Quality Management of Internal Problems

This scope item describes the management of internal problems, for example, deviations observed during production or storage of goods.

Leveraging quality notifications, the quality engineer can capture all problem-related information. Further immediate actions can be captured for documentation purposes. To identify the root cause of the complaint, the quality engineer starts a root cause analysis. After having identified the error and the related root cause, the quality engineer classifies this information using code groups, codes, and free text information.

The quality engineer defines corrective and preventive actions either globally at notification level or per defect. The quality engineer assigns one processor to each action. The action is processed and action processors give feedback per action.

Finally, the quality engineer reviews each action and closes the notification.

Key Process Steps Covered

  • Create quality notification with basic data
  • Capture defects, define root cause analysis, and document immediate actions
  • Define corrective actions
  • Execute root cause analysis and corrective actions, and document outcome
  • Review root cause analysis and document root cause, review corrective actions
  • Define preventive actions
  • Execute preventive actions and document outcome
  • Review preventive actions
  • Complete quality notification

Benefits

  • Capture problem details, related defects, causes, and activities in one place
  • Manage different types of activities (for example immediate, corrective, and preventive actions)
  • Assign a person responsible to each action and track action status and outcome