Process fmea generator

Skill a5c-ai/babysitter/library/specializations/domains/science/biomedical-engineering/skills/process-fmea-generator

Process Failure Mode and Effects Analysis (PFMEA) skill for manufacturing risk assessmentFrom its SKILL.md

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npx -y skills add a5c-ai/babysitter --skill process-fmea-generator

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SKILL.md

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Process FMEA Generator Skill

Purpose

The Process FMEA Generator Skill supports manufacturing risk assessment through systematic Process FMEA methodology, identifying potential process failures and control measures per AIAG guidelines and ISO 13485.

Capabilities

PFMEA worksheet generation
Process step decomposition
Failure mode identification by process type
Control plan development
Statistical process control recommendations
Inspection point identification
OOS/OOT handling procedures
Process capability linkage
Detection method specification
Risk reduction verification
Control plan integration

Usage Guidelines

When to Use

Developing manufacturing processes
Assessing process risks
Designing control plans
Planning process validation

Prerequisites

Process flow documented
Equipment specifications available
Quality requirements defined
Historical process data accessible

Best Practices

Include cross-functional team
Link to design FMEA outputs
Integrate with control plans
Update with process changes

Process Integration

This skill integrates with the following processes:

Design for Manufacturing and Assembly (DFMA)
Sterilization Validation
Design Control Process Implementation
Medical Device Risk Management (ISO 14971)

Dependencies

AIAG PFMEA templates
ISO 13485 requirements
Process documentation
SPC tools
Control plan templates

Configuration

process-fmea-generator:
  process-types:
    - machining
    - molding
    - assembly
    - cleaning
    - packaging
    - sterilization
  rating-scales:
    severity: 1-10
    occurrence: 1-10
    detection: 1-10
  control-types:
    - prevention
    - detection

Output Artifacts

PFMEA worksheets
Process flow diagrams
Control plans
SPC implementation plans
Inspection procedures
OOS/OOT procedures
Action item tracking
Risk reduction verification

Quality Criteria

All process steps analyzed
Failure modes comprehensively identified
Controls address high-risk items
Detection methods effective
Control plans complete
Integration with design FMEA

What ships with it

Read from the repository

Just SKILL.md. No reference files, no scripts.