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advances, international regulatory harmonization, and global competition results in processes and controls that are out of date almost as soon as they are approved.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).
I made this same distinction when it came to taking advantage of quality by design and open innovation collaborations with universities in a compliant and flexible manner in chapter six. Compliance and controls should focus more on the end goal – the records produced – rather than the compliance of university processes.
Throughout part one of this book, I described the rapid, continuously expanding amount of knowledge, technology, and sub-sub-specializations. Focusing on ensuring every process is controlled to a high degree of quality is a Sisyphean task. Instead, by focusing on the primary goal of a quality system – to ensure the company complies with written regulations and expectations in order to develop and sell medicinal products – ensuring process quality becomes only one tactic among many. Focusing on this end goal offers the company far more flexibility and opportunity for cost-effectiveness.
Define a Visual Quality System Framework
When executives can work with the end business goal in mind, they can step away from the tactical to put together an overall quality system plan or framework that starts to balance compliance and control with cost-efficiencies and flexibility. Rather than tackle such a quality plan as a project, I encourage my clients to use a visual framework based on a tool they already have: the organizational chart. There are five steps to structure this framework:
1. Replace the typical job titles in each organizational chart box with potential SOP titles
2. Group these into functional areas; consider adopting something akin to the FDA’s breakdown of a quality management system into seven groupings: management, laboratory or design controls, production and processes, records management and change control, facilities and equipment, and continual improvement and corrective and preventative actions
3. Tie everything together, leading up to an overarching quality policy
4. Connect the quality policy to a set of guiding ethical principles or a code of conduct
5. Over time, distinguish the boxes that represent each SOP as each SOP is implemented
Many of the SOPs and policies created will be dependent upon each specific company and its operational environment (e.g., the emphasis on privacy is greater in the European Union than in the US). The key is to keep the plan simple, structured, straightforward, and focused on complying with the regulatory expectations of a quality system.
Process Map and Rapid Prototype SOPs
The next step is to tackle the transience of processes and controls. If processes and controls risk becoming out of date faster, does that mean that SOPs are no longer feasible? No; documenting processes will always be necessary. It is the degree of documentation detail that is central to handling the transience of processes and controls.
To find a path forward, step back and consider the purpose of standard operating procedures. SOPs simply document processes in such a manner that by following the documented workflow, consistent results are produced within acceptable ranges and records are produced that prove this.
George Smith of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research has pointed out that as long as a company has a documented process and the records to prove that the process is followed, it does not matter if that process is “documented as a flowchart on a cocktail napkin or as a detailed 30-page SOP.” When it comes to SOPs, then, the only fixed compliance requirement is that the process and its decision-flow be documented; whether that documentation is in the form of a process diagram or a full-blown multi-page SOP is a business decision, not a regulatory requirement.
During my career as an executive in research and development (R&D) and new product commercialization organizations, I gained a deep appreciation for a development principle called “rapid prototyping.” Rapid prototyping is the use of models or tools to quickly develop prototype products that can be assessed, often through formal testing or consumer focus groups. Rapid prototyping can also be used in determining and embedding the minimum controls as early as possible in any process, procedure, or system design.
One approach to capitalizing on rapid prototyping with quality systems is to draft a flowchart before writing a specific SOP and highlight critical decision points and potential controls. Then use a mock walk-through or even a pilot plant test-run to assess the controls and the work flow. Refine and test again, this time in a different manner (e.g., if a mock walk-through was used beforehand, use a pilot plant test-run the second time). Finally, write and wordsmith the detail behind the flowchart.
A second approach, often more amenable to the 21st century knowledge factory of offices and meeting rooms, is to combine rapid prototyping with process mapping. Process mapping plots the course of a business workflow from start to finish. Toyota pioneered process mapping in the 1950s when it assessed how information and materials flowed through its factories. Toyota then focused on which steps added value and which steps detracted from efficiency and raised costs. By eliminating the wasteful steps and keeping the value-added steps Toyota cut costs, increased efficiency, and improved operational flexibility.
I teach clients this same approach for SOPs. An SOP process map shows how information and materials (such as forms and checklists) flow through an organization’s process and how decisions are made. Because processes often cross departmental boundaries, the use of process maps increases the chance for cross-functional coordination and involvement. Additionally, process maps:
1. Leave little room for arguments around phrasing and terminology; this, in turn, allows a more holistic view to dominate, providing greater opportunity for flexibility to be retained
2. Demonstrate the consistent, repeatability of a process, thus achieving a regulatory requirement
3. Quickly allow participants to identify steps in the overall process sequence that can be eliminated, combined, or improved, balancing compliance with cost-efficiencies
4. Clarify who is responsible for each step of a process, improving accountability
5. Allow easier identification of records produced as a result of following a particular process
6. Are ideal training vehicles, providing a quick visual overview of a process
7. Help ensure that potential continuous improvement elements add value to the process
Note for the reader: throughout this chapter I use the terms “quality system” and “quality management system” interchangeably.
Paton, Scott (2000) “Consumer-driven Six Sigma saves Ford $300 million,” Quality Digest, 1 September, http://www.qualitydigest.com/sept01/html/ford.html accessed on 23 November.
FDA (1999) Guide to Inspections of Quality Systems, August, http://www.fda.gov/downloads/ICECI/Inspections/UCM142981.pdf accessed on 23 November 2009.
Smith, George (2005) FDA’s Current Interpretation and Guidance for Computerized Systems. Presented at the IVT Computer Systems & Software Validation Conference, 25 April, Philadelphia, Pennsylvania.
About the Book
Get to Market Now!
Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine
by John Avellanet
Published by Logos Press
(ISBN 978-1-934899, 342 pages, soft cover, $64.95)
Available through bookstores, Amazon, Barnes & Noble, or the book's companion website: http://www.get2marketnow.com