AVAL.SP 2.2 Analyze Validation Results

The data resulting from validation tests, inspections, demonstrations, or evaluations are analyzed against defined validation criteria. Analysis reports indicate whether needs were met. In the case of deficiencies, these reports document the degree of success or failure and categorize probable causes of failure. The collected test, inspection, or review results are compared with established acceptance criteria to determine whether to proceed or to address requirements or design issues with the supplier.

Analysis reports or as-run validation documentation may also indicate that bad test results are due to a validation procedure problem or a validation environment problem.

Example Work Products

1. Validation deficiency reports
2. Validation issues
3. Procedure change request

Subpractices

1. Compare actual results to expected results.

2. Based on the established validation criteria, identify products and product components that do not perform suitably in their intended operating environments, or identify problems with methods, criteria, or the environment.

3. Analyze validation data for defects.

4. Record results of the analysis and identify issues.

5. Use validation results to compare actual measurements and product performance to the intended use or operational need.

6. Identify, document, and track action items to closure for work products that do not pass their validation.