Paperless manufacturing | Page 2 of 2 | Seabrook Technology Group

Paperless manufacturing | Page 2 of 2 | 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.

Paperless Manufacturing for Medical Device Manufacturers

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The FDA Case for Quality highlights the need for Systems Capability Maturity. Mature systems requires moving from using standalone systems to a system using a common platform with closed loop data sharing. Seabrook build this capability on Siemens Teamcenter PLM, a platform that has the capacity to manage all product and quality related data and share this data across the entire enterprise, the supply chain and if required with customers or partners. This is smart manufacturing, or Industry 4.0 for Medical Device manufacturers.

The webinar associated with this blog post focuses on paperless manufacturing. Everything revolves around quality – the impact on quality, a business case, the impact on operations and what results can one expect to achieve?

The FDA 2015 Quality Subsystem observations identify a high level breakdown of the source of quality issues experienced by medical device manufacturers. Taking a look at the recent FDA figures on Non-Compliance Observations, it is clear that production and process controls are a key source of issues. In our experience, over 50% of non conformances are a result of errors on paper, rather than problems with the product.

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

MESA, ISA & Seabrook

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Seabrook was delighted to meet with representatives of the Manufacturing Enterprise Solutions Association at the ISA’s first Food and Pharmaceutical Symposium to be held in Ireland. It was a great opportunity for us to catch up with MESA representatives and to discuss all that they have been doing in Ireland. We have always been extremely proud of our association with the organisation.

Desmond Savage gave a highly informative presentation on MESA during the food segment of the conference which was held at the Rochestown Park Hotel in Seabrook’s native Cork. The President of the ISA Ireland chapter, Alan Bateman, also recognised MESA’s support during his address to delegates. Pictured in the above photo taken at event are, from left to right, Ian Foley of Seabrook along with Wayne Bursey, Siemens, Peter Cullen, Rockwell Automation, Desmond Savage, ATS, and Andrew Daly, VisionID of the Ireland Special Interest Group.

MESA has some exciting events taking place over the next couple of weeks, including the Second International Virtual Internet of Things Conference in April and the Automation Conference and Expo in May. For a full list of MESA’s events, see http://www.mesa.org/en/newsevents/NewsEvents.asp

Manufacturing Execution Systems

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Manufacturing Execution Systems

Partnered with Siemens, Seabrook is a valued added reseller of the Camstar Medical Device Suite and has been a Camstar partner since 2006.

10 years on Camstar Medical Device Suite is still a leading solution in the medical device and diagnostics industry for error-proofing processes, paperless manufacturing and electronic device history records (eDHR). Emerging, midsize and global medical device and diagnostics organizations are faced with the challenge of balancing cost reductions and regulatory compliance while consistently producing high-quality products. Camstar Medical Device Suite has a proven track record of helping medical device and diagnostics companies excel in the face of these challenges.

Providing a powerful and flexible tool Camstar Medical Device Suite is a unique configuration of Camstar Enterprise platform. By effectively addressing the full range of business challenges that the industry faces, Camstar Medical Device Suite helps manufacturers become better, faster and cheaper. It does this by enabling you to build quality into the manufacturing process instead of testing quality coming out of the process, a mistake that often occurs in the manufacturing sector. Camstar Medical Device Suite has been deployed with powerful results in a variety of medical device product segments, such as diagnostics, orthopedics, cardiovascular, hospital and wound care, diabetes care, renal, blood care, vision and imaging. The solution is highly functional and flexible and provides an excellent user experience.

Benefits

  1. Proactively build quality into the manufacturing process
  2. Identify, analyze, solve and prevent problems while production continues
  3. Provide visibility into the performance of components, tests, etc.
  4. Enable you to understand fatigue impact, manual operation failure rates and time to ramp to quality
  5. Close the loop on continuous improvement initiatives
  6. Define, distribute and enforce process and engineering changes to any global factory

Quantifiable Value:

  1. $3.7M Recurring in Cost Reductions
  2. $1.6M (one-time) Inventory Reduction
  3. 5%-10% Yield Improvements
  4. 35% Increase in thruput (10k units)

Strategic Value:

  1. 100% reduction in Op Training Errors
  2. 75% Reduction in Field Actions
  3. 64% Reduction in Prod Inquiry Reports
  4. Enforced DFT Lowering Inventory/Lead Time

Key Values:

Paperless manufacturing

Replace manual paper manufacturing processes with proactive manufacturing execution that streamlines the process, delivering cost reductions and improved quality and compliance. The result is a complete electronic audit trail of all manufacturing activity and an electronic device history record. There is no paper, printing, moving or storage.

Automated enforcement and control Collect information and enforce business rules to achieve error-proof processes. Ensure the right procedures, operators, equipment and materials are used within specification and in the right sequence. Move to a review by exception product release process as a result of an automated self-auditing electronic device history record.

Lean and Six Sigma enablement

Lean and Six-Sigma initiatives are driven by data to establish a baseline, identify improvements, analyze results and control processes. Camstar Medical Device Suite provides the foundation by enabling you to collect integrated product, process and quality data in a structured electronic format in a matter of seconds. You can make your processes mistake proof with systemic enforcement to ensure control, closing the loop on continuous improvement initiatives.

Global process data management

Define, distribute and enforce process and engineering changes to any global factory. Complete audit trails make it possible to understand the impact of engineering change orders (ECOs) and the effectivity of corrective and preventive actions. Intelligent root cause analysis enables you to discover the true source of the problem by leveraging a growing knowledge base of granular product design, process design, manufacturing (as-built and inspection), field use and quality event data.

Containment management and forward/backward traceability

Use configurable searches such as where used analysis to identify suspect at-risk material based on unique criteria, such as a component lot, machine, operator, a specific shift, etc. Configure dynamic actions based on your business rules, then take quick action, such as hold, rework, material review board (MRB), quarantine, etc. All products, components and supplied materials are completely traceable.