104TPDA04036-B EMBRACING QUALITY CULTURE IN BIOPHARMACEUTICAL COMPANIES For Taiwan PDA Ben Chen, P.E. November 16, 2015

104TPDA04036-B

EMBRACING QUALITY CULTURE IN

BIOPHARMACEUTICAL COMPANIES

For Taiwan PDA

Ben Chen, P.E.

November 16, 2015

104TPDA04036-B

TOPICS

Ten Warning Signs of A Weak Quality Culture Quality Culture Measurement Quality Culture Summary Culture Transformation Douglas McGregor – Theory X and Y Leadership vs. Management Situational Leadership Communication Rules

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Taiwan PDANovember 16, 2015

BEN CHEN

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INTRODUCTION

Quality Culture plays a critical and complimentary role because it affects the decisions that contribute to the data that are used for calculating the metrics. A good quality culture is often described as one that puts the interest and safety of patients and consumers above all else and where people do what is right versus what is good enough.

Quality Drives Business; Not the Other Way Around!

Srinivasan and Kurey define Quality Culture as “an environment in which employees not only follow quality guidelines but also consistently see others taking quality-focused actions, hear others talking about quality, and feel quality all around them”

Systems, Not People, Drive Quality!


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BEN CHEN

What is Quality Culture?

An environment in which each and every person understands and embraces their responsibility for protecting product quality and patient safety.

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PURPOSE

This course will provide the aspects of quality culture, steps of culture transformation, and the skills of situational leadership for supervisors and non-supervisors to improve corporate quality culture and build a coherent approach, which the pharmaceutical industry and regulators can adopt.

Taiwan PDANovember 16, 2015 BEN CHEN

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TEN WARNING SIGNS OF A WEAK QUALITY CULTURE

Reference: Culture of Quality (Forbes Insight)

1. The CEO and other senior executives rarely discuss quality—let alone performance against quality objectives.

2. The company’s quality vision is either non-existent or has minimal linkage to business strategy.

3. Managers throughout the organization either fail to consistently emphasize quality or are resistant to quality initiatives.

4. The organization has few if any feedback loops for continuous improvement of processes.

5. The company lacks formal mechanisms for collecting and analyzing customer feedback.

6. Metrics used for performance evaluation feature little-to-no mention of quality goals.

7. Employees are not familiar with the company’s quality vision and values—or perhaps worse, view them as mere slogans.

8. Training and development do not emphasize quality.

9. New hires are not formally introduced to the organization’s quality vision and values.

10. The organization experiences frequent, though often minor, setbacks owing to inconsistent quality.


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QUALITY CULTURE MEASUREMENT The PDA Quality Metrics Task Force has hypothesized that there are certain

behaviors that correlate with a strong quality culture, and that these behaviors are driven by maturity attributes that can be measured and quantified.


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The executives and non-executives view themselves with regards to maturity level

More executives were selecting a higher number of observed cross-functional behaviors than non-executives.

Density curves of the cross-functional vision category per survey

It should be no surprise that executives have a rosier view than non-executives. while 75% of senior or C-suite titles believe this, responses drop to less than half among those with quality job titles. The further from the C-suite, the less favorable the view of the culture of.

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QUALITY CULTURE SUMMARY


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The top five observed behaviors and top five maturity attributes from those identified by the PDA. The observed behaviors identified were 1.Leaders who exemplify quality culture behavior2.Incentive program supports a strong quality culture3.Timely feedback and coaching of job performance4.Following clear and transparent governance processes5.Adoption of a quality by design (QbD) mindset and approach

Similarly, the top five maturity attributes identified were 1.Management communication that quality is everyone's responsibility2.Site has formal quality improvement objectives and targets3.Clear performance criteria for feedback and coaching4.Quality topics included in at least half of all-hands meetings5.Collecting error prevention metrics

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CULTURE TRANSFORMATION Matching the right person at the right job

1. Educational and career backgrounds

2. Douglas McGregor’s X-Y Theory

3. Job preference vs. company’s needs

Balancing the team strength 1. Levels of competence and commitment

2. RACI & leadership identification

3. Set effective “SMART” goals

Exercising effective leadership1. The traits of effective leaders

2. The traits of successful managers

3. Situational leadership styles

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CULTURE TRANSFORMATIONMATCHING THE RIGHT PERSON AT THE RIGHT JOB


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1. Educational and career backgrounds Meeting employees one-on-one to get acquainted with them from personal levels and learn

about their educational and career paths to see if they do what they know. Providing peer mentorship and on-the-job training to subordinates who need to close their gaps

between what they do and what they know.

