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IJQRM QUALITY PAPER

31,7
A revised FMEA application to
the quality control management
788 Claudia Paciarotti, Giovanni Mazzuto and Davide D’Ettorre
DIISM, Università Politecnica delle Marche, Ancona, Italy
Received 13 February 2013
Revised 11 June 2013
Accepted 5 September 2013 Abstract
Purpose – The purpose of this paper is to propose a cost-effective, time-saving and easy-to-use failure
modes and effects analysis (FMEA) system applied on the quality control of supplied products. The
traditional FMEA has been modified and adapted to fit the quality control features and requirements.
The paper introduces a new and revised FMEA approach, where the “failure concept” has been
modified with “defect concept.”
Design/methodology/approach – The typical FMEA parameters have been modified, and a
non-linear scale has been introduced to better evaluate the FMEA parameters. In addition, two weight
functions have been introduced in the risk priority number (RPN) calculus in order to consider different
critical situations previously ignored and the RPN is assigned to several similar products in order to
reduce the problem of complexity.
Findings – A complete procedure is provided in order to assist managers in deciding on the critical
suppliers, the creation of homogeneous families overcome the complexity of single product code
approach, in RPN definition the relative importance of factors is evaluated.
Originality/value – This different approach facilitates the quality control managers acting as a
structured and “friendly” decision support system: the quality control manager can easily evaluate
the critical situations and simulate different scenarios of corrective actions in order to choose the
best one. This FMEA technique is a dynamic tool and the performed process is an iterative one.
The method has been applied in a small medium enterprise producing hydro massage bathtub,
shower, spas and that commercializes bathroom furniture. The firm application has been carried out
involving a cross-functional and multidisciplinary team.
Keywords Methodology, FMEA, Risk assessment, Quality control, Supplied products quality
Paper type Research paper

1. Introduction
During recent years, the worldwide economic crisis and globalization of markets have
heavily affected industrial production systems. Increasing customer requests in term
of product quality, cost and flexibility forces more and more enterprises to adopt lean
manufacturing strategies, in order to pursue the elimination of waste through continuous
improvement and thus increasing product quality and supply chain competitiveness.
This paper discusses the quality control of lean factory suppliers. The correct choice
of suppliers is a key element for component quality improvement (Li and Zabinsky,
2011; Lin, 2012). The quality of supplied components allows a reduction in failures or
waste during product manufacturing/assembly and prevents after sales problems.
According to De Toni et al. (1995), as far as the value chain is concerned, quality can
be classified as:
International Journal of Quality &
. in-bound quality: vendor quality and delivery performance;
Reliability Management
Vol. 31 No. 7, 2014 . internal quality: product design, process engineering, manufacturing quality
pp. 788-810
r Emerald Group Publishing Limited performance; and
0265-671X
DOI 10.1108/IJQRM-02-2013-0028 . out-bound quality: sales and distribution quality performance.
This paper analyses the purchased products’ quality performance, thus dealing A revised FMEA
with in-bound quality as reported by Robinson and Malhotra (2005), which can be application
considered as the first element in “supply chain quality management.” One of the most
important goals of this research is to provide an innovative quality risk management
methodology (Sun et al., 2012), reducing the risks linked to the use of defective
products.
As discussed by Ahire et al. (1995), total quality management (TQM) is “an 789
integrative philosophy of management for continuously improving the quality of
products and processes to achieve customer satisfaction.” Companies adopting
traditional quality control systems can base their activity on early inspection and
removal (or rework) of defective products and on a late identification of failure causes
(or defects). The TQM approach instead focuses on the removal of defective products to
be produced and or commercialized analysing the whys of non-compliance aspects
through analytical tools such as root cause analysis. In this context the use of TQM
proactive tools, such as failure mode and effects analysis (FMEA) and fault tree
analysis (FTA), flowcharting and process mapping becomes crucial for successful
implementation.
FMEA is a well-known tool for assessing potential failure modes for a product or
process. It provides decision guidelines based on cost and quality elements (Chao and
Ishii, 2007). In this paper a modified version of FMEA technique applied to supplied
products is discussed in order to define a set of risk priority number (RPN)-based rules
to be used as a support system to implement quality improvement actions.
The paper is organized as follows: Section 2 discusses the relevant FMEA literature.
Section 3 focuses on the research approach: the traditional and revised FMEA
techniques are described in Sections 3.1 and 3.2; Section 3.2 explains how the
traditional FMEA theory has been modified in order to apply its concept to quality
control. In particular, a new evaluation of RPN O, S and D parameters is detailed.
A description of the research method is proposed in subsection 3.3 and the case study
is presented in subsection 3.4. Section 4 highlights the study results and, finally, the
conclusions are reported in Section 5.

