A Closer Look at the Importance of Quality Critical Inspection

Take a moment to imagine the idea-to-market development process for one of your devices. Starting at the concept phase, you move through design iterations, which culminate in final specifications. Your new product is then manufactured for the first time using component parts developed for this specific purpose. Assuming it passes first article inspection and clears all necessary regulatory compliance hurdles, manufacturing proceeds so that you can meet market demand for your new device.

This process carries significant risk. Not only do you invest time and free cash in R&D and product development, time to market depends on clearing those essential hurdles. And the vigilance and focus on quality—and patient safety—can never wane.

Quality critical inspection is an absolute fundamental aspect of managing your risk as a manufacturer. Throughout the manufacturing cycle, inspections take place on a regular basis. Parts are selected at random and subjected to inspection of their critical to quality dimensions to ensure you’re producing product that is ready to be safely and successfully implanted into patients.

When conducted by an expert independent partner, best-in-class quality critical inspection reduces the risk of potential problems, upholds high patient safety standards, and ensures your products remain in compliance with all regulatory standards. Entrusting quality critical inspection to an independent partner has an array of benefits. It reduces the potential for adverse patient outcomes, product recalls, or product development delays that could ultimately damage your profitability. In addition, you benefit from the kind of broad industry perspective such a partner brings to the process.

Here is a closer look at three aspects of best-in-class quality critical inspection expertise, and how using an independent partner can be advantageous.

Highly trained industry personnel
Think of it this way: would you write an article for a widely read industry publication without consulting an editor and engaging a proofreader?

When the stakes are high, seek out expertise. Expertise boils down to knowing what to look for, where problems are most likely to arise, and how things should perform. It requires an industry understanding both deep and broad. Therefore, you should entrust quality critical inspections to highly trained staff with detailed knowledge and years of industry experience.

State-of-the-art equipment
Do you have the capital for investment in the right equipment using the latest in technology?
Highly trained personnel alone aren’t enough. Quality critical inspection should be conducted on highly sensitive machinery with contemporary technology. Be sure you know what equipment (and therefore which inspections) are available, including such inspections and verifications as:
• Coordinate Measuring Machine (CMM) programming and inspection
• Optical and digital comparator measurement and tolerance verification
• Geometric dimension and tolerance verification
• Caliper and micrometer measurement

Effective processes and protocols
Even the best personnel and equipment fall short without the right processes.

Highly effective processes and protocols are the last aspect of superior quality critical inspection. Processes must be established, but for you to remain in compliance, rigorous protocols need to be established and consistently performed and monitored. Doing so in a way that keeps you in compliance can put extraordinary pressure on your key resources—like staff, time, and facility capacity. Often, this area is where outsourcing proves the most advantageous choice.

When all aspects—personnel, equipment, and processes and protocols—work in concert, you benefit. Engaging such expertise can ultimately be one of the best ways to significantly reduce your risk.

At Millstone, we get it. We believe quality drives patient success. That’s why we’ve perfected all the capabilities medical device manufacturers need to get to market. Today we offer post-manufacturing and aftermarket services to more than 50 customers, including some of the top 10 orthopedic companies in the world. We are constantly evolving our processes and services to help OEMs achieve sustainable success. We offer clean room packaging, medical device specific warehousing, finished goods distribution, loaner kit management, advanced inspection and reverse logistics services—all with an unparalleled focus on quality.

What could we help you do better? Learn more at http://millstonemedical.com.


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