Food safety has never been subject to more scrutiny than now, both globally and regionally. According to a major World Health Organisation study on the burden of foodborne diseases published in December 2015, 1,420,000 people die annually, of which about a third are children aged five years and under. In fact, one in 10 of us will fall victim to some food related illness every year.
Apart from the risks to personal health, businesses and even countries can suffer serious consequences from food safety related issues. For example, the Chinese melamine milk scandal (where dangerous adulterants were added to milk products to boost profit margin) has largely destroyed confidence in powdered milk formula from China, to the extent that Chinese tourists will often look to stock up on brands they consider safer when travelling outside the country, emptying supermarket shelves in the process. The Chinese government has since taken extremely harsh action against individuals they found to be responsible in that incident.
Also, the Maggi noodle recall in India last year inflicted serious damage to the brand. Regulators claimed that the noodles contained high levels of lead, which the supplier, Nestlé, disputed, but a recall was mandatory with a direct cost running into the high tens of millions of dollars and incalculable reputational damage.
To us in Southeast Asia, food is very important. During our travels around the region, it can be a big pleasure to experience the different smells, tastes and textures of the local specialties with their seemingly infinite variety of delights. But how can we be sure that we are following best practices in ensuring our food is safe and wholesome?
Managing Risks From The Big Picture
Happily, the steps needed to prevent food-borne illnesses are not particularly difficult or expensive, and rely on common sense management of risks.
If we look at the production of processed food products on a reasonably large commercial scale, we find generally that there is good practice in most factories; undoubtedly businesses do not wish for their customers to fall ill. However, there is always room for improvement, and one of the guiding principles in food safety management is to continuously improve and learn from the experience of others.
The food and beverage industry has been slower than some industries—pharmaceuticals for example—in adopting a formal regulatory framework but in many regions including ASEAN, the regulatory and advisory frameworks are starting to form and strengthen, based on existing good practice and experience from other regions.
If we look at global trends, the tendency is to hold suppliers increasingly responsible for all aspects of the supply chain, ‘from farm to fork’. Even the best-managed factory depends on the quality of its raw materials, and in localities where incomes are low, there is always a temptation to adulterate or cheat. Therefore, vigilance along the supply chain is often as important as inside the processing plant.
The US Food Safety Modernisation Act (FSMA) is the most developed manifestation of this, with suppliers held responsible for their up and downstream supply chains. Although this applies only to US domestic producers and exporters to the US, this gives us an indication of where regulation is heading. The US Food and Drug Administration rules have already become the ‘gold standard’ in the Pharmaceutical industry globally, and we can expect that to extend to the food and beverage industry.
Most food safety regimes globally rely on a methodology based on HACCP (Hazard Analysis of Critical Control Points). This requires a supplier to evaluate risk areas in the production and supply chain, and ensures measurements and tests at critical points detect problems before product is shipped.
For example, if a sterilisation process is required, a record of temperature against time must be maintained and reviewed before shipment. Alternatively, a test should be used to determine the composition of raw milk prior to acceptance in a dairy.
There is an increasing focus on prevention rather than detection, and this is central to the US FSMA as well as being a good practice generally. It is better to stop a problem happening than detect it, or risk hazardous products being shipped because of a problem with a test. So for example with a sterilisation process, a producer might implement a system such that product is not released from a retort until the correct temperature or time profile has been achieved.
Keeping Ahead Of Audits
Food safety management systems can be quite complex and multifaceted. They will incorporate everything from hygiene and plant organisation through to maintaining records of production parameters and equipment calibration, perhaps also training records, as well as traceability of batches of finished product in case a product recall is needed.
There is often a significant paper element—paper is attractive because it can be easily filed—and in any case, many records will naturally be in a paper format anyway, for example the equipment checks that may come from an inspection checklist on a clipboard.
Yet, the experience of other regulated industries is that however attractive paper might seem, digitised records have significant and winning advantages. The reason for that is in the nature of the regulation process, which is based on audits by the regulator.
Audits of a food safety management system can happen at any time. Random or planned checks may be made, or an audit may be enforced because of a complaint or field food safety issue. The process involves the examination of the HACCP plan, and checking of records.
