410 lines
19 KiB
TypeScript
410 lines
19 KiB
TypeScript
import type { AnalysisContext } from '../types/analysis'
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import { getAnalysisDefinition } from '../config/analysis-config'
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import {
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buildAeMonthlyByOccurrence,
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buildComplaintPareto,
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buildComplianceMatching,
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buildGlobalMonthlyPpm,
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buildInjuryDeviceMatrix,
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buildProvinceAeCounts,
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buildPsurTopProducts,
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buildReportingLagDays,
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buildSaeMonthlyByOccurrence,
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buildSaeShareMonthly,
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buildTopDeviceFailures,
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isSaeRecord,
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} from './aggregate'
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import {
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buildBatchComplaintVsAeCounts,
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buildComplaintBatchTop,
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buildComplaintCloseCycleDays,
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buildComplaintMonthly,
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buildCompensationDist,
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buildDefectConfirmedProductFault,
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buildFaultByRegisterMonthMatrix,
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buildHospitalAeVsAdmissionScatter,
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buildHospitalComplaintVsAdmissionQty,
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buildHospitalProductComplaintRate,
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buildInvestigationConclusionDist,
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buildIsAeRateByProduct,
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buildProductComplaintHalfYearGrowth,
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buildProvinceComplaintHalfYearGrowth,
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buildTopFaultTypes,
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buildTopHospitalsComplaints,
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buildTopProductsComplaints,
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} from './quality-aggregate'
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import {
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buildDealerComplaintRatePer1000,
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buildDealerOpWrongRatePer1000,
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buildOpWrongDealerCounts,
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buildOpWrongHospitalTop,
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buildProductOpWrongSharePct,
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buildProvinceComplaintCounts,
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buildProvinceComplaintRatePer1000,
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} from './marketing-aggregate'
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export type InsightDimension = '合规' | '质量' | '营销' | '事件实质'
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export interface InsightRow {
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dimension: InsightDimension
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pageTitle: string
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chartId: string
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chartTitle: string
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bullets: string[]
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}
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const PAGE_ORDER: { key: string; dimension: InsightDimension }[] = [
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{ key: 'compliance-psur', dimension: '合规' },
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{ key: 'compliance-audit', dimension: '合规' },
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{ key: 'quality-concentration', dimension: '质量' },
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{ key: 'quality-trends', dimension: '质量' },
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{ key: 'quality-complaint-sales', dimension: '质量' },
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{ key: 'quality-complaint-investigation', dimension: '质量' },
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{ key: 'quality-complaint-batch', dimension: '质量' },
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{ key: 'quality-ae-cause', dimension: '质量' },
