure. Because of this convolution, completing a process
FMEA is more complicated and time-consuming than the other types of FMEA.
It focuses on potential failure modes associated with both the process
safety/effectiveness efficiency, and the functions of a product caused by the process
problems. [6] These problems may be potential ones or ones already known (through
warranties, circuit board field failure records, inspection and repair data, and
customer service records) [4].
Process FMEA begins with a process flow chart development. This flow chart
provides an overview of the complete production processes for the manufacturing of

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a part. The flow chart should display the sequence of each manufacturing/assembly
operation and show how these functions generate the required product
characteristics. Process FMEA identifies the potential process failures and
determines the possible causes in the manufacturing, assembly, and service
operations. The customer effects of the failures are crucial in the ratings of the failure
modes. The corrective actions taken for each failure mode in process FMEA
eliminate the failure causes in manufacturing/assembly processes, the customer
effects, and the occurrence of the failure conditions [5].
II.2.7. Stages of FMEA
Failure Mode and Effects Analysis (FMEA) is a structured, bottom-up
approach that starts with known potential failure modes at one level and investigates
the effect on the next sub-system level. All complex systems are composed of several
subsystems which can be further broken down up to a component level. A complete
FMEA analysis of a system therefore spans all the levels in the hierarchy from
bottom to top [23].
There is no standard application process for FMEA. But after deciding which
type of FMEA at where will be used, generally the steps are followed shown in
Figure II.5. Notwithstanding every company can form and follow an analysis process
that conforms to its organizational structure, requests and targets.
FMEA is performed to a different degree of detail. It may contain the analysis
of system functions only, hardware, software, or it may be extended to analysis of all
system components. Dependent on the depth of analysis it might contain analysis of
each potential failure mode, or it might contain only the failure modes that might be
of a concern and need to be addressed [11].
A form is used to manage the process and record the actions at all stages. At
each stage all the evaluations are recorded on that form. There is a sample form
provided in Appendix 1.

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31

Collecting component and

process function information

Determining potential failure modes

Checking the effects of each failure

Determining the causes of each failure

Finding occurence
rating

Finding severity
rating

Listing the current

process controls

Finding
Detectability Rating

Computing Risk
Priority Number

Correction
action
required?

Y
Recommending
corrective actions

Improvements

Preparing FMEA
report

Figure II.5. The FMEA Procedure [24]

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There are three stages that are very critical in the FMEA process to ensure the
success of the analysis. The first stage is to determine the potential failure modes.
The second stage is to find the data for occurrence, severity, and detectability ratings.
The third stage is the modification of the current product/process design and
development of the control process based on FMEA report.
There are two different quantitative approaches to the detail FMEA. One
applies physics of failure concepts for calculation of probabilities of failure modes
occurrence and the other relies on estimation of those values based on experience,
engineering judgment or experience with similar products.
The first approach is explained a thorough calculation of all of the inputs. Here,
the comparison of the original to the reduced risk is relatively easy. The product
reliability improvement can be measured with some certainty.
The other approach, widely applied, relies on estimation of values entered into
the FMEA table. This estimation is done by experts in with the best of their
knowledge and experience. The estimated values however may not represent the real
parameters. This is usually the case with estimation of probability of occurrence
which is greatly dependent on stresses, their combination, magnitude, and duration of
their application. This dependency is highly sensitive to the changes in applied
stresses (usually in accordance with the power law); therefore the lack of detailed
information about the actual stresses might lead to erroneous estimations. Errors of
the same kind may be then made regarding mitigations and measurement of
improvements. With this method, the product reliability improvement is only a
comparison to the previous condition, and if quantified, may be difficult to defend
[11].
A total understanding of the product/process functions and careful gathering of
the data ensure the correctness of the FMEA report. The usefulness of the FMEA
depends on the third stage of the process. To modify the design to eliminate the
failure modes, and to develop the process control to reduce the occurrence of the
failures to a minimum, should be the major goals for the implementation of FMEA.
II.2.7.1. Forming the FMEA Team
FMEA is generally carried out by a team of people with direct knowledge of
products and processes in question [25]. They should take pre-training to apply the
method successfully [4].

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33

The FMEA methodology is a team effort where the responsible engineer

involves assembly, manufacturing materials, service, quality, supplier, and the next
customer (whether internal or external). The team leader has certain responsibilities,
which include determining the meeting time and place, communicating with the rest
of the team, coordinating corrective action assignments and follow-up, keeping files
and records of FMEA forms, leading the team through completion of the forms,
keeping the process moving, and finally, drawing everyone into participation [2].
The purposes of forming a FMEA team are:
i.

Working of all related departments concurrently early times.

ii.

Using a wide range of information and experience.

iii.

Increasing the new ideas.

iv.

Making decisions on time preventing delays.

v.

Making decisions providing agreement in a wide participation ambience.

vi.

Improving and provoking the relationships between the departments.

vii.

Creating synergy in the team with giving personal tasks to people.

For each FMEA project, different teams should be formed. There should be 5-8

people in the team. It would be great if a member joins to team from top management
to show top managements support [15].
II.2.7.2. Determining the Potential Failure Modes
Failure modes are defined differently for design and process FMEA.
In design FMEA, the potential failure mode information can be one of two
things. First may be the method in which the item being analyzed may fail to meet
the design criteria. Second may be a method that may cause a potential failure in
higher-level system or may be the result of a low-level systems failure.
In process FMEA, one of three types of failures should be listed here. The first
and most prevalent is the manner in which the process could potentially fail to meet
the process requirements. The two remaining modes include potential failure in a
subsequent (downstream) operation and an effect associated with a potential failure
mode in a previous (upstream) operation. It should, for the most part, be assumed
that the incoming parts and/or material are correct according to the general definition
of nonconformity.
It is important to consider and list each potential failure mode. All potential
failure modes must be considered, including those may occur under particular

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34

opening conditions and under usage conditions, even if these conditions are outside
the range given for normal usage. A good starting point when listing potential failure
modes is to consider past failures, concern reports, and group brainstorming. Also
potential failure modes must be described in technical terms, not terms describing
what the customer will see as the failure. Some typical failure modes may include
cracked, deformed, and loosened, leaked, sticked, short circuited, oxidized, and
fractured [2].
II.2.7.3. Determining the Effects of Potential Failure Modes
The potential effects of failure are the effects of the failure as perceived by the
customer. The customer may be internal or may be the end user of the product. The
effects of failure must be described in terms of what the customer will notice or
experience, so if conditions are given by the customer there will be no dispute as to
which mode caused the particular failure effect. It must also be stated whether the
failure will impact personnel safety or break any product regulations. This section of
the study must also forecast what affects the particular failure may have on other
systems or subsystems in immediate contact with the system failure. For example, a
part may fracture, which may cause vibration of the subsystem in contact with the
fractured part, resulting in an intermittent system operation be able to cause
performance to degrade and then ultimately lead to customer dissatisfaction. Some
typical effects of failure may include erratic operation, noise, and poor appearance,
lack of stability, intermittent, and impaired operation [2].
One thing that the team members should bear in mind is that no matter how
small the probability is for a critical failure mode (with a catastrophic effect); this
failure mode should still be in the top list of items to be removed [5].
II.2.7.4. Determining the Potential Cause(s) of Failure
Every potential failure cause must be listed completely and concisely. Some
failure modes may have more than one cause; each of these must be examined and
listed separately. Then, each of these causes must be reviewed with equal weight.
Typical failure causes may include incorrect material specified, life assumption,
inadequate design, inadequate over-stressing, insufficient lubrication capability, poor
environment protection, and incorrect algorithm [2].

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35

II.2.7.5. Defining the Current Process Controls

The activities that assure the design sufficiency or process requirements for the
failure mode are listed. These activities may include, but are not limited to,
prevention measures, design validation, design verification for design FMEA and
incoming, process and final product quality control for process FMEA. These
controls may be supported through tests, which may include physical testing,
feasibility reviews, mathematical studies, and prototype testing. In general, there are
three types of controls that;
1.

Preventing or the causes or failure mode effects from occurrence or reducing

the rate of occurrence.

2.

Detecting the cause and leading to corrective actions.

3.

Detecting only the failure mode.

Obviously, the preferred method is to use the first type of control when

possible. If the first method is employed, the occurrence rating may be changed on
the following version of the document. If it is not possible to procure the first control
listed, the second and third controls may have to be used, preferably using the second
control listed over the third control [2].
II.2.7.6. Evaluation
After getting the failure modes, they are prioritized. The criteria used for this
evaluation are provided.
Occurrence:
Occurrence is the chance that one of the specific causes will occur. This must
be done for every cause listed. Reduction or removal in occurrence rating must not
come from any reasoning except for a direct change in the design. The likelihood of
occurrence is based on a 1-to-10 scale, with 1 being the least chance of occurrence
and 10 being the highest chance of occurrence. A sample scale can be seen in Table
II.4. Some questions are provided below that can help make this evaluation:
i.

What is the service history/field experience with similar systems?

ii.

Is the component similar to a previous system or sub-system?

iii.

How significant are the changes if the component is a new model?

iv.

Is the component completely new?

v.

Is the component application any different than before?

vi.

Is the component environment any different than before [2]?

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36

Table II.4. FMEA Occurrence Rating Guideline [15, 19]

PROBABILITY OF A

FAILURE RATE

RATING

Almost Never / Not likely.

< 1/1.500.000

Remote / Documented low

1/150.000

1/15.000

1/ 2.000

Low / Documented moderate

failure rate.

1/400

Medium / Undocumented

1/80

1/20

1/8

Very High / Failures common.

1/3

Almost Certain / Failures nearly

> 1/2

10

FAILURE

failure rate
Very Slight / Undocumented
low failure rate.
Slight / Failures occur from time
to time.

moderate failure rate.

Moderate High / Documented
high failure rate.
High / Undocumented high
failure rate.

always occur.

Severity:
Severity is the assessment of the seriousness of the potential failure modes
effect to the next component, sub-system, system, or customer if it occurs. It is
important to realize that the severity applies only to the effect of the failure, not the
potential failure mode. Reduction in severity rating must not come from any
reasoning except for a direct change in the design. Severity should be rated on a 1-to10 scale, with a 1 being none and a 10 being the most severe [1]. Table II.5 shows a
scale which is accepted generally.

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37

Table II.5. Severity Rating Table [15]

SEVERITY
CLASS

RATING

CRITERIA

None

No effect on product performance or process.

Very Minor

Very minor effect on product performance or process. Failure

is noticed by customers.

Minor

Minor effect on product performance or process. Failure is

noticed by customers.

Very Low

Very low effect on product performance or process. Failure is

noticed by customers. And customer lives some annoyances
when using the product.

Low

Low effect on product performance or process. Customer

feels some annoyances when using the product. Some part
which makes using easier works with low performance.

Moderate

It causes to re-treat or repair of the product. Product

performance is low. Product is working but some parts which
makes the usage easier is not working.

High

High effect on product performance or process. Product can

not be used. Some of the products (<100 %) need to be
separated as waste. Customer dissatisfaction.

Very High

All of products can be separated as waste. Product can not be

used. High customer dissatisfaction.

Serious

A break down related with safety and regulations. Failure

occurs with a warning. The results can be fatal.

Hazardous

10

A break down related with safety and regulations. Failure

occurs without a warning. The results can be fatal.

Detectability:
This section of the study is a relative measure of the assessment of the ability
of control to detect either a potential cause or subsequent failure mode before the
component, sub-system, or system is completed for process/ design FMEA.
Detectability is an assessment of the probability that the proposed current process
control will detect a potential weakness or subsequent failure mode before the part;
component or operation leaves the manufacturing operation, assembly or service
location for process FMEA. It is important to assume that the failure has occurred

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38

and then assess the capabilities of the current process control to prevent the shipment
of the part having this nonconformity or failure mode. It should not be assumed
automatically that detectability rating is low because occurrence is low, but assessing
the ability of the process controls to detect low frequency failure modes or prevent
them from going further in the process [1]. A sample table for detectability rating is
provided below.

Table II.6. Detectability Rating Guideline [15]

DETECTABILITY RATING

CRITERIA

Almost Certain

Current controls will detect the failure cause absolutely.

Very High

Current controls will detect the failure cause in very

high probability.

High

Current controls will detect the failure cause in high

probability.

Moderately High

Current controls will detect the failure cause in

moderate high probability.

Medium

Current controls will detect the failure cause in medium

probability.

Low

Current controls will detect the failure cause in low

probability.

Very Low

Current controls will detect the failure cause in very low

probability.

Remote

Current controls will detect the failure cause in remote

probability.

