MES | Page 3 of 4 | Seabrook Technology Group

MES | Page 3 of 4 | Seabrook Technology Group

Process Changes and Quality Control for Medical Device Manufacturers

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When we talk about managing process changes in an environment using MES the first benefit we see is the environment already has tighter controls in place. This means the process of changing our environment has to be more tightly controlled.

The second key element is the process changes are enforced. This prevents an operator from reverting to a previous method, tool, or material. An operator that hasn’t been trained on the new operation, is restricted from continuing the manufacturing process.

A strong validated MES is one that has been configured to include key data collection, well defined specifications, and a complete product workflow. A strong validated MES, can provide more effective real-time enforcement and make training simpler.

The ultimate goal of a paperless manufacturing solution is to have compliance be a by-product of operational excellence. Because MES can maintain device history in real-time, you are able to provide batch history records and/or device history records quickly and efficiently. Beyond the BHR and DHR, MES provides greater visibility into the history of manufacturing. Unlike a paper solution, your stored information is structured. From structured information a variety of reports can be generated on demand. Reports such as preventative maintenance, operator training, and non-conformance resolutions. All of this information becomes very valuable when showing your process well defined and followed.

To learn more, click here to request a recording of the presentation.

Why MES can – and does – work for SMBs

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A question often posed by smaller and medium sized manufacturing enterprises, is whether they really need a Manufacturing Execution System (MES). Sometimes they will argue that because of their size and the volume of their output, they have no need for MES. Regardless of the size of a manufacturing organization however, MES is necessary to achieve lean manufacturing, operational excellence and, will become even more mission critical as we edge closer to Industry 4.0.

This is especially true for medical device manufacturers. Heavily regulated industries need robust tracking and tracing capabilities. Manufacturing processes in this sector are becoming increasingly complex in order to keep up with the demand for more sophisticated products and in order to comply with more stringent regulations. Whether you are a small manufacturer or a global giant, you will have to produce devices of unprecedented quality, while simultaneously complying with ever stricter regulations in order to remain relevant and competitive.

MES and Lean Manufacturing

Reducing the cost of goods sold through lean manufacturing and the elimination of waste is a target for every medical device manufacturer, regardless of size. Eradication of waste can be achieved easily with MES. For example, it facilitates a paperless system.

In an assessment we undertook for a cardiac resuscitation device company that implemented Camstar MES, we found that there was an $88,000 reduction in paperwork management costs and a $32,600 drop in paper costs, storage and boxing costs. Benefiting from cost reduction while moving towards lean manufacturing is advantageous for SMBs in such a competitive industry as medical device manufacturing.

MES and accurate reporting of real-time data

A manufacturer’s future competitive advantage will be contingent on the integration of accurate and real-time data from the shop floor to the business floor. Medical device manufacturers of all sizes need to ensure that the machines on the factory floor are communicating with each other and with the organization’s enterprise level systems. MES facilitates this communication. It also removes the risk of human error from manual inputting of data.

MES can feed back real-time data from the factory floor that is precise and that identifies and corrects operational problems and issues. The visibility of this real time data allows manufacturers to take immediate action. These rapid responses are crucial in today’s market. Any improvements on the shop floor are also communicated with precision and in real time, leading to more efficient processes. In short, MES drives operations and operational excellence.

Can SMBs afford MES?

Although SMBs do not have the same economies of scale as their larger counterparts, the argument still stands that MES is a necessity as we move ever closer to Industry 4.0. The good news is that the cost of technology is falling. MES is becoming more affordable for SMBs – who will see a Return on Investment shortly after implementation. For example, in the first three months after implementation, cost reductions, improved productivity and enhanced efficiency will be experienced. A year on, an organization will see shorter workflow cycles, coupled with other benefits. And these benefits will continue to build on each other until true intelligent and lean manufacturing is achieved.

Of course for SMBs, the vendor they choose is also an extremely important consideration. When making the investment, you need to be sure that you will also have continuous support, back-up and expertise to rely on. Seabrook Technology Group excels at this. We are recognized specialists in MES and lean manufacturing. To find out more about our package, contact me at any time at [email protected]

 

MESA Ireland demystify Smart Manufacturing at Limerick meeting

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From L – R: Ian Foley, Seabrook Technology Group, Desmond Savage, ATS, Tom Murphy, IT Consultant, Wayne Bursey, Siemens & Andrew Daly, Vision ID

Over 40 professionals attended a very interactive and topical MESA Ireland meeting in the Castletroy Park Hotel on September 20. The principal topic for the day was ‘ Demystifying Smart Manufacturing ’ which was presented by Desmond Savage; MESA Ireland Co-Chairperson and Tom Murphy MESA Ireland Committee member. Other MESA Ireland committee members present on the day; Andrew Daly, Ian Foley and Wayne Bursey.

