Design for Quality Process Failure Mode and Effects Analysis
Design errors result in product errors - and there’s no room for error when it comes to a person’s health. Incorporating quality considerations into the design process will result in far fewer defects, lower costs, and speed the regulatory review process.
A medical OEM and its design and manufacturing partner must gain a clear understanding of the risks before committing tooling, fixturing, and implement layers of controls to mitigate those risks.
Celestica recommends conducting a Process Failure Mode and Effects Analysis (PFMEA) to scrutinize a product design and identify any potential failures that may occur during the manufacturing process resulting from human error or equipment malfunctions.
"If you wait until after releasing a product to manufacturing and discover an error, you have to spend more money and incur delays to retool and restart manufacturing," says Brian Blair, Celestica’s HealthTech Global Process Control Leader.
"When a customer makes a purchase, they’re not paying for a product - they’re paying for its functionality and reliability. Functions deliver value. If a $1 million product fails, its value to the customer falls to zero. And ultimately, this will have a great impact on the brand."
Brian Blair, HealthTech Global Process Control Leader, Celestica
Begin by creating a cross-functional team of representatives from design, engineering, manufacturing and quality assurance charged with finding ways to streamline the manufacturing process, such as automating manual processes or eliminating product features that do not deliver value to users.
The PFMEA team requires both information (i.e., users, parts, processes, performance) and time to capture and evaluate all possible issues. A PFMEA is a regimented process that must be followed step-by-step to ensure it captures all possibilities and their probabilities.
The outcome is a set of controls that will make the manufacturing process far more robust and greatly improve the likelihood of delivering a high quality product to customers.
Design for Quality
Eliminate Defects Sooner
“The earlier you identify and fix defects, the better. 95% of the cost of a product is baked into the design - that’s where the requirements are cemented. If you discover defects after manufacturing has begun, you’ll waste time and money on retooling and remanufacturing, and inevitably suffer delivery delays.”
Brian Blair, Health Tech Global Process Control Leader, Celestica
It’s not uncommon for medical OEMs, particularly smaller and early stage companies, to want to leverage automated assembly to eliminate manual processes. But many may not have the requisite capabilities in-house. After performing an initial PFMEA, customers contract Celestica to own the automated program from design through delivery. After the product transfer, ideally early in the design process, Celestica performs a comprehensive risk assessment to evaluate the PFMEA and achieve zero defect before committing tooling, fixturing, etc.