Integrated Risk Framework (IRF)—Interconnection of the Ishikawa Diagram with the Enhanced HACCP System in Risk Assessment for the Sustainable Food Industry

Abstract

This paper presents a new risk assessment methodology called the Integrated Risk Framework (IRF) through the application of Ishikawa diagrams combined with the enhanced Hazard Analysis and Critical Control Point (HACCP) system. This risk investigation technique aims to ensure a significantly higher level of quality, safety, and sustainability in food products by using improved classical methods with strong intercorrelation capabilities. The methodology proposes expanding the typology of basic physical, chemical, and biological risks outlined by the ISO 22000 Food Safety Management System standard, adding other auxiliary risks such as allergens, fraud/sabotage, Kosher/Halal compliance, Rapid Alert System for Food and Feed notification, or additional specific risks such as irradiation, radioactivity, genetically modified organisms, polycyclic aromatic hydrocarbons, African swine fever, peste of small ruminants, etc. depending on the specific technological process or ingredients. Simultaneously, it identifies causes for each operation in the technological flow based on the 5M diagram: Man, Method, Material, Machine, and Environment. For each identified risk and cause, its impact was determined according to its severity and likelihood of occurrence. The final effect is defined as the risk class, calculated as the arithmetic mean of the impact derived at each process stage based on the identified risks and causes. Within the study, the methodology was applied to the spring water bottling process. This provided a new perspective on analyzing the risk factors during the bottling operations by concurrently using Ishikawa diagrams and HACCP principles throughout the product’s technological flow. The results of the study can form new methodologies aimed at enhancing sustainable food safety management strategy. In risk assessment using these two tools, the possibility of cumulative or synergistic effects is considered, resulting in better control of all factors that may affect the manufacturing process. This new perspective on studying the dynamics of risk factor analysis through the simultaneous use of the fishbone diagram and the classical HACCP system can be extrapolated and applied to any manufacturing process in the food industry and beyond.

1. Introduction

Sustainability has become a central element in the modern global economy, and companies are taking their responsibilities in this area more seriously than ever. In this regard, measures are being implemented to ensure that all company operations—manufacturing processes, product distribution, and financial operations—comply with international standards that include sustainability as a key component. In the food industry, sustainable investments offer competitive advantages. Companies that adopt eco-friendly and ethical practices, such as reducing food waste, using renewable energy, and partnering with sustainable suppliers, can achieve cost savings, access new markets, enhance their reputation, and meet the growing demand from environmentally conscious consumers. IFRS S1 provides guidelines for disclosing sustainability risks and opportunities that affect financial decisions [1]. IFRS S2 requires food industry entities to disclose climate-related risks and opportunities, covering their impact on financial performance, supply chains, and operations, including governance, strategy, emissions, energy use, and climate resilience metrics for transparency [2]. The UN Global Compact Guide to Corporate Sustainability emphasizes responsible practices in the food industry, such as promoting sustainable agriculture, reducing environmental impact, ensuring ethical labor practices, and supporting food security to contribute to a sustainable future [3]. These standards have a significant impact on a company’s reputation and credibility. Moreover, they play a crucial role in raising awareness of specific issues and enabling the implementation of risk management practices, facilitating the improvement of systems, processes, internal controls, and overall company performance. Last but not least, they impact the environment and contribute to creating a sustainable future for everyone. By adhering to these standards, companies can ensure their operations are conducted responsibly and in a way that benefits the environment, society, and the economy [4,5].

Most food processing companies support adopting risk management methodologies within a sustainable development framework, emphasizing access to high-quality food while fostering long-term social and economic growth and preserving the environment for future generations. Integrating sustainability into the food processing industry through a unified risk management system aligned with food codex standards and HACCP (Hazard Analysis and Critical Control Points) methodology to enhance quality of life by prioritizing health through comprehensive food chain monitoring [6].

Retrospective or repressive controls (like detective and corrective controls) are inefficient, uneconomical, and risky because potential risks are identified too late, with undesirable effects having already occurred [7]. As far back as 2400 years ago, the Athenians had the notion of danger and risk, as they possessed the ability to assess risk before making decisions [8]. However, the development of science over the past century has led to a deeper understanding of risk analysis as a distinct scientific concept [9].

At the level of each organization, management constantly faces internal and external factors and influences that can disrupt activities and hinder the achievement of objectives. All activities (operational, technological, financial, strategic, legislation compliance, political, environmental, and social) within an organization involve risks [10]. They should manage risk by identifying, eliminating, and assessing it, alongside implementing control measures to limit consequences and corrective actions, in addition to continuous monitoring of risks [11,12].

For better risk management, standards can be used as working tools to streamline the company’s actions (technological processes, services, or products). Thus, along the lines of risk management, several standards are operational that allow for the definition and classification of risks, the design of the organizational framework for risk management, the implementation of risk management, monitoring, reviewing, and continuous improvement of the organizational framework, communication and consultation, establishing the context, risk identification, risk analysis, risk estimation, risk treatment, and integration with other management systems [13,14,15].

HACCP is an effective method for ensuring food safety from raw material production to final product consumption [16]. The HACCP system was developed in the 1960s by the Pillsbury Company in collaboration with NASA, the U.S. Army’s Natick Laboratories, and the Air Force’s Space Laboratory Design Group, as part of research for food products intended for American space programs [17]. The research group aimed to create safe, encapsulated food for space mission, ensuring it was free from contamination [18,19].

The HACCP method was first introduced publicly in 1971 at the National Conference on Food Protection, with Pillsbury training FDA specialists [20]. In 1975, the U.S. Department of Agriculture adopted HACCP for meat plant inspections. The World Health Organization, the International Commission on Microbiological Specifications for Foods, and the Codex Alimentarius Commission support HACCP [21], and recent EU legislation [22] requires food businesses to implement and maintain a procedure based on HACCP principles.

A key aspect of HACCP is ensuring traceability throughout the food production chain [23], and it has been recognized by international organizations as the most effective method of controlling foodborne diseases [17], with the primary goal being the prevention of issues.

HACCP plans use seven fundamental principles: hazard analysis, identification of critical control points (CCPs), setting critical limits, monitoring, corrective actions, verification, and documentation and record-keeping [24]. These steps ensure that any deviation is identified and appropriate actions are taken to promptly restore control.

HACCP is a management that analyzes and controls biological, chemical, and physical hazards throughout the entire food production process [25]. However, the standard HACCP system can be considered sustainable because it promotes safe and responsible practices in food production, which contributes to sustainability goals. Among them are the following: reducing food waste, protecting natural resources, promoting public health, improving consumer confidence, and supporting regulatory compliance. Yet, sustainable HACCP extends this approach by incorporating environmentally friendly and cost-effective practices. Emerging insights reveal that sustainable HACCP benefits not only environmental health but also enhances business sustainability, aligning ecological responsibility with economic viability [26]. The weaknesses of HACCP include its focus solely on food safety, without integrating broader aspects such as sustainability or social responsibility. Additionally, HACCP does not address long-term or emerging risks, such as climate change or economic risks, and requires constant updates to remain relevant. Furthermore, it relies on advanced technical expertise, whereas other more complex systems may offer more flexible and easier-to-implement solutions.

