Lokunarangodage
C.V.K.*1,
Wickramasinghe I.1, Ranaweera K.K.D.S.1
1Department of Food Science and Technology, Faculty of
Applied Sciences, University of Sri Jayewardenepura, Gangodawila, Nugegoda, Sri
Lanka.
Journal of Tea Science Research, 2015, Vol.5, No.12
doi: 10.5376/jtsr.2015.05.0012
doi: 10.5376/jtsr.2015.05.0012
Abstract
Keywords ISO
22000:2005; Food Safety; PRP, HACCP; GMP; FSMS
Introduction
According
to the Webster’s Ninth New Collage Dictionary (2015) safety is defined as the
“condition of being safe from undergoing or causing hurt, injury or loss” and
according to the FAO and WHO (1997) food safety is the “assurance that food
will not cause any harm to the consumer when prepared and/or consumed according
to the intended use”. Ensuring food safety in current complex society is an
intimidating task which is possible only with corporation and collective
efforts of all stakeholders in food supply chain including consumer
organizations, industry and the government
(Motarjemi and Mortimore, 2005). On the other hand, food safety is a
global phenomenon growing its importance everyday due to the concerns in public
health and impact on global trade (Burros, 1997), where, food safety control
combines both performance-based approaches such as end-product testing,
inspection and sample testing and integrated process-based approaches such as
regular audits, assessment by third party
auditors, accreditation to food safety management (Mensah and Julien,
2011). In addition, quality is an essential necessity of the competitiveness
and organization’s survival in highly competitive
global economy with continuous improvement of product, process and
services (Gavin, 1993; Misterek et al., 1990) where industry has upward moving
trends in implementing food quality assurance systems as well as food safety
assurance systems. The food safety assurance systems were required for
manufacturing organizations to ensure food safety and compliance to statutory
and regulatory requirements as well as customer requirements in food supply
chain (Trienekens and Zuurbier, 2007).
Technically
speaking, standards environment has transformed
in recent years (Humphrey and Memodovic, 2006), where standards now encompass
much more than product standards which include standards related to production,
handling and processing, in order to ensure that products meet certain desired
physical characteristics. Standards are agreed criteria, or as to Hawkins,
‘external points of reference’, by which a
product or service’s performance, its technical, physical
characteristics, conditions and/or the process under which it has been produced
or delivered can be assessed (Hawkins as cited in Nadvi and Waltring, 2004).
Labour (SEDEC, OSHAS, ETP), and environmental (ISO, 9001, ISO 14001, ISO 22000,
HACCP, GMP) standards are two type of examples for process standards where the
objective lies not in the product but in the process itself. As Humphrey and
Memedovic (2006) stated, the standard environment of agribusiness shows four
main trends: (a) increasing stringency of
public mandatory standards; (b) a shift from product standards to process
standards; (c) increasing importance of private standards; and (d) increasing
scope of standards.
On
the other hand, organization’s competitiveness and position in global food
trade can be strengthened through implementation of quality assurance systems
(Karipidis et al., 2009) where quality management system can be defined as a
complete set of written procedures, practical applications, records of evidence
and training (Newman, 2005). Food manufacturers are interested in implementing
food safety and quality systems such as Hazard Analysis Critical Control Point
(HACCP) and ISO 9001 Quality Management Systems to comply with quality
practices (Ziggers and Trienekens, 1999) where ISO 9001:2008 basically
concentrate on process management requirements while HACCP is focused on
technological aspects of food safety assurance (Luning and Marcelis, 2006). Thus,
Manning and Baines (2004) emphasized that both food safety and quality of the
product and its manufacturing process can be addressed through effective
quality assurance systems by splitting product and the process where quality
can be defined in terms of intrinsic quality (product) and extrinsic quality
(process).
Accordingly,
the ISO 22000:2005 was introduced
to the world with objective of assuring food safety in food supply chain
(Trienekens and Zuurbier, 2007) where synergetic effect of HACCP, GMP and ISO 9001:2008 was expected instead of applying
three systems individually in food industry. Thus ISO
22000:2005 has created a more resilient basis for establishing and demonstrating compliance of organization’s
quality management systems with appropriate documentation and procedures
defined by the standard, where controls has to be established for every aspects of production process while
documenting all the operational procedures as well as managerial actions
(Mamalis et al., 2009). ISO 22000:2005 was developed for food industry where it
is directly applicable with the core
production areas of manufacturing process which is a valuable tool for
manufacturers in order to ensure that both quality assurance standards and food
quality procedures have been met and achieved. Thus it ensures consumers are
safe with their choices while considering food safety is a critical control
point in industry‘s future. The
implementation of ISO 22000:2005 in industry is related to the structure of
manufacturing facility, to the nature and number of products that produced and
consumed globally and finally, to the procedures of production.
