The Importance of Metrology and Inspection Gap Analysis for Medical Device Manufacturers

July 7, 2022

The Importance of Metrology and Inspection Gap Analysis for Medical Device Manufacturers

July 7, 2022

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To remain competitive, compliant, and profitable, there needs to be a continuous drive for improvement in all elements of a medical device manufacturing operation. For example, there has been a push forward in recent years in the adoption of automation technologies as well as technologies that fall under the Industry 4.0 umbrella. There is the same need for improvement in quality assurance processes and, specifically, metrology and inspection processes.

This requirement to continuously improve is where metrology and inspection gap analysis becomes important.

What Is Metrology and Inspection Gap Analysis?

In general, gap analysis involves defining what you are doing, how it could be done in the future, and the benefits of making the recommended changes.

In metrology and inspection specifically, the gap analysis process looks at your current metrology and inspection procedures. This will include assessing the machines and equipment that you use, as well as the software.

A gap analysis will assess the metrology and inspection process, too, from the point where the component leaves the production line to the completion of the inspection. The assessment will also include looking at the involvement of operators and the steps they need to take to complete the inspection process, as well as how data is captured, stored, processed, and transmitted.

The Objectives of Metrology and Inspection Gap Analysis

  • Minimize the requirement for operator intervention
  • Reduce the number of steps required for metrology and inspection processes
  • Minimize the risk of human error where operator intervention is essential
  • Ensure maximum repeatability and reproducibility
  • Automate data collection and optimize the use of data to improve quality control processes
  • Ensure quality staff have a sufficient level of skill
  • Future proof the metrology and inspection process

The Benefits of Metrology and Inspection Gap Analysis

Metrology and inspection gap analysis is important in all manufacturing environments, but there is an added level of importance in industries like medical device manufacturing. Medical device manufacturing is generally high-speed and high-volume, plus there are significant compliance requirements.

Taking these points about medical device manufacturing into consideration, examples of the benefits of metrology and inspection gap analysis include:

  • Improving compliance processes by ensuring inspection and validation are fully streamlined
  • Improving product quality and enhancing product safety through optimized processes and fit-for-purpose machines, equipment, and fixtures.
  • Automating data processes to improve the use of data, including traceability and quality assurance optimization
  • Optimizing the use of quality department resources by identifying opportunities for metrology and inspection automation.
  • Bridging skills gaps by first understanding where the gaps exist and then recommending suitable training.
  • Improving production line efficiency through the identification of inline inspection opportunities.

Suitable for All Metrology and Inspection Processes, Even Those that Are Working Well

Even if you have a metrology and inspection process that is working for your organization, conducting a gap analysis is still a worthwhile exercise. The gap analysis process could identify opportunities for further improvements, such as those outlined above. It can also stress-test your current metrology and inspection processes to find potential weaknesses in certain scenarios.

For example, what would be the impact on quality control and inspection if there was a spike in demand for a component or product? How would your metrology and inspection processes be impacted by a change in product design, especially in relation to materials, the complexity of the device, or a decrease in component size?

The above are just some examples. An effective gap analysis process will look at your facility, production line, processes, workflows, and future plans to understand if and where improvements can be made.

Ultimately, a Metrology Gap Analysis is About Delivering Value and ROI

In the field of metrology and inspection, technologies, machines, and processes continuously advance and improve. However, it is important to point out that a gap analysis is not about recommending a switch to the latest and most expensive equipment, or the latest leading-edge (and probably unrefined) inspection process.

Effective gap analysis is instead about identifying value for your quality control and manufacturing operations. It is also about ensuring there is a clear return on investment that can be achieved by implementing the recommended improvements. At Verus Metrology, we believe that just because something can be done doesn’t mean it should be done. With metrology and inspection, all processes, machines, and equipment need to be right for your business. This is what gap analysis can achieve. Get in touch with us today if you would like to find out more.

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.