Design qualification: catching problems before installation
DQ documents that the chosen design meets the URS. It is cheapest place to fix a cold room with a door on the wrong wall.
Design qualification is the documented verification that the proposed design of facilities, equipment or systems is suitable for the intended purpose. It is performed against the URS before installation and often before purchase.
What to check for a storage space
- Refrigeration or HVAC capacity against heat load, including door traffic and lighting.
- Airflow design: will product positions receive circulation? Where are dead zones likely?
- Provision for monitoring sensors and their cabling or wireless coverage.
- Alarm architecture and independence from the control system.
- Door, dock and airlock arrangements against the expected traffic.
- Data handling: logging, retention, access, audit trails.
The output is a DQ report with a traceability matrix from requirement to design element.
Frequently asked questions
- Is DQ required for off-the-shelf equipment?
- Annex 15 expects the design to be verified against requirements regardless of source; for standard equipment the DQ may be brief, but the comparison should exist.
References
- [1]EudraLex Volume 4, Annex 15: Qualification and Validation (2015)
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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