Presentation Title Here

Report
Designing a Sustainable
Training and Compliance Program
The Roadmap
Agenda: Leaders in Life Sciences Learning
• 9:00 – 9:30
• 9:30 – 11:00
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11:15 – 11:30
11:30 – 12:00
12:00 – 12:30
12:30 – 13:30
13:30 – 15:30
15:30 – 16:00
Breakfast and networking
Building and Implementing a quality and compliance
learning programme
- Elements of a sustainable & scalable programme
- Role-based training formula
- Optimisation through integrations
- Meeting goals: metrics, dashboards, reporting
- Best practices
Break
Company presentation/case study
Regulatory update
Lunch
User Group
Open discussion, concluding remarks and adjournment
The Road to Compliance and Training Success
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Do you feel that you have a plan?
Does it have many spokes or is the road straight and clearly defined?
How do you measure success?
The road starts with …
striving for compliance.
But, the road does not end there…
Knowledge Solutions that Assure Compliance
and Improve Business Performance
How can you and your company
develop the long-term plan to
Improve Business Performance?
Business Challenges
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Too much paper – heavy
administrative burden
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Performance issues impact
product quality
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Unable to keep up with everchanging regulatory
requirements
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Difficulty with new hire induction
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Unable to easily track training
history by employee
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Lack of conformance to Internal
Policies/Procedures
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Unqualified personnel operating
complex equipment
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How to validate delivery &
understanding of critical
Information
•
Managing External Training
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“Stigma” of compliance training
How to make training engaging
•
Global Training Challenges
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Key considerations for success
• What is driving the programme? Corporate initiative or regulatory action?
• Have the executive sponsors support the initiative?
• Do you understand your users and corporate culture?
• Have you assessed your organisational structure and role-based training
requirements
• How quickly to adopt new programme elements?
- Speed of change, appetite for change
• How to measure, report and manage progress and risk
• What is your strategy for keeping the programme valid and applicable
You’ve got to have a plan …
• Know your objective
• Plan your route
• Assess the risks
• Avoid traffic chaos
• Don’t get distracted
• Good documentation
• Technology helps
Aligning with Organisational Objectives
• Pro-active approach
• Agreed & Documented
- High level guiding principles
- Working level procedures
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Objectives
Training standards
Consistency throughout
Timely maintained
Prioritise Training
• Based on need
• Analyse the risk to the
organisation
• Identify critical factors
-People
-Tasks
• Quantify impact
• Timely delivery
• Invest more in highest
priorities
Lessons from Toyota
• Failure to identify root cause
• Failure to recognise trends in "adverse events"
• Failure to employ policies and procedures to enable rapid ow
of critical information across the organisation
• Failure to adapt to working, learning + cultural conditions of
global enterprise
• Failure to provide regulators with full and accurate safety
records and complaint history
• Failure to manage quality of supplier products
• Failure to recognise the impact of rapid growth on corporate
culture
Training Complexity
Kind of
Training
Awareness
Structured &
Tested
Qualification
Characteristics
No Assessment
Training + KTA
Training + SDA
Level
Low
KTA: Knowledge Transfer Assessment
SDA: Skill Demonstration Assessment
SME
Qualification
Qualification
across relevant
SOPs
High
Consider different learning styles
Appropriate Training, Materials & Instructors
• Training
- Analyse task / skill
- Break down into discrete steps
- Train each step
- Blend different methods. (OJT,
Classroom, Online)
• Instructors
- Use SMEs
- Knowledgable
- Skilled Communicators
- Qualified & Current
Training must be effective
appropriate metrics, feedback, surveys
• Materials
- Well Developed
- Native Language
- Interesting & Varied
Training Function is THE Hub
Training Drivers
Customer
Groups
Cultural,
Strategic,
Legislative,
Personal
Individual,
Organisational
End User
Your organizations customers benefit from
improved product quality, and efficacy
Monitor, Adjust & Change
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Effectiveness should be monitored
Regulatory advice – track operator errors
Modify materials as needed
Feedback from trainees
Trained personnel should demonstrate improved
performance
• Change training in good time
Documentation
• All aspects of training to be documented
• Version & Change Control
• Meet needs of Org & External Audit
Efficient & Cost Effective
• Minimize waste
• Measure ROI
• Demonstrate Value to Organisation
Working Together
• Management Stakeholders
- Set clear expectations
- Support appropriate training methods (OJT, Classroom, On-line)
• Trainers
- Resources, time, investment
- Development of training materials
• Trainees (learners)
- Required to perform task post training
- Require efficient use of their time
- Require effective training
- Provide dedication and commitment
These groups must work towards a common goal
Senior Management Support
• Critical Success Factor
• Management Provide
- Resources
- Time
- Personnel
- Funding
• Training is an investment in the future
Developing Your
Learning Culture
Visibility to Learning in an Organization
The ROLES Based Training Formula
Company
Level
R eview your training matrix
O rganize training into Curricula
L everage User Groups
E mploy Recurring Assignments
S ystem Maintenance
HR, Legal, Corporate
Location
Level
Facility-Specific (EH&S)
Dept
Level
SOP, Departmental
P&P
Role
Level
SOP, JobSpecific
ROLES: Review Your Training Matrix
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Review what you have now (be honest)
Determine what is missing
Perform a risk based analysis
Start slow and build with consistency
Build your internal processes
ROLES: Organize Training into Curricula
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Manageable Size
Curriculum Types
Due Dates / Retraining Periods
Sequencing
Define your process for maintaining curricula
ROLES: Leverage User Groups
• User Groups are “Containers” for users
• Use Custom Field values as automated membership criteria
• Use Suggested Membership for cross-training and developmental
assignments
• Use Group Types for cataloging of User Groups and for creating
hierarchical arrangements of your Groups
ROLES: Employ Recurring Assignments
Role-Based User Groups
Role-Based Curricula
Location
Level
Company
Level
Dept
Level
Role
Level
Recurring Assignment
ROLES : System Maintenance
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Standardize nomenclature and other meta data
Create an assign Security Roles as appropriate
Decentralize system administration where and how it is appropriate
Monitor the system through standardized reporting
Maintain control of data entry and system usage through documented
procedures and monitoring
-Users, Training Items, Curricula, User Groups
• This is an exercise in continuous improvement
• There may be on-going consolidation and refinement opportunities
ROLES: Training Metrics
Refining Your Training Program – Continuous Improvement
• Audit and Maintain your System
- Process, Process, Process!!!
