Quality Assurance is an extensive practice used for assuring the quality of products. It includes all planned and systematic activities that are implemented to provide adequate confidence that the organization fulfills the requirements for quality.
At Zeon, we have a dedicated Quality Assurance team, which strives for continuous improvements in our quality functions, like, constantly working to enhance the existing quality of products and services by optimizing existing production processes and introducing new processes.
Zeon’s QA team has separate members for audit that focus on working with the clients to ensure that all client needs are met and sustained. Additionally, the team also has a separate documentation cell whose responsibility is to provide a library of all documents and also make sure that all documents are current and complete.
Our Quality Assurance team focuses on process improvements. The goal of the team is to reduce variance in processes in order to predict the quality of an output (final or interim product), gather best practices for the company, reduce cost, and reduce time to market. Quality Assurance is strongly linked to innovation and creativity.
An excellent communication between the Quality Assurance/Quality Control groups and process owners helps in attaining quality excellence in the organization. The team has the following roles:
- To establish a quality system by describing how the company follows cGMP, operates to maintain a state of control and keeps quality management systems current with GMP, GLP, GSP, GDP, etc.
- To audit compliance to the quality system by reporting quality system performance metrics, including trends, and management review meetings, that help in informed decision-making and in proactive targeted actions.
- To establish procedures and specifications to ensure these are current, appropriate and followed.
- To perform the Validation and Qualification by ensuring that all equipment/ instruments are qualified and all process and methods are validated.
- To establish manufacturing controls to ensure appropriate manufacturing in-process controls are implemented.
- To perform laboratory tests or examinations of components, containers, in-process materials, packaging materials and raw material products, using validated methods against scientifically-derived, fit-for-purpose specifications.
- To ensure investigation of non-conformance by ensuring investigation is conducted and root cause is eliminated for production and control record errors, discrepancies, and failures to meet specifications, including quality attributes.
- To remain independent by ensure there is no conflict of interest between regulatory responsibilities and actual daily activities.
By way of adopting different quality management systems in Zeon, we properly establish and manage quality assurance systems with their integral well-written SOPs and other quality documents for achievement of company objectives. We aim at achieving high quality in processes, procedures, systems, and people, with high quality in products, and services. All these quality excellence attributes lead to the enhancement of the following:
- Customer satisfaction.
- Timely registration with a regulatory body.
- Operational excellences results such as revenue, profitability, and market share.
- Alignment of processes with achievement of best results.
- Understanding and motivating employees towards the company’s quality policy and business objectives, as well as participation in continual quality improvement initiatives.
- Increasing confidence of interested customers for effectiveness and efficiency of company’s performance and reputation.