Quality Test Definition Management: Tasks (Level 3)
- Managing new quality test definitions
- How do we realize that there is a need for a new test specification?
- Which format will be needed?
- Does the test specification exist in a different format (e.g. paper-based)?
- If it exists already, where should it be stored in the future?
- Who will author new test specifications?
- How will new test specifications be checked and released?
- Who needs to be informed about new test specifications?
- Managing changes to quality test definitions
- What is the actual format of specifications?
- How do we ensure the specifications are actual and valid?
- Who is in charge of modifying specifications?
- How will updated/changed test specifications be checked and released?
- Who needs to be informed about changes?
- Providing quality test definitions to other applications, personnel, or activities
- What will have impact(s) on other resources within laboratory or production line? (Devices, Workers, aso.)
- Who needs to be informed about new or changed specifications?
- Which ISA95 functionalities will be used within the specification?
- How will the information be exchanged?
- Managing the exchange of quality test definition information
- Who or which function/activity needs to be informed about new or changed specifications?
- When and how often?
- How will the information be exchanged?
- How will it be ensured that the information is received and processed?
- Optimizing quality test definitions based on quality test analysis
- How to determine if tests are efficient?
- Is there a risk-based quality management?
- Which raw materials parameter, process or in-process control parameter does have an influence on the Quality (Critical Quality Attributes)?
- Which measurements could help to ensure the Quality is in range?
- Which are the target parameters, tolerances and trajectories of such parameters?
- What will trigger the optimization of the quality test specification?
- Generating and maintaining quality test definitions not related to product, such as for test equipment validation and standard sample validation
- Are there any quality tests for Equipment (Validation, Safety,..), laboratory devices, procedures, aso.?
- If yes, how are they defined and maintained?
- Managing the key performance indicator (KPI) definitions associated with quality tests
- Which KPIs do exist? How are they defined?
- Which data is needed to calculate such KPIs (also refer to "Quality Test Data Collection"?
