The purpose of a safety management system
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A safety and management system is a proactive system that controls all aspect of a product’s quality and safety; it acts as a framework within which the HACCP process can be managed as legal requirement. The system is expansive across the company; everyone is involved and will have received the appropriate training. In addition, the system is documented so that it can be audited both internally and externally by third party auditors, for certification purposes.
The use of a safety and QMS ensures that all aspects of a business are working cost effectively. It provides a competitive advantage (Nicolaides, 2004), which can increase marketing and sales opportunities; this helps the company gain new customers in addition to retaining existing business.
By working within a Safety and QMS, the whole workforce will be involved, subsequently improving communication, morale and job satisfaction. Though the QMS is not a pre-requisite programme for hygiene practices (Mortimore and Wallace, 2001), it is often implemented to manage the pre-requisite programme and HACCP systems so that any element of the operation can be effectively controlled. One of the elements of operation can be CCPs which, being the points where control is effected, are essential for product safety.
HACCP by itself will not guarantee safe food. Rather, in order to be effective, HACCP needs the support provided by other management systems operating within the business of which pre-requisite programme is one of them.
Pre-requisite programmes are, therefore, the good manufacturing practices (GMPs) or good hygiene practices (GHPs) that any reputable food business operator would be adhering to in order to ensure that safe, wholesome food is provided to the consumer (Mortimore and Wallace, 2001).
As a result, Quality Management Systems act as a framework within which the activity of the pre-requisite programme and HACCP can be managed as explained above.
Figure 1 illustrates the programme of the QMS:
Quality Management System
Total Food Safety
HACCP Study Personal hygiene training
HACCP Plan Building and equipment design
HACCP team Sanitation and maintenance
Training and awareness Pest control systems
Commitment Raw material control
Waste and drainage controls
Traceability and recall procedures
Good Hygiene practices
Supplier quality assurance
Glass/ metal Management
Figure. 1 Quality Management Systems
Source: Mortimore (2001)
1.2. The project rationale, aims and objectives
The primary aim of a Safety and QMS is to ensure that customer requirements are met consistently. Both HACCP and such a Safety and QMS aim at preventing non-conformity (Mortimore, 2001), placing emphasis on effective corrective action and getting it right first time.
Ocean Food is an SME producing ready chilled foods without any documented procedures and relying only on work instructions. It employs about 15-20 people with the owner acting as the Managing Director, Production and Sales Co-ordinator. The size of this production business and its limited resources has, however, limited the engagement of competent technical personnel and the implementation of a fully-fledged technical department. These reasons have made Safety Management Systems and documentation procedures virtually non-existent in the company. As a food producing company Ocean Foods operation must comply in all respects with the provisions of the Food Safety Act 1990 (Amendment) Regulations 2004 and the General Food Regulations 2004, in addition to all relevant UK legislation and EU Regulations and all other applicable codes of practice. An example of this is the Regulation 852/2004, concerning the hygiene of food stuffs across all food sectors.
The Directive is a horizontal Directive, and thus applies across the whole of the food industry (Forsythe, 2002), covering producers, manufacturers, distributors, wholesalers, retailers and caterers. In essence, this Directive combines the proactive approach of food safety by HACCP implementation and codes of Good Hygienic Practice into food law.
As aforementioned, times have changed, and the company can not longer be complacent about food safety. Customers have become more aware of and concerned about the potential dangers of unsafe food and foodborne illness (Loken, 1995). Hence, it is important to design a system, which will prevent or reduce food hazards to a minimum.
It is for these reasons that the research project is undertaken to investigate the issues that are caused when a Safety and Quality Management System is introduced into a SME such as Ocean Foods. It will also investigate the difficultites that have been found as a result of the new operational systems, in addition to analysing the solutions developed to overcome the identified difficulties, and the opportunities offered to strengthen the system.
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Finally, the new systems will articulate the procedure which must be followed to ensure that all Ocean Food products are completely traceable from raw material to finished product and that records are kept (General Product Safety Directive 2001/95/EC), hence ensuring that the company will comply with the relevant legislation in the UK and EU in the interests of public safety.
Therefore, the aim of this project shall be:
To investigate, identify issues and related solutions for SME for developing, implementing and maintaining a Safety and QMS.
To research how a user friendly Safety and Quality System Manual can be developed to encourage employee training by SMEs.
To outline, with the Manual, the guidelines for Good Manufacturing Practice (GMP) in the company, thereby helping to understand legislation and how it needs to be complied with.
The above aims will help to understand constraints of introducing food safety and quality management systems into SMEs such as Ocean Foods.
