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

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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







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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 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)


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)


A Change Management task

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A parallel and common implementation method for both pilots


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







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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and

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ffe

ctiv

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Trai

nin

g in

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wri

tin

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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

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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


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!

piloting job instructions in a gmp regulated environment€¦ · presentation: 1a. change agenda...

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