2. Literature review
FMEA is “a systematic method of analysing and ranking the risks associated with
various product (or process) failure modes (both existing and potential), prioritizing
them for remedial action, acting on the highest ranked items, revaluating those items
and returning to the prioritization step in a continuous loop until marginal returns set
in” (Dailey, 2004). FMEA investigates causes and effects of potential failure modes in
order to assure quality and reliability of a product or process. The use of the FMEA tool
is very important, especially in the earliest development phases (Dittmann et al., 2004).
FMEA timing is essential: an early implementation of the technique is crucial for
reducing and/or eliminating the corrective actions, thus reducing the cost of a late non-
compliance identification.
FMEA application dates back to 1949 when the US Army used it in the aeronautic
sector in order to solve reliability and safety problems during the design and
production phases. Over the years, the FMEA tool has become standard practice in
Japanese, American and European manufacturing companies (Norell, 1993): from
aerospace (NASA) to the automotive and electronics sectors, from the food industry to
the energy sector and the medical and pharmaceutical arenas. FMEA provides
qualitative and quantitative information about reliability and safety for both simple
IJQRM products and complex systems (Hawkins and Wollons, 1998), in order to implement a
31,7 good risk management strategy. Huang et al. (1999) also developed a prototype
computer system that supports FMEA on the internet, thus enhancing its wide
applicability. FMEA tools and techniques can be successfully applied to several
engineering fields, as is briefly shown in Table I.
FMEA outcome is the RPN, a parameter that defines the product criticality level.
790 Many researchers have questioned the validity of RPN in real cases (Bowles, 2003) and
many of them have tried to create a more objective method: Kara-Zaitri et al. (1992)
discussed a methodology which uses a probabilistic combination of RPN to calculate
the importance of an event; Barends et al. (2012) proposed a probabilistic modification
of FMEA in order to have a quantitative esteem of failure mode occurrence and
detection. Ben-Daya and Raouf (1996) calculated a RPN on a logarithmic scale;
Bevilacqua et al. (2000) used a combination of FMECA with Monte Carlo simulation to
obtain a more realistic measure of RPN, evaluated as the sum of six parameters (safety,
machine importance for the process, maintenance costs, failure frequency, downtime
length and operating conditions) multiplied by a seventh factor (the machine access
difficulty); FMEA has been modified by Sankar and Prabhu (2001) by applying an
“if-then” rule for the RPN calculation; Lee (2001) encodes DFMEA models of a
mechatronic system with the use of Bayesian probabilistic networks; He and Adamyan
(2001) used the Petri net methodology to study failure effects; to consider all possible
combinations of failures is impossible for an FMEA team, so Price and Taylor (2002)
studied a system which uses simulation to select the most likely combinations of
failures for an automated investigation; Chin et al. (2009) proposed an integrated
approach between FMEA and data envelopment analysis (DEA) to determinate the
RPN in terms of overall risks, calculated as the average of the maximum and minimum
risk of each failure mode.
Over the years, researchers have used the FMEA technique integrated with fuzzy
logic in order to obtain more realistic information. Bowles and Pelaez (1995) were the
first authors to use FMEA along with fuzzy logic; based on Bowles’ idea, Xu et al.
(2002) used this method to improve the quality of a turbocharger system; Puente
et al. (2002) used a fuzzy decision model for applying FMEA to a wide variety of
problems; Pillay and Wang (2003) proposed a new approach, integrating FMEA, fuzzy
rules and grey relation theory in order to exceed the several drawbacks of traditional
FMEA; Braglia et al. (2003) utilized “the technique for order preference by similarity to
ideal solution” in a fuzzy mode in order to evaluate the relative importance of the RPN;
FMEA and fuzzy techniques were applied to a nuclear reliability engineering problem
by Guimaraes Ferreira and Lapa (2004) and Tay and Lim (2006) used a generic fuzzy
logic-based FMEA method to simplify the RPN calculation; Yang et al. (2008) proposed
an approach called fuzzy rule-based Bayesian reasoning and his validity was tested in
the maritime collision risk due to technical failures; Hu et al. (2009) utilized the FMEA
tool related with the fuzzy analytic hierarchy process to study the risks of green
components. For an exhaustive literature review, Liu et al. (2013) analysed 75 FMEA
papers published between 1992 and 2012.
Since this paper refers to the FMEA application for quality control, it is worth
highlighting that in the study by Korayem and Iravani (2008) the RPN calculus is
unchanged. The abovementioned authors studied an integrated application of FMEA
technique and quality function deployment (QFD) in the design of two robots for
industrial and medical applications, a field where high levels of reliability, performance
and quality are crucial. Although the FMEA parameters were studied according
Authors Application field Description