Very Remote

Current controls will detect the failure cause in very

remote probability.

Almost Impossible

10

Current control will detect the failure cause almost

never or there is no control here.

II.2.7.7. Calculating the Risk Priority Number (RPN)

Risk Priority Number is the product of the severity (S), occurrence (O), and
detectability (D) ratings, as shown below:
RPN = (S) x (O) x (D)
After completing the calculations of RPNs, all the failures are listed in order to
their RPNs and corrective actions are planned and taken according to this order.

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39

Values for the RPN can range from 1 to 1000, with 1 being the smallest risk
possible. The value of RPN is then used to rank order the various concern in the
design or production process. For concerns with a relatively high RPN, the
engineering team must make efforts to take corrective action to reduce RPN.
Likewise, because a certain concern has a relatively low RPN, the engineering team
should not overlook the concern and neglect an effort to reduce the RPN. This is
especially true when the severity of a concern is high. In this case, a low RPN may
be extremely misleading, not placing enough importance on a concern where the
severity level may be disastrous [2]. It should nevertheless remain in the top part of
the rating for analysis. Generally, control for this failure type will involve 100 per
cent inspection [26].
II.2.7.8. Corrective Actions
After every concern has been taken into account and given a risk priority
number, the team should begin to examine the corrective action(s) that may be
implemented, beginning with the concern of the greatest RPN and working in
descending order according to RPN.
The purpose of the corrective actions is to reduce one or more of the criteria
that constitute the risk priority number. An increase in design validation actions will
result in a reduction in only the detectability rating. Only removing of controlling
one or more causes/mechanisms of the failure mode through design revision can
effect a reduction in the occurrence rating. And only a design revision can bring
about a reduction in the severity rating. Some actions that should be considered when
attempting to reduce the three ratings include, but are not limited to: design of
experiments,

revised

design,

revised

test

plan,

and

revised

material

selection/specification.
It is important to enter None if there are no recommended actions available
to reduce any of the rating criteria. This is done so future users of the document will
know the concern has been considered [2].
After the corrective actions are taken, RPNs are recalculated and FMEA form
is updated.
An order of priorities must be followed to decide corrective action. This order
of preference is generally the following changes in product design, the service or the
general process; an increase in control and inspection measures. Design is most

29
40

effective at reducing risk indexes, mainly because of the repercussions it has on

reducing the frequency of failures. In contrast, control mainly affects detectability.
The following priorities order can thus be established for applying corrective actions:
(1)

Eliminate the cause of the failure: The design of a part might be changed, for
example, so that another piece that is similar and easily mistaken for it is not
incorrectly assembled.

(2)

Reduce the frequency or likelihood of occurrence: Instead of trying to

eliminate the root cause of the failure, the system is strengthened so it can
resist.

(3)

Reduce the severity of the failure: This can only be achieved with failure free
design or by using redundant systems.

(4)

Increase the likelihood of detectability: By increasing controls or designing an

improvement of the existing controls [26].
Difficulties associated with FMEA implementation include the timing of the

FMEA process at the product/process design stage, the establishment of a welltrained and balanced FMEA team, the coordination of individual departments in
generating an accurate FMEA report, and agreement on the FMEA report to improve
product/process designs by all departments. The intention of the FMEA application
is to shorten the time length for the design, and it must be verified that all
requirements are met before the design completion. The full cooperation of all
departments is required to start the FMEA study.
A major problem in FMEA implementation is to utilize the FMEA report in the
overall quality system implementation to improve the product and the manufacturing
operations. So the problem is not only to generate FMEA report, but also to use the
FMEA information in the overall quality system operation to improve the
product/process/service [5].

30
41

PART III A PROCESS FMEA IMPLEMENTATION STUDY IN A

PACKAGING COMPANY

A PROCESS FMEA IMPLEMENTATION STUDY IN A

PACKAGING COMPANY

III.1. OBJECTIVES of the IMPLEMENTATION

Process FMEA method is frequently used in several industries, especially in
automotive industry in last decade. This method is generally applied before the
production of a new product which has just been designed or before modifying
existing processes. This study is carried out in SUNJUT A.., in order to integrate
Process FMEA into a real case study. The main aim of this Process FMEA
application is to reduce high customer complaints and failure rates of the sewing
process. Furthermore, the other objectives are listed below.
i.

To see and show how this method can help develop an existing process.

ii.

To determine the risk level of the process and then to decrease it.

iii.

To reveal the renovation need by over viewing all the process.

iv.

To measure the efficiency of corrective actions done for failures this occurred
before.

v.

To look at the process from outside with a different point of view.

vi.

To eliminate the blaming attitude lived in past failure analysis experiences. So

the fear and resistance can be broken and people can look at process from
outside.

vii.

To respond the increasing reliability requirement in big bag industry.

viii. To decrease the high failure and customer complaint rate and their costs.
ix.

To form a method for collecting failure data which the company currently does
not have an effective one.

III.2. SCOPE of the IMPLEMENTATION

This implementation study was conducted in SUNJUT A.. who is a packaging
company and produces big bag as a product.

31
42

Information about the Company:

SUNJUT A. is one of the biggest bigbag producer companies in the world. It
was founded in 1968 and it is operating production on two factories which are in
Dudullu and Hadmky plants.
The company produces polypropylene (PP) sewing thread, webbing, fabric,
netting, and as a final product, big bag. Approximately 1300 people are working in
the company.
Export is composing approximately 90% of the companys trade. SUNJUT
A.. is capable of to reach any country in the world with its five sales offices in
USA, Germany, France, China and Turkey.
The company has proved its production quality as a holder of ISO 9001:2000
Quality Management System since 1995 [27].
Information about Bigbag:
Bigbag also known as flexible intermediate bulk container (FIBC) is defined as
an intermediate bulk container, having a body made of flexible fabric, which is
intended for shipment of solid material in powder, flake, or granular form. It is
designed to be lifted from the top by means of integral, permanently attached devices
such as lift loops or straps as seen in Figure III.1. Bigbags are used in several
industries such as chemical, pharmaceutical and food.

32
43

Top spout
Top fabric

Lifting device

Body fabric

Bottom Fabric

Bottom Spout

Figure III.1. Drawing of a Bigbag

Basically, the production process of a bigbag is composed of four main sub

processes. These are extrusion, weaving including coating, cutting and sewing.
Details of the whole process can be seen in Figure III.2.

33
44

RAW
MATERIAL
STORAGE
Polypropylene,
Additives
Yarn

Yarn
EXTRUSION

NARROW
WEAVING

FABRIC
WEAVING

Fabric
Webbing
COATING

Coated Fabric
CUTTING

Cutted Fabric
and Webbing

SEWING

Bigbag

END
PRODUCT
STORAGE
Figure III.2. The Overall Production Process of a Bigbag

34
45

FIBCs are generally manufactured to meet specific requirements of the

container users. The height of the container, the diameter and length of the
spouts, coated or uncoated fabric will be specified according to the type of product
that will be shipped [28].
The basic quality characteristics of a bigbag are;
i.

To carry the weight which is specified without no damage

ii.

Not to leak the product which is being shipped

iii.

Not to have any foreign body inside

III.3. STEPS of the IMPLEMENTATION STUDY
This Process FMEA study was implemented in order as given in Figure II.5.
III.3.1. Analyzing the Process
At first a flow chart of the sewing process was drawn to help understanding

each step of the process by the team members. Figure III.3. shows this flow chart.
There are optionally thirteen different steps in the process depending on the
specification of the product. Nearly thirty people are working in the process.

35
46

SPOUT VERTICAL SEWING

SPOUT DIAMETER SEWING
Y
BAFFLE/
SKIRT?

SEWING BAFFLE/SKIRT

N
Y

ZIGZAG
WEBBING
SEWING

ZIGZAG
WEBBING
SEWING?
N
BODY SEWING

BOTTOM SEWING

PLACING /
STICKYING
THE LINER?

PLACING / STICKYING
THE LINER
Y
N

TOP FABRIC/ACCESSORY
SEWING

TYING OF SPOUT

FOLDING/ CONDUCTIVITY
CONTROL

METAL
DETECTOR?
Y
N
PRESSING

PACKAGING

Figure III.3. Bigbag Sewing Process

36
47

METAL DETECTOR
CONTROL

III.3.2. Forming the FMEA Team

The FMEA team was formed of members who are working in different
positions in the sewing process. These members are:
i.

Production Responsible

ii.

Quality Manager

iii.

Production Quality Control Responsible

iv.

Production Chief

v.

Maintenance Responsible

vi.

Quality Assurance Engineer

After forming the team, training about the method was given to team members.

In addition, the form that will be used during the study was explained to them. It was
decided that the meetings would be held at least once in two weeks they would be
planned and conducted by Quality Assurance Engineer. It was planned to use
brainstorming technique during the meetings.
III.3.3. Determining the Potential Failure Modes
At first all the failure modes were determined step by step in the sewing
process. While doing this, a basic assumption of the Process FMEA was accepted by
all members of the team. This basic assumption was to assume that the raw materials
were good and failure free and everybody else upstream in the process was doing
FMEA to ensure only good materials going down in the chain [29]. All the team
members were encouraged to contribute to this stage. Every idea was discussed.
Knowledge from past incident investigations and the experiences of staff that
work with the production of bigbags on a daily basis had provided valuable
information that went into identifying the failure modes.
At the end of this stage, 104 individuals of failures were determined. Sewing of
body fabric step has the most to be 18. Then the other main sewing process steps are
lined up after to be 9, 10 and 11. Table III.1. shows the detailed information about
failure frequencies.

37
48

Table III.1. Frequency of Failures at Each Process Step

NO

Frequency of
Failures

PROCESS STEPS

SPOUT VERTICAL SEWING

FILLING SPOUT DIAMETER SEWING

DISCHARGE SPOUT DIAMETER SEWING

10

BAFFLE/SKIRT SEWING

11

ZIGZAG WEBBING SEWING

10

SEWING OF BODY FABRIC

18

SEWING OF BOTTOM FABRIC

PLACING / LABELLING THE PE LINERS

SEWING OF TOP FABRIC/ACCESSORIES

10

10

TYING UP THE DISCHARGE SPOUT

11

FOLDING

12

METAL DETECTING

13

PRESSING

The graphical presentation of this data can also be seen in Figure III.4. In this
figure the numbers on the axis label from 1 to 13 represent the process steps as
showed in the Table III.1. These numbers will represent the process steps in all the
figures which have the same notation coming after this part as same as here.

38
49

Figure III.4. Failure Frequencies of Process Steps

When all the failure modes are inspected, some of them were noticed that
they could emerge in different steps independently. These kind of multiple failures
are presented in Table III.2.

Table III.2. Multiple Failures in the Sewing Process

MULTIPLE FAILURES

Frequency
10

1 Becoming folds on sewing sides

2 Loosing stitch

3 Missing sewing yarn

4 Wide sewing holes

5 Wide sewing step distance

III.3.4. Determining the Effects of Failure Modes

After determining all the failure modes, the effects of each one on customers
were defined. Then the severity rating evaluation was conducted according to Table
III.3 for each effect. This table was adapted for team members usage from Table
II.5. It was intended to make team members understand the rating logic easier. Past
experiences were taken reference to build up this adaptation.

39
50

Table III.3. Severity Rating Guideline Used in Implementation Study

GENERAL CRITERIA FOR
SEVERITY
The customer does not feel
indisposed because of failure;
probably he does not notice it.

Failure bothers customer very

slightly. He feels just a little
performance loss.

Failure bothers the customer. It

can cause damages at the
equipment that is used.

COMPANY CRITERIA FOR

SEVERITY

RATING

The customer does not notice the failure.

1(none)

The customer notices the failure but there

is no obstacle to use product. He requests 2(very minor)
not to be repeated.
The customer notices the failure. A small
operation (repair, changing) may be
needed.
Product will be used in another place.
The customer gets price reduction.

4(very low)

A repair with moderate cost is needed.

5(low)

A repair with big cost is needed.

High customer dissatisfaction.

It is not possible to correct the
product. Breakdowns can
happen in the process.

Failure can affect safety

conditions at vital levels.

3(minor)

6(moderate)

The customer rejects the product. But

there is no damage to his machines or
other products. He requests just the costs
of products.

7(high)

The customer rejects the product. And

the failure causes damages on machines
and other products. So he requests these
damages' costs in addition to product
cost.

8(very high)

Fatal accidents happen with warning.

Fatal accidents happen without warning.

