When an organization has introduced a change control system as quality management tool, the quality assurance has to ensure the effectiveness of the change control framework utilizing the data available and make changes as when required.
To determine the effectiveness of change control system the following checklist/data is required:
- Total number of effectively completed change control procedures per one year.
- Total number of process/procedures that were terminated prematurely due to procedure deviations.
- Total expenditure required for completion of change control which includes, time loss, manpower and other cost involved.
- Total effective time required for completion of change control procedures: from application to completion.
- Ratio of number of deviations to total number of change control procedures per year.
- Total number of OOS/OOT/OOC requests raised per one year.
- Number of market complaints per one year
- Number of stability issues per batch reviews/recalls per one year. (updated on 23/11/2020)