Atkinson et al. (1992), Hydraulic system They built an object-oriented software library representing models of hydraulic circuits, in order to analyse the
Hogan et al. (1992) performance of failure mode and effects analysis and fault tree analysis on any arbitrary hydraulic circuit
Gilchrist (1993) Failure cost FMEA was used to obtain the risk of failure in terms of cost
Braglia (2000) Domestic appliance An alternative multi-attribute decision-making approach for prioritizing failures in failure mode is presented to solve the
manufacturer fundamental question of ranking
Tarum (2001) Process selection Potential failures were identified from a financial point of view, developing a method called failure modes, effects, and
(financial) risk analysis (FMERA)
Scipioni et al. (2002) Food industries The FMEA methodology, integrated with HACCP system is used to assure products quality, and as a mean to improve
operational performance of the production cycle
Spencer and Particle accelerator A set of analysis procedures for magnet designers was developed to improve the reliability of a particular style of magnet
Rhee (2003)
Rhee and Ishii (2003) Particle accelerator A new methodology, life cost-based FMEA, was introduced to measure risk in terms of cost
Capunzo et al. (2004) Chemistry FMEA was experimented in a clinical laboratory, evaluating and measuring the hazards of a process malfunction
Nichols et al. (2004) Chemistry FMEA was conducted to determine the various processes that could lead to an identification error in point-of-care testing
Cassanelli et al. Motor control Ordinary FMEA was applied during the design phase of an electric motor control system and performed to understand
(2006) system the failure mechanism of the indicted component and integrate
Bertolini et al. (2006) Food industries An FMEA application in the farming and food industries is presented for detecting the possible critical points of its
traceability system and at proposing improvements
Almannai et al. Manufacturing This paper describes an integrated approach developed for supporting management in addressing technology,
(2008) automation organisation, merging the quality function deployment technique and the FMEA technique
Pinna et al. (2008) Handling transfer FMEA is used to study safety-relevant implications arising from possible failures in performing remote handling
system operations at ITER facility, and possible incidental scenarios were defined as output
Chiozza and Ponzetti Healthcare The FMEA process and review data available on the application of this technique to laboratory medicine are used,
(2009) obtaining a significant reduction of the RPN applying FMEA to blood cross-matching
Arabian- Reliability of a FMEA method has been used to study the reliability of many different power generation systems. Comparison is made
Hoseynabadi et al. wind turbine between the quantitative results of an FMEA and reliability field data from real wind turbine systems and their
(2010) assemblies
Hassan et al. (2010) Process plan An approach to develop a quality/cost-based conceptual process planning is presented, considering the quality
characteristics and the process elements in QFD method as input to complete FMEA
Nikolić et al. (2011) Energy business The risks in the business of the public enterprise are analysed, identifying the risk as commercial, financial and political,
classification immanent for project finance, and their evaluation was done using FMEA
application

FMEA applications
A revised FMEA

791

Table I.
IJQRM to QFD, there is no way to identify a different critical situation by analysing the
31,7 RPN value.
In this paper, traditional FMEA is modified in order to fit better with the specific
features of the quality control. The modified RPN formulation proposed here
allows the main and most diffused shortcoming of the traditional FMEA as for
instance: “The relative importance among O, S and D is not taken into consideration”,
792 “The three risk factors are difficult to be precisely evaluated” and “The RPN cannot
be used to measure the effectiveness of corrective actions” (Liu et al., 2013) to be
overcome.
Chen and Ko (2009) proposed a methodology which incorporates FMEA into QFD
using a Fuzzy ordered weighted geometric averaging , in order to consider the design
risks related to customer satisfaction; a similar approach was used by Wang et al.
(2009) through a fuzzy weighted geometric means and also by Zhang and Chu (2009)
which applied a fuzzy weighted least squares model; Zhang and Chu (2011) proposed
the fuzzy method as an effective solution to calculate the RPN under uncertainty.
All these works allows the analyst to use a different approach for RPN evaluation, but
their practical application can be quite difficult in the absence of a robust mathematical
background.
The present paper suggests a different approach for FMEA application, providing
managers with a simple and “user-friendly” tool.

3. Research approach
3.1 FMEA methodology
The application of the FMEA method can be divided into three subsequent phases:
. qualitative analysis, based on the identification of all potential failure modes,
causes and effects;
. quantitative analysis, based on the evaluation of the RPN index; and
. corrective analysis, based on the implementation of improvement strategies in
order to reduce the risk level.
The FMEA work team is generally a multi-disciplinary one composed of people from
different areas (design, manufacturing, management, etc.) skilled with specific product/
process know-how. It is also important to detect a group leader acting as a team
facilitator.
A schematic description of the FMEA process is shown in Figure 1 (McDermott
et al., 1996).
The first step in the FMEA process is the product/process data collection and
arrangement, based on the experts’ opinion and/or on historical data.
The second step is concerned with the identification of all the relevant potential
failure modes, and in particular with the failure mode detectability D, that is the
capability to detect and locate the failure itself.
The third step determines the failure mode severity S in order to understand the
possible fault consequences in terms of functionality and/or production losses, from a
system performance and/or customer satisfaction point of view.
The last parameter to be evaluated is the failure mode occurrence O, related to the
probability that the failure will occur.
Detectability, severity and occurrence are usually defined through the use of discrete
values ranked on a predefined scale. The most common rating is scaled from 1 to 10
 Data collection A revised FMEA
application

