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Why FMEA is Critical in Medical Cart Manufacturing

Posted by Brittany Beckmann on February 18, 2016

Customers who entrust a manufacturer with their medical cart design and production have high expectations about quality and reliability. That’s understandable, and it’s also why manufacturers need to plan for failure in order to prevent it.

Good medical cart manufacturers rely on failure mode and effects analysis (FMEA) to identify and eliminate potential defects early in the process in order to avoid costly late-stage correction. The result? Quality medical carts, pride in craftsmanship and satisfied customers.

What’s FMEA?

Failures Modes and Effects Analysis, or FMEA, presents an effective method for identifying any plausible issues or concerns that may arise in any given design or redesign project.

Dissecting the name further provides a better understanding of the process. “Failure modes” refers to how and the number of ways something might fail, and the actual or plausible negative effects. “Effects analysis” refers to the analysis of the failure modes and their impact.

What are DFMEA and PFMEA?

There are two types of FMEA that are tailored toward specific points of focus: Design Failures Modes and Effects Analysis (DFMEA) and Process Failure Modes and Effects Analysis (PFMEA).

DFMEA

Design Failures Modes and Effects Analysis (DFMEA) typically occurs during the design stage of a project in order to:

  • Determine how the design may fail
  • Assign a coordinating ranking
  • Take necessary action

DFMEA is revisited throughout the entirety of the project to ensure safety during the evolution of the design.

PFMEA

Process Failure Modes and Effects Analysis (PFMEA) takes place prior to the product being made and emphasizes manufacturing process outcomes, including:

  • The number of errors that occur
  • The effect of the errors
  • Ways to eliminate errors
  • Determination of if the product will get to the customer on time, without defects

While DFMEA and PFMEA have distinct focuses, they are both based on a points system that indicates when the team needs to take action on potential failure modes.

DFMEA and PFMEA play critical roles in:

  • Brainstorming potential failures
  • Examining the effects of those failures
  • Determining the severity of a failure and its detection rating
  • Assigning the Risk Priority Number (RPN)

If the RPN reaches a certain level, the team develops and executes a plan of action. Afterwards, team members repeat the process to evaluate their actions’ success.

What’s MFMEA?

Materials Failure Modes and Effects Analysis (MFMEA) is a process specific to HUI. While similar to other FMEA processes, MFMEA emphasizes materials, specifically the risk of material outages caused by suppliers or other circumstances, and material delivery lead-times. Supplier quality is researched and discussed thoroughly for optimal results. In some cases, this leads to developing a contingency plan.

MFMEA accounts for the volume requirements, the need for any unique and raw materials, their availability and tooling requirements.

Taking this “extra step” approach to medical cart manufacturing ensures HUI produces superior, defect-free products that consistently exceed customer expectations.

To learn more about FMEA, like the mechanics of the scoring system, check out the details online, or contact us today. We’re happy to help!

HUI 60601-1 Third Edition Cheat Sheet

Topics: Insider


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