Selecting the appropriate hygienic design during the concept stage of a hygienic entity is crucial for ensuring food safety, operational efficiency, and sustainability in food manufacturing. This article complements another published in Food Safety Magazine in April 2023, where our colleagues discussed the total cost of ownership in relation to hygienic design.¹ It explores key factors that should be considered for the development and assessment of hygienic design.

Purpose of Hygienic Design

Hygienic design aims to prevent biological, chemical, and physical contamination of food products. As a prerequisite program, it supports HACCP within a Food Safety Management System by minimizing hygiene risks and facilitating measures such as cleaning, sanitizing, and maintenance.

The Global Food Safety Initiative (GFSI) acknowledged the importance of hygienic design for food safety and introduced related benchmarking requirements in 2020.² These requirements are categorized under two scopes: JI for building constructors and equipment manufacturers, and JII for building and equipment users.

These scopes emphasize a Hygienic Design Management Process undertaken by a multi-disciplinary team aimed at mitigating hygienic design risks to enhance food safety. This process is integral to the culture of all engagements across the entire food supply chain, from farm to fork, and from concept to the construction of a hygienic entity.

Certification program owners, like Brand Reputation Compliance Global Standards (BRCGS) and Food Safety System Certification 22000 (FSSC 22000), have begun to include hygienic design considerations of the new scopes in their GFSI-recognized certification schemes.

Hygienic design not only mitigates food safety risks, but also significantly influences food quality compliance and operational performance, including efficiency and sustainability. It should be applied at all stages of the supply chain. The intended use and fitness for purpose will determine the specifics of the design and fabrication of each entity. Just as a key is crafted to fit a specific lock, hygienic design solutions should be tailored to meet specific requirements, ensuring hygiene, functionality, and overall performance. The extent to which hygienic design principles are applied will vary based on the food safety and quality risks identified by multidisciplinary teams, as well as other potential losses.

Hygienic Design Risk Management Guideline

Recently, the European Hygienic Engineering and Design Group (EHEDG) issued guideline Document 58, titled "Hygienic Design Risk Management."³ This document provides guidance on managing hygiene risks in the design of food-related manufacturing equipment and buildings. It focuses on food safety and quality, offering a step-by-step approach to hygiene risk management, including risk identification, analysis, reduction, and ongoing monitoring.

EHEDG suggests thoroughly describing the intended use as part of the first step for a risk-based design approach. This description should consider:

1. The physical boundaries (scope), which include various aspects of products, construction materials, processes, equipment, environment, and flows of people, equipment, and materials
2. The environment in which the hygienic entity will operate (context)
3. The objective criteria the entity will need to meet (criteria).

Scope of Intended Use

Key parameters of food products (raw materials and ingredients), such as their physical state (viscosity, particle size, water activity, etc.) and chemical parameters (acidity, oxidative stability, polarity, etc.), will influence the microbiological susceptibility of processes and products and should be understood. These parameters will impact plant layout and hygienic zoning, such as basic-, medium-, or high-hygiene zones, as well as equipment design.

The intended shelf life under anticipated conditions, including storage conditions like frozen, chilled, cooled, ambient, or other temperature settings, will determine the necessary design and hygienic measures.

The initial microbiological and physical (e.g., foreign material) contamination level of raw materials is crucial for implementing effective preventive measures.

Hygienic design may encompass various pieces and parts of equipment, buildings, and associated infrastructure. This includes evaluating the materials of construction, specific equipment parts, utilities, modules, units, process lines, rooms, buildings, factories, or even the entire site. Each component should be scrutinized to ensure it meets hygienic design needs and does not pose any hygiene risks. The extent to which these items will be integrated and interact with each other should be thoroughly examined.

Understanding the limits of food processing equipment, typically provided by the supplier, is essential to ensure it operates as intended within safe parameters.

Process parameters like pasteurization, sterilization, freezing, drying, etc., as well as process conditions such as hold time, idle time, and temperature parameters to prevent microbial growth and contamination, must be determined upfront. Additionally, whether the processing is open or closed impacts the hygienic design requirements.

Cleaning regime conditions, whether wash down, controlled wet, or dry, and the methods used [e.g., clean in place (CIP) or manual], including chemicals, concentration, and temperature, should be defined.

Context for Intended Use

Understanding the position in the supply chain is essential, as it determines the specific hygiene requirements and potential risks at each stage. Additionally, assessing the position in the lifecycle of the entity—from assembly and installation to startup and in-service with all use modes (operation, cleaning and disinfection, and maintenance)—is crucial to identify and mitigate risks throughout the entity's lifespan.

Ensuring compliance with the relevant legal and regulatory environment is another critical aspect, encompassing both the regulations in the producing country and those in the countries where the products will be used. It is also important to consider whether there has been a history of hygienic design management, or if it is a legacy situation. This historical context can influence current practices and highlight areas needing improvement.

The kind of environment in which the building or equipment will operate, including weather conditions, maximum temperatures, humidity levels, and tolerance to dust and chemicals, should be addressed. Learning from past experiences and addressing previously encountered issues can significantly enhance the effectiveness of current hygiene practices. Additionally, anticipating future developments allows for proactive risk management and adaptation to emerging trends.

The expected flows of people and materials within the building under all possible circumstances—including production, non-production, cleaning, maintenance, shutdowns, holidays, emergency exercises, and emergencies—should be specified. This includes all types of people (operators, staff, management, visitors, auditors, maintenance, suppliers, laboratory, quality, cleaning) and vehicles (cars, trucks, forklifts, cleaning vehicles, trolleys), as well as all types of materials (raw materials, end products, residues, waste, tools, equipment, packaging materials, utilities).

