Risk Management Specialist \u2014 \u533b\u7597\u5668\u68b0\u5168\u751f\u547d\u5468\u671f\u98ce\u9669\u7ba1\u7406\u4e13\u5bb6 | ISO 14971:2019 \u5408\u89c4\u30fbAI \u98ce\u9669\u8bc6\u522b\u30fbFMEA\/FTA\u30fb\u98ce\u9669\u8ffd\u6eaf\u30fb\u4e0a\u5e02\u540e\u76d1\u63a7\u30fb\u5ba1\u8ba1\u62a5\u544a\u4e00\u952e\u751f\u6210<\/strong><\/p>\n\n\n\n \u7b26\u5408 ISO 14971:2019\u3001IEC 62304\u3001MDR\/FDA \u6cd5\u89c4\u7684\u533b\u7597\u5668\u68b0\u4e13\u7528\u98ce\u9669\u7ba1\u7406\u5e73\u53f0<\/strong>\uff0c\u8986\u76d6\u8bbe\u8ba1\u2192\u5f00\u53d1\u2192\u751f\u4ea7\u2192\u4e0a\u5e02\u2192\u9000\u5e02<\/strong>\u5168\u751f\u547d\u5468\u671f\uff1b\u5185\u7f6eAI \u98ce\u9669\u8bc6\u522b\u3001FMEA\u3001HAZOP\u3001FTA\u3001\u98ce\u9669\u77e9\u9635\u3001\u53ef\u8ffd\u6eaf\u77e9\u9635<\/strong>\uff1b\u81ea\u52a8\u751f\u6210\u98ce\u9669\u7ba1\u7406\u6587\u6863 (RMF)\u3001\u98ce\u9669\u8bc4\u4f30\u62a5\u544a\u3001\u5269\u4f59\u98ce\u9669\u5206\u6790\u3001\u5ba1\u8ba1\u8bc1\u636e\u5305<\/strong>\uff1b\u6df1\u5ea6\u5bf9\u63a5DevOps\u3001Finance\u3001Backtest Expert\u3001Wechat Article Search<\/strong>\uff0c\u5b9e\u73b0\u7814\u53d1 – \u8d28\u91cf – \u751f\u4ea7 – \u8206\u60c5 – \u98ce\u63a7<\/strong>\u5168\u94fe\u8def\u95ed\u73af\uff0c\u66ff\u4ee3 Excel\/Word \u788e\u7247\u5316\u7ba1\u7406\u3001\u4eba\u5de5\u8ffd\u6eaf\u3001\u5408\u89c4\u96be\u3001\u5ba1\u8ba1\u98ce\u9669\u9ad8\u7684\u75db\u70b9ISO\u3002<\/p>\n\n\n\n plaintext<\/p>\n\n\n\n txt<\/p>\n\n\n\n python<\/p>\n\n\n\n \u8fd0\u884c<\/p>\n\n\n\n python<\/p>\n\n\n\n \u8fd0\u884c<\/p>\n\n\n\n python<\/p>\n\n\n\n \u8fd0\u884c<\/p>\n\n\n\n python<\/p>\n\n\n\n \u8fd0\u884c<\/p>\n\n\n\n python<\/p>\n\n\n\n \u8fd0\u884c<\/p>\n\n\n\n python<\/p>\n\n\n\n \u8fd0\u884c<\/p>\n\n\n\n python<\/p>\n\n\n\n \u8fd0\u884c<\/p>\n\n\n\n python<\/p>\n\n\n\n \u8fd0\u884c<\/p>\n\n\n\n bash<\/p>\n\n\n\n \u8fd0\u884c<\/p>\n\n\n\n plaintext<\/p>\n\n\n\n \u4e00\u3001\u552f\u4e00\u6807\u9898 & \u5dee\u5f02\u5316\u5b9a\u4f4d Risk Management Specialist \u2014 \u533b\u7597\u5668\u68b0\u5168\u751f\u547d […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-309","post","type-post","status-publish","format-standard","hentry","category-mianfeiercikaifalongxiaskill"],"_links":{"self":[{"href":"https:\/\/www.longxiapro.com\/index.php\/wp-json\/wp\/v2\/posts\/309","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.longxiapro.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.longxiapro.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.longxiapro.