Due to the growth of information age as
well as creation of awareness among consumers, the food safety requirements are
never been so as high today where ISO 22000:2005 has become a valuable tool in
assessing and preventing food safety even before it started. In contrast, quality is a very difficult term
to define or to understand and measuring which cannot be taken as an
absolute. The quality assurance is a
guarantee of agreed-upon specifications has been delivered (Mamalis et al.,
2009). In addition to that, few writers conclude that, explicitly or implicitly
the quality is simple; nevertheless many treatises on quality conclude that it is
complex, multidimensional, and relative (Meiselman, 2001). According to Juran
(1989), Quality is not a scientific or a technical word, it is not a physical
entity, but it is a very useful concept in general life and management. Thus,
terms ‘‘food quality’’ and ‘‘food safety’’ mean different things to different
people based on their perception.
Consequently, food quality is considered as
an interesting concept where it transcends all steps and all actors within the
food chain covering one step forward and one step backward; however it is of an
intangible nature because it is perceived individually (Olsen et al., 2008).
Meaning of the food quality can be vary depending on the situation and can
encompass parameters as diverse as organoleptic characteristics, physical and
functional properties, nutrient content and consumer protection from fraud. On
the other hand, safety is more straightforward, relating to the content of
various chemical and microbiological elements in food (Burlingame and Pineiro,
2007). Food safety and food quality assurance are forms of guarantees, where
assurance of quality is a guarantee that agreed-upon specifications have been
met. However, if the safety related specifications are included in the quality
assurance system, then the assurance of quality incorporates safety (Holleran
et al., 1999). Nevertheless, consumer is the key to defining quality, where a company’s internal definition of
quality is meaningless if it fails to reflect consumer requirements (Kontogeorgos and Semos, 2008). Because it is not
just like in the past, today retailers are using recognized certification frameworks (hands-off), which set out
the basic minimum requirements of food safety acceptable for their consumers in
the global food context, where suppler required to be certified by third party
auditors, even before qualifying to supply food with specific certifications
whether voluntarily or mandatorily sought by suppliers (Mensah and Julien,
2011). This type of buying consolidation has given rise to “buyer-driven
chains” and sourcing patterns, which extends well beyond national boundaries;
facilitated by developments in communications and transportation, crating a
policy environment conducive to more liberal trade (Henson and Reardon, 2005; OECD, 2006; Fulponi 2005; Nadvi and Waltring,
2004).
In the current context, food firms are facing
increasingly intense competitive markets and are implementing quality assurance
systems (Ziggers and Trienekens, 1999) where
each quality assurance system covers different quality aspects e.g.,
some focus on management aspects (ISO), whereas others focus on technology
aspects (GMP, HACCP). The current standards were developed focusing to run on
multiple platform quality assurance systems which are often combined to assure
several quality aspects, for assuring food safety and food quality e.g., the
combination of HACCP and ISO 9001:2000 (Van der Spiegel et al., 2004).
Nowadays, Safe production and supply of safe food products are the main aims of
the food and beverage industry. Food companies adopt quality assurance systems
like HACCP, ISO 9001:2008 and ISO 22000:2005
which have widespread international acceptance to control activities, processes,
procedures and resources according to these standards (Mamalis et al., 2009).
ISO 22000:2005
Awareness of consumer and
product safety has probably never been so high as today. Significant food
crises in world during the past decades have raised doubts in the consumer’s
mind and created a lack of trust and confidence in products put on the market.
Fortunately, most companies already take product quality and consumer safety
very seriously. A lot of good practices have been developed and implemented on
a voluntary basis. These practices ensure that product safety has never been as
high as it is today (The Traceability Blue
Book, 2004). Companies continuously challenge their internal quality
systems and work on continuous improvement, thanks to new technologies and ways
of working.
