PFMEA (Process Failure Mode and Effects Analysis): -Identify Failure Modes &Determine Effects of Failure

 Step 2 – Identify Failure Modes 

The second step in the PFMEA process is to identify potential failure modes—in other words, to examine how a process, product, or component might fail to meet its intended function. Failure modes can arise from various sources, including human factors, mechanical issues, or system-level flaws. Recognizing these modes early helps prevent problems before they impact quality, safety, or performance.

Types of Failures:

1. Human Errors
   Mistakes made by operators or employees, such as incorrect assembly, skipped steps, or poor judgment, can lead to process failures.

2. Machine Failures
   These include equipment malfunctions like breakdowns, wear and tear, or calibration errors.

3. System Defects
   Flaws in software, design, or workflow systems that affect how the entire process functions.

Root Cause Analysis Techniques:

To effectively prevent or correct failure modes, it’s crucial to understand why they occur. Root cause analysis tools help identify the underlying cause of a problem:

1. 5 Whys Technique
   Ask “Why?” repeatedly (typically five times) to drill down to the root of the issue.
   Example:

   • Problem: Product not delivered on time

   • Why 1: Machine stopped

   • Why 2: Overheated

   • Why 3: Cooling system failed

   • Why 4: No maintenance done

   • Why 5: Maintenance schedule not followed

2. Fishbone Diagram (Ishikawa)
   A visual tool that categorizes possible causes of a problem into groups such as People, Machines, Methods, Materials, Environment, and Measurement. It helps teams brainstorm and analyze all possible causes.

 Real-World Examples:

• A pharmaceutical packaging line stops due to a sensor malfunction (machine failure), delaying shipment.

• An operator forgets to tighten bolts in an engine assembly, causing product recalls (human error).

• A software glitch in an online order system causes duplicate orders (system defect).

These failures can cause delays, cost overruns, customer complaints, and even legal issues.

 Step 3 – Determine Effects of Failure 

Once failure modes are identified, the next step is to analyze their potential effects. This means understanding how each failure impacts the process, product, safety, and customer satisfaction.

Impact Areas:

1. Production Impact
   Failures can halt production, increase scrap/rework, or reduce overall efficiency.

2. Safety Impact
   Some failures may lead to workplace injuries, environmental hazards, or health risks.

3. Customer Satisfaction
   Defective products or delays can result in poor customer experience, loss of trust, or reputation damage.

 Short-term vs. Long-term Consequences:

• Short-term: Immediate losses such as downtime, waste, and overtime costs.

• Long-term: Deeper impacts like decreased brand loyalty, increased maintenance needs, and regulatory issues.

 Classification of Effects Based on Severity:

Effects are typically classified using a Severity Rating Scale, often from 1 to 10, where:

• 1–3: Minor inconvenience, easily fixable, no major impact.

• 4–6: Moderate impact, may require some rework or process adjustments.

• 7–10: Serious impact, possible safety risk or major customer dissatisfaction.

This classification helps prioritize which failures must be addressed first.