What are the key elements of a design qualification (DQ) protocol and report?

1 DQ Protocol

A DQ protocol is a document that defines the scope, objectives, criteria, methods, and responsibilities for conducting the DQ. It also includes the acceptance criteria, test procedures, and verification activities that will be performed to demonstrate that the design of the equipment meets the user requirements and specifications. A DQ protocol should be prepared and approved before the design of the equipment is finalized, and should be based on a risk assessment and a design review.

2 DQ Report

A DQ report is a document that summarizes the results of the DQ and provides evidence that the design of the equipment meets the user requirements and specifications. It should also identify any deviations, non-conformities, or corrective actions that occurred during the DQ and how they were resolved or mitigated. After completion of the DQ, a DQ report should be prepared and approved, containing elements such as a summary of the objectives, scope, criteria, methods and responsibilities; reference to the protocol and any amendments or deviations; description of the equipment design; list of user requirements and specifications; summary of test procedures, verification activities and acceptance criteria; summary of test results, data and observations; list of deviations, non-conformities or corrective actions; conclusion as to whether the design meets user requirements and specifications; and a signature page confirming approval and authorization.

5 Best Practices for DQ Protocol and Report

To ensure that your DQ protocol and report meet the regulatory requirements and are of high quality, you should follow a standard format and structure, use clear and concise language, and reference any relevant documents. Additionally, make sure to include all the necessary information in your DQ protocol and report, such as objectives, scope, criteria, methods, responsibilities, acceptance criteria, test results, deviations, non-conformities, corrective actions and conclusion. Furthermore, use objective and verifiable evidence to support your test results and conclusion in your DQ report. Additionally, incorporate traceability matrices or tables to link user requirements and specifications to verification or validation methods and test results in your DQ report. Finally, make sure that your DQ protocol and report are reviewed and approved by the authorized personnel before signing and dating them.