International trade of
food products are increasing while increase in scientific knowledge about
hazards associated with foods and their consequent effects on health have made
people critically think about their food habits. Thus, there is a growing
concern on food safety, because, growing consumer awareness, more foods
prepared away from home, rising of incidence of food born illness in some
countries, globalization and less barriers to trade present new food safety
challenges, unfamiliar hazards or new hazards. For an example, 70% of the
approximate 1.5 billion case of diarrhea that occur globally each year are
directly caused by chemical or biological contamination of food and more food
allergies have been reported over recent years, and the number of people with
food allergies is still increasing (DEFRA, 2008).
Foodborne
illness is a preventable disease affecting all people, which has significant
impact on public health and significant trade implications on economies. As to the published data, around 76 million cases of foodborne
illness occur each year in the United States, costing between USD 6.5 and USD
34.9 billion in medical care and lost productivity (Buzby and Roberts, 1997;
Mead et al., 1999)
To date, there are 250+
types of food borne illness have been identified with the effects ranging from
acute to chronic illness such as mild symptoms to life threatening, i.e.
Sequelae - septicemia, abortion, arthritis, hemolytic uremic syndrome,
Guillain-Barre syndrome, botulism and death. Foodborne illness is significantly
underreported, due to the lack of awareness among community where diarrheal
diseases alone - a considerable proportion of
which is foodborne illness is killing around 1.9 million children
globally every year (WHO, 2008). In addition, food born diseases cause 76 million illnesses while hospitalizing around
325,000 with 5,000 deaths in the United States each year (Mead et al., 1999).
Over 40 different food born microbial pathogens including fungi, viruses,
parasites, and bacteria, were believed to cause human illnesses at the time and
it was estimated that for six bacterial pathogens, the costs of human illness
were estimated to be USD 9.3 – USD 12.9 billion annually, of these costs, USD
2.9 – USD 6.7 billion were attributed to food borne bacteria (USDA, 1996).
These estimates were developed to provide an analytical support for USDA’s
Hazard Analysis and Critical Control Point (HACCP) system initiated for meat
and poultry at the beginning which overrule entire food industry today with
amalgamating in to the core of the various global food standards.
Previously,
product safety was perceived and positioned as the voluntary
responsibility of companies but the publication of EU Directive 2001/95/EC on
General Product Safety in December 2001, and EU Regulation 178/2002 on Food
Safety in January 2002 brought about a significant change (The Traceability
Blue Book, 2004). In recent years, trade barriers related to tariffs and quotas
have been lowered considerably with the involvement of World Trade
Organization, which has fostered growing interdependencies through the exchange
of food products, across national borders where emphasis has being focused on
non-tariff barriers and the wider recognition of their impact on trade (Henson
and Caswell, 1999).
Today, European
legislation constitutes a set of requirements that each company manufacturing,
distributing, importing and/or exporting products to and from Europe must
comply with. Beyond the legal aspect, consumer safety is primarily a question
of business ethics and responsibility. Good product quality and product safety
contribute to build up consumer confidence and consequently strengthen the
image of a company or a brand in the consumer’s mind (The Traceability Blue
Book, 2004). Failure to respect consumers’ needs and expectations may be interpreted as betraying this confidence and
consequently may lead, in the long term and the worst case, to damage
for a company and its brand image and in some cases for the business partners
and the whole industry. This is what is at stake when quality and safety are
compromised.
Considering these food
safety problems and trade issues generated over the time, the International
Standard Organization developed the ISO 22000:2005 Food Safety Management
System to harmonize the requirements of various food safety standards into
integrated system while eliminating lots of trade issues faced on exports. Thus
ISO 22000:2005 is an international, auditable standard which specifies the
requirements for food safety management system by incorporating all the
elements of Good Manufacturing Practices (GMP) and Hazard Analysis Critical
Control Points (HACCP) together with a comprehensive management system (Pillay
and Muliyil, 2005). The new standard ensures the complete food safety of entire
food supply chain while satisfying global food safety statutory and regulatory
requirements.
ISO
22000:2005 is a quality assurance system introduced by ISO, to
ensure consumer safety through food safety while eliminating trade issues,
which was a further development of HACCP and other available food safety/quality
assurance systems that ensures the food safety of entire food supply chain from
farm to fork. It promotes the conformity to the international standard of the
product or services offered by providing the assurance of quality, safety and
reliability (Tajkarimi, 2007). According to the Food safety experts in the
field, set of well-functioning prerequisite programmes (PRPs) initially
simplify and strengthen the HACCP plan, where ISO 22000:2005 is a HACCP-type
standard which fits very well with ISO 9001:2000 because, it was especially
developed to assure food safety. ISO
22000:2005 has dynamically combine the HACCP principles and application
steps with prerequisite programmes, using the hazard analysis to determine the
strategy to be used to ensure hazard control
by combining the prerequisite programmes and the HACCP plan (Faergemand,
2005).