2. Douglas McGregor’s X-Y Theory Most people prefer ‘Y-theory’ management.

These people are generally uncomfortable

in ‘X-theory’ situations and are unlikely to

be productive, especially long-term, and are

likely to seek alternative situations.

3. Job preference vs. company’s needs Understanding how much employees enjoy their jobs and what their short-term and long-term

career goals are. (Periodically) Working with HR to develop employee retention program. (Periodically)

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CULTURE TRANSFORMATIONBALANCING THE TEAM STRENGTH


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1. Levels of competence and commitment Identifying high or low level of competence and

of commitment. Equalizing levels of competence and

commitment among teams.

2. RACI & leadership identification Establishing RACI of the tasks of each team. Defining roles and responsibilities. Evaluating headcount conditions.

3. Set Effective “SMART” Goals Identifying Company’s goals and defining

personal “SMART” goals. Developing personal action plan

to success. Monitoring performance progress.

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CULTURE TRANSFORMATIONEXERCISING EFFECTIVE LEADERSHIP


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1. The traits of effective leaders according to Kazmier: Intelligence Communication skills Ability to assess group goals

2. The traits of successful managers according to Yntema: Ability to see and solve problems Ability to deal with people effectively Communication ability Organizational ability Persistent effort A good memory

3. Situational leadership stylesDirecting, Coaching, Supporting, and Delegating Leadership Styles

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X-Y THEORY’ QUESTIONNAIRE

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X-Y THEORY’ QUESTIONNAIRE(Continued)

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Score the statements (5 = always, 4 = mostly, 3 = often, 2 = occasionally, 1 = rarely, 0 = never)

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DOUGLAS MCGREGOR - THEORY X YDouglas McGregor, an American social psychologist, proposed his famous X-Y theory in his 1960 book 'The Human Side Of Enterprise'. Theory x and theory y are still referred to commonly in the field of management and motivation. McGregor's XY Theory remains central to organizational development, and to improving organizational culture.

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• A good leader is an effective leader, who possesses Y-Theory characteristics and understands that authority only exists to the extent where subordinates will allow it to exist. The leader has to make his subordinates believe that his subordinates are his best interests, he can maintain strengthened relationships with the informal organizations, and he makes sound decisions all the time to gain or sustain his authority.

• A good leader is a visionary leader, who is guided by principle and always helps his team take steps that are difficult in the short term but helpful in the long term. To be helpful to his team in the long term, he would educate his team and then motivate them to sacrifice in the short term in order to achieve greater benefits over the longer term.

• The best leader walks behind his subordinates and serves them in whatever way that he can as described by Lao-tzu, the ancient Chinese philosopher: “To lead the people, walk behind them.” In addition, a good lead should possess three traits according to Kazmier: intelligence, communication skill, and the ability to assess group goals.


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SITUATIONAL LEADERSHIP


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Purposes:

•Breaking In

•Developing Competence

•Gaining Commitment

Goals:

•Retaining Talent

•Reducing Turnover

•Enhancing Efficiency

•Strengthening Communications

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SITUATIONAL LEADERSHIPBreaking In

• Thinking of yourself as a supervisor instead of as a worker.o Past: Measuring how well you did your specialty.

o Now: Measuring how well you keep your team as a whole.

• Overcoming Resentmento The reasons for resentment may not always be clear or rational. (i.e.

