The natural tendency of many individuals and organizations when presented with a problem is to jump to a solution, any solution. They do not systemically analyze the problem to determine a root cause before considering potential solutions. Reliability engineering and predictive maintenance have two major objectives: Preventing catastrophic failures of critical plant production systems and avoiding deviations from acceptable performance levels that result in personal injury, environmental impact, capacity loss or poor product quality.
This course provides clarification of regulatory expectations and guidance and the essential skills necessary to ensure effective and efficient investigations. Topics will examine each step of the investigation process from failure identification and notification through documentation. Participants will practice root cause analysis techniques and identify corrective and/or preventive actions towards successful remediation.
At the end of this course, you should be able to:
This course is designed for personnel who are responsible for the failure and deviation investigation process in a GMP (Global Process Management) Environment and Maintenance Engineers. This course will be practical in its application and particularly valuable to those newer to this field or those who wish to refresh their knowledge of root cause analysis and investigative techniques.
1. What is failure
2. Understanding the roots
3. RCA Techniques
4. Pareto Analysis
5. Fishbone Diagram
6. HUMAN ERROR & ITS CAUSES
7.Risk management
8. RCM Principles and Methodology
9.FAILURE REPORTING
10.ANALYSIS
11.Maintenance management system
12. Preventive / Corrective Actions (CAPA) Guidelines
Note:
Pre & Post Tests will be conducted.
Case Studies, Group Exercises, Group Discussions, Last Day Review & Assessments will be carried out.
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Define Management Consultancy & Training Certificate of course completion will be issued to all attendees.
A highly interactive combination of lectures and discussion sessions will be managed to maximize the amount and quality of information and knowledge transfer. The sessions will start by raising the most relevant questions and motivating everybody to find the right answers. You will also be encouraged to raise your questions and to share in the development of the right answers using your analysis and experiences. Tests of the multiple-choice type will be made available daily to examine the effectiveness of delivering the course.
Very useful Course Materials will be given.
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