Facilitation is the Key to Successful FMEAs

October 19, 2017 ||
The Failure Modes and Effects Analysis (FMEA) is a versatile risk management tool that has been around for several decades, first used by the US Armed Forces in 1949. It started gaining popularity in the 1960’s with its use in the aerospace industry during the Apollo missions. FMEA has been…

GEP In Projects – To Practice, Or Not To Practice?

October 17, 2017 ||
As responsible Project Managers, we need to deliver maximum benefits realization to our project stakeholders on each project.  The key to maximum benefits realization is clearly delineating stakeholder requirements and assuring these requirements are satisfied throughout the project lifecycle.  A critical component for assuring stakeholder requirements are satisfied is following…

The Data Life Cycle

October 10, 2017 ||
The ISPE Good Practice Guide on Records and Data Integrity defines a data life cycle consisting of:  Creation — Processing — Review, Reporting, and Use — Retention and Retrieval — Destruction A robust data integrity program ensures data integrity across this entire life cycle. Such a program would include a risk-based analysis of all data flows to identify,…

What do NASA Missions and Pharmaceutical Manufacturing have in common?

October 5, 2017 ||
NASA recently ended a 20 year 5-Billion-mile space journey as its Cassini space probe burned up in Saturn’s atmosphere (NASA.gov Cassini Mission Site). This $3.26 billion joint venture with ESA (the European Space Agency) opened our eyes to the ringed planet. Completing the mission was no small feat, and the…

Maximizing the Impact of Factory Acceptance Testing

September 19, 2017 ||
  Your equipment is ordered.  The schedule is set.  The team travel plans are made. But are you ready to maximize your experience at the original equipment manufacturer’s factory floor?  This post will review some key points to consider in maximizing the Factory Acceptance Testing (FAT) as part of the…