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process-fmea-generator skill

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This skill generates PFMEA worksheets and control plans to identify process failures and guide risk reduction across manufacturing steps.

npx playbooks add skill a5c-ai/babysitter --skill process-fmea-generator

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SKILL.md

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---
name: process-fmea-generator
description: Process Failure Mode and Effects Analysis (PFMEA) skill for manufacturing risk assessment
allowed-tools:
  - Read
  - Write
  - Glob
  - Grep
  - Edit
  - Bash
metadata:
  specialization: biomedical-engineering
  domain: science
  category: Sterilization and Manufacturing
  skill-id: BME-SK-028
---

# 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

```yaml
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

Overview

This skill generates Process Failure Mode and Effects Analysis (PFMEA) outputs to support manufacturing risk assessment and control planning. It produces worksheets, control plans, SPC recommendations, and inspection points aligned with AIAG and ISO guidance. The skill helps teams turn process flows and data into prioritized risk mitigation actions.

How this skill works

Given a documented process flow, equipment details, quality requirements, and any historical data, the skill decomposes process steps, identifies potential failure modes by process type, and recommends detection and prevention controls. It calculates severity/occurrence/detection ratings, suggests SPC schemes, links process capability to risk, and exports PFMEA worksheets and control plans for follow-up. The output includes OOS/OOT handling steps and verification actions for risk reduction.

When to use it

During development or redesign of a manufacturing process to identify risks early
When creating or updating control plans and inspection procedures
Prior to process validation or transfer to production
To assess and prioritize failure modes for corrective actions
When integrating process risk into medical device or regulated product workflows

Best practices

Run PFMEA with a cross-functional team including engineering, quality, and operations
Start from an accurate process flow and include equipment and material specs
Link findings to design FMEA, control plans, and change management
Use historical defect and SPC data to inform occurrence and detection ratings
Update the PFMEA after process changes and verification activities

Example use cases

Create a PFMEA and control plan for a new injection-molding production line
Assess assembly station risks and define inspection points to reduce escapes
Develop SPC implementation and sampling plans for a machining cell
Define OOS/OOT procedures and containment for sterilization or cleaning steps
Prioritize corrective actions when incoming material variability affects yield

FAQ

What inputs are required to run the PFMEA?

A documented process flow, equipment and material specifications, quality requirements, and any available historical process or defect data.

Which standards does the skill follow?

Outputs are aligned with AIAG PFMEA practices and ISO 13485 expectations for manufacturing risk management.