Infection control in healthcare facilities demands stringent environmental sanitation standards, including the application of antimicrobial wall surfaces to mitigate the risk of Healthcare-Associated Infections (HAIs). PT Sindotech Aditama, a small-to-medium manufacturing enterprise, is developing specialized antimicrobial paint for hospitals and clinics. However, the commercialization of this specialized chemical product involves substantial uncertainties, such as technical efficacy degradation, compliance with medical household product (PKRT) regulations, operational risks during application in sterile areas, and supply chain vulnerabilities for active biocidal agents. This study aims to formulate an integrated Risk Plan aligned with the company's strategic planning using an Enterprise Risk Management (ERM) framework based on ISO 31000. The analytical methodology involves identifying potential risk events, evaluating probabilities and consequences to establish the Risk Priority Number (RPN), and formulating structured risk treatment strategies. The resulting framework provides a comprehensive risk management architecture featuring a four-tier risk escalation protocol based on risk scores, a structured quarterly monitoring cycle, and formal recording and reporting mechanisms directed to executive leadership. Implementing this framework enables PT Sindotech Aditama to proactively mitigate operational and regulatory vulnerabilities, ensure compliance with healthcare standards, and achieve sustainable business growth across its five-year strategic trajectory.
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