Definition of the term („What are preventive actions?“)
The ISO 9000 describes a preventive action as a “measure to eliminate the cause of a detected fault or another undesirable situation”. The primary objective is to identify causes of errors before they occur, to prevent them and thus make sure that an error does not occur.
What is required as part of preventive actions?
The ISO 9001 calls for preventive actions to eliminate possible causes of errors to prevent them from occurring. Moreover, it requires that the resulting measures have to be matched to the scope of the possible error. Furthermore, a clearly documented procedure is requested with the following scope:
- Searching for possible errors and their causes
- An evaluation of the action to prevent the possible error from occurring
- Research and implementation of required actions
- Documentation of the results of the actions taken
- An evaluation of the effectiveness of the actions taken
Discover the suitable software for preventive measures
When are the preventive actions applied and required?
Corrective And Preventive Actions (CAPA) are among the required elements of a GMP compliant process (QMS). Moreover they are one of the most critical parts in audits. Ever since the introduction of a QMS, it has become the element of a QMS which has posed the greatest obstacles with regard to understanding, acceptance and implementation across the company.
What is the difference between corrective actions and preventive actions?
Generally, two different procedures to prevent errors are differentiated. The corrective action on the one hand and the preventive action on the other hand. If a fault or deviation has already been detected, the further procedure is described as a corrective action in the form of an error analysis and eliminating measure. However, if no fault or deviation has been detected yet, but a possible cause of errors has already been identified, then the following procedure is declared as a preventive action.
Benefits of preventive actions
This procedure allows you to maintain a high product quality at all times as well as significantly reduce costs caused by a possible error.