SESSION 5. Food safety measures and management systems in dairy processing
Abstract
The Australian dairy industry has an enviable record in terms of food safety. To keep this record in tact, the industry and regulatory agencies have worked closely together, in partnership, to further enhance the framework for milk and milk product safety. The cornerstone for this has been the development and implementation of HACCP based food safety programs through-chain, from farm to distribution. Over the past two decades, industry and government have operated these programs in the manufacturing sector. Use of these programs has been expanded over the past five years to include on-farm, farm milk collection and distribution sectors. The HACCP system approach is based on Codex guidelines.
This paper reviews the approaches taken and experiences gained within the Australian dairy industry in the use of HACCP-based food safety systems. It highlights the importance of getting the system right for industry and government, the need for continuous review and feedback from all sectors, the standardisation of the audit process and the value and imperative for validation and verification of the systems.
1 INTRODUCTION
The Australian dairy industry is recognised as one of the most efficient food based industries in the world. It is Australia’s third largest rural industry, behind the wheat and beef industries, operating in all states. The gross value of dairy production at farm gate prices is estimated at $2.8 billion for 2002/03 and at $8.5 billion at ex factory level in value added products. Despite its significance at the national level, the Australian industry produces only 2% of the world’s cow milk. However, Australia ranks third in terms of world dairy trade, accounting for 17% of all dairy product exports [1].
Fifty-five per cent Australian milk production is exported, primarily as manufactured product at a value of $3.25 billion.
Victoria accounts for 64% of the total milk production in Australia, NSW 13%, Queensland 7%, SA 6%, Tasmania 6% and WA 4% respectively [1]. Over the past few decades there has been a trend to fewer farms, larger herds and improved productivity.
Productivity has improved through better farm management practices, improved feeding, better animal genetics and breeding programs. Milk production has increased steadily over the decades - 1980 (5.43 billion litres), 1990 (6.26 billion litres) to 2002/03 (10.33 billion litres). The average annual milk production per cow is currently 4,800 litres [1].
The variety of manufactured milk and dairy products available today differs greatly in the range and number to those available 25 years ago. The types of products available 25 years ago were predominantly constituted of butter, cream, cheddar cheese, dried milk, pasteurised milk, yoghurt, evaporated milk and ice cream. In 2003, the range has been extended to include a complex myriad of products including; milk protein products, whey products, dairy desserts, cultured milk, dairy spreads/blends, numerous cheese varieties, milk beverages and specialties, recombined products and frozen milk products.
Milk is processed by both farmer-owned co-operatives and public and private companies in Australia. Co-operatives dominate the industry, accounting for 70% of all milk output.
2 AUSTRALIAN DAIRY FOOD SAFETY - SETTING
THE SCENE Advancements in technology and greater product range have added significantly to the issues relating to milk and milk product safety. Pasteurisation or validated equivalents, though, remain the most critical control point in terms of food safety for milk and milk products.
The Australian dairy industry has an enviable record in terms of food safety. Although milk and milk products have traditionally been regarded as high risk products, there have not been many reported outbreaks of dairy related food borne illness since the inception of the pasteurisation process. Reported outbreaks have been Salmonella in baby formula in the 1970s and in gelato in 1998 [4].
The industry’s focus on safety is very high and over the past decade there have been significant steps taken to protect and enhance its record. Traditionally, dairy food safety was covered by inspection and end product testing systems, undertaken by both manufacturers and regulatory bodies throughout Australia. Inspection was targeted mainly at visible hygiene, adherence to GMP/ Codes of Practice and end product testing. Each state has had a dairy authority responsible for milk and dairy product safety under State based legislation. The Australian Quarantine and Inspection Service (AQIS) is the federal agency responsible for ensuring that exports/exporters comply with national export control orders [3] and overseas importing requirements.
Today, the accepted industry standards within Australia are based on HACCP principles - a huge departure from reliance on inspection and end product testing. These systems have and are being developed and implemented across all sectors of industry from on-farm to distribution. As well as the industry sectors adopting these systems, both state and Commonwealth regulatory agencies have embraced HACCP for their operational systems.
The Australian dairy industry has therefore been at the forefront of HACCP based food safety systems for many years.
The first approach of introducing HACCP was with the processing/manufacturing sector some 15 years ago. The next sector to be tackled was on-farm, followed by wholesale storage and distribution and the retail/home delivery distribution transport sector. There is currently discussion on extending these programs into dairy retail areas. HACCPbased programs have been adopted already by the large/ medium sized supermarket chains and also some large foodservice transport organisations.
