Glossary Term
Statistical Process Control (SPC)
Definition
Statistical Process Control (SPC) is a methodology used to monitor, control, and improve the quality of processes through the use of statistical techniques. In SPC, data collected from the production process is analyzed to identify variability and ensure that processes are operating within set limits. By using control charts and other statistical tools, SPC helps identify any deviations or abnormalities in the process, allowing manufacturers to take corrective actions before defects or issues impact product quality. SPC is commonly used in manufacturing environments to maintain consistency, ensure quality, and reduce waste.
Relevance to the MedTech Industry
Statistical Process Control is critical for ensuring that medical devices are manufactured to the highest standards of safety and performance. Medical device manufacturing must meet stringent regulatory requirements (such as those set by the FDA or ISO 13485), and SPC helps manufacturers stay compliant by maintaining consistent product quality and reducing variability in the production process. This ensures that each device meets the necessary specifications and is safe for use by patients. SPC is particularly important in the MedTech sector, where even small defects or deviations can have significant patient safety implications.
Additional Information & Related Terms
Related Terms
Process Capability: A measure of how well a process performs relative to the specifications or limits of a product, often quantified by indices like Cp and Cpk.
Control Chart: A graphical tool used in SPC to monitor process behavior over time, identifying trends and variation in production.
Six Sigma: A methodology focused on improving quality by identifying and eliminating defects in processes, often using SPC as a key tool.
Quality Management System (QMS): A structured system that ensures product quality, incorporating tools like SPC to monitor and improve processes.
Defect Reduction: The process of identifying and eliminating sources of defects in manufacturing, with SPC often used to monitor and control process variation.