Breaking Out of Silos: Overcoming Organizational Segmentation

In highly segmented organizations, communication is good up and down an organizational silo but poor across organizations. Unfortunately, this type of structure is rampant in many medical device companies. The marketing group communicates poorly with the product design group. The product design group communicates poorly with the advanced manufacturing engineering department. The advanced manufacturing engineering people, in turn, communicates poorly with the manufacturing people. The quality group tends to live outside this circle, functioning in a classical “quality cops” role.

FDA contributes to this organizational malaise by generating separate documents for design control, process validation, test methods, and software validation. Their attempts at communicating that an overall “systems approach” is necessary are not being received by all in the medical community.

Many organizations have had excellent success by using truly cross-functional teams. One approach is to have teams that actually wear different hats as the primary product activity shifts from predesign to detailed design to prototype to volume manufacturing. Additionally, having the cross-functional teams use tools such as quantitative market research, KJ diagrams, simplified QFD, and Designed Experiments can greatly enhance the combined organizational intelligence about the product and process required to create the product.

Using a truly cross-functional team that can communicate and work together toward a common goal is especially important for process validation efforts. Recently, I was working with a medium sized medical device company on some experimental design and process validation activities. The validation team consisted mainly of manufacturing operations and mechanical engineering personnel. The function of quality was to generate procedures, then audit, and critique protocols and completed qualifications. Auditing is certainly an important role within a medical device company, but wouldn’t the team be in a better position to conduct validation activities in an effective and efficient manner if the quality engineers were party to PV activity from its initiation?   Quality engineering concerns could then be raised and resolved early in the development of the validation protocols, not after they had been prepared. Quality engineering needs to partner in the process…not just “quality cops”.

Robert G. Launsby is the founder of Launsby Consulting (Colorado Springs, CO). He is also the author of "The High Cost of Outsourcing to China."