How to Build a Culture of Quality in a Medical Device Company to build... · Selling Quality to...

How to Build

a Culture of Quality

in a Medical Device Company

Copyright GCI, Inc. 2016

How Do We Define Quality?

Juran said quality means “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 QSR defines quality as, “The totality of features and characteristics

that bear on the ability of a device to satisfy fitness-for-use, including

safety and performance.”

ASQ: “Quality is the systematic pursuit of excellence.”


Various Definitions of Quality

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

Verification (does it meet product specification)

Validation (does it meet user needs and intended uses)

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


Quality is Difficult to Define!

For purposes of this discussion, let’s use:

A “Quality” medical product meets specifications that are

designed to ensure proper clinical performance, and is

manufactured under conditions that are controlled to assure

consistent, correct results.


Selling Quality to Company Leadership

Why is it such a challenge?

It does not drive sales

It’s hard to measure

The case usually made for a strong quality system involves primarily avoidance of

adverse consequences.

You never hear anyone say “If we have a better quality system we will sell more

products!”

According to Melissa Faulkner, quality is secondary to cost for most consumers1.

1 Faulkner, M. “2011 Future of Quality Study,” American Society for Quality.

The Use of Key Performance Indicators to

Measure and Incentivize Quality

KPIs

Initial targets

Data collection

Revised targets


KPIs’ Influence on Quality

“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!

Beware conflicts between incentives by departments that work at odds.

The answer is strategic harmonization of goals across the organization, with

quality receiving equal consideration to other success factors.

Better yet, strategic harmonization of lead measures across the organization.


Lead Measures and Lag Measures

Lag Measures are the goals we want to accomplish.

Lead Measures are both predictive, meaning they lead to the accomplishment

of the Lag Measure or goal, and they are influenceable, meaning you can do

something about them1.

1Brian Critchfield, Naval Marketing, https://navelmarketing.com/2013/04/16/lead-measures-vs-lag-measures/

https://navelmarketing.com/2013/04/16/lead-measures-vs-lag-measures/










The Trouble with Lag Measures

“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


Example of a Lag Measure KPI

“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.


Example of A Lead Measure KPI

“Deliver a successful PAI for Product X” by ensuring:

Internal audits up to date and all N/Cs addressed

CAPAs closed on time with VoE or written justification for delay

Design History File for Product X reviewed by independent party

Test Methods and Manufacturing Processes Validated

Design verification and validation completed and any discrepancies resolved; statistical

techniques are legitimate and justified in writing.

Appropriate regulatory filings in place.

Management reviews provide appropriately-scaled resources commensurate with key

product issues (e.g., audits, NCMRs, SCARs, etc.)


Corporate Culture Defined 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.”

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)

Every company has a corporate culture, whether it’s defined intentionally or emerges organically.

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?


Our Corporate Culture

Periodic, anonymous employee surveys

At GCI, we appointed a “Cultural Committee”

Our mission is to build a community of coworkers by fostering a productive,

energetic, and rewarding workplace environment that inspires creativity and

social responsibility for all of our employees while promoting individual

contributions and a strong work ethic.

KPIs were then implemented and tracked and changed regularly to ensure

data-driven conclusions and decision-making.


Our Experience

Our remediation practice puts us in frequent contact with companies that have

been the subject of some sort of regulatory enforcement crisis, failed PAI, 483,

Warning Letter, consent decree, 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.

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

many places.


Key Reasons Companies Develop a “Quality

Culture Problem” Oversimplification. Symptoms include:

A belief that there is a single point of failure in a complex system and that by addressing that single point we can fix the system (fixing your brakes doesn’t make you a better driver).

When issues are discovered, they’re addressed ‘from here on out,’ with little or no thought to updating currently-marketed legacy products.

Lack of Communication. Exemplified by:

Insufficient integration of quality systems and cultures of merged or acquired entity into the corporate culture.

Inadequate filtering of procedural updates, learnings, across multiple facilities and departments.

Benign ignorance. Symptoms include:

Leadership has experience running manufacturing operations but is unaware of current best practices. For instance, processes are validated but inspection methods are not.

