Files
claude-skills-reference/ra-qm-team/capa-officer/scripts/root_cause_analyzer.py
sudabg 059f91f1a4 feat: add 5 production Python tools for RA/QM skills (#238)
Add comprehensive CLI tools for regulatory affairs and quality management:

1. regulatory-affairs-head/scripts/regulatory_pathway_analyzer.py
   - FDA/EU MDR/UK UKCA/Health Canada/TGA pathway analysis
   - Timeline & cost estimation, optimal submission sequence

2. capa-officer/scripts/root_cause_analyzer.py
   - 5-Why, Fishbone, Fault Tree analysis methods
   - Auto-generates CAPA recommendations

3. risk-management-specialist/scripts/fmea_analyzer.py
   - ISO 14971 / IEC 60812 compliant FMEA
   - RPN calculation, risk reduction strategies

4. quality-manager-qmr/scripts/quality_effectiveness_monitor.py
   - QMS metric tracking, trend analysis
   - Predictive alerts, management review summaries

5. quality-documentation-manager/scripts/document_version_control.py
   - Semantic versioning, change control
   - Electronic signatures, document matrix

All tools: argparse CLI, JSON I/O, demo mode, dataclasses, docstrings.

Closes #238
2026-03-13 22:26:03 +08:00

487 lines
17 KiB
Python

#!/usr/bin/env python3
"""
Root Cause Analyzer - Structured root cause analysis for CAPA investigations.
Supports multiple analysis methodologies:
- 5-Why Analysis
- Fishbone (Ishikawa) Diagram
- Fault Tree Analysis
- Kepner-Tregoe Problem Analysis
Generates structured root cause reports and CAPA recommendations.
Usage:
python root_cause_analyzer.py --method 5why --problem "High defect rate in assembly line"
python root_cause_analyzer.py --interactive
python root_cause_analyzer.py --data investigation.json --output json
"""
import argparse
import json
import sys
from dataclasses import dataclass, field, asdict
from typing import List, Dict, Optional
from enum import Enum
from datetime import datetime
class AnalysisMethod(Enum):
FIVE_WHY = "5-Why"
FISHBONE = "Fishbone"
FAULT_TREE = "Fault Tree"
KEPNER_TREGOE = "Kepner-Tregoe"
class RootCauseCategory(Enum):
MAN = "Man (People)"
MACHINE = "Machine (Equipment)"
MATERIAL = "Material"
METHOD = "Method (Process)"
MEASUREMENT = "Measurement"
ENVIRONMENT = "Environment"
MANAGEMENT = "Management (Policy)"
SOFTWARE = "Software/Data"
class SeverityLevel(Enum):
LOW = "Low"
MEDIUM = "Medium"
HIGH = "High"
CRITICAL = "Critical"
@dataclass
class WhyStep:
"""A single step in 5-Why analysis."""
level: int
question: str
answer: str
evidence: str = ""
verified: bool = False
@dataclass
class FishboneCause:
"""A cause in fishbone analysis."""
category: str
cause: str
sub_causes: List[str] = field(default_factory=list)
is_root: bool = False
evidence: str = ""
@dataclass
class FaultEvent:
"""An event in fault tree analysis."""
event_id: str
description: str
is_basic: bool = True # Basic events have no children
gate_type: str = "OR" # OR, AND
children: List[str] = field(default_factory=list)
probability: Optional[float] = None
@dataclass
class RootCauseFinding:
"""Identified root cause with evidence."""
cause_id: str
description: str
category: str
evidence: List[str] = field(default_factory=list)
contributing_factors: List[str] = field(default_factory=list)
systemic: bool = False # Whether it's a systemic vs. local issue
@dataclass
class CAPARecommendation:
"""Corrective or preventive action recommendation."""
action_id: str
action_type: str # "Corrective" or "Preventive"
description: str
addresses_cause: str # cause_id
priority: str
estimated_effort: str
responsible_role: str
effectiveness_criteria: List[str] = field(default_factory=list)
@dataclass
class RootCauseAnalysis:
"""Complete root cause analysis result."""
investigation_id: str
problem_statement: str
analysis_method: str
