Ludus Ready Training · Episode 04

Which criteria pack?

Press play — with sound

Training · Episode 04

Which criteria pack?

The checks follow the document, not the other way around.

The wrong pack
still produces flags

SOP pack

Version and effective date

Deviation handling section

Roles and responsibilities

DEV-2418

Deviation record

Never ran · Root-cause adequacy

One document, one pack

Packs live in the repo under version control, one versioned file per criteria set.

Plan, or results?

Protocol

Limits and objectives fixed while nothing has run yet.

approved first

Report

Conclusions carried by the data printed in the file.

One level down

SOP-0412 rev 3

6.1 Stage the transfer panel at the port

6.2 Sanitize the panel before connection

6.3 Record the connection in the batch record

SOP pack

WI-0412-02

6.2.1Wipe outward with 70 percent IPA, two passes

6.2.2Keep the surface wet for 60 seconds

6.2.3Initial and date the panel log

Work instruction pack

Overlays stack on top

Figuresconditionalfile has images

Cross-documentconditionalreference attached

ALCOAalways on

Quality event pack · 6 checks

Every check carries a fixed source, written by a human and stored with the criterion.

When two packs both fit

Reportconclusions and data1 of 2

DEV-2418deviation investigation report

Quality eventroot cause and impact2 of 2

Which of these two is it?

In Dry Run

The pack is settled
before anything is checked.

Quality event · 6 criteria

FLAG Impact assessment — record states no product impact; no batch or lot is named.

REVIEW Investigation before disposition — nothing in the record dates either step.

6 criteria checked · 1 flag · 2 need review

Read the guide Open criteria See the demo

1 / 8

Reduced-motion is on, so the episode won't auto-play — use the arrows to step through.

Hit play with sound. Narration is AI-generated. Substance from Doc-type chooser. · All Training