CHAPTER 2. – LITERATURE REVIEW
This chapter briefly describes an SME and outlines the requirement for a Safety and Quality Management System (SQMS) and the role and responsibility of the Management in ensuring safety requirements are met. It also emphasises the importance of training employees, the role of audit in verifying the efficacy of the QMS, and issues that can affect small scale businesses when implementing a SQMS. Furthermore, it discusses the importance of HACCP as an effective way of managing food safety.
The chapter discusses studies in the literature that have assessed the SQMS, with particular reference to Small and Medium Establishments (SMEs). Particularly, it examines the impact of legislative requirements on SMEs, the unique problems encountered by SMEs in establishing SQMS and implementing an HACCP system, as well as possible solutions.
2.1. What is an SME?
SME is a commonly used acronym for ”Small and Medium-Sized Enterprise” and has become something of a ‘catch all term’ (Hillary, 2000), used whenever anything other than big business is being discussed. It is currently used extensively among policy makers, support organisations, the government and researchers, but significantly, not by SMEs themselves. As far as they are concerned they are just business, and can’t see why they should be defined by such narrow variables such as size, turnover and ownership (Hillary, 1995).
In 1996, the EU attempted to define this extremely diverse sector by differentiating between an SME and a small enterprise, based on employee numbers, turnover or balance sheet total, and ownership (CEC, 1996). According to these definitions, an SME has fewer than 250 employees and either an annual turnover not exceeding 40 Million Euros or an annual balance sheet total not exceeding 27 Million Euros, and is an independent enterprise, i.e. 25% or more of the capital or voting rights cannot be owned by (a) larger enterprise(s), as illustrated in Figure 2. As also been seen, a further distinction is made between micro, small and medium firms.
An SMEcan be define as an Organisation which
Has no more than 50 employees.
Has either an annual turnover of less than Euro 40 million, or an annual
balance sheet total less than Euro 27 million.
Is less than 25% owned by one, or several, enterprise(s) not satisfying the same criteria.
0- 9 employees
Figure 2. Illustrates Small and medium sized enterprises and definition and categorisation
Source: Small Business Services (2003)
By contrast, a small enterprise has fewer than 50 employees (CEC, 1996), and either an annual turnover not exceeding 7 Million Euro, or an annual balance sheet total not exceeding 5 Million Euro, and is an independent enterprise, i.e. 35% or more of the capital or voting rights cannot be owned by (a) larger enterprise(s).
2.2. Why is a Safety and Quality Management System is needed by SMEs?
Regardless of the size or type of organisation, quality Management prides itself on the reduction of errors… Subsequently, the adoption of a Safety and QMS may help in implementing the following (Waller et al., 1993) by SMEs.
Creating an appropriate management structure that will ensure that the processes needed for the quality management system are established, implemented and maintained.
Defining requirements for the ISO 9001-2008 Quality Management System.
Agreeing and formalising documented procedures required by the ISO 9001-2008 standard.
Taking corrective action to eliminate the cause of non-conformity, with aim to prevent recurrence.
Carrying out internal audits at planned intervals in order to determine whether the QMS conforms to the planned arrangement of the requirements of ISO 9001-2008.
Improving efficiencies of those involved by offering information and training orientated awareness of the relevancy and importance of their activities.
Increasing customer satisfaction to ensure that customer requirements are determined and met.
What are the driving forces for adopting safety and QMS by SMEs
There are a number of driving forces for SMEs to procure Safety and QMS. Perhaps most significant are the issues of legislation and customer requirements. Today’s consumers are preoccupied with knowing that the food they purchase and consume is safe, regardless of where it has been grown or processed. Furthermore, retailers require suppliers to demonstrate that they are providing safe, quality food that meets the expectations of the consumer. (www.sqfi.com). subsequently, retailers have identified the need for consistent, internationally accepted food safety and quality management systems.
2.3.1. Food hygiene legislation
The primary objective of new EU food hygiene legislation is to optimise public health protection by building on, improving and modernising the existing EU legislation (www.food.gov.uk). The new legislation articulates that the duty of Food Business Operators is to produce safe food. This is a requirement that is contained in current legislation and is underpinned by general food law.
Much of the detailed legislation on food standards originates in the European Union. There are details on proposals to consolidate and simplify food hygiene legislation as well as details of other European legislation. On 29 April 2004 new EU food hygiene legislation was adopted and came into force from 1 January 2006.
The EU legislation, for example, includes a farm in the fork approach to food safety, hence including primary production (i.e. farmers and growers) in food hygiene legislation for the first time in the majority of cases.
