Why Quality Doesnt Matter

Why “Quality”
Doesn’t Matter
Big “Q” versus Little “q”
Quality
vs.
quality
Today’s “Quality”
The Quality Organization owns a term that:

–Is not easily defined or understood
–Is met with resistance
–Is viewed as a barrier by cross-functional partners
–Has a history of not demonstrating improvement as
FDA findings have been the same for decades
How is quality defined?
• Reliable/consistent product
Different stakeholders
• Product cures the patient
(internally and externally) have
• No patient harm different interpretations
• Product is always available

• Less failures
• More efficient process
• Product meets specifications
• State of the art facility
• Trained and educated employees
• Greatest value for lowest cost
quality is in the eye of the beholder….
So if we can’t define “quality”, then…
• How can we increase quality?

– And what do we mean by increase?
– And do we actually need to increase quality, or is the
current state sufficient?
• How can we gain cross-functional buy-in?

– Can you buy-in to something you can’t define?
Maybe….but:
– Can you co-own something you can’t define? Not really
• So in the end, does Quality and/or quality really

matter?
– It doesn’t as we (the industry) are operating today
What is the Outcome
of Today’s Typical
Quality Model?
…Repetitive Failures
Top 5 FDA Citations Across 11 Years
FY06 FY14 FY15 FY16 FY17
211.22(d) 211.22(d) 211.22(d) 211.22(d) 211.22(d)

1
211.110(a) 211.160(b) 211.160(b) 211.160(b) 211.160(b)

2
211.192 211.192 211.192 211.192 211.192

3
211.160(b) 211.100(a) 211.113(b) 211.100(a) 211.100(a)

4
211.100(a) 211.67(b) 211.100(a) 211.42(c)(10)(iv) 211.67(b)

5
Presented by Dell Moller, FDA, during the March 2018 FDA/Xavier PharmaLink Conference
“The definition of
insanity is doing the
same thing over and
over again, but
expecting different
results”
--Albert Einstein
We asked your peers:
What should “Quality”
stop doing?
STOP!
• Adding processes and layers of complexity

• Trying to make decisions for other functions and other
subject matter experts
• Supporting unclear Quality leadership objectives or
measures
• Agreeing to approve temporary standards or stop gaps
• Scorecarding everything under the sun that does not
appear to have obvious connection to business success
STOP!
• Thinking people will strive for quality without

appropriate motivation
• Being seen as the roadblock by other departments
• Making so many changes
• Trying to always catch me doing something wrong
• Using “compliance” as the goal
• Being the police
• Being reactive
I wish Quality would stop doing
many things. I say this with love, as
I’ve worked as a Quality
professional for many years.
Stop requiring meaningless

deliverables and compliance to
unclear, hard to follow processes
And Don’t Forget….
Our Minds are not built for quality…
Olny srmat poelpe can raed tihs. I cdnuolt blveiee taht I

cluod aulaclty uesdnatnrd waht I was rdanieg.
Aoccdrnig to rscheearch at Cmabrigde Uinervtisy, it
deosn't mttaer in waht oredr the ltteers in a wrod are, the
olny iprmoatnt tihng is taht the frist and lsat ltteer be in
the rghit pclae. The rset can be a taotl mses and you can
sitll raed it wouthit a porbelm. Tihs is bcuseae the huamn
mnid deos not raed ervey lteter by istlef, but the wrod as a
wlohe.
15
…Our Minds are Built for Innovation
It’s Time for
Change
The paradigm can be
shifted, and it starts
with Quality
Let’s find out

how…........
So Let’s Create
Quality for the 21st
Century
…….with and for all business partners
And it Starts with
“Why”
18
How to Communicate
WHAT
HOW
WHY
Simon Sinek Ted Talk

