Top Methods for Achieving Compliance through Quality Inspection

One of the most important processes at any company who designs or manufactures a product is proper quality control. The impact is harsh and swift for companies who are lax in producing quality products. In the age of social media, with product reviews and increased competition, it is more important than ever to strive in the pursuit of 100% quality or risk losing compliance with ISO or FDA and even worse, alienating your customers.

Luckily, there is a framework of standards that are in place to ensure that products are produced to spec in a format that anybody can understand. These standards are a tool to ensure a proper and complete First Article Inspection Report (FAIR). Keeping these methods in place is not for the faint of heart however. Many manual processes are relied upon to make sure that the drawing specifications match the reports that each framework specifies. These processes, while critically important, often pose a bottleneck in the parts manufacturing process due to a high labor component. Balloon drawing detailing all part specifications

A ballooned drawing is a required element of a First Article Inspection Report package along with a corresponding form that matches the balloon numbers, specification being called out, the tooling used to verify the specification and the actual measured value. The form is usually specific to your own company or to an international or industry standard. Without enhanced first article inspection software, the process is tedious and error prone. The graphic below reflects the documentation process:

Top Methods for Achieving Compliance through Quality Inspection

Balloon: A quality engineer will take a print copy of the customer blueprint, grab a circle template and draw balloons next to each dimension, geometric tolerance, note and any other information of the drawing that needs to be verified by a First Article Inspection. A sequential number is then assigned to each balloon.

Transcribe: The engineer then is tasked with copying the dimensional characteristic to another form, specific to your quality standard, which sometimes an Excel spreadsheet or a paper form. As you may expect, it is easy to transpose a number or decimal place by conducting this by hand.

Calculate: Once the nominal values are copied to the Excel form, the engineer calculates the upper and lower limits for each of the dimensions using the Unless Otherwise Specified tolerances called out for in the title block. Some dimensions will already have upper and lower limit dimensions called out, so those are hand transcribed.

Validate: Once the forms are created and parts are produced, an inspector can utilize these forms to enter the final measured value of the specification and determine if it is in or out of spec.

A typical drawing with 100 characteristics will average 6 hours to produce accurately using the above steps. This is typically a major bottleneck in manufacturing companies everywhere.

Enhanced First Article Inspection

We now have tools available for enhanced digital reporting of these specifications readily available that vastly reduced the amount of time it takes to create accurate and timely reports for statistical process control. Software can be utilized to grab the dimensional and material specifications, calculate upper and lower limits and populate an Excel spreadsheet according to your industry or company standard, reducing report creation time from 50% to 90% with less error.

Quality Management Standards by Industry

Let’s walk though some of the available standards by industry and cite a couple of examples on how to achieve compliance and reduce bottlenecks.

Top Methods for Achieving Compliance through Quality Inspection

1. Aerospace (AS9102)

If you are involved the aerospace component supply chain, you are well aware of the criticality of the components produced, and the stringent requirements for certifying their correct manufacture. The AS9100 series of standards outlines the quality management system for aerospace parts. AS9102 specifically provides for standard guidelines and forms to use in the inspection of these parts. Let’s looks at two items that are required by this framework.

AS9102 Forms 1-3: A part form that outlines items relating to requisition, raw materials and specifications called out from a blueprint. As outlined above, transcription errors and the sheer amount of time that it takes to fill out this form make this a burdensome process, yet it must be done to ensure quality. Filling out this form using enhanced FAIR software saves a lot of time and reduces errors in transcription and calculation.

Top Methods for Achieving Compliance through Quality Inspection

A filled out FAIR, based on the AS9102 standard, form 3.

Top Methods for Achieving Compliance through Quality Inspection

A balloon drawing, citing several item numbers matching column 5 in the form above.

Top Methods for Achieving Compliance through Quality Inspection

2. Medical (FDA 21CFR Part 820 QSR and ISO 13485)

Medical devices firms know all too well that they must meet stringent standards for safety, reliability and quality. The consequences of poor quality in these devices are clearly defined and can start with an FDA warning letter (which is public knowledge), Audits, Civil litigation and even criminal prosecution. The process of documenting quality inspections can be very costly and error-prone if you don’t have the right tools for the job.

There are two standards in particular that are related to first article inspection of medical devices, ISO 13485 and FDA 21CFR Part 820 QSR. Like the AS9102 standard, a balloon drawing and a standard form is required to demonstrate the part has been manufactured correctly.

However, many medical product designs are created with detailed shapes and contours that are hard to inspect with traditional measuring equipment, such as dial calipers and depth gages. CMM (Coordinate Measuring Machines) are used to rapidly inspection parts over and over again, in a consistent way, and even and in hard to measure places. These systems will spit out a number of measured results. Nonetheless, these results then need to be transcribed into the appropriate quality form. Enhanced first article inspection software can connect with your CMM data output and feed the actual measured results into your FAIR.

Top Methods for Achieving Compliance through Quality Inspection

Balloon drawing showing dimensions meeting and not meeting specifications through color coding, based on input from a CMM.

There are many other industries with regulations that can benefit from enhanced first article inspection software, including the automotive industry (PPAP), the nuclear components market, the oil & gas field and even companies who have developed their own standards, like United Technologies (ASQR-01)

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CAPINC was founded on one core principle: Provide the best solutions and services to assist our customers in designing and developing better products. CAPINC provides premier solutions and services in New England to assist our customers in accelerating their design and development process for better mechanical products. Our award winning technical support team is comprised of industry experts with hundreds of years of combined practical experience in mechanical design, design validation and analysis, product data management, and technical communication. We are the award winning 3D solutions partner offering SolidWorks software and training, and the entire Stratasys line of 3D printers and production systems. For more tech tips and blog tutorials check out CAPINC's blog and videos.
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