Gilbert A. Cortes CQE, CQA, MBB, Quality Engineering Director, Johnson & Johnson
Additive Manufacturing (AM) is an innovative technology that has the capability to transform the Medical Device market place by delivering customer-specific healthcare solutions. There are some potential challenges to the existing quality systems that need to be considered in order to realize the benefit of this disruptive technology. These opportunities include developing innovative solutions to design controls and production and process controls.
In subtractive manufacturing methods, design controls are applied to each processing step to ensure that the part quality requirements are met as the part is created and assembled. In the case of AM, however, the manufacturing process is fundamentally different in that it is made in fewer steps and the manufacturing process gives the part its unique geometry, precision, inherent strength, etc. in the same operation. Another challenge is the concept of the lot size that in AM is equal to one. Software validation is another area that for AM requires a different approach.
Each of these challenges can be overcome by developing effective strategies within the various quality Systems impacted that will allow for patient specific solutions to be realized containing the adequate level of controls.