To address these limitations, tools like the fishbone (Ishikawa or cause-and-effect) diagram can complement HACCP by providing a structured approach to identify and analyze the root causes of problems across broader areas such as quality improvement and process optimization [27]. It is basically a visual tool that illustrates the different factors that contribute to a problem. It is intended to help identify the causes of a problem and suggest potential actions for resolution. The fishbone diagram is an analytical tool that offers a structured approach to examining effects and identifying the causes that create or contribute to those effects [28]. The Ishikawa diagram visually illustrates the relationships between an event (effect) and its various causes. Its structured format encourages systematic thinking among team members. Key benefits of using a fishbone diagram include identifying the root causes of a problem or quality issue, promoting group participation and leveraging collective knowledge, and pinpointing areas where data collection is needed for further analysis [29].

The overarching goal of sustainable development in the field of water is focused on the continuous growth of the population, aligned socio-economically with resources and consumption at a global level. In this context, standards and techniques for ensuring quality and food safety are presented, along with the potential for their interrelation. These are comparatively applied within a case study on the water bottling process. Both the classical HACCP system and the proposed, improved methodology are presented as tools to support the sustainable management of water resources.

The overall objective aimed to design a new methodology and technique for risk investigation to ensure a high level of quality and safety for bottled water, utilizing improved classical methods with robust intercorrelation capabilities. A fresh perspective was provided in studying the dynamics of risk factor analysis in the spring water bottling process by concurrently applying the Ishikawa diagram and HACCP principles.

The methodology proposed extending the typology of physical, chemical, and biological risks outlined in the ISO 22000 standard [30] to include additional risks such as allergens, fraud/sabotage, Kosher/Halal compliance, Rapid Alert System for Food and Feed (RASFF) alerts, or others (e.g., genetically modified organisms (GMOs), irradiation, radioactivity, polycyclic aromatic hydrocarbons (PAHs), African swine fever (ASF), peste of small ruminants (PPR), etc.), depending on the specifics of the technological process. Simultaneously, the causes for each operation within the technological flow were identified based on the 5M analysis (Man, Method, Materials, Machines, Environment). For each identified risk and cause, its impact was determined by evaluating the severity and probability of occurrence. The final effect was defined as a risk class, calculated as the arithmetic mean of the resulting impact for each stage of the process, based on the identified risks and their causes.

2. Materials and Methods

2.1. Fundamental Principles, Basic Concepts, and Specific Implementation Steps

The new risk assessment methodology, Integrated Risk Framework (IRF), in technological processes in the food industry, is essential for ensuring product quality and safety. The steps for implementing IRF are basically the same as those for HACCP, but with a greater focus on risk. This systematic approach unfolds in several key steps, each playing a specific role in identifying and managing risks:

1. Establishing the technological flow chart: The first step involves creating a diagram that illustrates each stage of the technological process. This allows a clear visualization of the workflow and subsequent identification of critical phases.

2. Risk analysis: basic, auxiliary, and specific risks: The next stage entails evaluating the risks associated with each step, classifying them into basic risks (fundamental for the process, also provided in the classical HACCP analysis—physical, chemical, and biological risks), auxiliary risks (supporting the risk identification process—e.g., allergens, fraud/sabotage, Kosher/Halal compliance, RASFF notification), and specific risks (related to particular conditions imposed by the ingredients and specific technological processes—e.g., irradiation, radioactivity, GMOs, PAHs, ASF, PPR, etc.).

3. Identifying causes that may lead to potential risks: This step is accomplished using fishbone diagrams based on the 5M analysis and by applying the “5 Whys” technique to uncover the root causes of risks. This is a new step introduced by the proposed methodology.

4. Evaluating risks for each hazard: Each identified risk is assessed on four severity levels: low, medium, high, and critical. In this stage, the impact (I) and risk class (RC) are calculated, providing a basis for risk management. Using the impact (as arithmetic mean of frequency and severity) for (1) each stage of the process, (2) each basic, auxiliary, and specific risk, and (3) each factor (cause) using the 5M gives the analysis greater precision and complexity. The risk class was calculated using Formula (1):

RC = (I_Man +I_Machine + I_Material, +I_Method + I_Environment)/5;

RC = [(G_Man + F_Man)/2 + (G_Machine + F_Machine)/2 + (G_Materiale + F_Material)/2 + (G_Method + F_Method)/2 + (G_Environment + F_Environment)/2]/5,

(1)

where RC represents risk class; I represents impact (due to Man, Machine, Material, Method, and Environment); G represents severity (due to Man, Machine, Material, Method, and Environment); and F represents frequency (due to Man, Machine, Material, Method, and Environment).

5. Identifying measures and developing the control plan: The final step involves developing preventive and corrective measures, as well as formulating a control plan that ensures effective monitoring and management of risks throughout the technological process.

The risk analysis involves going through several stages detailed in Figure 1:

By following these steps, the methodology ensures a comprehensive and rigorous approach to risk management, thereby contributing to the enhancement of food safety and product quality [31].

2.2. The Tools and Techniques Used for the Integrated Risk Framework (IRF) Methodology

In this innovative approach of risk analysis, two main tools are primarily used: the ISO 22000 standard (including enhanced HACCP principles) and the Ishikawa cause-and-effect diagram, along with the 5M technique [32]. These tools are integrated to enable a detailed, preventive, and dynamic analysis of risks, taking into account the potential cumulative or synergistic effects between the involved factors. Here is a detailed explanation of the specific tools and techniques:

1. ISO 22000 standard and enhanced HACCP principles

ISO 22000 is an international standard for food safety management, providing a framework for identifying and controlling risks across the entire production chain.

Enhanced HACCP is a systematic risk prevention system based on hazard analysis and the establishment of CCPs. It ensures the identification of critical risks at each stage of the process, allowing for real-time monitoring and corrective actions.

The main stages of HACCP include the following:

• Identification and analysis of hazards;
• Determining the CCPs;
• Establishing critical limits for each CCP;
• Monitoring and applying corrective actions when necessary.

2. Ishikawa cause-and-effect diagram (5M diagram)

The Ishikawa diagram, also known as the “cause-and-effect” diagram or “fishbone diagram”, is used to systematically structure and identify potential causes of a risk. This diagram is highly effective in visualizing risk factors from multiple angles and identifying complex causal relationships that may contribute to process issues.

The 5M analysis is a central element of the Ishikawa diagram and allows for the detailing of potential causes according to the following:

• Materials—quality of raw materials and ingredients used;
• Machines—performance of equipment and its maintenance;
• Manpower—level of training, competencies, and work practices of staff;
• Methods—procedures and working methods implemented in the technological process;
• Environment—environmental conditions such as temperature, humidity, and cleanliness.

