Interview Neil Roche, Snr Global Technical Consultant , Enterprise System Partners, Ireland
we.CONECT:
Please describe the business of your company:
Neil Roche, ESP:
ESP (Enterprise System Partners) provides global expertise in the complementary fields of MES & Serialization for the life sciences industry.
We offer specialist support and consulting services exclusively to manufacturing operations in biotechnology, pharmaceutical and medical devices.
Our expert consultants and engineers have delivered support to clients worldwide for the concept, planning, vendor selection, design and implementation of systems for the entire manufacturing landscape from process automation to the enterprise layer.
We have led the management of global and plant level deployments through the full project life cycle.
we.CONECT:
How do you see the role of MES evolving for life sciences manufacturers?
Neil Roche, ESP:
MES is still relatively new to life sciences, and as such it’s only in the last number of years that we are starting to see the widespread integration of MES between the automation & enterprise layers.
There has been a reluctance to tightly integrate MES to automation and enterprise. With the advances in the MES software offerings combined with the knowledge & experience acquired by the manufacturers, we are now seeing customers striving to yield more benefits from their MES investment.
we.CONECT:
What were the key drivers for implementing MES?
Neil Roche, ESP:
Improved product quality, reduction of cost and ultimately improved patient safety. There are often long lists of benefits that can be attributed to the introduction of an MES system, but at the end of the day the manufacturer is looking to the MES to help produce a product more efficiently, with fewer errors in a shorter lead-time.
In detailing an ROI this may be described as removal of human verification, elimination of double entry, reduced review or review by exception.
we.CONECT:
How does technology platform standardization help a global manufacturing company?
Neil Roche, ESP:
Global companies generally have a high degree of standardization within their IT systems and infrastructure. MES is no different and the benefits of standardization are many.
Use of the same platform, whether it’s the hardware, peripherals, operating system and MES software allows for leveraging of documentation, validation & technical expertise.
The standard platform allows sites to get up to speed more quickly, minimizing the need to start a completely new MES implementation every time a new site comes on-board.
we.CONECT:
How can individual sites handle their local requirements, such as languages, time zones, and shifts?
Neil Roche, ESP:
The software platforms themselves handle a lot of the localization, most of the systems will handle multi-language and time-zones, and shift patterns tend to be a site specific configuration.
The approach is really dependent on the company themselves, if other software is standardized to a set language such as English then it makes sense to be consistent and keep the MES the same. If the paper based batch records are localized to a different language then the equivalent electronic batch record should be in the same language.
we.CONECT:
What are manufacturers’ priorities when selecting an MES?
Neil Roche, ESP:
Many factors are assessed when selecting an MES system; How good a fit is the software for the manufacturing process, interfaces to existing and planned systems (level 2 & 4), the maturity of the software and vendor – is there a history of successful deployments in similar companies & processes?
Customers also look at the product road-map, what the vendor is planning for the software, future proofing for both platforms and requirements? Are there upgrade routes that avoid a lock-in to a particular version of the software?
There is also the question of ease of use for the customer and the front line users. What level of customization is required to make the system work for existing processes and systems?
The weighting a particular company will put on each of these factors will vary depending on the size of the company and the scope of implementations in different sites.
we.CONECT:
How are manufacturers gauging the success of implementations worldwide and collecting valuable feedback from local sites?
Neil Roche, ESP:
The manufacturers are looking to the metrics of time and expense with global rollouts. What they want to see is that the implementations are getting easier and more efficient as they progress. They want to see that lessons have been learned and that the overall MES knowledge-base is expanding.
It’s very important to gather the experiences of the local sites. Manufacturers need to have the sites invested in the process so that they can both leverage centralized knowledge and experience, and the local sites feel that they are contributing to this knowledge-base.
we.CONECT:
What are the main pitfalls in project management & execution?
Neil Roche, ESP:
It’s very important to scope out the project in as much detail as possible in the early stages with regard to tasks, resources, deliverables & budgets. If the investment isn’t made at the start of the project the execution phase will be troubled with lack of resources & time, ultimately distracting the project from the technical job at hand.
A strong management backing both globally and at a site level is also a key factor to successful roll-outs.
With the groundwork and management sponsorship in place the task of executing the implementation can be much more focused. There are always the unforeseen and unexpected problems to overcome, but with a strong foundation this in itself is easier to deal with.
Some of the pitfalls that show up regularly in system implementations are Training, Procedure updates and resource access (both equipment and personnel).
we.CONECT:
What benefit did a company achieve or expect to achieve from an MES investment?
Neil Roche, ESP:
The benefits manufacturers are looking for from MES investments are things such as; reduction in human error, faster approval of batches, easier access and visibility of batch data and process improvements.
In some cases the manufacturer is looking to grow and scale their business and find that trying to do this without MES and other software solutions is not feasible, considering the headcount required to run a paper-based operation.
we.CONECT:
What is in your opinion the benefit of an MES installation and how can manufacturers calculate a ROI?
Neil Roche, ESP:
As mentioned earlier there are many benefits gained by businesses through using an MES solution.
A lot of these benefits are easily measurable such as; number of people required to manufacture a batch, manufacturing lead-time, approval lead-times, number of errors relating to materials, equipment and other items now under to the control of the MES system.
The important thing is to have a set of measurements that are objective and can be quantified prior to, and after an MES implementation.
we.CONECT:
How can manufacturers use an MES in order to improve plant & production processes?
Neil Roche, ESP:
MES by its very nature introduces an extra level of consistency to the manufacturing process. Whether it’s as a result of recreating the batch record in an electronic format or having to define limits or rules required by the MES system to function, the net result is a better defined and consistent process.
The other factor which is starting to be tapped by the MES vendors and the manufacturers is the accessibility of data being recorded. In the same way that data historians allow analysis of data across time periods and batches, MES data is being recorded and can now be a repository of data for process improvement as well as problem containment.
Mr. Roche, thanks a lot for the interview.
Interview Partner: we.CONECT &
Neil Roche
Neil Roche is a Senior MES technical specialist with strong experience of PAS-X. He has more than 15 years’ industry experience with over 7 years’ experience implementing MES on global projects for ESP.