release: v0.20 Codex-ready skill-driven core
This commit is contained in:
kai
+455
-26
@@ -192,10 +192,10 @@ def write_material_brief(
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def _axis_prompt_brief(axis: str, method: ResearchMethod) -> str:
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prompts = {
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"input_material_findings": "从用户材料中提取现场事实、审计发现、复盘记录和内部答复，并标注原始材料位置。",
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"nmpa_fda_ema_ich_who_baseline": "把 NMPA、FDA、EMA、ICH、WHO、药典或 Annex 1 等要求转化为可核验的法规基线。",
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"quality_system_gap": "把现场发现映射到质量体系流程缺口，覆盖偏差、变更、CAPA、文件、培训和数据完整性。",
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"manufacturing_process_risk": "围绕生产工艺、设施、公用系统、CPP/CQA、验证和无菌保障识别系统性风险。",
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"operations_management_gap": "诊断运营管理、跨部门协同、会议机制、指标体系和交付节奏的结构性问题。",
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"nmpa_fda_ema_ich_who_baseline": "把 NMPA、FDA、EMA、ICH、WHO、药典或 Annex 1 等要求转化为可核验的法规基线，并纳入 FDA warning letters 与会议材料作为执法尺度参照。",
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"quality_system_gap": "把现场发现映射到质量体系流程缺口，覆盖偏差、变更、CAPA、文件、培训和数据完整性；优先检索 FDA warning letters 中同类缺陷的执法表述。",
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"manufacturing_process_risk": "围绕生产工艺、设施、公用系统、CPP/CQA、验证和无菌保障识别系统性风险，并用 FDA warning letters / inspection enforcement examples 校准严重度。",
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"operations_management_gap": "诊断运营管理、跨部门协同、会议机制、指标体系和交付节奏的结构性问题，并参考 FDA 会议纪要/meeting materials 中对质量治理的关注点。",
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"team_capability": "识别人员能力、岗位职责、质量文化和管理梯队方面的缺口与建设路径。",
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"capa_roadmap": "把差距转化为短中长期 CAPA 组合，要求绑定 owner、期限、优先级、关闭证据和复核机制。",
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"verification_evidence": "定义整改完成后可被审计接受的验证证据，包括记录、报告、趋势和管理评审输入。",
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@@ -213,13 +213,366 @@ def _material_paths(manifest: dict[str, Any]) -> list[dict[str, str]]:
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return materials
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def _keywords_from_title(title: str) -> list[str]:
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english = re.findall(r"[A-Za-z][A-Za-z0-9/+-]{1,}", title)
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chinese_parts = re.split(r"[，,、；;：:\s]+|和|与|及|的|在|为|从|来自|集中|决定|需要|形成|成为|不是|而是", title)
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domain_terms = [
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"审计",
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"商业化",
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"阶段门",
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"风险",
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"法规",
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"欧盟",
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"NMPA",
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"GMP",
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"ICH",
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"无菌",
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"RABS",
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"First Air",
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"APS",
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"灯检",
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"隧道",
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"原液",
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"WFI",
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"SCADA",
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"EMS",
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"CPP",
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"CQA",
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"PPQ",
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"清洁验证",
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"偏差",
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"变更",
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"CAPA",
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"数据完整性",
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"人员",
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"培训",
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"质量文化",
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"运营",
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"跨部门",
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"指标",
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"团队",
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"CDMO",
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"整改",
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"owner",
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]
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title_terms = [term for term in domain_terms if term in title]