Structure
of the ISO 22000:2005
ISO 22000:2005 is a
federative standard which harmonized the most of the food safety requirements
set by different global standards and compatible with any food safety
regulation worldwide. Nevertheless, ISO 22000:2005 is the first in a family of
standards which is entirely focused on food
safety that introduced focusing entire food chain, it includes the
following documents:
[ ISO/TS
22003:2013, Food safety management systems – Requirements for bodies providing
audit and certification of food safety management systems (www.iso.org)
[ ISO/TS
22004:2014, Food safety management systems – Guidance on the application of ISO
22000:2005 (www.iso.org).
[ ISO
22005:2007, Traceability in the feed and food chain – General principles and
guidance for system design and development (www.iso.org).
[ ISO
22002-I:2009, Prerequisite programs on food safety – Part I: Food manufacturing
(www.iso.org).
This
international standard specifies the requirements for a food safety management
system (FSMS) that combines the following generally recognized key elements to
ensure food safety along the food chain, up to the point of final consumption,
that are,
- Interactive communication
- System management
- HACCP principles
- Prerequisite programs (Mensah and Julien, 2011)
Communication
along the food chain is essential to ensure that all relevant food safety
hazards are identified and adequately controlled at each step within the food
chain. This implies the importance of communication between organizations
between both upstream and downstream in the
food chain. Recognition of the organization’s role and the position
within the food chain is essential to ensure effective interactive communication
throughout chain in order to deliver safe food product to the end user (ISO
22000:2005, 2005).
The
most effective food safety systems are established, operated and updated within
the framework of a structured management system and incorporated into overall
management activities of the organization concerned which provide the maximum
benefits for interested parties.
The
standard integrates the HACCP system and application steps developed by Codex
Alimentarius Commission. By means of auditable requirements, it combines the
HACCP plan with (PRPs) perquisite programs (ISO 22000:2005, 2005). On the other
hand, new standard offers an alternative to
food manufacturers who do not implement ISO 9001:2000, while they want
to have an effective food safety management system (Aggelogiannopoulos et al.,
2007) as it combines a series of advantages, involving quality management,
external and in house communi- cations,
designating responsibility, implementing crisis management, continual
improvement, good health practices and differentiating between PRP, OPRP and
CCP (Talbot, 2007).
The
ISO 22000:2005 FSMS has been developed based on risk based management model
focusing the entire food supply chain through harmonization. The risk based
management model has eight steps,
Through
RBMM each and every processing step is evaluated for its suitability, if any
step is not complying with validation requirements, (Figure 1) will start from
the beginning until it can be validated.
According
to the figure 2, ISO 22000:2005 has been developed basically merging GMP, HACCP
and ISO 9001:2000. Here the foundation layer
is consist of GMP/GHP/GAP, Codex
General Principles of Food
Figure 1 – Risk
Based Management System (RBMM)
Hygiene
and prerequisite programs which altogether create
very sound infrastructure and physical requirements to implement food
safety requirements inside the plant focusing on basic food hygiene standards.
The ISO
22000:2005 FSMS has 3 major pillars/ layers to the standard; which can be shown
as;
Figure 2 – Three
Layer Model of ISO 22000:2005
The total
food safety is achieved through HACCP system of Codex Alimentarius using its
seven principles to identify hazards and to control them under strict
management plan. This includes the hazard analysis, identification of critical
control points, establishment of critical control limits, monitoring
procedures, corrective actions, record keeping and verification activities.
However, these requirements are applied through mandatory food safety procedures.
In addition, same procedures and activities
are applied to the prerequisite programs and operational prerequisite
programs identified according to the risk levels of the product manufactured.
The ISO 22000:2005 management elements are handled through
mandatory food safety procedures, that consists,
- Control of documents
- Control of records
- Corrections
- Corrective Actions
- Potentially Unsafe products
- Withdrawals
- Internal Audits
These
procedures are basically identical to ISO 9001:2000, and compatible with its
requirements.
