FDA QSR Forcing Questions
The FDA QSR Forcing Questions skill pressure-tests US medical-device QSR compliance by interrogating six critical areas (complaints/MDR, process validation, DHRs, CAPAs, labeling, and Form 483 history) before audits or inspections. It produces a structured readiness report with a verdict and top actions.
✨ What it does
- Checks complaint log completeness and MDR-reporting decision tree application
- Verifies process validation (IQ/OQ/PQ) status and revalidation triggers per 21 CFR 820.75
- Assesses DHR completeness and 2-year retention compliance per 21 CFR 820.180
- Evaluates CAPA effectiveness verification and flags aging CAPAs over 90 days
- Reviews labeling and UDI compliance per 21 CFR 801 and 830
- Tracks Form 483 and Warning Letter closure status
🎯 When to use it
- Before an annual internal QSR audit
- Before a pre-FDA-inspection readiness review for any device commercially distributed in the US
- After receiving Form 483 observations or a Warning Letter
- After an MDR-reportable event or before a recall decision
- Before submitting a 510(k) or PMA where QSR posture affects approval timeline
🚀 How to use
Trigger: /cs:fda-qsr-audit-prep
Trigger with the slash command /cs:fda-qsr-audit-prep <scope> where is the area to audit (e.g., a product line, facility, or process). The skill expects compliance state data and optionally submission tracking and PHI inventory files. It runs scripts to check QSR posture, track submissions, assess HIPAA overlap if applicable, and simulate an FDA inspection. Example prompts:
/cs:fda-qsr-audit-prep cardiac-device-line
/cs:fda-qsr-audit-prep manufacturing-site
📄 Output: A markdown report titled 'FDA QSR Audit Prep: <scope>' with sections for each QSR area, a verdict (green/yellow/red), and top 3 actions with owners and FDA timelines.
📦 Add this skill to Claude Code
# 1. Get the skills repo
git clone --depth 1 https://github.com/alirezarezvani/claude-skills /tmp/claude-skills
# 2. Copy this skill into your project (or ~/.claude/skills for all projects)
mkdir -p .claude/skills
cp -r /tmp/claude-skills/compliance-os/skills/fda-qsr-audit-prep .claude/skills/fda-qsr-audit-prepSkill source: compliance-os/skills/fda-qsr-audit-prep/SKILL.md
⚠️ Good to know
Requires access to compliance state data and relevant scripts; for Warning Letter responses or recall decisions, outside counsel is recommended.
❓ FAQ
What are the six forcing questions?
The six questions cover complaint files and MDR reports, process validation revalidation, DHRs for the last 2 years, CAPAs with effectiveness verification, labeling review, and Form 483 closure status.
How does this skill relate to ISO 13485?
Post-Feb 2026, FDA QSR is substantially harmonized with ISO 13485, so the skill cross-walks findings to ISO 13485 and identifies FDA-specific overlays like labeling and MDR reporting.
What is the output format?
The output is a markdown report with sections for each QSR area, a verdict (green/yellow/red), and top 3 actions with owners and FDA timelines.
🤖 Overview, features, install steps and FAQ were generated from the project's SKILL.md on Sep 4, 2026. Always check the original source before running commands.