Food Control 13 (2002) 495–501

www.elsevier.com/locate/foodcont

FMEA methodology design, implementation and integration with

HACCP system in a food company
Antonio Scipioni *, Giovanni Saccarola, Angela Centazzo, Francesca Arena
Dipartimento di Processi Chimici dell’Ingegneria, Centro Studi Qualit
a-Ambiente, Universit
a di Padova, Via Manzolo 9, 35131 Padova, Italy
Received 9 October 2001; received in revised form 12 February 2002; accepted 12 February 2002

Abstract
This paper reports the description of FMEA methodology design and implementation in a food company, where, integrated with
HACCP system, it is used as a tool to assure products quality, and as a mean to improve operational performance of the production
cycle. The work was developed in an Italian confectionery industry, Elledı SpA, in co-operation with part of the internal staff,
chosen as FMEA team members, and was focused on the study of wafer biscuit production lines.
All the work done permits to increase company knowledge and control capacity on processes and products. The generated data
can be used as a useful technical database for future update of FMEA in Elledı and as a model of FMEA design for similar
company.

2002 Elsevier Science Ltd. All rights reserved.

Keywords: HACCP; FMEA; Food quality; Critical control points

1. Introduction: food quality 2. Material and methods

Quality is defined as the group of those product
characteristics that satisfy explicit and implicit customer
requirements.
Thanks to the adoption of predefined standards,
Quality Assurance means to give to the customer the
warranty that the company works on the basis of these
requirements. In Food Industry two different aspects of
product quality can be identified: on one hand, food
safety and sanitary integrity, compulsory requirements
for selling a food; on the other hand all those compo-
nents, such as exterior aspect, functionality, nutritional
characteristics, etc., that attract the customer (Scipioni
& Andreazza, 1997).
The application of failure mode and effects analysis
(FMEA) methodology and the integration of its results
in the HACCP system already implemented in the com-
pany empowered the study and analysis of both the
aspects of food quality.
*
Corresponding author. Tel.: +39-049-827-5539; fax: +39-049-827-
5785.
E-mail address: scipioni@unipd.it (A. Scipioni).
2.1. FMEA – failure mode and effects analysis
FMEA is a systematic process meant for reliability
analysis (Elliott James, 1998). It improves operational
performance of the production cycles and reduces their
overall risk level. This task is achieved by means of
preventing the system potential failures that have been
identified through the preliminary analysis and the col-
lection of plant historical data (Sachs Neville, 1993).
The FMEA methodology was developed and imple-
mented for the first time in 1949 by the United States
Army. In the 1970s, thanks to its characteristics of
strength and validity, its application field extended first
to aerospace and automotive industry, then to general
manufacturing (SVRP, 1997).
Today FMEA is mainly applied in industrial pro-
duction of machinery, motor cars, mechanical and elec-
tronic components: the introduction of FMEA in a food
company can be considered as a step in a new direction.
The main problem faced in the adaptation of this tech-
nique to a production process was the difference between
its preventive vision (inclined towards continual im-
provement) and rigorous style and the practical meth-
odology of small and medium size companies. The

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496 A. Scipioni et al. / Food Control 13 (2002) 495–501

Table 1
Evaluation criteria of failure severity
Evaluation criteria Severity class Severity
Stop time of the plant lasts some minutes, damage can be immediately repaired Low 2–4
Stop time of the plant is higher than 10 min, action to repair/substitute damaged part Medium 5–6
Stop time of the plant is prolonged, electronic or mechanic maintenance required High 7–8
Failure affects machine operator safety or non compliance with government regulation Very high 9–10

