fda-qsr-audit-prep
by alirezarezvanifda-qsr-audit-prep is a Compliance Review skill for FDA medical-device QSR audit readiness. Use it to pressure-test complaint files, MDR decisions, CAPA links, process validation, Form 483 responses, and QMSR transition evidence with six inspection-style questions.
This skill scores 70/100, which means it is acceptable for directory listing but should be presented as a lightweight audit-prep prompt rather than a complete compliance toolkit. Directory users get a clear command, strong use cases, and a practical FDA QSR forcing-question structure, but adoption confidence is limited by the lack of supporting references, templates, install instructions, and deeper execution artifacts.
- Clear triggerability: the frontmatter and body define `/cs:fda-qsr-audit-prep <scope>` and list specific situations such as annual internal audit, FDA inspection readiness, Form 483 response, Warning Letter receipt, MDR event, recall decision, and 510(k)/PMA preparation.
- Provides domain-specific audit leverage beyond a generic prompt by framing a six-question FDA QSR interrogation around complaint files, MDR reporting, process validation, and cited regulatory areas such as 21 CFR 820.198, 21 CFR 803, and 21 CFR 820.75.
- The skill is not placeholder-like: it has valid frontmatter, a substantial SKILL.md body, multiple headings, workflow signals, and no placeholder or experimental markers.
- No support files, references, templates, scripts, or install command are provided, so users must rely entirely on the single SKILL.md.
- The `<scope>` argument is named in the command but repository evidence does not show much guidance on how to define scope or tailor outputs for different device classes, audit types, or remediation phases.
Overview of fda-qsr-audit-prep skill
What fda-qsr-audit-prep is for
fda-qsr-audit-prep is a compliance review skill for pressure-testing FDA medical-device quality system readiness against 21 CFR Part 820 QSR topics, with attention to the QMSR transition and ISO 13485 alignment after February 2026. It is designed as a “forcing questions” workflow: instead of producing a broad audit checklist, it interrogates the evidence a quality team would need before an internal audit, FDA inspection, Form 483 response, warning-letter follow-up, MDR-related review, recall decision, or 510(k)/PMA readiness discussion.
Best-fit users and review situations
This fda-qsr-audit-prep skill is most useful for QA/RA teams, compliance consultants, founders at regulated device companies, internal auditors, and operators preparing evidence packages for US-distributed medical devices. It fits situations where you already have quality records and need to identify weak spots: complaint files, MDR decisions, CAPA evidence, process validation status, management review inputs, design controls, and supplier controls. It is less useful if you want a general FDA explainer with no device, process, or document context.
Main differentiator: six audit-pressure questions
The skill’s value is its narrow audit posture. It focuses on six high-risk QSR questions that map to common FDA inspection concerns, especially complaints and MDR reporting under 21 CFR 820.198 and 21 CFR 803, process validation under 21 CFR 820.75, and related quality system evidence. This makes it better for a readiness interrogation than a generic “prepare me for an FDA audit” prompt, because it pushes for document-level proof, timelines, decision rationale, and unresolved gaps.
How to Use fda-qsr-audit-prep skill
fda-qsr-audit-prep install and repository check
Install from the GitHub skill repository with:
npx skills add alirezarezvani/claude-skills --skill fda-qsr-audit-prep
The source path is compliance-os/skills/fda-qsr-audit-prep, and the key file to read first is SKILL.md. There are no visible companion rules/, resources/, references/, or scripts/ folders in the current file tree, so adoption is simple but also means the skill depends heavily on your prompt inputs and your own quality records. Before using it for compliance-sensitive work, review the full SKILL.md so you understand the six questions and the intended scope.
Basic fda-qsr-audit-prep usage pattern
Call the skill with a concrete scope, for example:
/cs:fda-qsr-audit-prep complaint handling and MDR readiness for Q4 2025
A weak prompt says: “Check our QSR readiness.” A stronger prompt gives the device category, review period, regulated market, quality process, current trigger, and evidence available:
“Use /cs:fda-qsr-audit-prep for a pre-FDA-inspection readiness review of our Class II reusable device, US commercial distribution, covering Q3–Q4 2025. Focus on complaint handling, MDR decision documentation, CAPA linkage, and process validation. Available records include complaint log export, MDR assessment forms, CAPA register, validation master plan, last management review deck, and supplier nonconformance log. Identify missing evidence, likely auditor follow-ups, and priority remediation actions.”