Jealousy) o No magic formulas, but try to ask your subordinates for their advice – they

are flattered when asked. What if you solicit advice and then don’t take it?1. Reject it privately. Never embarrass a person by turning down his or her

suggestions in front of others.2. Do it diplomatically. Instead of telling them their advice is not good, ask

further questions about it. Good questions will enable them to find the weaknesses in their advice.

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SITUATIONAL LEADERSHIPBreaking In (Continued)

• What should we do to give respect to our people? o Ask for their adviceo Listen to themo Give them responsibilityo Be there for your people


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• What do we do to earn respect?

o Be good in what you doo Treat your people fairlyo Stick up for your peopleo Give your people credit

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What is Situational Leadership?

The situational leadership (theory) model is a leadership theory developed by Paul Hersey, professor

and author of the book The Situational Leader, and Ken Blanchard, leadership guru and author of The

One Minute Manager. The theory was first introduced as "Life Cycle Theory of Leadership". During

the mid-1970s, "Life Cycle Theory of Leadership" was renamed "Situational Leadership theory".

Situational Leadership II is an improved version and has been the world’s most taught leadership model

for more than 30 years. Its foundation lies in teaching leaders to diagnose the needs of an individual or a

team and then use the appropriate leadership style to respond to the needs of the person and the

situation. For individuals, teams, and whole organizations, the Situational suite of programs equips

people at all levels of your organization to lead at a higher level.

The Ken Blanchard Companies is the leading institute for leadership training

http://www.kenblanchard.com/Solutions/Situational-Leadership-Development/Situational-Leadership-II

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S3 S2

S1

High Directive and Low Supportive Behavior

S4

Low Supportive and Low Directive Behavior

High Directive and High Supportive Behavior

High Supportive and Low Directive Behavior

DEVELOPMENT LEVEL OF FOLLOWER(S)

LOW

D1HIGH MODERATE

D3D4D2

(High)

DIRECTIVE BEHAVIOR (High)(Low)

S U P P O R T I V E

B E H A V I O R

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LEVELS OF DEVELOPMENTD1

LOW COMPETENCE, HIGH COMMITMENT


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“Enthusiastic Beginner”

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ENTHUSIASTIC BEGINNER


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Development Level 1Low Competence • High Commitment

Characteristics/Needs•Recognition of enthusiasm and transferable skills•Clear goals and roles•Standards for what a good job looks like•Timelines and Priorities•Information on how data about performance will be collected and shared•Action plans-specific direction about how, when, and with whom•Boundaries and limits•Information about the goal or task and the organization•The unwritten rules on "how things work around here"•A step-by step process for learning new skills•Hands-on training-being shown and told how•Concrete examples of how others accomplish the goal or task•Opportunities to practice•Frequent feedback on results•Solutions to problems

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SOME COMPETENCE, LOW COMMITMENT


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“Disillusioned Learner”

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DISILLUSIONED LEARNER


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Development Level 2Low to Some Competence • Low Commitment

Characteristics/Needs•Clear goals•Perspective•Frequent feedback•Praise for making progress•Help in analyzing successes and failures; assurance that it is OK to make mistakes•Explanations of why the goal or task is important•Opportunities to discuss concerns and share feelings•Involvement and influence in decision making and problem solv ing•Encouragement•Advice/additional next steps/alternatives•Coaching to build and refine skills

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MODERATE TO HIGH COMPETENCE, VARIABLE COMMITMENT


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“Reluctant Contributor”(Capable, but Cautious Performer)

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RELUCTANT CONTRIBUTOR


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Development Level 3 Moderate to High Competence • Variable Commitment

Characteristics/Needs•An approachable mentor or coach•Opportunities to test ideas•Opportunities to express concerns and share feelings•Support and encouragement to develop self-reliant problem solving skills•Help in looking at experience and skills objectively, so confidence is built•Praise and recognition for high levels of competence and performance•Removal of obstacles to goal accomplishment•A kick-start to overcome procrastination

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S3 S2

S1


S4





LOW

D1HIGH MODERATE

D3D4D2

(High)


S U P P O R T I V E

B E H A V I O R

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HIGH COMPETENCE, HIGH COMMITMENT


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“Peak Performer”(Self-Reliant Achiever)

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PEAK PERFORMER


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Development Level 4 High Competence • High Commitment

Characteristics/Needs•Variety and challenge•A leader who is more of a mentor and col league than a manager•Acknowledgment of contributions•Autonomy and authority•Trust•Opportunities to share knowledge and skills with others

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DETERMINATION FOR LEVELS OF DEVELOPMENT


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Development Level Is Task Specific!

