Two medical device assembly associates working on a manufacturing floor. 

Scott Bridges, Senior Manufacturing Quality Engineer, Cogmedix
Daniel Irizarry, Manufacturing Quality Engineer, Cogmedix

Tribal Knowledge, Hidden Factories

Tribal knowledge in manufacturing, also known as a hidden factory, is information regarding a process that is not properly documented and is only available via word of mouth. The knowledge is transferred between associates, typically during peer-to-peer training, and is usually missing from released procedures and/or drawings. Although tribal knowledge may help foster team camaraderie, it ultimately hinders any potential process improvement or root cause analysis. This knowledge can be highly detrimental in a regulated and cGMP controlled manufacturing environment. The knowledge can become easily lost with the movement of associates across different product lines, which can equate to a decrease in efficiency in a production line.

Associates tend to keep tribal knowledge to themselves as they may feel it places them at an advantage. An associate’s work may appear to be of higher quality compared to other associates, which could give them a sense of job security. The associate may also feel that there will be consequences if they admit to potential process improvements being performed that aren’t formally documented. 

Exposing Tribal Knowledge in Manufacturing

Medical device manufacturing associates at a desk collaborating on process documentation

One goal in manufacturing is to expose the hidden factory and formally document the processes that are being performed. An effective way to achieve this goal is to promote open communication during process improvement activities and Challenge Busters within the production floor, and to reward the associates for their ideas. 

Another method is to regularly sit with associates, monitor the process, and promote an open forum to discuss any desired changes to that process. All changes to a process must be vetted or tested on controlled products and then verified – this should be clear to the associates so that they understand the importance in accurately documenting and capturing a process. Although time consuming, another method in exposing tribal knowledge is conducting regular time studies and monitoring process time and yield variation between associates. For example, if Associate A performs a process much quicker than Associate B, there may be a lack of knowledge between the two associates and Associate A may have tribal knowledge of the process. A process may allow for variation but there should never be variation due to “tricks of the trade” or “hidden factories”.

Capturing and Documenting Hidden Processes

Three medical device manufacturing associates at a desk documenting manufacturing processes

Tribal knowledge can be captured in many ways such as redlined work instructions, drawing or quality alerts, or visual aids so that all associates on the production floor can become aware of the updated method(s). Another method to capture tribal knowledge is through a nonconformance report or a formal engineering change order to update the appropriate documentation. 

At Cogmedix, we often come across tribal knowledge when onboarding a new customer, as well as throughout the co-build process. It’s an integral part of our system to capture all tribal knowledge in the assembly, test and inspection processes to ensure our clients products are built with consistency and the highest level of quality, ensuring successful transition and scalability from day one.