Corrective Action Audit Checklist
Your corrective action system is at the heart of your management system and demonstrates your commitment to improvement.
Here is a 10 point checklist to audit your system…
1. Do you have a documented procedure for your CA system?
2. Do you identify and define the sources of problems in your procedure? Do the sources of information include (use all that apply):
- Product nonconformity/failure
- Internal audits
- Complaints, feedback and returned product
- Process and quality issues
- Out of specification results
- Calibration failures
- Supplier issues
- Accidents & Near Misses
- Environmental Issues
- Certification Body findings
- Regulatory Body non-conformities
3. Do you have a documented nonconformity investigation procedure? Does the procedure control and prevent the release of nonconforming product/service? Does this procedure also include additional ‘containment action’ to control product that is currently being processed and to identify nonconforming product which may have been released?
4. Is the data in the CA system reported in an accurate and timely way? Is the data in the CA analysed to identify actions to prevent the nonconformity from happening again? Is the amount of time spent on investigating each CA appropriate for the significance and risk of the issue?
5. Have actions from the CA investigation been identified and implemented to stop the issue from re-occurring? Are the actions appropriate for the significance and risk of the issue?
6. Do you analyse trends of product and quality data to identify unfavourable system/process or product trends? Have any trends been identified that may require CA?
7. Do you use statistical methods (where necessary) to detect recurring problems? Are results analysed across processes to determine the extent of problems?
8. Do you review corrective actions to ensure the actions were effective? Is this documented?
9. Does the information from CA feed back into design, purchasing, production controls and risk management (FMEA/ASPECTS & RISK ASSESSMENTS)?
10. Do you communicate the information from the CA system across the organisation, including the review of the CA information in the management review?