CORPORATE CULTURE OF QUALITY - · PDF fileCONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP....

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED.

CORPORATE

CULTURE OF

QUALITY

David L. Chesney, Vice President, Strategic

Compliance Services

PAREXEL Consulting, Waltham, MA USA

[email protected]

+1-781-434-4092

IVT Quality Metrics and Management

Week, Coronado, CA

February 22-24, 2016

mailto:[email protected]

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED.

QUALITY +

CULTURE = ??

It would appear we need to define some

terms…..

2

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. /

QUALITY DEFINED

• Definitions abound! 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 (begs a new

question, “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.”

• The FDCA Sections 501(b) and (c) define adulteration of compendial

and noncompendial drugs, respectively, in part, as

– [501(b)] “…(its) strength differs from, or its quality or purity falls below,

the standard set forth in (the applicable) compendium…” or

– 501(c)] “…If it is not subject to the provisions of paragraph (b) of this

section and its strength differs from, or its purity or quality falls below,

that which it purports or is represented to possess”

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THE TERM “QUALITY” IS USED IN VARYING WAYS IN

OUR INDUSTRY• Sometimes it means “floor level” GMP compliance

• 21 CFR 210.1(a) states in part “The regulations set forth in this part …contain the

minimum current good manufacturing practice for methods to be used in, and the

facilities or controls to be used for, the manufacture, processing, packing, or holding of a

drug …” (emphasis added)

• Sometimes it means elevating the standard to the maximum feasible level

• Sometimes it refers to attributes of a product

• Sometimes it refers to the Quality Unit , as in “Let’s ask Quality what they

think…”

• Sometimes it refers to a mindset or approach to the job one is doing

• “Big Q” – the attributes of quality of the product

• “Little q” – Quality Operations; the job of the Quality Unit

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QUALITY IS NOT EASY 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 PHARMACEUTICAL

COMPANY LEADERSHIP – WHY? --

• Because, for the most part, it does not drive sales in this industry.

• The case usually made for a strong quality system involves

primarily avoidance of adverse consequences:

• We’ll reduce deviations

• We’ll have less defects and rejections

• We’ll have fewer recalls, complaints and adverse publicity

• We’ll have less regulatory problems and associated costs

• You never hear anyone say “If we have a better quality system we

will sell more products!”

• In other industries that works: Cars, consumer electronics,

barbeque grills, furniture, etc. Pharmaceuticals? Not so much.

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IS THAT REALLY TRUE??!

• Probably. Some possibly controversial thoughts:

• Those in this room are among the most highly astute consumers of

pharmaceutical products. But when we get prescriptions filled, most likely we

direct little more than idle curiosity toward who made the product.

• Even if we know who made it, if we have never worked there and we don’t work

for FDA, we probably don’t really have a clue how good their quality systems

are. But we purchase and use the product anyway.

• The general public is even less aware and less able to judge pharmaceutical

quality than we are. So how could it have much influence on purchase

decisions?

• We don’t buy cars, noise cancelling headsets, appliances, computers, etc. that

way. We read Consumer Reports, research the product on line, or rely on our

own judgment of the quality of the product and reputation of the manufacturer.

• That translates into sales. Ask Bose, Weber Grill Company, top car companies,

and Apple if their investment in quality pays dividends. Then ask your CEO.

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WHO “OWNS” QUALITY?

• Everyone. No exceptions.

• Who owns 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 the adherence to required GMP controls

• Evaluation of the adherence to company standards and internal controls that may go

beyond 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

• There are many different definitions; a sampling:

• From investopedia.com:

• “The beliefs and behaviors that determine how a company's employees and

management interact and handle outside business transactions. Often, corporate culture

is implied, not expressly defined, and develops organically over time from the cumulative

traits of the people the company hires. A company's culture will be reflected in its dress

code, business hours, office setup, employee benefits, turnover, hiring decisions,

treatment of clients, client satisfaction and every other aspect of operations.”

• From wikipedia.com:

• “Organizational culture is the behavior of humans who are part of an organization and the

meanings that the people attach to their actions. Culture includes the organization

values, visions, norms, working language, systems, symbols, beliefs, and habits. It is also

the pattern of such collective behaviors and assumptions that are taught to new

organizational members as a way of perceiving, and even thinking and feeling.

Organizational culture affects the way people and groups interact with each other, with

clients, and with stakeholders.”

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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.”

• One of the more thought-provoking definitions is 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 follows that it can be

deliberately changed when necessary. But how? And how do you

know it is necessary?

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OUR EXPERIENCE

• For better or worse, our consulting practice puts us in frequent contact

with companies that have been the subject of some sort of regulatory

enforcement crisis, failed PAI, Warning Letter, seizure, consent decree of

permanent injunction, data integrity problem, etc. etc. etc.

• In virtually every case, at some point, someone will say something like…:

• “Our culture does not support quality”

• “The issue is cultural here, it runs deep”

• “We need to change the culture if we are going to fix this”

• The need to address the culture is frequently recognized but rarely acted

upon in a deliberate way, though sometimes it happens anyway

• What follows is the result of having observed this process play out many

times in many places

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FIVE REASONS COMPANIES DEVELOP A “QUALITY

CULTURE PROBLEM”

1. Benign ignorance. Symptoms include:

A. Focus on clinical trial progress, particularly when successful, and ignoring need to

assure sound manufacturing processes and process understanding

B. Leadership that has no experience running manufacturing operations and simply has

no idea of what it takes. Often seen in companies that mature from a development

focused environment to one where someone decides to commercialize something

themselves rather than sell it off and start over.

