{ "schema_version": 2, "workflow_key": "rdev", "product_domains": [ "medical_device" ], "stages": [ { "key": "RD01_planning", "name": "01 设计和开发策划", "position": 10, "optional": false, "doc_tasks": [ { "key": "rd_proposal", "title": "项目建议书", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_proposal", "output_doc_type": "rd_proposal", "output_doc_title": "项目建议书" }, { "key": "rd_design_plan", "title": "设计开发计划任务书", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_design_plan", "output_doc_type": "rd_design_plan", "output_doc_title": "设计开发计划任务书" } ] }, { "key": "RD02_planning_review", "name": "02 策划评审", "position": 20, "optional": false, "doc_tasks": [ { "key": "rd_planning_review", "title": "设计和开发策划评审记录", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_planning_review", "output_doc_type": "rd_planning_review", "output_doc_title": "设计和开发策划评审记录" } ] }, { "key": "RD03_design_input", "name": "03 设计输入", "position": 30, "optional": false, "doc_tasks": [ { "key": "rd_user_needs", "title": "用户需求规格书", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_user_needs", "output_doc_type": "rd_user_needs", "output_doc_title": "用户需求规格书" }, { "key": "rd_regs_stds", "title": "法规和标准清单", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_regs_stds", "output_doc_type": "rd_regs_stds", "output_doc_title": "法规和标准清单" }, { "key": "rd_adverse_events", "title": "同类产品不良事件信息", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_adverse_events", "output_doc_type": "rd_adverse_events", "output_doc_title": "同类产品不良事件信息" }, { "key": "rd_system_reqs", "title": "系统需求规格书", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_system_reqs", "output_doc_type": "rd_system_reqs", "output_doc_title": "系统需求规格书" }, { "key": "rd_risk_plan", "title": "风险管理计划", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_risk_plan", "output_doc_type": "rd_risk_plan", "output_doc_title": "风险管理计划" }, { "key": "rd_hazard_analysis", "title": "安全性问题清单及可能危险分析表", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_hazard_analysis", "output_doc_type": "rd_hazard_analysis", "output_doc_title": "安全性问题清单及可能危险分析表" }, { "key": "rd_sw_plan", "title": "软件开发计划", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_sw_plan", "output_doc_type": "rd_sw_plan", "output_doc_title": "软件开发计划" }, { "key": "rd_sw_reqs", "title": "软件需求规格书", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_sw_reqs", "output_doc_type": "rd_sw_reqs", "output_doc_title": "软件需求规格书" }, { "key": "rd_sw_config", "title": "软件配置及维护计划", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_sw_config", "output_doc_type": "rd_sw_config", "output_doc_title": "软件配置及维护计划" }, { "key": "rd_design_input_spec", "title": "设计输入规格书", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_design_input_spec", "output_doc_type": "rd_design_input_spec", "output_doc_title": "设计输入规格书" }, { "key": "rd_design_input_list", "title": "设计输入清单", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_design_input_list", "output_doc_type": "rd_design_input_list", "output_doc_title": "设计输入清单" }, { "key": "rd_system_design", "title": "系统设计方案", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_system_design", "output_doc_type": "rd_system_design", "output_doc_title": "系统设计方案" } ] }, { "key": "RD04_requirements_review", "name": "04 需求评审", "position": 40, "optional": false, "doc_tasks": [ { "key": "rd_req_review", "title": "需求评审记录", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_req_review", "output_doc_type": "rd_req_review", "output_doc_title": "需求评审记录" } ] }, { "key": "RD05_input_phase_review", "name": "05 输入阶段评审", "position": 50, "optional": false, "doc_tasks": [ { "key": "rd_input_phase_review", "title": "设计开发评审记录(阶段3和4)", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_input_phase_review", "output_doc_type": "rd_input_phase_review", "output_doc_title": "设计开发评审记录(阶段3和4)" } ] }, { "key": "RD06_design_output", "name": "06 设计输出", "position": 60, "optional": false, "doc_tasks": [ { "key": "rd_drawings_3d", "title": "2D图纸和3D模型", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_drawings_3d", "output_doc_type": "rd_drawings_3d", "output_doc_title": "2D图纸和3D模型" }, { "key": "rd_product_bom", "title": "产品BOM", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_product_bom", "output_doc_type": "rd_product_bom", "output_doc_title": "产品BOM" }, { "key": "rd_ee_bom", "title": "电子电气BOM", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_ee_bom", "output_doc_type": "rd_ee_bom", "output_doc_title": "电子电气BOM" }, { "key": "rd_pcba", "title": "PCBA原理图及Layout", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_pcba", "output_doc_type": "rd_pcba", "output_doc_title": "PCBA原理图及Layout" }, { "key": "rd_electrical_sys", "title": "系统电气设计图", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_electrical_sys", "output_doc_type": "rd_electrical_sys", "output_doc_title": "系统电气设计图" }, { "key": "rd_sw_arch", "title": "软件概要设计方案", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_sw_arch", "output_doc_type": "rd_sw_arch", "output_doc_title": "软件概要设计方案" }, { "key": "rd_sw_ui", "title": "软件UI设计文档", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_sw_ui", "output_doc_type": "rd_sw_ui", "output_doc_title": "软件UI设计文档" }, { "key": "rd_purchase_spec", "title": "采购技术规范", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_purchase_spec", "output_doc_type": "rd_purchase_spec", "output_doc_title": "采购技术规范" }, { "key": "rd_process_flow", "title": "工艺流程图及作业指导", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_process_flow", "output_doc_type": "rd_process_flow", "output_doc_title": "工艺流程图及作业指导" }, { "key": "rd_packaging", "title": "包装图纸和设计要求", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_packaging", "output_doc_type": "rd_packaging", "output_doc_title": "包装图纸和设计要求" }, { "key": "rd_ifu", "title": "产品使用说明书", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_ifu", "output_doc_type": "rd_ifu", "output_doc_title": "产品使用说明书" }, { "key": "rd_incoming_iqc", "title": "原材料进货检验规范", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_incoming_iqc", "output_doc_type": "rd_incoming_iqc", "output_doc_title": "原材料进货检验规范" }, { "key": "rd_ipqc", "title": "生产过程检验规范", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_ipqc", "output_doc_type": "rd_ipqc", "output_doc_title": "生产过程检验规范" }, { "key": "rd_fqc", "title": "成品检验规范", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_fqc", "output_doc_type": "rd_fqc", "output_doc_title": "成品检验规范" }, { "key": "rd_tech_req", "title": "产品技术要求", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_tech_req", "output_doc_type": "rd_tech_req", "output_doc_title": "产品技术要求" }, { "key": "rd_risk_report", "title": "风险管理报告", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_risk_report", "output_doc_type": "rd_risk_report", "output_doc_title": "风险管理报告" }, { "key": "rd_design_output_list", "title": "设计输出清单", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_design_output_list", "output_doc_type": "rd_design_output_list", "output_doc_title": "设计输出清单" } ] }, { "key": "RD07_output_review", "name": "07 输出评审", "position": 70, "optional": false, "doc_tasks": [ { "key": "rd_output_review", "title": "设计开发评审记录(阶段6)", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_output_review", "output_doc_type": "rd_output_review", "output_doc_title": "设计开发评审记录(阶段6)" } ] }, { "key": "RD08_verification", "name": "08 验证", "position": 80, "optional": false, "doc_tasks": [ { "key": "rd_prototype_photos", "title": "样机照片", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_prototype_photos", "output_doc_type": "rd_prototype_photos", "output_doc_title": "样机照片" }, { "key": "rd_design_vv", "title": "设计验证方案", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_design_vv", "output_doc_type": "rd_design_vv", "output_doc_title": "设计验证方案" }, { "key": "rd_shelf_life", "title": "货架寿命方案", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_shelf_life", "output_doc_type": "rd_shelf_life", "output_doc_title": "货架寿命方案" }, { "key": "rd_lifetime", "title": "产品使用期限研究方案", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_lifetime", "output_doc_type": "rd_lifetime", "output_doc_title": "产品使用期限研究方案" }, { "key": "rd_biocompatibility", "title": "生物学检测方案", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_biocompatibility", "output_doc_type": "rd_biocompatibility", "output_doc_title": "生物学检测方案" }, { "key": "rd_cleaning", "title": "清洁消毒验证方案", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_cleaning", "output_doc_type": "rd_cleaning", "output_doc_title": "清洁消毒验证方案" }, { "key": "rd_emc_safety", "title": "EMC及安规摸底报告", