The next logical discussion is the second half of the Corrective and Preventive Action (CAPA) subject. According to ISO 9001 section 8.5.3, Preventive Actions identify and eliminate the causes of potential nonconformities in order to prevent occurrence. These are proactive measures, instead of the reactive steps taken for a Corrective Action.
The main goal for Preventive Actions is to avoid creating non-conformances, but they are also intended to include improvements in efficiency. Typically a company will create Action plans in response to Preventive Actions. Once something is identified as a potential source of problems, you will need to assess how likely that situation is to actually happen and if the costs associated with reducing the potential effect are worth it.
Opportunities for preventive measures can evolve from:
- Management review process
- Monitoring or analyzing processes
- Analysis of customer feedback
- Trends in root cause analysis of corrective actions
- Risk assessment, FMEA findings
- Suggestions for improvement from employees
- Production planning
- Changes in regulations or standards
- New technology assessment
- Audit findings (internal, external, regulatory)
ISO 9001 requires a documented procedure for preventive actions. The procedure should include information on how the potential problem is identified, where and how to record it, who has the responsibility to investigate the cause, who can decide what actions to take, how you will record the actions taken, what steps are taken to assess the solution and document any evidence, and to identify when it is appropriate to close the Preventive Action. The documentation of Preventive Actions provides evidence that you have a quality system in place and that your company is able to anticipate, identify and eliminate potential issues. It is also required, as well, to maintain the records for the actions identified and what steps were taken to reduce the potential risk.
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