Determine potential
D FMEA report
failure modes

no
793

Determine the effects Correction

S RPN
of each failure required?

yes
Determine the causes
O
of each failure Corrective actions

Figure 1.
modification data FMEA process

for each parameter, where higher scores are associated with higher potential risks.
Severity, occurrence and detectability ranking criteria are summarized, respectively,
in Tables II-IV.
The RPN value, evaluated ad D, S and O product, is then used to generate a risk
ranking:

RPN ¼ O  S  D ð1Þ

RPN knowledge assures that the team members focus on the most critical failure
modes, thus classifying corrective actions into two categories:
(1) preventive actions, in order to avoid the failure situation; and
(2) corrective actions, in order to minimize the effects produced by a failure.
Finally, RPN recalculation and risk ranking updating are carried out.

Severity Description Ranking

Dangerously high The failure effect is hazardous for customer/user safety 10

Extremely high The same as above only with warning 9
Very high The product is not operative 8
High High degradation of product and customer dissatisfaction 7
Moderate Partial malfunction of the product and customer dissatisfaction 6
Low The product could be reworked and some customer dissatisfaction 5
Very low The failure could be noticed by many customers 4
Minor The failure could be noticed by few customers 3
Very minor The failure is not apparent to the customer 2 Table II.
None No effect 1 Severity ranking criteria
IJQRM Occurrence Description Frequency Ranking
31,7
Very high Failure is almost inevitable 1 in 2 10
1 in 3 9
High Repeated failure 1 in 8 8
1 in 20 7
794 Moderate Occasional failure 1 in 80 6
1 in 400 5
1 in 2,000 4
Table III. Low Relatively few failures 1 in 15,000 3
Occurrence 1 in 150,000 2
ranking criteria Remote Failure is unlikely 1 in 1,500,000 1

Detectability Description Ranking

Absolute uncertainty Impossible to detect the failure 10

Very remote Very difficult to detect the failure 9
Remote Difficult to detect the failure 8
Very low Very low chance to detect failure 7
Low Low chance to detect failure 6
Moderate Moderate chance to detect failure 5
Moderately high Moderately high chance to detect failure 4
Table IV. High Probably the current control will detect the failure 3
Detectability Very high High probably the current control will detect the failure 2
ranking criteria Almost certain Surely the current control will detect the failure 1

3.2 The revised FMEA approach

The traditional FMEA theory has here been modified in order to fit the tool to the
quality control. In particular O, S and D parameters will be evaluated differently.
As reported in Section 3.1, the traditional FMEA approach adopts a linear scale for
determining O, S and D and their numerical values. In the proposed approach the scale
becomes the non-linear one in the range {1 3 9}. The use of the modified non-linear
scale has been identified in accordance with the firm’s FMEA team in order to define a
“friendly” decision support system, also taking into account a widespread opinion of
inadequacy of the traditional approach. Several studies have recently highlighted
the need for an FMEA technique amendment and improvement and the choice of the
reduced scale range has been derived from QFD, continuous product improvement tool
(Govers, 2001) and in particular from the “relationships matrix” between customer
needs and design characteristics. Limiting the parameter variability range allows
the modified FMEA to be a leaner and faster tool, preserving at the same time its
effectiveness and powerful outcomes.
Another important change in this revised FMEA approach regards the meaning of
FMEA parameters, which have been modified in order to fit with the “defect concept”
rather than the “failure concept.”
The defectiveness probability O, as is more clearly detailed below, has been linked
to the acceptance quality limit (AQL) indicator. The AQL parameter provides an
indication that as long as the percentage of defective products ( PD) of the supplied lots
is less than the AQL, the majority of the lots will be accepted.
 The severity parameter (S) has been evaluated analysing the product impact on the A revised FMEA
final customer, both in terms of costs and customer/user safety and satisfaction. application
The detectability parameter (D) reflects the chance to detect potential defect modes
according to the quality control procedures of the supplied product lots. It is important
to highlight that parameter D is not a product family characteristic; it depends on
autonomous decisions of the quality controller, being mainly based on his or her
experience. 795
Tables V-VII show the criteria used in order to define the FMEA parameters values.
Once occurrence, severity and detectability have been evaluated for each product
family it will be possible to calculate the RPN.
The methodological approach used here, and proposed to implement FMEA,
integrates the traditional approach and quality control concepts.
The first proposed change to the traditional FMEA tool takes into account
the introduction of a weight function for the occurrence parameter. According to the
traditional approach, if the supplied lot percentage defectiveness exceeds a specific
AQL, the occurrence parameter is set to the higher value, ignoring the actual
percentage defectiveness value. In such a case the use of traditional RPN tends to
assigns the higher occurrence value to product families with different defectiveness
probability, i.e., 2 and 25 per cent, all above a predefined AQL value (i.e. 1 per cent), thus
underrating the most critical situation. In our proposal this shortcoming is overcome
by introducing the weight function of Equation (2) that has been linked to the