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 two mirror images:

A. The blockbuster product that has sustained us for years is going off patent and we

have nothing coming down the pike to replace it. We have to push product out the

door while we still can. Or alternatively:

B. Our new product is a blockbuster, we need to shove as much of it out there as fast as

possible to satisfy impatient investors, recoup our development costs and drive up the

stock price. Don’t slow that process down for “bureaucratic reasons”!

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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 modality for use in this disease condition

D. FDA has inspected us several times over many years and never found anything

seriously wrong (abdication of quality responsibility to the regulator)

E. We have small numbers of complaints and adverse events reported

F. Our product has been sold in Whoknowswhereistan for years with no issues

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 well worn “science versus compliance” debate

A. We have the science to support this, who needs those pencil headed bureaucrats and

their documentation rules!

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 an empty exercise and basically worthless.

• 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,

yes, that involves compliance.

• You need both. There is 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

• Employees understand indications for use of products and how quality attributes

influence product performance and patient safety. Litmus test: Ask an employee what the

product he/she is working on is used for.

• 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 the quality function “philosophically

and materially”

• Authority is commensurate with responsibility

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TOP FIVE CHARACTERISTICS OF COMPANIES WITH A

CULTURE THAT SUPPORTS QUALITY

4. Quality Organization strongly positioned in the corporate

hierarchy

• The Quality organization is at a peer level to other operational units

• Strong, consistent shop floor presence of Quality Unit on all operational shifts

• Personnel in the Quality organization are respected for their knowledge and

professionalism, even when there are disagreements

• Litmus test: Check the corporate web site. Look at the featured members of the senior

leadership team. Is the Head of Quality among them? Individuals featured here

communicate to the outside world which parts of the organization are deemed critical to

its success.

• 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”

• Litmus test: Re-read your corporate quality statement. Does it align with your daily

experience?16


SOME OTHER INDICATORS OF A STRONG QUALITY

CULTURE

• CAPAs are raised proactively in certain cases, before there is a deviation,

failure or something that needs a fix, to prevent ever having the problem in

the first place.

• Quality Unit personnel are sought out for their opinions, as trusted

advisors, not adversaries

• Manufacturing personnel down to the lowest level are empowered to take

necessary corrective actions, including halting production, when things go

wrong. And, when necessary, they do, without waiting for the Quality Unit

to tell them to.

• Managers at all levels are visible, frequently, on the shop floor. They talk to

working level employees and have first hand knowledge of conditions and

emerging issues. Quality Unit personnel are on the floor on all shifts.

• The test of a corrective action is how well it worked, not just that an

objective was met within an established time frame.

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INCENTIVE SYSTEMS AND THEIR INFLUENCE ON

CORPORATE CULTURE

• “What gets measured gets done” (an old maxim from the

Management by Objectives approach, attributed to several people)

• What gets tangibly incentivized gets done first!

• Systems that incentivize “pushing product out the door” or which

have unbalanced objectives that fail to consider quality and

compliance can quickly drive behaviors in the wrong direction

• The answer is strategic harmonization of goals across the

organization, with quality receiving equal consideration to other

success factors.

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EXAMPLE OF A STRATEGICALLY HARMONIZED

OBJECTIVE

• “Deliver a successful PAI for Product X”

• Meets business objectives

• Easily measurable – in fact, binary (yes/no)!

• Meets needs of patients and health care practitioners by providing access to a new

modality

• Satisfies investor concerns

• Each organizational element, Manufacturing Operations, Quality, Regulatory Affairs, QC,

Facilities Engineering, etc. needs to perform certain tasks in furtherance of the objective.

Tactics will differ horizontally across the organization and even vertically within

departments (individual contributors will do different things than their supervisors, mid

level managers and senior managers) but all share in the end result.

• Allows no room for compromise on quality and compliance objectives since failing to

meet these will result in the objective not being met.

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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.

• Don’t throw the baby out with the bath water, just be careful what you are actually

incentivizing.

• Use metrics that matter, and consider the law of unintended consequences

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EXCELLENCE

COMPETENCE

UNDERSTANDING

AWARENESS

INNOCENCE

Quality Culture Maturity Model

Quality mainly outsourced to

regulators

I’m good because I passed

the last inspection


the last inspection

21 | ICH Q10 | Juan Andres | Process Improvement

Source:

EXCELLENCE

COMPETENCE

UNDERSTANDING

AWARENESS

INNOCENCE

Quality Culture Maturity Model

Quality mainly outsourced to

regulators

Quality Unit will identify the issues

Quality Systems and metrics reveal

reality, and drive action

Quality mindset in all functions

Design Quality in & anticipate issues

Competitive advantage through

prevention of Quality issues


the last inspection


the last inspection

It’s good as long as Quality

approves it

It’s good as long as Quality

approves it

We review Q. along with other

aspects of the business

We review Q. along with other

aspects of the business

Tolerance to problems and

mistakes is minimal

Tolerance to problems and

mistakes is minimal

Failure to integrate Quality is

not even an option

Failure to integrate Quality is

not even an option

22 | ICH Q10 | Juan Andres | Process Improvement

Source:


ACTION PLAN FOR

ENHANCING

CORPORATE QUALITY

CULTURE

1. Publish a strong corporate quality vision and

mission statement.

2. Back it up with consistent actions that send

the message that you mean what you say.

Really.

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 commensurate with responsibility.

6. Put a Quality presence “on the floor” in

manufacturing and laboratory areas. Engage

QA and operations personnel on issues in real

time.

7. Hold the Quality Organization accountable to

high standards of good science, sound logic

and reasonable theories of regulatory

compliance. Avoid being pedantic or nit-picky.

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CORPORATE CULTURE OF QUALITY - · PDF fileCONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP....

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