3. Evaluation of cumulative and synergistic effects

This approach allows for analysis not only of the effects of each individual factor but also of the potential cumulative and synergistic interactions between different factors. For example, certain combinations of lower-quality materials and equipment defects can amplify risks. The proposed methodology enables the evaluation and addressing of these complex effects.

4. Dynamic monitoring and control of risks

The integration of HACCP and the Ishikawa diagram allows for continuous monitoring and real-time adjustment of control measures. In this method, changes in any of the analyzed factors are easily identified and controlled through CCP monitoring charts. The adaptability of this combination provides dynamic and prompt control of risks, which is crucial for maintaining process stability.

5. Documentation and internal process auditing

ISO 22000 and HACCP require documentation of all risk control and verification activities. The Ishikawa cause-and-effect diagram helps organize information regarding the causes and actions taken, facilitating the auditing process and subsequent risk analysis if necessary.

By combining these tools and techniques, this methodology provides a comprehensive, flexible, and effective approach that can be applied to any manufacturing process, not only in the food industry.

2.3. Advantages and Outcomes of the Proposed Methodology Compared to Classical HACCP

The innovative approach described offers numerous advantages in risk analysis and control, especially in the food industry context, due to the combination of HACCP principles and the Ishikawa cause-and-effect diagram, supported by the 5M [33]. The following are the main advantages of this method:

(a)

Detailed and structured identification of causes

The Ishikawa diagram allows for a visual and systematic analysis of potential causes of risks. By using the 5M, the method facilitates the detailed identification of risk sources, covering all critical aspects of the technological process. This reduces the chances of overlooking a risk factor, ensuring complete coverage of possible causes [34].

(b)

Evaluation of synergistic and cumulative risks

The approach allows not only for an individual evaluation of risk factors but also an analysis of cumulative or synergistic effects. This perspective is essential in complex processes, where interactions between factors can amplify risks. The ISO 22000 system and enhanced HACCP principles provide the necessary framework for such detailed evaluation [35].

(c)

Real-time risk control and high adaptability

By integrating the ISO 22000 standard, which focuses on food safety risk management, the system enables continuous monitoring and updating of control measures based on changes occurring in the manufacturing process [36]. The Ishikawa diagram is flexible and can be adapted to quickly reflect changes in operations or technologies, providing a dynamic tool for risk assessment.

(d)

Improved coordination between departments

The methodology encourages collaboration between teams and departments, as identifying and controlling causes often requires the involvement of multiple functions (production, maintenance, quality, human resources). This facilitates interdepartmental communication, leading to better coordination and efficient implementation of preventive measures.

(e)

Potential for extrapolation to other industries

Since this methodology is applicable to any manufacturing process, it can be used not only in the food industry but also in other sectors that require strict risk control, such as cosmetics, the pharmaceutical industry, chemical industries, or medical equipment production, etc.

(f)

Improved product quality and customer satisfaction

By systematically preventing risks and minimizing incidents in production processes, superior product quality is ensured. This leads to increased customer satisfaction and, consequently, the strengthening of the brand’s reputation [37].

(g)

Reduction of risk-related costs

Better risk control reduces the likelihood of defects and non-conformities, which helps lower the costs associated with rectifying them, product recalls, or compensating customers.

Overall, the advantages of using IRF derive from the ability to identify high-impact risks for each stage of the process. At the same time, the causes of their occurrence are analyzed based on the following factors: materials, machines (equipment), operating methods, workers, and environment, which form the “5M”.

The outcomes of implementing the IRF System include an expanded typology of risks, which addresses new and emerging threats such as allergens, fraud, GMOs, radioactivity, irradiation, and zoonotic diseases like African swine fever. It also offers a more detailed analysis of risk causes through the use of the Ishikawa diagram (5M: Man, Method, Material, Machine, Environment), enabling a deeper understanding of potential hazards. Additionally, the system integrates sustainability factors, incorporating ethical considerations such as Kosher/Halal compliance and notifications from the Rapid Alert System for Food and Feed (RASFF). The methodology is flexible and adaptable to industry-specific processes and ingredients, while the use of impact in quantitative risk assessment provides a more solid basis for informed decision-making.

While HACCP remains a robust system for food safety, IRF introduces a more innovative and integrated approach, addressing new risks, sustainability, and adaptability, making it more suitable for the current and future challenges of the food industry.

3. Application of the Integrated Risk Framework (IRF) Methodology: Case Study

The innovative integration of a sustainable development approach will be made by progressive actions using the results of a management system through the improved HACCP tool and the cause-and-effect diagram. In bottled water production multiple water purification technologies are used. The water treatment process starts with filtration of the raw source water that originates from the natural spring [38,39]. To ensure its preservability, carbon dioxide is added to sparkling water, while still water uses disinfectant technologies (ozonation) [40,41].

The water supply infrastructure is vulnerable to various unpredictable natural and human-made risks at every stage [42]. Several risk analysis methods have been developed for various technological systems within the water industry, including techniques such as checklists, event tree analysis (ETA), Bayesian network analysis, Monte Carlo analysis, bowtie analysis, fault tree analysis (FTA), failure mode and effects analysis (FMEA), HACCP, hazard and operability study (HAZOP), probabilistic risk assessment (PRA), risk matrices, what-if analysis (risk scenario analysis), key risk indicators (KRIs), multi-criteria decision analysis (MCDA), dynamic risk assessment (DRA), and SWOT analysis [43].

Safety is the ability to withstand anticipated threats with a certain level of probability. Risks can be identified at every stage of production and distribution, and they must be recognized, analyzed, and mitigated [44].

A flow diagram of the bottled natural spring water manufacturing process is represented in Figure 2.

3.1. Implementation of the Classical HACCP System

The HACCP system uses a method for controlling critical points during product processing to prevent the occurrence of health safety issues. The system systematically identifies and evaluates potential physical, chemical, and biological risks and the measures to control them to ensure food safety [22,30].

The determination of potential biological, chemical, and physical risks that could affect product safety and consumer health includes the following:

1. Biological risks, which are represented by microorganisms and parasites present in food products or that may accidentally contaminate them. During handling, processing, storage, and transportation, these risks can develop beyond legal limits and cause consumer illnesses. They are caused by the microbiota and parasites in the products, additives, packaging materials, water, and air [45]. Microorganisms can include bacteria, molds, and yeasts, which result from a lack of sanitation.

2. Chemical risks, which are characterized by chemical components, poisonous compounds characteristic of food products that exceed legal limits. These are caused by the purity of additives, the presence of heavy metals, and pesticides in agri-food products [46]. A classification of these includes the following: agricultural chemicals (pesticides); environmental pollutants (heavy metals—Pb, Cd, Hg—dust, smoke); process additives (coloring agents, fats, lubricants, detergents and disinfectants, paints); packaging materials (inks); and unauthorized additives (added before final use—Hg, As).