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_emc_safety", "output_doc_type": "rd_emc_safety", "output_doc_title": "EMC及安规摸底报告" }, { "key": "rd_risk_report_v", "title": "风险管理报告(验证阶段)", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_risk_report_v", "output_doc_type": "rd_risk_report_v", "output_doc_title": "风险管理报告(验证阶段)" }, { "key": "rd_sw_release", "title": "软件发布清单", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_sw_release", "output_doc_type": "rd_sw_release", "output_doc_title": "软件发布清单" }, { "key": "rd_sw_unit_test", "title": "软件单元测试报告", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_sw_unit_test", "output_doc_type": "rd_sw_unit_test", "output_doc_title": "软件单元测试报告" }, { "key": "rd_sw_sys_test", "title": "软件系统测试报告", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_sw_sys_test", "output_doc_type": "rd_sw_sys_test", "output_doc_title": "软件系统测试报告" }, { "key": "rd_qualified_suppliers", "title": "合格供方名录", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_qualified_suppliers", "output_doc_type": "rd_qualified_suppliers", "output_doc_title": "合格供方名录" } ] }, { "key": "RD09_verification_review", "name": "09 验证评审", "position": 90, "optional": false, "doc_tasks": [ { "key": "rd_verification_review", "title": "设计开发评审记录(验证阶段)", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_verification_review", "output_doc_type": "rd_verification_review", "output_doc_title": "设计开发评审记录(验证阶段)" } ] }, { "key": "RD10_transfer", "name": "10 转换", "position": 100, "optional": false, "doc_tasks": [ { "key": "rd_dmr_list", "title": "DMR文件清单", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_dmr_list", "output_doc_type": "rd_dmr_list", "output_doc_title": "DMR文件清单" }, { "key": "rd_pack_ship", "title": "包装运输方案", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_pack_ship", "output_doc_type": "rd_pack_ship", "output_doc_title": "包装运输方案" }, { "key": "rd_risk_report_t", "title": "风险管理报告(转换阶段)", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_risk_report_t", "output_doc_type": "rd_risk_report_t", "output_doc_title": "风险管理报告(转换阶段)" } ] }, { "key": "RD11_transfer_review", "name": "11 转换评审", "position": 110, "optional": false, "doc_tasks": [ { "key": "rd_transfer_review", "title": "设计开发评审记录(转换阶段)", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_transfer_review", "output_doc_type": "rd_transfer_review", "output_doc_title": "设计开发评审记录(转换阶段)" } ] }, { "key": "RD12_validation", "name": "12 确认", "position": 120, "optional": false, "doc_tasks": [ { "key": "rd_validation_plan", "title": "设计确认方案", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_validation_plan", "output_doc_type": "rd_validation_plan", "output_doc_title": "设计确认方案" }, { "key": "rd_use_error", "title": "使用错误评估报告", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_use_error", "output_doc_type": "rd_use_error", "output_doc_title": "使用错误评估报告" }, { "key": "rd_animal_study", "title": "动物试验方案", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_animal_study", "output_doc_type": "rd_animal_study", "output_doc_title": "动物试验方案" }, { "key": "rd_sw_quality", "title": "软件质量测试报告", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_sw_quality", "output_doc_type": "rd_sw_quality", "output_doc_title": "软件质量测试报告" }, { "key": "rd_clinical", "title": "临床试验报告", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_clinical", "output_doc_type": "rd_clinical", "output_doc_title": "临床试验报告" }, { "key": "rd_risk_report_val", "title": "风险管理报告(确认阶段)", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_risk_report_val", "output_doc_type": "rd_risk_report_val", "output_doc_title": "风险管理报告(确认阶段)" }, { "key": "rd_user_test", "title": "用户测试报告", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_user_test", "output_doc_type": "rd_user_test", "output_doc_title": "用户测试报告" } ] }, { "key": "RD13_validation_report", "name": "13 设计确认报告", "position": 130, "optional": false, "doc_tasks": [ { "key": "rd_design_validation_report", "title": "设计确认报告", "default_enabled": true, "creator_configurable": true, "blocking_when_enabled": true, "executor_key": "squad.rdev_doc.v1", "quality_gate_key": "quality.generic.v1", "template_asset_key": "rd_design_validation_report", "output_doc_type": "rd_design_validation_report", "output_doc_title": "设计确认报告" } ] } ] }