By name: "KSB-D06-K0017" description: "Failure Mode and Effects Analysis (FMEA): Proactive analysis identifying potential failure points before errors occur..." version: "1.0.0" domain: "D06" domain_name: "Medication Errors & Quality" type: "Knowledge" proficiency_level: "L1" bloom_level: "remember" triggers: - "explain failure mode and effects analysis (fmea)" - "what is failure mode and effects analysis (fmea)" - "define failure mode and effects analysis (fmea)" 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-K0017: Failure Mode and Effects Analysis (FMEA)
Overview
Domain: D06 - Medication Errors & Quality Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Remember
Description
Proactive analysis identifying potential failure points before errors occur
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:
- Demonstrate L1 proficiency in failure mode and effects analysis (fmea)
- Apply remember level cognitive skills to define the topic
- Reference relevant regulatory guidance (FDA-CFR-001, FDA-CFR-003, ICH-E2A, ICH-E2B(R3), ICH-E2D, EMA-GVP-003)
- Connect to related EPAs: EPA-01, EPA-07, EPA-09
Key Competencies
- Proactive analysis identifying potential failure points before errors occur
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
Generated from PV KSB Framework v1.0 | 2025-12-31