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{ key: 'quality-ae-only', dimension: '质量' },
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{ key: 'quality-ae-with-complaint', dimension: '质量' },
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{ key: 'marketing-operation-training', dimension: '营销' },
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{ key: 'marketing-region-dealer', dimension: '营销' },
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{ key: 'substance-matrix', dimension: '事件实质' },
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{ key: 'substance-seasonality', dimension: '事件实质' },
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]
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function seriesPeak<T extends string | number>(labels: T[], values: number[], unit: string): string[] {
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if (!labels.length) return ['当前序列无有效数据点。']
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let maxI = 0
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let minI = 0
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for (let i = 1; i < values.length; i++) {
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if (values[i] > values[maxI]) maxI = i
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if (values[i] < values[minI]) minI = i
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}
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const sum = values.reduce((a, b) => a + b, 0)
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const avg = sum / values.length
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const bullets = [
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`统计范围内合计 ${sum}${unit}，覆盖 ${labels.length} 个序列点。`,
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`峰值出现在「${labels[maxI]}」（${values[maxI]}${unit}）；低谷为「${labels[minI]}」（${values[minI]}${unit}）。`,
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]
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if (values[maxI] > avg * 1.25) bullets.push('峰值明显高于均值，建议结合下钻维度核查是否存在集中爆发或外部因素。')
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else bullets.push('波动相对温和，可继续跟踪后续周期是否突破历史区间。')
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return bullets
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}
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type Builder = (ctx: AnalysisContext) => string[]
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const INSIGHTS: Record<string, Builder> = {
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'psur-monthly': (ctx) => {
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const t = buildAeMonthlyByOccurrence(ctx)
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return seriesPeak(t.months, t.values, ' 条 AE')
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},
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'psur-ppm': (ctx) => {
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const p = buildGlobalMonthlyPpm(ctx)
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const pairs = p.months.map((m, i) => ({ m, v: p.ppm[i] }))
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const valid = pairs.filter((x) => x.v != null) as { m: string; v: number }[]
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if (!valid.length) return ['多数月份缺少入院量分母，PPM 不可算；需检查入院数据覆盖。']
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const vals = valid.map((x) => x.v)
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const maxI = vals.indexOf(Math.max(...vals))
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return [
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`可计算 PPM 的月份共 ${valid.length} 个；最高 PPM 出现在 ${valid[maxI].m}（${valid[maxI].v}）。`,
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'PPM 同时受分子（AE 条数）与分母（CY Qty）波动影响，解读时需双因子对照。',
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]
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},
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'psur-device-top': (ctx) => {
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const top = buildTopDeviceFailures(ctx, 10)
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if (!top.labels.length) return ['暂无器械故障字段数据。']
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return [
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`报告条数最多的器械故障表现为「${top.labels[0]}」（${top.values[0]} 条）。`,
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`Top3 合计约占当期可分类故障的显著份额，适合作为 PSUR「常见原因」叙述抓手。`,
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]
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},
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'psur-product-top': (ctx) => {
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const t = buildPsurTopProducts(ctx)
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if (!t.labels.length) return ['暂无产品维度 AE。']
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return [`AE 条数最高的产品为「${t.labels[0]}」（${t.values[0]} 条）。`, '建议与投诉侧同产品趋势对照阅读，区分监管通道与市场通道信号。']
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},
