White Bead Production Company Activity/GMP Refresher Session
Description
Quality management is all about the process – people must understand that the process above all else defines and produces the level of quality that it is programmed to provide.
Based on Dr. Deming’s red bead experiment, the instructor creates the White Bead Production Company, and provides a fun and interactive demonstration of the importance of process quality and the effects of a flawed process that goes unchecked. The activity incorporates high-level GMP concepts, and the debrief correlates the principles behind the activity to FDA audit observations, making it an ideal candidate for use as a GMP refresher session.
How can this activity be used?
The activity can be used as a short demonstration of the impact of process quality on operation, or can be used as a deeper exploration of the impact of process quality and personnel management on personnel engagement. The activity highlights:
The quality of the process as the ultimate driver of the performance of the people and the process
Personnel management and motivation tactics do not address system problems – and may in fact serve to create frustrated, disengaged personnel
Human error may be a function of the process and not an actual human error
The importance of identifying and addressing the root cause of problems.
This activity kit can be used:
To provide a short demonstration in a larger course on quality management systems/ICH Q10
To provide a significant, yet simple example of the importance of continuous improvement, as a GMP refresher course
As an activity exploring personnel engagement in a management development setting
It can be used with as few as 4 people, up to groups of 100 or more. The short demonstration takes approximately 15 minutes to run, a more in-depth version of the activity can take up to 1 hour.
This kit can also be used to teach statistical process control using methodology defined by Dr. Deming and others, if desired.
What’s included in the kit?
4,000 white beads
1,000 red beads
80 multicolored beads (optional use)
Custom-made sampling device
Latching plastic storage container
Fabric bag
Presentation slides and script, suitable for a 1 hour instructor-led training course
USB drive with activity instructions and prepared slide content
Links to Dr. Deming’s red bead experiment information, and alternate activity scripts