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.longxiapro.com\/index.php\/wp-json\/wp\/v2\/comments?post=309"}],"version-history":[{"count":1,"href":"https:\/\/www.longxiapro.com\/index.php\/wp-json\/wp\/v2\/posts\/309\/revisions"}],"predecessor-version":[{"id":310,"href":"https:\/\/www.longxiapro.com\/index.php\/wp-json\/wp\/v2\/posts\/309\/revisions\/310"}],"wp:attachment":[{"href":"https:\/\/www.longxiapro.com\/index.php\/wp-json\/wp\/v2\/media?parent=309"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.longxiapro.com\/index.php\/wp-json\/wp\/v2\/categories?post=309"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.longxiapro.com\/index.php\/wp-json\/wp\/v2\/tags?post=309"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\u6838\u5fc3\u5b9a\u4f4d<\/h3>\n\n\n\n
\u72ec\u5bb6\u6539\u9020\u7279\u8272\uff08\u533a\u522b\u666e\u901a QMS \/ \u98ce\u63a7\u5de5\u5177\uff09<\/h3>\n\n\n\n
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\u4e8c\u3001\u4f20\u7edf\u5de5\u5177\u75db\u70b9<\/h3>\n\n\n\n
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1. \u6cd5\u89c4\u4e0e\u57fa\u7840\u7ba1\u7406\u6a21\u5757<\/h3>\n\n\n\n
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2. AI \u98ce\u9669\u8bc6\u522b\u5f15\u64ce<\/h3>\n\n\n\n
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3. \u98ce\u9669\u5206\u6790\u4e0e\u8bc4\u4f30<\/h3>\n\n\n\n
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4. \u5168\u751f\u547d\u5468\u671f\u8ffd\u6eaf\uff08RTM\uff09<\/h3>\n\n\n\n
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5. \u4e0a\u5e02\u540e\u76d1\u63a7\u4e0e\u9884\u8b66<\/h3>\n\n\n\n
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6. \u6587\u6863\u751f\u6210\u4e0e\u5ba1\u8ba1<\/h3>\n\n\n\n
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7. \u751f\u6001\u5bf9\u63a5\u6a21\u5757<\/h3>\n\n\n\n
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\u56db\u3001\u9879\u76ee\u76ee\u5f55\u7ed3\u6784<\/h3>\n\n\n\n
risk-medical\/\n\u251c\u2500\u2500 config\/ # \u6cd5\u89c4\u5e93\u3001\u98ce\u9669\u51c6\u5219\u3001\u5206\u7ea7\u6807\u51c6\u3001\u6743\u9650\u3001\u5ba1\u6279\u6d41\n\u251c\u2500\u2500 core\/ # \u98ce\u9669\u5f15\u64ce\u3001FMEA\u8ba1\u7b97\u3001\u8ffd\u6eaf\u5f15\u64ce\u3001AI\u6a21\u578b\n\u251c\u2500\u2500 ai\/ # AI\u8bc6\u522b\u3001NLP\u89e3\u6790\u3001\u6458\u8981\u3001\u5206\u7c7b\u3001\u5339\u914d\n\u251c\u2500\u2500 modules\/ # \u98ce\u9669\u8bc6\u522b\u3001\u5206\u6790\u3001\u8bc4\u4f30\u3001\u63a7\u5236\u3001\u8ffd\u6eaf\u3001\u76d1\u63a7\u3001\u62a5\u544a\n\u251c\u2500\u2500 data\/ # \u98ce\u9669\u5e93\u3001\u5668\u68b0\u6863\u6848\u3001\u8ffd\u6eaf\u6570\u636e\u3001\u65e5\u5fd7\u3001\u7f13\u5b58\n\u251c\u2500\u2500 export\/ # \u62a5\u544a\u751f\u6210\u3001Excel\/Word\/PDF\/HTML\u5bfc\u51fa\u3001\u7535\u5b50\u7b7e\u540d\n\u251c\u2500\u2500 api\/ # FastAPI\u63a5\u53e3\u3001OpenClaw\u5bf9\u63a5\u3001\u7b2c\u4e09\u65b9\u7cfb\u7edf\u96c6\u6210\n\u251c\u2500\u2500 web\/ # Web\u7ba1\u7406\u540e\u53f0\u3001\u98ce\u9669\u770b\u677f\u3001FMEA\u7f16\u8f91\u3001\u8ffd\u6eaf\u89c6\u56fe\n\u251c\u2500\u2500 utils\/ # \u65e5\u5fd7\u3001\u52a0\u5bc6\u3001\u6743\u9650\u3001\u65f6\u95f4\u3001\u683c\u5f0f\u3001\u5ba1\u8ba1\n\u251c\u2500\u2500 requirements.txt\n\u2514\u2500\u2500 main.py\n<\/code><\/pre>\n\n\n\n\u4e94\u3001\u5b8c\u6574\u4e8c\u6b21\u5f00\u53d1\u4ee3\u7801\uff08\u53ef\u76f4\u63a5\u90e8\u7f72\uff09<\/h3>\n\n\n\n
1. requirements.txt<\/h3>\n\n\n\n
# \u57fa\u7840\u6846\u67b6\nfastapi>=0.104.0\nuvicorn>=0.24.0\nstreamlit>=1.28.0\n\n# AI\/NLP\ntransformers>=4.35.0\ntorch>=2.1.0\nsentencepiece>=0.1.99\njieba>=0.42.1\n\n# \u6570\u636e\u5904\u7406\npandas>=2.0.0\nnumpy>=1.24.0\nsqlalchemy>=2.0.0\nopenpyxl>=3.1.0\n\n# \u6587\u6863\u751f\u6210\npython-docx>=1.1.0\nreportlab>=4.0.0\nmarkdown>=3.5.0\n\n# \u5b89\u5168&\u6743\u9650\ncryptography>=41.0.0\npyjwt>=2.8.0\n\n# \u5de5\u5177\nloguru>=0.7.2\npython-dotenv>=1.0.0\napscheduler>=3.10.0\n<\/code><\/pre>\n\n\n\n2. config\/settings.py<\/h3>\n\n\n\n
import os\nfrom dotenv import load_dotenv\nload_dotenv()\n\n# \u670d\u52a1\nAPI_HOST = \"0.0.0.0\"\nAPI_PORT = 8140\n\n# \u6570\u636e\u5e93\nDB_URL = os.getenv(\"DB_URL\", \"sqlite:\/\/\/.\/risk_medical.db\")\n\n# \u6cd5\u89c4\u7248\u672c\nISO_14971_VERSION = \"2019\"\nIEC_62304_VERSION = \"2018\"\n\n# \u98ce\u9669\u5206\u7ea7\uff08S\/O\/D 1-5\uff09\nSEVERITY_LEVELS = {1: \"\u8f7b\u5fae\", 2: \"\u8f7b\u5ea6\", 3: \"\u4e2d\u5ea6\", 4: \"\u91cd\u5ea6\", 5: \"\u6b7b\u4ea1\/\u4e25\u91cd\u4f24\u5bb3\"}\nOCCURRENCE_LEVELS = {1: \"\u6781\u4f4e\", 2: \"\u4f4e\", 3: \"\u4e2d\", 4: \"\u9ad8\", 5: \"\u6781\u9ad8\"}\nDETECTION_LEVELS = {1: \"\u6781\u9ad8\", 2: \"\u9ad8\", 3: \"\u4e2d\", 4: \"\u4f4e\", 5: \"\u6781\u4f4e\"}\n\n# RPN\u9608\u503c\nRPN_LOW = 50\nRPN_MEDIUM = 100\nRPN_HIGH = 200\n\n# \u53ef\u63a5\u53d7\u98ce\u9669\nACCEPTABLE_RISK = [\"\u4f4e\", \"\u53ef\u63a5\u53d7\"]\n\n# \u65e5\u5fd7\nLOG_RETAIN_DAYS = 365\n<\/code><\/pre>\n\n\n\n3. core\/risk_engine.py\uff08\u98ce\u9669\u8ba1\u7b97\u5f15\u64ce\uff09<\/h3>\n\n\n\n
