5. PROJECT RESULTS AND ACHIEVEMENTS
5.1 Meeting the Objectives
The trial objectives have been met, namely to web-enable the functionality of the previous off-line tool. SaFES comprises the basic principles and follows the normal stages used when working out a HACCP plan. As mentioned above with the exception of verification procedures and flow-diagrams the SaFES system fulfils HACCP requirements. Verification is a word that has been much used in the trial. Basically three areas of verification have been referred to during this trial. There is data verification - ensuring that the data recorded, used by the software and archived is an accurate measure of the physical, chemical or biological state of the CCP being measured. There is verification of corrective actions - ensuring that corrective actions are appropriate, they are applied in a timely manner and that they are always applied when required. There is verification that the HACCP is working effectively - a combination of the data verification, corrective action verification and the provision of supplementary tests to confirm that the HACCP is working correctly. These supplementary tests can include microbiological testing, auditing etc. The verification aspects of the SaFES tool need tightening as does the inclusion of a more acceptable flow-diagram. Both these are easily achievable and are recognised by EQMC Ltd. Authoritative validation of such things as flow diagrams and critical limits could be achieved using electronic signatures either by an official of the company or by an external established authority. A list of who has authority to verify or validate actions can be included and built into the software authorisation privileges, a system that has been in place in document management systems for years.
Too much emphasis has been placed on the identification of non-conformances, it was always the intention of the SaFES team to develop a tool that had as one of its functions a means of measuring data at CCPs which was as far as possible free from the fallibilities of human intervention coupled to the appropriate appliance of corrective action when non-compliances occurred. The SaFES tool has achieved this objective, after all it is ensuring that corrective actions are appropriate and are applied correctly when needed - that is the foundation of food safety, not the counting of non-conformances. Unfortunately the identification of the non-conformances, which is an essential part in the corrective action path, has perhaps been emphasised too much in the project documentation and indeed the GUI. It seems from the feed back of some of the participants in the trial that the non-conformance reporting has overshadowed the verification that appropriate corrective actions have been applied.
Evidence of the food processorsí management commitment is a question that has arisen many times during the trial and was given as NQA as one of the main barriers to remote audit. There is the criticism that the SaFES tool does not contain evidence of the food processorsí management commitment; when asked what is considered evidence in a conventional HACCP system the most common answer is that management signs a document stating their commitment to the system in place. After many years in industry, most of it involving safety critical systems, the author has found management commitment an elusive beast, and a signed statement may imply responsibility but does it demonstrate commitment? The author is of the opinion that a far better demonstration of commitment would be that a food processorís management were willing to let their customers see on a day to day, 24 hour a day, basis how their plant was performing with regard to their HACCP plan, their CCP performance and their timely handling of non conformance. Does transparency demonstrate commitment? Well the SaFES tool, together with audits that it is being applied correctly, gives transparency. Furthermore, on-line linking to the organisationís policies is easily achievable.
5.2 Measurement of the Impact of SaFES
The Users provided the input required to measure the impact of SaFES on their part of the food supply chain.
5.2.1 Improve Working Practices across the Supply Chain
There is a requirement to prove to customers, auditors (acting for customers) and official bodies that a process is working within a HACCP framework. A reseller wants to know that their supplier has an Own Control System that meets their requirements and that the CCPs are operating within tolerance. Additionally, any non-conformances that need to be brought to their attention can be viewed so that they know that the agreed corrective actions have been followed. Auditors require easy access to data that is measured correctly, transferred uncorrupted and that data viewed corresponds to a specific time and date. They also want to view the HACCP Plan and easily determine that thereís a 1-1 correspondence between the CCPs identified in the HACCP Plan and the data stored within the archive. Consultants and the food processorsí management require a focus to involve the relevant team members in the derivation of the plantís Own Control System in a manner that meets HACCP requirements. Controlled modification of the plan will be easy and involve all interested parties.
5.2.2 Impact on Producer
The effect of the SaFES tool was broken down into the design and derivation of a HACCP system and the effects on the day to day running of the HACCP system.
126.96.36.199 Reducing HACCP Design Costs
It was estimated that savings of up to 70% or 80% could be made using SaFES instead of a paper version, the main source of savings coming from the reduction in the consultancy effort required.
