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FOOD QUALITY AND SAFETY MANAGEMENT SYSTEMS: A BRIEF ANALYSIS OF

THE INDIVIDUAL AND INTEGRATED APPROACHES

Article · May 2005

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 G. Rotaru, et al. Scientifical Researches. Agroalimentary Processes and
Technologies, Volume XI, No. 1 (2005), 229-236
FOOD QUALITY AND SAFETY MANAGEMENT SYSTEMS:A
BRIEF ANALYSIS OF THE INDIVIDUAL AND INTEGRATED
APPROACHES
Gabriela Rotaru, Nicoleta Sava, Daniela Borda, Silvius Stanciu
1
Department of Bioengineering, Faculty of Food Science and Engineering,
“Dunarea de Jos” University, Domneasca 111, 800201 Galati, Romania
Abstract
The food industry has a number of Quality Assurance (QA) systems available like
GMP (Good Manufacturing Practices), HACCP (Hazard Analysis. Critical Control
Points), ISO (International Organisation for Standardisation) standards. These
systems and their combinations are recommended for food quality and safety
assurance. The agri-food production requires a specific approach to achieve the
expected quality level. It is important to know to what extent the systems contribute to
the total quality of the product and to balance the tools used for achieving the quality
and safety objectives.
Keywords: food, quality, safety, quality and safety management systems.
Introduction
Despite the huge efforts paid by the food safety authorities, specialists and
industry, food safety still remains critical and often is coming into spotlights
attracting media’s attention with outbreaks that can bring a stack of multiple negative
consequences. Such major events like BSE in 2000, dioxin or PCB crisis in 1999 and
others questioned the effectiveness of the food quality assurance systems and food
safety management applied and demonstrate that new tools are needed to
complement the actual systems in place. When evaluating the negative consequences
one have to take into account the medical costs incurred, the economical losses that
can badly shake local small industries, and least but not last consumers` trust.
The safety paradigm is that although food is safer, consumers` attitude is
dominated by high levels of uncertainty. In this changing climate we however, need
to recognise the effort EU authorities make to restore consumers` trust and enforce
new regulations and better communicate food safety related issues. An important
feature of food industry is that producers, in order to cope with market needs and
legal requirements, have to satisfy both safety and quality criteria for their products.
Having multiple options in the form of different quality and/or management systems,
food producers should decide the most appropriate one for its specific activity and
should establish, document and implement effective systems for managing quality
and safety (van der Speigel et al., 2003).
Among the available Quality Assurance (QA) systems there are at hand
today systems such as: GMPs (Good Manufacturing Practices), GHPs (Good
Hygiene Practices), GAPs (Good Agricultural Practices) or other prerequisite
systems and HACCP (Hazard Analysis. Critical Control Points) (van der Speigel et
al., 2003).

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 Food quality and safety management systems:a brief analysis of the
individual and integrated approaches
Management systems such as ISO 9000, or integrated management systems
according to ISO 22000:2005 (Food safety management systems - Requirements for
any organization in the food chain) are also accessible for producers
This paper discusses the most important theoretical systems and identifies
several factors that limits or contribute to the successful implementation of quality,
safety or integrated systems applied in the food industry.
Individual quality and/or safety management systems for food industry
- A quality management system (QMS) system can be defined as: a set of co-
ordinated activities to direct and control an organization in order to continually
improve the effectiveness and efficiency of it performance.
Food quality is a complex concept that can be assessed only in relation to
food safety. To be considered safe for consumption, a food must meet: legislative
requirements; technological criteria; hygiene requirements; transport and handling
requirements; trading conditions and satisfy its intended use.
The relation between quality and safety is intricate and although safety
cannot be viewed as a totally independent aspect from quality, recognising the
complexity of both concepts brought the need of managing them separately. In fact
the reasoning behind separating food safety from quality was the need to place the
concept of safety first and above all the other quality aspects.
The result can be classified in quality assurance systems (QA) that
includes the prerequisites (GMPs, GHPs, GAPs) and HACCP; quality management
systems (QMS) that refers to ISO or TQM; and integrated systems (IS) such as
ISO 22000.
The systems can be classified according to the extent of activities they
cover, in:
- basic safety systems: prerequisites (GAPs, GMPs, GLPs, etc.);
- advanced safety systems such as HACCP;
- integrated food safety management – ISO 22000;
- basic quality management systems - ISO 9001;
- advanced quality management systems - ISO 9004.
A part of the quality assurance systems and prerequisite programs that are
applied by the industry are presented bellow.
Good Manufacturing Practices - GMP. GMPs as defined by the Food and
Drug Administration in 21 CFR part 110 are the minimum sanitary and processing
requirements for food companies. The basic aim of GMP is concerned with the
precautions needed to ensure adherence to all quality and safety basic requirements,
like:
- elimination, prevention, minimisation of all product failures in the broadest
sense;
- consistently yields safe, ensuring a certain quality uniformity.
Prerequisite programs provide the basic environmental and operating
conditions that are necessary for the production of safe, wholesome food.

