Eisai
Production Operations
Employee Development
Solid
Dose 101
Production Operations Employee Development
Safety
Creating and Transferring Knowledge…
Pharma
Work
GMP
…for the manufacturing of products that
benefit both patients and their families.
Employee Development Model
Recruiting
Skills/
Training
Development
Compensation
Performance
Management
Organizational Systems
Job Specific
Technical Knowledge
and Skills Competency
Production
Operations
Specific
Integrity
Personal Effectiveness
Competency
Quality
(GMP)
Respect
Core
Business
Application
EHS
Foundational
Professionalism
Required
Competency (GMP/EHS)
Quality
Teamwork
Why did we develop this program?
 Employee Survey Results
 Meet our Future Business Needs
 Remain Globally Competitive
Project Management Proposal
July 19, 2006
Employee Survey Results
 Rewards of work survey conducted
• 85% Response Rate
 Areas Employees Not Satisfied:
Project
Management
 Pay
Process
Proposal
 Talent & Performance Management
 Career Opportunities
July 19, 2006
How do we know if we are getting
returns on our investments ?
• Quality Improvements
• Reduced Turnover
• Improved Employee
Satisfaction
• Highly Productive and
Knowledgeable Workforce
How We Got From….
Now
Then
Then
 Why do my co-workers get paid more or the same as me
and I have more knowledge and do more?
 Is there a way to have a more objective method to
measure skills, knowledge and performance?
 What is required to move to the next position?
 How can we get more training?
Program Objectives
Employees are paid based on knowledge, skills and
performance.
Employees know what is expected of them in their current
position.
Employees know what it takes to move to the next position.
Employees have individual development plan.
Career Ladder
Technicians and Team Leads
Team Leads
Proficient
Mastery
3
3P
3M
2
2P
2M
1
1P
1M
Technicians
Proficient
Mastery
3
3W
3P
3M
2
2W
2P
2M
1
1W
1P
Levels
Levels
Level Progression
Working
Knowledge
1M
Skill Step Progression
Groups Included: Manufacturing,
Packaging, Mechanics
Project Process
3. Competencies Mapped
(skills/knowledge defined)
1. Career Ladder
Qualification/Assessment
Documents Developed
Employees Assessed/
Mapped to Level & Pay
2. Data Gather for Task Analysis
Job Descriptions (written/evaluation/pay scale)
Learning Plan
Learning Resources Made Available
Data Gather
Task Analysis
ACTIVITY
TASKS/STEPS
EQUIP’T /
TOOLS/
DOCS
KNOWLEDGE /
SKILLS /
ATTITUDE
PERFORMANCE
EXPECTATION
S
PERFORMANCE
MEASUREMEN
T
LEARNING
(Knowledg
e transfer)
Line A
Operate Palace
Bottle
Unscrambl
er

Turn on/off
Main power

Start/Stop
equipment

Correctly
identify
cases

Load
bottles into
hopper

Turn on/off
air supply

Monitor
component
flow

Reload
component
s
SOP #PK88
GMP’s
Line overview
Location,
purpose of
equipment
component
s
Basic equipment
operation
HMI screens and
equipment
controls
Able to keep
equipment
operating 100%
Able to perform
changeovers
without
assistance,
according to
SOPs, and
within a specified
time
Able to clean
equipment and
work areas
according to
SOPs
Line efficiencies as
measured by
throughput
# completed batches
Presentation/De
moTransfer
skills = OJT
with use of
references
(20 hrs. Filler,
Labeler; 5
hrs. other
units)
Reinforce
concepts
/practice
skills =
Hands on
with trainer
feedback
and
explanation
Mapping to the Job Description
Major
Activities
Tasks/Steps
Competency Grouping
Working
Knowledge
Proficient
Mastery
Equipment Operation
X
X
X
Clean Equipment
X
X
X
Changeover
X
X
X
Competencies
Write policies and procedures for equipment
X (Level 3)
Training others on equipment
Troubleshooting
X)
Adjustments requiring physical intervention, I.e.,
changing codes, adjusting PE’s, etc.
Inspection
X
X
X
X
X
X (Level 2
and above)
X
X
X
Competencies
Competencies
Working
Knowledge
Proficient
Mastery
Equipment Operation
X
X
X
Clean Equipment
X
X
X
Changeover
X
X
X
Write policies and
procedures for equipment
X (Level 3)
Training others on
equipment
Troubleshooting
X)
Adjustments requiring
physical intervention, I.e.,
changing codes, adjusting
PE’s, etc.
Inspection
Performance Levels
X
X
X
X
X
X (Level 2 and
above)
X
X
X
Mastery (M)
Packaging
Position Chart
Assessments
Develop Assessment
Skill Assessments
Skill Assessment
Qualification Process
Course
Module 1
(ie Cleaning)
Module 2
Module 3
Module
Delivered
(Classroom
/Online/
Self Study)
Module
Delivered
(0nline
Classroom
Self Study
Module
Delivered
(0nline/
Classroom
Self Study)
Knowledge
Check
OJT
Performance
Evaluated
Knowledge
Check
OJT
Performance
Evaluated
Knowledge
Check
OJT
Performance
Evaluated
Qualified
Qualification
Pay and
Progression
System End
Results
Training
Opportunities
Levels
Competencies
Level
III
4 lines
Same as Level II Competencies
In addition to:
Training Administration; Presentation
Leadership/Mentoring
Advanced Troubleshooting (Mechanics
Skills)
Document Revisions/Writing
EHS Certification
SAP Investigations
Maintain PI Sheets
Level II
3 lines
Same as Level I Competencies
In addition to:
Documentation Review
SAP
MS Word/Excel
Perform carry over
Pull and Verify Samples
Level I
2 lines
Line Operations
Proper Documentation Practices
Training other employees on
Equipment
Computer (Windows, e-mail, eLLIE
(SOP Reading; Online Training)
GMP Knowledge
Proper Documentation Practices
Team Player
Communication
Line Supply
TRAINING PROVIDED
Shutdown Training
– Public Speaking
– On-the-Job Training
– Mechanical Skills
– Solid Dose Overview
– Technical Writing
Onsite Training
– Microsoft Word, Excel,
PowerPoint
– Deliberate Documentation
Knowledge Space
SIMULATION - MANUFACTURING
Screen shot to be added
COMPUTER BASED COURSES - SAFETY
Team Training
The right pieces … for
Performance
Competencies
Career Ladder
Skills/
Knowledge
Training
Business Impact
• Quality Improvements
• Reduced Turnover
• Improved Employee
Satisfaction
• Highly Productive and
Knowledgeable Workforce
Program Check In
Focus Group Feedback
 Pace
 Revaluate timing (ie pay increase 3 mos., 6
mos?)
 Training
 Limited due to staff
 Pay
 Market Analysis
 Make Lead Pay and Level/Step Info Public
Management Response
Action: Will not change pace at this time. Program
is new; difficult to change without sufficient data.
ACTION: Provide additional training options:
 Micro sampling (environment / water)
 Instrument calibration
 Cleaning validation (swab sampling)
Options will continue to expand based on business opportunities, (e.g.,
in-process lab)
ACTION: Hire temps to provide opportunity for our
full time regular employees to train in other areas.
ACTION: Add wage information for Manufacturing,
Packaging, Leads and Mechanics to Public Drive
ACTION: Annual Survey of Industry Wages
Learnings
 Successes
 Vice President Support
 Employees involved at each step
 “Pull” by employees for training
 Interest in expanding programs to other areas
 Challenges
 Ability to rotate based on business needs
 Adding additional training modules
QUESTIONS