January 2018 | Seabrook Technology Group

Monthly: January 2018

Enabling Operational Excellence Through Manufacturing Intelligence

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The single source of truth in enabling operational excellence through manufacturing intelligence is does your data tell the same story regardless of who is looking at it? Or is it easily misrepresented? Data should be guiding your organization for strategic as well as operational decisions and direction. The data visualization should clearly show the health of your organization.

Seabrook define Enterprise Intelligence as “The Execution of a Technological Strategy enabling Integrated process and environmental knowledge to be leveraged in standard practices to achieve operational excellence”.

Transformation does not happen overnight and your data and analytical maturity will not either. The following are the foundational pieces to progressing a BI initiative:

  • KPI’s and Detailed Definitions
  • Inventory of System of Records
  • Canonical Definitions to clear up any discrepancies across business units, systems, etc. so that every system is speaking the same language at the BI level.
  • Action plan
  • What is to be measured, used, and communicated
  • What will be open for discover models
  • Alert & Notifications scenario definitions
  • Business Rules for automated responses and actions based on certain KPI violations

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

Building a Case for Paperless Manufacturing

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This Building a Case for Paperless Manufacturing blog will discuss two areas:

  1. What are the areas where we have seen high levels of return on investment.
  2. How do you go about creating a roadmap towards paperless manufacturing.

The biggest cost reduction we see when eliminating paper is the cost of “operator Handling and Document”. The review, inspection, and transportation of paper can require several full-time people.

The second biggest area we have seen related to paper costs is customer complaint processing. This includes any analytical processing that is done on the data stored in the paper DHR.

The third largest expense we encounter because of paper is storage space. In some cases, companies are required to keep paperwork up to 10 years following the products lifecycle, and many companies have over 100 years of paperwork in storage. Federal guidelines require that paperwork be stored in such a way that the information won’t become degraded. That means facilities must be climate controlled and secure which further adds to the cost of storage.

The final paper related costs that are sometimes overlooked are directly related to the paper itself. This includes the pens and transport equipment.

Medical device manufacturing is faced with many complexities. Product lifecycles are becoming shorter and shorter. If you are going to be able to compete in the industry, you need to be able to change your manufacturing process quickly. With products becoming more complex, it is increasingly more difficult to meet regulatory pressures. This means that each manufacturing process change is likely to be a change that increases the number of steps involved and the information that needs included.

By automating your manufacturing process, you also automate a portion of your manufacturing process changes. If you are using a PLM or Product Lifecycle Management system, you can automate the design and development of your product for an even more efficient process of managing manufacturing changes.

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

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.

CAPA for Medical Device Manufacturers

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Medical device manufacturing is a highly regulated activity. Some manufacturers may be dealing with one regulator or they may be working with multiple regulators. In this blog post and subsequent webinar, Seabrook will talk in the context of FDA, 21 CFR 820. FDA: CFR 21 820.100 corrective and preventative action states “each manufacturer shall establish and maintain procedures for implementing corrective and preventive action”.

FDA 2015 Quality Subsystem Observations tell us that CAPA accounts for 32% of observations. CAPA is as problematic as physically manufacturing the product. The three areas generating the highest numbers of CAPA non compliance issues are 820.90 – Nonconforming product, 820.100 – Corrective and preventative action, 820.198 – Complaint files. In all three the number has risen from 2014 to 2015.

When managing CAPA specifically, organizations face several challenges with disparate quality systems. These include:

  • Time to Closure: Without a centralized system for quality, completing a corrective or preventative action can be arduous and long process.
  • Time and Effort: Organizations face difficulty with aligning and executing on deliverables for preventing a root cause from reoccurring in the future. Deliverables may include changing work instructions, educating employees, communicating root causes to the broader enterprise, or an engineering change order. These deliverables touch many areas across the engineering process and broader value chain, such as design, control plans, production processes, equipment, facilities, materials, and more.
  • Rework and Repeat Actions: Companies with disparate quality systems tend to have higher rework rates and more repeat efforts in regard to the identification of a specific root cause. Reasons for this include incomplete investigations due to lapses in manual processes, poor documentation and communication of previous root cause analysis efforts, and inconsistent processes between plants, facilities, and business units.
  • Increased Risk: Without a centralized system for communicating and collaborating on corrective and preventative actions, root causes have a greater chance of both not getting resolved and not being communicated to the broader enterprise. The lack of visibility with manual processes increases risk at the point of the root cause, as well as in all dependent processes across the value chain.

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