3. Physical risks, which are represented by foreign objects found in food products or that may enter them during food handling (rings, earrings, hairpins, coins, buttons, human hair, nails, pieces of nail polish, bandages, wound patches, tampons, cigarette butts). Other foreign objects that may enter due to external contamination include the following: pieces of plastic (plastic cups, closure rings), glass, hard plastic (from lighting fixtures, hydrants, windows, machinery), rubber pieces (gaskets), sand, soil, stones, leaves, pits, dust, cardboard, paper, labels, cleaning materials (rags, broom debris, brushes), screws, nuts, nails, wires, etc. Physical risks also include rodent droppings, insect carcasses, rodents, or other pests [47]. Another classification of potential physical risks includes the following: agricultural products (sand, soil, gravel, pits, leaves, wood); glass (glass packaging, light bulbs); metals (screws, parts from machinery); pests (spiders, flies, mice); plastic, paper (packaging materials); maintenance (electric cables, rags, brushes, fragments resulting from drilling or mechanical shocks); personal items (coins, earrings, rings, hairpins); sabotage (pesticides, additives).

Identification and assessment are based on the company’s food safety policy, client requirements, Good Manufacturing Practices measures, product descriptions that include identifying intended use, raw material descriptions, flow diagrams, process stages descriptions, work instructions, and layout sketches [42].

According to the matrix shown in

Table 1. Risk assessment matrix for classical HACCP [48].

Severity [G]	Frequency [F]
	Low (the Event Is Unlikely to Happen)	Medium (an Event with a Low Chance of Occurring)	High (the Event Is Likely to Happen)
Low (low risk and no significant impact)	1	2	3
Medium (it may affect the process/product)	2	3	4
High (it affects the organization, process, or product on a large scale)	3	4	4

, within the classical HACCP system, each hazard related to food product safety is evaluated based on the severity (G) of the hazard and the likelihood of occurrence (F) of the hazard at the respective production stage. Identification and evaluation are performed for each stage of the technological process. Based on these elements, the risk class (hazard relevance) is determined [48].

For risks identified as non-significant, specifically those with a score of 1 can be monitored without immediate measures, or for those with a score of 2 preventive measures (operational prerequisite programs—PRPs) will be established to keep these hazards under control.

Risks identified as significant indicate a high risk that requires immediate intervention to prevent serious consequences. These have a score of 3 or 4 and are subject to evaluation using a decision tree to determine which risks need to be controlled through CCPs.

Table 2. Assessment of hazards for the CCPs established for carbonated water.

Step	Hazard	Hazard Description	G	F	RC	Q1	Q2	Q3	Q4	CCP
Mechanical filtration	Physical	Impurities (sand, soil, sediment, sludge, rust, or suspended particles)	Low	High	3	Yes	Yes	-	-	CCP1
CO2 impregnation	Biological	Pathogenic agents: E. coli, Clostridium spp. L. monocytogenes, Salmonella spp., Staphyloccocus spp., Y. enterocolitica, C. jejuni, P. aeruginosa, Shigella spp., Streptococcus Faecalis, Legionella spp., etc.; parasites	High	Low	3	Yes	Yes	-	-	CCP2

Abbreviations: G—severity; F—probability of occurrence; RC—risk class; CCP—critical control point; Q_1–4—the questions in the decision tree.

and

Table 3. CCP control plan related to the process of obtaining carbonated spring water.

Step	CCP	Control Measures	Critical Limits	Monitoring	Corrective Actions and Measures	Records, Documents	Responsibilities
Mechanical filtration	CCP1	- Δp monitoring at the plate filter, - Calibrating the pressure gauges.	maximum 4 bar	Every hour	- Filter replacement, - Filter washing, - Filter inspection, - Staff training.	- Operational control sheet, - Input water quality, monitoring register.	- Operator, - Quality Control Laboratory, - Maintenance Manager.
Carbonation	CCP2	- Determining the CO2 content in the product	Minimum 2500 mg/L CO2	For each batch	- CO2 cylinder replacement, - CO2 flow adjustment, - Staff training.	- Operational control sheet, - Finished product quality, monitoring register.	- Operator, - Quality Control Laboratory, - Maintenance Manager.

Abbreviations: CCP—critical control point; Δp—pressure difference; CO₂—carbon dioxide.

present the analysis and assessment of the hazards related to the CCPs identified in the technological process for obtaining carbonated spring water, as well as the monitoring table and corrective actions for the CCPs.

Table 4. Hazard analysis and assessment corresponding to the CCPs established for still water.

Step	Hazard	Hazard Description	G	F	RC	Q1	Q2	Q3	Q4	CCP
Mechanical filtration	Physical	Impurities (sand, soil, sediment, mud, rust or suspended particles)	Low	High	3	Yes	Yes	-	-	CCP1
Ozone treatment	Biological	Pathogens (E. coli, Clostridium spp., Listeria monocytogenes, Salmonella spp., Staphyloccocus spp., Yersinia enterocolitica, Campylobacter jejuni, Pseudomonas aeruginosa, Shigella spp., Streptococcus Faecalis, Legionella spp., etc.) Parasites	High	Low	3	Yes	Yes	-	-	CCP2

Abbreviations: G—Severity; F—Probability of occurrence; RC—Risk class; Q_1–4—the decision tree questions; CCP—critical control point.

and

Table 5. Monitoring and remediation plan for CCPs related to the process of obtaining still spring water.

Step	CCP	Control Measures	Critical Limits	Monitoring	Corrective Measures and Actions	Records	Responsibilities
Mechanical filtration	CCP1	-Δp monitoring on the plate filter; -Calibration of pressure gauges.	Maximum 4 bar	Every one hour	-Change of filter cartridges; -Filter washing; -Plate filter overhaul; -Staff training.	-Operational checklist; -Water monitoring register.	-Operators; -Quality control laboratory; -Maintenance coordinator.
Ozone treatment	CCP2	-Monitoring pressure of ozonated air; -Analysis of residual O3 in the product.	0.05 mg/L O3 residual	Every batch	-O3 generator maintenance; -O3 generator air flow adjustment; -Operator training.	-Operational control sheet; -Finished product quality monitoring register.	-Operator; -Quality control laboratory; -Maintenance manager.

Abbreviations: CCP—critical control point; Δp—pressure difference; O₃—ozone.

detail the analysis and assessment of risks associated with the CCPs identified within the technological flow of still spring water production, respectively the table regarding monitoring and corrective measures applicable to them.

3.2. Implementation of the Integrated Risk Framework (IRF) System

If in a previous study [25] we carried out a more simplistic approach with the methodology by identifying only physical, chemical, and biological hazards, in the present study additional hazards were investigated—auxiliary and additional specific risks—so that risk elements can be identified, evaluated, and managed in an integrated system.

