Feedback, KPIs critical to FDA’s case for efficient manufacturing

The U.S. Food and Drug Administration (FDA) is promoting how knowledge acquired in the development, manufacture, and use of one generation of product can be applied to future generations that a company plans to market. To do this, the FDA is using total product lifecycle (TPLC) to show how feedback and key performance indicators (KPIs) can make manufacturing more efficient, resulting in lower-c...

05/01/2009


The U.S. Food and Drug Administration (FDA) is promoting how knowledge acquired in the development, manufacture, and use of one generation of product can be applied to future generations that a company plans to market. To do this, the FDA is using total product lifecycle (TPLC) to show how feedback and key performance indicators (KPIs) can make manufacturing more efficient, resulting in lower-cost medical devices.

Providing a feedback loop between shop floor data and the design of the next generation product is indispensible in TPLC. Incorporating strategies such as robust design and designing for manufacturability enable product designers to take into consideration process capabilities. This could have a significant impact in increasing product quality while reducing manufacturing costs.

FDA also has been very proactive is in communicating its support for an industry-wide shift towards a focus on control theory and away from testing to document quality.

The agency defines the “desired state” as follows:

  • Product quality and performance achieved and assured by design of effective and efficient manufacturing processes;

  • Product specifications based on mechanistic understanding of how formulation and process factors impact product performance; and

  • Ability to effect continuous improvement and continuous “real time” assurance of quality.

To meet FDA’s stated “desired state,” manufacturers must attain real-time visibility into their processes to separate the wheat from the chaff. This requires deep knowledge of critical-to-quality variables and KPIs.

To move towards operational excellence, device manufacturers must identify “golden” (optimal) and “lead” (first) units, lots or batches and analyze key parameters that produced them. They must also compare and contrast such batches to identify parameters that are inconsequential to product quality. This approach can provide a deep understanding of the process to enable the development of KPIs to reduce variability, increase yields, and lower costs.





The Engineers' Choice Awards highlight some of the best new control, instrumentation and automation products as chosen by...
The System Integrator Giants program lists the top 100 system integrators among companies listed in CFE Media's Global System Integrator Database.
Each year, a panel of Control Engineering and Plant Engineering editors and industry expert judges select the System Integrator of the Year Award winners in three categories.
This eGuide illustrates solutions, applications and benefits of machine vision systems.
Learn how to increase device reliability in harsh environments and decrease unplanned system downtime.
This eGuide contains a series of articles and videos that considers theoretical and practical; immediate needs and a look into the future.
Women in engineering; Engineering Leaders Under 40; PID benefits and drawbacks; Ladder logic; Cloud computing
Robotic integration and cloud connections; SCADA and cybersecurity; Motor efficiency standards; Open- and closed-loop control; Augmented reality
Controller programming; Safety networks; Enclosure design; Power quality; Safety integrity levels; Increasing process efficiency
This article collection contains several articles on how advancements in vision system designs, computing power, algorithms, optics, and communications are making machine vision more cost effective than ever before.
Featured articles highlight technologies that enable the Industrial Internet of Things, IIoT-related products and strategies to get data more easily to the user.
This digital report will explore several aspects of how IIoT will transform manufacturing in the coming years.

Find and connect with the most suitable service provider for your unique application. Start searching the Global System Integrator Database Now!

