Kevin Ong, Ph.D., P.E.
“Design controls” is a broad term that describes several procedures and processes used throughout the design and manufacture of a product, the basic focus of which are to ensure the most effective product design and that what is produced consistently reflects that design and the product's intended use. Design inputs, outputs, review, change controls, validation, verification, transfer (to manufacturing), and the design history file all constitute aspects of design controls. In the FDA’s Quality System Regulations, design controls are addressed in 21 CFR Part 820, Subpart C (§ 820.30).
Having effective design controls in place can go a long way in preventing and bolstering the defense against products-liability claims alleging a design defect—one of three bases for products liability. The basic allegation behind a design-defect claim is that a safer design exists for the product in question, but that the manufacturer failed to use the safer design. Robust design controls help to ensure that the safest, technologically feasible, design for the product is being used. Further, in the event of litigation, design controls can be used by the manufacturer to demonstrate that the risks associated with alternative designs were weighed and considered.
In addition to creating products liability risks for design flaws, failure to institute sufficient design controls is likely to result in regulatory actions. Design controls constitute about a quarter of what the FDA evaluates during a site inspection. This emphasis appears to be appropriate, as the FDA found that approximately 44 percent of the quality problems that led to voluntary recall actions during a six-year period in the 1990’s may have been prevented by adequate design controls.1 As a significant part of the FDA’s focus in inspections, it is not surprising that 55 percent of Warning Letters issued in 2010 cited design controls as a deficiency.2
Design controls not only assure the most efficacious product design and that design inputs meet outputs, design controls also have important advantages for regulatory compliance and products-liability avoidance.
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