manufacturing process monitoring, standard for large
corporations, is usually not implemented in the pro-
duction cycle by small and medium size companies.
It is interesting to observe how these difficulties have
been solved through the adaptation of conceptual
FMEA, as described in the reference manuals, in the
analysed case.
Applying an FMEA to a production cycle means
following a series of successive steps: analysis of the
process or product in every single part, list of identified
potential failures, evaluation of their frequency, severity
(in terms of effects of the failure to the process and to the
surroundings) and detection technique, global evalua-
tion of the problem and identification of the corrective
actions and control plans that could eliminate or reduce
the chance of the potential failures.
This task cannot be achieved on an individual basis
because FMEA is a team function. In the analysed case,
the FMEA team included some members of the internal
staff knowledgeable and experienced in the product or
process. They were the Production Manager, the Qual-
ity Assurance Manager, the Mechanical Manager, the
Maintenance Operators and the Group Leads, and one
external member, the FMEA expert, with the task of co-
ordinate team activities based on the implementation of
FMEA theory and the data collected during the work.
The most important aspect of FMEA is the evalua-
tion of the risk level of potential failures identified for
every sub-system or component. The global value of the
damages caused on the function or on the surroundings
by every failure is indicated with the risk priority num-
ber (RPN). This number (from 1 to 1000) is an index
obtained from the multiplication of three risk parame-
ters, which are:
• Severity of the worst potential resulting outcome due
to the failure in terms of safety and system function-
ality (Severity).
• Relative probability that the failure will occur (Oc-
currence).
• Probability that the failure mode will be detected and/
or corrected by the applicable controls installed on
the production lines (Detection).
As a guide to the evaluation of these parameters, the
FMEA team defines numerical scales, created on the
basis of traceable generic examples on reference manuals
and adapted at the particular risk situation of the sys-
tem. In this way every failure can be evaluated with a
precise risk value.
Besides the definition of the FMEA form (reported
next), the scale drafting is one of the FMEA steps that
allows more freedom of choice to the team.
There is no standard for the choice of scale ranking,
but, generally, FMEA team prefers ranking of 1 to 10,
because it provides ease of interpretation, and, at the
same time, accuracy and precision (Stamatis, 1995).
Tables 1 and 2 report the numerical scales used in this
case.
2.2. Operative application of the methodology
The FMEA design and implementation requires a
careful knowledge of the system. Before reporting the
result of the practical application of the FMEA (as
evaluation scales definition, FMEA form choice, system
risk level calculation), it is important to emphasise that
the first phase of the work consisted in the extensive
collection of data and information about products,
production lines and machinery through visits to the
production plants and personnel interviews.
The adaptation of FMEA to the company manu-
facturing process required a great effort by the team.
The most challenging task has been the data collection,
both the technical documentation on products and

Table 2
Evaluation criteria of failure detection
Production line situation Failure individuation Detection
Computerised monitoring with immediate advice and registration of occurred failure Very high 1
Failure easily by visual control on production chain or final product
Remote chance that product quality would be affected by the defect High 2–5
Process controls can detect failure mode or cause
High likelihood that product quality would be affected by the defect Moderate 6–8
Process controls will and/or cannot probably detect failure mode or cause Low 9–10
 A. Scipioni et al. / Food Control 13 (2002) 495–501
production lines, and the data entry relative to failures
occurred in the manufacturing lines.
In the logic that a bigger database guarantees a better
FMEA implementation, the ideal process would be a
process controlled by computerised devices with a con-
tinuous detection and registration of production pa-
rameters and negative events.
From this point of view the production lines of Elledı
SpA are inadequate. Most of the lines were not auto-
matically monitored and the failure registration was
entered, thanks to the active collaboration of the line
operators.
The collection of the forms prepared by FMEA team
and filled by the group leaders resulted in a fast but
detailed registration of every trouble occurred during
operational time and the detection of the failures char-
acteristic of the system.
Fig. 1 reports an example of a failure registration
form used by FMEA operators.
Weekly interviews to line operators allowed the
FMEA team not only to collect objective data on oc-
curred damages but also useful opinions on the actual
machinery performances.
Fig. 1. Failure registration form.
497
As theory states, once FMEA team obtained all
the information available about known and/or poten-
tial failures of the system, it moved the operative phase
of risk evaluation through the definition of the FMEA
form.
Fig. 2 reports the form used in this work, it is based
on reference manuals and has been modified by FMEA
team to meet the company characteristics (FMC, 1997).
Each compiled form reported the detected failure ty-
pologies and some additional information associated
with them: potential causes, failure effects, description of
line controls that detect the failure and the evaluation of
the three risk parameters.
2.3. Risk parameters
Severity is an assessment of the seriousness of the
effect of the potential failure to the customer. The nu-
meric evaluation scale defined by FMEA team is based
upon the failure description adopted by the manufac-
turer, such as any possible problem that causes a pro-
duction interruption or a stop of the plants.
498 A. Scipioni et al. / Food Control 13 (2002) 495–501