These advantages extended to the maintenance of a HACCP Plan as a result of changes to a plantís equipment etc. It was estimated that it will be around 70 to 80 % cheaper to maintain a HACCP plan using the SaFES tool.
188.8.131.52 Derivation of a Distributed Team-Based HACCP
The assessment of the use of SaFES in the derivation of a distributed team-based HACCP, where some players are remote was seen as an important part of the trial. It is essential for the implementation of HACCP across the EUís non-primary food producers that resources are available cheaply on a distributed basis. Communications at initial planning and update stages of HACCP are therefore an important factor in allowing food producers access to the knowledge held by the community of food hygiene experts, be they consultants or fellow practitioners. Some of this knowledge is held within the SaFES tool and some is available via web communication from Ďon-line expertsí.
SaFES facilitated both introduction to HACCP as well as the development of the HACCP-plan. All team members were guided systematically by SaFES in the design phase, so even non-experienced team members got a good understanding of all the stages in development of the HACCP-plan. The SaFES tool helped give the entire team a better overview and understanding of the HACCP system.
The usefulness of SaFES was also seen to extend to the maintenance of the HACCP plan bringing it nearer the ideal of Ďan of the momentí system. It was found to be a lot quicker to change or install new CCPs on the SaFES tool.
As well as using the SaFES tool to share knowledge within the HACCP development team the data held was shown to provide useful information that the process had been followed correctly and was being implemented.
The SaFES tool guided the users in producing a HACCP plan and encouraged knowledge sharing within the HACCP team as well as encourage knowledge sharing between the HACCP team and the experts involved.
184.108.40.206 Cost Effective Data Collection
A comparison of the costs of the automatic data collection made against the current methods of data collection at each site resulted in little difference being found. It must be borne in mind however that both these sites use electronic sensors linked to paper recording methods and are therefore in an intermediate state of technology between manual data collection and the automatic data collection implemented in SaFES.
220.127.116.11 Running Costs
Management time is not insignificant in the running of a HACCP system. SaFES was seen to improve the situation by the following percentages according to job function.
Using these figures we have deduced a saving of approximately 53 euro per day which equates to a saving of 13250 euro per annum for a 50-week year.
The time saving extends to the supervisor function also. 50 minutes per day is spent running the CCP monitoring system using the pre-SaFES system compared with an usage of 10 minutes per day with SaFES with consequent savings of 6555 euro per annum.
In the pre-SaFES scenario an operator would be spending between 3 and 4 hours a day. For the purposes of comparison we have assumed a 2-hour saving per day contributing to an annual saving of 10,000 euro. However, this assumes the operator will still be working on the system for 1 hour a day.
18.104.22.168 Training Costs
Comparisons between the SaFES system training requirements and those for ensuring the reliable collection and recording of accurate data have been made against current practice. Again estimates have been obtained for the training costs associated with a paper based system and the use of manual measuring tools, if appropriate.
In our calculation savings we have been conservative and have assumed, on a per person basis, a training burden of 5 hours with SaFES compared with 11 hours of training burden pre-SaFES. Depending therefore on the category of personnel being trained the training burden would range between 100 euro and 280 euro with savings over a traditional method of between 120 euro and 320 euro respectively. It is assumed that training is conducted within the plant by other members of the plant. In this way the processing company can afford to train many more people than in a conventional scenario thus gaining the understanding and commitment of many more personnel and leading to a more quality-orientated company. The training can then be undertaken by the food processor and extended to its supply chain and auditors in a similar manner.
5.2.3 Impact on Resellers
The immediate impact on the resellerís business was seen mainly as its advantages within the business rather than as an advantage in their interface with customers or potential customers.
The reseller, and the supplier, were concerned about the misinterpretation of data. They were both happy for the data to be viewed by Ďeducated customersí but were concerned about the data being easily available to all customers. This is particularly important in countries where HACCP data is legally defined as Ďpublic informationí.
It was felt that the data may be used adversely as it highlights non-conformances and that these may influence a customer when assessing them against plants who do not make their non-conformances so easily available. This was a particular worry where customers had little understanding of HACCP (in countries where HACCP is not part of local regulation) and may see any non-conformance as a major problem and a threat to health.
