Qualtrax and the Power of Process Automation Featuring our invited presenter: Brenda Jackson, Quality Assurance Administrator for the North Carolina Department of Agriculture and Consumer Services (NCDA&CS)
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Qualtrax and the Power of Process AutomationFeaturing our invited presenter: Brenda Jackson, Quality Assurance Administrator for
the North Carolina Department of Agriculture and Consumer Services (NCDA&CS)
• All-in-One Compliance Management Solution
• ISO 9001:2015 Certified Organization
• Founded in 1993
• 97% customer renewal rate
• Headquartered in Blacksburg, VA
YOUR QUALTRAX PRESENTER
Account ExecutiveKaren Arrivillaga
• All-in-One Compliance Management Solution
• ISO 9001:2015 Certified Organization
• Founded in 1993
• 97% customer renewal rate
• Headquartered in Blacksburg, VA
YOUR QUALTRAX PRESENTER
Quality Assurance AdministratorNorth Carolina Department of Agriculture and
Consumer Services (NCDA&CS)
Brenda Jackson
OUR INVITED PRESENTER
● Tests human and animal food for pesticide residues, label claims, contaminants, and pathogens.
● Accredited to ISO/IEC 17025 since 2010
The Power of Process AutomationNORTH CAROLINA DEPARTMENT OF AGRICULTURE & CONSUMER SERVICES
Quality System Creation Paper-based records Multiple disconnected Access databases Shared network files
Manual formatting of documents (page number, version)
Manual print restriction
Manual filing of current and obsolete documents
Reporting = searching databases, paper files, network files Status updates = searching databases
Implementation process/timeline
Purchase
• January 2014
Training
• May, 2014
Document Import & User Setup
• July, 2014
User Training
• October, 2014
Workflow Implementation
• Oct-Dec, 2014
Complete Transition
• December, 2014
Functions incorporated into the system Document management Document
acknowledgement Competency assessments
(tests, training)
All quality processes Equipment management
Internal audits
Management review action items
Improvements
Reference method updates
Nonconformity/corrective action
Process Improvement/Automation
Biggest Impacts:VisibilityInformation RetrievalBroader OwnershipImproved
thoroughnessTime savings
Document Management: Benefits of Automation
“Manual” system Control requests to edit
FTE: unlocks documents
FTE: ensures review process
FTE: document management document id information,
publication,
filing
archiving
Permissions-based system Allow editing based on role
System guards draft documents
Review/approval process established during implementation
Document management automated
= 1 FTE
Document Management: Process Improvement
Improved ownership of lab in editing documents Review/release more thorough
Less frequent revisions mean:
Less work for lab staff
Less administrative work collecting/preparing/distributing copies
Fewer potential errors in document control
More thorough review = more accurate, robust lab work
Greater defensibility
Improved training
Area 113%
Area 222%
Area 320%
Area 445%
Prior to Qualtrax:Reissued <6 months
Area 1 Area 2 Area 3 Area 4
Document review/approval module:~ 20% rejected during review phase
Document Acknowledgement: Benefits of Automation
Acknowledgement sign-off automatically sent
Email notification One-click tracking
Historically, manual tracking ≈ 1 day/month Automated tracking
Reports scheduled for delivery
Reports elevated through hierarchy
On-demand reports
Put responsibility where it belongs.
Document Management: Benefits of Automation
Pre-scheduled, automated reminders! Document acknowledgement Periodic document review Test/training completion
Testing/Competency:Process Improvement
Permissions allow test creation & assignment Simple & quick test creation
Initial comprehension Refresher comprehension Focused evaluation
Automatic grading Easy to review multiple attempts, progress, entire group of test takers
Increased practicality of evaluating genuine understanding (competency).
