Sourcin IQPC Munich 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

NDA

Agenda

1. Single Use Ecosystem

2. Shop floor Set Up & Operations

3. Compliance

4. Case Study

5. Lessons Learnt and Conclusion

1. Single Use Ecosystem

«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– Deliver at point of use,

– Unpacking and check

– Installation

– Inflation

– Sensors and fluids

connections

– Run

• Stainless Steel– Gaskets/ Seals

– Valves & Air Filters connections

– Sensors

– SIP CIP

– Run

1000L Bioreators Set up comparison time wiseCourtesy of Sartorius Stedim biotech

Single-Use Stainless Steel

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 CDERTraining related 483 citations

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

DRUGS FY 2006 483 FY citations analysis rank freqTraining-operations, GMPs, written procedures 21 CFR 211.25(a) 9 60.00GMP Training Frequency 21 CFR 211.25(a) 23 38.00Training, Education, Experience overall 21 CFR 211.25(a) 62 16.00Supervisor Training/Education/Experience 21 CFR 211.25(b) 77 13.00 # Total Training citations in top 20 60.00% training citations in top 20 4.75%

2012 rank Freq

8 65.0013 54.0019 44.0097 9.00163.00

11.31%

Procedures not in writing/ fully followed

21 CFR 211.22(d)1 127 1 150 1 112 1 157 1 165 1 201 1 169

Absence of Written Procedures

21 CFR 211.100(a)5 83 7 62 7 52 6 75 6 89 2 128 3 116

Written procedures not established/ followed

21 CFR 211.67(b)10 54 10 52 9 43 9 64 7 80 7 89 7 73

SOPs not followed / documented

21 CFR 211.100(b)6 82 5 72 5 58 4 81 2 115 6 89 10 64

# Total SOPs related out of top 10 citations

2008 2009 2010 2011 2012

346 336 265 377 449 507 422

2006 2007

46.99% 44.70%42.51% 43.75% 43.09% 45.53% 46.72%

Responsibilities of quality control unit

Production and Process Controls

Cleaning and Maintenance

Production and Process Controls

How to ensure the instructions pertained in SOPs are fully understood and performed on a daily basis?Augment ownership of operations?

Top 10 Inspectional Observations – CDER SOP related 483 citations

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 HerkScientist USPVaccine Process and Analytical Development Archimedesweg 4-6PO Box 20482301 CA LeidenThe NetherlandsTel: +31 (0)71 519 9197Email: [email protected]

Leiden-USP-Valerio

Bern-Cell & virus banking-USP-Process characterization

Solna

Springhouse

External-Licensees-Partners

Key elements:-Training-Standardized Operation

Knowledge transfer for USP processes

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 sessionsi. Start, Pause, Replay, without fearing interrupting ii. Free up Expert time

Hands-on sessions

i. Efficient vs time and costsii. Minimize risk on production lines

Optimize skill sets

i. On-the-job assistanceii. Mentoring, learn by peer

Conclusion

Compliance & Cost controlFirst Hand Reference Tutorials

Efficient documentation process

Less deviations

CoordinationIrrespective of language

“Watch it and do it”

Expandable

Empower Personnel: Move from “certainty” to “routine dexterity”

Thank you

Expandable and language free www.sourcin.com

[email protected]