February 18, 2016
Meeting the acceptable quality level agreed upon with the customer (AQL) is a critical concern among manufacturers.
A cutting edge medical equipment manufacturer recently installed WinSPC software on its production floor to track and improve the quality of its tightly specified products. The company enlisted DataNet’s Services team to meet their one-of-a-kind need for a custom add-on application to extend WinSPC.
The DataNet Services team also performed an installation qualification and operational qualification (IQ/OQ). This qualification ensures compliance with industry regulations for business software used in the production of medical devices.
The custom application helps the manufacturer meet acceptable quality levels (AQLs). The AQL, a key metric used by manufacturers to communicate about quality levels with customers, defines the worst tolerable defect level for a product lot and dictates how many products in a lot must be inspected. The custom application built by the DataNet team aids in automating these two areas, as described in the following paragraphs.
First, the custom application lets floor workers know how many products to inspect in a given batch of medical tools. The company’s different products have different associated inspection levels, so intelligence as to which product is running is needed.
Based on which product a floor worker selects in WinSPC, and the lot size entered at start-up, the custom application calculates how many units need to be inspected by multiplying the inspection level percentage associated with the product by the size of the lot currently being produced. It then displays an on-screen prompt communicating to the worker how many products to inspect.
Second, the application displays the AQL status for personnel at the WinSPC stations. The worst acceptable quality level is displayed alongside the current quality level so that floor workers and management can gauge performance relative to the agreed-upon standard.
In addition to the custom AQL application, the DataNet Services team successfully performed a complete on-site installation and operational qualification (IQ/OQ) of the solution. This demonstrated that the system was functioning as intended and in accordance with industry regulatory requirements.
About DataNet Quality Systems
DataNet Quality Systems empowers manufacturers to improve products, processes, and profitability through real-time statistical software solutions. The company’s vision is to deliver trusted and capable technology solutions that allow manufacturers to create the highest quality product for the lowest possible cost. DataNet’s flagship product, WinSPC, provides statistical decision-making at the point of production and delivers real-time, actionable information to where it is needed most. With over 2500 customers worldwide and distributors across the globe, DataNet is dedicated to delivering a high level of customer service and support, shop-floor expertise, and training in the areas of Continuous Improvement, Six Sigma, and Lean Manufacturing services.