The Design Qualification (DQ) is the next step in the validation process of a new chamber, after the User Requirement Specification (URS). This document breaks down the high level requirements in the URS into individual detailed requirements and identifies where in the validation process the detailed requirements are confirmed and validated.
In the DQ document, all requirements from the URS (Illustration 1) should be broken down to the individual details level to allow the manufacturer to understand and build in as many of the requirements as possible. This also helps in the determination of a vendor justification.
Illustration 1 URS requirements
|Capacity||33 cu. ft.|
|Electrical Requirements||220 volt|
|Temperature Range||15 to 40 C|
|RH Range||20% to 80%|
|Special Operational Requirements|
|Auto shut off|
As titled, this document details the required options at a very detailed level and the internal/external specifications that are in effect that are needed to be followed. The DQ is used to communicate to the manufacturer required specific requirements the project. It also adds in the priority of the requirement and the specification(s) that requires it. The DQ identifies where in the validation process it will be tested to assure that the specification was met. This document should be referred to when developing and reviewing the IQ/OQ/PQ. The documentation of the specific requirements helps justifying the purchase the chamber and documents its intended use. Buying a chamber that does not meet all of your requirements does not save money, it can cost money in the remediation of a failed submission or the issuance of 483’s because the chamber did not comply with the needs.
When developing the individual details it is possible to document multiple URS requirements under multiple sections of the DQ. As noted below, the Controls section covers the temperature, RH and alarms requirements from Illustration number 1.
Illustration 2 DQ Breakdown
The addition of the Priority column in the document identifies the need of the option in the operation of the unit.. For a “H”igh, or a “M”edium level requirement, if the option is not available by the manufacturer, a secondary replacement source may need to be found to satisfy the requirement. For a “L”ow level requirement, the discussion of the missing requirement needs to be identified in the IQ/OQ/PQ section of the validation.
The listing of the Specification(s) column that requires the option identifies where the requirement originated from. The listing of the specification, details the need for the option, and provides background information in any discussions. With this document a vendor now has a way to understand your business needs for the chamber.
The validation identification section of the matrix, allows a reviewer to understand where the requirement will be verified and documented in the validation process. In the development of those sections, (IQ/OQ/PQ) the DQ should be reviewed to ensure that the required options are included.
Illustration 3, Validation Relationship
One requirement that people seem to take for granted is the Validation requirements of the chamber. This requirement needs to be documented in both the URS and DQ, as the intention is to run a validated chamber. As noted in illustration 1 of the URS, it was listed as a requirement. In Illustration 2 the requirement is listed and in Illustration 3, this shows the relationship to each section and where the requirements of each section are verified through the testing.