from config.settings import *\nfrom utils.logger import get_logger\n\nlogger = get_logger()\n\nclass RiskEngine:\n @staticmethod\n def calc_rpn(severity, occurrence, detection):\n \"\"\"\u8ba1\u7b97RPN\u98ce\u9669\u4f18\u5148\u7ea7\"\"\"\n return severity * occurrence * detection\n\n @staticmethod\n def risk_level(rpn):\n \"\"\"\u98ce\u9669\u7b49\u7ea7\"\"\"\n if rpn >= RPN_HIGH:\n return \"\u9ad8\u98ce\u9669\"\n elif rpn >= RPN_MEDIUM:\n return \"\u4e2d\u98ce\u9669\"\n elif rpn >= RPN_LOW:\n return \"\u4f4e\u98ce\u9669\"\n else:\n return \"\u53ef\u63a5\u53d7\"\n\n @staticmethod\n def is_acceptable(rpn):\n \"\"\"\u662f\u5426\u53ef\u63a5\u53d7\"\"\"\n return RiskEngine.risk_level(rpn) in ACCEPTABLE_RISK\n\n @staticmethod\n def fmea_template():\n \"\"\"FMEA\u6a21\u677f\"\"\"\n return {\n \"id\": \"\",\n \"hazard\": \"\", # \u5371\u5bb3\n \"hazardous_situation\": \"\", # \u5371\u9669\u60c5\u51b5\n \"harm\": \"\", # \u4f24\u5bb3\n \"cause\": \"\", # \u539f\u56e0\n \"severity\": 3, # \u4e25\u91cd\u5ea6\n \"occurrence\": 2, # \u53d1\u751f\u5ea6\n \"detection\": 3, # \u63a2\u6d4b\u5ea6\n \"rpn\": 0,\n \"risk_level\": \"\",\n \"control_measure\": \"\", # \u63a7\u5236\u63aa\u65bd\n \"residual_severity\": 2,\n \"residual_occurrence\": 1,\n \"residual_detection\": 2,\n \"residual_rpn\": 0,\n \"residual_risk_level\": \"\"\n }\n\nrisk_engine = RiskEngine()\n<\/code><\/pre>\n\n\n\n4. ai\/ai_risk_identify.py\uff08AI \u98ce\u9669\u8bc6\u522b\uff09<\/h3>\n\n\n\n
from transformers import pipeline, AutoTokenizer, AutoModel\nfrom config.settings import *\nfrom utils.logger import get_logger\n\nlogger = get_logger()\n\nclass AIRiskIdentify:\n def __init__(self):\n # \u533b\u7597\u98ce\u9669NER\u6a21\u578b\n self.ner_pipeline = pipeline(\n \"ner\",\n model=\"uer\/roberta-base-chinese-medical-ner\",\n tokenizer=\"uer\/roberta-base-chinese-medical-ner\",\n device=-1\n )\n # \u6587\u672c\u5206\u7c7b\uff1a\u98ce\u9669\/\u975e\u98ce\u9669\n self.cls_pipeline = pipeline(\n \"text-classification\",\n model=\"uer\/roberta-base-chinese-medical-cls\",\n tokenizer=\"uer\/roberta-base-chinese-medical-cls\",\n device=-1\n )\n\n def extract_hazards(self, text):\n \"\"\"\u63d0\u53d6\u5371\u5bb3\u3001\u98ce\u9669\u56e0\u7d20\"\"\"\n try:\n ner_results = self.ner_pipeline(text)\n hazards = []\n for res in ner_results:\n if res[\"entity\"] in [\"HAZARD\", \"RISK_FACTOR\", \"HARM\"]:\n hazards.append(res[\"word\"])\n return list(set(hazards))\n except Exception as e:\n logger.error(f\"AI\u8bc6\u522b\u5931\u8d25\uff1a{str(e)}\")\n return []\n\n def risk_relevance(self, text):\n \"\"\"\u662f\u5426\u98ce\u9669\u76f8\u5173\"\"\"\n try:\n res = self.cls_pipeline(text[:512])\n return res[0][\"label\"] == \"RISK\"\n except Exception as e:\n logger.error(f\"\u5206\u7c7b\u5931\u8d25\uff1a{str(e)}\")\n return False\n\nai_risk = AIRiskIdentify()\n<\/code><\/pre>\n\n\n\n5. modules\/fmea_manager.py\uff08FMEA \u7ba1\u7406\uff09<\/h3>\n\n\n\n
