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AI agent for process development scientists

Process Capability Monitoring Agent

Early detection of declining process capability

MonitoringAnalysisScience and research
See how it worksGet access
Process Capability Monitoring Agent: what goes in, what the agent does and what you get

What it does

Critical quality attributes should stay well within specification, and slow drifts are easy to miss batch by batch. After each batch, this agent adds results to control charts, calculates process capability, and applies trend rules such as several points in a row on one side of the mean. It flags shifts, trends and low capability. Before raising an alert, it checks for data entry errors, like a misplaced decimal. If it finds one, it asks for a correction and checks the chart again. For real signals, it links them to process changes, equipment work or raw material lots from the same period. It drafts a monitoring summary that also feeds the annual product review. You decide whether to open an investigation. Edge case: a shift that lines up with a new raw material lot is linked to that lot.

How it works

Follow the arrows from top to bottom. The orange dashed arrow is the loop: when a check fails, the agent goes back and tries again.

Start and resultWhat it doesA check on its own workWaits for your OKGoes back and retries
Yes, continueApprovedNo 1 STARTS WHEN Batch results in 2 USES A TOOL Update control charts 3 DOES Apply trend rules and calculate capability 4 CHECKS THE RESULT Are signals real and not data errors? If not: correct data and recheck. Back to step 2. 5 DOES Link signals to changes or lots 6 YOU APPROVE Scientist decides on investigation 7 RESULT Monitoring summary
Read the steps as a list
  1. Batch results in
  2. Update control charts
  3. Apply trend rules and calculate capability
  4. Are signals real and not data errors?If not: correct data and recheck. Back to step 2.
  5. Link signals to changes or lots
  6. Scientist decides on investigationThe agent waits here for your OK.
  7. Monitoring summary

How it decides

It applies control chart rules and flags capability below the target.

  • Use standard trend rules
  • Flag capability below target
  • Link to raw material lots

Make it yours

Every agent is a starting point. You choose these settings for your own situation.

  • Capability target (default 1.33)
  • Trend rules
  • Attributes
  • Report frequency

What keeps you in control

It always asks you first

  • Opening investigations

Hard limits

  • Never changes specifications

It stops when

  • Done: summary filed
  • Stop: results missing

Set it up

We guide you through the set-up, step by step

Members get the full set-up guide for this agent. No technical skills needed: you copy, paste and upload.

10 minto set it up in your AI
5 AIsChatGPT, Claude, Copilot, Gemini, Grok
  • One set of instructions to paste into your AI, with the clicks for ChatGPT, Claude, Microsoft 365 Copilot, Gemini and Grok
  • The agent then walks you through connecting your own data, one source at a time
  • A downloadable copy with the flow chart, the rules and the full guide
Get access to this agent

An example run

What happensAfter batch 41, assay results showed seven points in a row above the mean. The agent first checked the data. One value of 103.8% was entered as 108.3%, so it went back, used the corrected value, and the run dropped to six points. A real trend remained and capability fell from 1.6 to 1.3. The agent linked it to a new excipient lot. The scientist approved a small investigation.

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