The meeting kicked off with Ian introducing the group and Desmond presenting on MESA International and the latest initiatives. MESA International is a not-for-profit association that promotes best practices in Manufacturing Enterprise Solutions. Some of the trending topics currently on-going within MESA, include:

mesairelandmeetinglimericksept20desmondsavage

Desmond Savage, ATS, introducing MESA International.

Following the introduction, Tom and Desmond presented the main topic of the day ‘Demystifying Smart Manufacturing’. Tom kicked off discussing the history of Industry 4.0 and the evolution of the Smart Manufacturing initiative. During this presentation, there was great discussions with the audience on topics such as:

  • What are the challenges and barriers that currently exist e.g. difficult regulation and lack of education
  • Ireland has been very successful in implementing Lean and Six Sigma/Shingo projects, but the focus for Smart Manufacturing does not seem to exist; should there be government sponsored initiatives? Should MESA play a role?
  • Data – Many customers were focused on data; how to use it, how to store it and how to benefit from it. The focus on Industry 4.0 and Internet of Things is driving customers to use this data and explore potential business advantages from it. Data driven services are a key topic for now for the discrete manufacturing environments.
  • Members – Current membership options are available here.
  • MESA to get involved with Industry 4.0 Ireland Inc. but which one, as there seems to be 2 or 3 at the moment.
  • The slides presented can be accessed here 

 

mesairelandmeetinglimericksept20tommurphy

Tom Murphy, IT Consultant, presenting ‘Demystifying Smart Manufacturing’

Following the presentation, a networking lunch was hosted in the same room which gave the participants the opportunity to continue the vibrant discussions. For those who could afford the time, Vistakon, a Johnson & Johnson company who are one of the world’s leading producers of contact lenses, offered to host a group and give a tour of their advanced manufacturing facility location 10 minutes away. The feedback from the tour was very positive and the MESA Ireland Special Interest Group (SIG) again would like to extend our thanks for the support and time given by Vistakon.

Please watch out for upcoming events hosted by MESA Ireland SIG (see LinkedIn Group) and if not already a member of MESA, join today and help build a vibrant community of Irish manufacturing professionals contributing to Demystifying Smart Manufacturing!

 

 

John Dzelme Article

Seabrook COO John Dzelme writes guest article for the renowned Qmed

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Our Global Chief Operating Officer John Dzelme has written a thought provoking and highly informative article on the future of MES for the highly respected Qmed website.

John Dzelme, who is an internationally recognized expert in MES and lean manufacturing, discusses how MES will become more mission critical than ever for med tech and medical device manufacturers in Industry 4.0.

He writes how MES will enable med device manufacturers to achieve streamlined, operating excellence – and how MES can communicate with other mission critical systems, like PLM to dramatically reduce the risk of production issues, while enhancing product quality, as medical devices, regulation and demand from consumers become increasingly more complex.

You can read the full article here

 

John Dzelme Camstar MES

CAMSTAR MES in California

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Seabrook is very much looking forward to attending our partner CAMSTAR MES’s upcoming MES workshop and plant tour at Fresenius Medical Care centre in Concord, California on April 20th. Our Global Chief Operating Officer, John Dzelme – an internationally recognised expert in MES, will chair an engaging roundtable discussion on Leveraging MES for Continuous Improvement at this exclusive event.

Seabrook has been a long term partner of CAMSTAR®, a Siemens company, and we are delighted to be taking part in an event that showcases the many and considerable benefits of MES.

There will also be a tour of the Fresenius plant, where the company will demonstrate how it uses CAMSTAR® MES in its daily operations to ensure high product quality and regulatory compliance. Other discussions, which Seabrook will contribute to, include how MES can drive business decision making, lean and continuous improvement, product traceability and FDA Case for Quality.

For more information, see ww.camstar.industrysoftware.automation.siemens.com

Image: Seabrook Global Chief Operating Officer John Dzelme giving an MES presentation.