METHODOLOGY FOR FAILURE MODE AND EFFECTS ANALYSIS (FMEA)

Client: M/s ___ Title: METHODOLOGY FOR FAILURE MODE AND EFFECTS ANALYSIS (FMEA)
21/03/2026	A	Draft	SS	YSG	YSG
Date	Rev	Remarks / Revision Summary	Prepared	Checked	Approved
			HSE RMSPL
REVISION RECORDS

 

 

DISCLAIMER

HSE Risk Management Services Private Limited accepts no liability or responsibility whatsoever for it in respect of any use of or reliance upon this Methodology by any third party.

Copying this Methodology without the permission of HSE Risk Management Services Private Limited is not permitted.

OBJECTIVE

The objective of the Failure Mode and Effects Analysis (FMEA) is to systematically identify potential failure modes of equipment, systems, or processes, evaluate their effects on system performance, and prioritize risks based on severity, occurrence, and detectability.

The study aims to ensure that potential failures are proactively identified and mitigated to reduce risks to personnel, environment, assets, and operational reliability, and to define necessary corrective and preventive actions.

SCOPE

The scope of the FMEA includes:

• Equipment and machinery systems
• Process systems and sub-systems
• Electrical and instrumentation systems
• Control systems and automation components
• Mechanical components and assemblies
• Human interactions and operational practices

FMEA is typically applied during:

• Design stage (Design FMEA – DFMEA)
• Process stage (Process FMEA – PFMEA)
• Modification or upgrade of existing systems
• Reliability and maintenance improvement studies

Reference/ International Standards & Guidelines for FMEA

1. IEC 60812 – Failure Modes and Effects Analysis (FMEA)
2. AIAG & VDA FMEA Handbook
3. ISO 9001 – Quality Management Systems
4. ISO 31000 – Risk Management
5. SAE J1739 – FMEA Standard
6. CCPS Guidelines for Risk Based Process Safety

ORDER OF PRECENDENCE

1. As per Client Guidelines
2. National & International reference books.

Proposed Methodology

1. Introduction
2. FMEA follows a structured and systematic approach to identify failure modes, analyze their consequences, and prioritize actions based on risk ranking.
   1. Methodology
3. System / Process Breakdown<br>The system is divided into manageable elements such as equipment, components, or process steps for detailed analysis.
4. Form the FMEA Team

Minimum Team Composition

• FMEA Facilitator / Leader
• FMEA Scribe
• Process Engineer
• Design / Mechanical Engineer
• Electrical / Instrumentation Engineer
• Operations Representative
• Maintenance Engineer
• HSE / Safety Engineer
• Identification of Safety-Related Signals<br>Define the intended function of each system, sub-system, or component.
• Identification of Failure Modes<br>Identify all possible ways in which each component or system can fail (e.g., failure to start, leakage, blockage, incorrect operation).
• Identification of Effects of Failure<br>Determine the consequences of each failure mode on:
• System performance
• Safety
• Environment
• Production
• Identification of Causes of Failure<br>Identify the root causes for each failure mode such as:
• Design deficiencies
• Material failure
• Human error
• External conditions
• Current Controls / Safeguards Identification<br>Identify existing controls that prevent or detect failures, such as:
• Alarms and interlocks
• Preventive maintenance
• Inspection systems
• Operating procedures
• Risk Evaluation (RPN Calculation)<br>Risk is evaluated using: RPN=S×O×D

Where:

• S = Severity
• O = Occurrence
• D = Detection
• Risk Prioritization

Failure modes are ranked based on Risk Priority Number (RPN) to identify critical risks requiring action.

• Recommendations and Actions

Recommend corrective and preventive actions to reduce:

• Severity
• Occurrence
• Improve detection
• Re-evaluation of Risk

After implementing actions, reassess RPN to confirm risk reduction.

1. Documents Requirement

Essential documents include:

1. P&IDs / Process Flow Diagrams
2. Equipment datasheets
3. Design documents
4. Maintenance records
5. Failure history data
6. Operating procedures
7. Control philosophy
   1. Project Deliverables

Table 1:FMEA Study

Sr. No.	Document Deliverable
	Executive Summary
	Document Review
	Submission of terms of reference
	FMEA Methodology
	FMEA Worksheet
	List of failure modes and effects
	Risk ranking (RPN) summary
	Critical failure modes list
	Recommended actions with responsibilities and timelines
	Updated risk register
	Participant attendance sheet

1. Fundamental Assumption

The FMEA Methodology is based on the following assumption:

• System design information is available and accurate
• Failures are considered one at a time unless otherwise justified
• Historical and expert judgment data are used for evaluation
• Detection mechanisms are assumed to function as designed

1. Software to be used
2. PHA Pro version 8.19 software.
3. FMEA worksheets (Excel-based or client-specific formats)