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A First Article Inspection (FAI) is a production validation process for verifying that a new or modified production process produces conforming parts that meet the manufacturing specification detailed in technical or engineering drawings. Typically, a supplier performs the FAI and the purchaser reviews the report. The FAI process usually consists of fully testing and inspecting either the first part produced by the new process or a sample from the first batch of parts. First article inspection is typically a purchase order requirement of the purchaser for the supplier to complete. If the manufacturer doesn't have the in-house capability or if the purchaser requests, the first article inspection may be conducted by an approved subcontract supplier such as a dimensional inspection/metrology laboratory.
Dimensional characteristics (size, shape, and feature location) are normally inspected using calibrated tools such as Coordinate Measuring Machines (CMMs), Vernier calipers, Go/no go gauges, etc. It may also be a requirement for material testing to be completed, checking the hardness, conductivity and other properties.
First article inspections are commonplace for military subcontractors. The protocol is, however, required for design verification, purchasing controls, from the supplier and the purchasers receiving inspection in many non-military industries, particularly aerospace, automotive and medical manufacturing.
Manufacturers delivering products to government bodies or in regulated industries such as medical device must typically meet more stringent requirements than international requirements. If there are special test requirements outside of the suppliers capability then test maybe subcontracted to a 3rd party accredited testing lab. [1] This is normally called First Article Test and is a separate activity from FAI.
Some general standards which apply to first article inspection are produced by the ISO (International Organization for Standardization), the SAE AS (Society of Automotive Engineers Aerospace Standards), the IEC (International Electrotechnical Commission), the IAF (International Accreditation Forum) the ILAC (International Laboratory Accreditation Cooperation) however more stringent regulations may apply in the U.S. in regulated industries.
First article inspection can fulfill the process validation requirement of a quality management system such as ISO9001, EN9100, and AS9100. Within the Aerospace industry SAE AS9102 Aerospace First Article Inspection Requirement is used. This standard also supports the Aerospace Series – Requirements for Advanced Product Quality, Planning and Production Part Approval Process.
With the use of modern computers in the manufacturing environment, first article inspections are no longer being used with the traditional three form layout on paper but instead recorded digitally and stored on servers for easy access and organization. Recording the first article digitally eliminates errors with the help of software that keeps track of the FAIs and generates reports immediately after successful completion of an FAI.
AS9102 is the North American aerospace standard for First Article Inspection Requirements (like SJAC9102 for Japanese Aerospace Standards and EN9102 for European Aerospace Standards). First article inspection can be documented on Forms 1 (Part Number Accountability), 2 (Product Accountability), and 3 (Characteristic Accountability, Verification and Compatibility Evaluation).[ citation needed ]
Form 3 may often be referred to 3D data models or 2D technical data sheets (also called ballooned drawings), where the characterics are uniquely identified.[ citation needed ]
Some software solutions insert a grid on the 2D data sheets, so that the measured characteristics may be uniquely identified by the part number and the related revision number of the 2D data sheet, and the relative position of the characteristics on it (e.g.: in quarter A2, C10).[ citation needed ]
In a 3D data model, the point of each measured characteristics is uniquely identified by three numbers: the coordinate vector, that gives his Triangulation in a 3D space.[ citation needed ]
First Article Inspection is part of AS9145, Requirements for Advanced Product Quality Planning and Production Part Approval Process (APQP/PPAP), Phase 4 and is a required document for APQP/PPAP approval. See Production Part Approval Process.
Many large aerospace companies including Bombardier Aerospace, and Spirit AeroSystems have recently switched to enhanced first article inspections in order to keep track of the numerous first articles received by different companies within the company's supply chain. Suppliers to these companies, including Machine Shops, are also turning to enhanced first article inspections to improve manufacturing productivity and throughput by eliminating the manual process of creating FAIs. [2] [3] Customers who perform such inspections are recommended to identify this in the contract, and to use specific forms to document the results. [4]
Conformance testing — an element of conformity assessment, and also known as compliance testing, or type testing — is testing or other activities that determine whether a process, product, or service complies with the requirements of a specification, technical standard, contract, or regulation. Testing is often either logical testing or physical testing. The test procedures may involve other criteria from mathematical testing or chemical testing. Beyond simple conformance, other requirements for efficiency, interoperability, or compliance may apply. Conformance testing may be undertaken by the producer of the product or service being assessed, by a user, or by an accredited independent organization, which can sometimes be the author of the standard being used. When testing is accompanied by certification, the products or services may then be advertised as being certified in compliance with the referred technical standard. Manufacturers and suppliers of products and services rely on such certification including listing on the certification body's website, to assure quality to the end user and that competing suppliers are on the same level.
