In general terms, Quality management refers to the set of all those activities and tasks that must be executed to maintain a desired level of excellence in overall operations as a whole. Starting with the determination of a quality policy and then implementing the plans with prospects of quality control and improvements- are the main aspect of this management tool. It offers several benefits for the organizations like enhanced efficiency, consistent control, better risk management and increased customer satisfaction, etc. In contractual situations, assured quality generates a greater confidence in the supplier which is an indispensible tool for establishing one in the market.
While quality problems can be found in any industry, they are frequenting considerably more in the pharmaceuticals and medical-spaces. So a special attention towards quality maintenance is getting more focus. Many companies reveal that they are struggling to maintain quality. It is not because of lack of efforts, the effective overall management is challenging because of:
- Increasing product complexity leading to greater challenges in supplies and distributions
- Globalization of supply chain
- Authoritative Regulations from FDA and others expecting pharmaceuticals to take full ownership of supply and distributions
The last few years have witnessed a high drug-recall which were mostly attributed to poor supply management. Other factors were:
- Lack of collaboration in the design phase
- Lack of robust quality system in supply and distribution
- Lack of capabilities in manufacturing facilities
As per the World Health Organization’s Good Distribution Practice, a supplier must have a documented quality policy- formally expressed and authenticated by the management, with clear mention of all its intentions in regards to the quality. Including an appropriate infrastructure covering procedure, processes and resources along with the systematic actions required to ensure the confidence that the products/services with documentation will satisfy the quality requirements. Out of these the second requirement is made mandatory to be followed.
The focus on quality management by pharmaceuticals organizations is more than a century old. In his ground-breaking book, ‘The Principles of Scientific Management’, Fredrick Taylor fabricated the first framework for quality maintenance and management in Industrial organizations in 1911. They year 1920 witnessed the adoption of statistical methods for quality assurance by manufacturing organizations. Since then quality management theories and practices have evolved greatly and have adapted into frameworks and guidance to comply with the regulations. The main elements of quality management for pharmaceutical companies can be categorized into following 7 factors:
1. Customer Focus:
Organizations achieve success when they earn customer confidence, and therefore ISO has given clear clarion, “Exceed Customer’s Expectations”.
2. Employee Involvements:
Late W. Edward Deming was the first to propose the idea of self-directed teams in quality driven environment (The Deming Management Method, 1986). He proposed that employees are ultimately responsible for quality, and argued that true continuous improvement could not be achieved unless leadership provides workers with the needed resources. Based on those practices most of the leading pharmaceutical companies are imposing quality as a personal goal.
3. Process-Centered Approach:
Considering and managing the overall activities as interrelated process leads to consistent and predictable results and such process centered management supports continuous improvement and enhanced efficiency.
4. Integrated systems:
An organization can only optimize products and performance by understanding how a system produces results. Comprehensive software application helps in seamless operations and better management of tasks.
5. Strategic and Systematic Approach:
A strategic approach to Pharma-leadership allows a company to become more forward-thinking. Instead of focusing on immediate objectives, management review efforts are driven by a clear roadmap for clinical development.
6. Continuous Improvements
Effective relationships and communication are crucial to achieving the alignment of people, processes and technology. Systems for communication should support real-time, productive dialogue between leadership, quality, employees, and third-party organizations in the supply chain.