Quality is the adversary of progress. Let’s not empower that department.


Key Reasons Companies Develop a “Quality

Culture Problem”

Protection through scarcity. Looks like this:

Our product is in short supply

Our product is high medical need (or A and B together)

Our product is the only modality for use in this disease condition

Minimization. Symptoms include:

We have to hit a window of opportunity with XYZ show whether the product is ready or not.

We have only so many dollars to get the product on the market. Once revenue is being

generated, we can make it better (rarely happens without enforcement action).

Minimal compliance is all we need. Let’s ask for forgiveness rather than permission.

Arrogance. Exemplified by:

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

wrong (abdication of quality responsibility to the regulator)

We have small numbers of complaints and adverse events reported, and clinical

performance is more relevant than internal quality tests.


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. Words and actions.

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. For example, at

GCI, we create twice-yearly employee/patient interaction events.

For every tangible product a company creates, the people who create it not only believe in the

product but want to have it for themselves.




2. Authority is commensurate with responsibility

The Quality organization is at a peer level to other operational units. Quality Head reports to the

same level as Head of Manufacturing Operations, Regulatory Affairs, and other key senior leaders of

the company.

Strong, consistent shop floor presence of Quality Unit, including quality engineers, on all operational

shifts.

Personnel in the Quality organization are respected for their knowledge and professionalism, even

when there are disagreements, and there are adequate quality resources (dollars and people) prior to

enforcement actions.

Even production operators are empowered to stop production if a quality issue arises on the line.

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.




3. Actions are aligned with policies about quality

Compliance issues must be viewed as an opportunity to creatively solve problems, try new models,

and develop new approaches.

“The standard of quality you release to the market is your real standard”

Proactive CAPA and focus on VoE.

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


EXCELLENCE

COMPETENCE

UNDERSTANDING

AWARENESS

INNOCENCE

Quality Culture Maturity Model1

Quality mainly outsourced to regulators

“I’m good because I passed the last inspection.”

“It’s good as long as Quality approves it, but I’m worried

about our next inspection.”

Quality Systems and metrics reveal reality, and drive

action. “Crap! We have skeletons we have not excavated

and the inspector is likely to find them.”

We design quality in & anticipate issues

“I have a plan to excavate those skeletons.”

“My organization regularly seeks out and rectifies quality

concerns and applies that learning to the prevention of

future issues.”


1 ICH Q10 | Juan Andres | Process Improvement

A 16-Step Action Plan for Enhancing Corporate

Quality Culture

1. Publish a clear corporate quality vision and mission statement. For example, a four-point plan

to implement a streamlined quality system.

2. Back it up with consistent actions that send the message that you mean what you say.

3. Implement KPIs and rewards. Tie managers’ bonuses to quality metrics.

4. Make patients who use your products visible to your employees.

5. Position the Quality Organization at the highest level, at a minimum as a peer to other

operational units in the company. 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 entire organization accountable to high standards of good science, sound logic and

reasonable theories of regulatory compliance. Implement an accountability policy from the

management level all the way to the operators.


A 16-Step Action Plan for Enhancing Corporate

Quality Culture

8. Remediate backward and forward. Legacy products must comply too.

9. Be fair. Don’t hold quality accountable for elements outside of their control.

10. Make it fun to do the right things. Celebrate when things go right.

11. Follow get-well plans with stay-well plans.

12. Budget for on-going remediation/updates for continuous improvement.

13. Periodically benchmark with third parties and a subscription to a standards database.

14. Every decision is based on risk. Invest in your Risk Management tools.

15. Ensure management and engineers can balance the LTPD/AQL quality equation.

16. Use a simple plan with adequate training. Streamline archaic or overly-complicated systems to

make it easy to do the right things. For example, we’ve seen KPIs for QA approval times, so

they don’t hold things up.


GCI thanks D. Chesney for providing input to this presentation.

Contact

Information

Roberta Goode

[email protected]

www.GoodeCompliance.com

(954) 399-7510


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