230
 G. Rotaru, et al. Scientifical Researches. Agroalimentary Processes and
Technologies, Volume XI, No. 1 (2005), 229-236
The Codex Alimentarius General Principles of Food Hygiene describe the
basic conditions and practices expected for foods intended for international trade. In
addition to the requirements specified in regulations, industry often adopts policies
and procedures that are specific to their operations.
GMP guidelines are not prescriptive instructions on how to manufacture
products. They are a series of general principles that must be followed during
manufacturing.
When a company is setting up its quality program and manufacturing
process, there may be many ways it can fulfill GMP requirements. It is the company's
responsibility to determine the most effective and efficient quality process.
Hazard Analysis. Critical Control Points – HACCP.
HACCP is a preventative, proactive and systematic approach of food safety,
which relies on the identification and control of the all the known associated health
hazards in the food chain. The system based on seven principles was developed to
control the biological, chemical, and physical hazards from the raw material
production, through manufacturing, distribution and consumption of the finished
product.
According to Codex Alimentarius (Alinorm 97/13A, Appendix III), the
safety of foods is principally assured by control at the source, product design and
process control and the application of Good Hygienic Practices during production
processing (including labelling), handling, distribution, storage, sale, preparation
and use, in conjunction with the application of the HACCP system.
The production of safe food products requires that the HACCP system be
built upon a solid foundation of prerequisite programs. While prerequisite programs
may impact upon food safety, they also are concerned with ensuring that foods are
wholesome and suitable for consumption. HACCP plans are narrower in scope, being
limited to ensuring food is safe to consume (FDA, 1997).
ISO 9000 series of standards had a major revision in the year 2000 when
three standards (9001, 9002, and 9003) were combined into one, called 9001. Design
and development procedures are required only if a company is in fact engaged in the
production and development of new products. ISO 9001 made a radical change in
thinking by actually placing the concept of process management front and centre.
The process management refers to the monitoring and optimisation of a
company's tasks and activities, instead of just relying on inspection of the final
product. This standard also demanded involvement by upper management in order to
integrate quality into the business system and prevent handing over the quality
functions to junior administrators.
Another goal of the standard is to improve effectiveness via measuring
process performance using statistical tools to assess the effectiveness of tasks and
activities.
Expectations of continual process improvement and tracking customer
satisfaction are made explicitly in standards` principles.

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 Food quality and safety management systems:a brief analysis of the
individual and integrated approaches
ISO 9004 goes beyond ISO 9001 and provides guidance on how one can
continually improve its business' quality management system. This can benefit not
only one`s customers but also: employees; owners; suppliers; society in general.
ISO 22000:2005 is a food safety management standard that is developed
based on the ISO 9001 approach. The standard was especially developed to manage
food safety. ISO 22000:2005 specifies requirements to enable an organization:
- to plan, implement, operate, maintain and update a food safety management
system aimed at providing products that, according to their intended use, are safe
for the consumer;
- to demonstrate compliance with food safety requirements;
- to evaluate and assess customer requirements and demonstrate conformity
with those mutually agreed customer requirements that relate to food safety, in
order to enhance customer satisfaction;
- to effectively communicate food safety issues to their suppliers, customers and
relevant interested parties in the food chain;
- to ensure that the organization is consistent with the declaration of food
safety policy;
- to demonstrate such conformity to relevant interested parties;
- to seek certification or registration of its food safety management system by an
external organization, or make a self-assessment or self-declaration of
conformity to ISO 22000:2005.
Total Quality Management – TQM is an integrative philosophy of
management for continuously improving the quality of products and processes
(Ahire, 1997).
TQM functions on the premise that the quality of products and processes is
the responsibility of everyone who is involved with the production or the services
offered by an organization (Rotaru et al., 2005).
Integrated approaches for food industry - The agri-food production
requires specific approaches to achieve the expected quality level. It is important to
know to what extent the systems contribute to the total quality (van der Speigel et al.,
2003).
The effective integration of the above mentioned individual systems will
improve the performance of the organization. Efstratiadis and Arvanitoyannis (2000)
mentioned that HACCP as a part of a quality system not only manages to provide
safe food products, but also assure a better and more effective implementation of the
entire quality system.
It is important to make distinction between the terms assurance and
management. The term assurance relates to a product itself and involves all the
safety assurance systems (GMP, GHP and HACCP) and the Quality Assurance
Control Points (QACP), the later referring to quality assurance, not safety (Sikora
and Strada, 2003). Maintenance and/or introduction of the all the other quality
characteristics of the food (nutritional, sensory and convenience values) in quality
assurance systems is not requested by law, albeit desirable by customers.