Know Your
“Why”
Michael Jr. Video

Stakeholder
Awareness
Valid Product Failure Complaint
What value do internal
What important
Stakeholder stakeholders bring, and
questions will your
Examples what do external
stakeholder have?
stakeholders expect?
Procurement
Marketing
Legal (internal)
Finance
Patient/Users
Suppliers
Investors
Engage your Cross-
Functional Peers in
these discussions!
What important questions Internal What is the value your
will your stakeholder have? Stakeholder Stakeholder brings to the
situation?
How will this impact the supply Procurement Ability to source additional
chain? Do we need more suppliers if needed
materials? Supplier failure?
What was the impact to the Marketing Understanding of user needs
patient/consumer? What is the and alternative product options
damage to the Brand? Label claim
issue?
What is the liability of the company Legal Understanding of product and
related to the patient/consumer, company liability
the Brand? Contract violations of considerations. Negotiations
suppliers, contractors, etc.? with suppliers, contractors.
How long will it be removed from Finance Assessment of financial impact
the market? What resources are
required to remediate? Cost of
failure?
What important questions External What type of information
will your stakeholder Stakeholder are they expecting to have
have? communicated to them?
Am I safe? Can I trust the next Patients/Users Confirmation of the issue they
prescription/product? Will the brought to you, health impact they
product stockout? can expect, replacement timing
Is my material implicated in the Suppliers Timely information related to

failure? Does this change the investigation progress and
order forecast? What is the conclusions. Order forecast.
conclusion and resolution?
What is the liability of the Investors Timely communication related to

company related to the understanding of product and
patient/consumer, the Brand? company liability considerations.
Will sales decline? Are other Understanding of impact.
products impacted? Regulator
concerns?
How Can You
Communicate the “Why”
…..now that you understand your Stakeholder’s needs

and contributions?
26
Table Discussions
1. How would you communicate the need to your cross-

functional peer to close investigations within 30
days?
2. How would you communicate the need to your cross-

functional peer to engage more fully in the Quality
Management Review meeting?
3. How would you communicate the need to your

senior management to increase headcount in your
understaffed Quality Organization?
How about:
1. I am working to identify how to increase the

percentage of time your equipment is operational.
Studies have shown that if failures are investigated
within 30 days, then there is a greater chance the true
root cause can be identified due to the freshness of the
incident in the minds of the employees. What can we
do together to decrease the amount of time it takes to
close investigations?
No mention of FDA regulations, or FDA enforcement.

This makes great business sense!!
How about:
2. I think if we work together, we can identify signals

to prevent failures that shut down your operations.
Can we discuss the measures that are most
important to you, and how we can improve those
measures? If we share this cross-functionally and
with senior management, then we can co-own the
success of this outcome. Would you mind
presenting this information each month so you can
share the insights you have on what is actually
happening?
How About:
3. Our total time offline increased by 13% for each of the past 6
months due to a gap in headcount we have in the Quality
Organization. This gap has already cost our site $3.4M. I can
share the detailed numbers with you, but here are the options
we have developed:
a. Hire 3 FT employees starting next month. Impact: no increase in
expense, since these FT are in our budget.
b. Hire 5 Contract employees for this fiscal year to address the backlog
we have. Impact: no increase in expenses, since 5 Contract
employees = 3 FT employees with benefits. However, training
temporary help results in lost time.
c. Continue as is. Impact will continue, but the % time offline will grow
from 25% to 32% of our fiscal year projections since our forecast
volumes increase. Total loss this FY = $9.3M
How can “Quality”
become a better asset
for the company?
Once Again,
Look in the
Mirror
The paradigm can be

shifted, and it starts
with
Quality
How can Quality become an Asset?
• By understanding where you fit into the larger business of the

organization. (stop focusing on tasks)
• By understanding where your company fits into the global

competitive landscape. (understand larger influencers)
• By communicating in terms that will drive desired behavior across

the business:
– Instead of: # of open CAPA, # of failures, 483 observations, FDA warning
letters
– Shift to: # of days off the market, # of manhours wasted (or saved), greater
net profit by % or $
– And that these numbers can be improved by increasing the RFT rate and
predicting failures
How can Quality become an Asset?
• By understanding risk and stakeholder needs