Occurrence Description Probability (%) Ranking

High The percentage of defective products is higher than AQL 41 9

Medium The percentage of defective products is less or equal than 0oXp1 3 Table V.
AQL and higher than zero Occurrence ranking
Low The percentage of defective products is null 0 1 criteria

Severity Description Ranking

High The defect mode could impact on the customer safety and satisfaction, 9
generating high costs. The product cost is extremely high
Medium The defect mode does not impact on the customer safety and satisfaction, but 3
over the time it could generate performance degradation. The product cost is Table VI.
medium-high Severity ranking
Low Potential defect mode is easily solvable. The product cost is low 1 criteria

Detectability Description Ranking

Remote The supplied product is not qualitatively checked in the factory, so the 9
defect mode could be detected by the customer
Moderate The product is not checked in acceptance, but the potential defect could be 3 Table VII.
detected during the internal operations or before product leaving the factory Detectability ranking
High The defect mode could be detected by the quality control in acceptance 1 criteria
IJQRM defectiveness probability Pd:
31,7 
1 if Pd X10%
f ðP d Þ ¼ ð2Þ
1 otherwise

The second change regards product families with both severity and detectability
796 parameters equal to 9. According to the studied firm’s quality control rules, it is not
acceptable that important products (S ¼ 9) are not controlled (D ¼ 9). Such a situation
could be acceptable only in presence of a supplier quality certificate attesting to the
lot compliance, otherwise a different quality control rule should be implemented. The
revised RPN highlighting this critical situation is tackled by introducing another
weight function, as shown in Equation (3):

0 if S ¼ 9; D ¼ 9; CF ¼ 0
gðS; D; CFÞ ¼ ð3Þ
1 otherwise

where CF is a Boolean variable equal to 1 if the quality certificate is released, and 0 in

the other case.
The introduction of the two weight functions previously described lead to a the
modified RPN formulation of Equation (4):

RPN ¼ f ðpD Þ  gðS; D; CFÞ  ½O  S  D ð4Þ

Equation 4 highlights an RPN value varying in the range (729 729): a negative RPN
value identifies a defectiveness probability of a product family higher than 10 per cent;
a null RPN identifies the lack of quality control for an important product family and of
the supplier quality certificate.

3.3 The research method

The research approach here proposed consists of six sequential steps, briefly described
in the following (as shown in Figure 2):
(1) problem identification;
(2) experts panel definition: each component must be chosen according to criteria
of competence and area;
(3) data set analysis: the panel of experts analyse the available data for the specific
problem;

Problem identification Defects Analysis

Definition of the panel of

RPN definition
experts

Figure 2.
The research
approach schema Dataset Analysis Results analysis
 (4) defects analysis: each product is analysed in depth in order to define the A revised FMEA
parameters O, D and S; application
(5) RPN definition: information from O, D, S, f(PD) and g(S,D,CF) are used to
evaluate RPN according to the revised FMEA approach; and
(6) results analysis: the results are analysed in order to define the proper corrective
actions. 797
The approach proposed in this work tries to take into account the main factors
influencing the manufactured product quality. An ad hoc panel of experts was created
in order to encourage communication during joint application design ( JAD) type
meetings in order to effectively define and review the quality requirements for
the product family. The panel was made up of seven participants and included
two academics, whose research studies are mainly focused on quality control, two
managers of the company, two factory supervisors and one operator. The panel
worked for a period of about two weeks in order to outline the main factors which
influence the quality of the product and to develop a user-friendly tool. The
methodology consists of two main phases: collection and structuring of knowledge.
The collection and structuring of knowledge took place in a group session and it is
based on the collection and the organization of the inputs.
In particular, the “defect analysis” is structured as shown in Figure 3.

3.4 Case study

This section describes the real application of the modified FMEA to the quality control
department of an Italian small to medium enterprise. The company produces hydro
massage bathtubs and showers, and markets bathroom furniture. Using yearly about
12,000 different items. The products data are collected in the product database
organized as shown in Table VIII.
Owing to the very large amount of purchased items, the modified FMEA tools have
been applied to a family level, grouping several different items characterized by
relevant similarities. Each purchased product family has been assigned an RPN in
order to turn quality staff attention only towards crucial and critical products families.
The typical family structure is shown in Figure 4.
The purchased products are classified in product classes and then further subdivided
in subclasses. A subclass can also be formed by items coming from different
suppliers. Different quality control policies can be set up for items provided by the
same supplier. Different products belonging to the same subclass and provided by
the same supplier are grouped according to the detectability parameter. The features
of each group are stored in the groups database; as is briefly shown in Table IX.
Each product family resulted in being composed of homogeneous items and
characterized by a unique RPN value. Once the rules for defining homogeneous items
groups have been identified, the specific developer software tool helps the decision
maker to identify the family products groups, to evaluate RPN and to define possible
scenarios for quality control policy amendment.
The software tool flowchart is shown in Figure 5, and is briefly described as follows:
(1) The “Create” task prepares data input, analyses the product database and
creates the groups database including every groups’ features. Root 1 on
the flowchart, the “Creating Groups” algorithm is used. The pseudo code of the
algorithm has been reported in Table X.
 31,7

