With a 21st century medicinal product development structure in place – from collecting voice of the customer information through quality by design and bookshelving – it is now time to turn attention to a modern, 21st century quality system. Just as today’s biopharmaceutical and device development rules are being rewritten to accommodate evolving scientific and engineering knowledge, the rules of the 20th century quality system are also being revised.
As I discussed in chapter three, traditional biopharmaceutical and device quality systems were built upon a post-World War II industrial era desire for uniformity and standardization. The very name of a quality system’s basic component, the standard operating procedure, seeks to enshrine the uniform conduct of a process. And yet, how well does this quest for conformity and standardization fit in a landscape of rapid knowledge growth and daily scientific discoveries where technology capabilities double every two years, global competition and generics force mounting price pressure, and the Food and Drug Administration (FDA) increasingly turns toward guidance publications rather than new regulations to lay out its evolving expectations?
The 5th century B.C. Greek philosopher Heraclitus wrote, “You cannot step twice into the same river; by the second step the river’s water has already changed.” A similar message is true for quality system executives today: the rapid rate of knowledge growth, scientific discovery, technology advances, international regulatory harmonization, and global competition results in processes and controls that are out of date almost as soon as they are approved. To successfully compete and comply, firms must transform their 20th century-based quality system into a flexible, cost-effective quality system grounded in the regulatory, product development, and personalized medicine landscape of the 21st century. Such a structure calls for revisions in five core quality system components:
1. Standard operating procedures
3. Risk-based decision-making
4. Cross-functional involvement
5. Continuous improvement
In this chapter, I walk through each of the changes necessary to build a lean quality system. Each of these revisions combats the five weaknesses of traditional, 20th century-based quality systems I noted in chapter three:
1. Risk aversion
2. Two-valued system thinking
3. Operational silos
4. Cost inefficiencies
5. Customer exclusions
I conclude this chapter with a case study showing how all five of these changes play out in one of the most challenging aspects of 21st century medicinal product development and commercialization: supplier management.
Standard Operating Procedures
A modernized, 21st century approach to standard operating procedures (SOPs) that balance flexibility, cost-efficiency, and compliance requires a company to:
• Link quality systems to business strategy
• Define a visual quality system framework
• Process-map and rapid prototype SOPs
• Write for flexibility
• Spell out the proof generated
• Strive for self-enforcement
Link Quality Systems to Business Strategy
Quality departments do not exist for the sake of quality. Rather, quality departments – quality assurance, quality management, quality control, etc. – exist to execute a component of overall corporate strategy. As an example, recall the slogan of the Ford Motor Co. in the 1980s, “Quality is Job 1.” Ford’s primary business objective was to sell more automobiles. However, in the 1980s, automotive sales were being driven by consumer perceptions of quality. To improve sales, Ford had to improve the public’s perception of Ford quality. So, Ford strengthened the reliability of its automobiles, used Total Quality Management techniques to drive down costs, and embarked upon an advertising campaign to make the public aware of its renewed commitment to quality. Quality was thus built into Ford cars not for quality’s own sake, but to support Ford’s business objective of selling more cars.
In a biopharmaceutical and device context, quality departments exist to implement and maintain the quality system required by regulatory health agencies and regulations. Additional quality system goals – achieving compliance with International Standards Organization (ISO) guidelines, implementing Six Sigma or Total Quality Management, etc. – should only be undertaken to support greater corporate strategies. Thus, biopharmaceutical and device corporate quality systems exist primarily to ensure compliance with FDA regulations and expectations, including appropriate rules from the International Conference on Harmonization (ICH) and the Global Harmonization Task Force (GHTF), so that the firm may develop and commercialize medicinal products.
Many quality management executives confuse this goal with a belief that their department’s role is to ensure quality in medicinal products and quality in the company’s processes and controls, assuming that by ensuring product and process quality, regulatory compliance is met. Unfortunately, quality is subjective; there can never be enough, especially when it comes to processes. As a result, quality executives strive for further and further control over processes, suppliers, product quality, etc., only to end up further and further away from meeting the business need of a balance between regulatory compliance and operational flexibility.
Just as Ford executives laid out that quality was only one tactic among many to achieve its overall business strategy, so too must biopharmaceutical and device executives make clear the role of quality in light of their business strategy (e.g., the quality department’s goal is to build operational procedures that comply with written regulatory expectations and rules so that the business may develop and sell its medicinal product).