Your trainers

Chris St Amour Christy Mazzarisi

Head of Solutions Consulting Principal Consultant

Dawn Niccum Maria Veleva

SVP QA & Compliance Principal Consultant
Quality Gains: The Power of Continuous
Improvement in Your QMS Health Regiment
Your trainer

Christy Mazzarisi
Principal Consultant

With over 17 years of industry experience as Head of Quality and a Quality systems professional, Christy is
most passionate about continuous improvement activities and consistently building quality into each area
of the life sciences. Her background? Think pharmaceutical and laboratory sciences, R&D and commercial
manufacturing, GMP & GLP, leading to strategic management of major programs such as gap analysis and
transformation of Product Quality Systems (PQS), SOP transformation and optimization, QMS frameworks,
and operational systems audits. So basically, the gamut.
Agenda
§ Bootcamp Module Refresh
§ Continuous Improvement Strategy
§ Proactive System Monitoring Tips
§ Quality Culture- Benefit of CQI
§ Return on Investment (ROI)
§ Key Take Away
 Refresh: Phased Approach to
eQMS Implementation

Phase 3
Audits
Phase 1 Supplier Qualification
Document
management System Phase 2
Learning management Change Control
System Quality Events
CAPA/ECs

Phase 4 Continuous Improvement,

Complaints APQRs...Down the road when
Inspections ready for commercialization
Continuous Quality Improvement
(CQI) 01 02
IDENTIFY
GOALS PLAN

DO

CQI is a process that

06 03
supports improvements in

PLAN

CHECK
business processes and EFFECTIVENESS DATA
CHECK COLLECTION
outputs using data and tools.
ACT

05 04

IMPLEMENT ANALYTICS
What does “good” look like?

Build a quality culture- Improve communication

Come back to this one! enterprise-wide

Meet or Exceed
Reduce compliance
Increase efficiencies Customer risks and support
and consistency
agency inspections
Expectation!
Reduce costs Increase sense of
(deviations, reworks, empowerment for
scrap, turnover, etc.) employees
What are the industry challenges?

Lack of process No stakeholder No support

understanding involvement from the top

Lack of strategy No commitment Quality not seen a

to CQI valued business partner
It is a cycle! Just a cost center
CQI Strategy for Deployment

What does good

Define and evaluate look like? Gather and
Build a core CQI team customer needs Define success. evaluate data

1 2 3 4 5 6 7 8

Define organizational goals Perform a current Create a Learn through

state assessment robust plan success and
failures as a team
Proactive Monitoring
1 Proactive Risk Management
Real-time analytics that support a
proactive approach to handling risks
and identifying bottlenecks.
2 Continuous Quality
Improvement
Robust analytics that helps Senior
Leadership see areas needed for
continuous improvement initiatives.
3 Holistic Dashboards
Dashboards that contain good data and
proper translation of information to allow
for adequate oversight of company
operations and vendor performance.
4 Reduction of Efforts
Having proactive monitoring, by way of robust
analytics, allows more time to be spent on value
added activities by reducing duplications of
events/documents, ensuring training is performed,
and having on-time audits.
Quality Culture—A Benefit of CQI
Key Performance
Indicators (KPIs)
KPIs show company
performance and with quality
built into your processes; the
better KPI data you will see.
Track leading indicators to
prove you are a proactive
organization built around
quality.
Quality Management
Review Boards
Having regularly scheduled
review boards is an indicator
that you have a strong culture
of quality.
Proves accountability of all
leaders in the organization, not
just Quality.
Risk-Based Approaches
Using risk-based thinking,
shows that you are maintaining
control over your people,
processes and technology.
Documenting your risk
assessments and mitigations
proves you take your business
seriously and embed quality
where it counts.
4-step Approach to Building a
Quality Culture

Step 1 Step 2 Step 3 Step 4 CQI

Understand the Follow the leader! Be proactive! Empower your

“why” quality employees!
functions as it does. It starts by leading by Build quality into your
Help stakeholders example from the top processes from the Support them to make
realize the value a down. Partnered with start or during a value-based decisions
culture of quality can Executives, Quality can review cycle. day to day and have
provide. truly lead by example confidence in why you
and shift mindset to hired them.
one of value.
Increases morale; leads to
less risk!
 Return on Investment (ROI)
Increase Accelerates Knowledge
Budget Saver Adds Value
Compliance Productivity Capture
• CQI costs • More • Remove • Let teams • CQI can
tend to be efficiencies, duplications, focus on what ensure
much less than create less gaps or matters most knowledge is
cost of NOT errors deficiencies • Efficiencies always being
implementing • Maintains across the create speed captured in
CQI culture of company systems or
• Decreases Quality • Only value- processes
budget added • Knowledge is
overtime activities left not lost with
people
Key Take Away

Continual improvement should be a “permanent objective of

the organization”, as mentioned in ISO 9001.

The one true goal for any company is for quality to be owned by
the entire organization and embedded in its culture.
~Anonymous Quality Mentor
Certificate of Achievement
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