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Qualtrax: Streamlining Document Management for GBRA's Superhero Lab

GBRA's Superhero Lab implemented Qualtrax, a computer-based quality management system, to streamline document management, improve document retrieval and traceability, and reduce errors and publication mistakes. This case study highlights the benefits and outcomes of implementing Qualtrax.

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Qualtrax: Streamlining Document Management for GBRA's Superhero Lab

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  1. GBRA’s Superhero:Qualtrax

  2. In the beginning.... • 700 documents; 260 bench sheets • Document management: combination of shared drives, manuals, binders and separate electronic archive system. • Hard copies of SOPs and bench sheets • Overflowing file cabinets (all not located in the same area)

  3. What happened.... • Personnel turn over • Deputy Lab Director’s role included QAO duties • SOP updates weren’t completed • Short Staffed • Equipment, hardware and software updates • Equipment was down during some updates

  4. Document approval process (pre Qualtrax) DLD/QAO emails supervisor & author to be sure edits happen Author puts completed document on share drive and emails supervisor Supervisor reviews, emails to Deputy Lab Director (DLD)/QAO LD emails comments to DLD/QAO & sometimes Supervisor and/or author DLD/QAO emails Lab Director (LD) Somebody emails corrected doc to DLD/QAO DLD/QAO prints copy, notifies approvers to sign DLD/QAO reviews/approves document LD emails approval to DLD/QAO DLD/QAO posts pdf copy to shared drive QAO archives paper and electronic versions, files new versions DLD/QAO chases down approvers for signature DLD/QAO scans approval page, inserts into electronic copy DLD/QAO notifies affected employees and conducts training

  5. Document approval process (pre Qualtrax) (cont’d)

  6. Document approval process (pre Qualtrax) (cont’d)

  7. Where We Wanted To Go….. • A computer-based quality management system we could use without having programming expertise • Pre-configured template solutions for SOPs, CAFs and other processes for rapid deployment of system • Keep all documents in one place and have improved document retrieval and traceability for staff and for more efficient internal/external audit assessments

  8. Where We Wanted To Go….(cont’d) • Documents will be kept up to date and revisions are tracked to help with audit readiness • Reduced publication errors 

  9. What We Gained with Qualtrax • 1 FTE-QAO • Deputy Laboratory Director can focus on primary duties • QAO would be GBRA Qualtrax Administrator • Document Management • Pre configured templates • Enable rapid deployment • Reduced implementation time • Better supportability and automatic upgrades

  10. What We Gained with Qualtrax (cont’d) • Error rate reduced: • Wrong copy published • Not having all signatures • Header typos • Notification errors • Responsibility & accountability rests with employee • Pickup/sign out • Ownership • Return/sign in

  11. Where we are headed….

  12. Old SOP Header and Signature Page New SOP Header

  13. Old SOP Footer New SOP Footer

  14. External Audit Management System(clause 4) Technical (clause 5) • Document Control • Management Review • Complaints & Feedback • Internal Audits • Other External Audits • Action Items • Continuous Improvement • Internal Audits • Corrective Action/Preventive Action • Training Records • Equipment Records & List • Calibration & Verification Records • Proficiency Tests • Data Packets • Reports

  15. ManagementRequirements Organization Qualtrax ManagementSystem DocumentControl Subcontracting of Test and Calibrations Purchasing, Services and Supplies Review of Request, Tender and Contracts Service to the Customer workflow Complaints Control of Nonconforming Testing Qualtrax & lab Improvements workflow Corrective Action Preventive Action Control of Records Internal Audit Management Review

  16. Training module TechnicalRequirements Lab Personnel Equipment Sampling Workflow General Lab Accommodation and Environmental Conditions Test Methods and Method Validation Lab & Workflow Lab Measurement Traceability and Calibration LIMS Handling of Calibration and Test Items Assuring the Quality of Test and Calibration Results Reporting the Results

  17. SUMMARY • Went from manual document control system to a complete, automated quality management system • Information Retrieval • Have workflows to assist in traceability of information for audits • Efficient System

  18. QUESTIONS?

  19. Have an awesome day!! Michelle Robertson GBRA Quality Assurance Officer/QualtraxAdministrator 933 East Court Street Seguin, TX 78155 Office: 830-379-5822, ext. 524 Email: mrobertson@gbra.org

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