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Ensure corrective actions address the root cause of nonconformities.
Do corrective actions address the root cause of nonconformities?
12.1 Corrective Actions
Root Cause Analysis Reports, Corrective Action Plans
12. Corrective and Preventive Actions
Verify preventive actions address potential nonconformities.
Do preventive actions address potential nonconformities?
12.2 Preventive Actions
Preventive Action Plans, Risk Assessments
Confirm the effectiveness of corrective and preventive actions is evaluated.
Is the effectiveness of corrective and preventive actions evaluated?
12.3 Effectiveness of Actions
Effectiveness Evaluation Records, Follow- up Reports
Ensure opportunities for improvement are identified and acted upon.
Are opportunities for improvement identified and acted upon?
13.1 Improvement Opportunities
13. Continual Improvement
Improvement Logs, Action Plans
Verify continual improvement is monitored and reviewed regularly.
Is continual improvement monitored and reviewed regularly?
13.2 Monitoring Improvement
Improvement Monitoring Records, Review Minutes
Ensure suppliers are evaluated and selected based on their ability to meet requirements.
Are suppliers evaluated and
14.1 Supplier Evaluation
Supplier Evaluation Records, Selection Criteria
14. Supplier Management
selected based on their ability to meet requirements?
Verify that supplier performance is monitored and reviewed regularly.
Is supplier performance monitored and reviewed regularly?
14.2 Supplier Performance Monitoring
Supplier Performance Reports, Review Logs
Confirm supplier audits are conducted as per the defined schedule.
Are supplier audits conducted as per the schedule?
14.3 Supplier Audits
Supplier Audit Plans, Audit Reports
Ensure control over outsourced processes affecting product conformity.
Is there control over outsourced processes affecting product conformity?
14.4 Control of Outsourced Processes
Outsourcing Agreements, Control Procedures
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