Pilot Study Maps Four Food Protection Domains in a Taiwanese Ganoderma Plant

A small and medium-sized Ganoderma biotechnology food manufacturer in Taiwan has become the setting for a pilot study that attempts to do something most food safety research reserves for large multinational corporations: build and quantitatively test an integrated Food Protection Management System, or FPMS, inside a resource-constrained plant. The study, published in Food Science & Nutrition, combined four traditionally separate protective frameworks — food safety (HACCP), food quality (QACCP), food defense (TACCP) and food fraud prevention (VACCP) — with a quantitative survey of food safety culture among the plant’s entire workforce of 44 employees. The researchers describe the work as a pilot observational study, and they are careful to frame its findings as observational trends from a single case rather than causal proof.

The motivation behind the study lies in a gap the authors identify between academic theory and small-enterprise practice. International academic and industry organizations have increasingly advocated integrating HACCP, TACCP, VACCP and quality management into a comprehensive Food Protection Management System, and numerous scholars have emphasized that any advanced management framework, absent an organizational food safety culture serving as the foundation of daily behavior, risks becoming a mere formality. Yet the existing literature on integrating FPMS and food safety culture has predominantly emphasized macro-level theoretical discussions or the promotion of international policy guidelines within large multinational enterprises. For small and medium-sized food enterprises, which face constrained resources, budgets and technical personnel, the authors argue that there is limited scientific evidence on how these frameworks can be concretely localized, how consensus on hazard ratings can be achieved across multi-stage processes, and how quantitative performance validation can be conducted after implementation.

High-value fungal biotechnology foods such as Ganoderma, known as Lingzhi, occupy a distinctive position in this risk landscape. Owing to their rich content of bioactive constituents such as polysaccharides and triterpenoids, these products are characterized by high processing technology barriers and highly attractive market economic value. The combination of substantial profit margins and complex multinational supply chains, the study notes, renders them high-risk targets for food fraud and intentional food defense threats. Traditionally, management systems in food plants have focused primarily on preventing unintentional microbiological, physical or chemical contamination through the standard HACCP system, but the authors contend that a single protective system is no longer sufficient to safeguard the authenticity, compliance and safety of high-value biotechnology foods under today’s globalized threat landscape.

Methodologically, the hazard and vulnerability assessment across the four domains was not determined by a single external expert. Instead, a cross-departmental food safety team of five members — including representatives from quality assurance, production and manufacturing, warehousing and logistics, and senior management — independently scored hazards and vulnerabilities using a standardized scoring matrix based on the product of severity and likelihood of occurrence. The matrix was developed in accordance with the HACCP guidelines issued by the Codex Alimentarius Commission and internationally recognized standards for food defense and vulnerability assessment, such as PAS 96:2017. When discrepancies arose among members’ scores, multiple rounds of focus group discussions were convened, with repeated deliberation based on scientific literature, regulatory standards and objective historical data, until all team members reached consensus on the risk level for each process step.

The assessment spanned the complete manufacturing process of the Ganoderma product, from strain acceptance and liquid and solid-state culture sterilization through drying, filling and sealing, to inner packaging labeling. Within the food safety domain, the heat sterilization steps — liquid culture medium sterilization and solid culture medium sterilization — were identified as Critical Control Points, requiring heating at 121°C ± 1°C for more than 20 to 40 minutes to ensure effective microbial kill. Cooling and drying were classified as an Operational Prerequisite Program, with drying requiring 65°C ± 2°C for more than 24 hours and a moisture content below 7 percent, while metal detection was classified as a Critical Control Point, with checks set at 1.5 mm for ferrous metals, 2.0 mm for non-ferrous metals and 2.5 mm for stainless steel. Within the food quality domain, the packaging and labeling steps were identified as the core focus of quality control, emphasizing seal integrity and dosage precision in accordance with 6σ statistical quality control rules.

For intentional threats and food fraud vulnerabilities, the study took account of the specific characteristics of high-value Ganoderma products and identified solid medium inoculation and filling/sealing as high-threat nodes, and strain acceptance and inner labeling as high-vulnerability nodes. To prevent risks of strain adulteration, counterfeiting or unidentified sourcing, the control measures included confirming that strains were sourced from Taiwan’s authorized strain collection center, conducting molecular biological authentication, establishing a supplier contract review mechanism, and implementing mass balance audits and barcode traceability systems. The authors argue that these identification results demonstrate that in small and medium-sized biotechnology food plants, reliance on traditional HACCP alone is no longer sufficient to address intentional threats within modern, complex supply chains, and that a complete protective barrier can only be established through the coordinated integration of the four domains.

