Our recent posts on the importance of Configuration Management (CM) in the medical device industry focused on defining the practice and why it is strategic for the sector, as well as the challenges it presents. This post addresses the support manufacturing execution systems (MES) and other systems provide in meeting those challenges.
According to Mike Cislo, specialist leader at Deloitte Consulting, MES plays three principal roles in supporting CM:
- Its primary role is to ensure that products are manufactured in accordance with approved design configuration and manufacturing specifications defined in the Device Master Record (i.e. to execute the electronic procedures developed by MES). In this role, it also enables automatic creation and export of an electronic Device History Record (eDHR) in a technology-neutral format to support post-manufacturing CM requirements.
- MES also supports design transfer and manufacturing procedure definition. It transforms manufacturing and test procedures into electronic procedures that specify the processing steps, materials, equipment, and training certifications for each operation or workstation. Further, it transforms developed procedures and workflows to the DMR with Product Lifecycle Management, where they can be reviewed, released for use, and transferred to production facilities. It also transfers routing diagrams to electronic workflows that can be used to manage the flow of production orders through operations.
- MES also provides strong support for service depots by transforming service procedures into electronic procedures, including the disassembly process, materials to be removed, and re-assembly procedures. It also employs the test procedures developed for manufacturing to test repaired or refurbished products, and initially develops the service procedures to support rework.
In terms of electronic data transfer, MES will collaborate with the Engineering Change Control process managed by PLM to create or revise DMR components that guide manufacturing. It receives the engineering bill of materials from PLM, and for each level of the BOM will obtain the DRM index, DRM components, and their associated artifacts. “This is the ability to communicate the DMR to systems that support production and quality operations in a manufacturing facility,” says Cislo. In order to that, MES:
- Defines all manufacturing and test procedures in a form that can be interpreted by downstream systems.
- Uses the downstream execution systems to model those procedures and give them back to PLM as part of the engineering change process to then be used for design transfer into the production manufacturing environment.
“In developing a DMR, you end up with a leveled DMR, where there is an index for each level,” explains Cislo. “The index points to a version-specific DMR component where manufacturing, test, and packaging procedures are defined.”
What works best in facilitating electronic design transfer is to have MES author or source DMR components. When you get to that point in the engineering change process, MES makes changes to the bill of materials based on changes and routes to PLM. “The development of the DMR is a collaboration between MES and PLM, with MES taking the yeoman’s share of work in defining manufacturing procedures,” says Cislo.
With respect to service, MES supports service depots in device tracking, process flow control, and test data management. MES plays a key role here by automating the process, representing service and repair procedures in the same way manufacturing procedures were represented, and supporting the “as-serviced” configuration in the DHR.
The benefits of MES to successfully implementing CM are considerable:
- 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 eDHR
- Enabling the report of “as-built” configurations to support installation and service
- Minimizing risk of non-verified and non-compliant device configurations
As new products and technologies proliferate, regulatory pressures increase (and vary across different markets), and the global marketplace continues to become more volatile and complex, these benefits are considerable as Configuration Management becomes more essential to conducting business successfully.