Fig. 2. FMEA form.

 A. Scipioni et al. / Food Control 13 (2002) 495–501 499

The FMEA team stated that the greater is the stop
time of the plant, the more serious is the failure that
caused it, as reported in Table 1.
Occurrence is the assessment of how frequently the
specific failure cause is projected to occur.
Usually in FMEA applications, an objective evalua-
tion criterion of Occurrence based upon daily or hourly
failure rates is used. In this case, like in many others
companies of Food Industry, a computerised monitor-
ing system was not implemented and a statistical data-
base was not available.
For this reason the FMEA team proposed the solu-
tion to evaluate Occurrence in a qualitative way con-
sidering direct experience on the production lines.
The last risk parameter to evaluate is the Detection,
such as the assessment of the probability that the pro-
cess monitoring system will detect a cause/mode of
failure before the component/product is released for
production and it will reach the customer. The detection
and registration method used in Elledı SpA is essentially
a visual control made by line operators. Cause of this,
the detection class associated with every failure could
not be very high. Nevertheless the failures that occurred
on the lines during the analysed period were generally
easily identifiable by visual control on production chain
or final product.
Table 2 reports all possible situations occurring in the
plants and the associated value of Detection.
2.4. FMEA implementation
On the basis of the calculated RPN, the FMEA team
defined a action strategy based on the risk categories, as
for example:
• Minor risk: no action is taken.
• Moderate risk: some action may take place.
• High risk: corrective action will take place.
• Critical risk: corrective actions will take place and ex-
tensive changes are required in the process/product.
If there were two or more failures with the same
RPN, the FMEA team addressed the failures based on
the level of Severity and, eventually, Detection.
These two are considered parameters of maximum
priority because they measure the most important as-
pects of the failure, i.e. the damages due to the function
(Severity) and the qualitative evaluation of the product
as it is perceived by the customer (Detection).
To reduce the system risk level, the FMEA team
decided to intervene in the system when the RPN was
equal to or greater than a threshold value of 50, or when

Table 3
Failure modes and RPN values
Failure mode RPN Final RPN Production step
Broken welding 72 54 Pre-cutting operations
Broken smearing-cream spirals 63 No action Pre-cutting operations
Broken wafer block weighing scales 48 No action Pre-cutting operations
Useless whipping cream tank 42 No action Pre-cutting operations
Improper working of smearing-cream machine 24 18 Pre-cutting operations
Improper working of wafer blocks press-machine 16 No action Pre-cutting operations
Incorrect regulation of packaging machinery 72 32 Size/taste change
Incorrect weight parameters regulation 36 32 Size/taste change
Broken braking engine 120 60 Wafer cutting
Stopped inverter 60 No action Wafer cutting
Tender wafer block 48 24 Wafer cutting
Broken blade 24 16 Wafer cutting
Broken dragging belt 24 No action Wafer cutting
Loosed transfer wafer chain 24 No action Wafer cutting
Broken cutting wafer slip way 20 No action Wafer cutting
Incorrect stamp position 150 45 Primary package
Imperfect fitting of package edges 105 42 Primary package
Improper working of trimming blade 90 40 Primary package
Broken vibration engine 64 48 Primary package
Incorrect wrapping paper position 60 32 Primary package
Broken wrapping paper 50 30 Primary package
Stick wafers 50 30 Primary package
Hard wafers 50 30 Primary package
Broken welding resistance wires 48 32 Primary package
Improper working of pliers 40 24 Primary package
Lost memory program 36 No action Primary package
Stopped wrapping paper advancement 32 No action Primary package
Device cutting/welding out of phase 18 No action Primary package
Incorrect sticking procedure 140 40 Final package
Jammed machinery 56 40 Final package
500 A. Scipioni et al. / Food Control 13 (2002) 495–501

