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Implement an Effective CSV Personnel Training Program | Apr 2017 | 1
Ivonne del C. Ramos Senior Quality Engineering Manager,
Validation COE Leader
Implement an Effective CSV Personnel Training Program
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• How many of you have a formal CSV Training program at your facility?
• How many of you have issues with CSV training program ?
• How many of you have audit observations due to inadequate CSV records?
• How many of you have plans to develop a new CSV training program at your facility?
Questions for the Audience
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You are in the correct place…
We can help you to implement an Effective CSV Personnel Training Program
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Course Objective & Approach
Objectives:
• Provide an overview of what is required to implement an effective CSV Personnel Training Program
Approach:
• Presentation
• Audience Interaction throughout presentation
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Creation of a CSV education and certification
program
SECTION 1
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CSV Education and Certification Program Purpose
• To ensure that authors and approvers of CSV records have the necessary knowledge to create and execute the CSV records according to established policies, procedures and regulations.
• To sustain CSV Program improvements and enhance the validation organization’s knowledge.
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What type of CSV group do you have ?
Dedicated CSV Group
OR
Shared CSV Group
What are the….
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Identify the target audience for each CSV Certification
How the target audience can be identified ?
o Need to identify possible authors and approvers for CSV records • CSV Engineers
• CSV Quality Engineers
• CSV Area Managers
• Or any other resource assigned to work on CSV !
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Structure of CSV Validation Certifications
STEP 1 – Define what type of learning do you want ?
Conceptual and scenario-based eLearning
Initial training
Refresher training
How-to videos or eLearning
Instructor-led presentations
Instructor-led classroom exercises/workshops
Knowledge checks and quizzes
Certification tests
Work instructions and procedures
Quick reference guides
Peer-to-peer learning, on-the-job training, social media, learning communities
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Structure of CSV Education Certifications
STEP 2 – Define certification levels
• CSV Fundamentals – Level 1
• CSV Fundamentals Proficiency – Level 2
• CSV Annual Refresher
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Certification Level Recommended Content Training Type
CSV Fundamentals – Level 1 • CSV Validation Policy • CSV Validation Procedures • CSV Principles • CSV Workshop
R & A R & A IL IL + Hands on
CSV Fundamentals Proficiency - Level 2
• Comprehensive Test to challenge • Procedure Knowledge • Procedure Execution • Do’s and Don’ts
E-learning
CSV Annual Refresher • CSV Fundamentals- Level 1 (deployed after 1 year)
Combination of e-learning and a test depending on updated course content
Certification Content
Legend : • R&A – Read and Acknowledge • IL – Instructor Led • E-learning – e-module assigned in Learning Management System • Hands-on – Real exercise of creating a CSV Document
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• Communication is important !
• Management needs to understand the goals / expectation of the CSV education and certification program to provide support and requested funding !
Communicate Goals/ Expectations
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Certifications and Training Development/
Deployment
SECTION 2
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You already decided the certifications to be created…
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Creation of Training Materials
• Based on employees learning needs and not on what’s easy for your trainers.
• Directly related to your learning objectives • Consider Adult Learning Principles
• Come to training with a lifetime of existing knowledge, experience, and opinions
• Are goal-oriented • Want training that is relevant • Want training that is task-oriented • Learn when they see “what’s in it for them” • Want to be and feel respected
Elements to consider
• Learning Needs
• Opportunity for feedback
• Related to learning objectives • Break training materials into small chunks – easier to be understood
• Based on Audit Learning Principles (experienced, goal oriented, what’s in it for me, relevant)
• Order your chunks in a logical manner
• Inclusion of hands on examples • Consider the use of “blended learning” – training in different formats
• Allowance of trainees to have extensive participation (No monologue!)
• Regulatory or Audit Observations
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PROs / CONs
Selection of deployment method for training process
Training deployment type
+ -
R & A • Individual pace • Easy to assign • Acceptable for general knowledge
Not enough for significant changes.
IL • Direct • Allows feedback • Highly recommended for specific
knowledge
Time consuming
E-learning • Individual pace • Effective when learning checks are
included.
Preparation, Cost and deployment at LMS.
IL + workshops • Direct • Immediate results are observed • Highly recommended to confirm
proficiency
Time consuming Preparation & Cost
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• Intended Use
• User requirements
• Functional requirements
• Creating CSV Stand Alone records
• Testing – how to create testing according to intended use / requirements.
• Traceability Matrix
• Objective Evidence
• Good Documentation practices
• Software type requirements
Topics to consider for CSV ( not all inclusive)
Definition and Importance
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• Can anyone be a trainer ?
Selection of Trainers
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• A command of the material.
o A good trainer knows the material, lives it, breathes it, and can infuse their own experience into it.
• Preparation and practice.
o A good trainer makes delivering a class look easy and seamless.
• Rhythm and energy
o A great trainer is attuned to his or her own energy level and that of the class.
Trainers qualities
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• Allow and encourage participants to learn from themselves
o There is a wealth of knowledge in the classroom, use it !
• Love for what they do
o Passion drives all !
Trainers qualities
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• How I can develop excellent trainers ?
Train the Trainers Program
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• Prepare participants to analyze their audiences and tailor materials
• Provides tactics for handling surprise situations and difficult participants.
• Provides best practices for engaging learners and encouraging discussion.
• Provide emphasis to the 5 steps learning method : o Discuss what they may already know.
o Describe the new content.
o Demonstrate how to perform key skills.
o Drill them by conducting a learning activity.
o Debrief what they learned.
Train the Trainers Program
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What to do if people are not trained according to
the certification program requirements?
SECTION 3
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• You are just starting with the education and certification process.
• Your people needs to continue creating and approving CVS records.
• What can you put in place to mitigate that your people is not still proficient in CSV ?
What would you do?
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• What is an Independent Review process?
o It is a mitigation that allows to conduct validation activities while the authors and approved of CSV records are trained according to the validation certifications created.
o Is a review performed by a qualified independent resource to ensure that validation records are accurate, complete and compliant.
Establishment of an Independent Review process
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• Creation of checklists
o Include all the criteria to be considered to ensure having stand alone, compliant and adequate documents.
o Checklist are used by an Independent Reviewer to document all the observations found during the review.
o The author should use the checklists to create the documents for avoidance of non compliant records.
How the Independent Review process is performed?
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• Creation of checklists
o The author/approvers need to ensure that observations found are addressed prior to final approval.
o Data obtained from the checklist can be used for : • Targeting common issues and define action plans
• Create metrics to verify documents adequacy
• Reinforce some training areas
How the Independent Review process is performed?
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Develop CSV training effectiveness
SECTION 4
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Who needs a CSV training effectiveness process?
All of us !
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Definition of CSV Training Effectiveness Strategy
• Training effectiveness strategy
o Sample CVS records • Create an effectiveness checklist
• Define evaluation criteria ( Critical, Major, Minor defects)
• Evaluate records against the effectiveness checklist
• Summarize results
– Check if issues are the same prior to the establishment of the CSV Education and Certification Program
» If so, something is wrong…
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Example of an effectiveness checklist
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• Now, you have some results about your CSV records…and they are not as expected.
Handling Training Effectiveness Failures
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Handling Training Effectiveness Failures
• Define action plan
o 1:1 Interview with impacted personnel • Additional Training needed?
• Different Trainer needed?
• CSV Training materials inadequate?
• CSV Procedures inadequate?
o Perform re-training
o Repeat Proficiency Test
o Repeat the effectiveness strategy
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• Create a metric for effectiveness process.
• Share results with Management.
• Evaluate CSV records adequacy through time to determine if improvements are observed.
Measuring effectiveness
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Thanks !