Rationale

This proposed revision introduces a requirement for manufacturers to provide an up-to-date organizational chart as part of their documentation or qualification package. The rationale for this addition is based on the following key points: 1. Clarity of Responsibilities and Communication Channels An organizational chart provides transparency into the structure of the manufacturing organization, helping to identify key personnel responsible for quality management, production, safety, and compliance. This facilitates clear communication between the manufacturer and regulatory or auditing bodies. 2. Verification of Competence and Oversight Understanding the hierarchy and roles within the organization helps ensure that appropriately qualified individuals are overseeing critical aspects of production and quality assurance. It supports the assessment of the manufacturer’s capability to meet the requirements of the standard. 3. Traceability and Accountability In the event of nonconformance or product-related issues, the organizational chart can help trace decision-making processes and identify responsible roles or departments, thereby enhancing accountability. 4. Alignment with Industry Best Practices Requiring organizational charts is consistent with best practices in quality management systems such as ISO 9001 and AS9100, where organizational structure and roles are essential components of compliance documentation. 5. Facilitation of Audits and Supplier Evaluations During audits or supplier evaluations, having an organizational chart readily available improves efficiency by providing auditors with a quick reference to the company’s structure and key personnel. This requirement is not intended to mandate a specific organizational structure, but rather to ensure visibility and clarity regarding how the manufacturer is organized to meet the obligations of the standard.