Qualification
Qualification of thermal packaging is documented evidence that a defined packaging configuration meets its requirements under specified conditions. The complete system and its scope of use are assessed, including product temperature, shipping duration, payload and external stresses.
What evidence is required?
- Requirements and acceptance criteria defined in advance, such as the temperature range to be maintained at the intended measurement locations.
- Clearly described components, preconditioning and packout, so the tested configuration is reproducible.
- Suitable tests with documented results: Operational Qualification (OQ) examines function under controlled conditions; Performance Qualification (PQ) examines performance under real operating conditions.
When must suitability be reassessed?
A different coolant pack, a changed payload or different transport conditions may fall outside the scope of the evidence. Such changes must be assessed through the prescribed change-control procedure. A single climate chamber test can form part of qualification, but does not replace defining and documenting the entire scope of use.
Related terms: Prequalification · Climate Chamber Test