September 2011 - Level 3 Inspection

Archive for September, 2011

FDA’s Five Year Plan: Better Documentation

The FDA recently unveiled its Strategic Priorities 2011-2015.
How will the next five years’ goals and objectives affect you?
“If it isn’t documented, it didn’t happen” is one of the FDA’s best-known unwritten rules.  As the agency’s resources are already stretched thin, the medical device industry is being held to an ever-higher standard of data collection.

With accurate and comprehensive computer-aided inspection (CAI) you can satisfy regulators by recording and documenting every surface data point and every extracted dimension for future reference — while cutting iterations, months, and millions of dollars from the process development schedule.  The same can hardly be said for fixed gauges or optical-comparator overlays!

Visit www.level3inspection.com or call us today to learn more!

WARSAW, IN • STUART, FL
574.383.9145 • 561.775.7911
Copyright © 2011 Level 3 Inspection LLC, All rights reserved.

Top Cutting Tool Performance

Level 3 Inspection and Smart Inspection Systems
Watch our YouTube video
Top Cutting Tool Performance

Given the rise of global supply chain competition, along with the projected annual growth rate of 8-10% in the worldwide medical device industry market, U.S. medical device manufacturers must continue their course of innovation.  Best practices, though crystallized, must constantly be reevaluated and revised where appropriate.

With literally hundreds of suppliers across the United States capable of producing spinal and TJR instrumentation, competition for lucrative OEM contracts is fierce.  Implant success depends on a number of factors – among which are the size, depth, and position of the hole in the bone.

So how can you make sure that your broaches and reamers will perform to an exceptional standard?

FORM before FIT

Cutting tool quality is critical and can depend on accuracy and truth-to-form of only a few thousandths of an inch.  Nonstandard or unanticipated wear patterns can have catastrophic consequences.  You as a manufacturer deserve the peace of mind of knowing the full geometry of your tooling – and not merely a few key dimensions.
Gain the Confidence of the Entire Geometry

Overseas suppliers have demonstrated a great willingness to apply inspection methods based on geometric form, and some are beginning to pull ahead of American manufacturers.  Why risk losing the best supplier contracts to other manufacturers by taking a trial-and-error approach to tooling development?
A Call to Action

Given the precarious situation in which the medical device industry finds itself – opportunity in exploding overseas markets coupled with threats from overseas competitors – there’s never been a more critical time to reexamine cherished misconceptions about what constitutes a reasonable standard of speed and quality in tooling development.  First movers will dominate share in their product category – perhaps permanently.  Let’s work together that they may continue to be fellow Americans.
Learn about the SmartInspectionStation™ (SiS™) by watching our SmartInspectionStation™ YouTube video.

Call 561.775.7911 today to schedule a discussion of application parameters and configuration criteria with an L3I engineer.
Copyright © 2011 Level 3 Inspection LLC, All rights reserved.

FDA’s Five Year Plan: Scientific Computing Initiative

The FDA recently unveiled its Strategic Priorities 2011-2015.

How will the next five years’ goals and objectives affect you?
At first glance, the FDA’s Scientific Computing Initiative might appear to concern only clinical data, but as the medical device industry continues to modernize its quality systems and harmonize engineering data with clinical outcomes in the still-evolving approval process, the FDA’s interest in inspection results isn’t likely to decrease.
Accurate and comprehensive computer-aided inspection (CAI) redefines standards by allowing manufacturers to build a vast and ever-growing repository of information about their products — while cutting iterations, months, and millions of dollars from the process development schedule.

Visit www.level3inspection.com or call us today to learn more!

WARSAW, IN • STUART, FL
574.383.9145 • 561.775.7911
Copyright © 2011 Level 3 Inspection LLC, All rights reserved.

Your Source For Vendor Qualification v2

Level 3 Inspection and Smart Inspection Systems
Watch our YouTube video
Verify Your Supply Chain Vendors

It’s a global parts market.  As a leading precision manufacturer, you have hundreds of suppliers (in the United States and beyond) to choose from for your outsourced parts.  But in a competitive and high-stakes industry, in which tolerances can be as minute as a few ten-thousandths of an inch, it’s critical that supply-chain parts be faithful to model and print.