The following are included in the new package of legislation:
Regulation 852/2004: Regarding the hygiene of foodstuffs:
The above regulation offers a “horizontal” rule which applies to the production of all foodstuffs and all stages of production, processing and distribution of food (including primary production). It introduces for all food sectors (with the exception of primary production), a requirement for food safety management procedures based on HACCP principles. The regulation also establishes the voluntary use of either national or Community good practice guides. Such guides are to be developed by the food business sectors concerned and are intended to assist food business operators in complying with the general high-level requirements and objectives of the regulation. (www.opsi.gov.uk)
Regulation 852/2004 further notes the need for food businesses to be registered with a competent authority. This is to ensure that enforcers know where food businesses are and can factor them into official control programmes. This Regulation also lays down basic hygiene requirements for premises, staff, packaging, storage, transport, and handling of foodstuffs
Regulation 853/2004: On laying down specific hygiene rules for food of animal origin:
This Regulation reflects the fact that products of animal origin tend to represent the
highest risk, supplementing Regulation 852/2004 by laying down specific requirements for food businesses dealing with foods of animal origin.
The Regulation requires the approval by enforcement authorities of premises handling products of animal origin (POAO). POAO will have to bear an identification mark displaying information about where the product was produced or handled. Fresh red meat and game meat will have to bear a health mark, applied under the supervision of the Official Veterinarian (OV).
Regulation 854/2004: On laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption:
The bulk of this Regulation concerns detailed rules for the conduct of meat hygiene controls, though rules are also noted regarding controls on live bivalve mollusks (and the areas from which they may be gathered), fishery products and raw milk and dairy products.
The changes to controls on meat hygiene are intended to take account of the introduction of HACCP-based procedures in slaughterhouses. These changes are also intended to take account of the fact that the traditional meat organoleptic-based inspection regime is not equipped to cope with the presence of pathogenic micro-organisms which now account for most meat- related food borne disease incidents. (www.opsi.gov.uk)
Directive 2002/99 further lays down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption.
Directive 2004/41 repeats certain directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption.
While the primary objective of the package of EU food hygiene proposals is to optimize public health protection by improving and modernising the existing EU legislation, such optimization will be achievable by SMEs and would be facilitated by the introduction of food safety management procedures based on the application of Hazard Analysis and Critical Control Points (HACCP) principles.
To summarise, some issues in the current legislation are as follows:
The current legislation exhibits inconsistencies in approach and a degree of
duplication that makes it difficult to interpret and to enforce.
It has not kept up with change and improvements in food technology.
Many of the businesses, particularly in the catering sector, have little knowledge of the hazards inherent in the operations they undertake (www.food.gov.uk) or how to control them.
Such issues are addressed in the new legislation, which acts to condense the requirements into three regulations rather than sixteen directives and updates much of the information contained in the older directives. The new legislation also acts to ensure that businesses identify hazards and control them in an appropriate manner (www.food.gov.uk).
2.4 What is BS EN ISO 9001-2008?
The BS EN ISO 9001-2008 is a series of documents that define requirements for the Quality Management System Standard. ISO 9001 is one of the documents in this set, and it contains the actual requirements to which an organisation must conform in order to become ISO 9001 registered (www.the9000store.com)
This BS EN ISO 9001-2008 standard is based on eight quality management principles, which are used by management in a variety of industries to improve the performance of a company and the quality of its products (www.nsf.org). These eight principles are:
Involvement of people
System approach to management
Factual approach to decision making
Mutually beneficial supplier relationships
2.5 International Standard requirement for Quality Management System (ISO 9001- 2008)
The requirement for a Quality Management System (QMS) should be the basis for all operations undertaken by SMEs . Food companies should establish, document, implement and maintain a QMS and continually improve its effectiveness. The QMS should be in accordance with the requirements of the international standard ISO 9001-2008 (ISO Standard), and thus SMEs should:
Identify gaps in the Safety quality management system that is in place.
Determine the sequence and interaction of safety and quality control processes.
Determine criteria and methods needed to ensure that both the operation and control of these processes are effective.
Ensure the availability of resources and information necessary to support the operation and monitoring of these processes.
Monitor measures in place and analyse the above processes.
Implement the actions necessary to achieve and improve on their planned results.
Identify and difficulties in implementation and generate solutions.
Ocean Foods encountered some difficulties in addressing the above issues, which must be dealt with for a successful QMS. These were:
They lacked a comprehensive QMS that would meet the requirements of the ISO 9001-2008 standard initially, because Ocean Foods only used work instructions and had inadequate staff training.
