FMEA: Anticipating and Preventing Process Failures Before They Happen

In any organization, regardless of industry or size, processes are the backbone of operations. From procurement and hiring to manufacturing and design, processes drive value delivery. However, each process carries an inherent risk: the risk of failure.

As project professionals, we're well acquainted with Murphy's Law - “Anything that can go wrong will go wrong.” But what if we could flip the script? What if we had a structured way to anticipate potential problems before they occur, and better yet, reduce or eliminate their impact? Enter FMEA - Failure Modes and Effects Analysis.

This article explores FMEA from a practical, project-based perspective. Whether you're in construction, manufacturing, healthcare, or IT, understanding how to implement FMEA can dramatically improve your ability to manage risk, drive performance, and increase stakeholder confidence.

What Is FMEA?

Failure Modes and Effects Analysis (FMEA) is a structured approach for identifying and prioritizing potential failures in a system, process, or design. Its purpose is to prevent problems before they occur, not react to them after the damage is done.

Initially developed by reliability engineers in the 1960s for NASA’s Apollo Space Program, FMEA has since become a standard tool across various industries, including automotive, aerospace, healthcare, and even service delivery.

FMEA helps project teams:

• Identify what could go wrong (failure modes)

• Assess the impact and severity of each failure

• Estimate how frequently it might occur

• Evaluate the ability to detect the failure before it causes harm

• Prioritize mitigation efforts based on the most critical risks

Types of FMEA: Design vs. Process

FMEA is typically applied in two distinct contexts:

1. Design FMEA (DFMEA): Focuses on analyzing potential failures in the design of a product or service.Examples:

   
   

   • Designing a new piece of medical equipment

   • Developing a software application or mobile device

   • Constructing a new hospital or plant layout

   
   

2. Process FMEA (PFMEA): Focuses on potential failures in a process - any sequence of activities that transforms inputs into outputs.Examples:

   
   

   • Manufacturing operations

   • Employee onboarding

   • Procurement or supply chain logistics

Despite their differences, the methodology remains essentially the same for both types.

How FMEA Works: Step-by-Step

FMEA is both analytical and collaborative. It typically involves a cross-functional team that brings diverse insights into how a process or product might fail.

Step 1: Identify the Process or System Under Review

Begin by defining the process, design, or system you wish to analyze clearly. This could be a whole workflow or a single component.

Step 2: List the Functions or Process Steps

Break down the process into logical steps or the system into its functions and components. Each step is examined for potential issues.

Step 3: Identify Potential Failure Modes

Ask: “What can go wrong?” This could include breakdowns, malfunctions, errors, or deviations from specifications. Each of these is a failure mode.

Step 4: Determine the Effects of Each Failure

For every failure mode, consider: “What happens if this failure occurs?” This is the effect of failure. Think in terms of safety, quality, customer satisfaction, compliance, etc.

Step 5: Assign a Severity Rating (S)

Use a scale from 1 to 10, where 10 means the effect is catastrophic (e.g., injury, major customer impact), and 1 is negligible.

Step 6: Determine Causes and Assign Occurrence Rating (O)

Ask: “What could cause this failure?”Evaluate the likelihood of the failure occurring. Again, use a 1 to 10 scale - 10 means it’s highly likely, 1 means rare.

Step 7: Identify Current Controls and Detection Rating (D)

What mechanisms are in place to detect or prevent this failure? Rate the effectiveness of detection from 1 to 10, where 10 means the failure is unlikely to be detected before it causes impact.

Step 8: Calculate the Risk Priority Number (RPN)

The RPN is calculated as: RPN = Severity × Occurrence × Detection

This number helps prioritize which failure modes to address first. The higher the RPN, the greater the need for corrective action.

Example: Partial FMEA Table

Here’s a simplified example of an FMEA for a document approval process:

Process Step	Failure Mode	Effect	S	Cause	O	Current Control	D	RPN
Review Document	Reviewer misses error	Incorrect document released	7	Inattentiveness, time pressure	6	Peer review process	4	168
Submit for Approval	Wrong version submitted	Delay or rework	5	Poor version control	5	Manual check	6	150

Based on the RPNs, the team might decide to implement a checklist or an automated version control system to reduce the risk of error.

Interpreting the RPN

While RPN is a helpful prioritization tool, keep in mind:

• A high severity alone may justify action, even if occurrence and detection are low.

• Detection is often the weakest link; if a failure can’t be detected early, it can do serious harm.

• Use RPN trends over time to track improvements and validate risk reduction.

FMEA in Project Management

For project professionals, FMEA is invaluable for:

• Risk Management: FMEA integrates well into the risk assessment and mitigation planning phases of a project.

• Quality Assurance: In quality-centric industries (like automotive or pharma), FMEA supports ISO, Six Sigma, and APQP practices.

• Stakeholder Confidence: Demonstrating proactive failure analysis enhances trust and transparency with clients and regulators.

• Continuous Improvement: FMEA is not a one-time activity. It should be updated as processes change, new data emerges, or incidents occur.

Best Practices for FMEA Success

1. Cross-functional Collaboration: Include operations, engineering, quality, and safety personnel to capture diverse perspectives.

2. Be Specific, Not Generic: Clearly define failure modes. Avoid vague statements like “it may not work.”

3. Focus on High-Impact Areas: Don’t waste time analyzing every step in a process. Use the Pareto Principle - start where the risk is most significant.

4. Update Regularly: Treat the FMEA as a living document. Review it during significant process changes or after incidents.

5. Link FMEA to Action: Use the RPN to trigger concrete improvements. Assign owners, deadlines, and follow-up mechanisms.

Conclusion: From Reaction to Prevention

FMEA is more than a risk tool - it’s a mindset shift. It helps teams move from reacting to problems to preventing them altogether. When done well, FMEA strengthens processes, improves product reliability, and builds a culture of proactive problem-solving.

In project-based environments where delays and failures carry high costs, mastering FMEA isn’t optional - it’s essential.

As the saying goes, “Whatever can go wrong will go wrong.” But with FMEA, what can go wrong becomes what won’t go wrong - because you’ve already planned for it.