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keywords = [item.strip() for item in [*english, *title_terms, *chinese_parts] if len(item.strip()) >= 2]
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seen: set[str] = set()
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unique: list[str] = []
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for keyword in keywords:
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if keyword not in seen:
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seen.add(keyword)
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unique.append(keyword)
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return unique[:12]
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def _material_lines_for_chapter(project_root: Path, manifest: dict[str, Any], title: str, *, limit: int = 4) -> list[str]:
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keywords = _keywords_from_title(title)
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candidates: list[tuple[int, int, str]] = []
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order = 0
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for item in manifest.get("material_inventory") or []:
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rel = item.get("ocr_extracted_to") or item.get("extracted_to")
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if not rel:
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continue
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path = project_root / rel
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if not path.exists():
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continue
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for raw in path.read_text(encoding="utf-8").splitlines():
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line = raw.strip()
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if len(line) < 8 or len(line) > 220:
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continue
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if line.startswith("#") or line.startswith("- source_path:") or line.startswith("- extracted_at:"):
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continue
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if "OCR Material:" in line:
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continue
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if re.match(r"^(审计对象|审计执行方|审计执行人|审计时间)[:：]", line):
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continue
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score = sum(1 for keyword in keywords if keyword and keyword in line)
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if score:
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order += 1
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candidates.append((score, order, f"{rel}：{line}"))
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candidates.sort(key=lambda item: (-item[0], item[1]))
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return [line for _, _, line in candidates[:limit]]
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def _minimum_evidence_for_method(method: ResearchMethod) -> dict[str, Any]:
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if method.key == "gmp_quality_operations_diagnosis":
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return {
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"local_material_quotes": 2,
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"official_regulatory_or_guideline_sources": 2,
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"enforcement_or_best_practice_precedents": 1,
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"counter_evidence_or_boundary_conditions": 1,
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"actionable_remediation_items": 3,
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}
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return {
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"high_quality_sources": 4,
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"tier_1_2_sources": 2,
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"counter_evidence_or_boundary_conditions": 1,
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"decision_relevant_implications": 2,
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}
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def _central_thesis(manifest: dict[str, Any], method: ResearchMethod) -> str:
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topic = manifest.get("topic") or manifest.get("report_title") or "本研究主题"
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if method.key == "gmp_quality_operations_diagnosis":
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return (
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f"初始主判断：{topic} 不应只按审计风险项数量来评价，而应从商业化 readiness、"
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"质量体系运行成熟度、生产工艺证据链和运营协同能力四条线同时诊断。Phase 2 必须用"
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"现场材料原文、官方法规/指南、执法案例或标杆实践来证明、修正或推翻这一判断。"
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)
