Sourcin IQPC Munich 2014

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Information about Sourcin IQPC Munich 2014
Health & Medicine

Published on March 6, 2014

Author: Sourcin1

Source: slideshare.net

Description

Sourcin IQPC presentation at Munich Feb 19-20 2014

Empowering Operations and Perfecting Compliance Technical Knowledge Management

Bespoken Instructions

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

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

Agenda 1. Single Use Ecosystem 2. Shop floor Set Up & Operations 3. Compliance 4. Case Study 5. Lessons Learnt and Conclusion

«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”

Single Use Last Decade Journey Single Use in production are pre-fabricated Units

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

Instructions at point-of-use Yet know-how and knowledge do not fully stand out from SOPs

Agenda 1. Single Use Ecosystem 2. Shop floor Set Up & Operations 3. Compliance 4. Case Study 5. Lessons Learnt and Conclusion

Set up a 50L Bioreactor S.U versus 50L Bio preparation S.S

50L Bio Single Use - courtesy of Crucell B.V.

CIP - SIP 50L Bio Stainless Steel

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

Single-Use Stainless Steel 1000L Bioreators Set up comparison time wise Courtesy of Sartorius Stedim biotech

The Last Mile: • Activities Changed • Skill Sets Changed • Logistic Changed • Risks Changed • Labor more Complex Disposables require to cope with a Shopfloor ECOSYSTEM change

Agenda 1. Single Use Ecosystem 2. Shop floor Set Up & Operations 3. Compliance 4. Case Study 5. Lessons Learnt and Conclusion

Compliance • CDER Enforcement Actions Top 20 483s FY 2012 • 44% SOP related • 11% Training related

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

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%

Agenda 1. Single Use Ecosystem 2. Shop floor Set Up & Operations 3. Compliance 4. Case Study 5. Lessons Learnt and Conclusion

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

Knowledge transfer for USP processes Solna Leiden -USP -Valerio Springhouse Key elements: -Training -Standardized Operation External -Licensees -Partners Bern -Cell & virus banking -USP -Process characterization

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

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

Video platform • Current platform: 7 applications with > 50 Mediabooks Used across different sites within Crucell Used for training of external parties as well

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

Agenda 1. Single Use Ecosystem 2. Shop floor Set Up & Operations 3. Compliance 4. Case Study 5. Lessons Learnt and Conclusion

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?

“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

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”

Thank you Expandable and language free www.sourcin.com aschmutz@sourcin.com

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