Best Practices Components of an Effective QSR/GMP Training Program · Best Practices Components of...
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Best Practices Components of an Effective QSR/GMP Training Program
Dave Peterson, Director, GMP & Quality Systems
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Objectives for this session:
To identify and share industry best practices for employee training‘Share’ means group participation as well
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Why look at ‘Best Practices?’
Because regulators often look at industry best practices to set the bar of expectation.
Often the case with many processes
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There shall be written procedures describing…
Establish a process hierarchyHigh level Corporate SOP – Policies and Principles
Company training policies for all sitesEnsures consistency, QSIT Inspections start here
Site level SOPs (Flowcharts)Applications may vary
Training level SOPTraining processes, methods, Needs Analysis
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A brief look at Needs Analysis
• Flow
• Is training part of the solution?• Why-why-why analysis• Case study – batch record errors (DHR)• Keep your ear to the ground
Requirements…Problems…Performance…Opportunity
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Roles and Responsibilities Who’s minding the store?
• Senior management- Set policies, provide adequate resources – incl. staffing
• Line management- Assure employees are qualified- Those not fully qualified are supervised (mentored)
• Trainers- Provide methods/techniques, facilitate
• Employee obligation to acquire SKAs
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Curriculum-driven approach
Each GMP/QSR position (role) has a training planQualification Curriculum – list of training itemsLearning sequence is importantMore to come later today
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OJT Methodology – TTT – Train the Trainer
For job specific tasks – written instructions1) I show you how and you observe me2) You show me back and I’ll observe and give you feedback3) You show me working independently4) Evaluate w/ success criteria
Useful for SMEs as a process
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Competency Evaluation
Absolutely expectedHow else do you know if successful?Many ways to measure -
- Test knowledge, demo skills, games, - simulations, etc.
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SOP Training
Among most widely used, but least successfulMost SOPs are simply text, read and understandGet creativeBring to some kind of applicationEstablish multiple levels of ‘need’Approved, train, then EffectiveExamples? Best approaches?
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Refresher vs. Ongoing
RefresherPeriodically repeat earlier training items (GMPs) where helpful Change up the venues, make it fun, ex. Jeopardy games, challenges,
humorous videos ,,,‘Re-qualify’ at defined intervals
Continuous, ongoing learningCompliance trends, awarenessNew regs, new applications, procedure changes, new systems…
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Change Control
Training materials should be version controlled, 1.0 vs 1.01 Documents, CBTs, ppts., classroom outlines/contentTraining items in your LMS, esp. SOPsCurriculaCan establish what the item was
historicallyCan have legal implications
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Contractors, temporary staff
ID a specific limited curriculum for each roleInclude:
Basic GMPs,Company policiesProcedures, OJT, and evaluation
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Documentation, Reporting outcomes
Paper-based system is minimally acceptableElectronic databases (LMS) preferredManage and MonitorReport progress to Mgmt.Summarize results in standard reportsRecords retention
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Onboarding new employees
Typically, classroom face to face discussionPre-requisite: complete CBTs as prepCover Co. policies and HR practicesReinforce corporate culture, ethics, conductMeet senior managers Move on to department training plans, OJT
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Quality Oversight QTraining system should have Quality review and approvalTraining departments can be decentralizedQuality = Ownership of the entire GMP training process, not HRQuality’s role is to view success at 50k levelCan provide valuable insight in to the training needs in manufacturing and development
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Is operator qualified on this equipment?
MES
Complete Training Matrix (role and resource based curricula)
LMS determines if the operator is qualified.
ComplianceWire
Grant Access
Yes
No
Operator prompted to train LMS provides applicable training Just in Time
Biometric Operator Login
Operator completes training
Yes
No
Supervisor is notified
Prevent Access
EDMS
Instructor LedReal time biometric attendance capture stand-up training
Real time on current SOPs
ComplianceWire & Manufacturing Control – Case study