The
ISO 22000:2005 FSMS also has procedure/ protocol for emergency preparedness and
response, which is inherited from reputed safety standards and that is
identical to ISO 9001:2000. The organization and the top management must be
prepared to respond to potential emergency situations and accidents that can
impact on food safety. These can include incidents such as fire, flooding,
bio-terrorism and sabotage, energy failure, vehicle accidents, contamination of
the environment, various types of weather-related events, or the impact of a
pandemic (Chambers, 2007).
A
food safety management system needs to be documented. This means that your
organization must have, as a minimum, a written food safety policy and related
objectives, the procedures and records required by ISO 22000:2005 and any other
documents that you might need to ensure the effective development,
implementation and updating of your system.
Any
business will not only need to document its policies and procedures but it will
have to have in place a procedure for controlling its documentation, including
records. Food safety management systems will change over time, as will the
people doing the activity. Therefore, one
reason for controlling documents is to ensure that the individual using
the document has the most recent version of the document. Part of document
control ensures that all the proposed changes are reviewed prior to
implementation so you can determine their effects on food safety and their impact on the management system. The documentation
system is also identical to the ISO 9001:2000 which consists of four
layers (Smith, 2002).
Figure 03 – ISO
22000:2005 Documentation Pyramid
As the organization develops its food safety
management system, it will be required to carefully document its activities.
These will include the written food safety policy and related objectives, food
safety procedures and the required records. However, the scope of the required
documentation is much broader. For example, in establishing your control
measures you are required to document your hazard assessment and your hazard
analysis, including the decision- making process and the selection of control
measures. The organization will have to document the validation of its system and
verification activities. The work of the food safety team and the management
review also require documentation (Chambers, 2007).
Prerequisite
programs were basically developed as part of good manufacturing practices
initially and later on it was became one of the major components in HACCP,
because most of the system developers wanted to keep lowest number of HACCP
studies in a system where PRPs were used to cover less critical control points
as well as which cannot be measured real time. In ISO 22000:2005, this
uncertainty was addressed with separating real time immeasurable critical
control points in to operational prerequisite programs.
This was not properly segregated in HACCP and later versions addressed
the issue up to a certain extent, but it didn’t completely cover the gap until
the ISO 22000:2005 was released.
Nevertheless,
all prerequisite programs have four common factors which are; address indirect
food safety issues, cover general programs related to food safety and it can be
applied to multiple production lines.
Momentary failure to meet prerequisite programs seldom results in a food
safety hazard (Surak, 2006). The organization should use documents of external
origin relevant for food safety in its various activities, for example in
meeting statutory, regulatory and customer requirements. In some situations,
electronic documentation may be required to comply with regulatory
requirements.
While
considering ISO 22000:2005 FSMS, the most of the management elements are
directly compatible with ISO 9001 in the areas such as (ISO 22000:2005, 2005),
4.2 Documentation requirements
5.1 Management commitment
5.2 Food safety policy
5.3 Food safety management system planning
5.4 Responsibility and authority
5.5 Food safety team leader
5.7 Emergency preparedness and response
5.8 Management review
6.2 Human resources
6.3 Infrastructure
6.4 Work environment
8.3 Control of monitoring and measuring
8.4.1 Internal
audit
Within the ISO 22000 FSMS, the following information
is collected (not a comprehensive list) and store as evidence of the system
development and maintenance.
- The food safety team and the competence of team members
- The scope of the combination of control measures
- Product characteristics (e.g. raw materials, ingredients and Product contact materials) as well as the end product characteristics and intended use
- Customer requirements
- Generic flow diagrams and site schematics
- Descriptions of process steps and control measures
- Details of the hazards identified and their acceptable limits
- Hazard assessment including the HACCP plan, product/process flow diagrams, hazard identification and hazard analysis
- Selection of the control measures
- Prerequisite programmes, including those initially selected and those determined by the hazard analysis as well as the management of the prerequisite programs
- Operational prerequisite programmes
- Critical control points and their critical limits, etc.
