Designing a Sustainable Training and Compliance Program The Roadmap.
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Transcript of Designing a Sustainable Training and Compliance Program The Roadmap.
Designing a Sustainable Training and Compliance Program
The Roadmap
Agenda: Leaders in Life Sciences LearningLeaders in Life Sciences Learning
• 9:00 – 9:30 Breakfast and networking• 9:30 – 11:00 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 • 11:15 – 11:30 Break• 11:30 – 12:00 Company presentation/case study• 12:00 – 12:30 Regulatory update• 12:30 – 13:30 Lunch• 13:30 – 15:30 User Group• 15:30 – 16:00 Open discussion, concluding remarks and adjournment
The Road to Compliance and Training Success
• 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?
striving for compliance.
But, the road does not end there…
The road starts with …
Knowledge Solutions that Assure Compliance and Improve Business Performance
How can you and your company develop the long-term plan to Improve Business Performance?
• Performance issues impact product quality
• Difficulty with new hire induction
• Unable to easily track training history by employee
• Unqualified personnel operating complex equipment
• Managing External Training
• “Stigma” of compliance training
• Global Training Challenges
Business Challenges• Too much paper – heavy
administrative burden
• Unable to keep up with ever-changing regulatory requirements
• Lack of conformance to Internal Policies/Procedures
• How to validate delivery & understanding of critical Information
• How to make training engaging
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
• 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
SME Qualification
Characteristics No Assessment Training + KTA Training + SDA Qualification across relevant SOPs
Level Low High
KTA: Knowledge Transfer AssessmentSDA: Skill Demonstration Assessment
Consider different learning styles
Appropriate Training, Materials & Instructors
• Instructors- Use SMEs
- Knowledgable
- Skilled Communicators
- Qualified & Current
• Materials- Well Developed
- Native Language
- Interesting & Varied
• Training- Analyse task / skill
- Break down into discrete steps
- Train each step
- Blend different methods. (OJT, Classroom, Online)
Training must be effectiveappropriate metrics, feedback, surveys
Training Function is THE Hub
Training Drivers Cultural, Strategic, Legislative, Personal
Customer Groups
Individual, Organisational
End UserYour organizations customers benefit from improved product quality, and efficacy
Monitor, Adjust & Change
• 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 ROLESROLES Based Training Formula
Company Level
Company Level
Location Level
Location Level
DeptLevelDeptLevel
RoleLevelRoleLevel
HR, Legal, Corporate
Facility-Specific (EH&S)
SOP, Departmental P&P
SOP, Job-Specific
R R eview your training matrix
O O rganize training into Curricula
L L everage User Groups
E E mploy Recurring Assignments
S S ystem Maintenance
RROLESOLES: Review Your Training Matrix
• 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
RROOLESLES: : OOrganize Training into Curricula
• Manageable Size• Curriculum Types• Due Dates / Retraining Periods• Sequencing• Define your process for maintaining curricula
ROROLLESES: 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
ROLROLEESS: Employ Recurring Assignments
Recurring Assignment
Role-Based User Groups Role-Based Curricula
Company Level
Location Level
DeptLevel
RoleLevel
ROLEROLESS : System Maintenance
• 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
ROLESROLES: 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
• Administrative Volume• Quantify your level of effort• Identify gaps with manual processes• Compliance Risk• Level of Visibility• Turn-around Time• Overhead Cost• Price
Value Add
• 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
Tools for Optimization
Best Practice• HRIS - Synchronizing user profile information• EDMS - Synchronizing training content• MES - Compliance Status Verification
EFFICIENCIES GAINED
Reduced risk of non-compliance
Reduced Administration
Reduction in Human Error
Data Integrity
IMPROVEMENTS
Documented objective training requirements
Documented objective non-ambiguous evidence of training / qualification
Consistent implementation of training requirements across roles
Proactive, not Reactive
Global Visibility
Sophistication of Implementation &Scope of Business Needs
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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
View TrendingData
Drill Down to Lower Org
levels
Measure your compliance
goals
Drill Down to View Users
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