FMEA with Control Plans within EASEworks
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 Effects Analysis (FMEA) and Control Plans. The difficulties for most companies is not in the creation of these documents but in the availability, maintenance and control of them.
A current and accessible FMEA is often required to comply with safety and quality standards, such as ISO 9001, QS 9000, ISO/TS 16949, Six Sigma, FDA Good Manufacturing Practices (GMPs), Process Safety Management Act (PSM), etc...
There is also a need to run metrics (for future product improvement) and reports against the FMEA data.
The FMEA and Control plans 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 (also know as a Process Change Notice), as well as having individual release, revision and signoff.
Control Plans assure a system is in place to control the risks of the same failure modes as identified in the PFMEA. While Control Plans can be developed independently of PFMEAs, that is inefficient and leads to documents that are not synchronized and may not have been updated.
Why EASE?
Presenting, Indexing, Controlling and Reporting is where the Manufacturing Document Management module of the EASEworks suite of software excels. FMEA and Control plans are a natural fit.
The benefits of using EASEMDM include:
- Creation, Maintenance and Control of integrated process flow, FMEA and Control Plans
- Full release, revision control and history
- FMEA status and email escalation
- FMEA reports and pareto charts
- Inclusion of FMEA and Control plans within the Change Control system