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return (
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f"初始主判断：{topic} 需要先形成可被证据推翻的观点型框架，再由 Phase 2 按方法论证据线"
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"逐项求证；不能把并发检索结果直接堆砌成报告。"
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)
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def _strategy_for_chapter(title: str, method: ResearchMethod) -> dict[str, Any]:
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"""Return non-tautological Phase 1 strategy text for a chapter title."""
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if method.key != "gmp_quality_operations_diagnosis":
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return {
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"core_question": f"本章需要判断：在什么证据条件下“{title}”成立，它会怎样改变最终决策？",
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"bold_hypothesis": f"初始假设不是复述标题，而是预判“{title}”背后存在一个可被验证的因果机制；Phase 2 需要找证据支持、修正或推翻这个机制。",
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"writing_claim": f"本章要把“{title}”写成一个可被证据检验的判断，而不是资料综述。",
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"counter_evidence": [
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"是否存在更简单的替代解释，能削弱本章主判断？",
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"关键证据是否只来自单一来源或利益相关来源？",
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"是否有反例显示本章判断只适用于部分场景？",
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],
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}
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strategies = [
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(
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("审计", "阶段门"),
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{
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"core_question": "审计报告的低/中风险项计数，是否低估了白帆从临床/受托生产走向商业化标准时需要跨过的阶段门？",
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"bold_hypothesis": "初始假设：白帆的硬件和文件基础总体可用，但审计材料暴露的是商业化 readiness 缺口，而不是简单的若干孤立缺陷；Phase 2 应验证这些缺口是否集中在无菌保障、工艺验证、质量闭环和运营节奏。",
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"writing_claim": "本章要先把“风险项清单”翻译成管理层可决策的阶段门地图，说明哪些问题影响商业化放行、客户审计和技术转移节奏。",
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"counter_evidence": [
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"是否已有整改证据证明这些问题只是审计时点的临时缺口？",
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"低/中风险评级是否足以说明商业化阶段门影响有限？",
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"审计范围有限是否导致本章不能外推到整体体系成熟度？",
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],
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},
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),
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(
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("法规", "欧盟", "NMPA", "ICH"),
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{
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"core_question": "如果按 EU Annex 1、NMPA GMP、ICH Q9/Q10 以及 FDA 执法尺度校准，哪些现场发现的严重度和整改优先级会发生变化？",
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"bold_hypothesis": "初始假设：白帆按国内 GMP 逻辑已具备基础合规框架，但若以欧盟无菌标准和质量风险管理要求衡量，部分“低风险/建议项”会转化为体系成熟度缺口。",
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"writing_claim": "本章要建立后文共用的法规基线，避免整改优先级只跟随原审计评级，而忽略国际化和商业化标准。",
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"counter_evidence": [
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"相关国际标准是否并不适用于当前产品阶段或委托生产边界？",
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"NMPA 与欧盟/美国要求之间是否存在可接受差异？",
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"是否有企业内部标准已经覆盖但审计材料未呈现？",
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],
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},
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),
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(
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("无菌", "RABS", "First Air", "APS", "灯检"),
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{
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"core_question": "制剂线的主要无菌风险，是硬件布局不足，还是人员干预、首次气流保护、APS 覆盖和灯检标准执行证据不足？",
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"bold_hypothesis": "初始假设：白帆制剂车间硬件基础并非主要短板，真正风险在于关键无菌行为和模拟验证是否能持续证明受控；Phase 2 应重点查 First Air、RABS 干预、APS 场景设计和灯检阳性样品管理。",
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"writing_claim": "本章要把无菌保障从“设施看起来合规”推进到“关键操作和验证证据可被审计接受”。",
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"counter_evidence": [
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"现场是否已有完整视频复核、APS 覆盖和再培训有效性证据？",
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"观察到的无菌动作问题是否只是个别人员或单次拍摄偏差？",
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"灯检和 RABS 风险是否已有 SOP、趋势和复核记录闭环？",
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],
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},
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),
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(
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("原液", "WFI", "SCADA", "EMS"),
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{
