Deviation Management

A deviation process is a set of procedures that are followed when a manufacturing process deviates from its standard or expected operating procedures. A deviation is an event or condition that falls outside of the specified process requirements or acceptance criteria.

The deviation process is an important quality management tool that helps to identify and correct any deviations that may occur during the manufacturing process. The following are some key steps in the deviation process:

  1. Identification of deviation: The first step in the deviation process is the identification of the deviation. This can be done through monitoring, testing, or inspection of the manufacturing process.
  2. Evaluation of the deviation: Once the deviation has been identified, it is important to evaluate its impact on the product and the manufacturing process. This involves analyzing the data collected during the monitoring, testing, or inspection process.
  3. Investigation of the deviation: If the deviation is found to be significant, an investigation may be required to determine the root cause of the deviation. This involves conducting a detailed analysis of the manufacturing process to identify any factors that may have contributed to the deviation.
  4. Documentation of the deviation: All information related to the deviation, including the investigation findings and corrective actions taken, should be documented in a deviation report.
  5. Corrective actions: Based on the investigation findings, corrective actions should be implemented to prevent the deviation from recurring. These actions may include process modifications, training, or other corrective actions.
  6. Review and approval: The deviation report and corrective actions should be reviewed and approved by the appropriate personnel to ensure that the corrective actions are effective and that the deviation has been properly addressed.