an operation. This lot/material collects engineering data from
the equipment, calculates derived parameters or indicators in
real time, associates them with the lot in electronic data collection, and posts the data into a statistical process control (SPC)
chart. If it detects a deviation, the system can hold the lot in
question and trigger an automatic CAPA protocol.
This is a typical manufacturing workflow used often in
many discrete industries. If MES/MOM and quality management are disparate systems, interoperability is still possible.
But it implies a tremendous effort for the different scenarios.
And far from being a one-time effort—such integration needs
to be monitored, maintained and evolved.
3. Master Data
If the subsystems, despite being interoperable, belong to different platforms, one of the most difficult aspects (which often is
ignored), is the master data (i.e., non-transactional data entities). The master data may include flow, step, resources, states
or parameters, and other information that manufacturing and
quality will need to be effective.
The master data elements are necessary for an MES transaction (moving a lot into an operation, for example) as well
as for a quality functions (such as CAPA, incoming material
inspections or operator quality instructions). If the systems
are separated, there are only two possibilities: Master data is
duplicated, or it is synchronized from an external master data
A master data system includes a set of processes, governance and tools to consistently define and manage the master
data. The effort associated with removing duplicates, removing
incorrect entered data and overall data synchronization and
standardization can become huge.
If all these functions and features belong to the same
4. Electronic Device History Records
platform, the master data can be unique, created and man-
aged within the same system, saving significant time and ef-
fort, not to mention the potential elimination of errors caused
by wrong master data.
The U.S. Food and Drug Administration’s CFR Title 21 requires manufacturers to maintain device history records
(DHR) for each batch or lot, to demonstrate it has been built
in accordance with its device master record, and must include
all dates, quantities, acceptance records, labels and device
identifiers along the manufacturing steps.
DHRs traditionally have been maintained by paper records, including production travelers and other documentation collected into the final record. Its electronic paperless
version, the eDHR, when implemented in the same MES/
MOM platform, automatically captures all required information in real-time and maintains an always accessible complete set of DHRs for every unit in the production line. In
fact, the DHR doesn’t even need to be built, as it represents
a view of the complete history records maintained by MES
systems for quality related purposes.
Furthermore, this same eDHR implemented in the MES
allows immediate navigation into related reports or more
detailed information from within the same system. So beyond regulatory compliance, this approach allows visibility
and traceability into manufacturing operations. In this environment, problem resolution practices can be implemented
easily, effectively and quickly as the MES provides real-time
information and guidance.
5. Additional Regulatory Compliance
Beyond the eDHR, several other CFR21 requirements are significantly easier to comply with if implemented in a common shop-floor platform. This includes system validations, audit trails, electronic signatures and documentation.
A few examples include:
certification modules, which automatically allow only cer-
tified personnel to perform certain types of transactions at
given steps and for given products.
two different persons or roles, which can be implemented
in the MES system with the associated electronic records
and audit trails.
determine the validity of the source of data input or operational instruction.
modern MOM platforms, particularly important given the
specific dynamic shop-floor context required to print the
right information on labels.
6. Integrated CAPA
In the same study, Advancers have achieved major improvements
Figure 2. More of the successful Advancer medical device companies
have information flows among MES/MOM and all their other enterprise
0% 20 40 60 80 100%
Interoperability between MES/MOM and other major applications
n Advancers n Others