Within the IRF system, the methodology proposes to expand the typology of basic physical, chemical, and biological risks related to the HACCP system (integral part of the ISO 22000 standard) with other auxiliary ones, such as allergens, fraud/sabotage, Kosher/Halal compliance, and notifications on the RASFF, or additional specific risks, such as GMOs, irradiation or radioactivity, PAHs, ASF, peste of small ruminants (PPR), etc. [49]. In this way, the improved HACCP system is obtained, where the identification of hazards associated with products is performed for each category of hazards described, and for every group of products in particular, for each operation in the technological flow separately. This, in conjunction with the 5M model, is very useful in analyzing processes, especially in production or management contexts, leading to the IRF system.

So, in the risk assessment, all the following possible risks that can impact food safety, as well as the health of personnel and consumers, are taken into account:

• Allergens are substances or foods to which the body has an allergic reaction of an immunological nature. The products that can cause food allergic reactions in the human body are the following 14 categories: cereals containing gluten, crustaceans and derived products, eggs and egg-based products, fish and derived products, peanuts and derived products, soy and soy-based products, milk and dairy products, nuts (walnuts, pistachios, etc.), hazelnuts, celery and derived products, sesame and sesame-based products, mustard and mustard-based products, SO₂ and sulphite content > 10 mg/kg, lupin, and molluscs [50];
• Fraud/sabotage is represented by treatments to modify the properties or defraud food products, in order to obtain financial benefits, increase the shelf life, improve sensory or physico-chemical properties, improve microbiological properties, etc. Fraud is represented by treatments to modify the properties of or falsify food products, and sabotage is represented by preventing, stopping, or altering an activity, produced in order to obtain benefits or for revenge, ill will, etc. Products, machinery and equipment, and working conditions can be sabotaged by unit operators, drivers, visiting personnel, etc. [51];
• Irradiation/radioactivity/GMOs are represented by genetically modified products or ingredients derived from GMOs or by products treated with ionizing radiation in order to preserve them or improve their properties. Products treated with ionizing radiation are vegetable food products, which can be treated with a maximum of 10 kGy (total average absorbed radiation dose) [52]. The use of irradiated products must be indicated to the consumer by their appropriate labeling. Failure to comply with this provision constitutes a violation of European requirements, which leads to the withdrawal and destruction of the entire irradiated quantity.
  Another risk is represented by radioactive contamination of food products. Radioactive contamination can occur following a nuclear accident or other radiological emergency. Thus, in areas with the risks described above, plants and feed can be contaminated, leading to the accumulation of radioactive isotopes in them.
  The European Union has established maximum levels of radioactive contamination of food products. Products and feed that exceed the legal limit will be withdrawn and neutralized.
  GMOs: This category includes organisms whose genetic material (DNA) has been modified in an unnatural way using DNA recombination technologies. The main types of products that can be genetically modified are the following: corn and its derivatives, soy and its derivatives, potato and its derivatives. The use of approved GMOs must be indicated to the consumer by appropriate labeling. Failure to comply with this provision constitutes a violation of European requirements, which leads to the withdrawal and destruction of the products in question [53];
• Kosher/Halal are food standards with religious roots according to which some food products are prohibited for consumption by Muslims or Jews. This also includes products that may come into contact with Kosher/Halal food or may be contaminated/may contaminate products permitted for consumption by the two communities. There are dangers for the Jewish and Muslim communities that may affect base materials, goods, intermediate products, and end products, in the case of products sold to them. These dangers (pork products and derivatives, carmine, alcohol, etc.) can arise from the use of products prohibited for consumption by the Jewish or Muslim community, from contamination during transport, handling, storage, and processing [54];
• PAHs are represented by plant products that can be contaminated with these hydrocarbons from crops (source of origin soil, water, etc.). They are hydrocarbons that can appear in plants, from the soil in which they were grown or the irrigation water [55];
• RASFF products are represented by non-compliant products reported on the European Rapid Alert System. They are non-compliant products that can enter the establishment or that can be processed in the establishment [56];
• Swine fever/peste of small ruminants are represented by products from animals sick with the swine fever/peste of small ruminants virus and which may have an impact on food safety. They are products derived from pigs/goats and sheep (collagen protein, gelatin, hemoglobin, etc.) which are contaminated with the swine fever virus and cause swine flu. To control this risk, specific measures are taken for the supply, storage of goods, and marketing. This risk is not allowed to occur in the unit [57];
• Other risks are represented by the risks specific to the activity carried out by each department in the unit related to the business process, understanding the context in which it operates, and understanding the needs and expectations of stakeholders.

Figure 3 exemplifies the way to establish the causes that can generate the risks associated with different manufacturing stages.

The root cause analysis is carried out for each hazard, for the 5M framework, and for each operation, so as to identify each susceptible hazard.

3.3. Applying the Integrated Risk Framework (IRF) Methodology to the Spring Water Bottling Flow

Figure 4 illustrates the use of the Ishikawa diagram to systematically identify and categorize the root causes of risks related with the water bottling steps. The diagram breaks down potential causes into key categories—such as equipment, materials, personnel, environment, and processes—that could contribute to quality and safety issues. For instance, potential causes could be categorized into areas such as equipment (e.g., improper sterilization of bottling machinery), materials (e.g., quality of bottles or caps), personnel (e.g., inadequate training in hygiene protocols), environment (e.g., exposure to airborne contaminants), and processes (e.g., inconsistent filling or capping procedures). This structured analysis supports targeted interventions to minimize risks, forming an essential part of a proactive risk management approach in the water bottling process.

Table 6. Causal analysis, based on the 5M framework, for every risk associated with the water bottling process.

Step	Risk	Type M
		Environment (M1)	Man (M2)	Method (M3)	Materials (M4)	Machines (M5)
BOTTLING	Physical	-Presence of foreign contaminants from the workplace; -Cross-contamination between handled products; -Contamination from PET bottles; -Contamination from airborne dust.	-Foreign objects from workers and their clothing; -Contamination due to the handling of raw materials and packaging; -Contamination due to storage of opened bottles for filling.	-Ignorance of work and sanitation standards; -Failure to comply with work and sanitation standards; -Unreviewed work and sanitation standards.	-Cross-contamination between containers (PET bottles); -Contamination from water with impurities.	-Contamination from transport equipment, machinery and equipment, working papers, foils, or labels; -Contamination from defective pallets.
	Chemical	-Contamination from chemicals (including sanitizing substances) handled in the same space.	-Contamination due to workers and working equipment; -CO2/O3 overdose.	-Ignorance or non-compliance with work and sanitation standards; -Unrevised work and sanitation standards.	-Contamination with chemicals (including sanitizing substances) handled or stored in the area; -Use of impure CO2/O3.	-Contamination from faulty machinery.
	Biological	-Microbial pollutants from the workplace; -Proliferation of microorganisms due to improper sanitation.	-Contamination from ill workers, those with sick pets, or dirty work equipment.	-Ignorance or non-compliance with work and sanitation standards; -Unrevised work and sanitation standards.	-Contamination from water, or microbiologically contaminated packaging.	-Contamination from unsanitized machinery, pallets, or shelves.
	Allergens	-Handling of allergenic foods inside the factory; -There is no delimitation of the dining room; -Contamination from air contaminated with allergens; -Inadequate operation of the ventilation/air filtration system; -Contamination from an environment that is not properly sanitized.	-Contamination from operators and their equipment; -Contamination from operators or other people passing through the area; -Contamination during dry cleaning.	-Ignorance of work and sanitation standards; -Failure to comply with work and sanitation standards; -Unrevised work and sanitation standards.	-Contamination between allergenic foods and containers (PET bottles) stored and handled in the same space.	-Contamination from transport equipment, shelves, pallets, or contaminated floors.
	Fraud	-	-Malicious actions by operators.	-	-Contamination from counterfeit, manipulated products.	-Sabotage of machinery and equipment.
	Kosher/ Halal	-Contamination from an environment that is not properly sanitized.	-Contamination with prohibited foods from operators and their equipment; -Contamination during handling and storage.	-Ignorance of work and sanitation standards; -Failure to comply with work and sanitation standards.	-	-Contamination from machinery, pallets, shelves, or contaminated with prohibited products.
	RASFF	-	-Contamination of products from operators who consumed batches of products notified to RASFF.	-	-Cross-contamination between products that have been reported to RASFF.	-Contamination from machinery, pallets, or contaminated with products that have been reported to RASFF.
	Other	-	-Failure to comply with EMM verification procedures or prescription/dosage.	-	-	-Defective, uncalibrated EMM.