798

Schema
IJQRM

Figure 3.
“Defect analysis”
Defining f(PD)

Analysis of the
Defining O
defect percentage

Analysis of the
Dataset Processing product impact on Defining D RPN
the final customer

Analysis of the
Quality Control Defining S Defining f(PD)
Procedure

Defining CF
 (2) Root 2 is followed in case of insertion of new items or supplier: product A revised FMEA
database and the groups database are consequently updated. application
(3) For each group (family) RPN is calculated and the product groups are ranked.
(4) The “Corrective action simulator” task allows evaluation of the effects of
different corrective actions on the risk ranking and the potential improvements
in the system. The quality controller can evaluate the different results of each 799
action and then choose the best solution.
(5) At the end of the analysis, the user can choose the corrective action (Roots 3
and 2). All databases are updated and a new risk analysis is carried out.
Specifically, the “Updating Group” algorithm distinguishes between
“updating” and “corrective” action.

4. Results and discussion

The product database is composed of 13 product classes, each of which consists of at
most nine subclasses. The whole supplier set is composed of 286 suppliers. Data
related to the first half of 2012 have been used. The product database size does not

Product Product Class Subclass Product Supplier Not

code description Class Subclass description description type Supplier description Incoming checked

6152730 OROGLA C 3 Methacrylate Particles Polyester F2 ARKEMA 2 0

et al. resin SRL Table VIII.
6182500 EPDM F 6 Plastic Tube Plastic F0 TRISTONE 1 0 Portion of product
TBE products FLOWTECH database

Product Class

Product Subclass

Supplier

Product Type

Figure 4.
Family structure

Class Subclass Supplier Defectiveness (%) Certificate O S D

Table IX.
E 5 F540009 12.8205 Yes 9 9 9 Portion of group
B 1 F201126 1.8547 No 1 3 3 database
IJQRM
31,7
Data=’Create’
Or Products DB
Data=item

800
2
Data
== 1
NO ’Create’?

YES

Algorithm for Algorithm for

Updating Group Creating Groups

Groups DB

Data=’Action’
RPN Calculus

Groups Ranking

Corrective
Actions Simulator

STOP NO Edit?

3
YES

Corrective
Actions
Figure 5.
The application
flowchart
 A revised FMEA
application

801

Table X.
Pseudo code of the
“Creating Groups”
algorithm

allow the authors to show the whole analysis performed. For this reason the results
analysis will explain in detail only two product subclasses:
. A1 – this subclass concerns the power unit of “hydro massage bathtub”; and
. E5 – this subclass concerns the assortment of metal screws.
The subclasses A1 and E5 are supplied by five and eight suppliers, respectively.
In order to better understand the meaning of the severity (S) parameter it is important
to analyse the defectiveness causes that can generate potential product defect.
The causes of defect for A1 can be “dimensional” (non-compliance of product
dimensions) and/or “functional” (non-compliance of products specifications both in
terms of technical and safety characteristics). The subclass A1 is critical in term
of safety because it is composed of electronic products in contact with water; it is
essential for product functionality and it is expensive.
Regarding the subclass E5, the potential causes of defect mainly concern the
mechanical-physical characteristics of some specific items such as, for example,
screws, nuts, bolts and similar. In such a situation the potential defect mode does not
have a serious effect on customer safety and satisfaction, as negative effects are easily
solvable during manufacturing/assembly and the product cost is relatively low.
These considerations allow the authors to assign a severity value equal to 9 for A1
and equal to 1 for E5.
IJQRM Regarding the detectability, the applied modality of control is not the same for all
31,7 codes of the subclasses A1 and E5. The operator establishes the codes to be checked
based mainly on his or her experience.
Using the “Creating Groups” algorithm, it is possible to cluster the subclasses A1
and E5 in homogenous groups (families) and to evaluate PDO values. The algorithm
outcome is shown in Table XI.
802 The functions f ( Pd), Equation (2), and g(S, D, CF), Equation (3), are automatically
calculated and a RPN value is associated with each family, Equation (4) (Table XII).
The families are classified by RPN in descending order. The partial family ranking
for A1 and E5 is summarized in Table XIII.
The supplied items risk ranking allows the authors to highlight the previously
detailed critical situation:
. The family A1-F620688-D3 has the higher RPN value. It means that it is more
critical than the other with a positive RPN.
. The family E5-F280110-D1 has a negative RPN value (RPN ¼ 9). It identifies a
defectiveness probability of a family higher than 10 per cent; in fact E5-F280110-
D1 has a defectiveness probability of 12.5 per cent.
. The family A1-F620688-D9 is characterize by a null RPN. It identifies the
situation in which an important product family is not controlled and the quality
certificate is not released by supplier.
Following company policy, families with null or negative RPN values need an
immediate corrective action to improve their quality control policy. It is mandatory to
reduce the higher RPN values, starting from the top of the list. The severity parameter
depends on the product itself and so it can be difficult to decrease. The main focus is to
reduce O and D values. As an example, it is possible to apply an acceptance quality

