More than Just Measurement:

Dimensional Inspection For

Medical Equipment
With the ever-increasing influx of automation in the manufacturing industry,
the process of prioritizing accurate measurements is needed now more than
ever to ensure that products are not only being manufactured on time, but that
production is repeatedly accurate. In this continuous, rapid-paced
environment, time is becoming an even more valuable commodity, making the
time-saving information provided by dimensional inspection an increasing
necessity.

WHAT IS DIMENSIONAL INSPECTION?

Dimensional inspection is sometimes referred to as dimensional

measurement or dimensional metrology and is a specialized field encompassing
a broad range of applications from large, complicated parts such as jet engine
turbines to extremely small parts with tight tolerances that are part of life-
saving medical devices. In manufacturing, this object might be a prototype for
R&D, or a custom-made component for a new production line, or even a
finished product. Simplified, dimensional inspection can be seen as the process
for comparing what an object actually is to what it is supposed to be, and uses
quantifiable values to measure virtually any physical characteristics such as:

Length, width, and height.

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Angles and perpendicularity.

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Roundness, flatness, and other geometric characteristics.

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Position.

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 Shape profiles.

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Surface characteristics.

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Edge sharpness.

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Thickness and uniformity.

WHY IS DIMENSIONAL INSPECTION IMPORTANT?

In general, when dimensional measurement is required, the results must be

both accurate and precise. Although multiple techniques and countless
applications exist, there are four main categories of dimensional inspection.

First Article Inspection. Implementing a manufacturing process requires

extreme attention to detail, especially if the process is new or if the equipment
has been specially designed. First article inspection is required to ensure that
the equipment was properly installed and calibrated, and to verify the
manufacturing process. Dimensional measurement is used to compare the first
objects from the manufacturing line to 3D CAD models, engineering drawings
with tolerances, and/or other specifications.

Quality Control. When objects coming off a manufacturing line must meet

certain quality standards, measurement equipment is used to confirm that the
dimensions fall within the required tolerance levels. In some cases, when the
tolerance levels are more rigorous, each object is measured automatically. In
other cases, batches might be spot-checked for quality.

Regulatory Compliance. In industries for which regulatory compliance is

necessary, dimensional measurement ensures that the required specifications
are met. Regulatory bodies such as the FDA or FAA often have requirements
regarding the dimensions of certain components.

High-Precision Engineering. When creating a larger assembly from smaller

parts, high precision is often required. If a minor flaw or inconsistency can
impact an entire process, ensuring that such imperfections do not exist is
critical.
The entire purpose of manufacturing is to create a process that is repeatable,
scalable, and reliable. When successful, it results in lower production costs and
lower pricing for the end user. However, precise, accurate measurements are
required for any manufacturing line to be successful.

Dimensional inspection during the production process can help prevent costly
errors such as:

Flawed batches. A production line that creates duplicate products

requires precision setup and alignment. Errors in the production line
can lead to entire batches of flawed goods, which can be quite expensive
in both time and cost to correct the production error. Dimensional
measurement is worth the investment to prevent these expensive
mistakes.

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Defective parts. Using dimensional inspection as part of the quality

control process for high-precision manufacturing ensures that each part
meets the required specifications.

Quality control is essential for producing consistent products, but

implementing dimensional measurement even earlier in the process can help
prevent costly manufacturing errors that can lead to problems.

WHAT FACTORS ARE INVOLVED IN USING DIMENSIONAL

MEASUREMENT EQUIPMENT?
Coordinate measuring machines (CMMs) range from basic XYZ readouts
utilizing hard-probes to fully automated systems with articulating
continuous contact probing that can perform CAD model-based
inspections. (Credit: Q-PLUS Labs)
After establishing which metrics you need to measure, the next step is
determining what dimensional measurement equipment can meet your needs,
and whether you have the capabilities to conduct these measurements in-
house or need to outsource the process to an accredited dimensional inspection
lab. You must also consider a broad range of factors and prioritize the ones that
are most important for the specific application.

Sensor Type. The most important principle in the field of dimensional

inspection is that the item being measured must not be altered during the
course of inspection by the measurement process itself. This is metrology's
prime directive.

Therefore, one of the most important decisions when integrating dimensional

inspection equipment is selecting the right type of sensor. This will depend
largely on the characteristics of the object being measured and may include
touch sensors, noncontact sensors, or a combination of both types. To narrow
down the options, answer a few key questions about the nature of the object:

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 Is the object rigid or pliable? Rigid objects can often be measured with
either a touch probe, laser, or camera sensor.

