TGFR Consulting LLC CAPA Investigations – The “Is/Is-Not” Exercise
Is/Is-Not analysis is the first step in a CAPA investigation. A good definition of the problem is key to finding the root cause.
Bad Meetings and Productivity
Working with many large corporations and their development teams, it has become clear that the changes in meeting frequency and structure have had a significant impact on productivity. Bad meetings and their impact on the productivity are a key impediment to achieving the overall organizational goals. The refrain from many individual contributors, “I’m in back …
Designing a Quality Management System – Detailed versus Directive Control
As organizations work to design and develop a quality management system (QMS), how to establish compliance becomes a key consideration. The choice of structure represents a continuum between two types of control Many factors influence the choice of control, and the right choice requires considering all of these factors. This choice may be a hybrid, …
Cohesion and Project Execution
Mowing the lawn, I usually listen to scholarly articles on You-Tube. It makes the effort of mowing have an additional payoff in that I can learn something. Yesterday I learned about cohesion and project execution from a very unusual source. I listened to an analysis of the Wehrmacht, (the German Army) performance in World War …
Project Failure – Undiscovered Rework and Project Planning
Failure to assess the status of work can result in rework, leading to project delays
Product Definition – VOB to Business Needs
This details how VOB translates into business needs.
Product Definition – From VOC to User Needs
Following the identification of the product idea, collecting the Voice of the Customer (VOC) and translating this VOC into high-level user needs begins. These user needs drive the product definition process. Simply stated, VOC (Voice of the Customer) expresses the effect that a customer would like the product to have on his life/environment. Creating good …
Medical Device Development – an Introduction
Medical Device development demands good system engineering and understanding the regulations, risk and clinical use that are unique to the medical device market. To get it right, the focus needs to be on a process that minimizes mistakes and maximizes success.
Hazards and Hazardous Situations
After task analysis has identified the failure modes, the next step is the mapping of hazards to these failure modes, identifying the sequence of events, and identifying the hazardous situation(s). The following figure illustrates the overall flow.
Task Analysis
Medical Device Task Analysis will form the basis of future risk and workflow development