The supply chain is a cost-effective source of small or simple parts, but quality assurance is an ongoing challenge.  Trial-and-error verification of every new supplier is an expensive proposition.

So how can you be confident in your stream of supply chain parts, without breaking the bank and wasting valuable time?
Fast & Economical
Avail yourself of fast, modern, and economical Computer Aided Inspection (CAI) by a credentialed, independent and impartial third party.  Level 3 Inspection is an ISO 9000, AS 9100 and AAAM 44.9 certified engineering and inspection firm, and is among the world’s most competent practitioners of White Light Scanning (WLS)-based CAI.
Objective Data …
Intelligently Managed

By coupling accurate and comprehensive surface scans with intelligent postprocessing, we can provide an objective, clear, and easy-to-understand index of part data, helping you choose quickly and easily from between part suppliers. And by tracing, tracking and trending the data over time, we’ll help you sustain a reliable supply of reliable parts – inexpensively!
Call 561.775.7911 today to schedule a discussion of application parameters and configuration criteria with an L3I engineer.
Copyright © 2011 Level 3 Inspection LLC, All rights reserved.

Quality Expo 2011

Meet us at Quality Expo — Booth 812, September 21, 2011
Level 3 Inspection to Unveil Robotic Inspection System at Quality Expo 2011
September 20-22, 2011, McCormick Place, Chicago
Level 3 Inspection is proud to announce, in partnership with ComScan, a robotic precision inspection system that is modular, affordable, upgradeable, and fast.

The SiS™ is an easy-to-use White Light Scanning (WLS) and Computer Aided Inspection (CAI) system that orthopaedic and other precision manufacturers can install practically anywhere in their operations. It uses fringe-light patterns to digitize the surfaces of orthopaedic implants and other precision manufactured parts, automatically generating full PDF inspection reports with minimal operator input and personnel training.

Come and see the magic at Booth 812 at the Quality Expo, September 20-22, 2011.

Further information can be obtained at 561.775.7911 or warsaw@level3inspection.com.
Level 3 Inspection • Smart Inspection Systems
STRATEGIES • SOLUTIONS • SYSTEMS • SUPPORT
AS9100 & ISO9001 Registered • AAAM 44.9-2010 Certified • CAGE Code 5UXW8
Stuart, FL 34997 • Warsaw, IN 46582

Please consider the environment before printing this email.
Copyright © 2011 Level 3 Inspection LLC, All rights reserved.

FDA’s Five Year Plan: Advance Regulatory Science and Innovation

The FDA recently unveiled its Strategic Priorities 2011-2015.
How will the next five years’ goals and objectives affect you?
First among the FDA’s newly redefined objectives is to strengthen regulatory science.  “Science underlies everything we do at this agency and to serve the public health we must have the capacity to effectively oversee the translation of breakthrough discoveries in science into innovative, safe, and effective products and life-saving therapies for the people who need them most,” says FDA Commissioner Margaret Hamburg.

Sophisticated informatics-based handling of clinical and engineering data will play a major role in the advancement of regulatory science.  With computer-aided inspection (CAI) you can satisfy regulators by recording and documenting every surface data point and every extracted dimension for future reference — while cutting iterations, months, and millions of dollars from the process development schedule.

Visit www.level3inspection.com or call us today to learn more!

WARSAW, IN • STUART, FL
574.383.9145 • 561.775.7911
Copyright © 2011 Level 3 Inspection LLC, All rights reserved.

