CORPORATE
CULTURE OF
QUALITY
September 26, 2014
David L. Chesney, Vice President and
Practice Lead, Strategic Compliance Services
PAREXEL Consulting, Waltham, MA USA
dave.chesney@parexel.com
+1-781-434-4092
Omics Group 3rd International Summit
on
GMP, GCP and Quality Control
Valencia Convention Center
Valencia, Spain
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QUALITY IS DIFFICULT TO DEFINE
• The editors of Quality Digest say that defining the word "quality" is
"no simple endeavor."
• Juran said quality meant “fitness for use”
• Deming said only the “customer” can define quality (so “who is the
customer”?)
• ISO Definition: “Quality is the totality of features and
characteristics of a product or service that bear on its ability to
satisfy stated or implied needs.”
• There are many other definitions in a variety of references
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QUALITY IS DIFFICULT TO DEFINE
• For purposes of this discussion, let’s use:
• A “Quality” drug product always meets specifications that are designed
to ensure proper clinical performance, and is manufactured under
conditions that are controlled to assure consistent correct results.
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“QUALITY” IS NOT EASY TO SELL TO COMPANY
LEADERSHIP – WHY? -• It is difficult to connect a strong quality system to sales success,
unlike other industries such as automobiles, consumer electronics
and other products where a reputation for quality increases sales.
• The case for a strong quality system involves avoiding problems,
not achieving success. If we have a strong quality system:
• We will reduce deviations
• We will have less defects and rejections
• We will have fewer recalls, complaints and adverse publicity
• We will have less regulatory problems and associated costs
• You rarely hear anyone say “If we have a better quality system we
will sell more products!”
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WHO IS RESPONSIBLE FOR QUALITY?
• Everyone. No exceptions.
• Who is responsible for quality operations? The Quality Unit. This
includes:
• Evaluation of materials
• Evaluation of Standard Operating Procedures
• Evaluation of changes to GMP governed issues, operations, and documents
• Evaluation of the adequacy of qualification and validation activities
• Evaluation of compliance with required GMP controls
• Evaluation of compliance with company standards and internal controls that may exceed
what is required by GMP
• Batch release, including whether deviations have been thoroughly investigated and the
impact of their occurrence has been properly evaluated
• Other activities within the scope of authority of the Quality Unit under GMP and company
procedures
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CORPORATE CULTURE DEFINED
• Ravasi, D., Schultz, M. (2006), Responding to organizational identity
threats: exploring the role of organizational culture, Academy of
Management Journal, Vol.49, No.3, pp. 433–458:
• “Organizational culture is a set of shared mental assumptions that guide interpretation
and action in organizations by defining appropriate behavior for various situations.”
• Or, from Needle, David (2004). Business in Context: An
Introduction to Business and Its Environment:
• “Corporate culture…refers to those cultures deliberately created by management to
achieve specific strategic ends.” (emphasis added)
• If culture is “deliberately created” it is logical to think that it can be
deliberately changed when necessary. But how? And how do you
know it is necessary?
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FIVE REASONS COMPANIES DEVELOP A “QUALITY
CULTURE PROBLEM”
1. Innocent ignorance. Symptoms include:
A.
Focus on clinical trial progress, particularly when successful, and ignoring the need to
assure sound manufacturing processes and process understanding
B.
Leadership that has no experience running manufacturing operations and has no idea
what it takes to do that well. We often see this in companies that mature from a
development focused environment to a decision to commercialize something
themselves rather than sell the idea and develop something new.
C.
“Virtual” organizations that think if you outsource everything you have no responsibility
for anything other than to sit back and reap the rewards
2. Pipeline panic. Symptoms include:
A.
The successful product that has sustained us for years is going off patent and we
have nothing in the pipeline to replace it. We have to push product out the door while
we still can. Or :
B.
Our new product is a big success, we need to move as much of it to the market as
fast as possible to satisfy impatient investors, recoup our development costs and drive
up the stock price.
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FIVE REASONS COMPANIES DEVELOP A “QUALITY
CULTURE PROBLEM”
3. False sense of regulatory invulnerability, which may be caused
by these or other things:
A.
Our product is in short supply
B.
Our product is high medical need (or A and B together)
C.
Our product is the only thing for use in this disease condition
D.
Authorities have inspected us several times over many years and never found
anything seriously wrong (giving up quality responsibility to the regulator)
E.
We have small numbers of complaints and adverse events reported
F.