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"core_question": "原液和公用系统的风险是否被一次性封闭工艺掩盖，真正缺口在 WFI、SCADA/EMS、离线记录和异常升级证据链？",
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"bold_hypothesis": "初始假设：一次性反应器和封闭转移降低了暴露风险，但不能自动证明系统受控；Phase 2 应验证 WFI 冷却回流、环境/压差报警、SCADA 数据和离线检测记录是否形成完整证据链。",
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"writing_claim": "本章要说明原液与公用系统不是“硬件先进即可”，而是要证明关键状态、报警、数据和异常处理持续受控。",
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"counter_evidence": [
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"WFI、SCADA/EMS 和离线记录是否已有验证报告与趋势复核？",
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"一次性系统是否已经充分降低共线和交叉污染风险？",
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"被指出的公用系统风险是否只是设计建议而非实际偏差？",
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],
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},
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),
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(
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("工艺", "CPP", "CQA", "PPQ", "清洁验证"),
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{
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"core_question": "现有 IND 阶段工艺规程和批记录，距离商业化 PPQ、控制策略和清洁验证所需证据还差在哪里？",
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"bold_hypothesis": "初始假设：白帆目前的工艺文件足以支撑临床阶段执行，但不足以支撑商业化批记录、CPP/CQA 控制、PPQ 和清洁验证闭环；Phase 2 应查明哪些字段、参数和验证证据必须前置补齐。",
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"writing_claim": "本章要把技术转移风险具体化为文件、参数、验证和批记录的硬门槛。",
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"counter_evidence": [
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"是否已有商业化模板、控制策略或 PPQ 草案未体现在审计材料中？",
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"当前项目阶段是否尚不需要完整商业化批记录要求？",
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"清洁验证和工艺验证是否已有主计划覆盖？",
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],
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},
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),
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(
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("偏差", "变更", "CAPA", "数据完整性"),
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{
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"core_question": "白帆的问题是没有质量流程，还是流程之间的事件分类、升级、CAPA 有效性和数据完整性尚未形成运行闭环？",
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"bold_hypothesis": "初始假设：白帆已有偏差、变更和 CAPA 的流程框架，但事件何时启动偏差、何时作为变更、如何证明 CAPA 有效，以及电子/纸质数据如何贯通，仍存在运行机制缺口。",
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"writing_claim": "本章要把质量体系从“有 SOP”推进到“事件能被正确分类、调查、纠正、验证并趋势复核”。",
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"counter_evidence": [
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"是否有趋势分析、管理评审和 CAPA effectiveness check 证明体系已经闭环？",
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"个别事件分类问题是否不足以代表体系性缺口？",
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"电子系统和纸质记录之间是否已有数据完整性控制？",
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],
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},
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),
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(
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("人员", "培训", "质量文化"),
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{
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"core_question": "培训记录齐全是否真的转化为一线无菌行为、偏差判断和质量风险意识？哪些证据能证明培训有效？",
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"bold_hypothesis": "初始假设：白帆不缺培训台账，缺的是把培训结果转化为现场行为的一致性证据；如果 First Air、干预动作、事件判断和灯检执行仍需反复提醒，问题就不是“再培训一次”，而是培训有效性确认和质量文化运行机制不足。",
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"writing_claim": "本章要把人员问题从“有没有培训”改写为“培训是否改变行为、降低风险、形成可复核证据”。",
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"counter_evidence": [
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"现场抽问、资格确认和再培训记录是否已证明人员理解到位？",
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"被观察到的行为问题是否只发生在少数岗位或单次演示？",
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"是否有岗位胜任力矩阵、年度复评和行为观察数据支撑人员能力？",
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],
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},
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),
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(
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("运营", "跨部门", "指标", "review"),
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{
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"core_question": "白帆当前整改和生产准备依赖个人推动，还是已经形成跨部门例会、问题升级、指标看板和管理层复核的运营系统？",
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"bold_hypothesis": "初始假设：运营短板不在于团队不努力，而在于缺少固定节奏和可视化管理系统；如果 owner、关闭证据、升级阈值和管理层 review 不稳定，整改会停留在临时协调，难以支撑商业化节奏。",
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"writing_claim": "本章要说明运营管理是 GMP 风险的放大器：没有节奏、看板和升级机制，技术和质量问题会反复跨部门漂移。",
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"counter_evidence": [
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||||
"是否已经存在稳定 PMO/例会/看板，只是未进入审计材料？",
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"短期临时协调是否足以覆盖当前项目阶段，不需要完整运营系统？",