- Programme elements concerning control of non-conformities verification including evaluation and handling of potentially unsafe product or nonconforming product
- Corrective action records
- Calibration records
- Traceability records
- Supplier evaluation records
- Results of validations
- Results of verification
- Raw material and ingredient records
- Internal and external communication
- Monitoring records for operational prerequisite program and HACCP plan
- Product withdrawal records
- Training and knowledge records
- Agreements with external food safety experts
- Results of internal and external audit
- Results of management review
Furthermore,
ISO 22000:2005 can be considered as a business management tool which links food
safety to business processes and encourages organizations to analyze customer
requirements, define processes and keep them in control where it enables integration
of quality management and food safety management (Mamalis et al., 2009). In
this way ISO 22000:2005 FSMS is considered as more focused, more coherent and
integrated food safety management system which can satisfy any food safety
statutory or regulatory requirements.
Weaknesses
Showcased in ISO 22000:2005 Standard
According
to the global food safety initiative (GFSI), ISO 22000:2005 was having problems
in defining prerequisite programs because set specifications are not adequate
to define PRPs, where GFSI has introduced clearly defined PRPs and other
regulatory controls in FSSC 22000 (Sansawt and Muliyil, 2012). Thus they have not approved the ISO
22000:2005 standard directly, but they have
added ISO 22002-1:2009 to the audit scope to improve the PRP requirements in addition to the accredited ISO
22000:2005 certificate to comply with GFSI’s approval. As to food safety
magazine “The committee that wrote the standard had to address several critical
issues with regard to prerequisite programs where there is not a standard
consensus of what constitutes prerequisite programs”(Surak, 2006). However, ISO
has rectified the errors on ISO 22000:2005 by introducing ISO 22002-1:2009 and
it has been revised in 2013. In contrast, GFSI further focus to comply with customer
and regulatory requirements in a single perspective. In addition to that, the
standard has not specified supplier
evaluation and selection in appropriate manner, while traceability was
introduced in other separate standard later on; which must have included into
the system at the beginning. The standard has set 568 major and minor
requirements (Shall) which are repeated in many places while compromising
reader.
Considering
above major reasons, ISO 22000:2005 can be considered as a loosely structured
standard even through it has all the relevant requirements and components to
control food safety in a harmonized manner. Thus it has to be reorganized and
streamlined into a single set of instructions within a single standard
document. Due to this reason, consultants in the industry as well as auditors are
mainly consider only complying with main standard or the ISO 22000:2005 where
other sister standards still remain as guidelines and their use and value
become minimal to the industry. GFSI has directly addressed this through
binding both standards as well as other applicable standards (PAS 220, ISO
22005, etc.) as a single unit to comply with.
On
the other hand, PRP and OPRP segregations need to be further explained to the
industry operators where there is no any proper explanations was given by any
of the experts. The standard was almost 10 years in existence and has adapted
by over 30,000 companies worldwide up to 2014 (ISO, 2015), but announcement of
the revision of the standard took very long time even after the problems were
identified and explained by many international experts. In the meantime, ISO
offered suitable solutions to the problems encountered, but delayed the
revision. Nonetheless, ISO 22000: 2005 was developed to harmonize the existing food
safety standards at the time of release, but unfortunately
it has increased the number of available standards in the world rather than
reducing the available numbers where it’s initial goal of once certified,
accepted by all the parties throughout the world was moved in to GFSI theme. In
addition, manufactures still have to certify for different certificates to sell
their products where FSSC 22000, the GFSI’s standard has gained the
significance while ISO 22000 has somewhat diminished its perspective from the
market unlike ISO 9001:2008.
Problems Encountered while
Implementing ISO 22000:2005
The PRP issue was highlighted in many
forums but unfortunately ISO didn’t address the issue where GFSI got the
millage and further strengthen their standard. Now they have added ISO
17025:2005 to the list of guidelines where the company does not need to
accredit their internal laboratory, but they need to follow the guidelines to
comply with it. The advantages are better control of the food safety and
reliability of the certification to the end user. In contrast, there are significant variations in food safety regulations across the globe
and among value
chains
which increase the burden of auditing costs of certifications on food
manufacturers, as retailers require different certification frameworks to qualify suppliers.
The impacts of these variations on
relevant actors present practical reasons
for the need of harmonizing food safety regulations (Motarjemi et al., 2001)
which are justifiable reasons that explains these variations (Henson and Jaffee, 2006). Some of these reasons are attributed to the distinct tastes, diets,
or income levels and perceptions that influence the tolerance of populations towards the risk associated with food.