9(serious)
10(hazardous)

After all the effects were emerged, each process step was evaluated according
to their severity ratings. Two parameters were calculated to compare the severity
level of each step. It was considered that they could help apprehend the process and
when deciding and prioritizing the corrective actions that will reduce the risk level of
the process. These are total and average severity rating of each step. Severity rating
data for each process step is shown in Table III.4.

40
51

Table III.4. Total and Average Severity Ratings of Each Process Step

NO PROCESS STEPS

Frequency
of Failures

Total
Severity
Ratings

Average
Severity
Rating

SPOUT VERTICAL SEWING

57,0

6,3

FILLING SPOUT DIAMETER

SEWING

22,0

4,4

DISCHARGE SPOUT
DIAMETER SEWING

10

77,0

7,7

BAFFLE/SKIRT SEWING

11

84,0

7,6

ZIGZAG WEBBING SEWING

10

80,0

8,0

SEWING OF BODY FABRIC

18

122,0

6,8

SEWING OF BOTTOM
FABRIC

72,0

8,0

PLACING / LABELLING THE

PE LINERS

39,0

6,5

SEWING OF TOP
FABRIC/ACCESSORIES

10

56,0

5,6

10

TYING UP THE DISCHARGE

SPOUT

41,0

8,2

11 FOLDING

33,0

6,6

12 METAL DETECTING

20,0

10,0

13 PRESSING

19,0

4,8

104

722,0

TOTAL

AVERAGE of the PROCESS

6,9

Total severity rating is a cumulative data. Therefore it can not reflect the real
comparision. Because the frequency of failures directly affects this value. Average
severity value will be more meaningful. It can be said that this value represents the
severity level if a failure occurs in that step. So according to these values, metal
detecting step seems the most severe one. Then tying up the discharge spout,
sewing the bottom fabric and zigzag webbing sewing steps are lined up after.
The graphical presentation of average severity ratings can be seen in Figure III.5.

41
52

Figure III.5. Average Severity Rating of Process Steps

On the other hand when the failures were examined one by one, some of them
were determined to be able to cause serious and hazardous results as seen in Table
III.5. 9 and 10 rating were given to these kinds of failures by the team.

42
53

Table III.5. Serious and Fatal Failures

NO

PROCESS
STEP /
FUNCTION

METAL
DETECTING

METAL
DETECTING

SEWING OF
BODY FABRIC

Unbalanced loop heights

The webbing can be broken and this

can cause fatal accidents.

15

ZIGZAG
WEBBING
SEWING

Nonconforming zigzag
sewing

The webbing can be broken and this

can cause fatal accidents.

25

ZIGZAG
WEBBING
SEWING

Wide sewing step distance

The webbing can be broken and this

can cause fatal accidents.

37

SEWING OF
SKIRT

Sewing the skirt deeply

It blocks the closing of skirt and cause

tension at the top side of bigbag. It
can also cause webbing broken and
tearing.

63

ZIGZAG
WEBBING
SEWING

All the sewing is only one

side of the webbing

The webbing can leave the body

fabric and this can cause fatal
accidents.

64

ZIGZAG
WEBBING
SEWING

Loosing stitch

The webbing can be broken and this

can cause fatal accidents.

75

TYING UP
THE
DISCHARGE
SPOUT

Tying up the spout below

the tying up belt.

It makes tension at diameter of spout

and it can be exploded.

79

FOLDING

Not completing the

conductivity test

Conductivity is failed, this can cause

explosion.

90

SEWING OF
SKIRT

Calculating the belt

distance wrongly

It blocks the closing of skirt and cause

tension at top. It can also cause
webbing broken and tearing.

91

SEWING OF
SKIRT

Nonconforming sewing
according to belt distances.

It blocks the closing of skirt and cause

tension at top. It can also cause
webbing broken and tearing.

93

ZIGZAG
WEBBING
SEWING

POTENTIAL FAILURE
MODE

POTENTIAL EFFECTS OF THE

FAILURE

A piece of metal might be dropped

Not to check the goods by into bigbag. This can be dangerous for
human health and machines of the
the metal detector
customers.
Not to apply the metal
A piece of metal might be dropped
detecting procedure
into bigbag. This can be dangerous for
according to the
human health and machines of the
instruction
customers.

Not to lock the zigzag

sewing

43
54

The webbing can be broken and this

can cause fatal accidents.

III.3.5. Determining the Causes of Failures

At this stage all the causes of each failure mode were determined. Then
occurrence ratings were given to each cause according to Table III.6. This table is
also adapted for this study from Table II.4. This adaptation was held by the team
according to members responsibility areas. The failure rate of the production was
not being calculated at the time. The existing data that can be used for this rating was
the customer complaint records in the company. In addition to that records people
also had experiences about the occurrence of failures during the production. Table
III.6. was formed respect to these points of view.

Table III.6. Occurrence Rating Table Used in Implementation Study

Failure Frequency Detected in the
Production
Very Little:

> 1 / year

Customer Complaint
Frequency

RATING

> 1 / year

1 / year

2
1 / year

Little:

Moderate:

2 / year

4-5 / year

4
1 / 6 months

1 / month
2-3 / month

5
6

1/ week

7
1 / month

High:
3-4 / week

1 / day

9
1 / week

Very High:
> 1 / day

10

After all the causes were determined, they are classified under two main
groups. These are human sourced and machine sourced problems.

55
44

Table III.7. Main Cause Groups of Failures

Failure
Frequency

Total RPN

Human sourced

87

83,6

15932

76,8

Machine sourced

17

16,3

4812

23,1

Total

104

Main Causes

20744

Human failures were composing the major part. When they were reviewed, it
was noticed that three main root causes were behind them. For machine failures are
composed of two types. All these are shown by a cause-effect (fishbone) diagram in
Figure III.6.
Main Causes of Sewing Process Failures
Personnel

Lack of training
High labor force turnover rate
Carelessness
Sewing Process
Failures
Becoming dull of bottom
sewing needles
Becoming dull of top
sewing needles
Material

Machines

Figure III.6. Main Root Causes of Sewing Process Failures

After the occurrence ratings were given to failures the whole process and each
step were evaluated with two parameters. These are total and average occurrence
ratings. These parameters can give an idea about the failure occurrence level of
whole process and each step. It can provide a criterion to monitor and compare them.
Total occurrence rating of "sewing body fabric" step is the highest one to be 77. High
45
56

frequency of failures is the main reason behind this value. But it does not reflect the
real criteria for occurrence. The average occurrence rating is more meaningful. This
parameter tells the probability level of a failure in that step. This information is
valuable when deciding the corrective actions. So, filling spout diameter step has
the highest average occurrence rating. Sewing of bottom fabric and metal
detecting steps come after that. The average occurrence rating of the process is
calculated to be 4,9. This value can be considered as high. Occurrence ratings data
are summarized in Table III.8. and shown in Figure III.7.

Table III.8. Total and Average Occurrence Ratings of the Process Steps

NO PROCESS STEPS

Frequency
of Failures

Total of
Occurrence
Ratings

Average
Occurrence
Rating

SPOUT VERTICAL SEWING

52,0

5,8

FILLING SPOUT DIAMETER

SEWING

34,0

6,8

DISCHARGE SPOUT
DIAMETER SEWING

10

58,0

5,8

BAFFLE/SKIRT SEWING

11

48,0

4,4

ZIGZAG WEBBING SEWING

10

48,0

4,8

SEWING OF BODY FABRIC

18

77,0

4,3

SEWING OF BOTTOM
FABRIC

54,0

6,0

PLACING / LABELLING THE

PE LINERS

21,0

3,5

SEWING OF TOP
FABRIC/ACCESSORIES

10

53,0

5,3

10

TIEING UP THE DISCHARGE

SPOUT

18,0

3,6

11 FOLDING

18,0

3,6

12 METAL DETECTING

12,0

6,0

13 PRESSING

20,0

5,0

104

513,0

TOTAL
AVERAGE of the PROCESS

6,9

46
57

4,9

Figure III.7. Average Occurrence Ratings of Process Steps

III.3.6. Defining the Current Process Controls
The current process controls which can detect the failure modes were
determined at this stage. Then for each failure cause, the detectability rating was
given by using rating system presented in Table II.6. This evaluation is done
according to team members experiences.
There are two main controls along the process. First one is the folding step, and
the second one is the quality control peoples check based on sampling. Meanwhile
all the people working in the process can also step in if anyone sees a failure.
After detectability ratings were assigned to all failures, it was searched that
whether it is possible to define each steps detectability power or not. If it is possible,
this would help to compare the steps and to know which one is more detectability
capacity. Then two parameters were calculated for this issue, total and average
detectability ratings. These data can be seen at Table III.9.

47
58

Table III.9. Total and Average Detectability Ratings of Process and Its Steps

NO PROCESS STEPS

Frequency
of Failures

Total of
Detectability
Ratings

Average
Detectability
Rating

SPOUT VERTICAL SEWING

43,0

4,8

FILLING SPOUT DIAMETER

SEWING

33,0

6,6

DISCHARGE SPOUT
DIAMETER SEWING

10

66,0

6,6

BAFFLE/SKIRT SEWING

11

54,0

4,9

ZIGZAG WEBBING SEWING

10

52,0

5,2

SEWING OF BODY FABRIC

18

114,0

6,3

SEWING OF BOTTOM
FABRIC

51,0

5,7

PLACING / LABELLING THE

PE LINERS

43,0

7,2

SEWING OF TOP
FABRIC/ACCESSORIES

10

59,0

5,9

10

TYING UP THE DISCHARGE

SPOUT

32,0

6,4

11 FOLDING

27,0

5,4

12 METAL DETECTING

17,0

8,5

13 PRESSING

32,0

8,0

104

623,0

TOTAL
AVERAGE of the PROCESS

6,0

Here again, sewing body fabric step has the highest total detectability rating to
be 114, subject to high frequency of failures. Average detectability rating is more
meaningful. It shows the detectability power of the control at that process step when
a failure occurs. As seen in Table III.9., metal detecting and pressing steps have
the highest two value with 8,5, and 8,0. It means that it is quite hard to detect a
failure if any failure occurs at these steps. And the average detectability rating of the

48
59

whole process is 6,0. It could be considered as a bit high. This value means that it is
not so easy to detect a failure which occurs in this process averagely. It will also be a
reference value for making comparison after corrective actions are performed.

Figure III.8. Average Detectability Rating of Process Steps

III.3.7. Calculating the RPN
Risk priority number for each failure mode was calculated by multiplying
severity, occurrence and detectability ratings after they were determined.
After these calculations, all the failures were prioritized from highest to lowest
according to their RPN values. All these failures prioritization can be seen at
Appendix 3.
The highest RPN value belongs to Not to check the goods by the metal
detector failure which can occur at metal detecting step. Some other failures with
high RPN are listed in Table III.10 below.

49
60

50

61

PRESSING

The product filled with can leak

out.
Fabric of the bigbag can be teared
and the product filled with can
leak out.

Breaking the Blocks when pressing

Becoming folds on
sewing sides

DISCHARGE SPOUT Becoming folds on

DIAMETER SEWING
sewing sides

SEWING OF
BOTTOM FABRIC

The product filled with can leak

out.

Unbalanced loop
heights

SEWING OF BODY
FABRIC

The webbing can be broken and

this can cause fatal accidents.

Wide sewing holes

SEWING OF
BOTTOM FABRIC

Fabric of the bigbag can be teared

and the product filled with can
leak out.

Fabric of the bigbag can be teared

and the product filled with can
leak out

DISCHARGE SPOUT
Wide sewing holes
DIAMETER SEWING

10

A piece of metal might be

dropped into bigbag. This can be
dangerous for human health and
machines of the customers.

10

Setting the pressure not

appropriately by pressing
operator

Sewing operator failure

Sewing operator failure

Sewing operator failure

Becoming dull of
sewing needles

Becoming dull of
sewing needles

The operator does not

exactly know the
procedure.

Negligence of the
production chief.

10

10

Light table control

Light table control

Light table control

Light table control

10

400

400

400

405

432

432

480

540

POTENTIAL EFFECTS OF THE

POTENTIAL CAUSES
CURRENT PROCESS
SEV.
OCC.
DET. RPN
FAILURE
OF THE FAILURE
CONTROLS

Not to apply the

metal detecting
2 METAL DETECTING
procedure according
to the instruction

POTENTIAL
FAILURE MODE
A piece of metal might be
dropped into bigbag. This can be
dangerous for human health and
machines of the customers.

PROCESS STEP /
FUNCTION

Not to check the

1 METAL DETECTING goods by the metal
detector

NO

Table III.10 First 8 Failure Modes According to Their RPN

And then all the failures were examined respect to their RPN values. And
such a classification was formed as seen at Table III.11.