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"owner、期限和关闭证据是否已经在复盘文件中基本清楚？",
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],
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},
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),
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||||
(
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||||
("团队", "CDMO", "能力矩阵"),
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||||
{
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||||
"core_question": "对标成熟 CDMO，白帆最需要补齐的是人数、岗位能力，还是 QA/MSAT/工程/项目管理之间的角色分工？",
|
||||
"bold_hypothesis": "初始假设：白帆的能力缺口不是简单扩编，而是商业化 CDMO 所需的角色矩阵尚未完全成型；Phase 2 应验证 QA 独立性、MSAT 工艺支持、工程保障、生产班组和 PMO 协同能力。",
|
||||
"writing_claim": "本章要给出面向商业化的团队能力地图，说明哪些能力必须自建，哪些可外部支持，哪些要通过机制补齐。",
|
||||
"counter_evidence": [
|
||||
"现有人员是否已具备商业化经验，只是材料未体现？",
|
||||
"对标 CDMO 是否会高估当前阶段所需组织复杂度？",
|
||||
"是否可通过顾问、外包或客户支持临时补足能力？",
|
||||
],
|
||||
},
|
||||
),
|
||||
(
|
||||
("整改", "owner", "路线图"),
|
||||
{
|
||||
"core_question": "哪些整改必须立即完成，哪些属于体系补强，哪些是能力建设？每项如何绑定 owner、关闭证据和复核窗口？",
|
||||
"bold_hypothesis": "初始假设：如果整改只按问题清单逐条关闭，会漏掉体系性根因；更有效的路线应分为立即纠偏、90 天体系补强和中长期能力建设三层，并为每层定义关闭证据。",
|
||||
"writing_claim": "本章要把诊断转化为可执行 CAPA 组合，而不是泛泛的改进建议。",
|
||||
"counter_evidence": [
|
||||
"是否已有整改计划足以覆盖 owner、期限、关闭证据和 QA verification？",
|
||||
"部分整改是否应前移或后移，避免资源过载？",
|
||||
"哪些建议若缺少法规证据，不应被列为强制整改？",
|
||||
],
|
||||
},
|
||||
),
|
||||
(
|
||||
("管理层", "CAPA", "总表"),
|
||||
{
|
||||
"core_question": "管理层应通过什么样的 CAPA 总表、法规映射表和复核节奏，持续判断整改是否真正降低风险？",
|
||||
"bold_hypothesis": "初始假设：白帆需要的不只是一次性报告，而是一套管理层可追踪的整改仪表盘；否则 CAPA 关闭会变成文件动作，无法证明风险趋势下降和商业化 readiness 提升。",
|
||||
"writing_claim": "本章要把报告成果固化成管理层治理工具：CAPA 总表、法规映射、证据包和复核节奏。",
|
||||
"counter_evidence": [
|
||||
"现有管理评审或质量例会是否已经能承担这个功能？",
|
||||
"过度表格化是否会增加一线负担而不改善风险？",
|
||||
"哪些指标真正能反映风险降低，而不是制造形式化 KPI？",
|
||||
],
|
||||
},
|
||||
),
|
||||
]
|
||||
for needles, strategy in strategies:
|
||||
if any(needle in title for needle in needles):
|
||||
return strategy
|
||||
return {
|
||||
"core_question": f"本章需要判断“{title}”背后的真实风险、适用边界和整改优先级。",
|
||||
"bold_hypothesis": f"初始假设：{title} 不是孤立问题，而是质量体系、工艺证据或运营机制中的一个可验证缺口；Phase 2 必须用材料原文和外部证据判断其严重度。",
|
||||
"writing_claim": f"本章要把“{title}”转化为可执行的诊断结论和整改要求。",
|
||||
"counter_evidence": [
|
||||
"该问题是否已有充分整改或验证证据？",
|
||||
"是否只是阶段性限制，而非系统性缺口？",
|
||||
"外部标准是否适用于当前业务边界？",
|
||||
],
|
||||
}
|
||||
|
||||
|
||||
def build_chapter_planning(
|
||||
project_root: Path,
|
||||
manifest: dict[str, Any],
|
||||
method: ResearchMethod,
|
||||
titles: list[str],
|
||||
*,
|
||||
quota: int,
|
||||
) -> list[dict[str, Any]]:
|
||||
"""Build hypothesis-driven chapter plans that become Phase 2 prompt context."""
|
||||
lanes = list(method.integrated_lanes or method.task_axes)
|
||||
minimum_evidence = _minimum_evidence_for_method(method)
|
||||
plans: list[dict[str, Any]] = []
|
||||
for idx, title in enumerate(titles, start=1):
|
||||
chapter_id = f"ch{idx:02d}"
|
||||
material_lines = _material_lines_for_chapter(project_root, manifest, title)
|
||||
if not material_lines:
|
||||
material_lines = ["未在材料中自动匹配到足够线索；Phase 2 必须先回读全部输入材料并补充原文摘录。"]
|
||||
strategy = _strategy_for_chapter(title, method)
|
||||
core_question = strategy["core_question"]
|
||||
bold_hypothesis = strategy["bold_hypothesis"]
|
||||
verification_plan = [
|
||||
"先从允许的本地材料提取 2-4 条原文证据，保留出处和上下文。",
|
||||
f"再按方法论 evidence lanes 求证：{'；'.join(lanes)}。",
|
||||
"每个核心判断至少匹配 2 个独立高质量来源；不足时降级为待验证判断。",
|
||||
"主动搜索反方证据、低严重度解释、适用范围限制或替代原因。",
|
||||
"输出时把证据、判断、整改/建议和待补证据分开，避免直接写成散文化正文。",
|
||||
]
|
||||
counter_evidence = strategy["counter_evidence"]
|
||||
writing_claim = strategy["writing_claim"]
|
||||
phase2_prompt_context = "\n".join(
|
||||
[
|
||||
f"章节：{chapter_id} {title}",
|
||||
core_question,
|
||||
bold_hypothesis,
|
||||
"材料起点：",
|
||||
*[f"- {line}" for line in material_lines],
|
||||
"求证路线：",
|
||||
*[f"- {item}" for item in verification_plan],
|
||||
"必须寻找的反方/边界：",
|
||||
*[f"- {item}" for item in counter_evidence],
|
||||
f"写作主张：{writing_claim}",
|
||||
f"最低证据要求：{json.dumps(minimum_evidence, ensure_ascii=False)}",
|
||||
]
|
||||
)
|
||||
plans.append(
|
||||
{
|
||||
"chapter_id": chapter_id,
|
||||
"title": title,
|
||||
"suggested_words": quota,
|
||||
"core_question": core_question,
|
||||
"bold_hypothesis": bold_hypothesis,
|
||||
"why_this_matters": "本章用于把 Phase1 的判断转化为 Phase2 可验证命题，并为最终报告保留清晰主线。",
|
||||
"material_starting_points": material_lines,
|
||||
"evidence_lanes": lanes,
|
||||
"verification_plan": verification_plan,
|
||||
"counter_evidence_to_seek": counter_evidence,
|
||||
"writing_claim": writing_claim,
|
||||
"minimum_evidence": minimum_evidence,
|
||||
"phase2_prompt_context": phase2_prompt_context,
|
||||
}
|
||||
)
|
||||
return plans
|
||||
|
||||
|
||||
def build_research_brief_payload(
|
||||
project_root: Path,
|
||||
manifest: dict[str, Any],
|
||||
method: ResearchMethod,
|
||||
chapter_planning: list[dict[str, Any]] | None = None,
|
||||
) -> dict[str, Any]:
|
||||
"""Create the file-backed Phase 1 research brief used by task-card generation."""
