Statistical Process Control for Medical Devices

by | Jan 31, 2022 | Compliance, Consulting Group, Medical Devices, QMS, Quality, Quality Systems, Regulatory, Standardization, Standards


There is an innate benefit to utilizing statistical techniques in any manufacturing process, but even more so for medical device firms. If you are trying to optimize your process or even simply validate it, you will need to utilize statistical techniques accurately. For many of us who are not statisticians, this can be a daunting task. The world of hypothesis testing, sampling plans, design of experiments, and central limit theorem can be unwelcoming, but it certainly doesn’t have to be.

Statistical Process Control, or SPC, has been around since the early 1920s and has only grown in popularity since then[1]. Today, SPC is the number one quality tool in driving continuous improvement for manufacturing processes. Whether you are trying to monitor process performance or justify why 100% inspection is not necessary, SPC has a tool for you. Control charts, histograms, Pareto charts, Ishikawa diagrams, gauge R&R, and measurement system analysis are all tools in the SPC toolbox that can be used to optimize medical device manufacturing processes.

One major area where SPC may benefit your process is utilizing control charts and statistical techniques to validate a process, thereby justifying why individual inspection of each unit is not necessary. With a well-executed study and sufficient documentation, batch release of products using control chart analysis is acceptable. This will save a manufacturer immeasurable time and resources.

SPC can be the basis of continuous improvement efforts, governed by CAPA’s or Quality Plans, and can demonstrate your organization’s commitment to quality to regulators and customers. Although these tools have been in use for decades, how each manufacturer implements them is different. SPC methods should be utilized in a specific way to ensure you are optimizing your process and enhancing your product. EMMA International’s team of experts have successfully deployed SPC tools for clients, resulting in reduced nonconforming product and optimized manufacturing capabilities. Give us a call at 248-987-4497 or email info@emmainternational.com to learn more!


[1] ASQ (n.d.) What is Statistical Process Control? Retrieved on 01.30.2022 from: https://asq.org/quality-resources/statistical-process-control#:~:text=SPC%20resources-,SPC%20Tools,typical%22%20process%20performance%2C%20occurs.

Madison Wheeler

Madison Wheeler

Director of Technical Operations - Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

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