As a result, we now have a virtual through-chain HACCP-based approach across the industry. It is important to emphasize that all the way through there has been a partnership between industry and government in developing the systems, both at state and national level and then fine tuning them to the extent where the industry has been ahead of food safety regulatory developments in the country, which has, in turn, positioned it well as an industry to proactively take on board changes in national food safety legislation.
The change to HACCP-based systems was due to two major reasons:
- Changes in the regulatory environment both nationally and internationally where HACCP-based systems have and are being written into legislation. For example - all states in Australia have adopted HACCP in manufacturing as a mandatory part of dairy industry regulations. HACCP in the other sectors of the industry is being progressively introduced. In NSW, for example, it is mandatory for HACCP in all sectors from farm to distribution. All states in Australia have, at a minimum, programs on-farm and in processing/manufacturing.
- Dairy companies and manufacturers adopting the systems for their own reasons, for example, to meet customer best practice expectations, as a direct result of market pressure and competition, to achieve fewer product failures or retrievals, to reduce waste, and reacting to export requirements.
As a result of the change, we now also see the role of the dairy regulatory authorities as one of certification and compliance auditing of HACCP-based systems. Authorities certify that the system developed and implemented by a farmer, manufacturer, wholesale distribution or retail/home delivery is appropriate and covers all identifiable hazards and checks processes and procedures to ensure the system is operative.
In developing HACCP systems, the state regulatory agencies have been mindful and worked in close co-operation with the federal agencies to ensure a uniform approach both nationally and that the systems also align with international expectations, thus attempting to cut down on duplication of audit and minimise differences in regulations from state to state, whilst also taking into account trade implications for the export market. Developing HACCPbased systems through-chain was a proactive step taken by the industry as a whole to ensure that export market access was maintained and also as a possible market advantage for Australian product prior to mandatory inclusion of such programs by importing countries.
The regulatory framework for dairy food safety in Australia is summarised below.
The dairy food safety schemes adopted by state regulatory agencies are all based on similar structures of program development, implementation and validation, the issue of a licence to individual businesses and adherence to compliance/verification audit programs. There are subtle differences in the approach taken by various states in the types of programs implemented and in the audit component of programs and systems which will be outlined later in this paper.
The principles that underpin the national regulatory framework are:
- All State Dairy/food authorities are committed to the development of a national dairy food safety framework as a priority
- Domestic dairy food safety standards and export dairy food safety standards are harmonised
- International principles in dairy food safety are recognised and adopted
- The framework includes non-prescriptive, outcome based dairy food safety standards and supporting guidelines and principles for verification
HACCP systems used in Australia are based on Codex Alimentarius Commission Guidelines (Committee on Food Hygiene) [2] for all sectors of the industry. Not all the plans developed though, could be considered traditional HACCP. The plans developed, documented and implemented do not revolve entirely on the monitoring, recording, corrective action and verification of identified CCPs. Whilst the models do this and identify all hazards and CCPs, they also allow for the inclusion of quality related and regulatory control points where required to help encompass the entire food safety and quality aspects of the sector involved. This is particularly the case for on-farm and storage and distribution sectors. Manufacturing/processing sector plans are more traditional HACCP systems. It is a practical and comprehensive working plan that includes safety and quality parameters. It is also an acceptable system for the industry itself, one in which they are comfortable working in.
The programs address the analysis and control of biological, chemical and physical hazards from on-farm production to raw material procurement, handling, manufacturing, packaging, product storage, distribution and transport.
3 VALIDATION AND VERIFICATION OF HACCP IN THE AUSTRALIAN DAIRY INDUSTRY
Validation and verification of HACCP plans is conducted by a combination of industry based, regulatory and/or third party audit in the Australian system.
At this point there is a need to define what is meant by the terms validation and verification as used in the Australian situation, prior to describing how industry and regulators have established operational procedures to incorporate them in practice.
The Australian industry uses the Codex definitions for the terms validation and verification:
Validation: obtaining evidence that the elements of the HACCP plan are effective. It asks the questions - does the HACCP plan developed ensure that the relevant hazards have been identified and can be controlled. Validation occurs during the plan development stage, but does need to be repeated should there be any change in the product or process [2].
Verification: the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine compliance with the HACCP plan. Verification is confirmation that the control measures are working [2].