Cloud, mobility, and remote operations; SCADA and contextual mobility; Custom UPS empowering a secure pipeline
Infrastructure for natural gas expansion; Artificial lift methods; Disruptive technology and fugitive gas emissions
Mobility as the means to offshore innovation; Preventing another Deepwater Horizon; ROVs as subsea robots; SCADA and the radio spectrum
Automation Engineer; Wood Group
System Integrator; Cross Integrated Systems Group
Jose S. Vasquez, Jr.
Fire & Life Safety Engineer; Technip USA Inc.
This course focuses on climate analysis, appropriateness of cooling system selection, and combining cooling systems.
This course will help identify and reveal electrical hazards and identify the solutions to implementing and maintaining a safe work environment.
This course explains how maintaining power and communication systems through emergency power-generation systems is critical.
The Engineers' Choice Awards highlight some of the best new control, instrumentation and automation products as chosen by...
The System Integrator Giants program lists the top 100 system integrators among companies listed in CFE Media's Global System Integrator Database.
Each year, a panel of Control Engineering and Plant Engineering editors and industry expert judges select the System Integrator of the Year Award winners in three categories.
This eGuide illustrates solutions, applications and benefits of machine vision systems.
Learn how to increase device reliability in harsh environments and decrease unplanned system downtime.
This eGuide contains a series of articles and videos that considers theoretical and practical; immediate needs and a look into the future.
Women in engineering; Engineering Leaders Under 40; PID benefits and drawbacks; Ladder logic; Cloud computing
Robotic integration and cloud connections; SCADA and cybersecurity; Motor efficiency standards; Open- and closed-loop control; Augmented reality
Controller programming; Safety networks; Enclosure design; Power quality; Safety integrity levels; Increasing process efficiency
This article collection contains several articles on how advancements in vision system designs, computing power, algorithms, optics, and communications are making machine vision more cost effective than ever before.
Featured articles highlight technologies that enable the Industrial Internet of Things, IIoT-related products and strategies to get data more easily to the user.
This digital report will explore several aspects of how IIoT will transform manufacturing in the coming years.

Find and connect with the most suitable service provider for your unique application. Start searching the Global System Integrator Database Now!

Cloud, mobility, and remote operations; SCADA and contextual mobility; Custom UPS empowering a secure pipeline
Infrastructure for natural gas expansion; Artificial lift methods; Disruptive technology and fugitive gas emissions
Mobility as the means to offshore innovation; Preventing another Deepwater Horizon; ROVs as subsea robots; SCADA and the radio spectrum
Automation Engineer; Wood Group
System Integrator; Cross Integrated Systems Group
Jose S. Vasquez, Jr.
Fire & Life Safety Engineer; Technip USA Inc.
This course focuses on climate analysis, appropriateness of cooling system selection, and combining cooling systems.
This course will help identify and reveal electrical hazards and identify the solutions to implementing and maintaining a safe work environment.
This course explains how maintaining power and communication systems through emergency power-generation systems is critical.
The Engineers' Choice Awards highlight some of the best new control, instrumentation and automation products as chosen by...
The System Integrator Giants program lists the top 100 system integrators among companies listed in CFE Media's Global System Integrator Database.
Each year, a panel of Control Engineering and Plant Engineering editors and industry expert judges select the System Integrator of the Year Award winners in three categories.
This eGuide illustrates solutions, applications and benefits of machine vision systems.
Learn how to increase device reliability in harsh environments and decrease unplanned system downtime.
This eGuide contains a series of articles and videos that considers theoretical and practical; immediate needs and a look into the future.
Women in engineering; Engineering Leaders Under 40; PID benefits and drawbacks; Ladder logic; Cloud computing
Robotic integration and cloud connections; SCADA and cybersecurity; Motor efficiency standards; Open- and closed-loop control; Augmented reality
Controller programming; Safety networks; Enclosure design; Power quality; Safety integrity levels; Increasing process efficiency
This article collection contains several articles on how advancements in vision system designs, computing power, algorithms, optics, and communications are making machine vision more cost effective than ever before.
Featured articles highlight technologies that enable the Industrial Internet of Things, IIoT-related products and strategies to get data more easily to the user.
This digital report will explore several aspects of how IIoT will transform manufacturing in the coming years.

Find and connect with the most suitable service provider for your unique application. Start searching the Global System Integrator Database Now!

Cloud, mobility, and remote operations; SCADA and contextual mobility; Custom UPS empowering a secure pipeline
Infrastructure for natural gas expansion; Artificial lift methods; Disruptive technology and fugitive gas emissions
Mobility as the means to offshore innovation; Preventing another Deepwater Horizon; ROVs as subsea robots; SCADA and the radio spectrum
Automation Engineer; Wood Group
System Integrator; Cross Integrated Systems Group
Jose S. Vasquez, Jr.
Fire & Life Safety Engineer; Technip USA Inc.
This course focuses on climate analysis, appropriateness of cooling system selection, and combining cooling systems.
This course will help identify and reveal electrical hazards and identify the solutions to implementing and maintaining a safe work environment.
This course explains how maintaining power and communication systems through emergency power-generation systems is critical.
click me