ksb-d06-k0016

name	KSB-D06-K0016
description	Root Cause Analysis (RCA): Comprehensive methodology for identifying fundamental causes of serious errors...
version	1.0.0
domain	D06
domain_name	Medication Errors & Quality
type	Knowledge
proficiency_level	L1
bloom_level	remember
triggers	["explain root cause analysis (rca)","what is root cause analysis (rca)","define root cause analysis (rca)"]
epa_mapping	EPA-01, EPA-07, EPA-09
cpa_mapping	CPA-01, CPA-03
regulatory_refs	FDA-CFR-001, FDA-CFR-003, ICH-E2A, ICH-E2B(R3), ICH-E2D, EMA-GVP-003

KSB-D06-K0016: Root Cause Analysis (RCA)

Overview

Domain: D06 - Medication Errors & Quality Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Remember

Description

Comprehensive methodology for identifying fundamental causes of serious errors

Context

• Major Section: Comprehensive Medication Error Taxonomy and Classification
• Section: Systematic Investigation Frameworks

EPA Mapping

• EPA-01:3001-3003
• EPA-07:3016-3017
• EPA-09:3020-3022

CPA Pathway

• CPA-01, CPA-03

Regulatory References

• FDA-CFR-001
• FDA-CFR-003
• ICH-E2A
• ICH-E2B(R3)
• ICH-E2D
• EMA-GVP-003

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in root cause analysis (rca)
2. Apply remember level cognitive skills to define the topic
3. Reference relevant regulatory guidance (FDA-CFR-001, FDA-CFR-003, ICH-E2A, ICH-E2B(R3), ICH-E2D, EMA-GVP-003)
4. Connect to related EPAs: EPA-01, EPA-07, EPA-09

Key Competencies

• Comprehensive methodology for identifying fundamental causes of serious errors

Assessment Criteria

• Can define core concepts independently
• Demonstrates understanding of regulatory context
• Applies knowledge appropriately to PV scenarios

Related Skills

• Other D06 skills in Systematic Investigation Frameworks
• Cross-domain integrations per DAG architecture

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Generated from PV KSB Framework v1.0 | 2025-12-31