What Ocean Foods already had documented was either out of date because it had not been updated to reflect changes in the relevant regulations, or simply did not comply, thereby preventing the system from working at the early stage of the implementation. This was dealt with by gradually introduction new procedures in accordance with current regulation.
Due to lack of previous proper training, the workers did not understand much of the quality-related jargon mentioned when trying to introduce new quality procedures, because they had not been exposed to it before.
Workers had very little knowledge about quality policy, if any, and most found it difficult to understand, because management had not previously committed to staff training on the subject.
2.5.1 Quality manual requirement
Companies in the food industry are required to establish and maintain a quality manual that includes:
The scope of the quality management system, including detail of any justification for any exclusion. Such exclusions must not affect the companies’ ability or responsibility to provide products that meet customer needs and applicable regulatory requirements.
The documented procedures established for the QMS to define the control needed are:
To approve documents in terms of their adequacy prior to issue
To ensure that changes and the current revision status of documents are identified
To ensure that relevant versions of applicable documents are available at the point of use.
To review and update as necessary and re-approve documents.
To ensure that documents remain legible and readily identifiable.
To prevent the unintended use of obsolete documents, and to apply suitable identification of them if they are retained for any purpose.
A description of the interaction between the processes of the QMS (ISO 9001-2008).
The difficulties identified according to Waller et al. (1993) in addressing the manual requirements include the lack of adequate standard work place references needed to carry out particular procedures. This is a particular problem for SMEs, of which Ocean Foods Limited in an example.
2.5.2 Record control requirements
A record needs to be established and maintained to provide evidence of conformity to requirements and of the effective operation of the Quality Management System. As previously mentioned, it must remain legible, readily identifiable, and retrievable. In addition, records must provide evidence that quality-ensuring processes are under control and ensure safe food (Mortimore, 2001). In essence, these records will normally involve the HACCP plan, and monitoring activities which serve to verify that the company has an on-going system in place. Records should be as simple as possible in order that members of staff have the time to keep them, and are thus more likely to do so.
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The Documented Quality System (DQS), a structure for documentation, requires that all activities which directly or indirectly affect quality be documented. ISO 9001:2008 provides guidelines on how to document a quality system. Records must be kept for a length of time that is defined by legislation, customers, and the shelf life of the product(s) in question. Records can be used to support due diligence (as required by UK legislation) or any other litigation proceedings (Mortimore, 2001). For one thing, records are needed so that the results of monitoring activities can be recorded. A documented quality system was set up in Ocean Foods and procedures for the collection, filling, retrieval and disposition of records developed by the writer.
Record-keeping and documentation is one of the HACCP principles, so when introducing an HACCP System the requirement for proper regulation of records is introduced as part of it, along with the difficulties that that entails. The concept of formalised pre-requisite programmes places in context various good practices (GMP, GHP, etc) providing a basic foundation upon which the HACCP plan is built (Wallace and Williams, 2001).
2.5.3 Management responsibility
Since management commitment is an element of the ISO 9001-2008 standard, there is a requirement for top management to show commitment to the development and improvement of the QMS through leadership and active participation (www.iqa.org). Top management must ensure that it understands and meets the regulatory and legal requirements with respect to the products and services it supplies.
Thus, management should provide evidence of its commitment to the development and implementation of the quality management system (Nicolaides, 2004) and continually improve its effectiveness by:
Communicating to the organisation the importance of meeting customer, as well as statutory and regulatory, requirements.
Establishing the quality policy that will meet their business objectives and satisfy their customers.
Ensuring that the policy also creates a framework for the organisation’s quality objectives, meaning that every goal they establish for the business must be measurable (www.bsiamericas.com), e.g. customer satisfaction, warranties, delivery time and meeting regulatory commitments.
Conducting management reviews at planned intervals to ensure the continuing suitability, adequacy and effectiveness of management.
Ensuring the availability of resources to implement and maintain the QMS and continually improving its effectiveness.
In the case of Ocean Foods, an identified issues concerning management was that there was a lack of commitment to the development of the QMS and the provision of resources, e.g. for the training of the staff.
2.5.4 QM manual review
The Quality Management Manual (QMM) is effectively a written summary of all the quality management activities in an organization. Its role is to represent quality management systems (Waller et al., 1993) as a practical reference book or guide to the QMS.
The core of a suitable manual should therefore include:
Results obtained from auditing.
Results obtained from customer feedback (customer questionnaire).
The conformity and performance of product process.
Status of preventative and corrective actions.
Any recommendations for further improvement.