root_causes: List[RootCauseFinding]
recommendations: List[CAPARecommendation]
analysis_details: Dict
confidence_level: float
investigator_notes: List[str] = field(default_factory=list)
class RootCauseAnalyzer:
"""Performs structured root cause analysis."""
def __init__(self):
self.analysis_steps = []
self.findings = []
def analyze_5why(self, problem: str, whys: List[Dict] = None) -> Dict:
"""Perform 5-Why analysis."""
steps = []
if whys:
for i, w in enumerate(whys, 1):
steps.append(WhyStep(
level=i,
question=w.get("question", f"Why did this occur? (Level {i})"),
answer=w.get("answer", ""),
evidence=w.get("evidence", ""),
verified=w.get("verified", False)
))
# Analyze depth and quality
depth = len(steps)
has_root = any(
s.answer and ("system" in s.answer.lower() or "policy" in s.answer.lower() or "process" in s.answer.lower())
for s in steps
)
return {
"method": "5-Why Analysis",
"steps": [asdict(s) for s in steps],
"depth": depth,
"reached_systemic_cause": has_root,
"quality_score": min(100, depth * 20 + (20 if has_root else 0))
}
def analyze_fishbone(self, problem: str, causes: List[Dict] = None) -> Dict:
"""Perform fishbone (Ishikawa) analysis."""
categories = {}
fishbone_causes = []
if causes:
for c in causes:
cat = c.get("category", "Method")
cause = c.get("cause", "")
sub = c.get("sub_causes", [])
if cat not in categories:
categories[cat] = []
categories[cat].append({
"cause": cause,
"sub_causes": sub,
"is_root": c.get("is_root", False),
"evidence": c.get("evidence", "")
})
fishbone_causes.append(FishboneCause(
category=cat,
cause=cause,
sub_causes=sub,
is_root=c.get("is_root", False),
evidence=c.get("evidence", "")
))
root_causes = [fc for fc in fishbone_causes if fc.is_root]
return {
"method": "Fishbone (Ishikawa) Analysis",
"problem": problem,
"categories": categories,
"total_causes": len(fishbone_causes),
"root_causes_identified": len(root_causes),
"categories_covered": list(categories.keys()),
"recommended_categories": [c.value for c in RootCauseCategory],
"missing_categories": [c.value for c in RootCauseCategory if c.value.split(" (")[0] not in categories]
}
def analyze_fault_tree(self, top_event: str, events: List[Dict] = None) -> Dict:
"""Perform fault tree analysis."""
fault_events = {}
if events:
for e in events:
fault_events[e["event_id"]] = FaultEvent(
event_id=e["event_id"],
description=e.get("description", ""),
is_basic=e.get("is_basic", True),
gate_type=e.get("gate_type", "OR"),
children=e.get("children", []),
probability=e.get("probability")
)
# Find basic events (root causes)
basic_events = {eid: ev for eid, ev in fault_events.items() if ev.is_basic}
intermediate_events = {eid: ev for eid, ev in fault_events.items() if not ev.is_basic}
return {
"method": "Fault Tree Analysis",
"top_event": top_event,
"total_events": len(fault_events),
"basic_events": len(basic_events),
"intermediate_events": len(intermediate_events),
"basic_event_details": [asdict(e) for e in basic_events.values()],
"cut_sets": self._find_cut_sets(fault_events)
}
def _find_cut_sets(self, events: Dict[str, FaultEvent]) -> List[List[str]]:
"""Find minimal cut sets (combinations of basic events that cause top event)."""
# Simplified cut set analysis
cut_sets = []
for eid, event in events.items():
if not event.is_basic and event.gate_type == "AND":
cut_sets.append(event.children)
return cut_sets[:5] # Return top 5
def generate_recommendations(
self,
root_causes: List[RootCauseFinding],
problem: str
) -> List[CAPARecommendation]:
"""Generate CAPA recommendations based on root causes."""
recommendations = []
for i, cause in enumerate(root_causes, 1):
# Corrective action (fix the immediate cause)
recommendations.append(CAPARecommendation(
action_id=f"CA-{i:03d}",
