The problem: deviations that lose their evidence
When the control chart, the deviation and the root cause sit in different places, closing a deviation means gathering evidence by hand.
Pilot lots are where scale-up problems show first. If the control chart, the batch record and the deviation are in different systems, the investigation spends its first days collecting evidence instead of finding the cause.
What this demo shows
- The control chart flags a lot over the viscosity limit.
- Open a deviation.
- Find the root cause.
- Close it with QA sign-off.
Why it matters
Your quality team should investigate the issue, not hunt for its history. A deviation that opens with the alert, product, plant and equipment already linked starts from the evidence.
Closing with QA sign-off and the root cause on record means the next pilot lot benefits from what this one taught, and the history is there when the product reaches the plant.
See it with your own data
This video is part of QMS. To see how it would work with your own formulations and records, request a demo. Our team replies within 30 minutes during business hours.
Read the transcript
In Uncountable, lab and quality data share one platform. So, a failing pilot lot goes from alert to closed deviation. One pilot lot reads 16,400 over its 15,000 viscosity limit, and the control chart flags it. Quality opens a deviation on that lot with the alert, product, plant, and equipment. The team records the root cause.
A premix held 40 minutes longer than the batch instructions allow. Quality assurance approves the investigation, and the deviation closes. Uncountable, every stage, one platform.