Our product has been sold in other countries for years with no problems
4. Egotism and arrogance. Exemplified by:
A.
We are the recognized industry leaders! We set the standard!
B.
The regulators do not understand our process!
C.
We are unique!
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TOP FIVE REASONS COMPANIES DEVELOP A “QUALITY
CULTURE PROBLEM”
5. The “science versus compliance” debate
A.
We have the science to support this, who needs GMP?
B.
Following GMP impedes creativity and slows the advance of science!
C.
We are the experts, don’t tell us how to do our job!
D.
“Everybody knows that”!
Some thoughts on this to bear in mind:
• Compliance without good science behind it is worthless. Science is the foundation.
• No matter how good the science, you cannot “test compliance into” a product, you must
build it in, which requires the application of sound quality management practices, and,
GMP compliance.
• You need both. There should be no debate.
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TOP FIVE CHARACTERISTICS OF COMPANIES WITH A
CULTURE THAT SUPPORTS QUALITY
1. Focus on the patient
• Patient needs and patient risk is in the forefront of every key decision
• Patient safety is the paramount driver of quality decisions (batch release, deviation
investigation approach, CAPA, etc.)
• There is continuous messaging from leadership about the importance of the patient
2. Everyone is held accountable for “Quality”; the Quality Unit is
held accountable for quality operations (tasks and activities) in
addition to “Quality” in the larger sense of the word
3. Top management supports quality with words, actions and
resources
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TOP FIVE CHARACTERISTICS OF COMPANIES WITH A
CULTURE THAT SUPPORTS QUALITY
4. The Quality Organization is strongly positioned in the corporate
hierarchy
• The Quality organization is at a peer level to other operational units
• Personnel in the Quality organization are respected for their knowledge and
professionalism, even when there are disagreements
• Quality Head reports to the same level as Head of Manufacturing Operations, Regulatory
Affairs, and other key senior leaders of the company.
5. Actions are aligned with policies about quality
• “The standard of quality you release to the market is your real standard”
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HOW WELL MEANING OBJECTIVES CAN HAVE
UNINTENDED CONSEQUENCES
• “Reduce deviations by 20% from last year”
• Sounds good at first; hard to argue with…but…
• Can incentivize under-reporting of things that go wrong in the interest of meeting the
objective
• Does not take into account production variables:
– Last year we made 100 batches and had 1000 recorded deviations
– This year we made 200 batches and had 1100 recorded deviations
» We failed to “reduce deviations by 20%” but we cut the rate of deviations from 10 per
batch to 5.5 per batch
• Does not take into account seriousness of deviations that do occur, root cause, whether
we had repeating deviations, etc.
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Source:
Quality Culture Maturity Model
EXCELLENCE
COMPETENCE
UNDERSTANDING
AWARENESS
INNOCENCE
Quality mainly outsourced to
regulators
13 | ICH Q10 | Juan Andres | Process Improvement
I’m good because I passed
the last inspection
Source:
Quality Culture Maturity Model
EXCELLENCE
Competitive advantage through
prevention of Quality issues
COMPETENCE
Quality mindset in all functions Failure to integrate Quality is
not even an option
Design Quality in & anticipate issues
UNDERSTANDING
AWARENESS
INNOCENCE
Quality Systems and metrics reveal
Tolerance to problems and
reality, and drive action
mistakes is minimal
We review Q. along with other
Quality Unit will identify the issues
aspects of the business
Quality mainly outsourced to
regulators
14 | ICH Q10 | Juan Andres | Process Improvement
I’m good as
because
It’s
long asI passed
Quality
the last inspection
approves
it
ACTION PLAN FOR
ENHANCING
CORPORATE QUALITY
CULTURE
1. Publish a strong corporate quality vision and
mission statement.
2. Support it with consistent actions that send
the message that you mean what you say.
3. Make patients who use your products visible
to your employees. Reinforce this often. Use
posters, videos, even focus group
discussions. Get the face of the patient in
front of your people.
4. Position the Quality Organization at the
highest level, at a minimum as a peer to other
operational units in the company.
5. Empower the Quality Organization with
authority equal to its responsibility.
6. Put a Quality presence “on the floor” in
manufacturing and laboratory areas. Engage
QA and operations personnel on issues when
they occur, not just later.
7. Hold the Quality Organization accountable to
high standards of good science, sound logic
and reasonable theories of regulatory
compliance..
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THANK YOU
¡Muchas gracias!
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