No manufacturing company can afford to skimp on quality. Amongst the techniques used today to achieve the highest possible quality and reliability are: Failure Modes and Effective Analysis (FMEA) and Control Plans.

The difficulty for most companies is not in the creation of these documents, but in the availability, maintenance, and control of them. Additionally, documents created in isolation don’t lend themselves to the need to run metrics (for future product improvement) and reports against the FMEA data.
A current and accessible AIAG compliant FMEA is often required to meet quality and safety standards, such as ISO 9001, QS 9000, IS/TS 16949, Six Sigma, FDA Good Manufacturing Practices (GMP’s), and the Process Safety Management Act.
The FMEA, Control Plans, and Process Flow Charts are linked, living documents. When a process or product changes, they need to be reviewed, along with other associated manufacturing documents, such as Work Instructions. Within EASEworks, all documents can be controlled using the Manufacturing Change Request Module as well as having individual release, revision, and sign-off.
Control Plans assure a system is in place to control the risks of the same failure modes as identified in the Process Failure Modes and Effects Analysis (PFMEA). Control Plans and Process Flow Charts can be developed independently of PFMEA’s. This is inefficient and leads to documents that are not synchronized and may not have been updated.

Benefits of Using EASEworks and FMEA


EASEworks integrates the Process Flow, the FMEA, and the Control Plans. Output is a revision controlled XLS document. All input is in the database for metrics. Every process must have at least one FMEA line item. Each FMEA line item must have a corresponding Control Plan item.


Each FMEA has revision control, change history, and complete copies of prior versions stored in a database.


FMEA’s are indexed by location (station/machine) and/or process.


Released FMEA’s are available via your Intranet as Excel documents.


Lean means change, and change means maintaining documents that reflect the change. Live links between PFMEA, Control Plans, and Change Control makes maintaining these documents effectively a reality.


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