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BFJ
118,9
A critical analysis of ISO
audits results
Ioannis S. Arvanitoyannis
2126 School of Technological Sciences, Hellenic Open University, Patras, Greece and
Department of Agriculture Ichthyology and Aquatic Environment,
Received 17 January 2016 University of Thessaly, Volos, Greece
Revised 3 April 2016
Accepted 4 April 2016
Konstantinos Samourelis
School of Technological Sciences, Hellenic Open University,
Patras, Greece, and
Konstantinos V. Kotsanopoulos
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Abstract
Purpose The purpose of this paper is to summarize and analyse the results of several food quality
and safety audits (ISO 9001, ISO 22000, ELOT 1416 and Codex Alimetarius) carried out in Greek food
companies processing products of animal origin.
Design/methodology/approach Specifically, both a quantitative and a qualitative review of the
results were carried out.
Findings It was revealed that the biggest ratio of non-conformities was recorded within the frame
of ELOT 1416 standard (Greek scheme for the certification of HACCP Management Systems), or
ELOT 1416 and ISO 9001 where a combination of standards was used. The highest ratio of
observations was recorded against ELOT 1416 when used in combination with ISO 9001. The highest
average of non-conformities per audit was recorded in meat (red meat and poultry) companies. With
regards to the observations recorded, the highest average per audit was recorded in companies
processing eggs. Considering the number of workers, the highest average of non-conformities per audit
was observed in small companies.
Research limitations/implications The limitations of the present study can be summarized into
the fact that although a high number of audit reports were taken into account, an audit is an
observation of the condition of a company on the day of the audit and the results can also be highly
dependent on the skills of the auditors.
Originality/value To the best of the authors knowledge this is the first paper that analyses a high
number of audit reports from Greek food companies and its conclusions can be of significant value to
both the auditors and the industry enabling a more focused approach in the conduction of audits and
implementation of the standards.
Keywords ISO 9001, ISO 22000, Food industries, Food safety audits, Non-conformities, Observations
Paper type Research paper
1. Introduction
Nowadays the development and implementation of food quality and safety
management systems is continuously increasing. he various food scandals, the
ever-expanding economic crisis, as well as the various policies implemented by food
companies in an effort to increase customer satisfaction through providing high quality
British Food Journal and safe products, have certainly contributed to this trend. Another important reason
Vol. 118 No. 9, 2016
pp. 2126-2139
of this increase is that sales departments in businesses now consider that a certificate
Emerald Group Publishing Limited
0007-070X
can potentially attract more customers (Djekic et al., 2011; Majstorovic and Marinkovic,
DOI 10.1108/BFJ-01-2016-0012 2011; Trienekens and Zuurbier, 2008; Efstratiadis et al., 2000).
For about 150 years the field of food safety has primarily focused on microbiological Critical
hazards. Nevertheless, in many countries foodborne disease incidents have become analysis of ISO
more frequent (Griffith, 2006) while environmental conditions in food manufacturing
plants greatly affect both food safety and quality (Smith, 2006). The main standards
audits results
implemented by companies that produce and process food of animal origin are
primarily related to the quality and safety of products, as well as the services provided.
Thus, the standards that have mainly been established and are applied in the Greek 2127
food industry are: ISO 9001, in its various valid editions, ISO 22000, as well as the
principles of Codex Alimentarius. The number of industries that applied ISO 14001
(2004) and OHSAS 18001 (2007) (ELOT 1801, 2008) were limited. The ELOT 1416
standard was valid and was applied within the Greek food industry until 2009.
The development of HACCP systems, as well as standards based on them, was an
important step towards the prevention of potential hazards and the protection of the
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health of the consumers. The most commonly applied standards in the Greek food
industry were ELOT EN ISO 1416 (2000), best known as ELOT 1416, as well as ELOT
EN ISO 22000 (2005) that incorporates the principles and the steps for the
implementation of HACCP as well as directions given by the committee of Codex
Alimentarius (Arvanitoyannis et al., 2001; Arvanitoyannis, 2009; Ashok et al., 2012).