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Is the object's surface reflective? If the surface is reflective, many laser

sensors may not be appropriate because the measurement results may
be incorrect or even completely invalid as a result of light scattering.

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What color is the object? If the object is matte black, difficulties may be
encountered with structured light scanners. If the object is clear glass,
there may be complications with focusing using vision systems.

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Can the object be touched? Softer objects such as elastomers typically

require noncontact sensors that will not compress or distort the surface
during the measurement process.

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Is the object very small? Not all sensors can produce the same
resolution. Small objects may require a more sensitive sensor or a
different type of equipment altogether.

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Does the object have internal geometry that cannot be seen? If the
object has cavities or passageways, specialized equipment that
incrementally slices the object — or can see through it using computed
tomography — may be needed to measure these surfaces.

Tolerance Requirements. Equally important as selecting the right sensor type

is ensuring that you understand and meet your tolerance requirements. In
dimensional measurement, tolerance refers to the acceptable deviation from
the desired outcome. For example, a medical device may need to be within 5 or
10 μm of the required diameter in order to pass an inspection. On the other
hand, a toy part may have a larger tolerance in the range of millimeters.

Understanding the required tolerance levels will help you select the right type
of dimensional inspection equipment. Think about the difference between
measuring with a ruler versus calipers. You can achieve a much higher degree
of accuracy and precision with calipers. Now think about measuring with
calipers versus an indicating micrometer with even higher accuracy and
precision. While an indicating micrometer might be able to achieve the highest
level of accuracy and precision, if your tolerance level is not so tight, then
calipers may suffice (and will be more affordable).

Portability. This is typically an easier question to answer, but it does narrow

the type of equipment you need to purchase. Will you be taking measurements
in the field or at a single location where the equipment can remain stationary?
Most of the time, the choice will be obvious and is driven by variables such as
part weight, size, and delicacy. However, if you are uncertain, think carefully
about how you will use the equipment in the future. While it might be
tempting to purchase portable equipment to have more flexibility, if you truly
do not require portability, you may be sacrificing other features that you could
get with stationary equipment. For example, the accuracy of a stationary
coordinate measuring machine (CMM) will be higher than the accuracy of a
portable CMM articulating arm.
Form and Contour Tracers are purpose-specific devices that use high
accuracy continuous contact sensors with varied styli to obtain small part
geometry such as fillet radii and chamfers or that measure roundness,
cylinidricity, and other geometric tolerances.(Credit: Q-PLUS Labs)
Size of the Objects Being Measured. You can put a turbofan blade into a
machine to analyze its contours, but you cannot do the same with an entire
aircraft. Dimensional inspection equipment can also be used to determine
metrics such as the space between bolt holes, but only if you use a probe small
enough to enter the holes. Knowing the sizes of all the objects you intend to
measure will help you select the right dimensional inspection equipment and
accessories.

Shape of the Objects Being Measured. Objects that have internal geometry

require different measuring methods than those that do not. You may need to
purchase accessories that enable internal measurements or use specialized
equipment dedicated to that purpose.
The shape of the object can also impact the type of equipment you purchase.
For example, if you need to measure the form of a small screw thread you will
either need a contact sensor that has a small enough tip (typically knife edge
sharp as with a contour tracer) to reach all the geometry, or a noncontact
optical sensor with sufficient magnification.

Speed. Do you need to get immediate pass/fail (attribute) quality control

results as objects come off a manufacturing line? Or do you require variable
data results with more comprehensive data that allows you to understand by
how much an object did not pass inspection and possibly why?

Of course there are countless other scenarios, but as with other factors,
understanding your requirements will help you make the right choice. If you
don't need real-time results, you can often get all the information you need
with less-expensive equipment.

Automatic or Manual. Some applications — typically those related to quality

control — require dimensional inspection equipment to operate automatically.
For example, wall thickness measurements from parts coming off a line can
provide real-time pass/fail information for manufacturers. Other applications,
such as thread gaging, require manual operation to achieve the desired results.

Ease of Use. Many types of dimensional inspection equipment require

programming or other specialized skills to properly operate, such as vector-
driven measurements. While training can provide many of the necessary skills,
some equipment requires a specialist. If you do not already have, or do not
intend to hire specialized staff to operate the equipment, you may find it
necessary to outsource some or all of your dimensional inspection needs to a
qualified provider.