Inputs that materially improve output quality
The skill performs best when you provide evidence categories, not just goals. Include record names, date ranges, responsible functions, open/closed status, and known concerns. For complaint and MDR review, provide complaint counts, serious injury/death/malfunction classifications, submission dates, non-reportability rationale, investigation closure dates, and links to CAPA or trending. For process validation, include IQ/OQ/PQ dates, revalidation triggers, process changes, nonconformances, and acceptance criteria. For Form 483 or warning-letter response, provide the observation text and your proposed corrective action.
Suggested workflow for Compliance Review
Use fda-qsr-audit-prep for Compliance Review in three passes. First, run a scoping pass to list the six audit questions and the evidence expected for your situation. Second, run an evidence-gap pass against your actual document inventory. Third, run a remediation pass asking for a prioritized action table with owner, evidence to create or retrieve, urgency, and inspection risk. Keep human regulatory review in the loop; the skill can structure the interrogation, but it does not replace legal, regulatory, or notified-body judgment.
fda-qsr-audit-prep skill FAQ
Is fda-qsr-audit-prep only for FDA inspections?
No. The skill is useful before FDA inspections, but the source workflow also points to annual internal QSR audits, Form 483 responses, warning letters, MDR-reportable events, recall decisions, and pre-submission readiness where QSR posture may affect timeline or credibility. The common thread is evidence readiness under FDA medical-device quality system expectations.
How is this different from a normal audit checklist prompt?
A checklist prompt often produces generic requirements. The fda-qsr-audit-prep guide is more confrontational: it asks the kinds of questions an auditor might use to expose missing records, weak rationale, stale validation, or disconnected CAPA. That makes it better for readiness reviews where you need to find failure points before an inspector or internal auditor does.
Can beginners use the fda-qsr-audit-prep skill?
Yes, but beginners should not treat the output as a compliance determination. If you are new to FDA QSR, first ask the skill to define the expected evidence for each question in plain language, then run it again with your actual records. Pair the result with internal QA/RA review, because terms like MDR reportability, process validation, CAPA effectiveness, and recall decision-making have specific regulatory consequences.
When should I not use this skill?
Do not use it as the sole basis for MDR filing decisions, recall strategy, legal responses to FDA, or certification claims. It is also not ideal for non-medical-device quality systems, purely EU MDR audits, or companies with no documented QMS evidence to review. In those cases, start with a broader QMS design or regulatory strategy workflow before using this audit-pressure skill.
How to Improve fda-qsr-audit-prep skill
Improve fda-qsr-audit-prep results with sharper scope
The most common failure mode is asking for “audit prep” without defining the regulated product, review trigger, and evidence set. Improve the result by specifying: device type and class, US distribution status, review period, process area, audit trigger, known weaknesses, and what documents you can provide. This lets the skill ask realistic follow-up questions instead of giving generic FDA quality system advice.
Turn first-pass findings into an evidence matrix
After the first output, ask the skill to convert findings into a matrix with columns for QSR topic, expected evidence, available evidence, gap, risk level, likely auditor follow-up, owner, and next action. This is especially useful for complaint/MDR, validation, CAPA, and management review topics because it separates “we have a procedure” from “we can prove it was followed.”
Watch for common audit-prep blind spots
Use the skill to challenge areas teams often under-document: MDR non-reportability rationale, complaint investigation timelines, complaint trending into management review, revalidation after process changes, CAPA effectiveness checks, supplier issue escalation, and linkage between nonconformances and risk management. Ask for “inspection-style follow-up questions” to reveal whether your evidence would withstand scrutiny.
Iterate with real records, not summaries only
For best fda-qsr-audit-prep usage, iterate from summary to record-level detail. Start with a process overview, then provide anonymized excerpts from logs, forms, CAPA records, validation summaries, or observation text. Ask the skill to distinguish missing evidence, inconsistent evidence, and weak narrative. That distinction helps teams decide whether to retrieve records, correct documentation, open CAPA, or escalate to regulatory counsel.