6.9.3.3風險和機遇的評審應形成包含但不限於以下方面的內容：a.風

6.9.3.3 The review of risks and opportunities shall be formed to include but not limited to the following aspects: <br>a. Risk assessment identification and evaluation form; <br>b. Risk response measures; <br>c. Opportunities for continuous improvement; <br>d. Product risks <br>e. Residual risks <br>6.10 The company needs to establish a communication mechanism between internal and external parties for risk management information, and communicate and feedback the results of self-inspection in a timely manner, so as to update process risks in a timely manner. <br>6.11 The results of process risk monitoring are included in the management review, and the company-level risk and opportunity list is updated. <br>6.12 Risk management of medical device products <br>6.12.1 During the design and development stage, the product department prepares a "risk management report" for each medical device product. <br>6.12.2 The "Risk Management Report" should be used as the input data of the design and passed to the person in charge of each project to implement the measures. <br>6.12.3 During the sample trial production process, the product department shall organize relevant units to verify the items listed in the "Risk Management Report" one by one to confirm the effectiveness of their control measures. <br>6.12.4 During the mass production stage, when there are engineering changes or design changes, the product department shall re-evaluate the "risk management report" and update it if necessary. <br><br>7. Relevant documents: <br>Internal and external environmental analysis management procedures of the company: QP-MR05 <br>FMEA management procedures: QP-MP02 <br>Production emergency response management procedures: QP-PP02 <br><br>8. Relevant forms: <br>Risk and opportunity identification assessment response measures form: F-RO01-001

6.9.3.3 The review of risks and opportunities shall result in content that includes, but is not limited to, the following:<br>a. Risk assessment identification and assessment forms;<br>Risk response measures;<br>c. Opportunities for continuous improvement;<br> d. Product risk.<br>e. Residual risk. <br>6.10 The Company shall establish a mechanism for communication between internal and external stakeholders for risk management information, and communicate feedback on the results of the self-examination in a timely manner in order to update the process risks in a timely manner.<br>6.11 The results of the process risk monitoring are incorporated into the management review and the update of the list of risks and opportunities at the corporate level is assessed.<br> 6.12 Risk management of medical device products.<br> 6.12.1 During the design and development phase, the Product Department prepares a "Risk Management Report" for each medical device product.<br>6.12.2 The Risk Management Report shall be transmitted as input data for the design to the project owners to implement the measures.<br>6.12.3 During sample testing, the Product Department shall organize the relevant units to verify the items listed in the Risk Management Report one by one to confirm the effectiveness of their control measures.<br>6.12.4 During the production phase, the Product Department shall re-evaluate the risk management report and, if necessary, update it in the event of an engineering or design change.<br><br>7. Related documents:<br>Internal and external environmental analysis management procedures: QP-MR05.<br>FMEA Manager: QP-MP02.<br>Production emergency management procedures: QP-PP02.<br><br>8. Related forms:<br>Risk Opportunity Identification Assessment Response Sheet: F-RO01-001.

6.9.3.3 the review of risks and opportunities shall include but not be limited to the following aspects:<br>a. Risk assessment identification and assessment form;<br>b. Risk response measures;<br>c. Opportunities for continuous improvement;<br>d. Product risk<br>e. Residual risk<br>6.10 the company shall establish a communication mechanism between internal and external interested parties for risk management information, and timely communicate and feedback the results of self inspection, so as to update the process risk in time.<br>6.11 the results of process risk monitoring are included in the management review, and the updating of risk and opportunity list at company level is evaluated.<br>6.12 risk management of medical device products<br>6.12.1 in the design and development stage, the product department shall prepare a "risk management report" for each medical device product.<br>6.12.2 the "risk management report" shall be delivered as the design input data to each project leader to implement the measures.<br>6.12.3 during the sample trial production process, the product department shall organize relevant units to verify the items listed in the "risk management report" one by one to confirm the effectiveness of the control measures.<br>6.12.4 during the mass production stage, in case of engineering change or design change, the product department shall re evaluate the "risk management report" and update it if necessary.<br>7. Related documents:<br>Internal and external environmental analysis management procedure: qp-mr05<br>FMEA management procedure: qp-mp02<br>Production emergency response management procedure: qp-pp02<br>8. Related forms:<br>Response measures for risk and opportunity identification and assessment: f-ro01-001<br>