action_type="Corrective",
description=f"Address immediate cause: {cause.description}",
addresses_cause=cause.cause_id,
priority=self._assess_priority(cause),
estimated_effort=self._estimate_effort(cause),
responsible_role=self._suggest_responsible(cause),
effectiveness_criteria=[
f"Elimination of {cause.description} confirmed by audit",
"No recurrence within 90 days",
"Metrics return to acceptable range"
]
))
# Preventive action (prevent recurrence in other areas)
if cause.systemic:
recommendations.append(CAPARecommendation(
action_id=f"PA-{i:03d}",
action_type="Preventive",
description=f"Systemic prevention: Update process/procedure to prevent similar issues",
addresses_cause=cause.cause_id,
priority="Medium",
estimated_effort="2-4 weeks",
responsible_role="Quality Manager",
effectiveness_criteria=[
"Updated procedure approved and implemented",
"Training completed for affected personnel",
"No similar issues in related processes within 6 months"
]
))
return recommendations
def _assess_priority(self, cause: RootCauseFinding) -> str:
if cause.systemic or "safety" in cause.description.lower():
return "High"
elif "quality" in cause.description.lower():
return "Medium"
return "Low"
def _estimate_effort(self, cause: RootCauseFinding) -> str:
if cause.systemic:
return "4-8 weeks"
elif len(cause.contributing_factors) > 3:
return "2-4 weeks"
return "1-2 weeks"
def _suggest_responsible(self, cause: RootCauseFinding) -> str:
category_roles = {
"Man": "Training Manager",
"Machine": "Engineering Manager",
"Material": "Supply Chain Manager",
"Method": "Process Owner",
"Measurement": "Quality Engineer",
"Environment": "Facilities Manager",
"Management": "Department Head",
"Software": "IT/Software Manager"
}
cat_key = cause.category.split(" (")[0] if "(" in cause.category else cause.category
return category_roles.get(cat_key, "Quality Manager")
def full_analysis(
self,
problem: str,
method: str = "5-Why",
analysis_data: Dict = None
) -> RootCauseAnalysis:
"""Perform complete root cause analysis."""
investigation_id = f"RCA-{datetime.now().strftime('%Y%m%d-%H%M')}"
analysis_details = {}
root_causes = []
if method == "5-Why" and analysis_data:
analysis_details = self.analyze_5why(problem, analysis_data.get("whys", []))
# Extract root cause from deepest why
steps = analysis_details.get("steps", [])
if steps:
last_step = steps[-1]
root_causes.append(RootCauseFinding(
cause_id="RC-001",
description=last_step.get("answer", "Unknown"),
category="Systemic",
evidence=[s.get("evidence", "") for s in steps if s.get("evidence")],
systemic=analysis_details.get("reached_systemic_cause", False)
))
elif method == "Fishbone" and analysis_data:
analysis_details = self.analyze_fishbone(problem, analysis_data.get("causes", []))
for i, cat in enumerate(analysis_data.get("causes", [])):
if cat.get("is_root"):
root_causes.append(RootCauseFinding(
cause_id=f"RC-{i+1:03d}",
description=cat.get("cause", ""),
category=cat.get("category", ""),
evidence=[cat.get("evidence", "")] if cat.get("evidence") else [],
sub_causes=cat.get("sub_causes", []),
systemic=True
))
recommendations = self.generate_recommendations(root_causes, problem)
# Confidence based on evidence and method
confidence = 0.7
if root_causes and any(rc.evidence for rc in root_causes):
confidence = 0.85
if len(root_causes) > 1:
confidence = min(0.95, confidence + 0.05)
return RootCauseAnalysis(
investigation_id=investigation_id,
problem_statement=problem,
analysis_method=method,
root_causes=root_causes,
recommendations=recommendations,
analysis_details=analysis_details,
confidence_level=confidence
)
def format_rca_text(rca: RootCauseAnalysis) -> str:
"""Format RCA report as text."""
lines = [
"=" * 70,
"ROOT CAUSE ANALYSIS REPORT",
"=" * 70,
