QIS provides for management of raw materials quality, real-time operations and process monitoring, product quality assurance, document control, product release, customer reporting and certification, environmental records, 21 CFR Part 11 compliance and much more.
With QIS, what was once a disconnected collection of independent, data-generating systems can now be brought together to achieve a more complete view of operations through a single source. More importantly, QIS analyzes that data and produces reports for the entire enterprise. It is not isolated to just one area only, but addresses the needs of your whole organization, whether manufacturing or business focused, from shop floor to top floor and across each respective level. Since operator actions influence executive-management decisions, we believe this integration is very important.
The functionality and capabilities of QIS are extensive and we could not possibly cover all the details. However to follow some of our core features that will give you a good insight into what QIS can do for you:
Documentation is essential in order to track product success and failure and ultimately set ideal standards by which all future production will be measured. Making sure all current documentation can be swiftly and easily accessed by the people running the process guarantees that they have the right information at their fingertips when making product and operational decisions in real-time.
QIS can help ensure your documentation is highly visible and easily understood by every member of your organisation so the right people know what to make, how to make it and what to do when it goes wrong….no mistakes…no excuses. With a touch of a button you can compare what is on the machine against what was planned, ensuring specifications are followed, recipes are managed and product consistency is achieved.
QIS manages all forms of reference documentation related to operations including (& not limited to) – Bill of Materials, Recipes, Operator Settings, Procedures, Manufacturing and Product Specifications, Test Methods and Health & Safety procedures.
QIS enables you to take raw process data and translate it into evidence for decisive action resulting in reduced variation, improved product consistency and quality, greater productivity, less waste and ultimately reduced costs.
The QIS Logsheet is a real time ‘single window’ view of plant operations and quality data. This includes product test results, process readings, SPC alarms and operator text comments, plus much more. Data is compared to the current specification and displayed with a clear ‘traffic light’ colour coding to immediately highlight control and acceptance status. The wide variety of real-time control and cross-machine profile charts available help operators distinguish between random fluctuations and true shifts within the process and take appropriate and timely action when needed
SPC Alarms enable close control of critical parameters with non-conformance, drifts and trend deviations immediately highlighted. When an SPC alarm is triggered by a parameter changing its control state, an authorized operator can acknowledge it and record the reason and any subsequent corrective action to be taken. All entries are date and time stamped to enable full decision tracking. Multiple alarms that have the same cause can be answered with a single entry. No more scattered hand written log sheets or piles of paperwork… Or hours manually spent drawing control charts!
With our advanced data library and technical analysis you can crunch months and years of data in seconds and then deliver very sophisticated statistical results in easy-to-understand graphical outputs.
Touch of a button analyses include Product and Process Capability Analysis, Control / Specification Limit Conformance Summaries, ‘What-If?’ facility and Analysis of Variance. The benefits that can be gained from using these tools are wide ranging and, with their ease of use and access, they can be used for every day decision support for Production, Quality, Environmental and Customer Management
Production summary provides a drill-down active report that allows rapid focus on the problem areas by process area, production run and process variable. By selecting a time period summary you can see everything that has happened by run, shift, day or longer. The failure reasons are clearly highlighted along with any out-of-control issues and are displayed as a ranked Pareto style chart.
QIS also includes a dedicated report writer tool that enables customer reports to be easily generated and if required automatically emailed to them. The on-line “English language” wizard makes light work of report design with no programming or database knowledge required. Reports can be readily customized with pictures and logos to personalize your customer service. Where required, restricted Internet access to QIS is available from a customer location. This eliminates the need for paper-based reports and the customer can view the data on-line straight from his PC, if necessary, prior to dispatch.
As an integral part of QIS, our asset monitoring and incident-tracking module provides a powerful drill down performance analysis that supports and informs continuous improvement and operational excellence programmes. It is simple and practical, taking indices for machine downtime, performance and quality and then providing a single OEE score that allocates a rating to the overall manufacturing efficiency. With fully configurable incident trees, incident alarms and configurable reporting it is easy to see not only where you are, but how you can improve too.
A Certificate of Analysis assures your customer that the properties of the products you have supplied meet specification, and is your assurance of the ‘quality’ of your product. The CoA module in QIS provides a flexible and configurable system that not only caters for all of the demands of satisfying ever increasing customer needs, it also caters for reporting of data from anywhere in the product genealogy.
Certifying the parameters of purchased raw materials that go into your product is often a necessity and one that can take many hours of research to establish. With integrated product tracking and data capture capabilities, from Supplier through Production to Customer this is can be achieved in your Certificates with ease. What you don’t need in a CoA is any surprises! Apart from the steps that can be configured along the along the way, such as Pallet certification, before a customer certificate is published it can be tested for compliance against internal specification or the customer‘s specification. This will highlight issues for review when invoked manually and quarantine those marked for automatic delivery.
Post-delivery you need to be sure you always have a secure record of what was sent to a customer, whatever the circumstances. This is essential for ISO9000/ISO13875 purposes. The QIS-CoA repository files a read-only copy of every CoA you publish ensuring a permanent, auditable record of what was sent irrespective of any post-delivery data changes. This feature also serves for repeat CoA printing where required.
Source: QiSOFT
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