The ISO 14001 (2004) standard was developed and implemented to cover
environmental issues and was followed by the ISO 14001 (2015), while OHSAS 18001
(2007) was developed and implemented to cover health and safety issues in the
workplace. These standards were also implemented in Greek industries in the form of
the corresponding harmonized model ELOT 1801 (2008) (Casadesus et al., 2008;
Granerud and Rocha, 2011; Muniz et al., 2012a, b; Metaxas and Tsavdaridou, 2012).
However very few Greek food industries implement some environmental management
or health management and work safety systems.
The majority of companies that implement a management system based on one of
the above-mentioned standards actually aim at getting the corresponding certificate.
In Greece, the accreditation body is the Hellenic Accreditation System S.A., known as
ESYD: Hellenic Accreditation System S.A., which checks, evaluates and accredits (or
rejects) the certification bodies based on the ISO 17021 (2011) standard (Anastasopoulos,
2005; Tanner, 2000). Possible reasons why certificates can be withdrawn are the high
number of non-conformities recorded or the type of non-conformities that rendered the
abidance to the certification impossible. Moreover, a possible reason can also be the
refusal of the industry to allow the annual programmed audit or an unannounced audit.
This can happen due to various reasons, such as a certification body change, lack of
interest in maintaining a valid certificate, or even the cost of the audit. Thus, the
withdrawal of a certificate is related either to the certification body or to a decision of
the company (Alic, 2012). For the purposes of this paper, non-conformity is defined as
the total absence or extended lack of conformance with the requirements of a standard.
An observation can be defined as the limited deviation from the requirements of a
standard that has the potential or trend to become non-conformity.
The aim of this paper is to summarize and analyse the results of several quality
and food safety audits carried out in Greek food industries that process products of
animal origin.
2. Methodology
In order to collect the data used for this research, the reports of 280 audits were
reviewed. Throughout this review, detailed information was collected with regards to
BFJ the name, the location and the type of the industry audited, the ISO standard audited,
118,9 the type of audit held, the total number of workers in each company and the number of
workers working in the production departments. The auditor who carried out the audit
as well as the years the audits took place were also recorded. Furthermore, the total
number of non-conformities and observations found in each audit and the types of non-
conformities and observations were also taken into account. Finally, the decisions of
2128 the certification body with regards to whether certification can be issued were also
recorded for each audit.
The data collected consist of the results of 280 audits held by 18 auditors. In total,
100 companies were audited. The audits were held in various Greek regions in the period
2008-2011. The standards audited were: Codex Alimentarius ELOT EN ISO 9001 (2000),
ELOT 1416, ELOT EN ISO 22000 (2005) and ELOT EN ISO 9001 (2008), and their
combinations. The audits were carried out through various stages and more specifically
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3. Results
3.1 Quantitative analysis
The total number of recorded non-conformities was 436, ranging from zero to ten non-
conformities per audit, while the total number of recorded observations was 73, ranging
from zero to six observations per audit. It is important to mention that non-conformities
and observations recorded during the conduction of 148 (52.85 per cent of all audits
conducted) and 44 audits (15.71 per cent of all audits), respectively.
The quantitative analysis of the data were based on the activity of the company
audited and the proportions of non-conformities and observations per audit. Figure 1
shows that the highest average percentage of non-conformities per audit (86.5 per cent)
was recorded in companies that produce meat products, followed by those producing
dairies (85.5 per cent), eggs (82 per cent) and other meat products (50 per cent). On the
contrary, the smallest average proportion of non-conformities per audit was observed
in audits of companies that produce fisheries (26 per cent).
With regards to the recorded observations, the highest average percentage per audit
was observed in companies producing egg products (25 per cent), followed by
companies producing dairy products (17 per cent) and meat products (7 per cent).
100
Critical
90 PROPORTION OF NON CONFORMITIES analysis of ISO
80
PROPORTION OF OBSERVATIONS
audits results
70
Proportion (%)
60
2129
50
40
30
20 Figure 1.
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10
Average proportions
of non-conformities
0 and observations per
MEAT DAIRY EGGS FISHERY OTHER company activity
Industry Activity
It could therefore be concluded that regardless of the standard the companies were
audited against, those that produced fishery products and the remaining animal
products, implemented their management system more effectively in comparison to the
companies producing eggs, dairy products and meat.
