Quality events
Signal detection and trend review
Paste batch, lab, environmental or equipment results; fixed statistical rules find limit breaches, shifts, trends and unusual variation, the AI explains each signal, and QA dispositions them and records a signed recommendation.
In the portal: /app/signals
The trend review procedure
- Person
1. Enter parameter and limits
Target, specification, action limits
- Person
2. Paste the results in order
3 to 2,000 points
- System
3. Apply the rules
Same data, same signals
- AI drafts
4. Explain each signal
Meaning, likely causes, next step
- Person
5. Disposition signals
Investigate, keep monitoring, not a signal
- Person
6. Recommendation
- E-signature
7. Review and sign
- Investigate → give the deviation or investigation reference raised in your QMS.
Start a review
- Step 1: Open Signal detection and choose New review.
- Step 2: Choose the Data source (batch data, lab results, environmental monitoring, equipment or utility monitoring, complaint or deviation rate, other) and name the Parameter, unit, product and process step.
- Step 3: Enter the target and limits you trend against (optional; each lower limit below its upper). Limits are fixed when the review is created; to trend against other limits, create a new review.
- Step 4: Paste the Results, in order, oldest first: one per line as "label, value, date" or a bare value. Header rows are skipped and reported.
- Step 5: Attach supporting files if useful (data export, specification, your trending or SPC procedure, previous trend report). If an SPC procedure is attached, the AI applies its rules.
- Step 6: Keep Detect signals now ticked and choose Create and analyze.
Detection rules
| Rule | Kind | Severity |
|---|---|---|
| Beyond specification limit | Limit | Critical |
| Beyond action limit | Limit | Major |
| Beyond 3 sigma | Outlier | Major |
| Two of three beyond 2 sigma, same side | Variation | Minor |
| Four of five beyond 1 sigma | Variation | Minor |
| Run of 7 or more above or below the target (or mean) | Shift | Major |
| 6 or more consecutive results rising or falling | Trend | Major |
| Sustained drift (10+ results, fitted change > 1.5 SD) | Trend | Major |
The statistics shown are n, mean, SD, minimum and maximum, mean ± 3 SD, Cpk (with specification limits), the fitted slope and the first-versus-last means. The AI explains each signal (what it means, likely causes, the suggested next step, its confidence), may add patterns the rules missed, and states the process state: In control, Shifted, Trending, Unstable, Out of specification or Insufficient data.
Disposition and recommendation
- For each signal choose Investigate (with the deviation or investigation reference), Keep monitoring or Not a signal, with a reason.
- Add a signal you see for anything the rules and AI missed.
- Record the Recommendation: no action (continue routine trending), increase monitoring, open a deviation or investigation, or raise a change control or CAPA.
Deviations, investigations and changes are raised in your QMS; this record documents the signals, your dispositions and the reasoning. For ongoing trending of the same parameter, make a control chart from the review and pin it to your dashboard.