Abbreviations: CO₂—carbon dioxide; O₃—ozone; RASFF—Rapid Alert System for Food and Feed; PET—polyethylene terephthalate; EMM—measuring and monitoring equipment.

presents an analysis of potential hazards at the water bottling stage, structured according to the 5M method: Man, Machine, Material, Method, and Environment. Each category examines specific causes related to quality and safety risks, such as human error, equipment issues, material quality, procedural inconsistencies, and environmental factors. This organized approach provides a clear framework for identifying and addressing each hazard, supporting a thorough risk assessment and control strategy for the bottling process.

3.3.1. Risk Assessment for Each Hazard

We have redefined and expanded the scale related to the frequency and severity of the occurrence of hazards and their impact, resulting in four levels: low, medium, high, and critical. The risk assessment is conducted by evaluating the frequency and likelihood of its occurrence, as well as the potential impact associated with the identified hazard.

Frequency (F) represents the likelihood or probability of the identified risk occurring more than once in the food product or that the activity undertaken will result in this risk occurring multiple times. It is categorized into four distinct levels of frequency:

-Low: considered practically unlikely to occur, representing a “theoretical risk”—once a year;

-Medium: has the potential to occur and has been observed to happen occasionally—monthly;

-High: occurs consistently and repeatedly within the context of the process or activity—weekly;

-Critical: is certain to occur as an inherent aspect of the process or activity—continuous.

Severity (G) refers to the potential consequences of the identified risk on product integrity, food safety, or the activities performed within the operational context of the department. It is categorized into four levels:

-Low: results in minor damage to products, consumers, and operational activities—e.g., minor sensory changes in the product, or related to ancillary processes;

-Medium: causes damage that impacts both products and the associated activities—e.g., degradations in the product’s sensory properties caused by the working environment and operators;

-High: leads to significant harm to products and operations and/or illness in the end consumer—products where control has lost (CCP, PRP): pests, physico-chemical contamination, etc.;

-Critical: involves catastrophic outcomes for products and operations, severe injuries, irreparable damage, or fatal consequences, which may manifest immediately or after a latency period—accidents with severe consequences (microbiological and physical contamination with foreign bodies, allergens, etc.).

Impact (I) represents the effect of the identified risk, determined as the arithmetic mean of its frequency and severity, and evaluated in relation to the 5M framework (Environment, Man, Method, Materials, and Machines) with respect to product integrity and food safety. It is categorized into four levels:

-Low: no intervention measures are necessary;

-Medium: periodic measures are required, often involving isolated or one-time actions;

-High: general control measures are needed, such as implementing procedures or work standards;

-Critical: specific control and monitoring measures are essential, tailored to address particular situations (e.g., PRPO, CCP).

The risk class (RC) represents the overall impact of the identified risk on the product, process, or activity. It is categorized into four levels:

-Low (1 to 2): No specific control or monitoring measures are necessary;

-Medium (2.1 to 2.5): Requires singular or isolated control measures;

-High (2.6 to 3): Necessitates general control measures, such as those derived from PRPs or hygiene procedures;

-Critical (>3): Demands urgent and highly specific control and monitoring measures, defined as PRPOs or CCPs.

Table 7. Identification of hazards and determination of risk class for the bottling stage of still water.

Step	Risk	M1			M2			M3			M4			M5			RC
		G	F	I	G	F	I	G	F	I	G	F	I	G	F	I
BOTTLING	Physical	3	1	2	3	1	2	2	1	1.5	2	1	1.5	3	1	2.5	1.9
	Chemical	3	1	2	3	1	2	2	1	1.5	3	1	2	4	1	2.5	2
	Biological	3	1	2	3	1	2	3	2	2.5	3	1	2	3	2	2.5	2.2
	Allergens	1	0	0.5	2	1	1.5	1	0	0.5	2	1	1.5	1	1	1	1
	Fraud	0	0	0	4	1	2.5	1	1	1	2	1	1.5	1	1	1	1.2
	Kosher/Halal	0	0	0	2	1	1.5	2	1	1.5	0	0	0	0	0	0	0.6
	RASFF	0	0	0	2	1	1.5	0	0	0	2	1	1.5	1	1	1	0.8
	Other	0	0	0	2	1	1	0	0	0	0	0	0	2	1	1.5	0.5

Scoring: frequency: 0—cannot happen, 1—occurs rarely (once a year), 2—may occur monthly, 3—may occur weekly, 4—can occur in every process; severity: 0—no risk, 1—no intervention risk (minor changes/modifications in quality that do not affect product safety), 2—minor risk but leads to qualitative depreciation of the product, with potential damage to products and operations, 3—major risk leading to product destruction or consumer illness, 4—severe accidents with irreparable damage. Abbreviations: M1—environment, M2—man, M3—method, M4—materials, M5—machines, G—severity, F—frequency, I—impact, RC—risk class (arithmetic mean of the impact on each M).

provides an example of the hazard assessment for the bottling stage of spring water, using the “5 Whys” method to evaluate each hazard associated with this stage.

3.3.2. Identification of Control Measures

Control measures are implemented for the primary causes identified to be capable of leading to the emergence of potential hazards, and they involve a range of techniques, activities, or actions aimed at mitigating or eliminating the identified risks. The basis for establishing control measures is rooted in the risk identification and hazard assessment phase.

After establishing the main causes that can generate potential hazards for all ingredients or auxiliary materials, respectively, for each stage of the process, we proceed to implement general control measures that can eliminate or mitigate this potential risk.