Class Subclass Supplier PD CF O D S

A 1 F620688 1.6495 0 9 3 9
A 1 F620688 2.6316 0 9 1 9
A 1 F630029 0 1 1 9 9
A 1 F340041 0 0 1 3 9
A 1 F340041 0 0 1 1 9
A 1 F991088 0 0 1 1 9
A 1 F240103 0 0 1 1 9
A 1 F620688 4.48 0 9 9 9
E 5 F280002 0 1 1 9 1
E 5 F250094 0 1 1 9 1
E 5 F210025 0 0 1 9 1
E 5 F280110 12.5 0 9 1 1
E 5 F250094 0 0 1 3 1
E 5 F250129 0 1 1 3 1
Table XI. E 5 F250094 0 0 1 1 1
“Creating groups” E 5 F280001 0 0 1 1 1
algorithm result for E 5 F620350 0 0 1 1 1
A1 and E5 subclass E 5 F990606 0 0 1 1 1
Class Subclass Supplier PD CF O D S f (PD ) g (S,D,CF) RPN
A revised FMEA
application
A 1 F620688 1.6495 0 9 3 9 1 1 243
A 1 F620688 2.6316 0 9 1 9 1 1 81
A 1 F630029 0 1 1 9 9 1 1 81
A 1 F340041 0 0 1 3 9 1 1 27
A 1 F340041 0 0 1 1 9 1 1 9 803
A 1 F991088 0 0 1 1 9 1 1 9
A 1 F240103 0 0 1 1 9 1 1 9
A 1 F620688 4.48 0 9 9 9 1 0 0
E 5 F280002 0 1 1 9 1 1 1 9
E 5 F250094 0 1 1 9 1 1 1 9
E 5 F210025 0 0 1 9 1 1 1 9
E 5 F280110 12.5 0 9 1 1 1 1 9
E 5 F250094 0 0 1 3 1 1 1 3
E 5 F250129 0 1 1 3 1 1 1 3
E 5 F250094 0 0 1 1 1 1 1 1
E 5 F280001 0 0 1 1 1 1 1 1 Table XII.
E 5 F620350 0 0 1 1 1 1 1 1 f(PD), g(S,D,CF) and
E 5 F990606 0 0 1 1 1 1 1 1 RPN values

Class Subclass Supplier PD CF O D S f (PD ) g (S,D,CF) RPN

A 1 F620688 1.6495 0 9 3 9 1 1 243

A 1 F620688 2.6316 0 9 1 9 1 1 81
A 1 F630029 0 1 1 9 9 1 1 81
A 1 F340041 0 0 1 3 9 1 1 27
A 1 F340041 0 0 1 1 9 1 1 9
A 1 F991088 0 0 1 1 9 1 1 9
A 1 F240103 0 0 1 1 9 1 1 9
E 5 F280002 0 1 1 9 1 1 1 9
E 5 F250094 0 1 1 9 1 1 1 9
E 5 F210025 0 0 1 9 1 1 1 9
E 5 F250094 0 0 1 3 1 1 1 3
E 5 F250129 0 1 1 3 1 1 1 3
E 5 F250094 0 0 1 1 1 1 1 1
E 5 F280001 0 0 1 1 1 1 1 1
E 5 F620350 0 0 1 1 1 1 1 1
E 5 F990606 0 0 1 1 1 1 1 1
A 1 F620688 4.48 0 9 9 9 1 0 0 Table XIII.
E 5 F280110 12.5 0 9 1 1 1 1 9 Families ranking

control in order to decrease the D value or to enhance knowledge sharing and

cooperation with the supplier in order to reduce the probability of defective products.
The choice of the possible corrective actions is constrained by the availability
of resources. Resources are upper bounded and short to allow all corrective actions
to be performed at the same time. A complete overview of the risk ranking is thus
mandatory to perform effective scarce resources management.
In order to prioritize the corrective actions, the tool “Corrective Action Simulation”
helps the analyst to define the possible scenarios of the proposed actions on the whole
IJQRM risk ranking. Furthermore, the economic impact of each proposed action needs to be
31,7 evaluated. Figure 6 shows the RPN distribution summarized in Table XII.
The main purpose of the corrective actions is to eliminate null and negative RPN
and to distribute the RPN within low-medium values. One of the possible corrective
actions is summarized in the following steps:
(1) Since a quality certificate is required for the family E5-F280110-D1, it is
804 possible to update D and O values. The availability of the quality certificate
removes the acceptance quality control, thus allowing the PD to be set to zero.
(2) Resource saved from E5-F280110-D1 acceptance quality control is re-allocated
to A1- F620688-D9 in order to avoid its null RPN value.
(3) The acceptance control for family E5-F990606- D1 can be avoided and assigned
to family A1-F620688-D3; family E5-F990606-D1 increases its RPN up to 9, i.e.
a no critical condition, while A1-F620688-D3 decreases its RPN to 81.
The Corrective Action Simulator provides the results of the described changes on
group composition, RPN and risk ranking updating. Figure 7 shows the new RPN
distribution.
It is also possible to observe that all null and negative RPN values have been
eliminated and RPN values are clustered in medium-low area.
The study here proposed has been performed for purchased items. A summary of
the risk ranking previously described is shown in Figure 8, where the RPN distribution
is shown.