Table III.11. Failure Data According to RPN Value Intervals

Frequency
of Failures

Cumulative
Frequency

Total
RPN

Cumulative
RPN

1000 > x 500

540

540

500 > x 400

2949

3489

17

400 > x 300

17

16

3119

6608

32

300 > x 200

28

45

43

6754

13362

65

200 > x 100

43

88

85

6442

19804

96

100 > x 0

16

104

100

940

20744

100

RPN

RPN value can vary from 0 to 1000. The failures which their RPNs are
between 200 and 300 have the highest Total RPN. Where there is only one failure
whichs RPN is between 500 and 1000, there are 43 failures that the RPN is between
100 and 200.

Figure III.9. Total RPN Percentage of Each Interval

51
62

Total RPN of the failures which their RPNs are higher then 200, consist the 65
% of the Total RPN of all failures. This percentage is composed by 45 different
failures. The Pareto diagram of this analysis can be seen below in Figure III.10.

Pareto Chart of RPN Values

100
80

15000
60

10000

40

5000

20

200
100
300
400 > x = 0
x=
x=
x=
x=
>
>
>
>
100
300
200
400
500

Total RPN
Percent
Cum %

Percent

Cumulative RPN

20000

6754
32,6
32,6

6442
31,1
63,6

3119
15,0
78,6

2949
14,2
92,9

940
4,5
97,4

r
Othe

540
2,6
100,0

Figure III.10. Pareto Chart of RPN Values According to Basic Intervals.

After all the RPNs are determined and evaluated, it was searched that whether
it is possible to define each steps risk level according to some parameters. Total and
average RPN value for each process step and also whole process were calculated.
Average RPN value is more meaningful at this evaluation, too. It represents the risk
level of that step. It is possible to compare the steps and to know which one is more
risky respect to that parameter. This information will be important when defining the
corrective actions.
And the average RPN value of the whole process is 199,5. It is not so logical to
evaluate this value, whether it is high or not. This value will be very helpful when
evaluating the efficiency of corrective actions. The total and average RPN values of
the process and its step are submitted in Table III.12 and Figure III.11.

52
63

Table III.12. Total and Average RPN Value of the Process and Its Steps.

NO PROCESS STEPS

Frequency
of Failures

Total of RPNs

Average RPN

SPOUT VERTICAL SEWING

1594

177,1

FILLING SPOUT DIAMETER

SEWING

958

191,6

DISCHARGE SPOUT
DIAMETER SEWING

10

2820

282,0

BAFFLE/SKIRT SEWING

11

1794

163,1

ZIGZAG WEBBING SEWING

10

2010

201,0

SEWING OF BODY FABRIC

18

3215

178,6

SEWING OF BOTTOM
FABRIC

2352

261,3

PLACING / LABELLING THE

PE LINERS

985

164,2

SEWING OF TOP
FABRIC/ACCESSORIES

10

1691

169,1

10

TIEING UP THE DISCHARGE

SPOUT

927

185,4

11 FOLDING

594

118,8

12 METAL DETECTING

1020

510,0

13 PRESSING

784

196,0

104

20744

TOTAL

AVERAGE of the PROCESS

199,5

When the average RPN values are examined, metal detecting step seems the
most risky one. But the frequency of that step is just 2. Discharge spout diameter
sewing and sewing of bottom fabric steps are lined up after with 282 and 261,3
values. The failure frequencies of these steps are 10 and 9. It is reasonable to say that
these steps are quite risky, too.

53
64

Figure III.11. Average RPN Values of Each Process Step

III.3.8. Recommending the Corrective Actions

According to FMEA procedure, the most important failures, characterized by
high RPN, should be separated from those characterized by a significantly lower
RPN value. Selected High Priority failures represent issues for corrective action
plan development. It is important to decide how to make a separation about this
issue. Common recommendations of the conventional FMEA are usually very
general concerning calculated RPN values. For example,
i.

For higher RPNs the team must work for reducing the calculated risk through
corrective action(s),

ii.

High RPNs should be focused on,

iii.

Team effort should be expended on top 20 to 30% of problems as defined by

RPN values.
Pareto analysis is another common practice of an FMEA team when analyzing

RPN values. It suggests a limited list for recommending corrective actions to Top
X Issues. Chosen X-value could be 3 or 5 or 10, etc. In any case, the X will be a
definitely random choice. Obviously, this kind of decision-making is not the best
way.
How to decide which RPN values characterize critical issues that should be
immediately treated was answered by a distribution analysis of the RPN values.
Although some other sophisticated statistical techniques supporting distribution
54
65

analysis, it is recommended here the application of a simple and quite effective

graphical tool for RPN value analysis. This tool actually represents graph of ordered
RPN values and is to so-called ScreePlot. Scree Plot settings require preliminary
ordering of the RPN values by size, from smallest to largest. These values are then
plotted, across the graph, by size. The calculated RPN values usually form a rightskewed distribution, with a short tail on the left (negligible risk values) and a long
tail on the right (due to critical risk values representing outliers from the
distribution analysis point of view) Therefore, a nonsymmetrical upward curve is
formed by the shape of the points on a Scree Plot. The plots lower long part is
characterized by a gradual increase of the RPN values that can, usually, fit a straight
line with a rather slight slope. The RPN values scattered around this line should be
considered negligible. The issues characterized by these RPN do not require
immediate attention. The short uppermost part of Scree Plot is characterized by an
increase of the RPN values (RPN jumps). A straight line with a very strong slope
could fit it. The RPN values scattered around this line are related to the most critical
issues of FMEA that need to be dealt with promptly. Scree-plot graph of this study is
provided Figure III.12.
According to the scree-plot, the limit value is determined as 240. This value
will be the reference for choosing which failure modes should be taken attention.
Upper this value there are 32 failures defined. The total RPN of these failures
composes 48% of the total RPN of whole process.

6655

Figure III.12. Scree Plot of RPN Values

As a result of interpretation of the scree plot, corrective actions were defined

for the failures whichs RPN is above 240 by the team. Some of the higher items are
provided Table III.13. below.

56
67

57 68

10

Not to apply the metal

detecting procedure according
to the instruction

Wide sewing holes

METAL
DETECTING

DISCHARGE SPOUT
DIAMETER
SEWING

Unbalanced loop heights

Becoming folds on sewing

sides

Becoming folds on sewing

sides

Breaking the B-locks when

pressing

SEWING OF BODY
FABRIC

DISCHARGE SPOUT
DIAMETER
SEWING

SEWING OF
BOTTOM FABRIC

PRESSING

Wide sewing holes

SEWING OF
BOTTOM FABRIC

4
8

10

Not to check the goods by the

metal detector

METAL
DETECTING

10

10

10

RESPONSIBILITY /
TARGET COMPLETION
DATE

A technician will check all the sewing needles once a

week.

A technician will check all the sewing needles once a

week.

All of current metal detector operators will be

retrained. And this training will be included to the
annual training plan.

Maintenance Responsible /
01.11.2007

Maintenance Responsible /
01.11.2007

Quality Assurance Engineer,

Quality Control Responsible /
01.11.2007

Quality control department will check usage of metal Quality Control Responsible /
detector daily.
01.11.2007

CORRECTIVE / PREVENTIVE ACTIONS

Changing the unit quantity of pallets in which articles

that this failure occured. Training of pressing
Q.C.Responsible,
400
operators. Opening one pallet in a week by quality Prod.Responsible / 01.11.2007
control department.

Installing an effective training system for sewing

Q.A.Engineer,
400 operators and retraining of all current operators about
Q.C.Responsible,
these failures.
Prod.Responsible / 01.11.2007

Installing an effective training system for sewing

Q.A.Engineer,
400 operators and retraining of all current operators about
Q.C.Responsible,
these failures.
Prod.Responsible / 01.11.2007

Installing an effective training system for sewing

Q.A.Engineer,
405 operators and retraining of all current operators about
Q.C.Responsible,
these failures.
Prod.Responsible / 01.11.2007

432

432

480

540

SEV. OCC. DET. RPN

POTENTIAL FAILURE
MODE

PROCESS STEP /
FUNCTION

NO

Table III.13. Corrective Actions of The Failures Which Have Higher RPNs

In addition to Scree-plot approach, two more approaches were used to choose

failures for which corrective actions would be performed.
As mentioned in the Part II.2.7.8. of this study, when making this decision, the
failures which can cause fatal and hazardous results should also be considered, too.
Therefore corrective actions were defined for also the failures which have severity
ratings 9 and 10, regardless of whether their RPN is above 240 or not.
Some failures were noticed that they could emerge in different steps of the
process, as explained in Part III.3.3. It was discussed that if a corrective action was
defined for a failure of them at one step, it could cover the same failure that might
occur at other steps and it would help to reduce the risk there, too. So, corrective
actions for these kinds of failures were expanded whether their RPN value is above
240 or not.
III.3.9. Improvements
Some of the recommendations could be immediately implemented with a
minimum of expense, while others would be more difficult and require additional
funding.
After the corrective actions were completed, a meeting was held to discuss the
failures and its RPNs. Except the severity rating, occurrence and detectability ratings
were reviewed. If the team had observed any improvements in the process during the
time after the corrective action started, they reflected these observations to the new
occurrence and detectability ratings. After that all of the RPNs are recalculated.
According to new RPNs, the whole process and its steps were analyzed. The
improvements were computed. Table III.14. shows observed improvements at RPNs
before and after corrective actions.

58
69

Table III.14. Improvements on RPNs Before and After Corrective Actions

NO PROCESS STEPS

Frequency
of
Failures

Before Corrective
Actions

After Corrective
Actions

Total of
RPNs

RPNs
Average

Total of
RPNs

RPNs
Average

Improvement
(%)

SPOUT
VERTICAL
SEWING

1594

177,1

1055

117,2

34

FILLING SPOUT
DIAMETER
SEWING

958

191,6

499

99,8

48

DISCHARGE
SPOUT
DIAMETER
SEWING

10

2820

282,0

1476

147,6

48

BAFFLE/SKIRT
SEWING

11

1794

163,1

1103

100,3

39

ZIGZAG
WEBBING
SEWING

10

2010

201,0

1212

121,2

40

SEWING OF
BODY FABRIC

18

3215

178,6

2562

142,3

20

SEWING OF
BOTTOM FABRIC

2352

261,3

1256

139,6

47

PLACING /
LABELLING THE
PE LINERS

985

164,2

889

148,2

10

SEWING OF TOP
FABRIC/
ACCESSORIES

10

1691

169,1

1012

101,2

40

10

TYING UP THE
DISCHARGE
SPOUT

927

185,4

754

150,8

19

11

FOLDING

594

118,8

534

106,8

10

12

METAL
DETECTING

1020

510,0

340

170,0

67

13

PRESSING

784

196,0

576

144,0

27

104

20744,0

TOTAL RPN of the

PROCESS

AVERAGE RPN of the PROCESS

13268,0
199,5

70
59

36
127,6

After that, the improvements in occurrence and detectability ratings were

computed too. All of this information is summarized in Table III.15., and Table
III.16., respectively, and then graphical representation is presented in Figure III.13.

