Good Practices (GxP) are the guidelines that regulated industries must follow to maintain compliance with standards and regulations promoted by voluntary trade organizations or mandated by government regulations. In the aerospace industry, the framework for compliance is very different than it is for the food manufacturing, medical device, or pharmaceutical industries. This article examines the mechanics of GxP in the aerospace industry.
Good practices are a framework of guidelines and standards set out to regulate various aspects of regulated industries. For example, in cold storage facilities temperatures must remain constant to prevent spoilage. Good practices outline what those temperatures are and the best way to monitor them or other environmental conditions. As Dickson points out, a solid GxP plan helps companies monitor with a sense of purpose and an understanding of the consequences.
Good practices are designated with “GxP,” and the “x” denotes a specific type of requirements. If the standards are intended for a laboratory setting, the “x” becomes an “L” to read GLP. The “x” is an “M” if the standards are intended for manufacturing (GMP) and if the guidelines center on distribution, the “x” becomes a “D” to read GDP. Finally, when a standard is referenced and more current versions of good practices have been promulgated, the GxP designation is preceded by a lower case letter “c” to denote current; for example, cGxP means current good practices.
What Are The Regulatory Bodies/Policies That Govern The Aerospace Industry?
Several agencies are responsible for regulating the activities of the aerospace industry. They include the following:
United States Department of Defence (DoD)
This is an executive branch department of the federal government. It focuses attention on the coordination and supervision of all agencies and functions of the US government related to national security and the US Armed Forces. The DoD was formed in 1947 and is headquartered at The Pentagon.
Federal Aviation Administration (FAA)
This is a United States government body that has the power to regulate all aspects of civil aviation. This extends across the nation and into the surrounding international airspace as well. Formed in 1958, the FAA is based in Washington, DC.
National Aeronautics and Space Administration (NASA)
This is an independent agency of the US federal government. We all recognize the main work of NASA; it is responsible for the civilian space program and research related to aeronautics and aerospace. Formed in 1958, NASA is based in Washington, DC.
The United States Environmental Protection Agency (EPA)
This is an independent agency of the US government that focuses primarily on environmental protection and has some purview of manufacturing practices that relate to aerospace. Formed in 1970, the EPA is based in Washington, DC.
What Are Some Examples of Key Areas For GxP In Aerospace?
GxP in the aerospace industry provides standards-related guidelines that aerospace equipment manufacturers are expected to reach and maintain in order to do business in that space. The FAA encourages manufacturers to implement compliance programs to optimize their manufacturing processes so that they are better positioned to withstand FAA inspections and scrutiny. Here are a few examples of where GxP plays a role in the aerospace industry.
AS9100 Quality Control Standard, Revision A
This is a standardized quality management system produced originally by the Society for Automotive Engineers and the European Association of Aerospace Engineers that predates International Organization for Standardization (ISO) 9001 and has fully integrated ISO 9001 requirements. The standard is intended to meet the quality requirements of the DoD, NASA, and FAA.
Category Parts List
This standard outlines specifics related to aircraft parts. It is aimed at keeping a consistent flow of approved parts for all kinds of aircraft, including commercial, private and military.
Reduced Vertical Separation Minimum (RVSM) Process for Production Aircraft with an Approved Type Design (General Requirements)
This is an FAA memorandum that provides guidelines for ensuring a specific aircraft meets the airworthiness standards and operational safety to fly with reduced vertical separation from other aircraft. Only aircraft with these approvals can fly under RVSM conditions, because local air and pressure changes created by planes flying closer to each other can damage planes.
Information: Qualification Standards for Nondestructive Testing
Nondestructive testing (NDT) is a method that detects and identifies the extent of damage in materials. The aerospace industry used NDT in the design, manufacture, and maintenance of all types of aircraft. Testing involved running processes on parts and components until they reached their breaking point. This provided valuable information about materials and their characteristics, including their ductility, fracture toughness, and tensile strength. However, once a piece of material was tested to destruction, it could not be used for anything else.
NDT methods have replaced this. NDT is now used throughout the lifecycle of a product without rendering that part non-serviceable as a result. There are two main methods used in NDT: surface techniques and sub-surface techniques. Interestingly, one of the oldest testing tools continues to be effective in today’s high-tech aviation industry–the trusty visual inspection. And many new tools have been introduced to the process to make complete and thorough visual inspections.
The aerospace industry is one of many heavily regulated industries in the United States. With several regulatory bodies overseeing the industry, it makes sense that standards are in place to maintain the industries and to regulate standardization. Without it, imagine the quality of parts and lack of compliance that could result. With an industry that puts people in the air for a living, it just makes sense that safety and quality would be key concerns addressed in GxP. As it turns out, these are two parts of the foundation of good practices regulation in the aerospace industry.