2. GBRA’s Superhero: Qualtrax

3. 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

4. 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

5. Document approval process (pre Qualtrax)
Supervisor reviews, s to Deputy Lab Director (DLD)/QAO
DLD/QAO s supervisor & author to be sure edits happen
Author puts completed document on share drive and s supervisor
DLD/QAO s
Lab Director (LD)
LD s comments to DLD/QAO & sometimes Supervisor and/or author
DLD/QAO prints copy, notifies approvers to sign
DLD/QAO reviews/approves document
Somebody s corrected doc to DLD/QAO
LD s approval to DLD/QAO
Poorly managed via (Lots of errors)
Records were in (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

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

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

8. 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

9. 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 

11. 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

12. 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

13. Where we are headed….

14. Old SOP Header and Signature Page
New SOP Header

15. Old SOP Footer
New SOP Footer

16. 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 clause 4 managed in Qualtrax – ease of review for completeness, retrieval

17. 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 clause 4 managed in Qualtrax – ease of review for completeness, retrieval
Qualtrax & lab
workflow

18. 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

19. 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

20. QUESTIONS?

21. Have an awesome day!! Michelle Robertson
GBRA Quality Assurance Officer/Qualtrax Administrator
933 East Court Street
Seguin, TX
Office: , ext. 524