Table III.15. Improvements at Occurrence Ratings Before and After Corrective

Actions
Failure
Before Corrective
Frequency
Actions

After Corrective
Actions

Improvement
(%)

NO

PROCESS STEPS

SPOUT VERTICAL
SEWING

52,0

5,8

41,0

4,6

21

FILLING SPOUT
DIAMETER
SEWING

34,0

6,8

20,0

4,0

41

DISCHARGE
SPOUT DIAMETER
SEWING

10

58,0

5,8

33,0

3,3

43

BAFFLE/SKIRT
SEWING

11

48,0

4,4

33,0

3,0

31

ZIGZAG WEBBING
SEWING

10

48,0

4,8

30,0

3,0

38

SEWING OF BODY
FABRIC

18

77,0

4,3

64,0

3,6

17

SEWING OF
BOTTOM FABRIC

54,0

6,0

38,0

4,2

30

PLACING /
LABELLING THE
PE LINERS

21,0

3,5

19,0

3,2

10

SEWING OF TOP
FABRIC/
ACCESSORIES

10

53,0

5,3

40,0

4,0

25

TYING UP THE
10 DISCHARGE
SPOUT

18,0

3,6

15,0

3,0

17

11 FOLDING

18,0

3,6

16,0

3,2

11

12,0

6,0

5,0

2,5

58

20,0

5,0

18,0

4,5

10

104

513,0

12

METAL
DETECTING

13 PRESSING
TOTAL VALUES

Total
Occur.
Total
Occur.
Occur. Rating Occur. Rating
Ratings Average Ratings Average

AVERAGE VALUES of the PROCESS

372,0
4,9

60
71

27
3,6

Table III.16. Improvements at Detectability Ratings Before and After Corrective

Actions
Failure
Before Corrective
Frequency
Actions

After Corrective
Actions
Improvement
(%)

NO

PROCESS STEPS

SPOUT VERTICAL
SEWING

43,0

4,8

40,0

4,4

FILLING SPOUT
DIAMETER
SEWING

33,0

6,6

30,0

6,0

DISCHARGE
SPOUT DIAMETER
SEWING

10

66,0

6,6

63,0

6,3

BAFFLE/SKIRT
SEWING

11

54,0

4,9

52,0

4,7

ZIGZAG WEBBING
SEWING

10

52,0

5,2

52,0

5,2

SEWING OF BODY
FABRIC

18

114,0

6,3

112,0

6,2

SEWING OF
BOTTOM FABRIC

51,0

5,7

44,0

4,9

14

PLACING /
LABELLING THE
PE LINERS

43,0

7,2

43,0

7,2

SEWING OF TOP
FABRIC/
ACCESSORIES

10

59,0

5,9

53,0

5,3

10

TYING UP THE
10 DISCHARGE
SPOUT

32,0

6,4

32,0

6,4

11 FOLDING

27,0

5,4

27,0

5,4

17,0

8,5

14,0

7,0

18

32,0

8,0

30,0

7,5

104

623,0

12

METAL
DETECTING

13 PRESSING
TOTAL VALUES

Total
Detect.
Total
Detect.
Detec. Rating Detect. Rating
Ratings Average Ratings Average

AVERAGE VALUES of
the PROCESS

592,0
6,0

61
72

5
5,7

Figure III.13. Graphical Representation of Improvements at Average Occurrence

and Detectability Ratings

As seen in the results, corrective actions were mostly affected the occurrence
ratings. The decrease in occurrence rating is higher than those of detectability. This is
what FMEA also suggests, too. First, the team always tried to develop a corrective
action which would reduce the occurrence of a failure. If it was not possible to
prevent the occurrence of a failure, then more controlling and detecting activities
have been added to reduce RPN value of that failure.

62
73

PART IV RESULTS and DISCUSSION

RESULTS AND DISCUSSION

In this study, a major problem of the bigbag manufacturer SUNJUT A., has
been described, and a solution to this problem is advised. The problem was the high
failure rate in the sewing process which caused customer complaints. The FMEA,
which is a quality and a reliability tool, was implemented to reduce this rate.
A flowchart was given for the process and a team was formed by the members
who worked at different positions related to the process, as the FMEA suggested.
This was beneficial in discovering 104 individual of failures at the next step. This
quantity was considered to be high when compared to the other studies in the
literature. Also it caused time of the study to be longer. Another significant discovery
was the repeating of the failures that occurred in different steps of the process. At the
end of this step, a classified failure list was obtained which was one of this studys
objectives.
Then the effects and the severity of each failure were defined by the team. A
scale from 1 to 10 was used in this evaluation. Thirteen failures with severity levels 9
and 10 were found to be serious. A search was made to find out whether it was
possible to compare process steps to each other with respect to their severity levels.
The search was expected to help apprehend the process and decide the corrective
actions. Two parameters were used; one of them was the total severity rating and the
second one was the average severity rating. After a discussion, the total severity
rating was found to be meaningless since it was affected by frequency of failures
directly. On the other hand, the average severity rating seemed to correspond to the
teams needs. When compared with respect to this parameter, the metal detecting
step was found to be at the top of the list, and it was followed by the zigzag webbing
sewing, sewing of body fabric, and tying up the discharge spout steps. The average
severity rating of the whole process was calculated to be 6,9. This value reflected the
severity characteristic of the process, the average reaction of the customer. In case of

63
74

a failure, some considerable bad result, such as high customer dissatisfaction, can be
expected.
At the fifth stage of the implementation, the causes and the occurrence level of
the failures were determined. The 87 percent of the causes were found to be human
sourced, while the rest was mechanical. Once more, the process steps were analyzed
with the assistance of two parameters; total and average occurrence ratings. The
highest total occurrence rating was that of the sewing of body fabric step, whereas
filling spout diameter sewing had the highest average occurrence rating. The
difference meant that there were more types of failures that could occur in the sewing
of body fabric step. But in the filling spout diameter sewing step, a failure has higher
probability to occur. The average occurrence rating of the whole process was found
to be 4,9. Since the occurrence rating evaluation was mostly based on qualitative
data, this value was not assumed to reflect the real likelihood of failure occurrence.
Therefore it was decided to accept this value as a reference to see the effectiveness of
corrective actions.
After the definition of the existing process controls and their detectability
ratings, two parameters, similar to the ones calculated for the previous ratings, were
used in order to compare the detectability power of the process steps. Here again the
average detectability rating was determined as the indicator. When compared with
respect to these values, the metal detecting and pressing steps had the two highest
values with 8,5 and 8,0. This was supposed to mean that, it would be hard to detect a
failure that occurred at these steps. The average detectability rating of the whole
process was calculated to be 6,0. This value gave an idea about the detectability
power of the whole process. But it can not represent the process because of the
qualitative evaluation of detectability rating. It would be better to use it merely as a
reference tool to see and compare the effectiveness of corrective actions.
After completion of all the ratings, risk priority numbers of each failure mode,
and as a result, the average risk priority number of the process were calculated. The
risk level of the process, which was another objective of this study was determined
with the average RPN of the process to be 199,5. According to average RPN values
of the steps, metal detecting and discharge spout sewing were found as the most risky
steps with 510 and 282 values.
The next step was to find out how to choose and determine the failures for
which the corrective actions would start. Three approaches were used for this
64
75

decision. First a sub limit of 240, for the RPNs, was determined with the assistance
of a scree plot. There were 32 failure modes found above this sub limit. Secondly, as
the conventional FMEA suggested, all the failures with severity ratings 9 and 10
were implicated. Finally, multiple failures explained in the Part III.3.3 were
implicated, since the corrective actions could also cover them. As a result corrective
actions were started for 64 of 104 failure modes.
After the corrective actions had been completed, a meeting was held to
evaluate existing situations of the failures. All of the ratings were reviewed by the
team and the RPNs were recalculated. According to these evaluations, the new
average RPN of the whole process was calculated to be 127,6 which meant 36%
improvement. 27% and 5% improvements were determined in the occurrence and
detectability ratings respectively. The highest RPN improvement was provided at
metal detecting step with 67%.
This study was conducted with periodical meetings. By focusing on the
process, the blaming attitude, which people used to have in the past experiences, was
not encountered. This was another objective of this study.
Consequently, the Process FMEA technique was found to be efficient for the
existing processes not as usual as in the industry and literature. With this method, the
risk level of the process was decreased. These improvement evaluations were based
on team members observations; hence the improvements at customer complaints
could not be measured because of the limited time. But decreases in these values are
also expected.

65
76

PART V CONCLUDING REMARKS AND RECOMENDATIONS

CONCLUDING REMARKS AND RECOMMENDATIONS

In this study, it was aimed to obtain practical information about FMEA by

applying it to a real manufacturing process problem in SUNJUT A.. The companys
one of main problems was high failure rate of the sewing process. One type of
FMEA, Process FMEA, was implemented to reduce this rate and increase the
reliability of the process.
104 individual of failures were determined at the start of the implementation by
the team. This number is quite high when comparing to other case studies in the
literature. This is mostly because the process is labor intensive. Then it was
recommended to install training system which had not existed before. This activity
formed main part of the corrective actions. Logically, if the process was more in
automated, the failures could be assumed to decrease probably. But the technology is
dependant to labor usage used in this sector. Unless the process is automated, the
training of labor should always be a main activity to keep the process reliable. In the
end %36 improvement was noted for human sourced failures.
The main root cause of the mechanical failures was composed of dull sewing
needles. A monitoring and detecting system was also recommended and
implemented for this kind of failure. This corrective action led 48% improvement at
machine sourced problems.
At the end of the study, total improvement has been observed 36% based on
the decline in RPNs. This value shows the benefit of Process FMEA also for the
existing processes.
The disadvantages lived in this study was composed of mainly qualitative
evaluations. Rating evaluations were mostly based on the experiences of the team
members. To surpass this disadvantage, the team members at least who had five
years experiences about the sewing process were chosen. Due to the large scope of
the project and high failure frequency, the FMEA process was quite time-consuming.

77
66

That was another disadvantage, but, however, team members generally feel the
results were well worth the time and will have a positive impact on overall process
safety.
There was an assumption at the beginning of the study. This assumption was
that the material comes into the process would always be failure free. But during the
process it was discussed and seemed several times, team members mentioned about
the failures related with non-conforming materials. Most of these complaints refer to
faulty materials coming from cutting process. As a future work, another process
FMEA study was recommended for the cutting process.
Another future work which is to set a collecting and recording failure data
system has been recommended. It will be provided with a recording form used by
quality control department during the process control. The failure list obtained from
this study will guide to preparing this form. It will be attached to order papers used in
the production. This form is provided in Appendix 2. It is intended to calculate real
failure rate and failure probabilities in the future.
Two parameters were calculated from the statistics of RPN and ratings to
analyze the sewing process and its steps. These are total and average values of RPN,
severity, occurrence and detectability ratings. These parameters makes easier to
apprehend characteristics of the process and its steps and to compare them. These
kinds of analysis' or similar studies were found in only a few sources of literature.
Thats why; there was not a chance to compare the results of this study to the others.

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67

REFERENCES

[1]

Ahmed, J.S.: Modern Approaches to Product Reliability Improvement,

International Journal of Quality and Reliability Management, (1996) 13.

[2]

Besterfield, D.H.: Besterfield-Michna, C.: Besterfield, G.H.: BesterfieldSacre, M.: Total Quality Management, 3 rd Ed; Prentice Hall, New Jersey,
USA, (2003) 377.

[3]

Booker, J.D.: Industrial Practice in Designing for Quality, International

Journal of Quality and Reliability Management, (2003) 20.

[4]

Stamatis, D.H.: Failure Mode and Effect Analysis, American Society for
Quality, Wisconsin, USA, (2003) 25.

[5]

Teng, S.H.: Ho, S.Y.: Failure Mode and Effects Analysis, an Integrated
Approach for Product Design and Process Control, International Journal of
Quality and Reliability Management, (1996) 13.

[6] Sharma, R.; Kumar, D.; Kumar, P.: Predicting uncertain behavior of industrial
system using FM-A practical case, Applied Soft Computing, 8 (2008) 96.

[7] Madu, C.N.: Quality and Reliability Corner, Strategic Value of Reliability and
Maintainability Management, International Journal of Quality and Reliability
Management, (2005) 22.

[8]

Yu, J: Kurwa, M: Ensuring a Successful New Product Launch, Circuits

Assembly, (2002) 13.

[9] White, D.: Application of Systems Thinking to Risk Management, A Review of

the Literature, Management Decision, (1995) 33.

68
75
79

[10] Tan, C.M.: Customer focused Build in Reliability: A Case Study,

International Journal of Quality and Reliability Management, (2003) 20.

[11] Krasich, M.: Can Failure Modes and Effects Analysis Assure a Reliable
Product?, Reliability and Maintainability, 2007 Annual Symposium, IEEE,
(2007), 277.

[12] Vintr, Z.; Vintr, M.: FMEA Used in Assessing Warranty Costs, Reliability
and Maintainability, 2005 Annual Symposium, IEEE, (2005) 331.

[13] Deb, S.; Ghoshal, S.; Mathur, A.; Shresta, R.; Pattipati, K.R.: Multisignal
Modeling for Diagnosis, FMECA and Reliability, International Conference
on Systems, Man, and Cybernetics 1998, IEEE, 3 (1998) 3026.

[14] www.angelfire.com/ky3/mujdatkaya/qs9000.doc (04.02.2008).

[15]

Pyzdek, T.: The Six Sigma Handbook, McGraw Hill, USA, (2003) 596.

[16] Crow, L.H.: Studies and Methods for Improving the Effectiveness of
Reliability Tasks, Reliability and Maintainability, 2005 Annual Symposium,
IEEE (2005) 14.

[17] Bidokhti, N.: How to Close the Gap between Hardware and Software Using
FMEA, Reliability and Maintainability, 2007 Annual Symposium, IEEE
(2007) 167.

