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

This pilot study investigated the implementation of an integrated Food Protection Management System and evaluated food safety culture maturity within a small-to-medium Ganoderma biotechnology facility in Taiwan. A systematic identification methodology spanning four critical domains, HACCP, QACCP, TACCP, and VACCP, was applied across 24 processing steps. Heat sterilization and metal detection were established as Critical Control Points for unintentional hazards. Concurrently, "solid medium inoculation (mixed)" and "filling/sealing," high-value "strain acceptance" and "inner labeling" were identified as high-threat and high-vulnerability nodes for intentional threats and food fraud, leading to mitigation strategies such as molecular biological authentication and mass balance auditing. To quantitatively evaluate organizational perceptions, a food safety culture survey was conducted among 44 employees using a 20-item scale (Cronbach's α = 0.86). The overall food safety culture maturity score reached 4.34 ± 0.65, corresponding to Level 4 (Good Awareness and Culture). An independent samples t-test revealed a statistically significant perception gap (p < 0.05) between managerial (4.65 ± 0.48) and non-managerial staff (4.30 ± 0.64). Furthermore, six-month tracking revealed positive observational trends in preliminary key performance indicators, including reduced product defect and customer complaint rates. This study offers a practical reference framework for resource-constrained biotechnology small and medium-sized food enterprises to integrate multi-domain protections and empirical food safety culture baselines to guide targeted employee training.