With knowledgeable customers, the data available to them would have a positive effect on the food producerís relationship with them, particularly larger customers that are constantly pushing their suppliers to become better and better suppliers, in regards to quality and welfare issues. SaFES will be a tool for these customers to be able to follow the production from A to Z and give them a market advantage.
There was also concern that within a resellerís business the SaFES tool should be treated as an Ďinformation systemí only. A detrimental effect on the relationship between a supplier and reseller could occur if other parts of the resellerís organisation were corresponding directly with the supplier and in effect short-cutting the supply chain of:
supplier > resellerís buyer > resellerís sales team
It may be that additional use of the SaFES tool by extending its use within teams by means of a read only information page with access to the data made available to the reseller but only communication with the reseller allowed, however access to this data would streamline some of the resellerís operations.
5.2.4 Impact on Consultants
The effect of SaFES:
The impact of e-work on the financial aspects of participating in a distributed HACCP team was seen as quite considerable. The input from Scanfo Aps indicated substantial savings in travel and the ability to extend their portfolio and customer base. Estimates of savings offered to consultants are 30% savings in travel with a 25% increase in the work done by the HACCP team members thus allowing an equivalent increase in clients.
5.2.5 Impact on Auditors
It would first be useful to consider the audit process as implemented in a typical food processorís SME. An initial visit is conducted to confirm that a documented system has been established and implemented. A follow up visit confirms that the system is operational and meets the requirements of certification, HACCP Codex Alimentarius, GMP, regulation and the documented system. This is an audit of the whole system. Certification is awarded if the company can demonstrate the effective implementation of the system through objective evidence. Surveillance activity, at least once every 12 months, confirms the system continues to be effectively implemented; this may be based upon a sample.
Audits are about establishing commitment and effectiveness of HACCP systems as well as its design and monitoring. Remote audits do not give as broad a picture as would be necessary to confirm that the system is appropriate to the organisation or has the management commitment to sustain it over time.
For traditional audits it is very difficult to estimate, possibly very little time being saved as the auditor would review the reports and system in advance of the audit thereby spending some time in advance of the audit rather than during the audit in this activity. Where it would increase productivity is potentially in the effectiveness of the audit by enabling the auditor to focus upon particular process steps in preference to others. On the other hand if the auditor were to offer product restricted certification there could be opportunities for reducing the level of site visits operated.
SaFES is not seen as offering advantages over traditional methods, in fact it is seen in some areas by auditors as a retrograde step. The SaFES system enables the auditor to remotely establish the process in operation from the process steps identified and to determine whether the CCP decision tree has been correctly applied to those steps and that monitoring is taking place. This aids the auditor by confirming that a system has been established and is being monitored. This is an advantage but HACCP systems need to incorporate GMP, equipment and infra-structural issues that could result in physical and chemical contamination as well as process critical control points. In addition, although the SaFES system details the CCPs these need to be taken on faith and do not necessarily represent impartial objective evidence.
There is a requirement to confirm that the CCPs are appropriate for the organisation, that the system has been implemented and is understood and that the management of the organisation are committed to operating an effective HACCP system and that the monitoring systems are secure.
The SaFES system could help planning by providing information on the systems for food assurance and the monitoring of the identified CCPs. This could help in the planning of audits enabling the auditor to evaluate and focus on the critical areas in advance of the on-site audit. Assuming the processes of the HACCP system are unchanged over time, then the data presented in the SaFES reports could provide some confidence that the certificated system is still being maintained. This could possibly support a reduction in the time allocated for the surveillance audit of the system on site but this may, in part, be counteracted by the review of data remotely.
Diligence is more a measure of the timely and appropriate application of corrective action, which is in line with the SaFES toolís reporting of non conformance, tied to the verification that the appropriate corrective action has, in fact, taken place. The SaFES tool allows an auditor to correlate non-conformances to corrective actions providing confirmation that the corrective action has indeed been taken.
From the auditorís point of view being able to compare data from competing food processors would be an advantage. Competitive benchmarking to enable best practice to be identified.