The average proportions of non-conformities and observations recorded for each
standard audited are presented in Figure 2. According to this Figure, it is evident that
the biggest number of non-conformities per audit was recorded during audits of the
ELOT 1416 standard, for as long as this standard was implemented by the Greek food
industry and regardless of whether it was implemented alone or in combination with
ISO 9001. Lower averages of non-conformities were recorded in companies that
100
PROPORTION OF NON CONFORMITIES
90 PROPORTION OF OBSERVATIONS
80
70
Proportion (%)
60
50
40
30
20
10
0
Figure 2.
01
16
ER
ER
16
S
00
00
IU
IU
90
14
14
TH
TH
22
22
R
TA
TA
Average proportions
O
T
O
O
O
O
O
O
IS
EN
EN
d
d
IS
IS
EL
EL
an
an
of non-conformities
IM
IM
d
d
an
01
an
AL
AL
00
90
and observations
01
01
22
EX
EX
90
O
90
O
D
D
IS
O
O
IS
C
C
IS
combination of
0
90
standards
O
IS
during the pre-assessment stages, followed by the first surveillance audits. During the
assessment, second surveillance, re-certification and re-assessment stage of the audits,
a lower number of non-conformities were recorded per audit. As regards the recorded
observations, the highest averages were found during the assessment stage of the
audits while their number decreased in the next stages of the audits. The certification
body that provided the data categorized the non-compliances to either non-conformities
or observations. During the pre-assessment audits, the proportion of the observations
against the non-conformities was very small. However, during the re-assessment audits
a very high proportion of observations was recorded. It can therefore be concluded
that there was initially a significant improvement in the management systems of the
industries aiming at obtaining certification, but the efforts made to comply with
the corresponding system lessened during the time period between the certification and
the first surveillance audit. Afterwards, the performance of the industries that manage
to maintain their certificate of compliance tends to steadily improve and the number of
issues related to the main requirements of the standards tends to decrease.
Figure 3 presents the average proportions of non-conformities and observations
recorded in relation to the number of individuals employed by the companies.
90
PROPORTION OF NON CONFORMITIES
PROPORTION OF OBSERVATIONS
80
70
60
Proportion (%)
50
40
30
Figure 3.
Average proportions
20
of non-conformities
and observations 10
per audit based
on number of 0
individuals employed -10 employees 11-20 employees 21-50 employees 51-100 employees >100 employees
by each company (very small) (small) (medium) (large) (very large)
Number of employees
The data in this figure indicate that the highest average of recorded non-conformities Critical
per audit was observed during audits in large companies. The smallest average was analysis of ISO
observed in very large companies that employed more than 100 individuals, probably
due to the fact that in these companies there is the possibility that part of the personnel
audits results
is dedicated to the continuous support of the management system, working exclusively
for this purpose. Also, another crucial factor that may have affected this result is the
provision of adequate resources used to support ISO systems, which is generally much 2131
more feasible in the case of very large companies. In the remaining categories of
companies, medium averages of non-conformities were observed. However, in contrast
to non-conformities, the average percentages of the recorded observations per audit
were lower for very small, small, medium-sized and large companies that employed up
to 100 individuals, and higher for companies that employ more than 100 individuals.
Taking into consideration the size of the companies based on the number of
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100
PROPORTION OF NON CONFORMITIES
PROPORTION OF OBSERVATIONS
90
80
70
Proportion (%)
60
50
40
Figure 4.
30 Average proportions
of non-conformities
20
and observations
10
per audit based
on number of
0 individuals working
-10 employees 11-20 employees 21-50 employees 51-100 employees > 100 employees in production
Number of employees
BFJ Based on the year of audit and regardless of the management system audited, the
118,9 average proportions of non-conformities were 85.3, 56.7, 28.3 and 27 per cent for 2008,
2009, 2010 and 2011, respectively, while the corresponding percentages of observations
were 12.7, 6.7, 5.0 and 10.3 per cent, respectively. It is obvious that during the time
period after the first implementation of management systems, the ratio of
non-conformities and observations recorded per audit tends to gradually decrease.