For risk class 3, together with the established control measures, PRPs are employed. These programs establish guidelines for working conditions, hygiene, and processing zones, ensuring control over food safety.

For risk class 4, the monitoring, inspection, and confirmation of control measures are conducted through the implementation of preliminary operational programs (PRPOs) and CCPs.

In

Table 8. Identification and establishment of control measures together with the responsible individuals for each risk.

M Type	Risk	Measures	Responsibilities/ Period
M1	-Contamination from chemicals (including sanitizing substances) used within the same area.	-Sanitation check through pH tests; -Elimination of chemicals from the area; -Sanitization and disinfection of the area.	-Flow control/annually; -Operations coordinator/daily.
M2	-Contamination from staff, visitors’ or gowns, caps, etc.; -CO2 or O3 overdose.	-Control of personnel health, hygiene, and compliance of protective equipment; -Monitoring the dosage through rapid testing.	-Operations coordinator/daily; -Laboratory assistant/daily.
M3	-Negligence or failure to adhere to work and sanitation standards, as well as preventive measures; -Unrevised work and sanitation procedures, risk prevention protocols.	-Regular training for production personnel; -Regular and systematic review of protocols.	-Process operators/upon hiring, quarterly, and annually.
M4	-Contamination from chemicals (including sanitizing agents) used or just kept in the immediate vicinity; -Utilization of contaminated, impure, or technical CO2 or O3.	-Handling detergents only when sanitizing; -Periodic monitoring of CO2 or O3 purity.	-Production coordinator/sanitation tests/internal control plan.
M5	-Contamination from defective or improperly sanitized equipment; -Failure to calibrate DMM.	-Equipment maintenance; -Adherence to hygiene and protocols; -DMM regular calibration.	-Operational staff/according to schedule; -Production coordinator/for sanitation; -Technical manager/according to schedule.

Abbreviations: DMM—measuring and measuring device; CO₂—carbon dioxide; O₃—ozone.

, an example of the identification of control measures for chemical hazards in the spring water bottling stage is presented.

3.3.3. Control Plan

To effectively manage the act of detecting possible risks and their corresponding control measures, it is essential to implement a control plan. This plan should outline the following: the stage in the process (position within the system), the specific hazard being controlled, the control measures in place, the procedures governing these controls, the monitoring procedures, corrective actions and adjustments, the individual responsible for process verification, and the associated documentation.

In

Table 9. Establishing the control plan for the bottling step.

M Type	Risk	Procedures	CCP/PRPO Determination					Corrections/Corrective Actions	Responsibility	Registration
			Q1	Q2	Q3	Q4	Type
M1	-Contamination from substances (such as sanitizing substances) used within the same area.	PRP	yes	no	no	-	N/A	Product separation, remediation/destruction	Quality manager	Sanitation sheets
M2	-Contamination caused by workers and equipment; -CO2/O3 overdose.	PRP	yes	no	no	-	N/A	Product separation, remediation /destruction	Quality manager	Personnel control procedure/ form
M3	-Lack of awareness or failure to comply with work and sanitation guidelines and safety measures; -Unrevised work, sanitation standards, and prevention measures.	PRP, OP, work standards and prevention	yes	no	no	-	N/A	Testing, retraining	Quality manager	Training report
M4	-Contamination with substances (such as sanitizing agents) handled or stored in the area; -Use of impure or technical CO2/O3.	PRP, self-control program	yes	no	no	-	N/A	Product separation/destruction	Quality manager	Sanitation sheets, maintenance sheets
M5	-Contamination resulting from improperly maintained or sanitized equipment; -Failure to calibrate EMM.	PRP, EMM verification program	yes	no	no	-	N/A	Product separation, remediation /destruction	Quality manager	Sanitation sheets, maintenance sheets

Abbreviations: PRPO—operational prerequisite program; PRP—prerequisite program; OP—operational procedurel Q_1–4—the decision tree questions; EMM—measuring and monitoring equipment.

, the control plan corresponding to the CCP established for the stage related to the bottling of spring water is established.

Risk analysis helps us to identify hazards that may affect the food safety. As described in the IRF, they can have low or high to critical impact. Loss of control or improper monitoring of high or critical hazards can have severe impact on food safety and consequently on consumer health. Thus, in order to identify the steps in the flow that can generate high or critical hazards, and to monitor and mitigate them, the decision tree for establishing critical control points was coupled with the risk analysis.

The control plan is developed by the risk analysis manager together with the entire HACCP team, which is made up of designated persons from all structures involved in the flow of materials. All records resulting from the risk analysis and the establishment of the control plan must be kept and archived according to a “records control” procedure.

3.4. Discussions

IRF and HACCP are related because they both focus on food safety risk management, but IRF builds on and improves upon the HACCP framework in several ways (

Table 10. The connection between classical HACCP and IRF.

	Method	Classical HACCP	IRF
Factor
Risk identification		Basic: physical, chemical, biological	-Basic: physical, chemical, and biological risks; -Auxiliary, supporting the risk identification process: allergens, fraud/sabotage, Kosher/Halal, RASFF alerts; -Specific, related to particular conditions imposed by the ingredients and specific technological processes: irradiation, radioactivity, GMOs, PAHs, ASF, PPR, etc.
Risk analysis		Based on severity and the likelihood of occurrence of the hazard;	-Based on impact for each risk (as arithmetic mean of frequency and severity).
Risk level		each identified risk is assessed on three severity levels: low, medium, and high	-Each identified risk is assessed on four severity levels: low, medium, high, and critical.
Identifying the causes		Process flow analysis	-Ishikawa diagram is employed to systematically identify potential causes of a risk, categorized under the 5M framework: Man, Machine, Material, Method, and Environment.
Risk class calculation		RC = G × F (matrix from Table 1)	I = G + F/2; RC = (IMan +IMachine + IMaterial, +IMethod + IMedium)/5.

Abbreviations: GMOs—genetically modified organisms; PAHs—polycyclic aromatic hydrocarbons; ASF—African swine fever; PPR—peste of small ruminants; RC—risk class; G—severity; F—frequency; I—impact due to Man, Machine, Material, Method, and Environment.

). The foundation remains the HACCP principles, but IRF incorporates these principles, such as hazard identification, risk assessment, and the establishment of critical control points, ensuring that food safety remains a core objective.

In terms of scope, IRF extends it to include modern and emerging risks, such as allergens, fraud, radioactivity, and zoonotic diseases. It adapts the HACCP framework to accommodate a wider range of potential hazards.

IRF integrates enhanced analytical tools such as Ishikawa diagrams (5M methodology) to perform a deeper root cause analysis for each hazard. This is a refinement of HACCP’s general focus on hazard sources, providing more detailed insights into the cause of hazards.

For quantitative risk classification, IRF uses a structured, quantitative method to assess risks based on severity and probability and their impact, which is a more nuanced approach compared to the qualitative or semi-quantitative risk assessments of HACCP.