3.1 Validation
HACCP plans for the industry in Australia have been developed either through direct development by companies or individuals or through the tailoring of generic manuals that were developed through industry and regulator collaboration. Examples of such plans are:
- a generic program developed by NSW and badged Quality Plus 2000 that covered farm, small processing, storage and distribution,
- Proven Perfect - a company derivative of Quality Plus, further refined and developed, suitable for all sectors of that business
- MG Milkcare - an on-farm company developed program
- Dairy First - developed in Victoria covering on-farm level
- Product generic manuals eg: ice cream, gelato
- Individual processing/manufacturing company programs
Initial HACCP plans put together had to include relevant validation data or evidence to demonstrate that hazards are able to be controlled. Larger manufacturing industry was capable of doing this in its own right, utilising a mixture of its own technical resources and skills and those of expert consultants. These types of businesses were able to provide validation data to substantiate their plans.
Smaller manufacturers did not usually have this capability or in-house expertise and therefore relied on assistance with generic model tailoring of programs with assistance from state regulators and, in the case of farms, the processing companies they supplied. In the case of the on-farm and distribution/transport sectors, generic programs were developed and then processing companies and the state regulators assisted in individual tailoring of the manuals. This has been achieved for the 10,500 dairy farms in Australia and a large percentage of the distribution and transport sector. For small manufacturers,
assistance with plan development, validation and implementation was primarily achieved via the state regulators, using generic models as a basis.
Assistance with validation of plans and ongoing validation requirements has been an important role for regulatory audit staff. A large part of the validation of HACCP plans from a regulators standpoint is that an expert resource is used to ensure that correct validation criteria are met through applying existing scientific knowledge, standards and statistical techniques through desk audits of plans and on-site validation audits.
3.2 Examples of validation requirements
On-farm: pesticide control, antibiotic control, medicines control, vat cooling calibration.
Processing: antibiotic testing methods, pasteurisation parameters, product formulations, product cooling rates, raw material specifications.
Distribution/storage/transport: spatial temperatures of rooms, vehicles.
The above is not an exhaustive list. There is also a requirement to validate pre-requisite programs including cleaning cycles and chemical concentrations and environmental monitoring programs.
Validation is required with any changes to product formulation or process changes, which may include changes in procedures on the line, changes in equipment, changes in distribution logistics, change in raw material supplier or specifications, changes in cleaning processes and changes in testing method technology.
3.3 Verification
Verification is a major part of the internal monitoring program for industry and the external regulatory or third party audit system, that gives a plan integrity.
As stated previously, the successful audit and continuation of the HACCP based programs, required a “new” inspection logic and new methodology to perform the task of control of industry HACCP.
For industry, it is vital that internal verification programs are understood and conducted thoroughly as it is equally vital that regulatory and third party food safety program auditors have a well developed ability to locate, interpret and apply the appropriate legislation as well as having a good grounding in scientific principles related to public health and food safety.
In the plans, verification is conducted in a number of ways:
- at a frequency determined in the documented plan of the company/business, conducted by staff through monitoring and record keeping, ie; internal verification.
- by regulatory or third party audit to verify the establishment is operating its plan satisfactorily,ensuring;
i. monitoring records are up to date and correct
ii. corrective actions are taken in a timely manner and resolved
iii. calibration criteria are met
iv. testing results are available and within specification
v. changes to systems, procedures, processes are actioned in the plan appropriately.
Re-defining the role of microbiological sampling and analysis has been attempted to coincide with industry HACCP programs. A conscious decision has been made to use microbiological sampling and testing data as part of the verification of systems. To this extent, a minimum testing requirement has been developed for the manufacturing sector for all products, based on food safety parameters. Larger manufacturers easily do more than the minimum requirement, whilst smaller manufacturers use the testing program as part of their HACCP plan.
4 AUDIT FUNCTION FOR HACCP SYSTEMS
The concern of multiple audits conducted by regulatory agencies and other audit groups is still an issue in Australia. It has partly been overcome by memorandum of understanding set up between government departments, but it still remains a burning issue between government and supermarkets and food service companies. Resolution of this issue will assist in reducing the number of multiple audits and extra cost to the industry.
Auditing procedures, across all industry sectors, follow a similar pattern. To be eligible to conduct audits, auditors are required to have requisite dairy industry education and experience and be a qualified Food Safety Auditor through qualification to a national criterion. Auditors are either from the regulatory stream or certified third party auditors, depending on in which state the audits occur.
