Summary
In short
- An out of specification investigation is a record used in KnowQuality that investigates an out of specification result to decide whether it is real before acting on it. It is built against ISO 17025 cl.7.10 and forms part of the Laboratory and Testing programme.
- Raised on every out of specification result. Carried out by the laboratory with quality.
- The template holds 53 fields across 6 sections.
- Scoring is investigations closed, where high is good.
- ISO 17025 is testing and calibration laboratory competence. What a laboratory must demonstrate to be accredited for the tests it reports.
- It connects to the rest of the library: links Micro results, Holds, CAPA.
What it is
What it is
What is an out of specification investigation?
An out of specification investigation is a record used in KnowQuality that investigates an out of specification result to decide whether it is real before acting on it. It is built against ISO 17025 cl.7.10 and forms part of the Laboratory and Testing programme.
When is an out of specification investigation completed?
An out of specification investigation is completed at the moment the event happens, rather than reconstructed afterwards. Raised on every out of specification result.
When to use it
When to use it, and when not to
This record 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 record covers has occurred, or is about to
- The workspace is being set up, or the register needs an entry added or retired
- You are running the Laboratory and Testing programme and this is one of its steps
- A linked record needs this one to exist: links micro results, holds, capa
Not for
- Laboratory Sample Log, which logs every sample taken for testing, with what it is, why it was taken and where it went.
- Microbiological Result Record, which records a micro result against its specification, with the action taken where it is out.
- Chemical and Compositional Result Record, which records analytical results for composition, additives, contaminants or nutritional claims.
- Anything outside KnowQuality, which belongs in the workspace that owns that process
Standards
What it is built against
ISO 17025Testing and calibration laboratory competence
What a laboratory must demonstrate to be accredited for the tests it reports.
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 specification investigation template based on?+
It is built against ISO 17025 cl.7.10. ISO 17025 is testing and calibration laboratory competence. What a laboratory must demonstrate to be accredited for the tests it reports. 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 specification investigation contain?+
There are 6 sections: header, phase one, the laboratory, retesting, phase two, the process, conclusion, result. Together they hold 53 fields, 41 of which are required.
How many out of specification investigation records should we have?+
This is a singleton. One record per workspace, set up once and maintained, rather than one per event. Other templates refer back to it.
Which programme does the out of specification investigation belong to?+
It is part of Laboratory and Testing. Results you can defend, and retesting governed by a protocol written before the retest.
How is an out of specification investigation scored?+
Scoring is investigations closed. High is good. Scores exist to make the form tell you something, not to produce a percentage for its own sake.
Can the out of specification investigation 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 specification investigation 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 17025 — Testing and calibration laboratory competence
- ISO — International Organization for Standardization