HOW DO YOU KNOW WHAT EQUIPMENT WILL BE THE BEST

FIT FOR A SPECIFIC APPLICATION?

Here is where knowledge and experience are paramount. Just making the
measurement of certain dimensions possible is difficult enough, let alone
making the measurements feasible. For every object imaginable, from a
nanoscale surface to a rocket engine, there are numerous measurement
opportunities. There are also multiple ways to execute each measurement
technique, and multiple devices and manufacturers from which to choose.

When investing in dimensional inspection equipment, the primary objectives

are to find a device or system that:

Allows for the inspection to be performed correctly, accurately and

precisely.
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Allows for the inspection to be performed as quickly as possible.

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Serves the functions you require.

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Is reliable and has a long lifetime.

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Can be easily operated and maintained.

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Fits the budget.

TYPES OF DIMENSIONAL INSPECTION EQUIPMENT

 Vision systems are similar to
optical comparators, but instead effectively project images directly onto a
screen while a camera with interchangeable objective lenses and/or zoom
optics relays images to the display. (Credit: Q-PLUS Labs)
There are three primary types of dimensional inspection equipment: precision
hand tools, contact sensor systems, and noncontact sensor systems.

Precision Hand Tools. Portable and generally easy to use, precision hand

tools are often capable of providing all the information you need. Some of the
advantages of using hand tools include factors such as relative low cost and
high portability.

However, some of the disadvantages of hand tools include the slow speeds with
which readings can be acquired, their relative inaccuracy compared to
dedicated systems, and difficulties in obtaining good repeatability and
reproducibility among different users compared to automated systems. Here
are some of the most common dimensional inspection hand tools:

Bore and ID gages measure the internal diameter of an object, either by

indicating the deviation from a predetermined standard or by providing
an actual measurement.
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Calipers provide inside, outside, depth, length, or step measurements

using various technologies. Certain types can also be used to compare or
transfer dimensions from one object to another, or to precisely mark a
measurement.

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Fixed gages are designed to quickly compare specific attributes to a

specified standard. They might measure thickness, length, angles, gear
teeth, radius, bead size, and a range of other parameters.

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Micrometers are used for precision dimensional gaging and may use
mechanical, digital, dial, scale, and laser technology. Micrometers can be
used to measure the thickness, length, depth, internal diameter, outer
diameter, height, roundness, or bore of an object.

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Protractors and angle gages measure the angle between two surfaces.
They can be fixed or variable depending on the intended use, and may
be designed to provide other functions such as simultaneous depth
measurements.

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Indicators and comparators amplify the movement of a precision spindle

or probe and display the results on a dial, digital display, or column.
Different levels of precision are available for a range of applications.

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Air gage instruments use changes in pressure and flow rates to measure
parameters such as thickness, depth, internal diameter, outer diameter,
bore, taper, and roundness.

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Plug and ring gages provide a pass/fail assessment for holes and bores,
and shafts and pins respectively, based on specified dimensional
 tolerances. A simple plug gage pin can do one remarkable thing that
advanced continuous contact CMMs cannot do: ensure that not a single
opposing point reading along the hole or bore is undersize. Since a hole
or bore theoretically has an infinite number of diametrically opposed
points, a CMM could sample points for a long time, but still only
approximate the resultant size.

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Threaded plug and gages qualitatively measure and/or verify thread size,
spacing, shape, geometry, or other parameters.

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Rules and length gages are used for length measurement, and much like
a measuring tape or a ruler, have a flat, graduated surface.

Contact Sensor Systems. For some dimensional inspection applications, the

best way to obtain measurements is by using a sensor that comes into contact
with the object. Though the probing forces can be extremely light, contact
sensors work best when the object is rigid and not pliable or fragile. They are
also often used when the surface of the object does not lend itself to optical
sensors, such as structured light scanners, because it is reflective or too dark.
The main categories of dimensional inspection contact sensor systems include
the following:

Coordinate measuring machines (CMMs) are mechanical systems that

use a contact measuring probe and transducer technology to convert
physical measurements of a surface into electrical signals that can be
processed and analyzed by metrology software. CMMs range from basic
XYZ readouts utilizing hard probes to fully automated systems with
articulating continuous contact probing that can perform CAD model-
based inspections.

