qmsWrapper provides a Search and Report tool that allows you to track the progress of all activities in your company, and it will make monitoring them very easy. You can check whether certain action achieves planned results, and to take appropriate measures in time if determined it doesn’t.
‘Search and Report’ is a module added to qmsWrapper as issues search engine and report generator. This module does search in all parts of the system and generates reports according to findings. The reports are available for export to Excel in a form of a table.
You can track the progress of each team member when it comes to the delegated assignments. It is allowed in the Issues tab above filters.
qmsWrapper will list all tasks assigned to, for example, John Smith that is in progress.
So, you can check whether John Smith can be burden with additional assignments.
One of the main requirements of ISO 13485 is the monitoring and measurement of processes, so you can track the progress of every initiated process.
Let’s say you want to have an overview of the CAPA process. In the Process tab, you can filter the search per this parameter.
qmsWrapper will list all initiated CAPA processes, so you can clearly see the status of your CAPAs. Whether they are completed, or certain CAPA should be addressed further.
These are references, for the details about a specific CAPA, just select it.
qmsWrapper allows you to extract data collected using a built template, under the Form tab. You just need to select a necessary template.
All reports can be exported to Excel, where more filtering can be done.
Information and data rising from the monitoring and measuring actions shall be investigated and evaluated. Sometimes, it’s used as an appropriate statistical technique.
The results can be compared against set KPIs for your processes, so you can compare expectations and reality. It’s used to define and evaluate how successful an organization is. Typically, is expressed in terms of making progress towards its long-term organizational goals.
This analysis has a great benefit to the organization and shall be used in various ways to evaluate the conformity of products and services to specifications, level of customer satisfaction, performance and evaluation of the quality management system, any need for improvement of the quality management system, etc.
To improve the products, processes, and QMS you can use these factors as inputs to the management review.