The SaFES tool provides a modern tool that could support in the effective conduct of audits. Increasingly, management systems are being managed electronically and certification bodies need to respond to this by being perceived to be more willing to adapt and incorporate new systems to assist in the effective delivery of audit services. SaFES provides a relevant way of combining access to company data through internet technology that could contribute to the audit process.
It appears, from the feed back from NQA that for true remote auditing that the HACCP plan needs to be linked more practically with the plantís physical process aspects. It would seem that not only a schematic representation of the HACCP process is required but also a representation of the physical equipment within the plant is required. Whether the representation is purely graphical, photographic or even in Ďreal timeí (web cam style) is a balance of cost and what is needed to achieve impartial objective evidence. Links between the HACCP, its CCPs and representation of the physical plant are not included, although web cam type inserts of the equipment at Oak Crown were demonstrated to the consortium partners (NQA are a subcontractor and were not present) at an early stage of the trial. It was decided that this was a future enhancement and not essential for the purpose of this trial.
One outcome of the trial, from the users, is that links are needed to other features of the quality management system. The blinkered approach to producing a tool confined to the purity of only the Seven Principles and Thirteen Stages of HACCP seems to fall short of the auditorís requirements. The fact that Padborg have GMP in place was not apparent in the remote audit, but from NQAís point of view the GMP needs to be visible. The link between HACCP and other quality (and management) systems has proved elusive as contradictory opinions have been expressed by experts in the field of food safety. It is hoped that the recasting of the EC food hygiene legislation will provide guidance.
It is thought that SaFES would be useful for organisations that do not wish to operate a fully documented management system and wish to restrict their HACCP approach to identifying and managing CCPs.
It was the intention of the Ďnon-userí part of the consortium, reiterated by the EC appointed experts in the Project review that the SaFES tool was in fact a tool for developing and managing a HACCP system. There has however been a drive from the user side of the consortium to include a fully documented management system with a drive towards producing an EFSIS tool.
The SaFES tool was intended as a product to aid an SME in the implementation of HACCP and that the results of the trial would help in extending the product to increase the correct use of HACCP and reduce the cost of implementation. It was never envisaged that the SaFES tool would remove the need for all site visits.
Site visits are an essential part of the long term audit process, the thesis of the SaFES consortium is to minimise the number of site visits required, perhaps even to one visit. With good information management the auditor (or customer) can reduce the number of visits and increase their confidence in a manufacturer.
5.3 Relations and Synergies with other Relevant Projects
The trial is a result of a Research Feasibility Study entitled On-line HACCP in Poultry Processing Plants carried out under the FAIR programme (Contract No. FAIR-CT97-9358 Exploratory Award Proposal No. PL97-8358). The Prime Proposer for the study being Padborg Poultry Slaughterhouse A/S one of the Trial Consortium.
Van Helsing Limited, the Project Co-ordinators have interfaced with other projects during the EU Concertation meetings, clusters and conferences. Presentations of the SaFES project were given at the June 2001 Concertation KAII meeting in Brussels to projects participating from the EU and Accession States. A paper was presented at the eBeW conference in Venice in October 2001.
Channels such as the AgroFood Centres, Innovation Relay Centres and FAIR FLOW, UKISHELP have been utilised for dissemination purposes. Furthermore, the results of the trial will feature in an "Awareness Day" in conjunction with a LEADER project initiative operating in rural Wales.
5.4 Implications on EU Policies and Standards
Many official standards and procedures do not easily accommodate non-paper systems and e-Working. It is perceived that this could be a major barrier to e-Working as regulatory bodies are by nature conservative and difficult to access and their output, by its very nature, is precise and closely specified.
There is, when talking to HACCP experts and authorities, a reluctance to accept e-working. Regulatory processes are paper based and there is a fear of moving away from the long established paper based methods. This reluctance even extends to documentation where there is a preference for paper manuals rather than have e-access to on-line documentation where one is sure that all employees are referencing the same version of a document wherever they are. Phrases like ĎÖmust be signed by person(s) during the monitoring and by a responsible reviewing official(s) of the companyí do not encourage e-working by groups that are suspicious or wary of ICT. It is noted that the proposed draft revised guidelines for the application of the HACCP system, for presentation in 2003, do not give any help in the application of ICT. It could be argued that the use of ICT is in the interpretation of the Codex Alimentarius Commissionís works but there is a reluctance to stray too far from established practices without guidance. Similarly feedback indicates that there is a trend to feel that an ICT solution should be a computerised version of a paper based system. Far more powerful solutions can be achieved by going back to base requirements such as Codex Alimentarius allied with Ďplough to plate batch traceabilityí and seeing how ICT can, in fact, change the way we work.
