Who should conduct our annual self-inspection to ensure objectivity?

The purpose of annual self-inspection is to conduct a critical and honest assessment of your own Quality Management System, so objectivity and independence are essential. To ensure this, the people or team conducting the self-inspection should be as independent as possible from the activities being inspected. Best practice is to: 1. Form a self-inspection team with members from different departments—for example, have production staff inspect the warehouse and warehouse staff inspect the quality control laboratory, creating cross-checks. 2. Appoint a member of management who is not directly responsible for specific operations, such as the quality assurance manager, to lead the team. 3. If the company’s size and resources permit, engage an independent external consultant or auditor to conduct the self-inspection. This can provide the most objective perspective and may bring experience of industry best practices. Regardless of who conducts it, self-inspection personnel must receive appropriate training and be familiar with GDP/GMP requirements and auditing techniques.