|
||||
axes = list(method.task_axes)
|
||||
chapter_planning = chapter_planning or []
|
||||
return {
|
||||
"version": "0.21-alpha",
|
||||
"topic": manifest.get("topic", project_root.name),
|
||||
@@ -228,6 +581,13 @@ def build_research_brief_payload(
|
||||
"work_language": "zh",
|
||||
"tone": "事实型、整改导向、面向管理层和质量/生产负责人；避免空泛咨询腔。",
|
||||
"central_question": f"如何基于已提供材料和权威法规/最佳实践，系统诊断“{manifest.get('topic', project_root.name)}”并形成可执行整改路线图？",
|
||||
"central_thesis": _central_thesis(manifest, method),
|
||||
"phase_logic": {
|
||||
"phase1": "大胆假设：结合输入材料、访谈信息和初步搜索，定下主基调、章节命题和求证路线。",
|
||||
"phase2": "小心求证：worker 只围绕 Phase1 命题收集、验证、证伪和补证，不自行重写研究方向。",
|
||||
"phase3": "一致性审校：检查 Phase1 假设与 Phase2 证据是否自洽，指出需要回炉的章节或证据缺口。",
|
||||
},
|
||||
"phase2_mode": "chapter_integrated",
|
||||
"success_criteria": [
|
||||
"每个核心判断都能回到用户材料、权威法规、最佳实践或反方证据。",
|
||||
"短中长期整改建议必须绑定优先级、责任、关闭证据和复核机制。",
|
||||
@@ -239,8 +599,10 @@ def build_research_brief_payload(
|
||||
"research_brief_path": "phase1/research_brief.json",
|
||||
},
|
||||
"materials": _material_paths(manifest),
|
||||
"chapter_planning": chapter_planning,
|
||||
"task_planning": {
|
||||
"chapter_source": "phase1/framework.md",
|
||||
"phase2_mode": "chapter_integrated",
|
||||
"axes": axes,
|
||||
"required_skills": [
|
||||
"deep-research",
|
||||
@@ -275,29 +637,62 @@ def write_research_brief(
|
||||
project_root: Path,
|
||||
manifest: dict[str, Any] | None = None,
|
||||
method: ResearchMethod | None = None,
|
||||
chapter_planning: list[dict[str, Any]] | None = None,
|
||||
) -> tuple[Path, Path]:
|
||||
manifest = manifest or load_manifest(project_root)
|
||||
method = method or ResearchMethodRegistry().get(manifest.get("research_method"))
|
||||
payload = build_research_brief_payload(project_root, manifest, method)
|
||||
payload = build_research_brief_payload(project_root, manifest, method, chapter_planning=chapter_planning)
|
||||
json_path = project_root / "phase1" / "research_brief.json"
|
||||
md_path = project_root / "phase1" / "research_brief.md"
|
||||
json_path.parent.mkdir(parents=True, exist_ok=True)
|
||||
hypothesis_path = project_root / "phase1" / "hypothesis_map.json"
|
||||
json_path.write_text(json.dumps(payload, ensure_ascii=False, indent=2) + "\n", encoding="utf-8")
|
||||
hypothesis_path.write_text(json.dumps(payload.get("chapter_planning") or [], ensure_ascii=False, indent=2) + "\n", encoding="utf-8")
|
||||
lines = [
|
||||
f"# Phase 1 Research Brief：{payload['topic']}",
|
||||
"",
|
||||
f"- research_method: {payload['research_method']}",
|
||||
f"- work_language: {payload['work_language']}",
|
||||
f"- tone: {payload['tone']}",
|
||||
f"- phase2_mode: {payload['phase2_mode']}",
|
||||
"",
|
||||
"## 中心问题",
|
||||
"",
|
||||
payload["central_question"],
|
||||
"",
|
||||
"## 成功标准",
|
||||
"## 主基调 / 大胆假设",
|
||||
"",
|
||||
payload["central_thesis"],
|
||||
"",
|
||||
"## Phase 逻辑",
|
||||
"",
|
||||
]
|
||||
