Quality Management

Documents & Templates

Design Validation
7.6 Design Validation Report

The Design Validation Report describes the results of executing a Protocol and these results are summarized as either PASS or FAIL. Design Validation Results that do not conform to the Requirement(s) are listed and described in detail in the NON-CONFORMANCE FINDINGS section of the Report (Section II). Non-conformances shall be investigated by the PL / HE until the root cause of the nonconformance is determined. Where appropriate, as part of the analysis, the non-conformance shall be duplicated (ability to induce the non-conformance provides a degree of assurance that the root cause was identified). Investigation shall take into consideration examples of common failure types such as: Use of inappropriate test/ evaluation methods for the parameter or function being evaluated Use of test equipment or tools that are not in calibration

Human error, including failure to conduct testing according to the requirements specified in the Protocol or in a referenced SOP, Standard, etc. Non-conformance Findings may be resolved by design modifications, changes to Requirements or, if appropriate, modifications to test or inspection equipment or methods. Design modifications will require Verification and may require a new Validation Protocol and Regression Testing. Requirements changes are processed using the appropriate Design Change SOP. Modifications to test or inspection equipment or methods necessitate a repeat of the test using an approved revised Protocol while resolutions must be conducted in a timely manner. Non-conformance Resolutions are described in detail in the NON-CONFORMANCE RESOLUTION section (Section II).
7.7 Acceptance of deviations and unresolved Non-conformances

Unresolved Non-conformances that do not affect safety or efficacy may be accepted with approval of the PL / HE, Quality Assurance, and the DRC. A detailed explanation of the reason for acceptance must be entered in the Design Validation Report, Section III by the PL /HE. When Non-conformances are accepted, the Risk Analysis must be reviewed and updated as necessary.
7.8 Approval and Design Review

Quality Assurance finally approves the Validation report. The PL / HE schedules a DRC meeting in accordance with the Design Review SOP to review the results of the Design Validation activities. The PL / HE, Quality Assurance, and DRC approve the Design Validation by signing the Design Validation Matrix in Section III. All documentation is filed in the DHF by Quality Assurance / Document Coordinator.
Document Type SOP Document ID XX_WWW_ZZZ_YYYY Version 1.0 Status Approved Page 11/24

Copyright by QMdocs 2010 Reproduction, photocopying, storage or transmission by magnetic or electronic means strictly prohibited by law. Neither the document nor the information contained therein may be reproduced or disclosed without written consent of QMdocs.