Since the plan of the company was to grow the organization handling all of the documents of the quality management system, it was going to be a challenge. There were going to be many changes to the quality manual and procedures that would require multiple copies to be controlled and distributed. It became apparent that an electronic, automated, system was needed to control all of the documents. If this system had the additional benefit of electronically maintaining NCRs, corrective and preventive actions, as well as training records, it would be a plus.
QIA was contacted to see what type of system they had available. Arrangements were made for their representatives to go to the manufacturing site and demo their web based QISS system to the plant management team. The team was impressed with all of the features the system had to offer. Of interest were the modules that electronically maintained the documented quality system, the NCRs, preventive and corrective actions, and all the employee training. The team was pleasantly surprised with how the system would send automatic notifications via email when actions such as document approvals were needed. How the document releases were tied directly to employee training on those documents, was a real plus. QIA quickly provided a quote for the system which included not only the document control, NCR, CAPA, and training modules, it also included other modules that would allow the organization to track gauge calibration, internal audits, and management review meetings.
The organization purchased the system and that same day the system was made available online to the organization. QIA provided on-site training on all the modules to key individuals in the organization. Once the training was complete the task at hand was to add all the employees and QMS documents to the system. This only took a couple of days since the system is intuitive and easy to use. The rest of the organization was trained by the system administrator which only took a couple of hours. After the system was ready to use all of the binders with the QMS documents were removed from the desks and offices of those who had them. The organization began to use the NCR and CAPA modules within a week and immediately saw the benefit of no longer needing to handle paperwork. As changes were being made to documents, notifications were being sent automatically to the organization. One plus of the system is that the training module is tied to the document management module so all new documents and changes automatically generated requirements and notifications to train on. Implementing QISS had a major impact on the organization by reducing the amount of paperwork being generated, reducing the amount of time for approvals and distribution of documents, and giving access to the entire organization on the status of the entire QMS by simply logging into the system.