Summary
In short
- An out of specification report is a record used in KnowQuality that records a laboratory or test result outside its specification limits. It is built against ISO 17025, FDA OOS guidance and forms part of the Nonconformance and Complaints programme.
- Raised when the result is confirmed. Completed by the lab with quality.
- The template holds 54 fields across 6 sections.
- 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: feeds RCA, Hold.
What it is
What it is
What is an out of specification report?
An out of specification report is a record used in KnowQuality that records a laboratory or test result outside its specification limits. It is built against ISO 17025, FDA OOS guidance and forms part of the Nonconformance and Complaints programme.
When is an out of specification report completed?
An out of specification report is completed at the moment the event happens, rather than reconstructed afterwards. Raised when the result is confirmed.
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
- A new record is needed; each one gets its own ID in the form CASE-2026-000
- You are running the Nonconformance and Complaints programme and this is one of its steps
- A linked record needs this one to exist: feeds rca, hold
Not for
- Product Nonconformance Report, which records product that does not meet specification.
- Process Deviation Report, which records a process that ran outside its set limits, even where the product still passed.
- Hold and Release Record, which places suspect product on hold and records the decision to release, rework or scrap it.
- 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.
FDA OOSOut of specification result guidance
How to investigate a failing laboratory result without retesting until you like the answer.
FDAFood and Drug Administration
The United States food and drug regulator.
FAQ
Frequently asked questions
What is the out of specification report template based on?+
It is built against ISO 17025, FDA OOS guidance. 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 report contain?+
There are 6 sections: header, the result, phase one, laboratory investigation, retest decision, phase two, process investigation, conclusion. Together they hold 54 fields, 37 of which are required.
How often is an out of specification report raised?+
A new record is raised at the moment the event happens, rather than reconstructed afterwards. Each one is given an ID in the form CASE-2026-000, so it can be traced and referenced from other records.
Which programme does the out of specification report belong to?+
It is part of Nonconformance and Complaints. Product decisions made by quality, and complaints traced to a cause rather than answered politely.
Can the out of specification report 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 report 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
- FDA OOS — Out of specification result guidance
- FDA — Food and Drug Administration