The natural tendency of many individuals and organizations when presented with a problem is to jump to a solution, any solution. They do not systematically 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 toward successful remediation.
At the end of this course you should be able to:
Failure Analysis
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
-THE CAUSES OF FAILURES
-The purpose of RCFA (Root cause failure analysis)
-EFFECTIVE USE OF THE ANALYSIS
-PERSONNEL REQUIREMENTS
-When to use of RCFA method
2. Understanding the roots
- PHYSICAL ROOTS
- HUMAN ROOTS
- Problem-Solving Process
- Define and Verify Root Causes
- Corrective Actions
3. RCA Techniques
The Fault Tree Approach& Role of Fault Trees in a PRA
The 5(five) whys
Fault Tree Analysis
Fault tree construction
4. Pareto Analysis
5. Fishbone Diagram
6. HUMAN ERROR & ITS CAUSES
7. Risk management
-QUANTITATIVE RISK (QRA)
-QUALITATIVE RISK
-Performance measurement
8. RCM Principles and Methodology
-RELIABILITY AND RISK PREDICTION
-ACHIEVING RELIABILITY AND SAFETY-INTEGRITY
-FAILURE RATE AND MEAN TIME BETWEEN FAILURES
-THE METHODOLOGY
-THE RELIABILITY PREDICTION METHOD
-The RCM task selection
-Methods of modeling
-The RCM implementation
-FMEA (FAILURE MODE AND EFFECT ANALYSIS)
-SAFETY INTEGRITY LEVELS (SIL)
9. FAILURE REPORTING
-Collecting the Data
-Reporting Equipment Failures
-Reporting Software Problems
10. ANALYSIS
Failure Analysis Process
Failure Review Board
Root Cause Analysis
Failed Parts Procurement
Corrective action
11. Maintenance management system
-Reactive Maintenance
-Preventive Maintenance
-Predictive Maintenance
-Proactive Maintenance
-Reliability Centered Maintenance
-Equipment Reliability Metrics
-Lateral learning
-LEARNING FROM FAILURE
-Performance monitoring
12. Preventive / Corrective Action (CAPA) Guidelines
-Corrective Actions
-Preventive Actions
-Differences between Corrective and Preventive Actions
-CAPA Procedures (Report Source, Explanation of the Problem, Evidence of the Problem.)
-Evaluation (Potential Impact Assessment of Risk. Remedial Action.)
-Investigation (Objective, Procedure, Responsibility / Resources.).
-Analysis (Possible Causes / Data Collection, Results and Data, Root Cause Analysis)
-Action Plan.
-Action Implementation
Note:
Pre & Post Tests will be conducted
Case Studies, Group Exercises, Group Discussions, Last Day Reviews & 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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