Documentation Thread - Requirements Specifications v. Qualification Testing

The BSUBAS BAS Subject Matter Expert (SME) provides Documentation Thread Analysis BSUBAS employs the “back and forth” method to ensure all specified requirements are captured in the Test Plan, the Test Protocols and the Qualification tests.

• Performance Qualification (PQ) test results are compared to the User Requirements Specification (URS) to ensure alignment.
• Operational Qualification (OQ) test results are compared to the Functional Requirements Specification (FS or FRS) to ensure alignment. 
• Installation Qualification (IQ) test results are compared to the Detailed Design Specifications, most commonly the Hardware Design Specification (HDS) and/or the Software Design Specification (SDS) as well as the Sequence of Operations (SOO) to ensure alignment.
• Note: Deviations between the SDS and the SOO are usually reviewed prior to the Installation Qualification review.

The conditions we are generally looking for are:

• Requirement Specification items not captured in Qualification Testing. 
• Gap Analysis of missed Requirements to determine corrective actions (Test Plan or Test Protocol corrections)
• Deviations that are documented are reviewed for alignment. Any remaining gaps are identified for corrective actions.