There is a lot written in the literature these days regarding how the quality profession is changing.  Last month we outlined ASQ's plans for changes in line with this overall quality culture shift (see: http://www.asqsandiego.org/news/mar03edmail.htm#edmessage).  ASQ has also put together a few web pages on their strategy (see: http://www.asq.org/strategy/ ).

Negative aspects of this shift would appear to be:

• The word "quality" is diminishing in use.

• The traditional roles of quality professionals are diminishing.

• The number of full time specialized quality professional positions may be diminishing.

• Less members will likely be interested in taking certification programs as they are in place today.      

 Positive aspects of this shift would appear to be:

• Other very large areas such as government agencies, medical services, and software industries are becoming much more quality oriented.

• Quality is becoming more integrated such that more (if not all) employees need to be more quality oriented than they are today. 

• More training overall is going to be required.

• Training efforts will be more associated with bottom line initiatives within the company.

• Quality professionals are taking on more advisory types of roles.

Therefore, things are expected to continue to get more competitive amongst our members and we will need to find new ways to help each other prepare to meet these changes.  One direction we plan to take along these lines is to continue to offer specialized workshops such as the one we are planning for next week on Validation and Verification.

3 Hour Workshop

This workshop will only be held if we get 15 or more members and currently we only have 7 signed up.  It will be taught by a real guru in the subject, Hank Posters who is a Registered Professional Quality Engineer with extensive V&V experience in the field of implantable medical devices. He is familiar with product requirements in the United States and Europe.   Mr. Posters holds a BS degree in Electrical Engineering and an MBA in Manufacturing Management. He is a senior member of the American Society for Quality. He is an ASQ certified Quality Engineer, Reliability Engineer, and Quality Manager.

While this workshop is oriented towards FDA compliant structures, the basic techniques apply to any process.  Sign up now to learn or review the details behind typical IP's, EP's, OP's, PP's, QP's, and PPQ's as taught be a real pro with a special guest talk from Kim Niles.  Other questions to be reviewed are as follows:

• Are you required to perform Design Verification and Validation activities?

• Are your companies Design V & V practices compliant to the FDA?

• Who is responsible to perform Design V & V activities?

• What quality tools are needed to perform Design V & V activities?

• When are accelerated testing methods appropriate?

• Where can I find the FDA’s Quality System Regulation requirements for V & V activities?

• How do I structure test plans & test report documents?

This presentation is for anyone working in any industry that is interested in V & V but it will place a special emphasis in how the FDA's Quality System Regulation has put renewed focus on design verification and validation test practices.

This workshop will give participants an overview of design evaluation and validation test principles most applicable to the medical technology industry. Requirements for developing and executing sound test plans, including some of the statistical and quality tools needed, will be discussed. Basic principles of accelerated testing will be explained. Also the documentation aspects of design evaluation and validation testing will be reviewed with practical suggestions on structuring test plans & reports.

Refresher Course Status

There are several courses started or planned.  There is still time to sign up for any course.  We are holding all classes except the CQM in the Erickson building with food provided to those held in the Erickson building.  See information below and on our education page for more details.

See you soon!