Regarding Configuration Management: Benefits of MES for CM [Part 6 of 6]
Discussing the Benefits of MES for CM
The use of manufacturing execution systems (MES) to support configuration management (CM) has a number of specific benefits for medical device manufacturers, including:
- Verification that products are manufactured per approved designs (i.e., per the DMR)
- Provision of objective evidence of compliance with 21 CFR Part 820.184 and 820.200 regulations
- Production of an electronic Device History Record (eDHR)
- Enabling export of “as built” configurations to support installation and maintenance procedures
- Minimizing risk of non-verified/non-compliant device configurations
For those medical device organizations using MES in CM efforts, the following benefits have been observed as typical:
In manufacturing:
- Product quality
- Right first time execution, globally
- Assurance that right configuration is tested/assembled
- Better product design based on data visibility
- The ability to search and contain suspect units rapidly
- Operations excellence
- Elimination of non value-added activities (with eDHR)
- Higher productivity, lower cycle times, increased throughput
- Lean enablement and single piece flow
- Support of continuous manufacturing improvement initiatives
In service and repair:
- Product quality
- Online availability of eDHR
- Faster root cause analysis
- Right first time service/repair (enforcement)
- The ability to search and contain suspect field units rapidly
- Operations excellence
- Elimination of non value-added activities
- Faster turnaround, higher efficiencies
- Continuous product enhancements/improvements
- Operations excellence
In today’s increasingly complex and competitive medical device manufacturing marketplace, where emerging markets are taking on an increasing role in revenues, benefits such as these can provide a healthy competitive edge.