f"Investigation ID: {rca.investigation_id}",
f"Analysis Method: {rca.analysis_method}",
f"Confidence Level: {rca.confidence_level:.0%}",
"",
"PROBLEM STATEMENT",
"-" * 40,
f" {rca.problem_statement}",
"",
"ROOT CAUSES IDENTIFIED",
"-" * 40,
]
for rc in rca.root_causes:
lines.extend([
f"",
f" [{rc.cause_id}] {rc.description}",
f" Category: {rc.category}",
f" Systemic: {'Yes' if rc.systemic else 'No'}",
])
if rc.evidence:
lines.append(f" Evidence:")
for ev in rc.evidence:
if ev:
lines.append(f"{ev}")
if rc.contributing_factors:
lines.append(f" Contributing Factors:")
for cf in rc.contributing_factors:
lines.append(f" - {cf}")
lines.extend([
"",
"RECOMMENDED ACTIONS",
"-" * 40,
])
for rec in rca.recommendations:
lines.extend([
f"",
f" [{rec.action_id}] {rec.action_type}: {rec.description}",
f" Priority: {rec.priority} | Effort: {rec.estimated_effort}",
f" Responsible: {rec.responsible_role}",
f" Effectiveness Criteria:",
])
for ec in rec.effectiveness_criteria:
lines.append(f"{ec}")
if "steps" in rca.analysis_details:
lines.extend([
"",
"5-WHY CHAIN",
"-" * 40,
])
for step in rca.analysis_details["steps"]:
lines.extend([
f"",
f" Why {step['level']}: {step['question']}",
f"{step['answer']}",
])
if step.get("evidence"):
lines.append(f" Evidence: {step['evidence']}")
lines.append("=" * 70)
return "\n".join(lines)
def main():
parser = argparse.ArgumentParser(description="Root Cause Analyzer for CAPA Investigations")
parser.add_argument("--problem", type=str, help="Problem statement")
parser.add_argument("--method", choices=["5why", "fishbone", "fault-tree", "kt"],
default="5why", help="Analysis method")
parser.add_argument("--data", type=str, help="JSON file with analysis data")
parser.add_argument("--output", choices=["text", "json"], default="text", help="Output format")
parser.add_argument("--interactive", action="store_true", help="Interactive mode")
args = parser.parse_args()
analyzer = RootCauseAnalyzer()
if args.data:
with open(args.data) as f:
data = json.load(f)
problem = data.get("problem", "Unknown problem")
method = data.get("method", "5-Why")
rca = analyzer.full_analysis(problem, method, data)
elif args.problem:
method_map = {"5why": "5-Why", "fishbone": "Fishbone", "fault-tree": "Fault Tree", "kt": "Kepner-Tregoe"}
rca = analyzer.full_analysis(args.problem, method_map.get(args.method, "5-Why"))
else:
# Demo
demo_data = {
"method": "5-Why",
"whys": [
{"question": "Why did the product fail inspection?", "answer": "Surface defect detected on 15% of units", "evidence": "QC inspection records"},
{"question": "Why did surface defects occur?", "answer": "Injection molding temperature was outside spec", "evidence": "Process monitoring data"},
{"question": "Why was temperature outside spec?", "answer": "Temperature controller calibration drift", "evidence": "Calibration log"},
{"question": "Why did calibration drift go undetected?", "answer": "No automated alert for drift, manual checks missed it", "evidence": "SOP review"},
{"question": "Why was there no automated alert?", "answer": "Process monitoring system lacks drift detection capability - systemic gap", "evidence": "System requirements review"}
]
}
rca = analyzer.full_analysis("High defect rate in injection molding process", "5-Why", demo_data)
if args.output == "json":
result = {
"investigation_id": rca.investigation_id,
"problem": rca.problem_statement,
"method": rca.analysis_method,
"root_causes": [asdict(rc) for rc in rca.root_causes],
"recommendations": [asdict(rec) for rec in rca.recommendations],
"analysis_details": rca.analysis_details,
"confidence": rca.confidence_level
}
print(json.dumps(result, indent=2, default=str))
else:
print(format_rca_text(rca))
if __name__ == "__main__":
main()