Metrology Benefits During Product Lifecycle

August 6, 2015

Metrology Benefits During Product Lifecycle

August 6, 2015

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At Verus, we have experienced significant growth in the demand for our metrology services since our beginning in 2008. So, what are the metrology benefits driving this growth?

By Nuala Baker

Metrology has always been a requirement in the manufacturing environment. In recent years, dependence on Metrology has increased dramatically and it has evolved into something that provides an invaluable insight into manufacturing processes and the parts that they produce. In addition, manufacturing tolerances have tightened substantially and continue to do so as high precision manufacturing becomes more demanding. All of these factors place more emphasis on the importance of high-quality measurement systems and high accuracy measurement analysis. This is made possible by the combination of advanced technology, time served experienced Metrology Engineers and cutting edge innovative Metrology Fixture solutions. At Verus we work with companies through all stages of the product lifecycle and have categorized the requirements and benefits of metrology as follows:

  1. Product Development

This is the beginning of any product. This is when the product is designed and the specifications are defined (including dimensional). It is the designer’s responsibility to ensure that what has been specified, in particular dimensional tolerances, is obtainable. Ideally, a Metrology expert would have input at this stage. Dimensional analysis may be required on prototype parts to confirm capabilities. If the manufacturing (including Metrology) capabilities are overestimated at this stage, it could spell failure for an entire project.

  1. Process Validation

Process validation is the next stage for a product. During this stage, the manufacturing process is verified (including the equipment and whether it was properly installed and calibrated). Moving on from this stage involves declaring that the product has met its’ specification and is ready to be manufactured.

Depending on individual requirements the following Metrology may be required at this stage:

ISIR (Initial Sample Inspection Report)

This is a full dimensional inspection. It is a time-consuming activity to measure all dimensions which is why it is performed on a small number of parts (e.g. for a 2 cavity mold, 1 part per cavity would be measured). This is, generally, the only point at which all dimensions are measured (unless a major change is made to the manufacturing process/setup at a later stage). From this point onwards, a much smaller number of dimensions are used to track the manufacturing process.

Critical/Control Dimensions


A Critical Dimension is defined as a dimension that is critical to the function of a product. A Control Dimension is defined as a dimension that will indicate whether the manufacturing process is in control. This type of dimensional measurement is performed on a larger number of samples (e.g. 30 samples per cavity per-process setting) but on a much smaller number of dimensions (usually around 5 dimensions). This data is then statistically analyzed to find out whether the manufacturing process is in control and ultimately if it will remain within the specification limits over a period of time.

Critical/Control Dimension Measurement Systems


As well as measuring the Critical/Control Dimensions at validation, the measurement system that is used may be developed so that it can be used during manufacturing. This system can then be used to measure parts on a regular basis or simply whenever it may be required. A good quality Metrology fixture is recommended for such a measurement system. This fixture should be capable of holding parts ranging from the lower to upper specification limits (at a bare minimum) in a repeatable manner.

The final measurement system would be subject to MSA (Measurement System Analysis) in the form of a Gauge R&R (Gauge Repeatability and Reproducibility). A Gauge R&R will indicate whether a measurement system is suitable for measuring a certain dimension with regards to that dimension’s tolerance.

  1. In-Process Measurements

This is the final stage, which can only start after process validation has been successful. At this point, a part is being manufactured. This stage can last any length of time, from minutes to years. A regular dimensional inspection is desirable to ensure that any changes to the manufacturing process are detected.

 The Critical/Control Dimension Measurement System mentioned previously, is an ideal method for keeping an eye on a manufacturing process. By performing regular dimensional inspection and statistically analyzing the data, it may be possible to predict an issue before it even occurs. This would prevent any losses e.g. dumping failing products, manufacturing line downtime, damage to a company’s reputation as a result of releasing bad products.

During this stage, further ISIRs may also be required if any change is made to the manufacturing process/setup e.g. cavity change to a mold tool, manufacturing process setting changes. Further measurements may also be required if any issues are experienced with the manufactured product.

Why choose Verus?

Here are some of the reasons why you should consider subcontracting your Metrology work to Verus Precision:

Equipment


We have access to a full range of equipment, from Coordinate Measuring Machines (CMMs) to Vision Systems. The manufacturers and software of this equipment are as varied as possible to allow us to be more flexible and to suit our customer’s needs. In terms of technology and equipment, our Metrology laboratory has everything you need to fulfill your everyday Metrology requirements.