In terms of sustainability and ethical integration, unlike HACCP, IRF incorporates sustainability factors and ethical considerations, such as Kosher/Halal compliance and the Rapid Alert System for Food and Feed (RASFF). This aligns risk management with broader societal and environmental objectives.

IRF is a dynamic and adaptive methodology, designed to adapt to the specific technological processes and ingredients of an operation, while HACCP follows a more static, generalized approach.

IRF and HACCP are interconnected, with IRF serving as an advanced evolution of the HACCP framework. It retains the basic principles of HACCP but expands and refines them to address contemporary challenges in food safety, quality and sustainability.

The Integrated Risk Framework (IRF) methodology contributes to sustainable practices in the following ways:

1. By integrating Ishikawa diagrams with an enhanced HACCP system, the IRF provides a comprehensive approach to identifying, preventing, and mitigating risks in food production. It goes beyond traditional ISO 22000 standards by incorporating auxiliary and specific risks such as allergens, fraud/sabotage, irradiation, radioactivity, GMOs, and emerging diseases like African swine fever. This ensures that potential hazards are anticipated and addressed proactively, preventing food safety issues that could harm public health or the environment;

2. The IRF’s systematic risk investigation ensures that food products meet higher safety and quality standards, reducing waste from recalls or production failures. By minimizing errors and inefficiencies, it supports the sustainable use of resources;

3. The framework adapts to specific technological processes or ingredients, enabling it to tailor risk assessments to diverse food production environments. This adaptability ensures that sustainability measures are relevant and impactful across varying contexts;

4. Using the 5M Ishikawa diagram (Man, Method, Material, Machine, and Environment), the IRF identifies root causes for risks in each operational stage. This targeted approach promotes efficient corrective actions, improving resource management and reducing environmental impact;

5. By calculating the risk class, based on impact, IRF provides precise quantitative information on risk levels. This enables data-driven decision-making to prioritize actions that enhance sustainability;

6. The framework includes risks tied to sustainability, such as fraud/sabotage (e.g., mislabeling of eco-friendly or ethical products) and alerts from the Rapid Alert System for Food and Feed. This ensures that the methodology addresses not only food safety but also ethical and environmental concerns;

7. By incorporating risks like Kosher/Halal certification, the IRF supports adherence to ethical and cultural standards, contributing to inclusivity and trustworthiness. It also ensures compliance with international regulations, reducing the risk of non-compliance-related waste or reputational damage

8. By streamlining risk assessment and control measures across the production process, the IRF helps optimize resource use, minimize waste, and reduce energy consumption, all of which contribute to sustainable food production practices.

The IRF methodology aligns with sustainable practices by integrating comprehensive risk assessment tools, addressing diverse hazards, and emphasizing preventive measures. This not only ensures higher safety and quality but also supports the efficient, ethical, and environmentally conscious production of food.

3.5. A Prospective Outlook: Future Directions and Objectives

To further develop the methodology based on the principles of ISO 22000 and improved HACCP, correlated with the Ishikawa cause-and-effect diagram and for a sustainable development, we can explore the following directions:

1. Interpreting the relevance of the methodology for future research;

-Interdisciplinary approach and broad applicability: This methodology provides a solid foundation for future research in risk analysis in various industries, as it integrates both systematic risk analysis (HACCP and ISO 22000) and cause identification through a visual and detailed methodology (Ishikawa diagram). This facilitates its use in other fields, such as the pharmaceutical, medical, or automotive industries, where rigorous quality and safety control are essential;

-In-depth investigation of synergistic effects: This methodology allows for the exploration of complex interactions and synergistic effects, an area that is often not addressed in traditional risk assessment methods. Future research could use this approach to better examine the cumulative effects of risk factors and the interdependencies between them;

-Development of predictive models: Integrating this methodology with data analysis techniques and predictive models could help forecast risks before they actually occur. This direction is essential for research aimed at automating risk assessment and implementing proactive quality management systems.

2. Recommendations for improving the methodology;

-Integration with digital tools and real-time monitoring systems: To maximize the efficiency of the methodology, it would be useful to integrate it with process monitoring software that tracks critical indicators in real time and alerts in case of deviations from established limits. This could improve rapid response to emerging risks;

-Improving the capacity to quantify risks: Currently, the cause-and-effect diagram is a qualitative tool. Integration with quantitative risk analysis techniques (such as FMEA or impact and probability quantification methods) would allow for the numerical assessment of risks and their prioritization according to severity;

-Development of detailed guides for the use of the methodology: Developing a set of procedures and step-by-step guides for applying the methodology would facilitate its adoption by organizations across industries, providing more clarity and consistency in implementation.

3. Suggestions for using the methodology in other case studies;

-Pharmaceutical industry: The methodology can be applied to control risks in drug production processes, where quality and safety standards are very strict. The Ishikawa diagram, combined with HACCP, can help identify risks of contamination or process error and implement preventive measures;

-Automotive industry: In the production of automotive components, where quality and safety are crucial, the methodology can be used to analyze the risks associated with production defects and the interaction between production factors (equipment, materials, methods);

-Energy sector: In power plants, the methodology could be used to assess risks related to maintenance and operation, where the complex interaction between factors (equipment, personnel, environment) can have significant cumulative effects on performance and safety;

-Extended food industry (supply and distribution chains): In addition to production, the methodology can also be applied in logistics and distribution, where risks related to maintaining food quality and safety are possible. Assessing risks throughout the supply chain would help maintain food safety all the way to the final consumer.

By applying this expanded methodology, organizations can gain better understanding and control over risks, adapting more effectively to the requirements of each sector.

4. Conclusions

This paper introduces a novel risk assessment methodology, the Integrated Risk Framework (IRF), which combines Ishikawa diagrams with an enhanced HACCP system for a sustainable development. This innovative approach aims to elevate the quality and safety of water-related processes through the improved application of classic methods, providing strong intercorrelation capabilities.

The IRF methodology expands the ISO 22000 Food Safety Management System’s core risk categories—physical, chemical, and biological—to include additional auxiliary risks such as allergens, fraud/sabotage, Kosher/Halal standards, RASFF notifications, and specific risks like GMOs, irradiation, PAHs, ASF, and PPR. Each risk and cause within the process is evaluated based on the 5M framework—Man, Method, Material, Machine, and Environment—to determine severity and likelihood, ultimately yielding a risk class.

This method was applied to the spring water bottling process, providing a fresh perspective on risk dynamics through Ishikawa diagrams and HACCP principles. The results offer an enhanced approach to food and water safety by addressing cumulative or synergistic effects, leading to comprehensive risk control across production stages. The implementation of this complex risk assessment methodology through the application of Ishikawa diagrams in conjunction with the enhanced HACCP system involves the use of both physical, chemical, and biological risks in the bottled water industry (recommended by standards), but also the assessment extended to other risks identified in the industry such as allergens, fraud/sabotage, Kosher/Halal, RASFF, etc. This leads to more efficient results in risk assessment for the entire food safety management system.