Piloting Job Instructions in a GMP regulated environment€¦ · presentation: 1a. Change agenda...
Transcript of Piloting Job Instructions in a GMP regulated environment€¦ · presentation: 1a. Change agenda...
15/11/2016
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Piloting Job Instructions in a GMP regulated environment
Novo Nordisk - Corporate Presentation 1
PARVANEH Research & Development Novo Nordisk, Denmark
Cristina de la Fuente SVP Training Partner
Diabetes Finished Products, Novo Nordisk A/S
Agenda
2 Presentation title Date
1 Introduction to Novo Nordisk
2 Job Instructions – where to start?
3 From pilot to global roll out
AGENDA MASTER SLIDE. Changes will be carried to all agenda divider slides when updated with Slidesright. The highlighter for divider slides is inserted below; changes to its design are applied to all divider slides (don't delete!)
How to use first time: 1. Edit agenda item text to suit 2. Copy item to add agenda point 3. Delete item to remove agenda point 4. Move item up or down to change agenda order 5a. Use toolbar Agenda>Update agendas to finalise 5b. Agenda divider slides will be added to presentation 6. Move divider slides to desired place in presentation (divider slide order in presentation is irrelevant, will be updated to reflect relative position) 7. Update agendas again 8. Agendas will be updated to reflect their relative position. How to change agenda throughout presentation: 1a. Change agenda master when needed, as described above 1b. Rearrange agenda dividers when needed, as described above 2. Use toolbar Agenda>Update agendas to update all agenda slides throughout presentation to reflect changes.
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Novo Nordisk at a glance
Novo Nordisk - Corporate Presentation 3
Novo Nordisk and Product Supply
• Novo Nordisk is a global healthcare
company with more than 90 years of
innovation and leadership in diabetes care
• Novo Nordisk also help people defeat
other serious chronic conditions as
haemophilia, growth disorders and
obesity
• Product Supply is responsible for the
supply of all marketed and phase III
development products within the
treatments of:
• Diabetes
• Haemophilia
• Growth disorders
• Menopause
• Obesity
ORLANDO CÁMARA GARCÍA Orlando has type 2 diabetes Mexico ALEX SILVERBERG
Sweden Alex has type 1 diabetes
PRODUCTS MARKETED IN
180 COUNTRIES
AFFILIATES IN COUNTRIES
R&D CENTRES IN CHINA, DENMARK,
INDIA AND US
75
EMPLOYS APPROXIMATELY
42,300 PEOPLE DKK 107.9 BILLION IN TOTAL REVENUE
230,000 SHAREHOLDERS
26,800,000 PEOPLE USE OUR PRODUCTS
SUPPLIER OF MORE THAN
HALF OF THE WORLD’S INSULIN
STRATEGIC PRODUCTION SITES
IN BRAZIL, CHINA, DENMARK, FRANCE AND US
GROWTH
DISORDERS
OBESITY
DIABETES
HAEMOPHILIA
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~4.000 PRODUCT VARIANTS
Product Supply Supplies products for all therapeutic areas
Hormone Replacement Therapy
12 PRODUCTION SITES WORLDWIDE
Growth hormone disorders
14.200 EMPLOYEES GLOBALLY
Haemophilia
Diabetes
Obesity
CARL LYONS Carl lives in Denmark and has haemophilia A
EVE BROUTY Eve lives in the US and has a BMI of 38
CONNER AND JO Conner and Jo both live with a growth disorder
JIM SHEEDER Jim has type 2 diabetes and lives in the US
TRINITY ALFARO Trinity lives in the US
and has type 1 diabetes
Product Supply A global network divided into different areas
Biopharm
DFP
DAPI
D&S
Bagsværd
Gentofte
Værløse
Hjørring
Kalunborg
Hillerød
Måløv
Koriyama
Tianjin
Kaluga
Chartres
Montes Claros
New Hampshire
Clayton
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Diabetes Finished Products
Employees
• ~ 6.230
Locations • Denmark (Hillerød, Kalundborg and
Bagsværd) • France (Chartres) • Brazil (Montes Claros) • USA (Clayton) • China (Tianjin)
Processes
DFP Montes Claros (BR)
DFP Bagsværd (DK)
DFP Hillerød (DK) DFP Kalundborg (DK)
DFP Clayton (US)
ERIK NIELSEN SCHMIDT AND LASSE BO
LUMHOLDT RIISAGER
Director and chemist at site Kalundborg
Denmark
DFP Chartres (FR)
DFP Tianjin (CN)
Agenda
8 Presentation title Date
1 Introduction to Novo Nordisk
2 Job Instructions – where to start?
3 From pilot to global roll out
AGENDA MASTER SLIDE. Changes will be carried to all agenda divider slides when updated with Slidesright. The highlighter for divider slides is inserted below; changes to its design are applied to all divider slides (don't delete!)
How to use first time: 1. Edit agenda item text to suit 2. Copy item to add agenda point 3. Delete item to remove agenda point 4. Move item up or down to change agenda order 5a. Use toolbar Agenda>Update agendas to finalise 5b. Agenda divider slides will be added to presentation 6. Move divider slides to desired place in presentation (divider slide order in presentation is irrelevant, will be updated to reflect relative position) 7. Update agendas again 8. Agendas will be updated to reflect their relative position. How to change agenda throughout presentation: 1a. Change agenda master when needed, as described above 1b. Rearrange agenda dividers when needed, as described above 2. Use toolbar Agenda>Update agendas to update all agenda slides throughout presentation to reflect changes.