The quantitative organizational component of the study rested on a 20-item food safety culture self-assessment questionnaire, designed from an established FSC maturity model and scored on a 5-point Likert scale. All 44 employees were surveyed using a top-down assessment approach, and the questionnaire’s reliability analysis yielded a Cronbach’s α coefficient of 0.86, indicating excellent internal consistency. Each employee’s total score across the 20 items was averaged and mapped to five maturity levels, ranging from Level 1 (Extreme Lack of Awareness) to Level 5 (Excellent Safety Culture). The overall average score for all employees was 4.34 ± 0.65, corresponding to Level 4 (Good Awareness and Culture) of the maturity model defined in the study.

Perhaps the most statistically robust finding of the pilot concerns a perception gap between organizational tiers. An independent samples t-test comparing management levels showed that the average score of the managerial tier was 4.65 ± 0.48, significantly higher than the 4.30 ± 0.64 observed in the non-managerial tier, a difference that was statistically significant at p < 0.05. The authors interpret this as evidence that although foundational food safety and protection awareness had been successfully established during the initial phase of FPMS implementation, with means above 4.0, a significant perception gap remained between the management decision-making level and frontline operators. They suggest that in resource-constrained enterprises, senior management typically possesses a more profound understanding of regulatory compliance and system architecture, while abstract protection concepts such as VACCP and TACCP are often difficult to rapidly and fully cascade downward to become part of the daily intuition of frontline employees. The data, they argue, suggest that future system optimization should move beyond establishing system documentation and instead implement highly targeted and contextualized training programs for non-managerial staff.

Beyond the survey, the study tracked six operational key performance indicators over a six-month period, encompassing production quality, customer feedback, human resources and cultural maturity. The plant maintained a stable commercial production volume of approximately 3500 kg (dry basis) per month during the observation period. Against this baseline, the product defect rate exhibited a steady downward trend, which the authors associate with the strict implementation of CCPs and OPRPs; the customer complaint rate decreased progressively over time; and customer satisfaction, based on monthly feedback from a denominator of approximately 32 B2B clients, demonstrated positive growth. Employee turnover showed a declining trend, supervisor satisfaction with frontline operators displayed continuous upward progress, and the overall FSC maturity score progressively advanced over the six months, stabilizing at Level 4. The authors explicitly caution, however, that because this is a single pilot case study lacking an independent control group, and given that operational data may be susceptible to confounding variables such as seasonality or market fluctuations, the reported data should be strictly interpreted as observational trends rather than direct causal effects.

The limitations of the pilot are acknowledged in detail. The study was conducted within a single small-to-medium Ganoderma biotechnology facility in Taiwan, and because different food industry sectors vary substantially in supply chain complexity, process risk profiles and regulatory environments, the specific identification results and operational parameters cannot be directly generalized across all food manufacturing domains without contextual adaptation. Operational circumstances prevented the formation of a parallel independent control group, the observation period for preliminary KPIs was limited to six months, and the FSC survey was restricted to the plant’s total workforce of 44 employees, with only five in the managerial subgroup, which limits broader longitudinal and high-power causal inferences. The authors recommend multi-center comparative studies across small and medium-sized enterprises of varying operational scales and product categories, longitudinal studies spanning 12 to 24 months to track the dynamic evolution of FSC maturity, and the simplification of TACCP and VACCP assessment tools with intuitive, contextualized training modules for frontline employees. Within those constraints, the pilot offers a practical reference model combining four protection domains with quantitative cultural assessment for resource-constrained biotechnology food enterprises.

Subject of Research: Integration of four food protection domains and quantitative food safety culture assessment in a small and medium-sized Ganoderma biotechnology food plant in Taiwan

Article Title: Identifying the Four Critical Domains of the Food Protection Management System: A Pilot Study on Ganoderma Biotechnology Products

Article References: Tsai, S.-W., Liao, M.-J., Chao, S.-C., & Chen, H.-J. (2026). Identifying the Four Critical Domains of the Food Protection Management System: A Pilot Study on Ganoderma Biotechnology Products. Food Science & Nutrition, 14(10), Article e72510. https://doi.org/10.1002/fsn3.72510

Image Credits: AI Generated

DOI: 10.1002/fsn3.72510

Keywords: Food Protection Management System, HACCP, QACCP, TACCP, VACCP, food safety culture, Ganoderma, food fraud, food defense, small and medium-sized food enterprises, pilot study, Taiwan