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Quality Management Process


A Quality Management Process is a workflow mechanism in an organization for ensuring that a team's deliverables are "fit for purpose".


Where Does the Quality Management Process Begin?

The start of the Quality Management Process involves setting quality targets to 'Plan the Quality'. The planned quality is termed as 'Quality Target Product Profile' in the 'Quality by Design' guidelines for the life science industries. The process of quality planning can be driven by:

      • Customer requirements, also known as 'Voice of the Customer.'
      • Applicable standards and regulations
      • Business goals
      • Manufacturing method
      • Employee key responsibility area
      • Interaction with other processes


Components of Quality Management Process

Afterwards, three key processes, namely, a "Quality Assurance Process", "Quality Control Process", and "Continuous Improvement Process", are set forth to measure, report and improve the deliverables' actual quality. These three processes are important components of the Quality Management Process are defined below:

      • Quality assurance (QA)  is a way of preventing mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers, which ISO 9000 defines as "part of quality management focused on providing confidence that quality requirements will be fulfilled."
      • Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements".
      • Continuous improvement process (abbreviated as CIP or CI) is an ongoing effort to improve products, services, or processes.


Why do we need Quality Management Process?

There are several reasons for organizations to implement Quality Management Process; some of those reasons are as below:

      • Improve customer satisfaction.
      • Statutory requirements like EU MDR
      • Achieve greater consistency in tasks and activities that are involved in the production of products and services.
      • Increase efficiency in processes, reduces wastage, and improve the use of time and other resources.


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