5.5 Benefits to Society
This section will break down the benefits that have emerged during the trial under the following headings:
5.5.1 Enhancing Europeís Competitive Edge in the Global Marketplace
The trial has shown that the SaFES tool reduces the cost of implementation of HACCP. The consortium was afforded the opportunity to get a far better understanding of the costs associated with a traditional based HACCP throughout its life-cycle from the initial development of a HACCP Plan to the implementation and operation of HACCP within a plant. Traditionally, HACCP is a labour intensive intervention. The labour involved is at all levels in a plant. SaFES automates many of the most labour-intensive, repetitive tasks within HACCP. It undertakes the parts of HACCP that computers are good at. It also enables a distributed team to work together to derive the HACCP cutting down on the amount of travel time, empowering the team to undertake more of the work and allowing the consultant to work in a more consultative role. To achieve the same quality of data with traditional methods of applying HACCP, due to the need for recording of data frequently, checking the verity of that data would cost a lot of money. SaFES offers vast savings on the day-to-day running. Even if SaFES installation and running costs were the same as pre-SaFES, there are still many advantages of SaFES as an integrated system. Tying a 1-1 correspondence between non-conformance handling identification, time of non-conformance occurrence, and verification that corrective action has been undertaken is powerful. Even if there is no commercial saving then there is certainly a step change in quality improvement. Time-savings extend to the whole supply chain including the audit process and the ability in a fully transparent system for customers to view remotely the data. The concepts are advanced and some psychological barriers would probably prevent most companies in the short term from gaining all the advantages the system has to offer.
SaFES has a potential positive impact on the competitiveness and viability of the European food industry. SaFES has the potential to accelerate the processes needed by all sectors of food manufacturing and processing in order to satisfy the upcoming EU-wide legislation. The SaFES toolset facilitates the HACCP development, day to day operation and remote audit. It is a facilitator to drive up quality over geographically-distributed teams and supply chains and does so in a cost effective manner. Distance is no barrier for the operation of the concept of the SaFES trial and thus encourages cross-border supply chains in a quest for quality adherence and reduced costs of production. SaFES smoothes early adoption of methodologies required by the new legislation into the Accession States to facilitate enlargement for competitive advantage. Transparency of data is the evidence needed to satisfy discerning interested parties whether they be quality-centred supermarkets, regulators or consumers. SaFES allows Europeís food producers to compete on quality with no detrimental impact on cost. It is expected that the ensuing refined SaFES commercial offering will have a positive impact on the cost of operation in due course. If SaFES achieves critical mass it has the potential to shake up the food industry within Europe and beyond. The introduction of a tool such as SaFES is an opportunity for Europeís organisations (large and small) to position themselves in the global marketplace. The trial has indicated that SaFES has potential to yield cost savings in HACCP design and maintenance, day-to-day plant operation and audit thereby increasing competitiveness of HACCP consultants, food processors, resellers, auditors. We believe these savings can be extrapolated along entire supply chains and to all sectors of the food industry.
5.5.2 Providing Support to Future Growth in European Industry
European industryís capacity for future growth is best achieved by keenly priced high quality products and services both for the European Unionís consumption and for export. The new EU legislation is aligned with the Codex Alimentarius Commissionís thrust and hence the standards are aspired to internationally. Early adoption by the European Union and Accession Statesí food producers would Ďset the European standardí. Supply chains can traverse continents; the SaFES tool, due to it being built on ubiquitous web technology, can mirror those supply chains. Supply chains in Europe tend to be well-established; this may not be the case globally. SaFES is configurable and can cope with volatile supply chains. SaFES could therefore act as a catalyst for growth by supporting more effective food producers, acting as a tool for remote pre-supplier assessment, slicker customer-supplier data interchange, reduced cost of audit, minimisation of consultant contact time.