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Articulating arms are another type of CMM that use rotary encoders on
multiple axes of rotation instead of linear scales to determine the
position in space of the hard probe or touch probe (laser line probes are
also a common accessory). Such systems are manual in nature but are
portable and able to reach around or into geometry in a way that cannot
be accomplished with a conventional CMM.
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Form and contour tracers are purpose-specific devices that use high-
accuracy continuous contact sensors with varied styli to obtain small
part geometry such as fillet radii and chamfers or that measure
roundness, cylinidricity, and other geometric tolerances.

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Optical CMMs are a lesser known but increasingly common hybrid of

non-contact and contact technology used for gathering measurement
data for areas that are difficult to reach. The handheld device transmits
data wirelessly and allows the operator to move both the part and the
scanner during the measuring process. Using stereoptics to scan an
object, the optical CMM uses 2-3 cameras to track either passive
retroreflective or active targets through space. This process allows
objects to be rebuilt in 3D via the device's reflectors.

Noncontact Optical Sensor Systems. In many cases, the object being

measured cannot or should not be touched by a contact probe or any other part
of the measurement device. In cases where the object is either soft, elastic, very
small, or fragile, optical inspection equipment may be most appropriate.

Optical Comparators. Optical comparators use light projected upon a screen

to obtain a magnified silhouette or shadow of the object of interest.
Measurements can be made by articulating the table axes to obtain width and
height. Physical overlays are commonly used for complex shapes and quick-
checks. Modern systems can employ fiber optic edge detection, automated
movement and measurement, and even digital overlays.

Vision Systems. Vision systems are similar to optical comparators, but instead

effectively project images directly onto a screen while a camera with
interchangeable objective lenses and/or zoom optics relays images to the
display. Most systems have edge detection and other sophisticated capabilities.
Automation via a computer and controller is common, and some systems even
come with multiple sensors including laser and touch probes.

3D Scanners. 3D scanners use lasers or structured light to capture 3D

information about the given object's geometry. In addition to measuring
objects and converting them to digital images, 3D scanners can also be used for
reverse engineering as well as for other applications.

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3D laser scanners — A laser, either as a single point, line, or an entire
field of view, is projected onto the surface of an object and a camera
captures the reflection. Each surface point is triangulated, measured,
and recorded to produce a 3D rendering of the shape and surface
measurements of the object.

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Structured light scanners — Sometimes also called white light or blue

light scanners, these devices use light from halogen or LED lights to
project a pattern of pixels onto the object. The pixels are distorted by the
surface of the object when viewed by one or more cameras that are
placed at an angle relative to the light projector, and measurements of
the light pattern can be used to reconstruct a 3D image.

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Range scanners — Range scanners use a time-of-flight laser rangefinder

based on LiDAR technology to measure the distance between the laser
and the object's surface. The laser rangefinder sends a pulse of light to
the object and measures the amount of time it takes for the reflection to
return in order to calculate the distance of each point on the surface.
Point measurements are taken by aiming the device at the object and
using a series of mirrors to redirect the light from the laser to different
areas on the object. Although the process may seem cumbersome,
typical time-of-flight 3D laser scanners can collect between 10,000 and
100,000 points per second, which is much faster (though less accurate)
than contact sensors.

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3D noncontact surface profilometers (a.k.a. nanoscanners) — With the

advent of nanotechnologies and growing demand for
micromanufacturing, the need for the ability to accurately measure very
small objects and geometry has increased the need for microanalysis.
This technology utilizes ranges from confocal laser microscopy to white
light interferometric optical profilometry. Typically, surface finish has
required the highest precision in dimensional metrology. In addition to
surface finish in 2D and 3D, now very small geometry can be
dimensionally characterized and inspected. Relevant characteristics
include flatness, wear, texture, sharpness, and other conditions that can
affect functionality, but might otherwise not show up in a dataset of
conventional metrology measurements.

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SUMMARY

Dimensional inspection is useful for much more than just production line setup
and quality control. Manufacturing (and much more) can greatly benefit from
dimensional measurement in all phases of product development ranging from
research and prototypes, to first article inspections and capability studies,
production inspection, to final inspection of the finished product. The
manufacturing process is full of potential pitfalls, especially when you are trying
to develop a new product on a tight timeline.

Understanding what it takes to integrate dimensional inspection into your

quality process, whether in-house or outsourcing to an accredited
measurement lab, will provide value and help your manufacturing process
operate more efficiently. An objective that can be measured and that gets
properly measured is an objective with the best chance of being brought to
fruition.