For more information see verusmetrology.com/metrology/equipment/

Fixtures


The majority of measurement systems and measurement analysis require a fixture that is capable of holding parts of varying size in position in a repeatable manner. If a fixture does not hold a part correctly, it compromises the accuracy and reliability of all measurements involved. Usually, it is possible to hold a part using a combination of clamps, gauge blocks, vices, etc. However, if the measurement being performed is on a difficult part to hold (due to shape/size/material) or the same measurements will be performed on a regular basis. The manufacture of a custom-designed fixture may be necessary/justifiable. We have access to our own fixture design and manufacturing department that specializes in creating innovative fixture solutions on a daily basis.

For more information see verusmetrology.com/metrology-fixtures/

Expertise & Experience


In the area of Metrology, expertise and experience can be difficult to find. Our Metrology team has a depth of knowledge that extends beyond the operation and programming of CMMs and Vision Systems. It also includes years of experience measuring parts on a daily basis across a wide range of industries ( Medical, Automotive, Aerospace, Consumer Products). It can be guaranteed that however challenging a part may be to measure, our team will find the best solution.

For more information see verusmetrology.com/team/

In summary, the success of our Metrology department is completely dependent on our reputation within the industry. The majority of our customers are repeat customers and use our service on a regular basis. This is why you can rest assured that the Metrology we perform is of the highest standard of quality.

Introduction 

As 2024 unfolds, the field of metrology is witnessing transformative changes. At Verus Metrology, we recognize the importance of keeping pace with technological advancements and new trends in the science of measurement. In this rapidly evolving landscape, innovations in metrology are not just about achieving precision; they are about meeting the evolving challenges of industries like medical devices, where accuracy is critical for ensuring safety and quality. This article explores the emerging trends and technological breakthroughs shaping metrology’s future. 

As 2024 unfolds, the field of metrology is witnessing transformative changes. At Verus Metrology, we recognize the importance of keeping pace with technological advancements and new trends in the science of measurement. In this rapidly evolving landscape, innovations in metrology are not just about achieving precision; they are about meeting the evolving challenges of industries like medical devices, where accuracy is critical for ensuring safety and quality. This article explores the emerging trends and technological breakthroughs shaping metrology’s future. 

Metrology Fixture Types – What’s Available, and Which is Best?

9 February 2023

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Fixture type and use cases

Metrology fixturing technologies continue to develop at a rapid pace, offering manufacturers in the medical device industry new and innovative solutions. Those solutions don’t just meet inspection and quality process requirements, but they also deliver efficiency savings and productivity gains. How do you know what metrology fixture types are available and which is best for your application? In this blog, we’ll outline the main options, their underlying technologies, and the use cases they are best suited for. 

However, it is also important to point out that the fixture types described in this blog represent broad categories. Within those categories, there is an infinite number of ways that a fixturing solution can be developed to meet your specific needs, reduce risk, and take advantage of opportunity

While there are metrology fixture types that we can explore, every fixture solution that we develop here at Verus Metrology is completely unique. In other words, fully customised for the product or component being measured, as well as the inspection machine, quality department workflows, production processes, and any other influencing factor. 

Metrology Fixture Types 

There are six main metrology fixture types: 

  • Auto rotational 
  • Manual rotator 
  • Multi-station
  • Proof of Principle (POP) 
  • Vision system 
  • Docking station 

 

Auto-Rotational Fixtures

Isometric view of an auto rotational metrology checking fixture, the automatic part of the fixture is the turning of the rail by a motor. The fixture has white plastic components held in place using brown clips

 

At a fundamental level, the job of a metrology fixture is to hold a product or component securely in place so it can be effectively inspected and measured. However, there are situations where the inspection process requires the part to be presented at different orientations to enable all the relevant measurements to be taken. This requirement for measurement in multiple orientations is increasing as medical device products become more complex and intricate. 

Auto-rotational fixtures enable the inspection of products and components in multiple orientations with minimal operator intervention. An auto-rotational fixture can be a single-station set-up, but they more commonly come in multi-station designs to minimise the time it takes to achieve your required sample rate. 

The most important feature of an auto-rotational fixture is that you can measure multiple components in multiple orientations in a single setup. 