Quality assurance (QA) is the term used in both manufacturing and service industries to describe the systematic efforts taken to assure that the product(s) delivered to customer(s) meet with the contractual and other agreed upon performance, design, reliability, and maintainability expectations of that customer. The core purpose of Quality Assurance is to prevent mistakes and defects in the development and production of both manufactured products, such as automobiles and shoes, and delivered services, such as automotive repair and athletic shoe design. Assuring quality and therefore avoiding problems and delays when delivering products or services to customers is what ISO 9000 defines as that "part of quality management focused on providing confidence that quality requirements will be fulfilled". This defect prevention aspect of quality assurance differs from the defect detection aspect of quality control and has been referred to as a shift left since it focuses on quality efforts earlier in product development and production and on avoiding defects in the first place rather than correcting them after the fact.
In software project management, software testing, and software engineering, verification and validation (V&V) is the process of checking that a software system meets specifications and requirements so that it fulfills its intended purpose. It may also be referred to as software quality control. It is normally the responsibility of software testers as part of the software development lifecycle. In simple terms, software verification is: "Assuming we should build X, does our software achieve its goals without any bugs or gaps?" On the other hand, software validation is: "Was X what we should have built? Does X meet the high-level requirements?"
A test plan is a document detailing the objectives, resources, and processes for a specific test session for a software or hardware product. The plan typically contains a detailed understanding of the eventual workflow.
Advanced product quality planning (APQP) is a framework of procedures and techniques used to develop products in industry, particularly in the automotive industry. It differs from Six Sigma in that the goal of Six Sigma is to reduce variation, but has similarities to Design for Six Sigma (DFSS).
Environmental stress screening (ESS) refers to the process of exposing a newly manufactured or repaired product or component to stresses such as thermal cycling and vibration in order to force latent defects to manifest themselves by permanent or catastrophic failure during the screening process. The surviving population, upon completion of screening, can be assumed to have a higher reliability than a similar unscreened population.
A measurement systems analysis (MSA) is a thorough assessment of a measurement process, and typically includes a specially designed experiment that seeks to identify the components of variation in that measurement process. Just as processes that produce a product may vary, the process of obtaining measurements and data may also have variation and produce incorrect results. A measurement systems analysis evaluates the test method, measuring instruments, and the entire process of obtaining measurements to ensure the integrity of data used for analysis and to understand the implications of measurement error for decisions made about a product or process. Proper measurement system analysis is critical for producing a consistent product in manufacturing and when left uncontrolled can result in a drift of key parameters and unusable final products. MSA is also an important element of Six Sigma methodology and of other quality management systems. MSA analyzes the collection of equipment, operations, procedures, software and personnel that affects the assignment of a number to a measurement characteristic.
Product certification or product qualification is the process of certifying that a certain product has passed performance tests and quality assurance tests, and meets qualification criteria stipulated in contracts, regulations, or specifications.
AS9100 is a widely adopted and standardized quality management system for the aerospace industry. It was released in October, 1999, by the Society of Automotive Engineers and the European Association of Aerospace Industries.
Similarly, the activity of qualifying systems and equipment is divided into a number of subsections including the following:
Production Part Approval Process (PPAP) is used in the automotive supply chain for establishing confidence in suppliers and their production processes. Actual measurements are taken from the parts produced and are used to complete the various test sheets of PPAP.
"All customer engineering design record and specification requirements are properly understood by the supplier and that the process has the potential to produce product consistently meeting these requirements during an actual production run at the quoted production rate." Version 4, 1 March 2006
Submittals in construction management can include: shop drawings, material data, samples, and product data. Submittals are required primarily for the architect and engineer to verify that the correct products will be installed on the project.
An independent test organization is an organization, person, or company that tests products, materials, software, etc. according to agreed requirements. The test organization can be affiliated with the government or universities or can be an independent testing laboratory. They are independent because they are not affiliated with the producer nor the user of the item being tested: no commercial bias is present. These "contract testing" facilities are sometimes called "third party" testing or evaluation facilities.
The South African National Accreditation System (SANAS) is the official accreditation body for South Africa. Founded in 1996, SANAS is headquartered in Pretoria, South Africa. SANAS accreditation certificates are a formal recognition by the Government of South Africa that an organisation is competent to perform specific tasks.
Verification and validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Integration verification and validation" can be abbreviated as "IV&V".
Weld quality assurance is the use of technological methods and actions to test or assure the quality of welds, and secondarily to confirm the presence, location and coverage of welds. In manufacturing, welds are used to join two or more metal surfaces. Because these connections may encounter loads and fatigue during product lifetime, there is a chance they may fail if not created to proper specification.
A specification often refers to a set of documented requirements to be satisfied by a material, design, product, or service. A specification is often a type of technical standard.
Verification in the field of space systems engineering covers two verification processes: Qualification and Acceptance
CSA CAN3-Z299 is a series of quality assurance standards developed by the Canadian Standards Association in the 1970s. It is an alternative to the ISO 9000 series of standards. The stated objectives of the Z299 series of standards are:
The Automotive Industry Action Group (AIAG) is a not-for-profit association founded in 1982 and based in Southfield, Michigan. It was originally created to develop recommendations and a framework for the improvement of quality in the North American automotive industry. The association's areas of interest have expanded to include product quality standards, bar code and RFID standards, materials management, EDI, returnable containers and packaging systems, and regulatory and customs issues.