Quality

Kepner-Tregoe

kt analysis · problem analysis

In short

A structured root-cause and decision-analysis methodology built around 'is/is-not' problem framing, used for complex multi-variable investigations.

Kepner-Tregoe (KT) is a rationale-based problem-analysis method that asks what is and what is not happening, where and where not, when and when not, and to what extent — then tests candidate causes against the 'is/is-not' signature. It complements 5 Whys / Fishbone when the failure mode is not obvious.

V5 surfaces KT worksheets inside the deviation/CAPA workflow so investigators retain the structured reasoning, not just the conclusion.

Regulatory anchors

ICH Q9

Where this term comes up

Pharmaceutical Medical Devices Chemicals

How V5 handles it

21 CFR Part 11 — signatures and audit history your team can validate.

V5 supports electronic signing, audit history and validation evidence. Whether your use meets Part 11 is established by your own validation and procedures.

Exploring software for this?

Try V5 free for 7 days with no card needed, or talk to our team about what applies to your operation.

Start free

Back to glossary

Next step

Try V5 with your own records, or ask a question first. Ask V5 opens with an editable question; nothing is sent until you choose to.

Start your free trial Browse all features