the Severity of the failure was considered too high to
permit the potential occurrence of the failure. The rea-
son of this choice is that with a statistical confidence of
95% and a maximum number possible for RPN of 1000
(10  10  10), the threshold is 5% of 1000.
The intervention was based on the identification of a
list of ‘‘Recommended Actions’’ that could prevent the
failures, reducing the rate of Occurrence and Detection.
The results obtained implementing the FMEA to the
production cycle of wafer biscuits, i.e. the corrective
actions recommended by FMEA team, have been rea-
lised into a series of preventive maintenance actions
and into a list of operative instructions, which have to
be done by operative personnel during standard work
operations.
The type of applied FMEA (process FMEA or
PFMEA) did not permit to modify the process, product
or machinery design, so for every failure the Severity
value have remained fixed and the recommended actions
have permitted to reduce only the values of Occurrence
and Detection.
The FMEA team decided to implement a PFMEA
because the analysed lines were already operative at the
beginning of the work and it was not feasible to apply a
study of design/project of the product or process (De-
sign FMEA).
The control and analysis of the failures affecting the
final product quality revealed that the most frequent
errors were not derived from mistakes in the recipes
formulation or from the inaccuracy in the preparation
or cooking procedure (failures linked with design de-
fects). The most common problems were technical due
to the operational process that could be detected, taped
and corrected only with a control that follows step by
step the production process. The last phase of the work
consisted in the revaluation of the risk parameters
for every failure. The improvements obtained by the
implementation of the recommended actions reduced
the individual RPN and of the global risk level of the
system.
2.5. HACCP–FMEA integration
The failures were studied independently from their
impact on final product quality because the actual scope
of FMEA was only the optimisation of used resources
and reduction of waste. Obviously all the failures neg-
atively affected system efficiency but, considering only
the final product quality, such as all qualitative aspects
perceived by the customer, the influence is different from
case to case.
For this reason an additional phase had been intro-
duced: the FMEA team tried to integrate the FMEA
study into the company HACCP system, already im-
plemented as required by an Italian law (D. Lgs 155/97).
The integration of FMEA results in HACCP system
was possible essentially, thanks to the similar preven-
tive approach of both the techniques, in fact the char-
acteristic HACCP control plans could be adapted by
FMEA team to include also all those preventive mea-
sures, defined during FMEA study, that were considered
basic elements for food safety and exterior aspects as-
surance.
From an operational point of view this part of the
work consisted in the evaluation of every single failure
impact on final product quality, in terms of food safety
and exterior aspects, and considering every product
characteristics that can affect customer satisfaction.
Exterior qualitative aspects, analysed in the integra-
tion, comprehend:
• food characteristics (dimensions, colour, shape),
• wrapping paper characteristics (material, thickness,
printing, typology of reported information – shelf-
life, nutritional data, language),
• primary package characteristics (cutting and welding,
filling, integrity),
• integrity of packaged product,
• cardboard characteristics (integrity, material, print-
ing, sticking, filling),
• storage and shipping conditions.
Then the results of this valuation were considered
during elaboration of HACCP control plan (and all the
other linked documentation).
In a certain sense all work done by FMEA team can
be considered as an additional phase of data collection
that permitted to identify further hazards and to define
further preventive actions that were necessary for food
safety assurance of final product, not only at produc-
tion time, but also at the moment of consumer con-
sumption.