232
 G. Rotaru, et al. Scientifical Researches. Agroalimentary Processes and
Technologies, Volume XI, No. 1 (2005), 229-236
On the other hand, the term management corresponds to a company’s
overall organisation as regards the products’ quality (including safety), and involves
quality management systems -QMS (ISO-9000, ISO-14000, etc.) as well as TQM.
Voluntarily implemented systems, known as quality assurance and management
systems include ISO 22000, ISO 9000, ISO14000 and/or ISO 18000.
ISO 9001 can play an important role within TQM, by strengthening systems
and procedures, but it is a small part of TQM activities. Thus, the QMS performance
would be significantly improved with increasing the level of understanding of the
relationship between all the quality and safety systems (Figure 1).To improve the
performance of these systems, food manufactures should combine or integrate such
systems as to assure that all the safety aspects of food and the necessary quality
attributes are covered. For example, HACCP principles are often combined with ISO
9001 so that the technological and management issues regarding food safety and
quality are achieved. Thus, ISO 9001 can be helpful for the application of HACCP
(Rotaru et al., 2005).

Figure 2. Implementing QMS (Teodoru, 1993)

Figure 1. Relationship between the
quality systems in food industry
Furthermore, food manufactures are obliged by legislation to apply HACCP
principles, while the other systems are applied voluntarily in the food industry.In
Table 1, an integrated model of the essential requirements for food industry is
presented.
Since the assurance of safe production and safe food products are mandatory
requirements for food industry, these can be attained by adopting a systematic and
organizational structure, controlling activities, processes, procedures and resources
according to the standards which constitute the basis for the quality and hygiene
systems, including HACCP, ISO 9001 and 14000 series (Early, 1995).
The standard ISO 22000:2005 offers an alternative to food organizations
which do not implement ISO 9001 and want to have an effective food safety
management system.
Implementing QMS - Implementing a fully documented QMS will
ensure that two important requirements will be met:

customers’ requirements – confidence in the ability of the organisation to
deliver the desired product and service consistently meeting their needs and
expectations.

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 Food quality and safety management systems:a brief analysis of the
individual and integrated approaches

the organisation’s requirements – both internally and externally, and at an

optimum cost with an efficient use of the available resources – materials,
working force, technology and information.
Table 1. Essential requirements for quality and safety assurance in the food industry
Features General requirements
1. Quality management Top management commitment;
Plan and share responsibilities;
Assign proper human and material resources;
Ensure an effective quality system
2. Staff Create an appropriate organizational framework;
Describe the key positions;
Train the workers;
Develop behavioral and attitude competencies
Supervise personal hygiene and health.
3. Production areas and Ensure proper facilities and equipment – constructions, installation; maintenance, environmental
equipment conditions, sanitizing, cleaning, validation of cleaning.
4. Documentation Document, develop, approve, update, distribute, and archive documentation.
5. Processing Validate the processes;
Prevent cross-contamination during manufacture;
Purchase good raw materials;
Ensure the quality of the process, for intermediate, bulk or end products;
Comply legal labeling requirements;
Ensure good quality of the end products (quarantine, storage, handling, delivery);
Track the products rejected recovered and returned (tracking and identification).
6. Quality control Apply good practices in the laboratory;
Apply sampling techniques;
Validate the analytical method;
Inspect the process;
Maintain, check and calibrate the measuring and monitoring devices.
7. Regulations Apply mandatory requirements;
Follow contractual requirements.
8. Consumer complaints Handle the complaints;
Document the Withdrawals / Recalls;
Analyze the decisions.
9. Self-inspection Perform internal audit.
Check compliance and corrective action
10. Supplier Identify and select key suppliers.
relationships Communicate clear and open.
Share information and future plans.
Establish joint development and improvement activities.
Inspire, encourage and recognize improvements and achievements.

A QMS have four main components: quality planning, quality control,

quality assurance and quality improvement (Figure 2):
When implementing an advanced/integrated food quality and safety management
system, the lack of financial and human resources conflicting with high costs, the low
personnel and time restrictions side by side with a general lack of knowledge and
experience are important constraints. A brief analysis of the decisive factors that
influence the application of advanced and/or integrated systems helps in
understanding the relationship between certain specific elements such as: internal
(staff involvement, communications, leadership), external (level of competition,
relationships with suppliers, customers and authorities), structural (size, ownership
structure) and the degree to which the management practices are applied (Figure 3).
Only if all these elements are well addressed an organizations have the preparedness
to implement an advanced management system.

