Title 14 of the Code of Federal Regulations (CFR) Part 21.137 outlines the requirements for a quality system that must be established by manufacturers of certain aeronautical products and parts. This regulation is part of the Federal Aviation Regulations (FARs) which govern all aspects of aviation in the United States. The key elements of 14 CFR 21.137 are:
- General Requirements: Manufacturers must establish and maintain a quality system that is appropriate for the product and complies with the standards set by the Federal Aviation Administration (FAA). This system should ensure that the products meet their approved design and are safe for operation.
- Quality System Elements: The regulation specifies various elements that must be included in the quality system. These typically include process control, inspection and testing procedures, control of production process changes, handling of materials, and quality records.
- Responsibility and Authority: The regulation requires that the manufacturer assigns responsibility and authority for ensuring that the quality system is implemented and maintained. This includes appointing personnel with the necessary authority to identify and correct quality issues.
- Data Control: Manufacturers must control and document the technical data related to the design, manufacture, and maintenance of the product. This includes specifications, drawings, process requirements, and inspection and test procedures.
- Inspection and Testing: The quality system must include procedures for regular inspection and testing throughout the manufacturing process to ensure continuous conformity with the approved design.
- Nonconforming Product Control: The regulation requires procedures for identifying, documenting, evaluating, segregating, and disposing of nonconforming products.
- Corrective Action: The system must include a process for taking corrective action when quality issues are identified. This includes investigating the cause of the nonconformity and implementing necessary changes to prevent recurrence.
- Records: Manufacturers must maintain records that demonstrate the product's conformity with its approved design and compliance with the quality system requirements. These records must be retained and made available for FAA inspection.
- Internal Audit: The regulation mandates regular internal audits of the quality system to ensure its effectiveness and compliance with the specified requirements.
- Supplier Control: If a manufacturer relies on suppliers for components or materials, the quality system must include procedures for ensuring that these suppliers meet the necessary quality standards.
- Training: Employees involved in the manufacturing process must receive appropriate training to ensure they are competent in their roles and understand the quality system requirements.
14 CFR 21.137 is critical for ensuring that aeronautical products and parts meet safety standards and function as intended. Compliance with these regulations is essential for manufacturers to obtain and maintain certification for their products.
