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The page below is a sample from the LabCE course Understanding and Utilizing Lean and Six Sigma in the Histology Laboratory. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Failure Mode Effect Analysis (FMEA)

Any project has some degree of risk associated with the organization's ability to create outcomes that meet customer's expectations. The failure mode effects analysis (FMEA) is a tool that is used to identify specific ways that a product, service or process may fail in meeting customer expectations. It can be extremely helpful in visualizing and specifically identifying ways to improve process performance, reliability, and safety particularly in a new product design or new process implementation. FMEA can also be used in existing processes to test the effectiveness of a proposed solution to a process problem. FMEA helps in the prevention of the occurrence of likely problems through identification and design of preventative or corrective measures.
An FMEA team typically consists of 6-10 people or stakeholders who analyze the voice of the customer (VOC) data and root cause information for the process being examined. The FMEA tool will assist in identification of every potential failure and the likely defects within a process-whether existing or merely proposed. The effects and risk of these failures can then be estimated and ranked by using the risk priority number (RPN). The RPN is a qualitative value derived by multiplying the values assigned to severity of impact, probability of occurrence, and likelihood of detection.

RPN = "severity of impact" x "probability of occurring" x "likelihood of detection"

Use a scale of 1-10 to assign a rating, with 10 as the highest risk and 1 as the lowest. The failure mode (defect) having the highest RPN will receive the highest priority for control and correction. Feasible actions are then determined which will eliminate or greatly reduce anticipated process problems that are root causes for defects.

Advantages of FMEA
  • Helps in accumulating knowledge gathered by the team and its experience in identifying and preventing known defects and errors.
  • The approach is logical and structured, which helps focus on the real process areas of concern.
  • Aids in identifying critical to quality (CTQ) characteristics.
Types of FMEA
  • Process FMEA is used to analyze processes when the main criteria being evaluated is the identification of failures or errors to produce a wishful requirement.
  • System FMEA is used to analyze a proposed process for weak points during its initial design to avoid future problems or defects.
  • Design FMEA analyzes the components of a process individually and focuses on the probability of failure in each component due to some fault in design, the "weak links" in a proposed process.

FMEA Template [click to view / print]

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