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'psur-sae-monthly': (ctx) => {
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const s = buildSaeMonthlyByOccurrence(ctx)
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return seriesPeak(s.months, s.values, ' 条 SAE')
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},
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'psur-sae-share': (ctx) => {
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const s = buildSaeShareMonthly(ctx)
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const avg = s.shares.reduce((a, b) => a + b, 0) / s.shares.length
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const maxI = s.shares.indexOf(Math.max(...s.shares))
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return [
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`SAE 占全部 AE 比例月均约 ${avg.toFixed(1)}%。`,
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`占比峰值出现在 ${s.months[maxI]}（${s.shares[maxI]}%），需关注是否伴随总量上升（量率齐升）。`,
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]
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},
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'psur-province': (ctx) => {
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const p = buildProvinceAeCounts(ctx)
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if (!p.labels.length) return ['暂无省级 AE 分布。']
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return [
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`AE 报告条数最多的省份为「${p.labels[0]}」（${p.values[0]} 条）。`,
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'省级绝对量需结合人口与装机/入院暴露进一步做率化，再判「热区」。',
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]
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},
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'psur-lag-histogram': (ctx) => {
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const lags = buildReportingLagDays(ctx).filter((d) => d >= 0)
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if (!lags.length) return ['缺少可计算的滞后天数（审核日或登记日为空）。']
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const mean = lags.reduce((a, b) => a + b, 0) / lags.length
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const ok = lags.filter((d) => d <= 15).length
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return [
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`有效样本 ${lags.length} 条，上报滞后（审核−登记）均值约 ${mean.toFixed(1)} 天。`,
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`其中 ≤15 天约占 ${((ok / lags.length) * 100).toFixed(1)}%（演示阈值）。`,
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]
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},
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'audit-summary-bar': (ctx) => {
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const m = buildComplianceMatching(ctx)
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return [
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`应报样本（投诉标记不良事件）共 ${m.flaggedTotal} 条，疑似漏报率 ${m.leakRate}%，匹配率 ${m.matchRate}%。`,
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`匹配子集上，按登记与按 C3 起算的 ≤15 天占比分别为 ${m.timelinessFromRegistrationPct}% 与 ${m.timelinessFromC3Pct}%。`,
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]
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},
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'audit-counts-pie': (ctx) => {
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const m = buildComplianceMatching(ctx)
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return [`已匹配 ${m.matched} 条，疑似漏报 ${m.missed} 条。`, '饼图结构用于审计抽样框说明；漏报清单需进入逐条调查闭环。']
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},
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'quality-pareto-chart': (ctx) => {
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const p = buildComplaintPareto(ctx)
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if (!p.labels.length) return ['暂无产品×故障组合数据。']
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return [
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`贡献最大的组合为「${p.labels[0]}」（${p.bars[0]} 条投诉）。`,
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`Top 组合累计占比曲线末点约 ${p.line[p.line.length - 1]}%，可据此划定「80% 投诉池」优先改进范围。`,
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]
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},
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'quality-batch-chart': (ctx) => {
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const b = buildComplaintBatchTop(ctx, 8)
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if (!b.labels.length) return ['暂无批号信息。']
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return [`投诉集中度最高的批号为「${b.labels[0]}」（${b.values[0]} 条）。`, '建议对 Top 批号启动批次质量回溯并与 AE 批号对照。']
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},
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'quality-hospital-top': (ctx) => {
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const t = buildTopHospitalsComplaints(ctx, 8)
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return [`投诉条数最多的医院为「${t.labels[0]}」（${t.values[0]} 条）。`, '医院端集中可与培训、跟台及备件策略联动。']