Table 4
Abstract of HACCP plan with integrated FMEA preventive actions
Phase Hazard FMEA preventive actions HACCP control
Wafer Anomalous aspect (colour, shape, etc.) Operative instructions about cooling parameters and controls Visual inspection
cooling by group lead
Primary Incorrect propriety of stamped data Definition of stamp life and periodical substitution Visual inspection
packaging (shelf-life, special information) by group lead
Primary Inadequate package shape and integrity Preventive control of integrity and position of wrapping paper reel Visual inspection
packaging Operative instructions of wrapping paper calibration by group lead
 A. Scipioni et al. / Food Control 13 (2002) 495–501
3. Results and discussion
3.1. FMEA recommended actions
The design and subsequent implementation of
FMEA in Elledı SpA has permitted to detect which were
the most probable and serious failures that can occur on
wafer production lines.
The criteria used to evaluate these failures were the
amount of damage caused to the production in terms of
lost production volume, idle time of the plants, waste of
raw material and resources, maintenance costs, etc.
Table 3 reports the list of failure modes individuated
by FMEA team for every production step and their
original and final associated RPN values reduced, thanks
to the execution of the recommended actions.
The reading of the table reveals that the ‘‘incorrect
stamp position’’ in primary package phase is the greatest
RPN failure individuated in the production cycle by
FMEA team. There are three reasons for this result:
high values of Occurrence and Detection (the damage
can be detected only by visual control of the operator on
final package), and high value of Severity, due to the fact
that the production of a defected final package is a vio-
lation of a compulsory regulation. This failure can be
easily prevented through the execution of the recom-
mended action such as the periodic replacement of the
stamp.
As this one, all the failures with a great RPN are
considered by FMEA team, thanks to the elaboration of
a preventive maintenance plan or to the definition of
some operative instructions.
3.2. Final product quality and integration with food safety
Through the valuation of the impact of every single
system failure and the seriousness of eventual damage
caused by unsuccessful execution of recommended ac-
tions, the FMEA team was able to define the priority
scale based on which the corrective actions individuated
by PFMEA can be taken on the production cycle.
Furthermore the analysis of the revealed failures
showed that the impact on safety and integrity of foods
is focused on the first steps of the production chain (as
receiving, storage, etc.). According to this, the Hazard
Analysis, that was conducted to determinate safety haz-
ards, CCP of the system (critical control point: step
where monitoring should be applied to prevent, elimi-
nate or reduce a food safety hazard) (NACMCF, 1997)
and relative control measures, underlined that the major
influence on food quality takes place only in the first
phase of the production cycle.
So, the concrete integration between FMEA and
HACCP was applied on the last production phases. In
fact the FMEA team focused his attention on the
501
analysis of the influence of the packaging operations
(and linked recommended actions) on final product
quality (included safety aspects).
What came out is that almost all the revealed failures
had not much influence on food integrity; however some
of them could cause defects, like inadequate integrity of
package, incorrect stamped data on primary packaging,
etc., that compromise the safety of the final product.
Consequently the FMEA team suggested to modify
all HACCP documentation influenced by these new
considerations. For example, how it is showed in Table
4, considering those cycle phases, reported in HACCP
control plan, in which there were no CCPs, HACCP
control measures reflect FMEA priorities. They were
translated in maintenance actions and operative in-
structions by FMEA team to assure risk level reduction,
and, in this way, they also permitted a more accurate
preventive control on final product integrity.
4. Conclusions
The task completed by the FMEA team can be sum-
marised in two complementary operations: the control
of exterior qualitative aspects and the implementation
and integration of the obtained results in the food con-
trol system built in the company on the basis of HACCP
principles.
The two methodologies operated in different produc-
tion phases and their simultaneous application allowed
to study and analyse every single step of production
cycle and to achieve an exhaustive knowledge and im-
provement of products and processes.
Acknowledgements
The authors are indebted to Mr. G. Lago and Dr. R.
Delfitto (Elledı SpA) for their availability and courtesy.
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