Design Qualification (DQ)

Design

Hello, good people of the world! How to define DQ? One way: DQ = documented verification that the proposed design of the facilities, equipment, or systems is suitable for the intended purpose

Responsibilities:

Validation is responsible for leading the design qualification effort, including generating design qualification protocols, leading the execution of DQ protocols, leading deviation corrective actions and resolution, and summarizing results in a final report and package.

Engineering is responsible for supporting design qualification execution, including providing design documents.

Quality Assurance is responsible for pre-approving DQ protocols, supporting design qualification execution, when needed, and approving DQ deviations and final reports.

Overview

Design Qualification may be performed at various stages in a given project, and more than one DQ may be performed. The timing of DQ may include:

  • Qualification of documents that define a scope of work for an internal or external supplier, such as: Request for Proposal (RFP), Request for Bid (RFB), Statement/Scope of Work (SoW), Purchase Order (PO), etc. The focus of the DQ in this case is to ensure applicable user requirements are adequately communicated in the scope document. Any discrepancies should be discovered and corrected before submission to any third party. Financial information, such as the purchase prices, are not relevant to the DQ and may be omitted or redacted as needed.
  • Qualification of design documents, submittals, proposed layout drawings, etc. generated by a supplier. The focus of the DQ here is to verify all user requirements will be met by the proposed design. Any discrepancies should be documented and communicated back to the supplier for revision to the deficient document.
  • Qualification of design documents after FAT. Documents may have changed as a result of FAT testing, and DQ will ensure all user requirements are still being met.
  • Any other time, to qualify the as-found state of design documents

Design Qualification may be comprised of two parts: User Requirements Verification and Design Verification. User Requirements Verification verifies all direct-quality-impact requirements defined in the URS are adequately captured in design documents. Design Verification verifies design documents align with the URS.

User Requirements Verification

Doc No. and Title:  URS 12345, Rev. 0, “User Requirements Specification for XYZ”

Req.    No.

Req.    Text

Impact    to Quality

Spec.    No. (Ver. /Date)

Spec.    Text

Comments

3.1.3.1.

The warehouse shall have a Building Management System which    will integrate with our existing Siemens Apogee system.

Direct

BMS FRS XYZ, Version B

“BMS points will integrate with    existing Apogee system.” None

5.2.1

The cold storage area will maintain temperature in the range of    5.0° +/-3°C.

Direct

Cutsheet ABC (09SEP12)

“Temperature control range: 2-8°C “ None

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