FMEA

The Language of Lean
Written By Lukas Breucha

Failure Mode Effects Analysis - FMEA

The method of the FMEA - Failure Mode and Effect Analysis has been used for years in the automotive and manufacturing industry.

The risk analysis framework has been applied in a wide range of industrial sectors. The first areas of application were traditionally in product development. Based on this the integration of the production process planning and the production. In the automotive industry, the joint creation of FMEA for products and processes by Today customer, supplier and subcontractor are a natural part of a cooperation. 

The user is guided through the "10 Steps to Creation of the FMEA".

Step 1 - Review the process

  • Use a process flow chart or an already existing value stream map to identify each part of a process

  • List all process steps in a FMEA table

  • If you think the list gets too long it might is. Use this chance to split up the process and cut the elephant. It makes more sense to work on smaller parts of the process instead of getting lost in the woods.

Step 2 - List potential failures

  • Review all existing data and documents that can give you a hint about each component that can lead to a failure

  • After having a complete list try to cut it down and to combine the parts of the initial list

  • The chances are high that you will identify several potential risks of failures for each component

Step 3 - List potential effects of failures

  • The effect is the outcome of a failure on the finished good or a process step

  • It is common that not only one effect will occur for a single failure, don’t be suprised

Step 4 - Assign the level of failure to risks

  • This is based on the consequences for each failure

  • Think about the ranking as the worst impact that it can have

Step 5 - Assign the possibility of occurrence

  • How high is the possibility of occurrence

  • What impact will it have if occur

Step 6 - How can it be detected

  • What are the chances that you will detect the failure before occurring

Step 7 - Calculate the RPN (Risk Priority Number)

  • Severity (S)

  • Severity x Occurence (S x O) = criticality

  • Severity x Occurence x Detection (S x O x D) = RPN

Step 8 - Define the action plan

  • With the decision making process followed by the prioritization from the RPN (Step 7) focus on the topics with the highest RPNs

  • Follow a classic action plan by defining who will be doing what till when

Step 9 - Take action

  • Get things done!

  • Implement the defined improvement actions

  • Follow the PDCA principle

    • Plan - done

    • Do - right now

    • Check - Step 10

    • Act - loop starts over

Step 10 - Re-evaluate the RPN

  • Time to check on the impact of your actions

  • Re-evaluate each potential failure identified and determine if the improvement measures have an effect or not

  • If not follow the PDCA and start over with step 8

The FMEA is linked to all CIP and Kaizen activities - there is always something to improve.

Lukas Breucha https://www.operationsinsider.com
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