Quality Risk Assessment (FMEA)

1. What this module does

You enter each failure mode with its scores, current controls and any action with the scores after it. The tool calculates the RPN, ranks the failure modes and draws a Pareto chart.

It flags failure modes above the RPN threshold or at high severity with no action, and residual risks still above the threshold.

What you get

• A Word or PDF report: Quality risk assessment (FMEA).

2. Before you start

Have these ready. You can still start with the example data and replace it piece by piece.

• The process steps and failure modes.
• Your scoring scales and RPN threshold.
• Actions, owners and scores after the actions.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/risk-assessment.html. The example is loaded when the page opens, so every panel already has realistic data. Follow the steps to see how it works, then replace the example with your own data.

1. Describe the assessment

   Enter the subject, the team and the scope, and set the RPN threshold and the severity that always needs an action.

   

2. Enter failure modes

   One row per failure mode, with scores from 1 to 10. Leave the after-action scores empty when there is no action.

3. Read the result

   The headline says whether residual risk is acceptable: "7 failure modes · residual risk acceptable".

   

4. Resolve alerts and download

   High-RPN failure modes with no action are major, as are residual risks above the threshold. A high-severity mode with no action needs an action or a documented rationale. Then preview and download.

   

4. Field reference

Every input in the tool, panel by panel. Tables accept rows pasted straight from Excel, comma-separated text, or a loaded file; check the columns after loading a file. Fields marked “when it applies” appear only for the choices that need them.

1 · Scope

2 · Failure modes

One row per failure mode. Scores 1–10. After-action scores may be left empty when no action is taken.

5. Checks and alerts

Calculations and pass/fail outcomes always come from fixed rules, never from AI. The tool checks:

• RPN = severity × occurrence × detection.
• Actions for high RPN and high severity.
• Residual risk below the threshold or accepted with a rationale.

How to resolve alerts

• Critical alerts block the download and must be fixed in the data. A failing result can instead be linked to an investigation: type the investigation reference and outcome and press Record.
• Major alerts block the download until you fix them or type a justification and press Accept justification.
• Minor alerts do not block anything. They are listed in the documents so the reviewer sees them.
• Some alerts have an Apply fix button that makes the change for you. Reopen undoes a justification.

Narratives

This module writes: Risk evaluation and conclusion. Each narrative is written by fixed rules from your data. You can edit it in the box. Rewrite with AI (where your plan includes AI) rewrites it in regulatory style; every number in the text is checked against your data, and a number that does not match is flagged under the box and blocks the download until you correct it. Reset to rule-based text brings back the original.

6. Preview, gap review and download

1. Press Preview next to a section, or Preview and download all. The document opens in a preview window, exactly as the Word file will read.
2. The left side lists the review, run on your device: gaps in the data (missing values, open alerts), gaps in the report (missing content the guidance expects, placeholders such as [site] or TBD left in the text) and, if you load the approved protocol under Compare with the protocol, differences from the protocol (requirements, criteria, batches or time points it plans that the report does not show).
3. Click a finding to jump to the place in the preview. Fix it in the tool, then preview again.
4. Optional AI review: a second read for contradictions, claims without data and vague wording. The report text is sent to Claude only when you press it, and only where your plan includes AI. Check every AI finding; AI can be wrong.
5. Press Download Word (.docx) or Download PDF. With several documents open, All as Word (.zip) and All as PDF (.zip) download the set. The download buttons stay disabled while a blocking alert is open; the preview still works.

Documents this module produces

Use Save project to keep your work as a file on your computer, and Open project to continue later. Start blank clears every field; Load example brings the example back. Nothing is stored on CMCfy servers.

7. US and EU submissions

ICH Q9(R1) applies in the US and the EU (EU GMP Part III).

8. Working with other modules

• Risk assessments support Change Control and the Process Validation Report.

9. Common pitfalls

• Scoring without defined scales.
• Accepting a severity 10 risk with no rationale.

10. Practice exercises

Each exercise starts from the example (press Load example to reset). We run these on every update of this guide, so the result you see should match.

1. Remove the acceptance rationale

   Clear the rationale for accepting residual risks.

   Expected resultThe headline shows one failure mode needs an action.