Kevin Lee, Industry Solutions Consultant, Pilgrim Quality Solutions, an IQVIA company
In my role as an industry solutions consultant for an enterprise Quality Management Solutions (QMS) provider, I get a lot of insight into the quality challenges facing manufacturing and service organizations. I’ve concluded that a lot of those challenges are internally generated.
The source, more often than not, is a communication issue, or a lack of communication between internal parties that are not on the same page regarding goals, objectives, strategies, or priorities. The result, far too often, is what some would call organizational paralysis. It’s what happens when multiple parties can’t agree to agree. No one wins, but everyone loses.
Business & Quality – aren’t they on the same team?
Interestingly, not long ago I attended the PDA/FDA Joint Regulatory Conference where one session in particular really struck a chord with me. “Business Challenges and the Quality Imperative” was presented by John Pinion, EVP Translational Sciences & Chief Quality Operations Officer at Ultragenyx Pharmaceutical, a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases. A portion of his presentation addressed the give-and-take nature of responding to some of the key business and quality concerns which are universal within life sciences enterprises.
Below is an outline of what Pinion refers to as “Quality Trade-off Paradigms” that executives must consider while managing their organizations. But should companies have to choose between a Business versus a Quality approach? For each paradigm, there is a strategy for eliminating the need for trade-offs.
Trade-off Paradigm #1: Cost Efficiency or Robust Quality
The constant push-pull of achieving excellent quality at the risk of higher costs confound managers daily. It is not enough to speed product to markets; those products must be quality products. Manufacturers must re-examine their quality culture, leadership commitment, processes, technology, and analytics to embed quality improvement across operations. In the long run, considering quality during every phase of the product’s lifecycle helps to reduce significantly the cost of quality.
Trade-off Paradigm #2: Quality or Business Focus
There is no business if quality is not a focus. Business and Quality must align strategically to ensure that both areas focus on the same goals, initiatives, and programs. Quality should never come behind, nor separately from the business. The business demands quality goods and services to grow and to remain viable. When an organization embeds quality into every aspect of its business, the organization achieves synergies, and then there are no trade-offs between business and quality. It’s simply a win-win across the board.
Trade off Paradigm #3: Freedom to Innovate or Disciplined Process
Innovation implies pushing the boundaries to discover something new, to imagine and create the impossible. Disciplined processes ensure that all innovations occur within the regulatory guidelines. Freedom to innovate within a Disciplined Process is a tightrope-walk life sciences companies traverse to bring new products/drugs to market that meet regulatory requirements.
Trade off Paradigm #4: GxP Quality as a “Check Box” Exercise
Quality should never exists as a checkbox exercise nor should quality serve as something representatives must do. Quality-centric organizations view quality as a strategic and a competitive advantage. There is tremendous business value in creating a global, enterprise quality system that achieves a single source of quality truth. For most businesses, building a global quality system involves changes to processes, systems, and culture. The Quality-centric organization yields fewer CAPAs, Complaints, and Recalls, resulting in more sales, and increased customer satisfaction.
Trade off Paradigm #5: Speed and Flexibility or a Quality Mindset
It is not enough to speed products to market. For the business to succeed, its products must be quality products. There’s no need for trade-offs. By creating products correctly the first time, with quality built-in, hindrances such as Nonconformances, CAPAs, and Complaints are quickly overcome and speed to market is accelerated. This understanding is inherent in, not separate from, a Quality Mindset. Manufacturers must examine their quality culture, leadership commitment, processes, technology, and analytics to embed a Quality Mindset across their operations.
The Case for Quality System Transformation
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