QC Manager™ Patent Pending
QC Manager helps blood centers automate and track the quality control process for all blood components set for qualification based on work flow and criteria set by the blood center's QC department. Using ScanStatistics, QC Manager allows blood centers to detect system-wide failures on different levels while also providing insights into less-than-optimal practices.
While Blood centers have sophisticated donor management systems, the quality control process is mainly manual and time consuming. Due to strict state and federal regulations, quality control documents must be closely tracked and audited on continuous basis. The administrative part consumes most of the Quality Control effort. Forms are filled out by hand and stored in archives for later retrieval for FDA audits or trend analyses. Retrieval of such documents is tedious and counter productive. QC Manager makes such tasks a thing of the past. QC Manager automates the QC process and allows the blood center QC department to focus on quality control rather than on the unproductive administrative tasks.
In a medium sized blood center, an average of 12 hours per day is spent processing QC forms. Running monthly reports takes 20 hours per week. This adds up to a total time spent of 356 hours per month.
If you are part of a blood center, which relies on time-consuming, manual, paper-driven processes, then you understand that such approach:
- is prone to human errors
- requires over testing
- commands long staff training time
- wastes time to run timely analysis and insights into the QC operation
-
inhibits blood center's ability to quickly implement new FDA guidelines such as the FDA's guidance document for Collection of Platelets by Automated Methods, which we completely automate using the Qualification Peformance Module.
QC Manager Features
- Built using industry-approved standards for product QC and guidelines
- Automated tracking of all monthly product QC
- Supports Codabar and ISBT barcode symbologies
- Centralized management of QC process (for all sites, products, equipment, etc)
- Paperless QC process and forms
- Automated calculations
- Real-time reporting and customized report templates (interim as well as month-end)
- Complete real-time visibility into QC Process immediately available for management(product, equipment, site, technician, date, etc)
- Trackability and traceability - complete field level audit trails and event logs (technicians, equipment, products, etc.)
- Customizable to comply with Title 21CFR Part 11 guidelines
QC Manager Benefits & ROI
- Manage quality control using Six Sigma based lean process.
- Significant reduction in QC effort with less time spent on (reporting, review, approvals, and less product to test).
- Determine level of process conformance across blood center sites, collection technologies and products using compliant statistical models.
- Reduce the number of unnecessary tests and consulting time required to determine sample size for every blood center and its branches - There is no need to hire a consultant to develop a QC plan when the system easily does so with few button clicks.
- Robust and extensive record keeping of quality control tests.
- Automated work flow system to replace complex and time-consuming calculations and decision trees.
- Track operational activities (processes, technical staff, equipment, and products)
- Avoid loss of data and difficulties associated with data retrieval.
- Replace outdated paper-based archives and the need for offsite document storage.
- Improve collaboration between multiple departments resulting from comprehensive reports and data view (over 30 pre-defined reports.)
Increased employee productivity and moralBy providing real-time results, blood centers are able to proactively perform critical Corrective and Preventative Actions (CAPA). - Track all corrective actions taken to resolve production and manufacturing issues.
- Help reduce blood center compliance risks significantly.
- Respond to audit requests instantly compared to current manual process of document retrieval.
- Integrate with other systems or run independently - there is no need to purchase costly blood management systems to improve QC.
To learn more about Sigma Blood QC Manager™, call us now and we will be glad to answer all of your questions.