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Principles of Due Diligence for Quality and Legal Defence

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With new sentencing guidelines released this year and changes to the regulatory landscape, due diligence should be front of mind for food manufacturers
For manufacturers of food products public health and safety has long been a primary focus and, with legislation evolving to further protect the end consumer, it is important to ensure products are safe, contaminant-free and unlikely to cause harm in any way. We live in litigious times, therefore embedding a culture of due diligence within your food safety plan is to be advised.

Essentially, due diligence can be defined, in the case of food safety regulations, as ‘taking all reasonable precautions to avoid the occurrence of a breach, whether personally or through any person under your control’. Systems of control appropriate to identifiable risks should be set up and procedures put in place to monitor the effectiveness of that system.

The law dictates that food manufacturers meet certain standards of care when performing any acts that could foreseeably harm others, and each has a duty of care to adhere to the guidelines accordingly. Any failure to meet the required standards could be regarded as negligence, so it is important to pay clear attention to detail – from selecting the right product inspection systems for your environment to the way in which operations are documented and reported on.

Components of a Failsafe and due diligent Product Inspection System

 
Setting the standard
The food industry has a reputation for setting high standards for itself, often ahead of the regulatory curve. Larger retailers have self-regulated in certain circumstances, due to a historical lack of common standards – a situation that has been addressed in the form of the Global Food Safety Initiative (GFSI) and the introduction of Hazard Analysis and Critical Control Points (HACCP). In the US, changes to the Food Safety Modernization Act (FSMA) and the introduction later this year of Hazard Analysis and Risk-based Preventive Controls (HARPC) will also add to the range of measures put in place to ensure protection against a growing list of food safety threats.

Where due diligence sits in conjunction with the standards set by the regulators is an important aspect to consider. Can it be proven that you have taken all measures deemed reasonable in order to ensure consumer protection? It is one thing to put measures in place, but quite another to monitor and evaluate the effectiveness of those measures. Your system must work and so too must your system of checks to ensure its effectiveness.

HARPC is a good example of how the industry is moving forward, stipulating as it does that manufacturers bound by it must first: conduct a hazard analysis for all procedures, identify critical control points (CCPs) and implement preventive controls, provide a plan in writing to describe how these hazards will be controlled (often through the deployment of product inspection systems), plus verify the effectiveness of said controls – maintaining written records of the processes followed – and to reanalyse the plan on a regular basis.

Should a food safety incident occur where a facility is following these guidelines, it should be very simple to identify whether or not the manufacturer was in clear breach of food safety guidelines, or whether they were simply the unfortunate victim of unusual or unforeseen circumstances – thus proving due diligence or not.

Due diligence as a legal defence
Should it be necessary to defend your business in court against a breach of food safety regulations, such as a contaminant having been discovered in a food product, one avenue open to you is to use due diligence as a defence. In order to do so, a person or organisation must prove that all steps considered to be reasonable were taken and carried out in order to avoid committing the offence. This, of course, is a fairly sweeping statement and how it is interpreted will vary depending on the individual circumstances of the case.

The first point to look at is that you must have taken some form of positive action to avoid potential issues if the defence is to be satisfied. It is not enough to say that because nothing has happened in the past you have no reason to suspect that anything will happen in the future. A reasonable step that has not been taken will likely lead to a failed defence.

Secondly, remember that ‘size matters’ when reasonable precautions are being defined by the courts. According to a recent analysis compiled by the London Borough of Hillingdon Council – based on past court decisions – ‘the size of the business, the amount of risk and the impact of failure associated with that risk are some of the factors that help to determine what “all reasonable steps” are’. A large company failing to have a system for procedural documentation, for example, may prove to be detrimental to the defence.

Remember, a defence of due diligence is a rare example of where the burden of proof lies with the defendant – not the prosecution – so the more thorough your food safety plan and processes are the better.

Harsher UK sentencing guidelines published
Stricter guidelines for food safety offences were published in February of this year in the UK, which now use a company’s turnover to calculate fines and the level of culpability and harm for sentencing purposes.

Offences are categorised using only culpability and harm factors, and a table for both has been compiled ranging from (for culpability) low – where, for example, ‘failings were minor and occurred as an isolated incident’ – to very high – which would constitute a ‘deliberate breach of or flagrant disregard for the law’. For harm, the categories refer to both actual harm and the risk of harm and range from Category 3 – low risk of adverse effect on individual and/or having a widespread impact – to Category 1 – where the risk of individual or widespread adverse effects is serious.

These regulations represent a hard line approach to food safety offences in the UK and, if rolled out globally, would lead to a lot of companies having to re-evaluate their food safety plans. It is difficult to put a number on individual offences in terms of liability, but fines can range from as little as £100 for a low culpability harm Category 3 offence, to a staggering £3m for very high culpability harm Category 1 – which would doubtless have a huge impact on even the largest companies. It is worth remembering also that for very large organisations, the regulations state: ‘Where an offending organisation’s turnover or equivalent greatly exceeds the threshold for large organisations [£50m turnover or equivalent per annum], it may be necessary to move outside the suggested range to achieve a proportionate sentence’.

Addressing concerns from the outset
One of the major risk factors when it comes to a breach of food safety regulations is that of physical contaminants entering the retail supply chain. The opportunities for contaminants to enter food products are many and varied, as the majority of equipment used in food processing is metal based – such as cutting blades, grinders, mixers and packaging machinery.

Product inspection systems such as x-ray machines, metal detectors, checkweighers and vision inspection systems[1]​ are used frequently in the food manufacturing environment and are often defined as CCPs following operational analyses into potential hazards. Choosing the correct system – or often a combination of systems – for your individual requirements is paramount, as is choosing systems that are capable of detecting all contaminant types. In addition to metal, items such as glass, rubber components, calcified bone and high density plastics are also capable of being introduced into products – either as a result of the manufacturing process or in the raw materials themselves.

However, as we have discussed, it is not enough to simply put these machines in place, as this alone will not eradicate the incidence of contaminants entering the product. Quality management must be handled by taking a total approach, ensuring the systems are calibrated correctly, that operational procedures are followed to the letter and that regulations are both understood and adhered to strictly by operators. Keeping detailed records of operator training is important, as is documenting procedures throughout all processes. By doing so you should be able to identify areas that need to be improved upon very quickly and to take action where required.
Ask the right questions and the rewards will become clear very quickly. How can I ensure that foreign bodies are detected to the highest levels? How do I maximise uptime? Can contaminated products be rejected effectively? Can data be stored and handled effectively should I need access to it at a later date? By working with experts to determine the correct product inspection solutions you will save time and money in the process of finding the answers you require, at the same time significantly reducing the risk of costly litigation, damage to brand reputation and, most importantly, damage to consumer health.

With everything taken into consideration, changes to the regulatory landscape have the potential to leave food manufacturers open to extremely costly litigation, therefore the equipment you purchase and how you prepare for such an eventuality has become more important than ever. Due diligence, as we have outlined, is more than just a legal defence. It is about good practices, efficient operations and ensuring that the products your company sends into the retail supply chain meet the very highest standards in terms of quality and safety. If your attention to detail is unwavering, not only will you reap the rewards of the associated uptime advantages, but should an issue occur where circumstances beyond your control interrupt that flow, you will be far better equipped to answer your case should the need ever arise.

Download the White Paper – Principles of Due Diligence, for quality control and legal defence

[1]​ For more information on the technologies available, click below and get in touch with Mettler-Toledo Product Inspection.