234
 G. Rotaru, et al. Scientifical Researches. Agroalimentary Processes and
Technologies, Volume XI, No. 1 (2005), 229-236
The organizations that implement TQM understand that customers will only
be satisfied if they consistently receive products and services that meet their needs,
are delivered when expected, and are priced for value. TQM organizations use the
techniques of process management to develop cost-controlled processes that are
stable and capable of meeting customer expectations.
TQM can be initiated by implementing ISO 9004 and this would be a step
further that implies changing in the organizational culture and a dedication for quality
and improvement.The principles of TQM are shown in Figure 4.

Figure 3. Factors affecting the

implementation of advanced/integrated Figure 4. The TQM principles
QMS
The success of TQM approach is achieved if the system is treated as a
strategic key business issue.
Additionally, we need to recognise that ISO and TQM focus more on the
managerial aspects, whereas GMP and HACCP focus on the technological aspects
(Hoogland et al., 1998). HACCP is the only quality assurance systems that consists
of a plan with 14 steps, in contrast with the checklist of ISO. GMP includes
guidelines and TQM uses awards or self-assessments (van der Speigel et al., 2003).
One of the key points to successful implementation of an
advanced/integrated management system is to recognize the need for continuous
improvement. Clause 8.5 ISO 9001 or 22000 urges a company to plan for corrective
and preventive action, and continuous improvement.
Application of this principle guarantees the company's efficiency and
competitiveness. In other words, a company that has been effectively implementing a
QMS will make continuous improvements. Hence, the effort to meet the standards`
requirements will bring the benefit of increasing the capability and the performance
of the organisation.
Conclusions
Successful implementation of food quality and safety management systems
is a necessity today.
In this paper, a brief analysis of the individual and integrated/advanced food
quality and safety management systems was made, together with the identification
and analysis of the factors that can influence the implementation process.

235
 Food quality and safety management systems:a brief analysis of the
individual and integrated approaches
The effectiveness of the integrated system is based on the relationship
between internal, external and structural factors. Besides these factors, food industry
have to balance the quality assurance and safety management systems, select the
proper ones according to its resources and needs and implement adequate tools for
continuously measuring and evaluating the performance of the individual or
advanced/integrated management systems.
References:
1. Ahire, S. L. (1997). Management Science- Total Quality Management
interfaces: An integrative framework. Interfaces 27 (6) 91-105.
2. Bolton, A. (1997). Quality management systems for the food industry: A guide
to ISO 9001/2. London: Blackie.
3. Early, R. (1995). Guide to quality management systems for the food industry.
London: Blackie.
4. Efstratiadis, M. M., & Arvanitoyannis, I. S. (2000). Implementation of
5. HACCP to large scale production line of Greek ouzo and brandy: a case study.
Food Control, 11, 19–30.
6. Hoogland, J.P, Jellema, A, Jorgen, M.T.G., (1998), Quality Assurance Systems,
In W.M.F. Jongen and M.T.G. Meulenberg Eds., Innovative of Food
productions systems: product quality and consumer acceptance, Wageningen:
Wageningen Pers.;
7. National advisory Committee on Microbiological Criteria for Foods/FDA
(1997), Hazard Analysis and Critical Control Point Principles and Application
Guidelines
(http://www.fda.gov/Food/FoodSafety/HazardAnalysisCriticalControlPointsHA
CCP/HACCPPrinciplesApplicationGuidelines/default.htm#app-a);
8. Luning, P.A., Marcelis, W.J., Jorgen, W.M.F., (2002), Food Quality
Management: a techno-managerial approach, Wageningen: Wageningen Pers.;
9. Rotaru, G., Borda, D, Sava, N., Stanciu, S. (2005), Quality Management in
Food Industry, Ed. Academica, Galati, Romania;
10. Van der Spiegel, M, Luning, P.A., Yiggers, G.W., Jongen, W.M.F. (2003),
Towards a conceptual model to measure effectiveness of food quality systems,
Trends in Food Science and Technology, 14, 424-431.
11. Sikora, T., Strada, A. (2003). Safety and Quality Assurance and Management
Systems in Food Industry: An Overview, available on line at
http://www.ip.aua.gr/Studies/Sikora-Strada_final.pdf.
12. Teodoru, T. (1993), Asigurarea calităţii. îndrumar metodologic, Ed. Tribuna
Economica, Bucureşti.

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