It’s time to update medical manufacturing measurement

Once a manufacturing process is approved by the U.S. Food and Drug Administration (FDA), it can be time consuming and difficult to change, so most manufacturers have used the same process for decades.

However, in medical manufacturing, the parts being created necessitate more modern, efficient inspection and measurement processes to ensure the highest quality. Though it might seem onerous, it’s possible to revise inspection and measurement methods without disrupting the entire process.

Why change now

The main reason for change is to improve the inspection and measurement process for greater efficiency. It’s the primary driver of any process change, but for medical manufacturers responsible for end products that impact people’s lives, there’s an underlying current of we must strive to always do better, also known as continuous improvement.

When it comes to inspection and measurement of medical parts and devices, digitized data collection translates to enhanced speed and efficiency for obtaining reliable data, leading to improved accuracy and reporting while eliminating transcription errors that can occur when taking a sheet full of measurements and typing them into Excel. Manufacturers also derive more meaningful insights from digitally collected data using statistical process control (SPC) tools, which improve part quality.

Investing in updated measurement products and software can cut costs in the long run due to decreased measurement errors resulting in less scrap and fewer product recalls.

Why the FDA comes into play

Falling under the purview of the FDA and its 21 CFR part 11 requirement, medical device manufacturers must adhere to this requirement if making a change from paper to digital records. This includes stipulations intended to ensure electronic data and records, including signatures, are “trustworthy, reliable, and generally equivalent to paper records.” So, medical manufacturers can update methods by going paperless while still adhering to current FDA process requirements.

Qualify the measurement process

Gage repeatability and reproducibility (GR&R) relates to measuring the degree of variation in part inspection – either in the ability to measure something repeatedly with a particular gage and get a similar number, or to what degree one person can measure the same thing another person measures and both arrive at the same number. GR&R tracks the degree of variation present with one person or multiple people measuring a part and combines these two variables to arrive at an overall level of variation, or trustworthiness, of the measurements.

However, GR&R is often underused because of a lack of engineers trained in conducting GR&R studies or capable of performing inspections using it. It’s usually when a problem occurs, such as a shipment returned or a product recall, that finally pushes manufacturers to use GR&R.

Despite the sophistication of the medical parts being produced by modern manufacturers, determining the right gage for the job – one that’s repeatable and reproducible – isn’t necessarily widespread or up-to-date. GR&R studies are essential to producing reliable data. Using GR&R software can alleviate many shortcomings that result from a lack of knowledge or understanding of how to perform a study, or how to choose from many studies. Choosing an off-the-shelf software comes with the added benefit of having the software vendor’s support team as a guide to getting started.

Overcoming outdated methods

While many medical manufacturers take direct electronic measurements from a gaging system, such as a coordinate measuring machine (CMM), many still use micrometers and height gages without a built-in electronic records component, increasing the margin of error in manufacturing.

Many companies use incoming inspection to help guarantee they’re receiving high-quality parts, with acceptance sampling or a determination of acceptance quality level (AQL), which can be manual or electronic, to reject or accept parts.

For example, in a lot of 1,000 parts, a preset amount is measured. Based on how many of those are failures will determine whether a shipment or lot can be accepted or rejected. Suppliers who convert to completely electronic leveraging inspection software can ease the burden and lessen the cost of incoming inspection for customers, leading to better supplier-customer relationships and increased profit margins.

What to look for in inspection software

Inspection software must ensure authenticity, integrity, and confidentiality, so signing and dating documents using e-signatures, stringent security, and password confidentiality are non-negotiable. Being able to create audit trails and thoroughly back up data to support data integrity and retrieval is also important, as this ensures the software can adhere to CFR Part 11 requirements.

Beyond the software, attention must be paid to where the data resides – computer or server – as the same security requirements apply to both. Inspection tools should have the ability to reliably send data to the software, so choose equipment that has a long reputation for quality to ensure the system can be successfully validated. All the tools and the system that handles data must be cared for – the accessories, the software, the devices, and the databases.

Still unsure?

Start with the benefits; whether you’re getting a new product line or starting a new process, this is the perfect place and time to implement quality process changes because you’re likely not holding up production to get approval. If nothing new is on the horizon, start in an area that has the most to gain from improved efficiency. This could be a high-volume production line or a critical part that could benefit from extra attention and improved analysis from digitized data.

It’s truly about starting small or, when possible, starting somewhere new and realizing the benefits versus attempting a major overhaul which can be cumbersome and counterproductive. Beginning this way is also more cost-effective, making it easier to achieve a return on investment as you pave the way to gathering reliable quality data.

Mitutoyo America Corp.; https://www.mitutoyo.com