Any good manufacturer will utilize a quality management system (QMS) to consistently meet customer requirements. Quality control (QC) is especially important during mass-production, if the product does not pass inspection, huge quantities can be rendered waste or scrap. To avoid lost time and material or poor-quality products, inspections must be made throughout the production process. What should be inspected and against what should that inspection be done? Naturally, the design and engineering specifications but, what happens when a nonconformity occurs partially through production or the part/assembly passes in-process inspection and does not fit a mating part? As part of any QMS, what and when inspections occur should be determined before production even begins. Predetermined specifications are the goal of any manufacturer but, they are more theoretical than physical and of little use when undertaking a corrective action process when a non-conformity occurs. A physical baseline is needed for comparison. To achieve that baseline a first article inspection (FAI) is performed.
What is a First Article? After prototype and pre-production phases are completed production can begin. A first article is a sample or part/assembly of the very first production run. A first article represents what can be expected when the item is mass-produced. First articles can be picked at random from the production line, they do not have to be the first part produced. Often one to three units are pulled for first article inspections (FAI), in some instances more units are required. What is a First Article Inspection? A first article inspection (also known as a production process verification) is a method of verifying a manufacturing process.
The FAI may compare:
• all geometric dimensions and characteristics
• UV resistance
• finish quality
• product identification
• statutory and regulatory requirements
• fit, form and function
• physical properties – weight, density, stiffness etc.
• insert, bushing, thread requirements to drawings, CAD models and other process requirements to ensure conformity to design. This verification is documented in a first article inspection report or FAIR. A FAI also ensures that operators understand process requirements, tooling is properly calibrated and the process is consistent.
What industries require FAI?
A FAI is not necessary for all parts and products. A FAI is not needed for unique, low quantity, and single production runs as well as, most low-cost consumer and promotional goods. Although, a limited inspection, similar to a FAI may be necessary.
Any products that:
• are expensive to manufacture
• contain expensive components/materials
• are difficult to rework
• have strict tolerancing
• require precision
• involve processes vulnerable to calibration error
• have high safety standards are likely to require a FAI
Industries that manufacture such products typically are:
• Medical • Military and Defense
• Electrical and Electronics
In general, certain industries or companies require a FAI more than others. When is a FAI needed? In the purchase order contract between purchaser and supplier is when a FAI is typically requested. The design stage should be completed and production processes should be determined before a FAI is performed since the FAI is used to verify the production process of the given product. Naturally, during the first run of the product is when a FAI should initially be performed.
Other circumstances may require a FAI such as:
• Design changes. Especially those that affect fit, form and function.
• When the design remains the same but, the materials or manufacturing source change.
• Long periods of time between runs. If any characteristics are affected by inactivity.
• When a sub-component of an assembly has changed that may affect fit or function.
• A change in process that may affect fit, form or function.
• When a tooling change occurs. Repairs of damaged or worn tools.
• When manufacturing is moved to another location/facility.
If the change might affect fit, form or function. Ultimately, a FAI is needed when required by a customer or a company’s QMS. What does a FAIR prove? Performing a FAI and compiling a FAIR provides objective evidence to the customer that manufacturing specifications, processes and repeatability of the part/assembly are understood and achievable.
The FAIR documents and verifies that:
• Engineering and design specification requirements are understood.
• Personnel understand tooling, materials and processes and are capable of producing compliant parts/assemblies consistently.
• Part/assembly baseline, definition, compliance and repeatability are established.
Essentially, the FAIR proves that the part/assembly can and will be manufactured to the customer’s specifications. What measurement methods are used for FAI? Physical, functional and dimensional characteristics are to be verified against drawings, CAD, engineering and other design specifications.
• The use of Go/No-Go gauges, such as plug, ring and snap gauges, can be utilized to accurately inspect dimensions. Though a Go/No-Go gauge does not provide a quantitative measurement, it can limit error and increase speed with a pass or fail determination.
• Hand tools: calipers, bore gauges, fixed gauges, micrometers, protractors, thread gauges, indicators and comparators.
• Coordinate Measuring Machine (CMM), vision systems.
• Arm based laser scanning and probing systems: Faro, Hexagon (Romer).
• Structured light 3D scanners: GOM ATOS Triple Scan, Steinbichler Comet.
• 3D inspection software: Geomagic Control X, GOM Inspect, Polyworks Regardless of the method used, all equipment should have current calibration certificates.
What is the difference between a FAIR and PPAP?
In a way, a FAIR is part of the production part approval process (PPAP). PPAP requirements include dimensional results and material, performance test results. All of which are tested and measured during the FAI process. One key difference is a PPAP may require a higher volume of samples than a typical FAI, 5-10 instead of 1-3. A PPAP may require only critical to quality (CtQ) dimensions be inspected instead of all called out dimensions and specifications. Overall, the focus of a FAIR is on verifying production results against product design. A PPAP covers 18 elements that may be required for submission, process verification included. A PPAP overall is a production plan, including engineering and design documentation/approval, both Design and Process Failure Mode and Effects Analysis (DFMEA and PFMEA), process flow, a control plan, measurement system analysis and other elements to provide evidence that requirements are met and the process is capable of reproducing quality parts consistently.
In other words, a FAIR is focused on material and the resulting part/assembly. A PPAP is more concerned with how that final result is achieved and that it can be produced consistently for extended production periods. Who performs a First Article Inspection? Typically, the responsibility is on the supplier to provide a FAIR. A supplier can perform the FAI in-house provided they are adequately equipped for the task. A purchaser may conduct an audit of a supplier’s QMS against ISO 9001 standards to ensure proper quality control processes. The FAI may also be performed by a third party chosen by the purchaser or the supplier. A professional third-party FAI may also be a preferred option if a supplier is not adequately equipped. In some cases, both the purchaser and supplier will provide a FAIR to ensure consistent results. Ultimately, the customer determines who will perform the FAI in the purchase order contract. Some suppliers will perform a FAI without requirement as a “best practice” to ensure quality and minimize non-conformities. Summary and Benefits.
Other than satisfying contractual agreements a FAI:
• Confirms the production process is capable of creating consistent parts/assemblies to customer requirements.
• Sets a baseline or gold standard for what the production process is capable of. • Aids in the corrective action process when a non-conformity occurs.
• Validates all designs and confirms the tooling is capable of producing the part/assembly within certain specifications.
• Will highlight any manufacturing process flaws.
• Will improve productions processes with regular implementation.
• Will help reduce waste of material and time.
• Will reduce the cost of a part/assembly and increase profitability.