Summary
In short
- An out of tolerance impact review is a review used in KnowQuality that works out what product may have been affected when a gauge is found out of calibration. It is built against ISO 9001 cl.7.1.5 and forms part of the Calibration and Measurement programme.
- Run whenever a calibration fails. Carried out by quality.
- The template holds 43 fields across 5 sections.
- ISO 9001 is quality management systems. The international standard for consistently meeting customer and regulatory requirements. Certifiable.
- It connects to the rest of the library: links Calibration; feeds Hold.
What it is
What it is
What is an out of tolerance impact review?
An out of tolerance impact review is a review used in KnowQuality that works out what product may have been affected when a gauge is found out of calibration. It is built against ISO 9001 cl.7.1.5 and forms part of the Calibration and Measurement programme.
When is an out of tolerance impact review completed?
An out of tolerance impact review is completed at the review interval, and after any trigger event. Run whenever a calibration fails.
When to use it
When to use it, and when not to
This review is one step in a larger programme. Using it for work that belongs to a neighbouring template produces records that are hard to report on later.
Use it for
- The event or activity this review covers has occurred, or is about to
- A new record is needed; each one gets its own ID in the form OOT-2026-000
- You are running the Calibration and Measurement programme and this is one of its steps
- A linked record needs this one to exist: links calibration; feeds hold
Not for
- Test Equipment Register, which lists every gauge, meter and instrument used to make quality decisions, with its calibration status.
- Calibration Record, which records the calibration of a piece of test equipment, including standard used, result and next due date.
- Gage R&R Study, which measures how much of your measurement variation comes from the gauge and the operator rather than the product.
- Anything outside KnowQuality, which belongs in the workspace that owns that process
Standards
What it is built against
ISO 9001Quality management systems
The international standard for consistently meeting customer and regulatory requirements. Certifiable.
ISOInternational Organization for Standardization
A voluntary international standard. Widely adopted, often required by customers, and certifiable where a management system standard.
FAQ
Frequently asked questions
What is the out of tolerance impact review template based on?+
It is built against ISO 9001 cl.7.1.5. ISO 9001 is quality management systems. The international standard for consistently meeting customer and regulatory requirements. Certifiable. ISO is international Organization for Standardization. A voluntary international standard. Widely adopted, often required by customers, and certifiable where a management system standard.
What sections does the out of tolerance impact review contain?+
There are 5 sections: header, the error, what was measured, assessment, outcome. Together they hold 43 fields, 32 of which are required.
How often is an out of tolerance impact review raised?+
A new record is raised at the review interval, and after any trigger event. Each one is given an ID in the form OOT-2026-000, so it can be traced and referenced from other records.
Which programme does the out of tolerance impact review belong to?+
It is part of Calibration and Measurement. Traceable calibration with a defined response when an instrument fails its check.
Can the out of tolerance impact review template be changed?+
Yes. Every field, option, score and conditional rule is editable, and the links to other templates come with it. Most teams install it as it is, run it for a cycle, then adjust.
The agents
What the agents do with it
The form is the easy part. Keeping it current, routing it to the right owner and holding the evidence together is the work that actually slips.
Holds the out of tolerance impact review library against your registers, routes each record to its owner, and keeps the evidence trail together.
Coordinates the crew, rolls completion and exceptions into one view, and holds every write for your approval before it touches a record.
This template lives in KnowQuality — quality and food safety. HACCP, nonconformance, traceability, laboratory and customer complaints.
Sources
Sources
- ISO 9001 — Quality management systems
- ISO — International Organization for Standardization