Manual Rotator Fixtures

Manual Rotator Metrology Fixtures by Verus Metrology

Manual rotator fixtures offer similar benefits to auto-rotational fixtures. The obvious main difference is that operators manually rotate components once they are loaded into the fixture. 

Manual rotator fixtures can be multi-station. They are also designed so that all measurements in all orientations can be taken in one set-up. So, while the operator will need to manually control the rotation mechanism, there is no requirement to touch or adjust the components as the fixture holds them securely in place during rotation. 

The benefits of manual rotator fixtures include: 

  • Significantly reduced operator intervention 
  • Improved measurement accuracy 
  • Elimination of errors 
  • Faster and more efficient metrology processes 

Furthermore, we can design your manual rotator fixture so it can be loaded with components away from your CMM. This improves CMM availability as the machine doesn’t have to sit idle while components are being loaded onto the fixture. 

Multi-Station Fixtures 

multi station rotator

According to FDA regulations and ISO 13485, it is essential that you can statistically justify sampling rates in your quality procedures using a risk-based approach. The operational part of this requirement isn’t covered in the guidelines, but it is an important business consideration. How do you efficiently, accurately, and cost-effectively inspect the number of products or components that are required to hit your sampling rate target? 

Multi-station fixtures are a common solution. We can design multi-station fixtures in any configuration. This could be a large cavity multi-station fixture, a fixture to inspect very small and complex medical devices, or solutions for products or components of any size, geometry, or characteristic. 

The benefits of multi-station fixtures include: 

  • Operator intervention is greatly reduced 
  • Fixtures only need to be loaded once before full inspection routines can take place on multiple products at the same time 
  • Reduce human error 
  • Speed up inspection processes while achieving your sampling rate target 
  • Reducing the cost of inspections 

 

Proof of Principle Multi-station Prototype Fixtures 

proof of principle

 

In many product development and process change situations, it is beneficial to have a POP fixture that can be used for verification and validation purposes. The approach we typically take at Verus Metrology is to design a multi-station fixture to deliver on your requirements. 

However, before this multi-station fixture design goes into manufacturing, we design and produce a single-station POP prototype fixture. This POP prototype can be manufactured quickly in our advanced manufacturing facility. We’ll then put it through a gage R&R study to give you confidence in its repeatability and reproducibility, before sending it to you for evaluation and testing. 

POP prototype fixtures offer a range of benefits: 

  • Facilitates design for inspection during the product development process 
  • Minimises delays in process verification 
  • Enhances and speeds up the design transfer process 
  • Reduces time to market in line with regulatory requirements 

 

Vision System Solutions

We also design and manufacture fixturing solutions for vision systems in addition to the fixtures we design for use on CMMs. Fixturing solutions that are optimised for vision systems have a number of specific and differentiating features, including ensuring there is a clean and clear view of the part. 

Vision system solutions can also allow for backlighting where necessary. Furthermore, a single set-up is all that is required for the full inspection routine to take place, with parts securely held with as little force as possible. 

 

Docking Systems 

Docking System Verus Metrolody

Docking systems enhance the efficiency of quality departments that use multiple fixtures and/or have high sampling rates. Docking systems are securely fixed to CMMs to make it quick and easy for technicians to load fixtures that are fully set up with components ready for inspection. Once the inspection routine for a fixture is complete, it can be quickly and easily removed from the docking system ready for the next fixture to be loaded. 

With a custom-designed docking system, you can have confidence that each changeover results in precisely secured fixtures for repeatable and reproduceable inspections. 

Choosing the Right Fixture for Your Requirements

There are many factors to consider when choosing the best type of metrology fixture for your requirements. Your budget is an important consideration, as are your ROI goals, quality processes, quality resources, and future requirements. 

The best approach is to speak to a fixture design expert to explore the options and get an understanding of what is possible. Contact us today to find out more. 

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About Verus Metrology Partners

Verus is committed to the enhancement of our client’s metrology laboratories, machine efficiencies, and inspection processes. Since our beginning, our expert metrology engineering team has partnered with some of the world’s largest MedTech multinationals.

 

We specialize in high quantity, difficult to measure, yet critically important, medical device parts. As well as working in the MedTech, Pharmaceutical and Personal Care industry, we also work with metrology departments in the FMCG and Aerospace industry.