MEDICAL DEVICE RISK MANAGEMENT

by Mr. Chet Haibel, M.S.E.E.

This is not just the usual Fault Tree Analysis (FTA) and Failure Mode and Effects Analysis (FMEA) class. Those topics are covered to be sure, but this class prescribes an approach that integrates the Risk Management process into New Product Development to save time and money by getting the product designed right the first time, starting with product architecture.

Conformity with ISO 14971:2007(E) and Title 21 CFR is clearly emphasized, but rather than just exposing what the regulations say, a simple way to conform with the least “side effort” is offered. A way is shown to automatically get congruence between complaint management, Medical Device Reporting, and new product launch. Comments about criteria for Field Corrective Action are made.

Class exercises (using actual products in closed classes) and class discussion make each session unique.

WHO SHOULD ATTEND

Engineers and Managers in New Product Development, Reliability, and Quality

Click here for a complete, printable, class description.
CLASSES ON RELIABILITY
Length Course Title Instructor
2 days 1. Introduction to Reliability & Weibull Analysis Chet Haibel, M.S.E.E.
2 days 2. HALT & HASS + Workshop Larry Edson, BSME, CQE
3 days 4. Demonstrating Reliability with Accel. Testing Larry Edson, BSME, CQE
4 days 6. Accelerated Test Data Analysis Wayne Nelson, Ph.D.
SPECIFIC TECHNICAL CLASSES
Length Course Title Instructor
2 days 7. Physics of Failure Mr. Abhijit Dasgupta, Ph.D.
2 days 8. Lead-Free Solder Joint Reliability Jean-Paul Clech, Ph.D.
1 day 9. Medical Device Risk Management Chet Haibel, M.S.E.E.
2 days 10. Preventing Thermal & Vibe Failures Larry Edson, BSME, CQE
CUSTOM SEMINARS OFFERED
Length Course Title Instructor
1 day 12. Integrating Adv. Quality, Reliability, Durability
(QRD) Tactics with Accelerated Product Dev.		 James G. McLeish, M.S.
3 days 13. HALT & HASS and Classical Rel. Methods Integrated Edson / Haibel
2 days 14. Preventing Vibration & Shock Failures Prof. Dave Steinberg, P.E.
2 days 15. Preventing Thermal Cycling & Vibrration Failures Prof. Dave Steinberg, P.E.
2 days 16. Cooling Techniques for Electronic Equipment Prof. Dave Steinberg, P.E.


Why Should My Company Develop a Basic Understanding of Reliability?
by Chet Haibel, M.S., CRE, CQE
When a company wants to move to the next level in reliability, for example when the Reliability Engineers want to institute HALT, Cycle Testing, Failure Analysis, Design for Reliability Guidelines, HASS, and such, they need the support of New Product Development engineers, project managers, supplier managers, material engineers, etc. After all, these are the folk who fear their schedule and budget may be adversely impacted. They need to understand that properly applied reliability techniques shorten schedules and save money. Everyone must be rowing the boat in the same direction. This starts with a common understanding of terms: the three kinds of failures, how each is caused, and therefore how each is discovered, corrected, and prevented. The role of stress in reliability is another key concept everyone in the company should understand.
(click to download the complete paper...)

Weibull Analysis Points to the Problem Location
by Chet Haibel, M.S., CRE, CQE,
as demonstrated in the "Introduction to Reliability & Weibull Analysis" Seminar.
One of the companies for whom I consulted last year had a vexing field issue with front panel keypads. Customers were complaining that keypads were hard to press. 136 complaints had occurred in the last five years on a product that was currently shipping at about 850 units per month. Service technicians were typically able to make customers happy by swapping out the keypad. But since the keypad was only a flat panel with a flexible printed circuit board "pigtail" with no replaceable parts, the keypads were not returned to the service depot. Measurements on new keypad assemblies showed that every one tested good, requiring well less than the specified 2 pounds of pushing force to achieve less than the specified maximum resistance of the switches.

That resulted in speculation that keypads were wearing out and ought to be included in preventive maintenance and swapped out along with the rechargeable batteries every two years. However, a life test on new keypads showed that while their resistance varied quite a bit from unit-to-unit and rose somewhat with initial use, they still met specifications at a million cycles, well beyond what customers could experience.
(click to download the complete paper...)
CLASS REGISTRATION
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Seminars fees for North America:
1 day - $695;
2 days - $1195; 3 days - $1595.
Click here for the long Registration Form
Contacts:
Hobbs Engineering Corp.
4300 West 100th Ave,
Westminster, CO 80031
Tel: 303-465-5988
Fax: 303-469-4353
learn@hobbsengr.com

©2008 Hobbs Engineering Corp.