Competence Includes

Task

Knowledge

Skills

Commitment Includes

Motivation

Confidence

It is very common that one person may have different

levels of development required from different projects

or assignments.

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S3 S2

S1


S4





LOW

D1HIGH MODERATE

D3D4D2

(High)


S U P P O R T I V E

B E H A V I O R

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LEADERSHIP STYLEDIRECTING (S1)

HIGH DIRECTION, LOW SUPPORT


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• Acknowledges enthusiasm and transferable skills• Defines goals, timelines, and priorities• Defines roles, limits, and boundaries• Takes the lead in action planning and problem solving• Organizes and shares information and resources• Develops a plan for learning and practicing new skills.• Teaches and shows how• Gives examples of what a good job would look like• Checks and monitors learning frequently to give feedback

“Leader Decides”

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LEADERSHIP STYLECOACHING (S2)

HIGH DIRECTION, HIGH SUPPORT

BEN CHEN34

• Involves the individual in clarifying goals and action plans, but makes final decisions

• Listens to the individual’s concerns and ideas• Provides perspective that progress is being made• Involves the individual in problem solving and decision making• Helps the individual analyze successes and failures and consider alternatives• Gives advice and ideas; shares examples of others’ work• Provides information, resources, and coaching to continue building and

refining skills• Explains why (about what and how)• Encourages and provides frequent feedback and praise to build competence.

“Let’s Talk, Leader Decides”


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LEADERSHIP STYLESUPPORTING (S3)

LOW DIRECTION, HIGH SUPPORT


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• Encourages the individual to take the lead in goal setting, action planning, and problem solving

• Asks questions, listens to concerns, and serves as a sounding board• Facilitates self-reliant problem solving and evaluation • Asks: How can I help?• Shares expertise and collaborates when asked• Provides support, reassurance, encouragement, and praise to acknowledge

competence and build commitment• Reflects on past successes and skills to build confidence• Suggests ways to make the goal more interesting or challenging, if motivation

is low• Removes obstacles to goal accomplishment

“Let’s Talk, D3 Decides”

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LEADERSHIP STYLEDELEGATING (S4)

LOW DIRECTION, LOW SUPPORT

BEN CHEN36

• Expects the individual to take charge and keep others informed• Expects the individual to take responsibility for goal setting, action planning,

and decision making; confirms plans• Trusts the individual’s judgment• Expects the individual to evaluate his or her own work and to continually

innovate• Encourages the individual to challenge himself or herself to even higher levels

of performance• Provides opportunities to share knowledge and skills, mentor and teach others• Acknowledges, values, and rewards contributions• Provides additional resources as required

“D4 Decides”


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COMMUNICATION RULES

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The Power of Transparent CommunicationBy Meg Whitman, CEO at HP

o Start small – Tear down “commando fence”o Communicate the problem, but focus on solutionso Empower your peopleo Transparency upwards and downwards in consistency


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BE A “SUPER” SUPERVISOR!

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The Goal is a Match:

S1 D1

S2 D2

S3 D3

S4 D4

Two Types of Mismatch:Oversupervision:

S1/S2 with D3/D4Undersupervision:

S3/S4 with D1/D2

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THANK YOU FOR YOUR ATTENTION!

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Any Questions?

Please contact

Ben Chen

E-Mail: [email protected]

Cell Phone #: (Taiwan) 0905-732-723

(US) (925) 621-9101


Documents

104TPDA04036-B EMBRACING QUALITY CULTURE IN BIOPHARMACEUTICAL COMPANIES For Taiwan PDA Ben Chen, P.E. November 16, 2015