Records must be original, not copies, must be attributable with a signature, must be contemporaneous—made at the time of processing—and not subject to falsification or tampering. They must unambiguously demonstrate adherence to HACCP criteria, and available on site for a period related to the shelf-life of product.
The problem with paper is that although it is easy to handle, it is also easy to lose or damage. Keeping paper records onsite without any possibility of backup is problematic in case of fire or flood, and in many cases, some degree of falsification is possible, particularly if, for example, operators at various process steps record temperature readings in handwriting.
Moreover, imagine a situation where raw materials have been incorrectly stored, introducing some sort of pathogen due to temperature/humidity problems. During an audit, how would you demonstrate due diligence in checking the quality of supplier hazard precautions if their records are on paper and hundreds of kilometres away?
The solution, of course, is digitisation of data, and particularly automated recording of process data around critical control points. Digitised data is easily transmitted from place to place, and may be backed up without compromising integrity. It is easy to imagine the idea of a ‘digital thread’ running from farm to fork, and providing suppliers with easy access to critical data for audit and for internal quality check (QC) tests.
Such that for example at the point at which an ingredient is delivered to the factory gate, an inspector can instantly access a chart of critical data trended over time on a mobile device or PC and reject non-conforming material. Or, a plant manager can obtain instantly a calibration certificate for a bulk milk chiller in the supply chain for raw milk.
Nevertheless, the benefits of digitised data are not simply to ease the process of food safety audit, as important as that is. Operations such as assessment of the efficiency of individual suppliers can be made, or overall equipment effectiveness (OEE) calculations can be run along the supply chain. As margins are squeezed, manufacturers who can work with their suppliers on efficiency will have a killer advantage.
There are also marketing benefits: imagine a consumer clicking on a QR code on a product and being able to see the farm responsible for the ingredients, connecting the urban consumer with the rural producer; a single product brand can now transform to become more than just a box and a logo.
Challenges With Digitisation
Modern graphical data recorders use clear displays to
show trends and alarms for prompt action in the factory.
So why do producers not switch to electronic record keeping? Well the reasons are complex, but cost is the critical issue.
Electronic data recording can be quite inexpensive, but units designed to meet the requirements of regulators particularly with respect to electronic signatures, protection against falsification of data, and batch data are traditionally very expensive, reflecting their use in very high value industries such as pharmaceutical production. The important standards to look for are adherence to the data logging requirements of FDA21CFR11 and FDA9CFR417.5.
Fortunately, the instrumentation industry is responding to the needs of the food and beverage industry and producing lower cost devices, often combining control and batch data recording for less than US$1,000. But these should be used with caution.
Many claims of compliance are questionable, so that for example, CSV files cannot comply with the regulatory requirements. PDF files are not original records, they are derived reports, and it must be possible for individuals or job functions to digitally sign the record, and to add annotations without compromising the integrity of the data.
So if a supplier cannot convincingly discuss these questions, it is imperative to find one who can. The difference in cost between a low and medium cost unit is tiny in comparison to the cost of a failed audit or food safety recall.
Another inhibiting factor is the difficulty of obtaining data from existing processes, which may have been running for years. Although there will often be sensors in place, these will be used by the process. In addition, a rule of data recording for critical control points is that independent measurements are required to cross check readings, and it may be difficult anyway to connect into a PLC system to obtain readings over communications.
In such cases, modular recording devices are a good solution to add a monitoring ‘wrapper’ around a production process that will often have been working for years or decades. Such devices have their own input/output modules, including high precision analogue inputs for temperature and pressure measurements.
They will also usually connect via Ethernet or serial communications to PLC systems to obtain or cross check other process data, with the possibility of raising alarms if inconsistencies are detected. A good instrumentation supplier will be able to advise on options and best practice.
Food safety should be the first concern of any responsible supplier, and there is an inexorable move globally and in our region towards digitised and automated data collection. This need not be expensive or require a major production refit, but take care to ensure your supplier meets the key standards for data integrity and digital signing.