There are three main areas of auditing:
- Certification audit (initial) to certify the system has identified all potential hazards and has in place the requisite control measures, recording
and corrective action, plus pre-requisite programs. This includes a review that validation criteria are met.
- Compliance audit - on-going and scheduled to check the system is working in practice. The number of audits conducted per year depends on a sector rating.
- Verification audit - verifies that changes in the individual circumstance have not altered or changed hazards, and verifies that the system is still sufficient to address food safety issues. This type of audit usually occurs annually for manufacturing sites or as required.
The certification of individual systems can be suspended or the frequency of audit increased if, during a compliance audit or special audit, the situation occurs where the auditor finds:
- the requirements of a critical element pertaining to food safety has not been met.
- there is an overall non compliance to the system that provides the auditor with sufficient evidence that the system is not being maintained and that the system is totally ineffective.
Audits conducted for regulatory agencies are done in a flexible manner across Australia, including the use of government only audit staff, government contracted audit staff and the use of external third party auditors, under prescribed criteria
5 HACCP - HAS IT BEEN SUCCESSFUL? WHAT ARE OUR EXPERIENCES IN HACCP, SOME OF THE DOWNSIDES?
The upside:
- embraced by industry, better control of processes
- no systems failures leading to outbreaks (still). We are attempting to gather industry data to better quantify the success of the program over time, this may prove difficult
- more efficient retrieval/traceback, more conducted in-house, and not distributed to consumers
- identified further hazards for example: use of fresh eggs in products like gelato, post pasteurisation ingredient addition (herbs, spices, nuts), allergen issues, supply inadequacies identified.
- less wastage identified.
- customer confidence - both national and international.
The downside or typical problems:
- Having implemented HACCP-based food safety programs for a number of years we are now reviewing what we have done in certain areas. This is a continuous process and we receive and value important feedback from industry. It is preferable not to have too many critical control points or the whole plan looses impact and action.
- Have to have industry on-side and understanding the process and have commitment at all levels in a manufacturing operation. This suffers especially in smaller manufacturing sites where there is often little technical input, time constraints, and a lack of or no training. There is a need for constant re-affirmation, training, cajoling by auditors to keep plans up to standard.
- Lack of validation of processing parameters for “newer” or innovative products by smaller manufacturers
- Lack of verification of critical control point monitoring, for example, lack of calibration of thermometers, holding tubes, pH probes, laboratory control cultures.
- Inadequate pre-requisite programs from the commencement of plan development and implementation.
- Difficult when there are supply and logistics problems - dollar incentive overrides HACCP if not controlled.
- Don’t want to be overly prescriptive, our plans may be over the top in some sectors, targeting quality and not food safety, this could be burdensome and not a direct benefit to industry - we are therefore tailoring plans and programs to fit the risk.
- Excessive, overly complex documentation and record keeping (ie; bookwork) for small processors, farmers and vendors - this can lead to a tick and flick mentality, filling in forms mindlessly - these forms have to be simple, less of them, user friendly, participants have to see the value in, a demonstrated benefit. A user non friendly program too often leads to inaccurate records and poor compliance
- Standardisation of audit both by industry, regulators and third party
- Cost of developing, implementing programs and then on-going costs, especially for small business.
6 CONCLUSION
The Australian dairy industry has undergone a tremendous “cultural” change in the way it handles food safety in the past 10 years in a further effort to enhance its record in regard to food safety. In introducing HACCP based systems across the industry we have attempted to build a benchmark for dairy food safety, one that is very much an industry/government partnership.
REFERENCES
1. Anonymous. Australian Dairy Industry in Focus 2003. Dairy Australia. (2003).
2. Anonymous. Codex Committee on Food Hygiene. HACCP System and Guidelines for its Application, Annexe to CAC/ RCP 1-1969, Rev 3. FAO, WHO, Rome, Italy (1997).
3. Anonymous. Export Control (Processed Food) Orders. Australian Quarantine and Inspection Service, Department of Agriculture, Fisheries and Forestry. Canberra, ACT, Australia (1992).
4. Jay, S.L., Davos, D., Dundas, M., Frankish, E., Lightfoot, D. Salmonella. In Foodborne Microorganisms of Public Health Significance. 6th Edition. Hocking, A.D. Editor in Chief. AIFST Inc (NSW Branch), Sydney, Australia. pp: 207-266 (2003).
| IDF/FAO international symposium on dairy safety and hygiene Cape Town, South Africa, March 2–5, 2004 |
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