3. Learning pathway
Knowledge definition*
The psychological result of perception,
learning and reasoning
• Something you have observed
• That you have interpreted and stored
• That you can apply to future situations
*Webster
4. How we work
Storyboard
• Transfer the full actual instructions into a synopsis of operations
• Customer project team approval
Capture
• Video capture on-site
• Selection of key steps
Project
• Organize the procedure relevant information
• Project Mediabooks
Libraries
• Released Mediabooks
• SOPs, Specimens, Warnings & Symbols Publishing
• Simplifying update and revision exercise
6. «Production blog»
• Paradigm changes: Single-use, global operations, flexibility…
• “Disposables do not come with instruction manuals; you have
to figure out yourself how to make them work in your specific
context.”
• “ Operations in modern stainless steel plants do not have
extensive manual skills therefore a considerable amount of
retraining is required (even for experienced operators) to
provide reproducible, accurate and compliant operations.”
• “Since operations are more manual they are highly susceptible
to operator-to-operator variation.”
• “Balance cost and compliance”
7. Single Use Last Decade Journey
Single Use in production are pre-fabricated Units
8. On-The-Job: Successful model…
IKEA
could never achieve such a lowcost position if
customers did not agree to take on some of the
tasks usually performed by manufacturers and
retailers, such as delivering furniture to their
homes and assembling it.
Jérôme Barthélemy: (Excerpts) FALL 2006 MIT SLOAN
MANAGEMENT REVIEW
Single Use is changing personnel daily life
14. Benchmark activities with Mediabooks
• Single Use activities
• Stainless Steel
– Deliver at point of use,
– Gaskets/ Seals
– Unpacking and check
– Valves & Air Filters connections
– Installation
– Sensors
– Inflation
– SIP CIP
– Sensors and fluids
connections
– Run
– Run
16. The Last Mile:
•
Activities Changed
•
Skill Sets Changed
•
Logistic Changed
•
Risks Changed
•
Labor more Complex
Disposables require to cope with a
Shopfloor ECOSYSTEM change
19. Top 20 Inspectional Observations CDER
Training related 483 citations
DRUGS
483 FY citations analysis
Training-operations, GMPs, written procedures
GMP Training Frequency
Training, Education, Experience overall
Supervisor Training/Education/Experience
# Total Training citations in top 20
% training citations in top 20
FY
21 CFR 211.25(a)
21 CFR 211.25(a)
21 CFR 211.25(a)
21 CFR 211.25(b)
2006
rank
freq
9 60.00
23 38.00
62 16.00
77 13.00
60.00
4.75%
2012
rank Freq
8 65.00
13 54.00
19 44.00
97
9.00
163.00
11.31%
How to ensure the training translate into less deviation and more
efficient processes?
«Retrain is not doing better»
FDA White Paper: March 2011
How To Reduce Human Error By Managing Human Factors White Paper
20. Top 10 Inspectional Observations – CDER
SOP related 483 citations
2006
Procedures not in
21 CFR 211.22(d)
Responsibilities of
1 127
writing/ fully followed quality control unit
Absence of Written
Production and
21 CFR 211.100(a)
5
83
Process Controls
Procedures
Written procedures
21 CFR 211.67(b)
Cleaning and
not established/
10 54
Maintenance
followed
Production and
SOPs not followed /
21 CFR 211.100(b)
6
82
Process Controls
documented
346
# Total SOPs related out of top 10 citations
42.51%
2007
2008
2009
2010
2011
2012
1
150
1
112
1
157
1
165
1
201 1 169
7
62
7
52
6
75
6
89
2
128 3 116
10
52
9
43
9
64
7
80
7
89
5
72
5
58
4
81
2
115
6
89 10 64
336
43.75%
265
43.09%
377
45.53%
449
46.72%
How to ensure the instructions pertained in SOPs are fully
understood and performed on a daily basis?
Augment ownership of operations?
507
46.99%
7
73
422
44.70%
22. Minimizing variability in process operations
using knowledge management platform
Herman van Herk
Scientist USP
Vaccine Process and Analytical Development
Archimedesweg 4-6
PO Box 2048
2301 CA Leiden
The Netherlands
Tel: +31 (0)71 519 9197
Email: hvanher@its.jnj.com
24. Training & standardized operation
• Training on a process, is dependent on factors like...
– Quality of procedures
– Know-how of trainer/trainee
– Scattered information
• Standardized operations
– Without a standard,
there can be no improvement
Sources: http://www.shmula.com
25. Project Sequence of Events
• Exploratory discussions and NDA
• Detailed definition of scope of work:
– Exchange of existing procedures
– Definition of ‘script’
• Detailed discussions on procedures
– Need for alignment how things should be done
• Video recording ‘as is’
– multi-angle video shooting
• Review of draft videos and finalize
• Finalization in Mediabook platform
26.
27. Video platform
• Current platform:
7 applications with > 50 Mediabooks
Used across different sites within Crucell
Used for training of external parties as well
28. Conclusion
• Multi-media tools help to:
• Learn from each other and analyze
• Show what cannot be written
• Train by reviewing key steps at its own pace
For Crucell, it is a strong tool for both training and
standardization of USP processes
30. Lessons Learnt and Questions
1. SOPs: Classrooms – Hands-on
Training efficacy?
Sole training material ?
2. «Retrain is not doing better»
FDA White Paper: March 2011
How To Reduce Human Error By Managing Human
Factors
3. Resources:
– Experts / Trainers availability
– Mentoring & Learn-by-peers
– On-the-Job
4.
Deviation costs avoidable?
Back to the roots?
31. “Flip the Classroom”
Assign «Lectures» as Homework:
Watch contextualized operations prior to hands-on sessions
i.
Start, Pause, Replay, without fearing interrupting
ii.
Free up Expert time
Hands-on sessions
i. Efficient vs time and costs
ii. Minimize risk on production lines
Optimize skill sets
i.
On-the-job assistance
ii. Mentoring, learn by peer
32. Conclusion
Compliance & Cost control
First Hand Reference Tutorials
Efficient documentation process
Less deviations
Expandable
Coordination
Irrespective of language
“Watch it and do it”
Empower Personnel: Move from “certainty” to “routine dexterity”
