Life Sciences Business Decisions Intersecting With Quality Risks

Effective business strategies accurately weigh opportunity against risk. Life sciences companies, in particular, often overlook a key factor that can easily unbalance the opportunity/risk balance: How will bottom-line business decisions affect product quality?

More than one CEO, confident in the company’s compliance policies and practices, has been blindsided by a product recall, safety alert, or curt warning letter from the FDA citing quality failures. A common denominator among these organizations is a narrow focus on compliance rather than a broad emphasis on quality. Compliance and quality are not synonymous, a point vigorously promoted by the FDA in its “Case for Quality” initiative, which calls for companies to adopt a view of compliance as one part of achieving overall quality rather than the ultimate goal. To do that, companies need to recognize the interrelationship of product quality and business decisions — and then take practical steps to address the potential risks created by the intersection of the two.

Risky Business
Strategic business decisions — mergers, acquisitions, market expansion, outsourcing, cost-cutting, corporate restructuring — are all developed under the gun of a pitching global economy, regulatory twists and turns, legal and illegal competition, and social upheaval. The opportunity/risk balance is identified and analyzed by teams of experts in a variety of departments/areas. Yet, even though the success of any decision is inescapably tied to the quality of its products, the Quality Department is often missing from this roundtable of experts, called in only after the decision has been made. Tearing down the silo that separates “quality” from “business” is the first clear step in achieving the FDA’s goal of a quality based viewpoint. The second step is factoring the potential that quality impacts into the decision itself.