June 2014

How to Hire Good Quality Assurance Personnel

Posted on Jun 29th, 2014 by Norm Howe

Manfred Kets de Vries said, “First class people hire first class people.  Second class people hire third class people.  How do you put this maxim into action?

Hiring the right personnel is always critical.  Hiring good QA personnel has a unique set of problems.  And – not to put too much pressure on you or anything – your department IS who you hire.

Speed Process Validation with Limited OQ

Posted on Jun 15th, 2014 by Norm Howe

speedWhen FDA published its guidance document on process validation in 2011 it re-affirmed the importance of process development.  This sounds like a lot of extra work for people who are barely managing IQOQPQ.

FDA had forced the issue a decade earlier with medical devices and design control.  Now they are telling manufacturers of drugs and biologicals that the DESIGN of their process is just as important as the qualification of their equipment.  But simply documenting Stage 1 of Process Validation is not enough.

It’s Chaotic on the Inside, but We’re Dedicated to Our Customers

Posted on Jun 7th, 2014 by Norm Howe

rushingIs your workplace chaotic?  Is everybody running in reactive mode?  Does everyone acknowledge that it’s hectic, and then excuse it by saying, ‘We’re responding to our customers’.  Yet, everyone knows that a hectic organization is a costly one, because rushing creates errors.  Nothing drives up costs like an error prone business.