Quality Management System (QMS)

Design and Development, Relational Database Management System (RDMS) and Web Portal Development Experience of Shannon L. Gaddis

 

This, a 2-year project. Deliverable: Quality Management System to assure compliance to applicable ISO 9001:2000 standards was developed using MS Access databases (back end). To provide corporate-wide access to a significant portion of the data collected an Intranet Web Portal had to be built to support this dynamic and everchaning production environment. Additionally, business performance metrics where measurable with some custom VBA programing allowing integration between MS Access and MS Excel . Email notifications, electronic forms and endless data interpretation opportunities because of the application integration.

  

Web Portal

This portal made information sharing and real-time data a complete 24/7 opportunity for this company. Thereby, making quality meeting, strategy meeetings, and daily performance review meetings very productive. Web pages are developed with ASP, CSS, XHTML, and Javascript. MS Access backend databases are developed and integrated using Visual Basic for Applications. Databases are integrated and interactive with MS Excel, Word and ASP web pages.
  • Document Control Database with Customized Reports:  Developed and implemented controls for the Quality Management System (QMS) and product documentation, External Standards, and customer-required specifications. Develop and maintain database systems to support the QMS. Maintain quality records, administer and record change history, and implement approved QMS changes.  Controled obsolete documentation, including disposition of discontinued or inactive documentation.  Handled design and development history records, including product and design transfers.  Updated Part Master Files and BOMs in database to be consistent with hard copy

  • Control of Quality Records: maintained regulatory registrations, certifications, listings and related correspondence.  Ensured current and complete audit and site inspection schedules and records.  Maintained current quality system records and reports, such as: audit reports and summaries; Management Review Records, and CAPA status.  Maintained all current and historical Design History Files (DHF) and Device Master Records (DMR), drawings, procedures, and reports

 
  • Audits:  Scheduled internal systems audit and generated status reports to facilitate closure of audit findings. Assisted as an Internal Auditor for 3 years.  Maintained the ISO QMS audit schedule and certification status.

    This will enable ISO elements, schedule, and results to all be reported and related.

    This will enable schedule, corrective action, and feedback to all be reported and related by audit date. This also will produce comprehensive audit results.

    I've only included the structure of the application developed using MS Access with VBA (Visual Basic for Applications); only to experience the functionality of the database.

 

 

Any update in this database will generate email
notification sent to related persons

  • CAPA (corrective and preventive action) Databases: Documented and updated CAPA information related to customer complaints.  Initiated, tracked and reported on CAPA status in the current company wide system to effect change.

    Application was developed using MS Access with VBA (Visual Basic for Applications).

    All CARs and PARs were linked to the audit database.

    Through this application email notifications are generated to facilitate the timely closure; In addition to open CAR and PARs and ECNs.

    Any update in this database will generate email notification sent to related persons

 

  • Compliance:  Administer of correspondence related to registrations, certifications, and required files and listings related to quality systems, product status and procedures.  Assisted with customer inquiries related to quality agreements and the QMS.  Notify customers of updates to quality system status (new site, new certificates, etc.)

    All of the compliance information is available through the eQMS Web Site. Including real-time reports, if this infomation is captured by production, and/or quality control area. If not, I can develop a mechanism to do so.
  • Training records:  Maintained employee training records including orientation (new hire) training, and individual training requirements to applicable policies and procedures. Reported on training status for company quality management systems, FDA Quality System Regulations and applicable ISO requirements when assigned.

    Developed an application to interact with the facility trainer, to ensure that the employees are adequaely trained and training is always available for continuous improvement.

    Developed a training tracking system that will ensure that employees are adequately training. If operator's errors reached unacceptable limits, the employee would be required to retrain in the specific area. This database is accessable by all shift supervisors. The training scheduling component of the systems is available only to the trainer to schedule training.

  • Business Metrics and production information collected and reported in Real time information in MS Access database:  Generated periodic reports on quality system metrics including specific facility metrics and corporate summaries of common facility performance metrics
  • Production MS Access databases to capture information from production teams and quality control teams, which will export into MS Excel for calculation to measure key performance metrics for real time results, and, .ASP web pages. The results are measured against the metrics set by, and updated by R&D directly through the web portal.
  • Supplier Approval Process:  Assisted purchasing department with supplier management system. Trend supplier quality performance and ensure assessments and actions are completed as required. Maintain supplier quality records and provide quality rating feedback to suppliers.

    Development of MS Excel Spreadsheet with the specific criteria and weight of criteria (sales department agrees on the weight of each criteria) generating automated ranking of suppliers. By automating this spreadsheet, sales can quickly access, qualify or disqualify suppliers.