Application Software Quality Assurance, one size doesn’t fit all. Some companies only need defect detection and tracking (Quality) in conjunction with scripted test scenarios (Assurance). Others need a comprehensive scope that includes Concept Documents, Requirements Documents, Project Plans, Functional Design Documents, Implementation Plans, Test Plans, Test Reports, Requirements Traceability Matrixes and Post-implementation Evaluations. Large scale projects often need process planning and resource allocation in addition to all of the above.
We provide expert leadership to satisfy all sizes of Application Software Quality Assurance needs. The work we do has a dramatic positive impact on the companies we serve. The following case studies illustrate how we have assisted our clients to achieve significant, tangible results.
Hutchinson Technology, a high-tech manufacturer in Hutchinson, Minnesota, engages in the design and manufacture of suspension assemblies for hard disk drives.
The manufacturer needed to implement the highly customized Camstar InSite Process Control System (PCS). After multiple attempts to move a fully functional version into production Gerry was brought in to reduce the number of defects occurring in PCS.
The defects were eliminated by:
1. Initiating the first corporate use of Test Director (Mercury Quality Center – MQC). This product was owned by the manufacturer but never implemented.
2. Implementing a quality assurance server structure.
3. Performing ad-hoc and structured testing.
4. Writing and executing MQC manual testing scripts.
The testing, defect documentation and resolution monitoring brought the PCS application into production defect free. Over the course of the project, three major and two minor versions were deployed.
Medtronic Cardiac Rhythm Disease Management (CRDM), constantly needs to add and update Information Technology applications. All Medtronic CRDM applications fall under the scope of FDA 21 CFR Part 11. While being monitored by the FDA the proof of “due diligence” is as important as the quality of the application in production.
The “due diligence” process consists of a) defining the addition/change with scope and requirements documents, b) getting signed approval of these documents, c) making the documented changes and only the documented changes, d) writing test scripts, cases and plans, e) creating a traceability matrix that cross references each requirement with at least one test script / case, f) documenting the results and g) getting signed approval of the process and all documents.
Gerry has performed this process for projects in the following areas: Product data management (multiple projects), environmental monitoring, receiving inventory product inspection (multiple projects), supplier and new product evaluation and testing (multiple projects), plus two different product version upgrades.
All projects have passed FDA inspections.
ECOLAB initiated a project to implement an international Product Data Management (PDM) application, which was called Ecolab Product Information Central (EPIC). A subset of Ecolab's products fell under FDA Regulations therefore the entire project was subject to FDA 21 CFR Part 11. Additional complexity resulted from the project being international in scope and the large staff involved with the quality assurance process.
Gerry consulted on the project and gave direction to quality assurance concepts that would ensure compliance with FDA Regulations. The effort was expanded from a passive pursuit to comply with FDA Regulations to one that would ensure "due diligence" and deliver defect free applications to production.
The process allowed the Project Leader to demonstrate, without error, the entire projects functionality to company directors and vice presidents 3 months prior to the scheduled implementation date. The project has passed FDA inspections. For exemplary performance an EPIC Project crystal ball was received.