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Areas of Concern - Reliability & Quality |
The medical device industry has several areas of concern for FMEA's:
- Lack of corporate consistency of FMEA documents
- Controlling supplier quality
- Problems with tracking changes - not all changes are recorded
- Lack of follow up to the changes to see if they are actually solving the problem
- Some companies do not think that they have a problem and therefore see no value in FMEA's
- Companies realize they need to perform an FMEA when it is too late
- Many companies do not know how to perform an FMEA properly
- Untrained staff performing FMEA's
- Engineers do not see the value in an FMEA, they find them too labor intensive
The Fundamental Purpose of FMEA is to identify problems and improve quality, product and process.
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