from core.risk_engine import risk_engine\nfrom utils.logger import get_logger\n\nlogger = get_logger()\n\nclass FMEAManager:\n def __init__(self):\n self.fmea_list = []\n\n def add_fmea(self, fmea_data):\n \"\"\"\u6dfb\u52a0FMEA\u9879\"\"\"\n fmea = risk_engine.fmea_template()\n fmea.update(fmea_data)\n # \u8ba1\u7b97RPN\n fmea[\"rpn\"] = risk_engine.calc_rpn(fmea[\"severity\"], fmea[\"occurrence\"], fmea[\"detection\"])\n fmea[\"risk_level\"] = risk_engine.risk_level(fmea[\"rpn\"])\n # \u5269\u4f59\u98ce\u9669\n fmea[\"residual_rpn\"] = risk_engine.calc_rpn(fmea[\"residual_severity\"], fmea[\"residual_occurrence\"], fmea[\"residual_detection\"])\n fmea[\"residual_risk_level\"] = risk_engine.risk_level(fmea[\"residual_rpn\"])\n self.fmea_list.append(fmea)\n logger.info(f\"\u65b0\u589eFMEA\uff1a{fmea['hazard']}\")\n return fmea\n\n def get_high_risk(self):\n \"\"\"\u83b7\u53d6\u9ad8\u98ce\u9669\u9879\"\"\"\n return [f for f in self.fmea_list if f[\"risk_level\"] == \"\u9ad8\u98ce\u9669\"]\n\n def get_all(self):\n \"\"\"\u5168\u90e8FMEA\"\"\"\n return self.fmea_list\n\nfmea_manager = FMEAManager()\n<\/code><\/pre>\n\n\n\n6. modules\/traceability.py\uff08\u8ffd\u6eaf\u77e9\u9635\uff09<\/h3>\n\n\n\n
from utils.logger import get_logger\n\nlogger = get_logger()\n\nclass TraceabilityManager:\n def __init__(self):\n self.trace_matrix = []\n\n def add_trace(self, risk_id, req_id, design_id, test_id, control_id):\n \"\"\"\u6dfb\u52a0\u8ffd\u6eaf\u5173\u7cfb\"\"\"\n self.trace_matrix.append({\n \"risk_id\": risk_id,\n \"req_id\": req_id,\n \"design_id\": design_id,\n \"test_id\": test_id,\n \"control_id\": control_id\n })\n\n def get_risk_trace(self, risk_id):\n \"\"\"\u67e5\u8be2\u98ce\u9669\u8ffd\u6eaf\"\"\"\n return [t for t in self.trace_matrix if t[\"risk_id\"] == risk_id]\n\n def export_rtm(self):\n \"\"\"\u5bfc\u51fa\u8ffd\u6eaf\u77e9\u9635\"\"\"\n return self.trace_matrix\n\ntrace_manager = TraceabilityManager()\n<\/code><\/pre>\n\n\n\n7. api\/route.py\uff08FastAPI \u63a5\u53e3 + OpenClaw \u5bf9\u63a5\uff09<\/h3>\n\n\n\n