Training Records:Benefits of Automation
Paper-based system Printed lists communicated
training needs to employees
Paper records of training easily lost
Authorizations – hand written signatures, easily lost
Status report of training meant reviewing paper files
Ongoing competency needs led to uncontrolled records
Automated system Training assignments developed per
test/technology
Assignments made to personnel groups Automatically assigned to group
members
Assignments appear on employee dashboard
Ability to upload documents/data
Electronic sign-off
Rapid, on-demand reporting, tracking
Scheduled Tests/Trainings:Benefits of Automation
Pre-schedule tests for specific date Pre-schedule trainings (including text, ppt, video material) for
specific date Focus efforts for in-person training on priority topics
Examples: Ethics/Professional Conduct policy
Impartiality, Conflict of Interest, Confidentiality arrangements
Internal auditor refresher
Training – Delivery on Demand:Benefits of Automation
New employee QMS training A few key points needed expeditiously upon hire
Review training material prior to face-to-face training improves outcomes
Minimize disruption to lab operations Not all training requires classroom time
Examples: system features, enabling Excel macros
Prepared training modules can be re-assigned as needed
Equipment Calibration Workflow:Benefits of Automation
Process step Manual system Automated system Improvement
Calibration schedule
Review logbook monthly
Appear in dashboard
Eliminate risk of missing item
Data review Spreadsheet sharing
Workflow routing Streamlined, avoid conflicting access to record and duplicates
Maintenance observations
Captured in paper logbooks
In workflow Improved ease of seeing history
Record storage Data/certificates stored separately from logbook
Upload data/certificates to workflow
Improved record retrieval; minimize risk of loss
Used for Balance, Pipette, Thermometer, Thermocouple, Tachometer, Hygrometer
Internal Audit Workflow:Process Improvement
Electronic records of assignments Are all the right documents included?
Auditor has to write/cite findings prior to review with QM.
Consistency between auditors, findings, citations.
Improved communication with lab supervision.
Ease of searching records.
Improved links between audit finding and CAR.
Improved completenessImproved clarity
Improved consistency of QMS
Improved information sharing
Reduce internal audit time by ~50%
Management Review Action Items Workflow:Benefits of Automation
Former requirements: actions, assigned to, agreed upon timescale Current requirements: status of actions from previous management
reviews
Typically, record actions during meeting shared via email, report….
Frequent lack of progress
Management Review Action Items Workflow:Benefits of Automation
Workflow: Real-time assignments
On owner’s dashboard daily
Ability to record progress in real time
Increased visibility, accountability
Management Review Action Items Workflow:Benefits of Automation
Workflow ensures completion Assign topics prior to meeting Record risks & opportunities prior to
meeting Improved management involvement Thoughtful, considered input
Record decisions Launch workflows - actions to address
risks & opportunities Automatically feed results back to
Management Review
Management Review agenda
Risk Assessment pre-assignments
Management Review
discussions
Risk Assessment follow-up
Reference Method Updates:Benefits of Automation
Circulate association publications to lab management Mailbox – no routing
Email – ignored
Multiple memberships - $$
Workflow Routing
Accountability
Relevant, reliable information sharing
Annual comment in Management Review meetings
Zero complaints since workflow initiated
Corrective Action Workflow:Benefits of Automation
Eliminate paper forms Leads to multiple copies, none
identical
Ensure each step is completed No skipping correction or
monitoring
Ensure appropriate oversight Supervisors/QA can see each step
Easily Include approval steps
Mandatory routing
Improved & efficient communication Comment fields enhance
explanations
Routing prevents delays in personal communications
Upload supporting evidence Avoid disconnected record
storage locations
Corrective Action:Process Improvement
System workflow = no paper forms to track Shortened duration due to increased visibility to supervision
0102030405060708090
100
Pre-workflow Post-workflow
Time to Close
42%
Benefits from Automation
No duplicate records Minimize lost records Responsibility properly
placed Increased thoroughness
of system system
Increased confidence in compliance
Shortened audit preparation time
Shortened onsite audit time for management
Impacts Improved visibility Faster processes Faster, thorough information
retrieval Broader participation/ownership Faster audits (time & money
savings) Reduced 1 FTE
All -In-One Quality Management System
“We are a lean organization – constantly trying to improve our processes while cutting away the waste,” explains Todaro. “That’s what drives us to improve our quality each and every day.”
Jim TodaroQuality Assurance Manager
Registration is closed!go.qualtrax.com/SuperQUC
Questions?
Karen Arrivillaga Account Executive
Qualtrax, [email protected]
Brenda JacksonQuality Assurance Administrator
North Carolina Department of Agriculture and Consumer Services
(NCDA&CS)
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