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},
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'quality-product-fault-top': (ctx) => {
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const t = buildTopFaultTypes(ctx, 8)
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return [`频次最高的故障类型为「${t.labels[0]}」（${t.values[0]} 次）。`, '一维故障分布可与 Pareto 组合图交叉验证。']
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},
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'trend-monthly': (ctx) => {
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const t = buildComplaintMonthly(ctx)
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return seriesPeak(t.months, t.values, ' 条投诉')
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},
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'trend-product-half': (ctx) => {
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const g = buildProductComplaintHalfYearGrowth(ctx)
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return [
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`按上下半年对比，满足「增速≥20%」预警规则的产品共 ${g.length} 个（演示规则）。`,
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g.length ? `预警列表首项产品为「${g[0].product}」，建议结合 Pareto 与批号视图复核。` : '当前样本未触发产品增速预警，可结合更长窗口观察。',
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]
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},
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'trend-product-alert': (ctx) => {
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const g = buildProductComplaintHalfYearGrowth(ctx)
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return [
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g.length
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? `预警列表首位产品为「${g[0].product}」，建议优先安排工程/质量联合复盘。`
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: '未识别到达阈的增速异常产品（或样本不足）。',
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]
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},
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'trend-province-half': (ctx) => {
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const rows = buildProvinceComplaintHalfYearGrowth(ctx)
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const hit = rows.filter((r) => r.hit)
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return [
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`共统计 ${rows.length} 个省份上下半年投诉量。`,
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hit.length ? `其中 ${hit.length} 个省下半年相对上半年增幅≥20%，需关注区域侧原因。` : '未识别省级增速达阈信号。',
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]
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},
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'qc-sales-scatter': (ctx) => {
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const pts = buildHospitalComplaintVsAdmissionQty(ctx)
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const hi = [...pts].sort((a, b) => b.complaints - a.complaints)[0]
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return [
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`共 ${pts.length} 家医院同时具有投诉与入院量数据。`,
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hi ? `投诉条数最多的是「${hi.hospital}」（${hi.complaints} 条，cyQty 汇总 ${hi.cyQty}）。` : '',
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'散点偏离带可提示「相对入院量投诉偏多」的医院，需结合床位与产品结构复核。',
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].filter(Boolean)
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},
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'qc-sales-rate': (ctx) => {
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const rows = buildHospitalProductComplaintRate(ctx)
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const top = rows[0]
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if (!top) return ['暂无医院×产品投诉率数据。']
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return [
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`医院×产品维度投诉率（件/千件）最高为「${top.hospital} / ${top.product}」（${top.ratePer1000}）。`,
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'率化结果对入院量分母敏感，脚注需固定为 CY Qty 与对齐键版本。',
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]
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},
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'qc-inv-pie': (ctx) => {
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const d = buildInvestigationConclusionDist(ctx)
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const top = d[0]
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return top ? [`调查结论占比最高为「${top[0]}」（${top[1]} 条）。`, '结构变化适合按季度监控，识别「产品缺陷成立」是否抬升。'] : ['暂无调查结论数据。']
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},
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'qc-defect-bar': (ctx) => {
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const d = buildDefectConfirmedProductFault(ctx)
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return d.labels.length
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? [`「产品缺陷成立」场景下，最高频组合为「${d.labels[0]}」（${d.values[0]} 条）。`, '该池子应进入 CAPA/设计变更输入优先级队列。']
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: ['暂无产品缺陷成立记录。']