[18] Mariani, R.; Boschi, G.; Colucci. F.: Using an innovative SoC-level FMEA
methodology to design in compliance with IEC61508, Design, Automation &
Test in Europe Conference & Exhibition, 07 (2007) 1.

[19] ISO 9004: Quality Management Systems- Guidelines for performance

improvements, International Organization of Standardization, Geneva,
Switzerland, (2000).

69
80

[20] Braglia, M.: MAFMA, Multi-Attribute Failure Mode Analysis, International

Journal of Quality and Reliability Management, (2000) 17.

[21] Prasad, S.: Improving Manufacturing Reliability in IC Package Assembly

Using FMEA Technique, IEEE/CHMT-90/EMT Symposium, (1990) 15.

[22] Connoly, C.: Hanshall, E.: Engineering Quality Improvement Programme,

World Class Design Manufacture, (1995) 2.

[23]

Sharma, R.K.: Kumar, D.: Kumar, P.: Systematic Failure Mode Effect
Analysis Using Fuzzy Linguistic Modeling, International Journal of Quality
and Reliability Management, (2005) 22.

[24] su, C.: Hata Tr ve Etkileri Analizi ve retim ve Hizmet Sektr

Uygulamalar, Yksek Lisans Tezi, Marmara niv. Sosyal Bilimler Enstits,
stanbul, Trkiye, (2002) 32.

[25] Daya, M.B.; Raouf, A.: A Revised FMEA Model, International Journal of
Quality and Reliability Management, (1996) 13.

[26] Puente, J.: Pino, R.: Priore, P.: De la Fuente, P.: A Decision Support System
for Applying Failure Mode and Effects Analysis, International Journal of
Quality and Reliability Management, (2002) 19.

[27]

www.sunjut.com.tr (04.02.2008).

[28] www.eskabigbag.com.tr (04.02.2008).

[29] Mena, M.G.: A Customized FMEA for Process Management in the IC

Assembly and Test Industry, Electronics Packaging Technology Conference,
Cavite, Phillipines, (2000) 22.
70
81

APPENDIXES

71
82

83

CURRENT
PROCESS
CONTROLS

Prepared by:

Process Responsible:

Rev.Date:

Start Date:

Rev.No:

RESULTS

FMEA NO: Page:

End Date:

D R CORRECTIVE / RESPONSIBILITY /
OD
TARGET
E P PREVE RPN
CE
S
R
NTIVE
COMPLETION
ACTIONS
CT
T
E
P
N
U
E
ACTIONS
DATE
TAKEN
E
V.
N
RC
C
R. T.
T.

FAILURE MODE and EFFECTS ANALYSIS

O
C
PROCESS
POTENTIAL
S
POTENTIAL
POTENTIAL CAUSES C
STEP /
EFFECTS OF THE E
NO
FAILURE MODE
OF THE FAILURE U
FUNCTION
FAILURE
V.
R
R.

FMEA TEAM:

PROCESS:

APPENDIX 1

84

ART NO

CHECKED BY:

ORDER
TOTAL
NO

APPENDIX II

KG

FAILURE

WORKSHOP :

QUANTITY

CORRECTIVE ACTION

DATE :

QUALITY CONTROL EVALUATION FORM

PR.
CHIEF
APP.

FORM 216 REV.00

QC
APP.

85

Not to apply A piece of metal might

The operator
the metal
be dropped into bigbag.
does not exactly
10
6
detecting
This can be dangerous
know the
procedure.
for human health.
procedure.

The product filled with

Sewing operator
Light table
8
10
can leak out.
failure
control

DISCHARGE
Becoming
SPOUT
6
folds on
DIAMETER
sewing sides
SEWING

Sewing operator
9
5
failure

Light table
control

The webbing can be

broken and this can
cause fatal accidents.

Light table
control

SEWING OF
Unbalanced
5
BODY
loop heights
FABRIC

DISCHARGE
Fabric of the bigbag can
Becoming dull
SPOUT
Wide sewing
be teared and the
3
8
of sewing
9
DIAMETER
holes
product filled with can
needles
SEWING
leak to outside.
Fabric of the bigbag can
SEWING OF
Becoming dull
Wide sewing
be teared and the
4 BOTTOM
8
of sewing
9
holes
product filled with can
FABRIC
needles
leak out.

METAL
2
DETECTING

Prepared by:
Quality Assurance Engineer

Not to check A piece of metal might

Negligence of
METAL
the goods by be dropped into bigbag.
1
10 the production 6
DETECTING the metal
This can be dangerous
chief.
detector
for human health.

PROCESS POTENTIAL
POTENTIAL
N
STEP /
FAILURE
EFFECTS OF THE
O
FUNCTION
MODE
FAILURE

Q. Manager, Production Responsible,

Q.Cont.Responsible, Production Chief,
Maintenance Responsible, Q.A.Engineer

FMEA TEAM:

Production Responsible

Process Responsible:

1/11

Page:

Quality control department Quality Control Q.C.Dept followed

will check usage of metal
Responsible /
the usage of metal 10 3 6 180
detector daily.
01.11.2007
detector daily.

S O D
E C E RPN
V. C. T.

RESULTS

ACTIONS
TAKEN

FMEA NO:

18.02.2008

End Date:

400

405

432

432

All the sewing

needles are being
8 4 6 192
checked once a
week.
All the sewing
Maintenance
needles are being
Responsible /
8 4 6 192
checked once a
01.11.2007
week.
All the operators
Q.A.Eng.,
have been retrained
Q.C.Resp.,
9 3 9 243
about the sewing
Pr.Resp./ 01.11.07
failures.
Maintenance
Responsible /
01.11.2007

Installing an effective
All the operators
Q.A.Eng.,
training system for sewing
have been retrained
Q.C.Resp.,
8 5 5 200
operators and retraining of
about the sewing
Pr.Resp./ 01.11.07
all current operators.
failures.

Installing an effective
training system for sewing
operators and retraining of
all current operators.

A technician will check all

the sewing needles once a
week.

A technician will check all

the sewing needles once a
week.

All metal detector operators

Retraining was
Q.A.Engineer,
will be retrained. This
performed. Periodic
480
Q.C.Responsible /
10 2 8 160
training will be included to
training is included
01.11.2007
the annual training plan.
into 2008 plan.

540

CORRECTIVE /
PREVENTIVE
ACTIONS

18.02.2008

Rev.No:

RESPONSIBLE/
TARGET
COMPLETION
DATE

14.06.2007

Start Date:

Revision Date:

FAILURE MODE and EFFECTS ANALYSIS

D
O
E
POTENTIAL C
S
CURRENT T
CAUSES OF C
E
PROCESS E RPN
THE
U
V.
CONTROLS C
FAILURE R
T
R.
.

SEWING

PROCESS:

APPENDIX 1II

86

PRESSING

Loosing
stitch

Becoming dull of
Light table
8 bottom sewing 8
control
needles

SEWING OF
Missing
14
TOP FABRIC sewing yarn

The product filled

with can leak out.

Becoming dull of
Light table
7 bottom sewing 8
control
needles

Fabric of the bigbag

SEWING OF Wide sewing can be teared and the
Becoming dull of
Light table
12
5
9
TOP FABRIC
holes
product filled with
sewing needles
control
can leak out.
Setting the thread
SPOUT
tension not
Loosing
The product filled
Light table
13 VERTICAL
7 appropriately by 8
stitch
with can leak out.
control
SEWING
the sewing
operator

FILLING
Fabric of the bigbag
SPOUT
Wide sewing can be teared and the
Becoming dull of
Light table
11
5
9
DIAMETER
holes
product filled with
sewing needles
control
SEWING
can leak out.

The product filled

with can leak out.

The product filled

with can leak out.

Setting the thread

tension not
Light table
8 appropriately by 8
control
the sewing
operator

Sewing operator
Light table
10
failure
control

Breaking the Fabric of the bigbag

Setting the
B-locks can be teared and the
pressure not
8
5
when
product filled with
appropriately by
pressing
can leak out.
pressing operator

SEWING OF
Missing
10 BOTTOM
sewing yarn
FABRIC

DISCHARGE
SPOUT
9
DIAMETER
SEWING

SEWING OF Becoming
The product filled
BOTTOM
folds on
with can leak out.
FABRIC
sewing sides

3 168

All the operators

A technician will check all
Q.A.Engineer,
have been retrained
336 the sewing needles once a Q.C.Resp., Pr.Resp./
7 8
about the sewing
week.
01.11.07
failures.

6 168

Installing an effective
Q.A.Engineer,
All the operators
training system for sewing Q.C.Responsible, have been retrained
336
7 4
operators and retraining of Prod.Responsible / about the sewing
all current operators.
01.11.2007
failures.

8 200

8 200

5 5

5 5

All the sewing

needles are being
checked once a
week.

All the sewing

needles are being
checked once a
week.

Maintenance
Responsible /
01.11.2007

Maintenance
Responsible /
01.11.2007

3 192

Q.A.Engineer,
All the operators
A technician will check all
Q.C.Responsible, have been retrained
384 the sewing needles once a
8 8
Prod.Responsible / about the sewing
week.
01.11.2007
failures.
A technician will check all
360 the sewing needles once a
week.

6 192

8 192

Changing the unit quantity

Pallet unit quantity
of pallets in which articles
of 20 articles has
that this failure occurred. Q.C.Responsible,
been changed.
400
Training of pressing
Prod.Responsible /
8 3
Training and weekly
operators. Opening one
01.11.2007
control was
pallet in a week by
performed.
q.c.department.
Installing an effective
Q.A.Engineer,
All the operators
training system for sewing Q.C.Responsible, have been retrained
384
8 4
operators and retraining of Prod.Responsible / about the sewing
all current operators.
01.11.2007
failures.

5 200

A technician will check all

360 the sewing needles once a
week.

10

Installing an effective
Q.A.Engineer,
All the operators
training system for sewing Q.C.Responsible, have been retrained
400
8 5
operators and retraining of Prod.Responsible / about the sewing
all current operators.
01.11.2007
failures.

87
9

DISCHARGE Not stiching the

SPOUT
impermeability The product filled
Sewing operator
Light table
8
4
DIAMETER
material
with can leak out.
failure
control
SEWING
appropriately

Setting the
The product filled
thread tension
Light table
Loosing stich
7
8
with can leak out.
wrongly by the
control
sewing operator

21

22

BAFFLE
SEWING

Light table
control

20

Sewing the
spout without
drawing the
star.

Dropping of
The product filled
Sewing operator
Light table
stitch onto fabric
7
7
with can leak out.
failure
control
from webbing

DISCHARGE
Becoming folds
SPOUT
The product filled
on sewing sides
8
DIAMETER
with can leak out.
at star spout
SEWING

19

ZIGZAG
WEBBING
SEWING

18

Becoming dull
Light table
of sewing
7
control
needles

Wide sewing The product filled

7
holes
with can leak out.

BAFFLE
SEWING

17
5

Wide sewing The product filled

7
holes
with can leak out.

SPOUT
VERTICAL
SEWING

16

Becoming dull
Light table
of sewing
9
control
needles

Sliding the
bottom fabric The product filled
Sewing operator
Light table
8
4
10
from the inside with can leak out.
failure
control
of body fabric

SEWING OF
BOTTOM
FABRIC

15
6

The webbing can

Nonconforming be broken and this
Sewing operator
Light table
9
6
zigzag sewing can cause fatal
failure
control
accidents.

ZIGZAG
WEBBING
SEWING

6 162

Maintenance
Responsible /
01.11.2007

Maintenance
Responsible /
01.11.2007

7 5

7 4

All the sewing

needles are being
checked once a
week.
All the sewing
needles are being
checked once a
week.

Installing an effective
Q.A.Engineer,
All the operators
training system for sewing Q.C.Responsible, have been retrained
280
7 4
operators and retraining of Prod.Responsible / about the the sewing
all current operators.
01.11.2007
failures.

The articles with

Checking and approving
star spout have been
Q.C.Responsible /
288 the star drawing by quality
checked and
8 3
01.11.2007
control department.
approved at each
drawing.
Installing an effective
Q.A.Engineer,
All the operators
training system for sewing Q.C.Responsible, have been retrained
288
8 2
operators and retraining of Prod.Responsible / about the the sewing
all current operators.
01.11.2007
failures.

Installing an effective
Q.A.Engineer,
All the operators
training system for sewing Q.C.Responsible, have been retrained
294
7 4
operators and retraining of Prod.Responsible / about the the sewing
all current operators.
01.11.2007
failures.

A technician will check all

294 the sewing needles once a
week.

A technician will check all

315 the sewing needles once a
week.

