What role should the Quality Department (QA/QC) play in our organisational structure?

In organisations operating in accordance with GDP/GMP, the Quality Unit has an independent and critical role. It consists of Quality Assurance (QA) and Quality Control (QC). QC primarily assesses whether the quality of raw materials, intermediates and finished products meets established standards through sampling and testing. QA has a broader role: it establishes, implements and maintains the company's overall Quality Management System (QMS), ensuring that all activities affecting product quality are controlled. The Quality Unit must be independent of the production or sales departments and have sufficient authority and resources to fulfil its responsibilities. Its core duties include approving or rejecting all quality-related materials and products, approving all SOPs and master documents, managing quality system processes such as deviations, changes and complaints, organising self-inspections, and making the final decision on whether each batch may be released for sale.