2132 One possible reason for these results can be the adaptation of the companies to the
systems requirements. Therefore following the conduction of the audits,
the performance of the companies tends to improve and the numbers of both
non-conformities and observations are reduced. Furthermore, another likely cause of
these results can be the fact that the audits of the certification bodies become less and
less strict after the implementation of the management systems.
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100
90
80
70
Proportion (%)
60
50
40
30
20
Figure 5.
Average percentage 10
of non-conformities
0
per section of the
4.1
4.2.1
4.2.2
4.2.3
4.2.4
5.1
5.2
5.3
5.4.1
5.4.2
5.5.1
5.5.2
5.5.3
5.6.1
5.6.2
5.6.3
6.1
6.2.1
6.2.2
6.3
6.4
7.1
7.2.1
7.2.2
7.2.3
7.3
7.4.1
7.4.2
7.4.3
7.5.1
7.5.2
7.5.3
7.5.4
7.5.5
7.6
8.1
8.2.1
8.2.2
8.2.3
8.2.4
8.3
8.4
8.5.1
8.5.2
8.5.3
100
90
80
70
60
Proportion (%)
50
40
30
20
Figure 6.
10
Average percentage
0
of non-conformities
per section of the
4.1
4.2.1
4.2.2
4.2.3
5.1
5.2
5.3
5.4
5.5
5.6.1
5.6.2
5.7
5.8.1
5.8.2
5.8.3
6.1
6.2.1
6.2.2
6.3
6.4
7.1
7.2.1
7.2.2
7.2.3
7.3.1
7.3.2
7.3.3
7.3.4
7.3.5
7.4.1
7.4.2
7.4.3
7.4.4
7.5
7.6.1
7.6.2
7.6.3
7.6.4
7.6.5
7.7
7.8
7.9
7.10.1
7.10.2
7.10.3
7.10.4
8.1
8.2
8.3
8.4.1
8.4.2
8.4.3
8.5.1
8.5.2
8.5.3
personnel was not trained, or because the requirements of the standard with regards to
training of employees were not met. These results are in agreement with the results
detailed in the study of Katsarou (2011) in which 53 audit reports held between 2009 and
2010 by two accredited Greek certification bodies in food industries were analysed. It was
proved that high percentages of non-conformities had been raised in relation to
paragraphs 7.2.3 and 7.3 of the standard. Furthermore, Djekic et al. (2011) who analysed
123 audit reports of audits conducted in 60 food companies based in three Balkan
countries, also indicated that the majority (59.6 per cent) of non-compliances (non-
conformities and observations) were related to prerequisite programmes, including GHP.
4. Discussion
It is important to mention that with regards to the analysis of the data per paragraph of
each standard, the ISO 9001 and ISO 22000 standards were only taken into account,
while the existing data for ELOT 1416 were not examined because, on the one hand it
has stopped being valid since 2009, and on the other hand there were data available
only for 2008 and 2009. Also, the existing data for the implementation and audit results
of Codex Alimentarius were very limited, while the number of companies that
implement it continuously decreases, and therefore there was no point in analysing
them any further.
It was found that the results regarding the frequency that observations were
raised in relation to paragraphs 8.2.4, 6.2.2 and 8.2.1 of ISO 9001, are in conformance
with the findings of the analysis of 15 audit reports held in 2009 and 2010 by an
accredited Greek certification body in companies that engaged in various activities.
Similarly, in this case high percentages of non-conformities in relation to
paragraphs 8.2 and 4.2 of the standard were recorded (Katsarou, 2011). The lack of
knowledge and training appears to be a fundamental obstacle in the development
and implementation of an effective management system in small to medium-sized
food companies, as shown in the study of Dora et al. (2013). Also, according to the
same study, the fact that some essential resources were not available, in
combination with the lack of knowledge and training, constituted an significant
obstacle to the implementation of effective management systems in small to
medium-sized food companies.