Criteria for Intended Use

The assessment must adhere to specific legal and regulatory requirements. These regulations vary by country and region, and compliance is essential to avoid legal issues and ensure food safety standards are met.

Industry standards also play a significant role. These standards provide a benchmark for best practices and help maintain consistency and quality across the industry.

Understanding and addressing customer requirements is another key criterion. This includes the needs of the next step in the supply chain, as well as the end users. Meeting these requirements ensures that the products are safe and suitable for their intended use.

The robustness of measures and procedures to prevent foreseeable misuse is critical. This involves implementing strong safeguards and protocols to mitigate risks and prevent contamination or other hygiene-related issues.

Additionally, safety, environmental, sustainability, and business constraints need to be considered. Balancing these factors ensures that the hygienic design not only protects food safety, but also aligns with broader organizational goals and responsibilities.

By addressing these factors related to scope, context, and criteria at an early stage in a project lifecycle, stakeholders can collaboratively develop and assess designs for food manufacturing equipment, buildings, infrastructure, and utilities that meet stringent hygiene standards while supporting efficient and sustainable food production.

Training Aspects

As mentioned at the beginning of this article, a cross-functional team should discuss the different factors to consider while making design decisions.

While each team member will bring their own expertise, the entire team should have basic knowledge of hygienic design. The importance of training for equipment manufacturers and processors is also mentioned in the GFSI Standard:

"Procedures shall be established, implemented, and maintained to ensure all employees and contractors involved in building and equipment evaluation, specification, purchase, maintenance, and hygienic design shall be trained in hygienic design principles appropriate to their tasks and to the hygienic design requirements of the building or equipment for its intended use."²

For some team members, the knowledge may have been acquired in school (e.g., engineers, food safety scientists, etc.) but for others, training by their employer will need to be provided. Various options are available to educate team members:

• Online audio tutorials that provide everyone with a basic understanding of hygienic design and align the team on terminology.
• Industry organizations that provide in-person training (e.g., EHDEG, NAMI, etc.)
• Colleges or universities that provide short courses on hygienic design
• Companies specializing in sanitation and hygienic design that offer workshops, in-person training at central locations, certifications, etc.

As mentioned above, not all team members may need the same level of training, depending on the level of knowledge they may have already acquired. The company should consider different options. For example:

• When many people from the same facility need training, would an on-location workshop to review their equipment and infrastructure be preferable? If a specific piece of equipment is to be reviewed, should the OEM be invited to participate?
• Should some on the core team obtain more in-depth training by attending an external training that will cover additional aspects?
• Should there be certified team members who will continuously update their knowledge to maintain their certifications?

Each of the different options has pros and cons. In general, one of the benefits of external training is exposing the participants to different ideas—not only from the trainers, but also from other participants.

In summary, as J. Edward Deming once said, "It is not enough to do your best; you must know what to do, and then do your best." The application of knowledge before making decisions about design, and at different stages of the commercialization process, will help the team design for greatness.

References

1. Brouillette, Richard and Dan Schmitz. "Designing for Greatness while Considering Total Cost of Ownership." Food Safety Magazine April/May 2023. https://www.food-safety.com/articles/8495-designing-for-greatness-while-considering-total-cost-of-ownership.
2. Global Food Safety Initiative (GFSI). "Benchmarking Requirements for CPOs Version 2020.1." February 26, 2020. https://mygfsi.com/wp-content/uploads/2020/02/GFSI-Benchmarking-Requirements-v2020.1-3.zip.
3. European Hygienic Engineering and Design Group (EHEDG). "Doc. 58: Hygienic Design Risk Management." https://www.ehedg.org/guidelines-working-groups/guidelines/guidelines/detail/hygienic-design-risk-management.

Dirk Nikoleiski is Regional Manager, EMEA at Commercial Food Sanitation with 30 years of experience in both the manufacturing and corporate environments. He held numerous plant and corporate roles at Kraft Foods, including quality manager, project manager (brownfield food plant), business development manager, and multiple corporate sanitation roles. Beside his leading roles at Kraft and Mondelez, Dirk was very engaged with NGOs, such as the European Hygienic Design Group (EHEDG), FoodDrinkEurope (FDE), and the Association of Chocolate, Biscuit and Confectionery Industries of Europe (Caobisco). In 2016, EHEDG honored Dirk for his outstanding and long-term commitment as well as for his distinguished services to the organization. As member of the allergen ad-hoc group at FDE, he contributed to a guideline on food allergen management for food manufacturers. Over the years, Dirk has also been an active speaker and author on sanitation and hygienic design. He holds a diploma in Food Technology from the Ostwestfalen-Lippe University of Applied Sciences in Lemgo, Germany, and he is also an authorized trainer for EHEDG.

Nicole Cammarata is Global Training manager, North America/U.S. for Commercial Food Sanitation. She assists food industry professionals in developing, improving, and meeting their food safety needs through comprehensive, in-person training courses and workshops. She leads the development of the CFS digital learning platform, providing a more blended learning approach for CFS customers to achieve their training needs. Nicole holds a bachelor's degree in Biology from the University of New Orleans. Prior to joining CFS, Nicole spent 16 years with Schlumberger Oilfield Services. She brings an extensive training, biological, and engineering background to CFS.