Cold Chain QA Plugin

An AI-powered quality assurance plugin for pharmaceutical cold chain operations, primarily designed for Cowork — also compatible with Claude Code. Automates deviation investigation, excursion triage, root cause analysis, CAPA management, and regulatory compliance workflows — all configurable to your organization's product specifications, temperature tolerances, and regulatory requirements.

Disclaimer: This plugin assists with QA workflows but does not replace qualified quality assurance professionals. All analysis should be reviewed by qualified QA personnel before being used for regulatory decisions, product disposition, or batch release. AI-generated analysis is a starting point for investigation, not a final determination.

Target Personas

• QA Analyst -- Deviation investigation, excursion assessment, CAPA documentation
• QA Manager -- Deviation trending, CAPA effectiveness review, regulatory audit prep
• Supply Chain / Logistics -- Shipment monitoring, carrier qualification, lane risk assessment
• Regulatory Affairs -- Compliance documentation, audit response, deviation reporting

Installation

claude plugins add coldchain-qa

Quick Start

1. Install the plugin

claude plugins add coldchain-qa

2. Configure your QA playbook

Create a local settings file to define your organization's product specifications, temperature requirements, and investigation procedures.

In your project's .claude/ directory, create a coldchain.local.md file:

# Cold Chain QA Playbook Configuration

## Product Specifications

### Product A — mRNA Vaccine
- Storage requirement: -90°C to -60°C (ultra-cold)
- Transport requirement: -90°C to -60°C
- Maximum cumulative excursion time: 2 hours above -60°C
- Acceptable temporary range: -60°C to -20°C for up to 30 minutes (single event)
- Shelf life impact: Any excursion above -20°C requires stability assessment
- Regulatory classification: Biological product (FDA 21 CFR 600)

### Product B — Monoclonal Antibody
- Storage requirement: 2°C to 8°C (refrigerated)
- Transport requirement: 2°C to 8°C
- Maximum cumulative excursion time: 4 hours outside range per shipment
- Acceptable temporary range: 0°C to 15°C for up to 2 hours
- Freeze sensitivity: ANY exposure below 0°C triggers mandatory investigation
- Regulatory classification: Biological product (FDA 21 CFR 600)

### Product C — Small Molecule (Tablet)
- Storage requirement: 15°C to 25°C (controlled room temperature)
- Transport requirement: 15°C to 30°C (with MKT assessment)
- Maximum cumulative excursion time: 24 hours outside 15-25°C
- Mean Kinetic Temperature threshold: 25°C over shipment duration
- Regulatory classification: Drug product (FDA 21 CFR 211)

## Deviation Classification Thresholds

### Critical
- Product exposed to conditions known to cause degradation
- Temperature excursion exceeds validated stability limits
- Freeze event for freeze-sensitive biologics
- Loss of temperature monitoring data during transport
- Multiple excursion events on same shipment

### Major
- Temperature excursion outside specification but within extended stability data
- Single excursion event within cumulative time limits
- Monitoring device malfunction discovered post-shipment
- Carrier deviation from approved shipping lane

### Minor
- Brief excursion within acceptable temporary range
- Documentation gap with no product impact
- Single event within validated Mean Kinetic Temperature limits

## Investigation Procedures

### Required Documentation
- Temperature monitoring data (full chain of custody)
- Shipment records and carrier documentation
- Product stability data for the excursion conditions
- Environmental monitoring records (for storage deviations)
- Maintenance records (for equipment-related deviations)

### Escalation Triggers
- Any critical deviation: immediate QA Manager notification
- Potential patient safety impact: immediate Regulatory Affairs notification
- Recurring deviation (3+ events same root cause in 6 months): CAPA required
- Deviation affecting distributed product: market action assessment required

## CAPA Requirements
- Root cause must be identified using structured methodology (5-Why, Fishbone, or Fault Tree)
- Corrective actions must address root cause, not just symptoms
- Effectiveness check required 90 days after implementation
- CAPA closure requires evidence of effectiveness, not just completion of actions

3. Connect your tools

The plugin works best when connected to your existing tools via MCP. See CONNECTORS.md for supported integrations.