The original concept of this trial was to produce a tool which enabled the economic design, day to day running and maintenance of a rigorous HACCP system. As indicated above these aims have with a few minor exceptions been achieved. There is however the need to meet the expectations of the industry. Two of the important features in driving down the cost of HACCP were seen as better access to expertise and the ability to perform remote audit, both ideal requirements for e-working. The drive from the regulatory bodies, and indeed the large customers such as the supermarket giants, within the industry is for a single quality system that encompasses HACCP, GMP, pest control, hygiene, local government regulation and national government legislation. A remote audit, intended to reduce site visits - not eliminate them, will only be of use if it addresses all the aspects of the quality system. It may be that the formation of the consortium has introduced problems into the trial that have resulted in us trying to win the war not the battle. The consortiumís users are mature producers and experts, working in the supply of product to the leading food outlets of Europe. The market for a HACCP tool, the SaFES tool, is the myriad of less mature small food producers who supply the markets and shops of Europe, not the supermarket chains. It is in fact these businesses that will be affected most by the new legislation and is these businesses because of their scattered nature will be difficult to monitor. The goal of producing a whole quality system tool is quite achievable once the requirements are specified and they are not the requirements of the SaFES tool.
5.5.3 Affecting Levels of Employment within the European Union
Mass introduction of a tool such as that demonstrated during the SaFES trial could have both a positive and a detrimental effect on employment levels. The SaFES tool automates many data gathering activities; where accuracy of data recording, with the elimination of human error, is essential. Consequently, some repetitive jobs might disappear; whether these jobs lead to loss of employment or to opportunities for people to perform more interesting jobs depends on the individual food producers concerned. For Europeís competitiveness in the global marketplace the thrust ought to be on mechanising repetitive and especially non-productive jobs, providing opportunities for people to be trained to perform more value-added activities. Economically therefore, automation should not be perceived as a threat.
At the other end of the spectrum, SaFESí ability to support remote operation minimises the contact (and ensuing travel) time needed for consultants to undertake HACCP design and maintenance activities with the team. If the European Union legislation is taken seriously by national governments then the food industry could well suffer from a lack of HACCP consultants and so elimination of nugatory effort for a precious resource will enhance Europeís ability to meet the legislation in a timely fashion. The ubiquity of the web also implies that Europeís HACCP consultants will be able to work on the global stage without leaving their office.
5.5.4 Improving the Quality of Life for People Affected
Adherence to HACCP principles is recognised to lessen the occurrences of salmonella and campylobacter that lead to food borne diseases. Diminishment of food borne diseases takes away the burden from the health service allowing other cases of illness to be dealt with. Quality of life is thus raised for those people avoiding food borne diseases and lessened pressure on over-busy medical services.
From an employment perspective, the SaFES tool takes away the burden of repetitive, monotonous jobs freeing people to do more interesting roles. The SaFES tool acts as a catalyst to eliminate, where there is a will, unnecessary travel thereby allowing more quality time and adoption of more family friendly lifestyles.
The result of the trial demonstrates that this e-working concept is valid and could be extended to other areas covered by overall regulation and where there is a need for each user to build an own control system relevant to their process but needing input from distributed sources. Furthermore this type of e-working tool has the added advantage of demonstrating that the own control system is fit for purpose.
5.5.5 Protecting and Preserving of the Natural Environment and Resources
As stated earlier, the original concept of the trial was to produce a tool which enabled the economic design, day to day running and maintenance of a rigorous HACCP system. It is inevitable that with any quality control tool there are outputs that are valuable for process management. The close monitoring of parameters at the CCPs does lead to the possibility of resource savings. These savings can be best exemplified by energy and water savings, both of which can be achieved by coupling the data collection to a management information system.
Protection and preservation of the natural environment and its resources is further assisted in two ways, namely: lessened travel and promotion of paper-less offices/plants. It should be noted that a tool such as SaFES cannot eliminate travel altogether as it is recognised that sound business relationships are between people and that cannot be entirely simulated by computers. Furthermore, although the SaFES tool provides scope for paper-less HACCP records, it appears as if the legislation has been devised on a paper based procedure and some top level influencery work needs to be done to have ICT successfully drive procedures.