The only significant problem identified in the manual review at Ocean Foods was the lack of appropriate quality procedures, which should form the fundamental part of an effective quality system.
2.5.6. Training of operatives
The training for quality should have, as its first objective, an appreciation of the personal responsibility for meeting ‘customer’ requirements (Oakland, 1995). This applies to every employee, from the most senior to the most junior.
The food industry QMM should provide some guidance with respect to training food industry operatives, including:
Determining the necessary competence of food handlers in performing work affecting product quality, evaluating present competence and determining action to be taken. Generally, the QMM should provide guidance on implementing initial plans, checking that the objectives have been achieved (Nicolaides, 2004) and taking corrective action if targets are not met.
Requiring that handlers be aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objective.
Being used to maintain appropriate records of education, training, skill and experiences acquired.
An identified problem in training food industry workers, in SMEs such as Ocean Foods, is the lack of management commitment to the whole processes in releasing money for training of its food handlers and to maintain the standard. This leads to an inability to make reviewing of the effectiveness of quality training programmes a continuous process.
The training that food handlers receive must be related to need, expectation and process improvement. Documentation procedures for identifying and reviewing individual training needs, and the ability to carry out the training effectively, must be established and maintained. Furthermore, training should be flexible in physical design, so that it can be easily used in the work place (Oakland, 1995).
2.6. Aims of implementing ISO 9001:2008 Standard
Implementation of this standard will enable SMEs to demonstrate their ability to consistently provide products that meet customer needs and applicable regulatory requirements. Therefore the aims and goals are usually based on the individual SMEs need for the following (www.iqa.org):
Enhanced customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to the customer and applicable regulatory requirements.
Performance improvement and an increase in bottom line profit
The effective management risk
Assurance of quality products or services for the customer
The basis for implementing a culture for opportunity
The acquisition of a symbol of international recognition (ISO 9001).
In order to achieve the above goals, the emphasis must be placed on:
Identifying the processes necessary for the effective implementation of the quality management system. These processes include the management, resource, product realisation and measurement processes that are relevant to the effective operation of QMS (www.ISO.org).
Understanding the interactions between these processes.
Documenting these processes to the extent necessary to ensure their effective operation and control. (If appropriate, processes can be documented using process maps, but this is not a requirement of ISO (9001-2008).
2.7 SMEs benefit of implemented ISO 9001:2008 (QMS)
Implementation of a safety and quality management system will vary depending on the type and size of the SME, and on its products. Each SME will have its own objectives, although the primary objective for most SMEs is to increase their profitability (www.ISO.org).
Because of the responsibilities set out in the ISO 9001:2008 Standard, SMEs often see an increased involvement of top management with regards to the Quality Management System. This involves setting of the Quality Policy and Quality Goals and Objectives. It continues with a Management Review looking at data from the QMS, and taking action to make sure that Quality Goals are met, new Goals are set, and continual improvement is achieved.
The QM system leads to a number of general benefits (Krause, 1996), including:
The company is focused towards the Quality Goals. Management is provided with data on a continual basis and able to see progress (or lack of progress) towards goals and to take appropriate action.
It provides a mechanism for reviewing goals and performance on a scheduled basis, and for taking action based on the evaluation.
Increased productivity results from the initial evaluation and improvement of processes that occurs during the implementation process.
Ability to remain/become competitive in the market.
Elimination of redundancy.
2.8. The impact of legislative requirements on SME’s
The process of demonstrating compliance with the legislation may be a barrier greater than actually complying with the legislation itself. SMEs are less likely to have formal systems for measuring, recording and managing their impacts, and they may not have the capacity to deal with demanding paper trails. The cost of audits and certification can be prohibitive. This is often the same however large the SMEs is, so they will constitute a far lower percentage of a large SMEs budget and thus have a far lower detrimental financial impact on them. Standards therefore often have a significant scale effect, which works against SMEs. In many developing countries, the high cost of certification is also due, in part, to a lack of local certifiers (www.inni.pacinst.org)
The use of a highly structured Hazard Analysis and Critical Control Point (HACCP) system in food-safety control is not new. Than et al. (2004) identified that HACCP is a scientific and systematic system for assuring food safety.
The first food-industry HACCP application was by the Pillsbury Company in the 1960s (Hulebak and Schlosser, 2002). They had been contracted by the National Aeronautics and Space Administration (NASA) in conjunction with the U.S. Army Natick Laboratories to design and produce foods for space flights. The cooperative HACCP program which evolved had the goal of nearly 100% assurance that space foods produced would be free of microbial or viral pat
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