Commands

/investigate-deviation — Deviation Investigation

Conduct a structured investigation of a temperature deviation event. Guides you through data collection, classification, root cause analysis, and documentation.

/investigate-deviation

Accepts: temperature data files, monitoring reports, shipment records, or pasted data. Will ask for context (product, shipment, timeline) and guide you through a full investigation workflow.

/triage-excursion — Excursion Pre-Screening

Rapid triage of a temperature excursion event. Classifies severity and determines whether the event requires full investigation or can be dispositioned with minimal review.

/triage-excursion

/root-cause — Root Cause Analysis

Guided root cause analysis using structured methodologies (5-Why, Fishbone/Ishikawa, Fault Tree). Helps identify systemic causes rather than surface-level explanations.

/root-cause

/brief — QA Briefing

Generate contextual briefings for QA operations.

/brief daily              # Morning brief: open deviations, pending CAPAs, upcoming audits
/brief deviation-trend    # Trending analysis of recent deviations
/brief audit-prep         # Prepare for an upcoming regulatory audit

/generate-capa — CAPA Generation

Generate a CAPA document from investigation findings. Includes root cause, corrective actions, preventive actions, effectiveness criteria, and timeline.

/generate-capa

Skills

Skill	Description
deviation-classification	Playbook-based deviation severity assessment, product impact evaluation, disposition recommendations
excursion-triage	Temperature excursion screening criteria, MKT calculation guidance, quick classification rules
regulatory-framework	FDA, WHO, EU GDP, ICH Q1A/Q7 guidelines knowledge, compliance requirements
risk-assessment	Severity-by-likelihood framework, patient safety impact assessment, product quality risk evaluation
capa-management	CAPA lifecycle best practices, root cause methodology, effectiveness verification criteria
cold-chain-fundamentals	Core domain knowledge: temperature-sensitive product types, monitoring technologies, shipping lane qualification, stability science basics

Example Workflows

Excursion Investigation

1. Receive temperature alarm notification from monitoring system
2. Run /triage-excursion with the temperature data
3. Get instant classification: GREEN (no impact, document and close), YELLOW (requires investigation), or RED (critical — immediate action required)
4. For YELLOW/RED, run /investigate-deviation to begin structured investigation
5. Use /root-cause to identify systemic cause
6. Run /generate-capa if corrective/preventive action is warranted

Daily QA Operations

1. Start your morning with /brief daily
2. Get a summary of open deviations, pending investigations, CAPA due dates, and upcoming audit milestones
3. Prioritize your day based on regulatory deadlines and product impact

Audit Preparation

1. Run /brief audit-prep before an FDA or client audit
2. Get a summary of deviation trends, open CAPAs, overdue items, and areas of risk
3. Identify gaps in documentation that need to be addressed before the audit

File Structure

coldchain-qa/
├── .claude-plugin/plugin.json
├── .mcp.json
├── README.md
├── commands/
│   ├── investigate-deviation.md
│   ├── triage-excursion.md
│   ├── root-cause.md
│   ├── brief.md
│   └── generate-capa.md
└── skills/
    ├── deviation-classification/SKILL.md
    ├── excursion-triage/SKILL.md
    ├── regulatory-framework/SKILL.md
    ├── risk-assessment/SKILL.md
    ├── capa-management/SKILL.md
    └── cold-chain-fundamentals/SKILL.md

Customization

QA Playbook Configuration

Your playbook is the heart of the deviation management system. Define your specifications in coldchain.local.md:

• Product specifications: Temperature ranges, excursion limits, stability data references
• Classification thresholds: What makes a deviation critical vs. major vs. minor for your organization
• Escalation triggers: When to notify QA management, regulatory affairs, or executive leadership
• Investigation procedures: Your organization's specific documentation and evidence requirements

Regulatory Configuration

Customize the regulatory framework skill to match your specific regulatory environment (FDA, EMA, WHO PQS, Health Canada, TGA, etc.) and the product types you handle.

Risk Framework

Customize the risk assessment matrix to match your organization's risk appetite, patient safety criteria, and product quality thresholds.