(internal and external)
• By removing barriers
• By streamlining and simplifying processes
• By operating in a way that is commensurate with the

need
• And……
By Becoming
Champions Against
Nonsense
Application
Pharma
Gowning Practice
36
Case Study….Imagine This
• What type of operation do you think

this employees is ready for?
• Answer: Fully enclosed Non-Sterile

Facility
• What could Risk Management have

done for this decision process?
– Do you think they understand their
process?
– Do they understand the risk and impact?
– Are resources being used appropriately?
– What is happening to the behavior?
37
Application
Training Design
38
Risk Model – Training Design
10
Competency Qualification,
Based, Apprentice
Demonstrations
Probability
Read and Competency
understand Based,
Demonstrations
0
0 10
Impact
39
The Good News:
We don’t want Quality

to own quality
Shift your paradigm towards:
Everyone owns “Right First Time”

and “Quality” removes the barriers
If you truly think of
Quality as “Right-First-
Time”, would you ever
think to “stick” it into a
department?
NO
Who wouldn’t be proud
to own Right-First-Time?
Imagine The Future of
Quality Operations
The Power of Artificial Intelligence
Today AI Realized
After the Fact Predictive
Periodic Continuous
Statistical Sample Totality
Imagine Continuous Product Quality Assurance!

43
“This is it. This is the
future of Quality.”
Art Czabaniuk
FDA Pharmaceutical
Program Director III,
District Director, ORA
“AI has the potential to fill

in the gaps we cannot get
to in our current
approach/paradigm.”
Cisco Vicenty
Program Manager,
Case for Quality, CDRH
Summary
Quality Today Doesn’t Matter because…..
– We can’t define what we own
• Current: many opinions
• Future: focus on Right-First-Time
– We use fear tactics to influence

• Current: FDA enforcement
• Future: Convey the value to cross-functional partners, the business and
patients
– We measure the means detached from the end

• Current: Open CAPA, Failures, OOS, Complaints, etc.
• Future: Time off market, production downtime, money, etc.
– We don’t understand the business

• Current: communicate in stories and data and studies
• Future: communicate in impact
Key Take-Aways
1. Reflect!
2. Seek and communicate through the
power of “why” to truly transform your
organization (and life)
3. Communicate to cross-functional peers
through an understanding of what is
important to them (ask them what’s
important!)
4. Become an asset. Align your actions to
improve the business. Good “Q”uality
and “q”uality drives exceptional business
outcomes
5. Develop leading edge solutions that can
drive “Quality for the 21st Century”
6. Reflect!
The Power of
Reflection
“We do not learn from

experience…
we learn from reflecting
on experience”.
John Dewey
American philosopher, psychologist
and educational reformer
Thank You!!

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Why “Quality”

The Quality Organization owns a term that:

• Product is always available

• How can we increase quality?

• How can we gain cross-functional buy-in?

• So in the end, does Quality and/or quality really

211.22(d) 211.22(d) 211.22(d) 211.22(d) 211.22(d)

211.110(a) 211.160(b) 211.160(b) 211.160(b) 211.160(b)

211.192 211.192 211.192 211.192 211.192

211.160(b) 211.100(a) 211.113(b) 211.100(a) 211.100(a)

211.100(a) 211.67(b) 211.100(a) 211.42(c)(10)(iv) 211.67(b)

• Adding processes and layers of complexity

• Thinking people will strive for quality without

Stop requiring meaningless

Olny srmat poelpe can raed tihs. I cdnuolt blveiee taht I

Let’s find out

Simon Sinek Ted Talk

Michael Jr. Video

Is my material implicated in the Suppliers Timely information related to

What is the liability of the Investors Timely communication related to

…..now that you understand your Stakeholder’s needs

1. How would you communicate the need to your cross-

2. How would you communicate the need to your cross-

3. How would you communicate the need to your

1. I am working to identify how to increase the

No mention of FDA regulations, or FDA enforcement.

2. I think if we work together, we can identify signals

The paradigm can be

• By understanding where you fit into the larger business of the

• By understanding where your company fits into the global

• By communicating in terms that will drive desired behavior across

• By understanding risk and stakeholder needs

• By streamlining and simplifying processes

• By operating in a way that is commensurate with the

• What type of operation do you think

• Answer: Fully enclosed Non-Sterile

• What could Risk Management have

We don’t want Quality

Shift your paradigm towards:

Everyone owns “Right First Time”

Statistical Sample Totality

Imagine Continuous Product Quality Assurance!

“AI has the potential to fill

– We use fear tactics to influence

– We measure the means detached from the end

– We don’t understand the business

“We do not learn from

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