When it comes to the Life Sciences industry, the need for innovation is clear. From traditional pharmaceuticals to new biotech companies, from medical devices to advanced diagnostics — and everything in between — strict regulatory requirements, patient and physician expectations, competition and time to market pressures form the perfect storm of demands on the industry.
This presents a unique set of challenges in implementing a total quality strategy in Life Sciences. Yet, the importance of this quality-centric approach cannot be overstated. After all, the innovations in this industry are helping people be healthier and even saving lives.
Total Quality Strategy
To address the unique combination of challenges in this highly regulated industry, a total quality strategy combining complete control and systems designed for the modern life sciences industry is required.
This total quality approach would align corporate, operational and market objectives, clearly defining roles and responsibilities, processes and procedures, tasks, technologies, areas of collaboration and metrics across the entire value chain. The overarching goal is to establish a single source of truth, referenced during the discovery and development phases, and incorporating material and product quality testing for end-to-end traceability, from the lab to the clinical trials to the market and back again. Only a systemic total quality strategy can meet the demands for high-quality data throughout the product lifecycle and ensure the quality of processes — all needed by the regulatory requirements and industry guidelines.
This current approach has its roots in the Total Quality Management (TQM) philosophy, designed in the 1980s to continuously improve the quality of manufactured products while improving customer satisfaction. TQM was not designed for life sciences or other highly regulated industries, but it has a lasting influence on good manufacturing practices (GMP), ISO standards, and some FDA quality guidance documents used in the industry.
TQM is a management approach to long-term business success through customer satisfaction, where every member of an organization participates in the continual improvement of products, services, processes and the culture in which they work. Total Quality Management utilizes data, strategies and effective communications to systematically integrate the quality discipline into the activities and culture of the entire organization.
A Brief History of Quality Management
To better understand present-day challenges in designing for total quality in the Life Sciences industry, it helps to review how quality management practices first came to be. The very first framework for quality in industrial organizations emerged in the 1911 book by Frederick Winslow Taylor. “The Principles of Scientific Management” clearly defined various tasks performed under standardized conditions and prescribed the use of inspections as a way to control quality. A decade later, the manufacturing industry started adopting the use of statistical methods for total quality assurance. This practice was further refined in Japan in the 1940s and 1950s by legendary quality pioneers William Edwards Deming, Dr. Joseph M. Juran and Armand V. Feigenbaum. Following the success of these quality programs in Japan, organizations around the world began implementing quality initiatives modeled after them.
While quality management practices evolved significantly over the last century and even more so during the last 40 years, the new total quality paradigms are emerging for highly regulated industries.
Quality Management in the Pharmaceutical Industry
One such highly regulated industry is Pharmaceuticals. The FDA ICH Q10 Pharmaceutical Quality System guidance document, written in 2009, outlines a risk-based framework of Total Quality Management. TQM spans the entire product development lifecycle, including pharmaceutical development, technology transfer, commercial manufacturing and product discontinuation. Going beyond good manufacturing practices (GMP), the Q10 model aims to achieve three main objectives:
- Achieve Product Realization
- Establish and Maintain a State of Control
- Facilitate Continual Improvement
The Q10 guidance set the new standard for pharmaceutical quality management:
- Quality is built into processes instead of improved with additional testing or inspections
- Rigorous, modern science is used throughout the product lifecycle
- Quantitative risk management is used to enable effective decision-making
- Organizations employ QMS software to assure knowledge management and transfer
- The industry adopts an integrated approach to development, manufacturing, and quality
ISO Quality Management Principles
The International Organization for Standardization (ISO) defines seven quality management principles (QMPs) on which ISO 9000, ISO 9001 and related ISO quality management standards are based. The seven quality management principles are:
- Customer focus
- Engagement of people
- Process approach
- Evidence-based decision making
- Relationship management
It is important to note that these principles are not listed in priority order. ISO states that the relative importance of each principle will vary from organization to organization and can be expected to change over time.
Quality at the Heart of Innovation
Innovation is at the heart of what moves life sciences forward. Similarly, quality needs to be at the heart of the innovation itself. Total control over quality at every stage of the product development lifecycle is the key to business success and developing pioneering advancements that change human lives for the better.
The total quality approach aims to address the issues of inconsistent business processes, legacy systems that impede collaboration and other internal and external barriers to quality-centric organization culture amid fierce competition and rapid technology and industry changes.
To consistently deliver excellent patient experiences, high-quality, safe and effective healthcare solutions and to effectively compete and grow in challenging markets, life sciences companies need total quality and compliance management systems and processes in their product lifecycle.