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Presentation title Date 9
Kalundborg
Hillerød
Bagsværd + support functions
Clayton
Tianjin
743 FTEs Operating since 1993
Montes Claros
Operating since 2003
Chartres
Operating since 1961
Operating since 1996
Operating since 1995
Operating since 1959 Operating since 1969
664 FTEs
607 FTEs
508 FTEs
456 FTEs
1021 FTEs
1100 FTEs
900 FTEs
Job Instructions DFP Pilots 27-04-2016 10
FP FlexPen Assembly
A3-A4 Line Clearance
AP Env. Monitoring
Green Zone Gowning
10 40 2
8 400
5
Area: Process:
# of Job Instructions: # of Operators: # of SOPs impacted:
Scoping the pilot projects. Where to write Job Instructions
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A 3-fold document:
1. Instruction (SOP)
2. Training Material
3. Process Confirmation tool
The dimensions of a Job Instruction in our GMP context (1/2)
Presentation title Date 11
3 systems to ensure sustainability:
1. Continuous Improvement
2. Quick Updates
3. Process Confirmation
The dimensions of a Job Instruction in our GMP context (2/2)
Presentation title Date 12
A Change Management task
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A parallel and common implementation method for both pilots
Presentation title Date 13
Nov Dec Jan Feb Mar Apr May Jun
2015/2016
Initiate Analyse Roll Out
G1 G2 G3
DFP Pilot Site Roll Out
Write Job Instructions
Develop Systems
Retrain all shifts
Systems go-live
Job Instructions in QBIQ
Updated SOP in QBIQ
Job Instructions DFP Pilots Slide no
14
400 operators in scope, critical operation
Create a Training simulation space
Production equipment availability
Start small – solve a problem
Site MOC Site Chartres
27-04-2016
Good Learnings
Challenges
Qualify operators in Job Break Down writing Involve supervisors as key stakeholder
Let Operators write the content Watch video
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And finally… the results Site Montes Claros, Brazil
Job Instructions DFP Pilots Slide no
15 27-04-2016
1 1
2
1 1
3
0 0 0 0
0.5
1
1.5
2
2.5
3
3.5
Jan Feb Mar Apr May June Jul Aug Sep
Deviations in line clearance operations
JI
And finally… the results Site Chartres, France
REDUCTION 98% NNP1
REDUCTION 94% NNP2
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Agenda
20 Presentation title Date
1 Introduction to Novo Nordisk
2 Job Instructions – where to start?
3 From pilot to global roll out
AGENDA MASTER SLIDE. Changes will be carried to all agenda divider slides when updated with Slidesright. The highlighter for divider slides is inserted below; changes to its design are applied to all divider slides (don't delete!)
How to use first time: 1. Edit agenda item text to suit 2. Copy item to add agenda point 3. Delete item to remove agenda point 4. Move item up or down to change agenda order 5a. Use toolbar Agenda>Update agendas to finalise 5b. Agenda divider slides will be added to presentation 6. Move divider slides to desired place in presentation (divider slide order in presentation is irrelevant, will be updated to reflect relative position) 7. Update agendas again 8. Agendas will be updated to reflect their relative position. How to change agenda throughout presentation: 1a. Change agenda master when needed, as described above 1b. Rearrange agenda dividers when needed, as described above 2. Use toolbar Agenda>Update agendas to update all agenda slides throughout presentation to reflect changes.
Pilot Wave
Start 2H 2016
2017 and beyond
Chartres
Montes Claros
• Chartres
• Montes Claros
• Bagsværd
• Tianjin
• Hillerød
• APX
• Kalundborg
• Clayton
Broad commitment to implement Job Instructions in new production sites and areas
DPG, 29 Jun 16 Job Instructions 21
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Documenting pilot learnings. The Job Instruction Implementation Standard
22
Write 1st draft x5 Tests Final draft
Review process 4P training with
JI
JI Process Confirmation
Improvement Ideas
Training in JI writing
20 Oct 2016 F2F - Job Instruction
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JIs
and
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Up
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JIs
and
SO
P e
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Trai
nin
g in
JI
wri
tin
g Train SFTs
Train end users
Create CR
Implement update flow system
Implement improvement ideas system
Training in PC
Approve CR with
planned actions
Identify ISOtrain
adjustments
Create PC plan and follow up governance Sy
ste
ms
go li
ve
Eval
uat
e s
ucc
ess
cri
teri
a
Project ManagerProcess Responsible/SupporterEnd user
JI creator/SOP authorTraining SupporterQA Supervisor of end users
Shop Floor Trainer (4P)
TrainingReview and approvalJI creation
PlanningAdministrative activitiesMilestoneSustainability
Job Instructions DPG, 29 Jun 16 23
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The process to build central support to the global roll out of Job Instructions
Presentation title Date 24
Standardize best practices
from pilots
Certify TWI trainers
Develop internal JI
Programmes
Handover to global
network
Ongoing support
25 Novo Nordisk - Corporate Presentation
We are not done changing lives!