5 140

9 144

6 144

6 168

6 168

5 175

Installing an effective
Q.A.Engineer,
All the operators
training system for sewing
Q.C.Responsible, have been retrained
320 operators and retraining of
8 2 10 160
Prod.Responsible / about the the sewing
all current operators about
01.11.2007
failures.
these failures.

Installing an effective
Q.A.Engineer,
All the operators
training system for sewing Q.C.Responsible, have been retrained
324
9 3
operators and retraining of Prod.Responsible / about the the sewing
all current operators.
01.11.2007
failures.

88

Wide sewing
step distance
6

Light table
control

DISCHARGE
Fabric of the bigbag
Becoming dull
SPOUT
Missing sewing can be teared and the
Light table
30
8
of bottom
5
DIAMETER
yarn
product filled with
control
sewing needles
SEWING
can leak out.

29

Fabric of the bigbag

Sewing the baffle
can be teared and the
Sewing operator
Light table
not like a straight
8
5
product filled with
failure
control
line
can leak out.

BAFFLE
SEWING

Light table
4
control

Tying people
failure

TYING UP
It blocks the opening
Equal tying ends
THE
of spouts. Customer
28
at star and rosette
8
DISCHARGE
can not fill the
spouts
SPOUT
bigbag.

It blocks the
discharging and
Sewing operator
Light table
8
4
causes the product
failure
control
filled with leak out.

Changing the
setting of
sewing step
distances by
operator.

Becoming dull
Light table
7
of bottom
8
control
sewing needles

The webbing can be

broken and this can 9
cause fatal accidents.

The product filled

with can leak out.

Missing sewing Fabric of the bigbag

SEWING OF
Becoming dull
of bottom fabric can be teared and the
Light table
27 BOTTOM
8
of bottom
4
at double chain product filled with
control
FABRIC
sewing needles
stitches
can leak out.

DISCHARGE
Sewing the
SPOUT
26
height of spout
DIAMETER
shortly
SEWING

25

ZIGZAG
WEBBING
SEWING

SEWING OF
Missing sewing
24
BODY
yarn
FABRIC

23

Fabric of the bigbag

ZIGZAG
Straight entrance can be teared and the
Sewing operator
Light table
WEBBING
8
7
of sewing
product filled with
failure
control
SEWING
can leak out.

All of the
mechanisms have
been closed.

9 2

Q.A.Engineer,
All the operators
A technician will check all
Q.C.Responsible, have been retrained
240 the sewing needles once a
8 5
Prod.Responsible / about the sewing
week.
01.11.2007
failures.

Installing an effective
Q.A.Engineer,
All the operators
training system for sewing Q.C.Responsible, have been retrained
240
8 3
operators and retraining of Prod.Responsible / about the sewing
all current operators.
01.11.2007
failures.

Installing an effective
Q.A.Engineer,
All the operators
training system for sewing Q.C.Responsible, have been retrained
256
8 2
operators and retraining of Prod.Responsible / about the sewing
all current operators.
01.11.2007
failures.

Q.A.Engineer,
All the operators
A technician will check all
Q.C.Responsible, have been retrained
256 the sewing needles once a
8 4
Prod.Responsible / about the sewing
week.
01.11.2007
failures.

Installing an effective
Q.A.Engineer,
All the operators
training system for sewing Q.C.Responsible, have been retrained
256
8 2
operators and retraining of Prod.Responsible / about the sewing
all current operators.
01.11.2007
failures.

Maintenance
Responsible /
01.11.2007

90

3 120

6 144

8 128

4 128

8 128

3 168

Q.A.Engineer,
All the operators
A technician will check all
Q.C.Responsible, have been retrained
280 the sewing needles once a
7 8
Prod.Responsible / about the sewing
week.
01.11.2007
failures.

Closing of the sewing step

270 distance mechanisms of the
sewing machines.

5 160

Installing an effective
Q.A.Engineer,
All the operators
training system for sewing Q.C.Responsible, have been retrained
280
8 4
operators and retraining of Prod.Responsible / about the sewing
all current operators.
01.11.2007
failures.

89

SPOUT
VERTICAL
SEWING

Sewing operator
Light table
6
8
failure
control

Adverse
Belt sewing point does
Sewing operator
Light table
spout vertical not conform. And sewing 7
8
failure
control
sewing
can be unstitched.

Becoming
The product filled with
folds on
can leak out.
sewing sides.

Opening the
machine cranks
Light table
8 more than inner 5
control
dimension.

The product filled with

can leak out.

Setting the
temperature
8
3
wrongly by the
operator
-

40

39

Fabric of the bigbag can

Becoming dull
SEWING OF Wide sewing
Light table
be teared and the product 7
of sewing
6
BODY FABRIC
holes
control
filled with can leak out.
needles

216

210

A technician will check

all the sewing needles
once a week.

A technician will check

210 all the sewing needles
once a week.

Installing an effective
training system for
216 sewing operators and
retraining of all current
operators.

216

216

224

224

Installing an effective
training system for
240 sewing operators and
retraining of all current
operators.
Installing an effective
training system for
240 sewing operators and
retraining of all current
operators.

Fabric of the bigbag can

Becoming dull
Missing
Light table
be teared and the product 7
of bottom
5
sewing yarn
control
filled with can leak out.
sewing needles

SPOUT
VERTICAL
SEWING

It blocks the closing of

skirt and cause tension at
SEWING OF
Sewing the
Sewing operator
Light table
37
the top side of bigbag, 9
3
SKIRT
skirt deeply
failure
control
webbing broken and
tearing.
TYING UP THE
Spout can be opened and
Tying people
Light table
38 DISCHARGE Loose tying this causes product filled 8
3
failure
control
SPOUT
with to leak out.

PLACING /
Melting of
36 LABELLING
liner
THE PE LINERS

Oil leakage
Negligence of
onto fabric
Customer can not use the
pressing
34
PRESSING
from
7
4
bigbag.
operator about
pressing
cleaning
machine.
Sliding the
SEWING OF
The product filled with
Sewing operator
Light table
35
skirt when
6
4
BODY FABRIC
can leak out.
failure
control
sewing

33

SEWING OF
32
BODY FABRIC

Opening the
PLACING / weld sides of
The product filled with
31 LABELLING the formliner
can leak out.
THE PE LINERS
when
sticking.

Maintenance
Responsible /
01.11.2007

Q.A.Engineer,
Q.C.Resp.
,Prod.Resp./
01.11.07

All the operators

have been
7 5
retrained about the
sewing failures.
All the sewing
needles are being
7 3
checked once a
week.

All the operators

have been
9 2
retrained about the
sewing failures.

All the operators

have been
6 4
retrained about the
sewing failures.

Q.A.Engineer,
Q.C.Resp.
,Prod.Resp./
01.11.07

Q.A.Engineer,
Q.C.Resp.,
Prod.Resp ./
01.11.07

All the operators

have been
8 3
retrained about the
sewing failures.

Q.A.Engineer,
Q.C.Resp.,
Prod.Resp. /
01.11.07

5 105

3 105

8 144

5 120

6 144

90

Becoming folds
The product filled with
on sewing sides at
8
can leak out.
star spout

50

BAFFLE
SEWING

Becoming folds The product filled with

7
on sewing sides
can leak out.

Dropping the
burned sewing
Customer can not use
48
FOLDING
yarn and dust
7
the bigbag.
proof pieces into
bigbag
Liner is teared.
Problems occur at
SEWING OF
Sliding the liner
49
filling process. The 7
BODY FABRIC
when sewing
product filled with can
leak out.

47

DISCHARGE
SPOUT
DIAMETER
SEWING

Sewing operator
failure

Sewing operator
failure

Negligence of
folding people

Sewing the spout

without drawing
the star by the
instruction of
prod.chief

Light table
control

46

SEWING OF
BOTTOM
FABRIC

Tieing people
failure

Changing the
setting of sewing
Wide sewing step The product filled with
step distances by
Light table
8
4
distance
can leak out.
operator or
control
production chief by
the time

Loosing stich

FILLING SPOUT
43
DIAMETER
SEWING

Light table
control

10

TYING UP THE Nonconforming

The product filled with
DISCHARGE
folding before
8
can leak out.
SPOUT
tieing up.

45

Sewing operator
failure

PLACING /
It blocks the filling
Being reverse of
Failure of stickying
Light table
LABELLING
proccess of customer. 5
5
liner
operator
control
THE PE LINERS
Bigbag does not stand.

Sewing crosses
The product filled with
over to weld at
7
can leak out.
formliner sewing.

44

42

Fabric of the bigbag can

be teared and the
Becoming dull of
Light table
7
5
product filled with can
sewing needles
control
leak out.

SEWING OF
BODY FABRIC

41

Wide sewing
holes

Setting the thread

The product filled with
tension not
Light table
5
8
can leak out.
appropriately by
control
the sewing operator

ZIGZAG
WEBBING
SEWING

Maintenance
Responsible /
01.11.2007

All the sewing

needles are
7 3
being checked
once a week.

Q.C.Resp. /
01.11.2007

Maintenance
Responsible /
01.11.2007

8 2

The articles
with star spout
have been
8 2
checked and
approved.

All of the
mechanisms
have been
closed.

Installing an effective
All the
Q.A.Engineer,
training system for
operators have
Q.C.Resp.,
189 sewing operators and
been retrained 7 2
Prod.Resp./
retraining of all current
about the the
01.11.07
operators.
sewing failures.

189

189

192

Checking and
approving the star
drawing by quality
control department.

Closing of the sewing

step distance
192
mechanisms of the
sewing machines.

200

200

Installing an effective
All the
Q.A.Engineer,
training system for
operators have
Q.C.Resp.,
200 sewing operators and
been retrained 5 4
Prod.Resp./
retraining of all current
about the the
01.11.2007
operators.
sewing failures.

210

A technician will
210 check all the sewing
needles once a week.
126

96

96

9 126

5 100

91

Light
table
control

Light
table
control

SPOUT
Becoming folds The product filled
Sewing operator
VERTICAL
7
3
on sewing sides with can leak out.
failure
SEWING

60

Light
table
control

Missing sewing
Becoming dull
SEWING OF
The product filled
59
at double chain
7
of bottom
4
TOP FABRIC
with can leak out.
stiches.
sewing needles

Changing the
setting of
sewing step
distances
Light
table
control

The product filled

7
with can leak out.
4

Wide sewing
step distance

SEWING OF
58
TOP FABRIC

Light
table
control

Setting the
The product filled
thread tension
7
4
with can leak out.
not
appropriately

Loosing stich

Light
table
control

Sewing can pass

SEWING OF Sewing ear parts
onto liner, causing
Sewing operator
BODY
smaller than
7
4
the product filled
failure
FABRIC
5cm.
with to leak out.

56

SEWING OF
57
TOP FABRIC

SEWING OF
Not starting Liner is teared. The
Sewing operator
BODY
sewing from the product filled with 7
3
failure
FABRIC
sticky tapes
can leak out.

The product filled

7
with can leak out.

55

Wide sewing
step distance
4

Changing the
setting of
sewing step
distances

53

SEWING OF
54
BODY
FABRIC

Light
table
control

Becoming dull
of bottom
5
sewing needles

BAFFLE
SEWING

Missing sewing The product filled

7
yarn
with can leak out.

Light
table
control

Not conform to It blocks the usage

Sewing operator
6
5
loop signs
of bigbag.
failure

ZIGZAG
WEBBING
SEWING

52

DISCHARGE
Rosette can not
SPOUT
Narrow folding move in the belt
Negligence of
51
5
4
DIAMETER of rosette spout and this will block
folding people
SEWING
opening.

84

84

84

84

8 112

Q.A.Engineer,
All the operators have
Q.C.Resp.,
been retrained about the 7 4
Prod.Resp. /
the sewing failures.
01.11.07
Installing an effective
Q.A.Engineer,
All the operators have
training system for sewing
Q.C.Resp.,
168
been retrained about the 7 2
operators and retraining of Prod.Resp. /
the sewing failures.
all current operators.
01.11.07

A technician will check all

168 the sewing needles once a
week.

3 105

All of the mechanisms

7 2
have been closed.

Closing of the sewing step Maintenance

168 distance mechanisms of the Responsible /
sewing machines.
01.11.2007

Installing an effective
Q.A.Engineer,
All the operators have
training system for sewing
Q.C.Resp.,
168
been retrained about the 7 2
operators and retraining of Prod.Resp. /
the sewing failures.
all current operators.
01.11.07

168

168

All of the mechanisms

7 2
have been closed.