Press Release – On-Site Inspection

Press Release
L3I Wows Onlookers with On-Site Turbine Inspection
BERLIN, Sept. 12, 2011 — Level 3 Inspection, a process engineering and inspection firm headquartered in Stuart, Florida, impressed observers in an August industrial gas turbine (IGT) field scanning project performed in record time at global IGT giant Siemens’s Berlin manufacturing center. Master scanning technician Wade Rigsby scanned a series of combustors, ducts and vanes on-site. The massive parts never had to leave the warehouse floor.
“By making our SmartFAI (First Article Inspection) process portable and global, we’ve demonstrated that we can pull together an inspection process on site without adding any down time for the customer,” said Scott McAfee, chief engineer and COO, referring to L3I’s First Article Inspection service. “High data density combined with complete inspection according to specs and requirements gives our customers the insights that they need to optimize their operations.”
L3I is expanding its field scanning operations to provide IGT component and engine manufacturers with plentiful surface dimensional data to find subtle process anomalies and wear trends, without the parts ever needing to leave the factory or power plant. With part surface point densities as high as 800 points per square millimeter — each point having its own precise 3D coordinates — manufacturers can gain new insights are available into the root causes of performance limits, develop a rework process, or verify repairs on any turbine engine component.
“Speed is the key. Traditional CMM-based processes are far too slow and costly in today’s competitive gas turbine parts market,” said Bill Greene, L3I’s CEO and director of business development. “Worse, CMM data are sparse and don’t allow trending over time. Fortunately, our 21st Century white light scanning experience, combined with the strongest airfoil domain expertise offers a vastly superior dimensional inspection capability for turbine manufacturers and their customers around the world.”
L3I prefers to treat its customers as partners. Any inspection process begins with a candid discussion of the problem. A comprehensive inspection strategy is planned and launched. Once a part has been scanned and a report saved, the inspection and analysis processes become repeatable, and can then be duplicated on other replacement parts or serviced parts. Ongoing trend analysis allows the team to study wear patterns, changes over time, or variations from part to part.
Facing a market that is tougher than ever, IGT manufacturers have to be ready to adjust — or overhaul — their design and manufacturing strategies while parts are still in development. Manufacturers need enough information to make the correct decisions the first time. By bringing fast, comprehensive, and repeatable inspection directly to the customer, L3I’s on-site approach solves the speed versus accuracy dilemma.
Further information can be obtained by contacting Bill Greene at 561.775.7911 or sales@level3inspection.com.
© 2011 Level 3 Inspection LLC • ALL SYSTEMS GO
1239 SE Indian St, Suite 107, Stuart, FL 34997 • sales@level3inspection.com • Tel: 888-4AS-9102 x102

FDA’s Five Year Plan: Doing More with Less

The FDA recently unveiled its Strategic Priorities 2011-2015.
How will the next five years’ goals and objectives affect you?
Everybody’s operating under a tighter budget these days.  “Lean government” has become a buzzword.  Even the politicians finally seem to have noticed lean processes that manufacturers have been studying and implementing for decades.

The FDA has noticed, too.

To serve the FDA’s objectives of efficiency, consistency and effectiveness, industry is being asked to revisit the way that processes are developed and documented – standardizing the enormous amounts of product data that manufacturers send in.  Ever more responsibility is shifting to the medical device industry to track data on its outsourced supplies.

With accurate and comprehensive computer-aided inspection (CAI) you can satisfy regulators by recording and documenting every surface data point and every extracted dimension for future reference.

Visit www.level3inspection.com or call us today to learn more!

WARSAW, IN • STUART, FL
574.383.9145 • 561.775.7911
Copyright © 2011 Level 3 Inspection LLC, All rights reserved.

IGT press release

Maintenance outage inspection has never been easier.
Reduce downtime with the best on-site inspection.
On-site inspection — anywhere on the planet!

We’re proud to announce our highly successful recent on-site turbine inspection at a Siemens plant in Berlin.

Press Release

White Light Scanning Pros

As design engineers with decades of experience in industrial gas turbine engine production and analysis, we at L3I understand the requirements and challenges of inspecting complex free-form geometry. We’re raising the standards for:
  • Maintenance outage inspection
  • Catastrophic failure consulting
  • Root cause analysis
  • First article inspection (FAI)
  • Part-to-part comparison
  • Process optimization
  • Prototype verification
  • Production inspection
  • Component lifespan estimates
  • CAD modeling & model validation
  • Multiple cavity dimensional analysis
  • Statistical process control (SPC)
  • Tooling inspection and optimization
  • Product Modernization™ (reverse engineering)
LEARN MORE HERE (will link back to flyer)
Copyright © 2012 Level 3 Inspection LLC, All rights reserved.

MENU