for phase_name, phase_text in payload["phase_logic"].items():
|
||||
lines.append(f"- `{phase_name}`：{phase_text}")
|
||||
lines.extend([
|
||||
"",
|
||||
"## 成功标准",
|
||||
"",
|
||||
])
|
||||
lines.extend(f"- {item}" for item in payload["success_criteria"])
|
||||
if payload.get("chapter_planning"):
|
||||
lines.extend(["", "## 章节命题与求证计划", ""])
|
||||
for item in payload["chapter_planning"]:
|
||||
lines.extend(
|
||||
[
|
||||
f"### {item['chapter_id']} {item['title']}",
|
||||
"",
|
||||
f"- 核心问题：{item['core_question']}",
|
||||
f"- 大胆假设：{item['bold_hypothesis']}",
|
||||
f"- 写作主张：{item['writing_claim']}",
|
||||
f"- 证据线：{'；'.join(item['evidence_lanes'])}",
|
||||
"- 材料起点：",
|
||||
]
|
||||
)
|
||||
lines.extend(f" - {line}" for line in item["material_starting_points"])
|
||||
lines.extend(["- 求证计划："])
|
||||
lines.extend(f" - {line}" for line in item["verification_plan"])
|
||||
lines.extend([""])
|
||||
lines.extend(["", "## 任务切分原则", ""])
|
||||
planning = payload["task_planning"]
|
||||
lines.append(planning["fragmentation_guard"])
|
||||
@@ -377,30 +772,49 @@ CHAPTER_TEMPLATES: dict[str, list[str]] = {
|
||||
"落地机制决定咨询建议能否转化为成果",
|
||||
],
|
||||
"gmp_quality_operations_diagnosis": [
|
||||
"现场审计发现需要先转化为可验证的系统性问题图谱",
|
||||
"法规基线决定质量体系差距的严重度与整改边界",
|
||||
"生产工艺体系风险来自流程、设施、公用系统和验证证据的耦合缺口",
|
||||
"偏差、变更、CAPA 和数据完整性决定质量系统能否闭环",
|
||||
"人员能力与质量文化决定制度是否真正落地",
|
||||
"运营管理问题需要区分组织、流程、会议机制和指标体系缺口",
|
||||
"跨部门协同断点会放大 GMP 风险和交付风险",
|
||||
"标杆实践应转化为短中长期整改组合而非口号",
|
||||
"整改路线图必须绑定责任、优先级、证据和复核机制",
|
||||
"管理层治理机制决定白帆能否从一次整改转向持续改进",
|
||||
"从审计清单到商业化阶段门",
|
||||
"用法规基线重新校准整改优先级",
|
||||
"制剂无菌保障：从硬件合规到行为受控",
|
||||
"原液与公用系统：封闭工艺背后的证据缺口",
|
||||
"工艺文件与验证：商业化转移的硬门槛",
|
||||
"质量系统闭环：偏差、变更、CAPA 与数据完整性",
|
||||
"人员能力：培训有效性比培训记录更关键",
|
||||
"运营节奏：从临时协调转向管理系统",
|
||||
"团队建设：按 CDMO 能力矩阵补齐角色",
|
||||
"整改路线图：立即纠偏、体系补强、能力建设",
|
||||
"管理层看板：用 CAPA 总表驱动复核",
|
||||
],
|
||||
}
|
||||
|
||||
|
||||
def render_framework(project_root: Path, *, method_key: str | None = None, chapter_count: int = 10) -> Path:
|
||||
def _existing_chapter_titles(project_root: Path) -> list[str]:
|
||||
framework_path = project_root / "phase1" / "framework.md"
|
||||
if not framework_path.exists():
|
||||
return []
|
||||
from scripts.runtime.tasks import parse_framework_chapters
|
||||
|
||||
chapters = parse_framework_chapters(framework_path.read_text(encoding="utf-8"))
|
||||
return [chapter.title for chapter in chapters if chapter.title]
|
||||
|
||||
|
||||
def render_framework(
|
||||
project_root: Path,
|
||||
*,
|
||||
method_key: str | None = None,
|
||||
chapter_count: int = 10,
|
||||
preserve_existing_outline: bool = False,
|
||||
) -> Path:
|
||||
manifest = load_manifest(project_root)
|
||||
registry = ResearchMethodRegistry()
|
||||
method = registry.get(method_key or manifest.get("research_method"))
|
||||
if method_key:
|
||||
manifest["research_method"] = method.key
|
||||