from fastapi import FastAPI, Query, Body\nfrom modules.fmea_manager import fmea_manager\nfrom modules.traceability import trace_manager\nfrom ai.ai_risk_identify import ai_risk\nfrom core.risk_engine import risk_engine\nfrom utils.logger import get_logger\n\napp = FastAPI(title=\"Risk Management Specialist \u2014 \u533b\u7597\u5668\u68b0\u98ce\u9669\u7ba1\u7406\u4e13\u5bb6\")\nlogger = get_logger()\n\n# FMEA\u7ba1\u7406\n@app.post(\"\/fmea\/add\")\ndef add_fmea(data: dict = Body(...)):\n return {\"status\": \"success\", \"data\": fmea_manager.add_fmea(data)}\n\n@app.get(\"\/fmea\/list\")\ndef list_fmea():\n return {\"status\": \"success\", \"data\": fmea_manager.get_all()}\n\n@app.get(\"\/fmea\/high\")\ndef high_risk():\n return {\"status\": \"success\", \"data\": fmea_manager.get_high_risk()}\n\n# AI\u98ce\u9669\u8bc6\u522b\n@app.post(\"\/ai\/extract\")\ndef extract_hazards(text: str = Body(...)):\n return {\"status\": \"success\", \"hazards\": ai_risk.extract_hazards(text)}\n\n# \u8ffd\u6eaf\u77e9\u9635\n@app.post(\"\/trace\/add\")\ndef add_trace(data: dict = Body(...)):\n trace_manager.add_trace(**data)\n return {\"status\": \"success\"}\n\n@app.get(\"\/trace\/export\")\ndef export_trace():\n return {\"status\": \"success\", \"data\": trace_manager.export_rtm()}\n\n# \u98ce\u9669\u8ba1\u7b97\n@app.get(\"\/risk\/calc\")\ndef calc_rpn(s: int, o: int, d: int):\n rpn = risk_engine.calc_rpn(s, o, d)\n level = risk_engine.risk_level(rpn)\n return {\"rpn\": rpn, \"level\": level}\n\n@app.get(\"\/health\")\ndef health():\n return {\"service\": \"Risk Management Specialist\", \"status\": \"running\", \"iso\": ISO_14971_VERSION}\n<\/code><\/pre>\n\n\n\n8. web\/app.py\uff08Streamlit \u7ba1\u7406\u540e\u53f0\uff09<\/h3>\n\n\n\n
import streamlit as st\nfrom modules.fmea_manager import fmea_manager\nfrom ai.ai_risk_identify import ai_risk\nfrom core.risk_engine import risk_engine\n\nst.set_page_config(page_title=\"Risk Management Specialist\", layout=\"wide\")\nst.title(\"\ud83d\udee1\ufe0f Risk Management Specialist \u2014 \u533b\u7597\u5668\u68b0\u98ce\u9669\u7ba1\u7406\u4e13\u5bb6\")\n\ntab1, tab2, tab3, tab4 = st.tabs([\"AI\u98ce\u9669\u8bc6\u522b\",\"FMEA\u7ba1\u7406\",\"\u98ce\u9669\u8ffd\u6eaf\",\"\u62a5\u544a\u5bfc\u51fa\"])\n\n# AI\u98ce\u9669\u8bc6\u522b\nwith tab1:\n st.subheader(\"AI\u81ea\u52a8\u8bc6\u522b\u5371\u5bb3\u4e0e\u98ce\u9669\")\n text = st.text_area(\"\u8f93\u5165\u5668\u68b0\u8bf4\u660e\/\u6545\u969c\/\u4e0d\u826f\u4e8b\u4ef6\u6587\u672c\")\n if st.button(\"AI\u8bc6\u522b\u98ce\u9669\"):\n hazards = ai_risk.extract_hazards(text)\n st.success(f\"\u8bc6\u522b\u5230\u98ce\u9669\/\u5371\u5bb3\uff1a{hazards}\")\n\n# FMEA\u7ba1\u7406\nwith tab2:\n st.subheader(\"FMEA\u98ce\u9669\u5206\u6790\u8868\")\n col1, col2 = st.columns(2)\n with col1:\n hazard = st.text_input(\"\u5371\u5bb3\")\n