The fact that the majority of observations were raised in relation to the
paragraphs 7.3.3, 7.2.3 and 6.2.2 of the ISO 22000 standard is in agreement with
studies that examined 28 dairy companies in Turkey, but also Turkish food
companies in general. These studies indicated that the main difficulties in
implementing food safety management systems were related to insufficient training
of employees and incorrect implementation of prerequisite programmes that occurred
due to the inadequate infrastructure of the companies (Karaman et al., 2012; Karaman,
2012; Bas et al., 2007).
The results with regards to the non-conformites raised in relation to paragraph 7.3.3
and with regards to record keeping of any training undertaken are in agreement with
the results detailed in the study of Katsarou (2011). In this study 53 audit reports held in
2009 and 2010 in food companies by two accredited Greek certification bodies were
analysed. It was proved that high average percentages of non-conformities had been
BFJ raised in relation to paragraphs 7.2.3 and 7.3 of the standard. The study of Djekic et al.
118,9 (2011) that was held in 60 food companies in three Balkan countries and analysed 123
audit reports also showed that the majority of non-compliances (non-conformities and
observations) (59.6 per cent) are related to prerequisite programmes, including GHP.
The total cost constitutes a major factor that renders the implementation of a food
safety management system in dairy companies and generally in Turkish food
2136 companies quite difficult, as shown in relevant studies (Karaman et al., 2012; Bas et al.,
2007). Also, according to Macheka et al. (2013), the lack of financial resources and the
insufficient infrastructures and installations constitute the most important reasons for
the development and implementation of ineffective food safety management systems in
companies in Zimbabwe.
Finally, the fact that all cancelations occurred in very small companies is in
agreement with the results of the study of Dora et al. (2013) who examined small to
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medium-sized European food companies. This study concluded that the smallest
industries had the worst records with regards to the implementation of
quality management systems. The study of Macheka et al. (2013) also reported that
industries of small size have a higher difficulty in implementing robust food safety
management systems.
5. Conclusion
Food companies can use the results of this analysis during the implementation of ISO
standards to enable more emphasis to be given on the requirements related with the
more frequently recorded non-conformities and observations.
This approach could probably limit the negative findings; facilitating the efforts for
continuous improvement based on proper infrastructures, educated personnel and
proper documentation. The results of this study results could also be useful for auditors
of food companies that belong to the animal product sector by enabling them to be
more careful when checking whether the corresponding aforementioned requirements
of the standards are met and satisfied.
This study could also encourage the preparation of similar reviews that examine
the results of audits in industries dealing with other categories of products. It would
also be interesting for future studies to review the results of audits in industries that
implement different standards, such as ISO 14001 (2004) and OHSAS 1800.
The implementation of the last two standards by Greek companies was minimal
until a few years ago. However, the continuously increasing interest of consumers
in the environmental sensitization of companies and the working environment
of employees, has led many companies to adopt and implement such management
systems. The results of this study, in combination with the guidelines of
the institution of agricultural advisors, could give solutions and assist producers
that implement management systems and be of benefit to both them and
the consumers.
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Appendix 1
90
60
Proportion (%)
50
40
30
Figure A1. 20
Average proportions
10
of non-conformities
and observations 0
recorded per year 2008 2009 2010 2011
Year
Appendix 2 Critical
analysis of ISO
35
PERCENTAGE OF CANCELLED CERTIFICATES
audits results
30
25
2139
Proportion (%)
20
15
10
5
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0
01
16
16
S
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00
IU
IU
90
14
14
22
22
R
TA
TA
O
T
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O
O
IS
EN
EN
IS
IS
EL
EL
IM
IM
d
d
an
an
AL
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01
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90
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Figure A2.
IS
C
C
IS
d
an
Percentage of
01
90
cancelled certificates
O
IS
per standard
Standards the audits were held against
Corresponding author
Konstantinos V. Kotsanopoulos can be contacted at: kostaskot@yahoo.gr
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