Preventive actions are pro-active – something could go wrong and these are actions taken to stop it from happening, or to stop it from becoming too severe.
In order to identify risks that need preventive action, adequate monitoring and controls must be in place in the quality system to assure that potential problems are identified and eliminated before they happen. If something in the quality system indicates that a possible problem may develop, a preventive action must be implemented to avert it and then eliminate the potential situation.
You can identify opportunities for preventive action in a number of ways:
- Through the management review process
- Process / Performance monitoring
- Analysis of warranty data and customer feedback for trends
- Process analysis
- Look for trends in the root causes of corrective actions
- Risk assessment, FMEA (Failure Mode Effects Analysis) – i.e. what could go wrong and what would happen if it did)
- Employee suggestions for improvement
- Contingency planning, Disaster recovery planning.
- Production planning
- Monitoring changes in legislation, regulations,
- Reviewing changes in the marketplace
- Assessing new technology
- Internal / External Quality Audit Findings
- Employee Observation
Once you’ve identified a potential source of problems and the possible effects, you need to assess how likely it is to happen, and whether the costs associated with reducing the risk are worth it. It is effectively risk management.
If you decide to do nothing, you will still need to document the reasons for your decision.
ISO 9001 requires that you document your Preventive Action procedure (clause 8.5.3). You are also required to keep records on Preventive actions you’ve identified and the actions you took.
When you write the procedure you need to keep in mind “say what you do, do what you say”. The procedure is the first part, and the records you keep prove the second part.
Your Preventive Action procedure will include information on:
- How you identify a potential problem
- Where and how it should be recorded
- how the cause should be investigated, and by who
- deciding on what action will be taken
- how to record the actions taken
- assessing the solution for effectiveness and documenting the evidence to support your decision.
- when and who can finally close the issue
The records you keep on preventive actions you’ve taken, provide evidence that an effective quality system has been implemented and that it is able to anticipate, identify and eliminate potential problems.
Preventive actions are recorded in QSToolbox with “Issues”. Our user guide has more information on how QSToolbox helps you manage various kinds of issues, including preventive actions.