Setting acceptance criteria for a mapping study
Acceptance criteria come from the product's storage condition, expressed as limits, a permitted excursion definition, and a rule for what happens at the boundary.
Criteria should be numerical and unambiguous: every sensor within 2.0 °C to 8.0 °C for the whole study, for example, with any reading outside that range counted as an excursion regardless of duration — or with a stated permitted duration if the product data support it.
Decide these explicitly
- Limits, including whether they are inclusive.
- Whether a single reading, or a period, constitutes an excursion.
- Which sensors are 'in scope' for acceptance (an ambient reference sensor is not).
- How measurement uncertainty is treated at the limit: a reading of 8.05 °C with an uncertainty of ±0.3 °C is not clearly outside.
- What happens on failure: exclusion of positions, remediation and re-mapping, or product-specific assessment.
Guidance on decision rules for conformity statements applies here as much as it does to calibration certificates: say how uncertainty was accounted for.
Frequently asked questions
- What are typical acceptance criteria for a 2–8 °C cold room mapping?
- Every in-scope sensor within 2.0–8.0 °C for the whole study, with any reading outside counted as an excursion unless the protocol defines a permitted duration supported by product data.
- Should acceptance criteria allow for sensor uncertainty?
- The product limits do not move; the decision rule states how uncertainty is handled — for example a guard band that treats 7.8 °C with U = 0.3 °C as not clearly within an 8.0 °C limit.
References
- [1]WHO Technical Supplement 8 to TRS 961 Annex 9: Temperature mapping of storage areas (2015)
- [2]ILAC-G8: Guidelines on Decision Rules and Statements of Conformity
General technical guidance written against the cited sources. It is not regulatory or legal advice and does not replace the applicable standard, guideline or a qualified reviewer's judgement.
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