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},
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'qc-comp-pie': (ctx) => {
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const d = buildCompensationDist(ctx)
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const top = d[0]
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return top ? [`赔付方式占比最高为「${top[0]}」（${top[1]} 次）。`, '可与缺陷成立子集交叉，观察质量失败外显成本结构。'] : ['暂无赔付数据。']
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},
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'qc-product-top': (ctx) => {
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const t = buildTopProductsComplaints(ctx, 8)
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return [`投诉条数最多的产品为「${t.labels[0]}」（${t.values[0]} 条）。`, '与调查/赔付饼图联读可快速定位「问题产品」。']
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},
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'qc-batch-ae': (ctx) => {
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const rows = buildBatchComplaintVsAeCounts(ctx).filter((r) => r.complaints + r.aeReports > 0)
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if (!rows.length) return ['暂无可对照的批号双通道数据。']
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const top = [...rows].sort((a, b) => b.complaints + b.aeReports - (a.complaints + a.aeReports))[0]
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return [
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`批号「${top.batchNo}」投诉 ${top.complaints} 条、AE ${top.aeReports} 条，合计通道压力最大（演示口径）。`,
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'双通道同升批号应优先纳入监管沟通与质量联合调查。',
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]
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},
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'qc-close-cycle': (ctx) => {
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const days = buildComplaintCloseCycleDays(ctx)
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if (!days.length) return ['缺少关闭日期或登记日期，无法计算周期。']
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const mean = days.reduce((a, b) => a + b, 0) / days.length
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return [`投诉关闭周期（关闭−登记）均值约 ${mean.toFixed(1)} 天。`, '分布右尾偏长通常与补件、调查反复或跨部门协同有关。']
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},
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'ae-scatter-hosp': (ctx) => {
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const pts = buildHospitalAeVsAdmissionScatter(ctx)
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const hi = [...pts].sort((a, b) => b.aeCount - a.aeCount)[0]
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return [
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`共 ${pts.length} 家医院具备 AE 与入院量对照数据。`,
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hi ? `AE 条数最多的是「${hi.hospital}」（${hi.aeCount} 条）。` : '',
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'该图为报告行为异常筛查视角，不等同于医院医疗质量差。',
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].filter(Boolean)
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},
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'ae-upgrade-rate': (ctx) => {
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const rows = buildIsAeRateByProduct(ctx)
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const top = [...rows].sort((a, b) => b.ratePct - a.ratePct)[0]
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return top
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? [`升级率（是否不良事件=是）最高的产品为「${top.product}」（${top.ratePct}%）。`, '跨 BU 对比可反映上报文化与流程差异。']
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: ['暂无升级率数据。']
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},
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'ae-only-failure': (ctx) => {
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const top = buildTopDeviceFailures(ctx, 8)
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return [`未并发投诉的 AE 中，器械故障 Top1 为「${top.labels[0]}」。`, '用于理解「仅监管通道」事件形态。']
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},
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'ae-only-monthly': (ctx) => {
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const t = buildAeMonthlyByOccurrence(ctx)
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return [`AE 仅报告维度下，月度峰值仍在「${t.months[t.values.indexOf(Math.max(...t.values))]}」。`, '与投诉月度曲线对照时注意双时间轴。']
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},
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'ae-with-fault': (ctx) => {
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const sub = ctx.complaints.filter((c) => c.isAe)
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const m = new Map<string, number>()
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sub.forEach((c) => m.set(c.faultType, (m.get(c.faultType) ?? 0) + 1))
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const sorted = [...m.entries()].sort((a, b) => b[1] - a[1])
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return sorted.length
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? [`已升级投诉中最高频故障为「${sorted[0][0]}」。`, '可与 AE 伤害×故障矩阵叙事衔接。']
