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.





No comments
The Top Plant program honors outstanding manufacturing facilities in North America. View the 2015 Top Plant.
The Product of the Year program recognizes products newly released in the manufacturing industries.
The Engineering Leaders Under 40 program identifies and gives recognition to young engineers who...
World-class maintenance: The three keys to success - Deploy people, process and technology; 2016 Lubrication Guide; Why hydraulic systems get hot
Your leaks start here: Take a disciplined approach with your hydraulic system; U.S. presence at Hannover Messe a rousing success
Hannover Messe 2016: Taking hold of the future - Partner Country status spotlights U.S. manufacturing; Honoring manufacturing excellence: The 2015 Product of the Year Winners
The digital oilfield: Utilizing Big Data can yield big savings; Virtualization a real solution; Tracking SIS performance
Getting to the bottom of subsea repairs: Older pipelines need more attention, and operators need a repair strategy; OTC preview; Offshore production difficult - and crucial
Digital oilfields: Integrated HMI/SCADA systems enable smarter data acquisition; Real-world impact of simulation; Electric actuator technology prospers in production fields
Improving flowmeter calibration; Selecting flowmeters for natural gas; Case study: Streamlining assembly systems using PC-based control; CLPM: Improving process efficiency, throughput
Putting COPS into context; Designing medium-voltage electrical systems; Planning and designing resilient, efficient data centers; The nine steps of designing generator fuel systems
Warehouse winter comfort: The HTHV solution; Cooling with natural gas; Plastics industry booming

Annual Salary Survey

Before the calendar turned, 2016 already had the makings of a pivotal year for manufacturing, and for the world.

There were the big events for the year, including the United States as Partner Country at Hannover Messe in April and the 2016 International Manufacturing Technology Show in Chicago in September. There's also the matter of the U.S. presidential elections in November, which promise to shape policy in manufacturing for years to come.

But the year started with global economic turmoil, as a slowdown in Chinese manufacturing triggered a worldwide stock hiccup that sent values plummeting. The continued plunge in world oil prices has resulted in a slowdown in exploration and, by extension, the manufacture of exploration equipment.

Read more: 2015 Salary Survey

Maintenance and reliability tips and best practices from the maintenance and reliability coaches at Allied Reliability Group.
The One Voice for Manufacturing blog reports on federal public policy issues impacting the manufacturing sector. One Voice is a joint effort by the National Tooling and Machining...
The Society for Maintenance and Reliability Professionals an organization devoted...
Join this ongoing discussion of machine guarding topics, including solutions assessments, regulatory compliance, gap analysis...
IMS Research, recently acquired by IHS Inc., is a leading independent supplier of market research and consultancy to the global electronics industry.
Maintenance is not optional in manufacturing. It’s a profit center, driving productivity and uptime while reducing overall repair costs.
The Lachance on CMMS blog is about current maintenance topics. Blogger Paul Lachance is president and chief technology officer for Smartware Group.
This article collection contains several articles on the vital role that compressed air plays in manufacturing plants.
This article collection contains several articles on the Industrial Internet of Things (IIoT) and how it is transforming manufacturing.
This article collection contains several articles on strategic maintenance and understanding all the parts of your plant.
click me