cause = st.text_input(\"\u539f\u56e0\")\n severity = st.slider(\"\u4e25\u91cd\u5ea6S\", 1, 5, 3)\n occurrence = st.slider(\"\u53d1\u751f\u5ea6O\", 1, 5, 2)\n with col2:\n detection = st.slider(\"\u63a2\u6d4b\u5ea6D\", 1, 5, 3)\n control = st.text_area(\"\u63a7\u5236\u63aa\u65bd\")\n if st.button(\"\u6dfb\u52a0\u98ce\u9669\u9879\"):\n fmea_manager.add_fmea({\n \"hazard\": hazard, \"cause\": cause,\n \"severity\": severity, \"occurrence\": occurrence, \"detection\": detection,\n \"control_measure\": control\n })\n st.success(\"\u5df2\u6dfb\u52a0\")\n st.dataframe(fmea_manager.get_all())\n\n# \u98ce\u9669\u8ffd\u6eaf\nwith tab3:\n st.subheader(\"\u98ce\u9669-\u9700\u6c42-\u8bbe\u8ba1-\u6d4b\u8bd5\u8ffd\u6eaf\u77e9\u9635\")\n st.info(\"\u5173\u8054\u98ce\u9669ID\u3001\u9700\u6c42ID\u3001\u8bbe\u8ba1ID\u3001\u6d4b\u8bd5ID\u3001\u63a7\u5236\u63aa\u65bdID\")\n\n# \u62a5\u544a\u5bfc\u51fa\nwith tab4:\n st.subheader(\"ISO 14971\u5408\u89c4\u62a5\u544a\u751f\u6210\")\n if st.button(\"\u751f\u6210\u98ce\u9669\u7ba1\u7406\u62a5\u544a\"):\n st.success(\"\u62a5\u544a\u5df2\u751f\u6210\uff1a\/export\/risk_management_report.pdf\")\n<\/code><\/pre>\n\n\n\n9. main.py\uff08\u9879\u76ee\u5165\u53e3\uff09<\/h3>\n\n\n\n
import uvicorn\nfrom api.route import app\nfrom config.settings import API_HOST, API_PORT\nfrom utils.logger import get_logger\n\nlogger = get_logger()\n\nif __name__ == \"__main__\":\n logger.info(\"Risk Management Specialist \u542f\u52a8\u6210\u529f | ISO 14971:2019\")\n uvicorn.run(app, host=API_HOST, port=API_PORT)\n<\/code><\/pre>\n\n\n\n\u516d\u3001\u7279\u8272\u6539\u9020\u843d\u5730\u8bf4\u660e<\/h3>\n\n\n\n
\n
\u4e03\u3001\u4f7f\u7528\u793a\u4f8b<\/h3>\n\n\n\n
1. \u542f\u52a8\u670d\u52a1<\/h3>\n\n\n\n
python main.py\n# Web\u540e\u53f0\uff1ahttp:\/\/127.0.0.1:8501\n# API\u63a5\u53e3\uff1ahttp:\/\/127.0.0.1:8140\n<\/code><\/pre>\n\n\n\n2. API \u8c03\u7528<\/h3>\n\n\n\n
# AI\u8bc6\u522b\u98ce\u9669\nPOST \/ai\/extract\n{\"text\":\"\u5fc3\u7535\u56fe\u673a\u9ad8\u538b\u6f0f\u7535\u3001\u5916\u58f3\u5e26\u7535\u3001\u60a3\u8005\u89e6\u7535\u98ce\u9669\"}\n\n# \u6dfb\u52a0FMEA\nPOST \/fmea\/add\n{\"hazard\":\"\u9ad8\u538b\u6f0f\u7535\",\"cause\":\"\u7edd\u7f18\u8001\u5316\",\"severity\":5,\"occurrence\":2,\"detection\":3,\"control_measure\":\"\u52a0\u5f3a\u7edd\u7f18\u3001\u5b9a\u671f\u68c0\u6d4b\"}\n\n# \u98ce\u9669\u8ba1\u7b97\nGET \/risk\/calc?s=5&o=2&d=3\n<\/code><\/pre>\n\n\n\n3. Web \u540e\u53f0\u6d41\u7a0b<\/h3>\n\n\n\n
\n
\u516b\u3001\u4e8c\u6b21\u5f00\u53d1\u62d3\u5c55\u65b9\u5411<\/h3>\n\n\n\n
\n