Quality Management Systems (QMS) Replacement

Overview

A mid-sized medical device company was in need of new Quality Systems, in particular the Complaint Handling and Corrective And Preventative Action (CAPA) systems.  Quality data was being collected on a dated, legacy system, which plagued users with frequent time-out errors.  Beyond this, the client’s Customer Relationship Management (CRM) solution was essentially non-existent, so any improvements in this area, which could be leveraged from the primary project were deemed a secondary priority by the project stakeholders.

Target

Overhaul and improve the Complaint Handling and CAPA processes and systems.

Solution Delivery

eta one's initial analysis, derived from the first 3 phases of its methodology (Formalize, Measure, Analyze), identified 20% of the data captured to be redundant or non-value added.  In addition, bottlenecks or process stagnancy accounted for approximately 30% of the cycle time in the Complaint Handling and CAPA processes.  Through rigorous future state process mapping and requirements gathering, eta one was able to work with this client to create requirements documentation and establish a tool scorecard with which to evaluate potential, off-the-shelf, configurable solutions.  One was chosen from a pool of 3 finalists and eta one partnered with this 3rd party vendor to configure their product according to the Functional Requirements Specification (FRS) we developed.

Results

The resulting system was validated, tested and rolled out with a mixture of eta one and internal resources.  It was met with wide acceptance and reduced cycle time by 55%.  The overall compliance risk to the client was dramatically reduced and five major risk areas (identified via an internal Quality Assurance audit) were completely eliminated by the new process and system implementation.  Importantly, through efficiency improvements (eta one's passion), process resource needs were reduced by 70%.

In addition, the new system had a front end, which allowed the client’s call center to develop a customer profile and history, further linking it with the sales and marketing systems.  This addressed the secondary need for the CRM system and further improved the impact of eta one's efforts on the organization’s investment and efforts.