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: ['暂无已升级投诉。']
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},
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'ae-with-monthly': (ctx) => {
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const sub = ctx.complaints.filter((c) => c.isAe)
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return [`当前样本中已升级投诉共 ${sub.length} 条。`, '登记月趋势用于观察升级投诉是否与活动期/政策窗口重叠。']
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},
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'mkt-op-hospital': (ctx) => {
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const d = buildOpWrongHospitalTop(ctx, 14)
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return d.labels.length
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? [`操作不当投诉最多的医院为「${d.labels[0]}」（${d.values[0]} 条）。`, '适合作为院内操作培训与跟台加强的优先名单。']
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: ['无操作不当子集样本。']
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},
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'mkt-op-dealer-count': (ctx) => {
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const d = buildOpWrongDealerCounts(ctx, 14)
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return d.labels.length
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? [`操作不当投诉条数最多的经销商为「${d.labels[0]}」（${d.values[0]} 条）。`, '渠道侧可安排联合巡院与标准操作复核。']
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: ['无操作不当子集样本。']
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},
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'mkt-op-dealer-rate': (ctx) => {
|
||
const d = buildDealerOpWrongRatePer1000(ctx, 14)
|
||
return d.labels.length
|
||
? [`操作不当率（件/千件）最高的经销商为「${d.labels[0]}」（${d.values[0]}）。`, '率化结果提示相对销量下的使用风险，不等于经销商储运问题。']
|
||
: ['无法计算经销商操作不当率（分母或分子不足）。']
|
||
},
|
||
'mkt-op-product-share': (ctx) => {
|
||
const d = buildProductOpWrongSharePct(ctx, 12)
|
||
return d.labels.length
|
||
? [`操作不当占该产品全部投诉比例最高为「${d.labels[0]}」（${d.values[0]}%）。`, '说明书与数字化指导素材可优先迭代该产品。']
|
||
: ['无操作不当占比数据。']
|
||
},
|
||
'mkt-rg-province-rate': (ctx) => {
|
||
const d = buildProvinceComplaintRatePer1000(ctx, 16)
|
||
return d.labels.length
|
||
? [`省级投诉率（件/千件）最高为「${d.labels[0]}」（${d.values[0]}）。`, '需与绝对量图对照，避免大省误判。']
|
||
: ['暂无省级投诉率数据。']
|
||
},
|
||
'mkt-rg-dealer-rate': (ctx) => {
|
||
const d = buildDealerComplaintRatePer1000(ctx, 16)
|
||
return d.labels.length
|
||
? [`经销商维度投诉率（件/千件）最高为「${d.labels[0]}」（${d.values[0]}）。`, '可作为渠道辅导与考核的量化参考之一。']
|
||
: ['暂无经销商投诉率数据。']
|
||
},
|
||
'mkt-rg-province-count': (ctx) => {
|
||
const d = buildProvinceComplaintCounts(ctx, 14)
|
||
return d.labels.length
|
||
? [`省级投诉绝对量最高为「${d.labels[0]}」（${d.values[0]} 条）。`, '与省级率图并列阅读，区分总量大与相对率高。']
|
||
: ['暂无省级投诉分布。']
|
||
},
|
||
'matrix-all': (ctx) => {
|
||
const { cells } = buildInjuryDeviceMatrix(ctx, false)
|
||
if (!cells.length) return ['暂无伤害×故障交叉数据。']
|
||
const top = [...cells].sort((a, b) => b.value - a.value)[0]
|
||
return [
|
||
`全量 AE 下最高频组合为「${top.injury} × ${top.device}」（${top.value} 条）。`,
|
||
'热力图用于 CAPA 优先级与医学叙述，不等同因果结论。',
|
||
]
|
||
},
|
||
'matrix-sae': (ctx) => {
|
||
const rows = ctx.ae.filter((r) => isSaeRecord(r))
|
||
const { cells } = buildInjuryDeviceMatrix(ctx, true)
|
||
if (!cells.length) return ['SAE 子集下暂无有效组合。']
|
||
const top = [...cells].sort((a, b) => b.value - a.value)[0]
|
||
return [
|
||
`当前 SAE 子集共 ${rows.length} 条；最高频伤害-故障组合为「${top.injury} × ${top.device}」。`,
|
||
'建议与严重医学评审及对外沟通材料要点对齐。',
|
||
]
|
||
},
|
||
'seasonality-heatmap': (ctx) => {
|
||
const { cells } = buildFaultByRegisterMonthMatrix(ctx)
|
||
if (!cells.length) return ['暂无故障×月份数据。']
|
||
const top = [...cells].sort((a, b) => b.value - a.value)[0]
|
||
return [
|
||
`投诉侧「故障×登记月」强度最高单元为「${top.fault} / ${top.month}」（${top.value} 条）。`,
|
||
'探索性结论需结合气候/医院排班等外部变量再验证。',
|
||
]
|
||
},
|
||
'seasonality-monthly-total': (ctx) => {
|
||
const t = buildComplaintMonthly(ctx)
|
||
const maxI = t.values.indexOf(Math.max(...t.values))
|
||
return [`投诉总量峰值月份为 ${t.months[maxI]}（${t.values[maxI]} 条）。`, '与热力图行合计应对齐，用于读整体季节性背景。']
|
||
},
|
||
}
|
||
|
||
export function buildComprehensiveInsightRows(context: AnalysisContext): InsightRow[] {
|
||
const rows: InsightRow[] = []
|
||
for (const { key, dimension } of PAGE_ORDER) {
|
||
const def = getAnalysisDefinition(key)
|
||
if (!def) continue
|
||
for (const sec of def.sections) {
|
||
for (const chart of sec.charts) {
|
||
if (chart.placeholder) continue
|
||
if (!chart.optionBuilder) continue
|
||
const builder = INSIGHTS[chart.id]
|
||
const bullets = builder ? builder(context) : ['该图表已接入数据视图；结论规则尚未注册，可在 comprehensive-insights.ts 中补充。']
|
||
rows.push({
|
||
dimension,
|
||
pageTitle: def.title,
|
||
chartId: chart.id,
|
||
chartTitle: chart.title,
|
||
bullets,
|
||
})
|
||
}
|
||
}
|
||
}
|
||
return rows
|
||
}
|
||
|
||
export function groupInsightsByDimension(rows: InsightRow[]): Record<InsightDimension, InsightRow[]> {
|
||
const init: Record<InsightDimension, InsightRow[]> = { 合规: [], 质量: [], 营销: [], 事件实质: [] }
|
||
for (const r of rows) init[r.dimension].push(r)
|
||
return init
|
||
}
|