Quality has become a life-or-death issue for companies and their customers. Thus, effective product quality needs to be a before-thought rather than an afterthought. To keep quality top of mind and top of design, quality tools are making their way into design tools. Since the beginning of ISO 9000 and 9001 product quality has required a systematic solution, and that solution is now at the design engineers' fingertips.
Many companies have implemented a document-management or records-management system as part of the product design process. Without a manageable system, quality documentation can stifle the design process. To manage this, PLM systems have taken on the task of managing the data involved in product quality.
The need to manage quality data and keep it close to the design process is a growing concern as products such as medical devices become more integral to our actual survival. “Quality issues are becoming bigger and bigger. Because of this, we’ve expanded our portfolio on quality, Kent Killmer, VP of marketing at Arena Solutions, told Design News . “Obviously the high-tech industry needs quality, but in medical it’s even more important; it’s life or death with no negotiation or equivocating.”
PLM Systems With Embedded Quality
Arena Solutions uses Arena Quality, a cloud-based tool designed to offer interdisciplinary visibility, supplier collaboration, and long-term tracking of quality resolutions. The tool is designed to enable companies to create and meet ISO standards, FDA regulations, and a spectrum of other product quality business processes, including; 21 CFR Part 11, 21 CFR Part 820, NCMR, CAPA, and 8D. The tool is embedded in Arena PLM.
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