Q.A.Engineer,
All the operators have
Q.C.Resp.,
been retrained about the 7 5
Prod.Resp. /
the sewing failures.
01.11.07

Closing of the sewing step Maintenance

168 distance mechanisms of the Responsible /
sewing machines.
01.11.2007

A technician will check all

175 the sewing needles once a
week.

180

180

92

The product filled

Sewing operator
Light table
7
3
with can leak out.
failure
control

The product filled

5
with can leak out.

The product filled

8
with can leak out.

FILLING
SPOUT
Missing
68
DIAMETER sewing yarn
SEWING

PLACING /
LABELLING
69
THE PE
LINERS

70

Fabric can be teared

Folding of
SEWING OF
because of extra
bottom fabric
Sewing operator
Light table
67 BOTTOM
tension.The product 8
5
at the middle
failure
control
FABRIC
filled with can leak
of the sewing.
out.

SPOUT
Wide sewing The product filled
VERTICAL
7
step distance with can leak out.
SEWING

Tearing of
liner

SEWING OF
Setting the
The product filled
Light table
66 BOTTOM Loosing stich
8 thread tension 4
with can leak out.
control
FABRIC
wrongly

Light table
control

Changing the
setting of
sewing step
distances
4

Negligence of
Light table
stickying
3
control
operators

Becoming dull
Light table
of bottom
5
control
sewing needles

162

system for sewing operators Q.C.Responsible, have been retrained

9 2
and retraining of all current Prod.Responsible /
about the the

140

144

Closing of the sewing step

distance mechanisms of the
sewing machines.

Maintenance
Responsible /
01.11.2007

All of the
mechanisms have 7 2
been closed.

Q.A.Engineer,
All the operators
A technician will check all the Q.C.Responsible, have been retrained
150
5 5
sewing needles once a week. Prod.Responsible /
about the the
01.11.2007
sewing failures.

160

Installing an effective training Q.A.Engineer,

All the operators
system for sewing operators Q.C.Responsible, have been retrained
160
8 2
and retraining of all current Prod.Responsible /
about the the
operators.
01.11.2007
sewing failures.

Maintenance
Responsible /
01.11.2007

Closing of the sewing step

distance mechanisms of the
sewing machines.

All of the
mechanisms have 8 2
been closed.

160

Installing an effective training Q.A.Engineer,

All the operators
system for sewing operators Q.C.Responsible, have been retrained
162
9 2
and retraining of all current Prod.Responsible /
about the the
operators.
01.11.2007
sewing failures.

168

168

Light table
control

Changing the
setting of
sewing step
distances

The webbing can be

ZIGZAG
broken and this can
Sewing operator
Light table
WEBBING Loosing stich
9
3
cause fatal
failure
control
SEWING
accidents.

DISCHARGE
SPOUT
Wide sewing The product filled
65
8
DIAMETER step distance with can leak out.
SEWING

64

62

SEWING OF Tearing of
The product filled
Sewing operator
Light table
BODY
liner at sewing
7
3
with can leak out.
failure
control
FABRIC
the liners
ZIGZAG
is only one broken and this can
Sewing operator
Light table
63 WEBBING
9
3
side of the
cause fatal
failure
control
SEWING

Sliding of
SEWING OF
fabric when
61
BODY
sewing the
FABRIC
webbing.

70

75

80

80

108

108

93

Wide sewing
step distance

The product filled

with can leak out.
7

Changing the
setting of
Light table
4
5
sewing step
control
distances

Pressing
operator
control
5

FOLDING

79

Installing an effective Q.A.Engineer, All the operators have

training system for
Q.C.Resp.,
been retrained about
120
10 2
operators and retraining
Pr.Resp./
the the sewing
of all of them.
01.11.07
failures.

Not completing Conductivitiy is

Failure of
Light table
conductivity failed, this can cause 10
4
3
folding people
control
test
explosion.

78

Installing an effective Q.A.Engineer, All the operators have

training system for
Q.C.Resp.,
been retrained about
128
2
operators and retraining
Pr.Resp./
the the sewing
of all of them.
01.11.07
failures.

135

Fabric of the bigbag

Becoming
SEWING OF
can be teared and
Sewing
Light table
folds on sewing
2
8
8
TOP FABRIC
the product filled
operator failure
control
sides
with can leak out.

Light table
9
control

Installing an effective Q.A.Engineer, All the operators have

training system for
Q.C.Resp.,
been retrained about
135
9
operators and retraining
Pr.Resp./
the the sewing
of all of them.
01.11.07
failures.

140

77

Installing an effective Q.A.Engineer, All the operators have

training system for
Q.C.Resp.,
been retrained about
140
7
operators and retraining
Pr.Resp./
the the sewing
of all of them.
01.11.07
failures.

All of the
mechanisms have
been closed.

Installing an effective Q.A.Engineer, All the operators have

training system for
Q.C.Resp.,
been retrained about
128
2
operators and retraining
Pr.Resp./
the the sewing
of all of them.
01.11.07
failures.

Failure of
stickying
operator

Tieing people
Light table
3
5
failure
control

Sewing
4
operator failure

Setting the
Light table
thread tension 4
5
control
wrongly

140

Closing of the sewing

Maintenance
140 step distance mechanisms Responsible /
of the sewing machines.
01.11.2007

FILLING
Fabric of the bigbag
Becoming
SPOUT
can be teared and
Sewing
Light table
folds on sewing
2
8
8
DIAMETER
the product filled
operator failure
control
sides
SEWING
with can leak out.

76

75

TYING UP
Tieing up the It makes tension at
THE
spout below the spout diameter and 9
DISCHARGE
tieing up belt. it can be exploded.
SPOUT
PLACING /
Liner drops to the
LABELLING Not stickying
bottom and
5
THE PE
of liner
customer can not fill
LINERS
the bigbag.

FOLDING

B-locks can be
broken, pieces can
drop into bigbag.
The fabric can be
teared.

Making bad
folding at
bigbags with
B-lock.

74

The product filled

with can leak out.

SEWING OF
73
Loosing stich
BODY FABRIC

It causes problems
Excess or less
in filling process of
SEWING OF folding if there
Sewing
Light table
72
customer. It can also 7
4
5
BODY FABRIC is folding at the
operator failure
control
cause fabric to be
sewing
teared.

71

BAFFLE
SEWING

60

64

64

90

70

70

94

SEWING OF

It blocks the
document entrance
of customer.

Sewing the
document bag
deeper.

90

89

Sewing
Light table
3
4
operator failure
control

Failure of the
Light table
production 3
3
control
chief

It blocks the closing

of skirt and cause
SEWING OF Calculating the belt
tension at top. It can 9
SKIRT
distance wrongly
cause webbing
broken.

Sewing
Light table
7
5
operator failure
control

The product filled

with can leak out.

Not sewing on
SEWING OF
folding if there is
BODY FABRIC
folding

Failure of
Light table
3
5
folding people
control

Sewing
Light table
5
3
operator failure
control

Making lampblack
For the food quality
traces when
bigbags, they can 7
burning the excess
not be used.
yarn.

Spout is cambered,
bigbag does not
stand smoothly.

SPOUT
VERTICAL
SEWING

88

Sewing
Light table
3
5
operator failure
control

Sewing the belt

above from the
correct point

FOLDING

87

Sewing
Light table
3
6
operator failure
control

Failure of
pressing
operators

Tieing people
Light table
3
5
failure
control

Sewing
Light table
5
6
operator failure
control

Changing the
setting of
Light table
4
6
sewing step
control
distances

SEWING OF Becoming folds on The product filled

TOP FABRIC
sewing sides
with can leak out.

Re-sewing of dust
SEWING OF
The product filled
proof and felt for
BODY FABRIC
with can leak out.
repair.

85

86

Customer can not

use the bigbag.

Missing loop

SEWING OF
BODY FABRIC

84

83

82

The product filled

with can leak out.

Wide sewing step

distance

TYING UP
Tying up the spout It makes camper,
THE
above the tying up bigbag does not
DISCHARGE
belt.
stand.
SPOUT
Placing the bigbags
Wrinkledness
into the pressing
become on the
PRESSING
machine not
fabric. Accessories
suitable.
can be teared.

81 ACCESSORIES

80

FILLING
SPOUT
DIAMETER
SEWING

81

84

105

105

Installing an effective
training system for
sewing operators and
retraining of all current
operators.

Q.A.Engineer,
Q.C.Resp.,
Pr.Resp. /
01.11.2007

Installing an effective Q.A.Engineer,

training system for
Q.C.Resp.,
105
sewing operators and
Pr.Resp. /
retraining of all of them. 01.11.2007

105

108

112

120

120

All the operators

have been
retrained about
the the sewing
failures.

All the operators

have been
retrained about
the the sewing
failures.

Closing of the sewing

Maintenance
All of the
120 step distance mechanisms Responsible / mechanisms have 5
of the sewing machines.
01.11.2007
been closed.

54

70

60

95

SEWING OF
BOTTOM
FABRIC

PRESSING

BAFFLE
SEWING

SPOUT
VERTICAL
SEWING

FOLDING

101

102

103

104

Customer
dissatisfaction.

Nonconforming
folding as
requested

Excess folding

Customer
dissatisfaction.
2

It blocks the filling

5
process of customer.

Folding the baffle The product filled

just from one side with can leak out.

Using printed
fabric for
strapping.

Sewing the bottom

Fabric of the bigbag
fabric with one
8
can be teared.
needle.

Not conform to It causes problems

SEWING OF
sewing distances in filling process of 4
BODY FABRIC
tolerances
customer.

SEWING OF
Sliding of top
The product filled
TOP FABRIC
fabric
with can leak out.
SPOUT
The product filled
VERTICAL
Narrow folding
with can leak out.
SEWING
It makes the baffle
BAFFLE
Excess or less
narrower and this
SEWING
folding
makes tearing.
ZIGZAG
Sliding the felt The product filled
WEBBING
when sewing
with can leak out.
SEWING
PLACING /
Not conform to It blocks the filling
LABELLING
sticky quantity
proccess of
THE PE LINERS written on order.
customer.

100

99

98

97

96

95

94

93

The webbing can be

broken. This can
9
cause fatal
accidents.

Light table
5 50
control

Light table
4 56
control

Light table
2 56
control

Light table
2 56
control

Light table
3 63
control

Sewing
Light table
operator 4
5 40
control
failure

Sewing
Light table
operator 4
2 40
control
failure

Sewing
Light table
operator 3
2 42
control
failure

Sewing
Light table
operator 4
6 48
control
failure

Sewing
Light table
operator 6
1 48
control
failure

Sewing
Light table
operator 4
3 48
control
failure

Sewing
operator
failure
Sewing
operator
failure
Sewing
operator
failure
Sewing
operator
failure
Sewing
operator
failure

Installing an effective
Q.A.Engineer,
Sewing
All the operators have
Light table
training system for sewing
Q.C.Resp.,
operator 4
2 72
been retrained about 9
control
operators and retraining of all Pr.Resp. /
failure
the sewing failures.
current operators.
01.11.2007

ZIGZAG
WEBBING
SEWING

92

Not to lock the

zigzag sewing

Sewing
Light table
operator 5
5 75
control
failure

Sewing the printed Labels can not be

labels deeper
read.

SEWING OF
ACCESSORIES

91

Installing an effective
Q.A.Engineer,
Sewing
All the operators have
Light table
training system for sewing
Q.C.Resp.,
operator 3
3 81
been retrained about 9
control
operators and retraining of all Pr.Resp. /
failure
the sewing failures.
current operators.
01.11.2007

Nonconforming It blocks the closing

sewing according of skirt and cause 9
to belt distances.
tension at top.

SEWING OF
SKIRT

54

54

CURRICULUM VITAE

AL DIRA
Birth Place: Denizli TURKEY
Birth Date: 02.01.1981
Education
1999-2003 Undergraduate Degree, Kocaeli University, Industrial Engineering Department
Professinal Work Experiences / Traineeships
11-2004 / ....

SUNJUT Co., stanbul - TURKEY ( www.sunjut.com.tr )

Quality System Engineer
07-2003 / 10-2003 ELIMSAN Co., Kocaeli TURKEY ( www.elimsangroup.com )
Asistant of Production Planning Chief
Experiences / Academic Projects and Thesis
At University;

Final Thesis: Solving a Bottleneck Problem with using Promodel Simulation Programme
in Production
Project II: Searching Simulation Concept
Project I: Management of Conflict, Negotiation and Ombudsmanship
Languages
English ( Advanced )
German ( Basic )
Computer Knowledge

Ms Office Programmes ( Word, Excel, Powerpoint )

Turbo Pascal Programming Language
Promodel Simulation Programme

96