Quality Initiatives – A Better Way to Make a Better Product
Life sciences companies have always made extremely high quality products – FDA oversight makes sure they do. But they have long tolerated less-than-perfect processes for manufacturing those drugs – long lead times, slow time-to-market and other inefficiencies are the norm in the industry. High scrap rates and rework are common.
As firms come under pressure to cut costs, most have implemented some kind of quality initiative to rectify these problems. The exact initiative varies from company to company – some focus on Lean Manufacturing, others on Six Sigma and Right First Time efforts – but they all have in common the goal of improving the quality of their process and the consistency of their final product by making ongoing process improvements, which can lead to substantial savings.
Challenges to Quality Initiatives
As with any organization, there are challenges. The constant struggle for resources means that decision-makers have to be able to demonstrate clear benefit to the company’s bottom line in the short term to justify the expenses.
What’s more, whatever changes they make must be done while remaining in compliance with FDA regulations. Any gains in consistency and efficiency would be more than offset by the consequences that can result from FDA warning letters, 483s and failed quality audits.
GE Intelligent Platforms Quality: The Insight You Need to Improve Quality
GE Intelligent Platform’s Plant Applications Quality solution is a powerful software module – part of the larger Proficy Plant Applications Collaborative Production Management suite – that supports and enables your quality initiative. Plant Applications Quality tracks and monitors your product and process quality in real time using data collected from all sources – manual and automatic. Reason codes, process values, research notes as well as recipe, batch, lot and materials information all are captured and analyzed to identify root cause problems. Alarms are exposed at data entry and data acquisition time, and it even has electronic signature capabilities.
Whether you’re performing statistical process control or process capability analysis, generating control charts or performing an annual product review, Plant Applications Quality gives you the data access and tools you need.