Robert Kavanagh, Author at Seabrook Technology Group | Page 2 of 3

All posts by Robert Kavanagh

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.

Document Controls for Medical Device Manufacturers

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FDA Case for Quality has three priorities for addressing the barriers to quality that were identified. One of these priorities is Focus on Quality. FDA and Case for Quality stakeholders consider compliance to be a baseline, and have shifted our focus increasingly to characteristics and practices that, when present in day-to-day device design and production, correlate to higher-quality outcomes. In this blog and subsequent webinar, we will discuss document control practices that will lead you to higher-quality outcomes.

Medical device manufacturing is a highly regulated activity. Some manufacturers may be dealing with one regulator or multiple regulators. In this webinar, Seabrook discuss in the context of FDA, 21 CFR 820.40., document controls.

FDA:CFR 21 820.40 Document control states, “Each manufacturer shall establish and maintain procedures to control all documents that are required by this part”.  But the documents come from multiple sources defined by other subparts, these subparts include:

820.30 – Design Controls

820.180 – General records requirements

820.181 – Device Master Record

820.184 – Device History Record

820.186 – Quality System Record

Therefore all of the critical documents that are generated or acquired need to be managed effectively. Document control is not a stand alone requirement but is part of the closed loops that run through the complete design and manufacturing process.

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

Festive Volunteering in the local Community

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PICTURED (L-R): John Dzelme, Chelsea & Adrienne Dzelme.

Seabrook Technology Group were delighted to volunteer on Monday, December 18th at the Wheeler Mission Center for Women & Children in Indianapolis, Indiana. The team volunteered in the Christmas Shop, where they lent a helping hand to local mothers with Christmas presents for their children ahead of the Christmas period.

Founded in 1893, Wheeler is the oldest continuously operating ministry of its kind in the state of Indiana. Wheeler Mission provide critically needed goods and services to the homeless, poor, and needy of central Indiana.

To learn more on the great work provided by the Wheeler Mission, click here.

Design Controls for Medical Device Manufacturers

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FDA Case for Quality has three priorities for addressing the barriers to quality that were identified. One of these priorities is Focus on Quality. FDA and Case for Quality stakeholders consider compliance to be a baseline, and have shifted our focus increasingly to characteristics and practices that, when present in day-to-day device design and production, correlate to higher-quality outcomes.

Many of the challenges medical device manufacturers face when designing products are familiar to all manufacturers, some are unique to the medical device industry. Medical device manufacturing is a commercial activity. When done correctly, the products can have a very positive impact on individuals or whole populations.

Medical device manufacturing is a highly regulated activity. Some manufacturers may be dealing with one regulator or multiple regulators. In this webinar, Seabrook discuss in the context of FDA, 21 CFR 820. The FDA definition of Design Controls states that each manufacturer is required by regulation to establish and maintain design control procedures for any class III or class II device, and a selected group of class I devices. The design control procedures ensure that specified design requirements are met.

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.