titles = CHAPTER_TEMPLATES.get(method.key) or CHAPTER_TEMPLATES["mckinsey_market"]
|
||||
existing_titles = _existing_chapter_titles(project_root) if preserve_existing_outline else []
|
||||
titles = existing_titles or CHAPTER_TEMPLATES.get(method.key) or CHAPTER_TEMPLATES["mckinsey_market"]
|
||||
chapter_count = max(8, min(15, chapter_count))
|
||||
selected = titles[:chapter_count]
|
||||
selected = titles[:chapter_count] if not existing_titles else titles
|
||||
quota = max(800, int(manifest.get("target_words", 30000)) // len(selected))
|
||||
chapter_planning = build_chapter_planning(project_root, manifest, method, selected, quota=quota)
|
||||
sections = "\n".join(f"- {item}" for item in method.framework_sections)
|
||||
axes = "、".join(method.task_axes)
|
||||
material_text = render_material_inventory(manifest.get("material_inventory") or [])
|
||||
@@ -430,17 +844,32 @@ def render_framework(project_root: Path, *, method_key: str | None = None, chapt
|
||||
"",
|
||||
"## 中心假设",
|
||||
"",
|
||||
f"围绕“{manifest['topic']}”形成可被证据支持或证伪的中文主线；所有核心判断必须绑定来源 ID。",
|
||||
_central_thesis(manifest, method),
|
||||
"",
|
||||
"Phase1 的职责是大胆假设：基于材料、访谈和初步搜索定下主基调、章节命题和求证路线。Phase2 的职责是小心求证：验证、证伪、补证，而不是重新发明报告方向。Phase3 则检查 Phase1 假设与 Phase2 证据是否自洽。",
|
||||
"",
|
||||
]
|
||||
for idx, title in enumerate(selected, start=1):
|
||||
for item in chapter_planning:
|
||||
lines.extend(
|
||||
[
|
||||
f"## 第{idx}章 {title}",
|
||||
f"## 第{int(item['chapter_id'][2:])}章 {item['title']}",
|
||||
"",
|
||||
f"建议字数：约 {quota} 字。",
|
||||
f"研究思路：围绕 `{method.key}` 的方法框架，从 {axes} 等任务轴并发收集 evidence packet，再由 chapter assembly 收束为完整中文章节。",
|
||||
"证据要求：至少 2 个独立 Tier 1-2 信源；不足时在正文标注待验证；必须包含反方证据。",
|
||||
f"建议字数：约 {item['suggested_words']} 字。",
|
||||
f"本章要解决的问题：{item['core_question']}",
|
||||
f"大胆假设：{item['bold_hypothesis']}",
|
||||
f"写作主张：{item['writing_claim']}",
|
||||
f"证据线：{'；'.join(item['evidence_lanes'])}",
|
||||
"",
|
||||
"材料起点：",
|
||||
*[f"- {line}" for line in item["material_starting_points"]],
|
||||
"",
|
||||
"求证计划：",
|
||||
*[f"- {line}" for line in item["verification_plan"]],
|
||||
"",
|
||||
"必须寻找的反方/边界：",
|
||||
*[f"- {line}" for line in item["counter_evidence_to_seek"]],
|
||||
"",
|
||||
f"最低证据要求：`{json.dumps(item['minimum_evidence'], ensure_ascii=False)}`",
|
||||
"",
|
||||
]
|
||||
)
|
||||
@@ -457,7 +886,7 @@ def render_framework(project_root: Path, *, method_key: str | None = None, chapt
|
||||
out = project_root / "phase1" / "framework.md"
|
||||
out.parent.mkdir(parents=True, exist_ok=True)
|
||||
out.write_text("\n".join(lines), encoding="utf-8")
|
||||
research_brief_md, research_brief_json = write_research_brief(project_root, manifest, method)
|
||||
research_brief_md, research_brief_json = write_research_brief(project_root, manifest, method, chapter_planning=chapter_planning)
|
||||
manifest["phase1"] = {
|
||||
"status": "completed",
|
||||
"approved": False,
|
||||
|
||||
Reference in New Issue
Block a user