Corrective actions are reactive – something has gone wrong and these are the actions taken to deal with the problem. Non-conformances are resolved through corrective actions.
This will include the immediate corrective actions you take to keep your customer happy, e.g. you sent the wrong part and will immediately replace it with the correct part.
However, ‘dealing with it’ for ISO 9001 means that you eliminate the problem AND make sure it will not happen again, so the corrective actions you take will also include the longer term actions you take to make sure the problem will not occur again.
The problem might be identified in processes, materials, suppliers, the product, the service, the workplace, or the management system itself.
You might find opportunities for corrective actions through:
- conducting workplace inspections
- testing, inspecting, and monitoring of plant and equipment
- consulting with staff
- customer feedback
- hazard reporting
- dealing with any non-conforming product
- investigating complaints
- reviewing system failures
- reviewing regulatory requirements
The ISO 9001:2008 standard requires that you have a documented procedure for Corrective Action (clause 8.5.2) and you must also maintain records of corrective actions and their results.
ISO 9001:2015 no longer requires a documented procedure for Corrective Action but you must still “retain documented information” i.e. keep records of what went wrong and how you corrected it.
You’ll need to establish the steps that will be taken to:
- review and document the problem
- contain or temporarily fix the problem. e.g. remove the defective product from production and quarantine it in a designated area for later investigation
- Investigate the cause of the problem – how did it happen, why did it happen, could it happen again?
- Propose an appropriate solution that will prevent the problem happening again. This will often mean a change to the process, and/or the system.
- You need to report on what actions were actually taken.
- After an appropriate period of time, you will need to assess whether the actions taken were successful in preventing recurrence. Document the evidence to support your decision.
- Once you are satisfied the problem is not recurring, you can close the issue.
Records of your corrective actions provide evidence that the problem was recognised, corrected, and proper controls installed to make sure that it does not happen again.
Corrective actions are recorded in QSToolbox as ‘Responses’ to an ‘Issue’. Our user guide has more information on how non-conformances and their corrective actions are recorded.