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, Inc.karen@qualtrax.com

Brenda JacksonQuality Assurance Administrator

North Carolina Department of Agriculture and Consumer Services

(NCDA&CS)