GBRA’s Superhero: Qualtrax

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Presentation transcript:

GBRA’s Superhero: Qualtrax

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) * Successful accreditation assessments despite manual system

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 Personnel turnover-no continuity and flow of information and tracking Deputy Lab Director role included QAO duties Despite issues we remained TNI accredited

Document approval process (pre Qualtrax) Supervisor reviews, emails to Deputy Lab Director (DLD)/QAO DLD/QAO emails supervisor & author to be sure edits happen Author puts completed document on share drive and emails supervisor DLD/QAO emails Lab Director (LD) LD emails comments to DLD/QAO & sometimes Supervisor and/or author DLD/QAO prints copy, notifies approvers to sign DLD/QAO reviews/approves document Somebody emails corrected doc to DLD/QAO LD emails approval to DLD/QAO Poorly managed via email (Lots of errors) Records were in email (not reliable on what was most current version) Documents were lost or forgotten Time consuming process Still, had no major audit deficiencies DLD/QAO chases down approvers for signature DLD/QAO scans approval page, inserts into electronic copy DLD/QAO posts pdf copy to shared drive DLD/QAO notifies affected employees and conducts training QAO archives paper and electronic versions, files new versions

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

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

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

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 

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 Time to evolve

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

Where we are headed….

Old SOP Header and Signature Page New SOP Header

Old SOP Footer New SOP Footer

External Audit Technical (clause 5) Management System(clause 4) Document Control Management Review Complaints & Feedback Internal Audits Other External Audits Action Items Continuous Improvement Corrective Action/Preventive Action Training Records Equipment Records & List Calibration & Verification Records Proficiency Tests Data Packets Reports All ISO 17025 clause 4 managed in Qualtrax – ease of review for completeness, retrieval

Management Requirements Organization Management System Document Control Review of Request, Tender and Contracts Subcontracting of Test and Calibrations Purchasing, Services and Supplies Service to the Customer Complaints Control of Nonconforming Testing Improvements Corrective Action Preventive Action Control of Records Internal Audit Management Review Qualtrax workflow All ISO 17025 clause 4 managed in Qualtrax – ease of review for completeness, retrieval Qualtrax & lab workflow

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

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

QUESTIONS?

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