Alternatively,
this will tend to increase the product price and the accumulated cost for the
production than it disserves where companies may tend to let down these
practices while make sure auditor meet the minimum requirement. Thus, consumer
safety is paramount when it comes to food safety regulation; yet, regulators
required to conduct due assessments of food safety risks on consumers as well
as cost implications of enforcement strategies on industry to help mitigate
costs incurred by industry, without compromising consumer safety (Mensah and
Julien, 2011).
Considering
the behaviour of enterprises, whether enterprises respond to standards in a
positive or negative manner depends on a variety of factors e.g. sector,
enterprise size, financial situation and level of risk adversity, which suggest
that the response of enterprises is not automatic and it reflects the interplay
among different types of incentives operating at the level of mandated
government regulation, pressure from the markets and liability laws (Jayasinghe
and Henson, 2007; Khatri and Collins, 2007; Henson and Hooker, 2001).
Therefore, addition of different extra guidelines will be good as well as bad,
because most of the current food safety certifications available in developing
countries do not fully complying with any of the available food safety
regulations, this may be the case for even developed countries, where audit
firms are also managing a business and they very rarely suspend any system they
accredit. Even in the process of accreditation, major food safety issues and
critical food safety violations are mostly recorded as minor food safety
violations. In addition, most of the certification firms at the beginning
(startup face in any country office) lose their controls to gain the market and
to attract more customers because all these system certifications have become
marketing tools. The food safety issues are further intensified due to such
situations as well as auditing practices. The auditor verifies only a fraction
of the system while most of the companies only comply food safety requirements
on the day of certification or surveillance audits. As previously discussed, different private standards introduced by brand manufacturers
(i.e. FSSC 22000) and retailers will further introduce more variations into
existing food safety regulations and the modes of conformity assessments (Henson and Mitullah, 2004) to
improve and differentiate their standards for one another. Thus a common reference point is required, explaining from where the process of harmonization of standards
could be started, to reduce multiple certifications on food enterprises. As an
initiative, SPS agreement which was introduced by the WTO facilitates a move towards this much needed common reference point, by providing a basis to establish equivalence and harmonize food safety regulations
(Mensah and Julian, 2011).
Future of ISO 22000:2005
Since ISO
22000 already announce the review of ISO 22000:2005 by 2017, the working
committees will continue to enhance the ISO 22000 FSMS, which will be a
competition between “Farm to Fork” and “Once Certified, Accepted Everywhere”.
Thus ISO 22000 will cover all the issues identified during last decade of
implementations, where GFSI many also start claiming some of the new problems
to directly comply with it or to accept the independent verifications conduct
by some other accredited auditor. This is because both organizations are
nonprofit organizations selling and profiting from their standards and as
annual fees. Thus both organizations want to promote their standard where
competition is expected.
On
contrary, ISO may further improve their multiple platform initiative while
customizing the ISO 22000:2005 such as ISO 9001:2015 DIS version. The ISO
9001:2015 DIS version has step out of the status quo and let the company decide
on the requirements based on the context of organization, while keeping the documented requirements as a mandatory
compliance criteria without specific terms or references which directly
cannot be applied to food safety, but it may be possible with modifications. As
it seems, ISO 22000:2005 may be modified to comply with generic format
discussed in the multiple platform initiative while strengthening the areas
which were lagged in the existing version. Nonetheless, virtual auditing and
third party certification based on the fourth player in the game may be able to
minimize the issues faced in the system, but this kind of models will have its
oven limitations while such kind of system may be highly valuable for contact
manufacturer monitoring as well as top management to find out real practices in
the system rather than certifications.
However, current auditing models are not 100% credible, where
alternative ways and technologies will have an opportunity to develop in the
future.
Conclusions
ISO
22000:2005 was developed based on the all elements of good manufacturing
practices and hazard analysis critical control points together with a
comprehensive management system developed based on ISO 9001:2000 management elements. ISO
22000:2005 has created a more resilient basis for establishing and demonstrating compliance of organization’s
food safety management system with appropriate documentation and procedures
defined by the standard. The GMP was implemented through prerequisite programs,
but specifications given in the standard on PRPs was not satisfactory where
additional guidelines were issue to rectify issues. ISO 22000:2005 is loosely
structured compared to the FSSC 22000,
because of its sister standards considered as guideline documents by
auditors and the consultants rather than part of the standard. The competition
among ISO 22000 and the FSSC 22000 will intensify in the future. Existing
auditing model is not 100% credible where alternative approaches are required.
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