Quality Assurance is planned and systematic activities implemented within the quality system that can be demonstrated to provide confidence that a product or service will fulfill requirements for quality. It is a system for evaluating performance, service, quality of a product against system, standard or specified requirement for customers.
Principles of Quality assurance
Quality assurance includes two major principles: Fit for purpose (i.e. product should be suitable for intended purpose) and Right first time (i.e. mistakes should be eliminated).
Based on ISO 9001, quality assurance in pharmaceuticals is concerned with providing confidence that requirements for quality are fulfilled. It consists of consists of eight major principles. These eight principles include:
- Focus on customer satisfaction.
- Emphasis on leadership.
- Involvement of personnel at all levels of organization.
- Management of activities and resources in a process.
- Adoption of a system approach to management.
- Facilitation of continuous improvement.
- Use of a factual approach for making decisions.
- Establishment of supplier relationships that is mutually beneficial.
Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.
Customer Focus leads to:
- Research and understand needs and expectations of customer.
- Ensure that objectives of organization are linked to customer needs and expectations.
- Communication of customer needs and expectations throughout organization.
- Measurement of customer satisfaction and acting on results.
- Systematically managing customer relationships.
- Ensure balanced approached between satisfying customers and other interested parties.
Leaders establish unity of purpose and direction of organization. They should create and maintain internal environment in which people can become fully involved in achieving the goals and objectives of QA.
Emphasizing Leadership leads to:
- Considering needs of all interested parties including customers, suppliers, owners, financiers, employees, local communities as a whole.
- Establish a clear vision of organizational future.
- Set challenging goals and targets.
- Inspire, encourage and recognize people’s contribution.
Involvement of personnel
People at all levels are essence of an organization and their full involvement enables their abilities to be used for organizational benefit.
Involvement of People leads to:
- Sharing of knowledge and experience freely.
- Understand importance of their contribution and role in the organization.
- Accept ownership of problems and their responsibility for solving them.
- Identify constraints to their performance.
Management of Resources
Desired results are achieved more efficiently when activities and resources are managed as a process.
- Establishing responsibility and accountability for managing key activities.
- Analyzing and measuring of capability of key activities.
- Systematically defining activities necessary to obtain a desired result.
- Focusing on factors such as resources, methods and materials that will improve key activities of organization.
- Identifying interfaces of key activities within and between functions of organization.
Systemic Approach to Management
Identifying, understanding and managing interrelated processes as a system contributes to effectiveness and efficiency of an organization in achieving its objectives.
Applying the Principle of System Approach to Management typically leads to:
- Structure a system to achieve objectives of organization in most effective and efficient way.
- Structure approaches which harmonize and integrate processes.
- Provide better understanding of roles and responsibilities.
- Continually improving system through measurement and evaluation.
- Understand interdependencies between processes of system.