5. Conclusion
This paper describes a cost-effective and easy-to-use FMEA system applied to the
quality control of supplied products. The work arises from the need to create and
implement a structured and lean procedure of quality control on purchased items.
The revised FMEA allows to study the products’ criticality from a quality control point
of view and to organize specific corrective actions for reducing the risk and improving
the efficiency and efficacy of quality control tasks.

35

30
RPN Frequency (%)

25

20

15

10

0
Figure 6.
9

81

27

0
–1

–3

–9

43

29
72

24

–2

–8

–2

–7

Initial RPN distribution

RPN
 60 A revised FMEA
application
50
RPN Frequency (%)

40

30 805
20

10

0 Figure 7.
Updated RPN
9

81

27

–1

–3

–9

43

29
72

24

–2

–8

–2

–7
distribution
RPN

35

30

25
RPN Frequency (%)

20

15

10

0 Figure 8.
9

81

27

–1

–3

–9

43

29

Comprehensive RPN
72

24

–2

–8

–2

–7

distribution
RPN

FMEA is used as a methodology to support the managers in their decision-making

processes about the incoming items’ quality control. The three risk parameters
traditionally used in FMEA (occurrence, severity and detectability) have been
re-interpreted and adapted to the features of quality control system. A cross-functional
and multidisciplinary team mainly composed of academics, managers of the company,
factory supervisors and operators defines rules for O, S and D assessing the RPN
equation. Particularly, the ad hoc panel of experts encourage communication and
meetings during which the members could contribute their knowledge and information
about the processes. An overall view of the as-is system provided by the risk ranking
based on RPN, allows a concentration of the efforts and corrective actions on the most
critical failure modes
IJQRM The most relevant outcomes of this research can be assessed as:
31,7 . The creation of homogeneous families to overcome the complexity of the single
product code approach: the quality control process is uniform for products of
the same family.
. The identification of a complete procedure in order to help managers to identify
806 critical suppliers.
. The availability of a user-friendly decision tool.
. An upgrade of the traditional FMEA technique introducing two weight
functionals to better select critical products groups.
. The development of powerful software acting as a decision support system
in order to easily apply the modified FMEA procedure. The quality control
manager can thus evaluate in real time all the critical situations and
simulate different corrective actions to help choose the best one. The P D
values and quality control policies are time-variable and the supplied items
can change. Consequently the development of such automatic and dynamic
tool, based on the Plan Do Check Act principles, is basic in quality control
management.
The proposed approach has been applied and tested for a specific test case for
a manufacturing firm, but it can be easily generalized and applied to other
more complex industrial sectors. The proposed methodology has proved to be
user-friendly, but at the same time able to propose several scenarios to the decision
maker for effectively managing the scarce resources available for the quality control
task.

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About the authors

Dr Claudia Paciarotti is a Full Time Researcher in Industrial Plants at the “Università Politecnica
delle Marche”, Ancona, Italy. Her research activity mainly deals with: use of rainwater catchment
systems, design and management aspects of “a global service” maintenance contract in hospitals
and health corporations, process management and reengineering in healthcare and third sector,
multiphase flow in oil and gas field, risk analysis in industrial plants and services sector.
She is the author of papers that have been published in national and international journals and
conference proceedings. Dr Claudia Paciarotti is the corresponding author and can be contacted
at: c.paciarotti@univpm.it
Dr Giovanni Mazzuto, PhD in Industrial Plants at the Politecnical University of Marche,
graduated in 2010 in engineering of the industrial automation at the University of Ancona.
His research activity mainly deals with environmental analysis of process plants and
maintenance management, analysis of the behaviour of the supply chain, project management
and product development. He is author of several papers that have been published on
international journals (International Journal of Production Research, Journal of Loss Prevention
IJQRM in the Process Industries, International Journal of Business Performance and Supply Chain
Modelling, International Journal for RF Technologies: Research and Applications) and conference
31,7 proceedings.
Dr Davide D’Ettorre, Phd Student in Industrial Plants at the “Università Politecnica delle
Marche”, Ancona, Italy. His research activity mainly deals with quality and supply chain
management. Particularly, the research theme concerns the development, integration and
810 implementation of innovative techniques about TQM and SCM for the improvement of product
and process quality along the supply chain; scheduling of quality control activities and
application of sampling plans on inbound products; study and application of JIT methodologies
and tools. His research works are in collaboration with Italian manufacturing companies.

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