- Garbage In = Garbage Out!
• Periodic Needs Analysis
- Maintain the Accuracy of your Training Matrix
• Keep your Training Materials Fresh
• Expand your Program to Other High Risk Areas
- Clinical Trials
- Supply Chain
- Other Plants, Locations, Divisions, Business Units, etc.
Optimizing Your
Training System
Optimization Driving Forces
Baseline Value
Value Add
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• Administration Reduction
• Automate Data-Entry through
Interoperability with Internal Systems
• Increase sustainability & longevity
• Reduce Compliance Risk
• Develop long-term relationships with
training recipients
• Increase customer satisfaction
Administrative Volume
Quantify your level of effort
Identify gaps with manual processes
Compliance Risk
Level of Visibility
Turn-around Time
Overhead Cost
Price
Tools for Optimization
Best Practice
• HRIS - Synchronizing user profile information
• EDMS - Synchronizing training content
• MES - Compliance Status Verification
IMPROVEMENTS
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Documented
objective training
requirements
Documented
objective nonambiguous evidence
of training /
qualification
Consistent
implementation of
training requirements
across roles
Proactive, not
Reactive
Managing Organisational Behavior and Performance
Dashboards & Metrics
Resource
Planning
CV Builder
Targeted Content
(Visual Job Aides,
CBT…)
Web Portal
Integrations
MES & Other
Integrations
Improved efficiency and value Added Return on Investment
Global Visibility
Self Registration
EDMS Integration
HRIS Integration
Base Implementation
ComplianceWire
(with Dynamic Dates, CICS,
Quiz Creator, Forms)
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Extended Reach
Biometrics & Single
Sign On (SSO)
EFFICIENCIES GAINED
Training Matrix &
Recurring Assignments
Sophistication of Implementation &
Scope of Business Needs
Reduced risk of noncompliance
Reduced
Administration
Reduction in Human
Error
Data Integrity
Professional Development Program
Your Development Journey
My Development Progress
My
Development
Planning
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Metrics & Reporting:
Communicating to
Executive Management
Executive Management: Communications
• Metrics / Reporting must be:
- Clear – Presented in a manner that is self explanatory
- Concise – Summary level information with detail as a backup
- Reliable – Information must be generated in a consistent fashion
- Timely – so that trend changes are quickly identified
- Actionable – Management must be able to make business decisions based upon this
information!
Management Dashboards: Clear
• This dashboard view lets management know that their company wide
compliance status is currently 100%.
• It also provides them with a minimum and optimum compliance ranges
• It lets them know the total number of users who are in compliance, at risk,
and/or not in compliance with regard to their assigned training
Management Reporting: Clear
• With this User Qualification Summary Report, management is able to
quickly understand the level of compliance within their organization.
• In this example, individuals within the quality department who are at risk
and / or who are currently out of compliance are designated by the colors
red and yellow.
• Fully qualified individuals are designated by the color green
Management Dashboards: Concise
• Management also needs the ability to access summary level
information such that users who are at risk or out of compliance
can be quickly identified
• Detailed level information can be accessed by clicking on each
user column under the heading of “In Compliance”, “At Risk” or
“Out of Compliance”
Management Reporting: Concise
• Management also needs the ability to access summary level information in report
form.
• The ability to create report queries that can be rerun on demand fulfills the need
for this type of management reporting
• Additionally, these reports can either be printed and or downloaded into an excel
file for further analysis
• This particular saved completions report will generate one year’s worth of training
and equivalent completions for all enabled users
Management Dashboards: Timely
• This dashboard view allows management to quickly view
historical compliance status information so that negative
trends can be quickly identified and reversed.
Management Dashboards: Reliable
The KE Learning Management System (LMS) is validated and
must therefore produce information that is:
- Dependable: Worthy of reliance of trust
- Authentic: Conforming to a fact or set of facts
- Consistent: Capable of being reproduced
- Reproducible: Capable of creating a copy or producing an equivalent
Management Dashboards: Actionable
• Management is able to quickly make decisions based
upon the information presented in the dashboard because
it is clear, concise, timely, reliable, and most
importantly…ACTIONABLE!
Metrics: Pulling It All Together
Measure your
compliance
goals
Printable
format
View Trending
Data
Drill Down to
View Users
Drill Down to
Lower Org
levels

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