© Ortho-Clinical Diagnostics, Inc.

Maximo at Ortho-Clinical Diagnostics

Cynthia Day

Operations Engineering

Engineering Systems

November 2014

2 © Ortho-Clinical Diagnostics, Inc.

Who – Introduction to OCD

Why – Why Maximo

When

What & How

–Equipment

– Introduction of Maximo

– Introduction of Calibration

– Introduction of enterprise CMMS

Conclusion

Agenda

3 © Ortho-Clinical Diagnostics, Inc.

Who - Introduction to OCD

4 © Ortho-Clinical Diagnostics, Inc.

2010

1997

1985

1989

1990

1993

1995

Amersham launches Amerlite Diagnostic

System with enhanced chemiluminescence

Launch of first HCV test

Eastman Kodak & Amersham

International joint venture

Kodak Clinical Diagnostics formed

J&J acquires Kodak Clinical, merges with Ortho Diagnostic

Systems & forms Ortho Clinical Diagnostics (OCD)

OCD launches VITROS ECi System

2004 OCD Launches ECiQ Immunodiagnostic System

2009

2012 Menu >50 assays

HIV, PSA, Syphilis

Manufacturing moves to new site in

Pencoed, South Wales

OCD Launches VITROS 3600 and 5600 Integrated Systems

2014 OCD becomes

stand alone

company

OCD Pencoed History

5 © Ortho-Clinical Diagnostics, Inc.

Products that save

lives

Professionals

dedicated to product

quality

Excellence through

technology

Purpose P PENCOED P

Supply >150 million test per

year to around the world

Provide high accuracy test

results that allow diagnosis of

diseases including hepatitis,

HIV, cancers and metabolic

diseases

Have quality central to our

thinking

6 © Ortho-Clinical Diagnostics, Inc.

OCD Key Facilities

Rochester, NY Research & Development

Equipment Mfg

Clinical Chemistry Slide Mfg Fluids / Micro tip Mfg

Raritan, NJ Worldwide HQ

Donor Screening Mfg

Immunohematology Mfg

Memphis, TN US Distribution Centre

Pencoed, Wales Immunoassay Mfg

Strasbourg, France

Worldwide Distribution Centre

7 © Ortho-Clinical Diagnostics, Inc.

Reproductive & Pregnancy

Kidney/Adrenal gland Cortisol

Digestive & Pancreas CA 19-9

CEA –

carcinoembryonic antigen

Thyroid & Parathyroid

Free or Total T3 and T4

Hormones TSH – Thyroid Stimulating

Hormone

T3U – T3-Hormone

Uptake iPTH – intact Parathyroid Hormone

Liver & Hepatitis A,B & C

HAV – Hepatitis A Virus

(HAV IgM, aHAV Total)

HBs/eAg – Hepatitis B

Antigen (HBsAg, HBsAg ES, HBeAg)

aHB – anti-Hepatitis B

Antibodies (aHBs, aHBc, aHBe)

aHCV – anti-

Hepatitis C Virus

AFP – Alpha

fetoprotein

HORMONES

Estradiol LH – Luteinising

Hormone

FSH – Follicle

Stimulating Hormone

Prolactin Progesterone b-hCG – Beta

Human Chorionic Gonadotrophin

Testosterone

DISEASE

Pregnancy - Screening For ToRC Diseases

Toxo – Toxoplasma gondii

Rub – Rubella

CMV – Cytomegallovirus

Toxo IgG, Toxo IgM Rub IgG, Rub IgM CMV IgG, CMV IgM

CANCER

CA 125 II

CA 15-3

AFP – Alpha

fetoprotein

PSA – Prostate

specific antigen (tPSA, fPSA)

HIV & Syphilis

HIV Combo

aHIV – anti Human

Immunodeficiency Virus

Syphilis

Blood & Bones Vitamins, Iron & Skeleton

Ferritin

B12

Folate (B9)

Vitamin D NTx

Cardiac

CK MB –

Creatine Kinase Troponin I ES

(Extra Sensitive)

Myoglobin

NTproBNP – N-terminus pro-

Brain Naturetic Peptide

Menu of Assays Product P PENCOED P

8 © Ortho-Clinical Diagnostics, Inc.

Enhanced Chemiluminescent Immunoassay

Kits, Calibrators, Range Verifiers, Signal Reagent,

Controls

Complex Biological Raw Materials / Processes

Range of Analyser Platforms (made in OCD Rochester)

Product P PENCOED P

9 © Ortho-Clinical Diagnostics, Inc.

How It Works Signal Reagent (Luminol + stabilisers)

Troponin I

Biotinylated Anti-Troponin I Antibody

HRP-Conjugated Antibody

Streptavidin Coated Well

Sample

Streptavidin Coated Well

Biotinylated Antibody

Sample, e.g. Troponin I

HRP-Conjugated Antibody

Product P PENCOED P

Sandwich Assay

10 © Ortho-Clinical Diagnostics, Inc.

Raw

Materials

Calibrators

Reagents

QC & Release

Formulation

Coated Wells

Conjugates

>850 Primary

Raw Materials

>80 conjugate

reaction types

Kit Assembly

>200 SKUs

>60 kit

combination

tests

15 microwell

coating types >200 formulation

types

>100 types

of reagent

>150 types of cals,

>50 types of

controls/RVs

Process Overview P PENCOED P

11 © Ortho-Clinical Diagnostics, Inc.

Why - Maximo

12 © Ortho-Clinical Diagnostics, Inc.

Reasons to implement Maximo

• Consolidation

• Maintenance planning

• Standard and consistent practice

• Record maintenance

• Data retrieval and analysis

• Change control

• Quality, Regulatory and Compliance

• Business benefits

13 © Ortho-Clinical Diagnostics, Inc.

When - Maximo

14 © Ortho-Clinical Diagnostics, Inc.

Maximo Journey

Paper based

System

Nov 2007

Maximo 5.2 Maintenance

Jan and July 2008

Maximo 5.2 Second site: Pencoed

Maximo Calibration

Nov 2013

Maximo 7.5

J&J eCMMS

Third site: Facilities

Maximo 7.5 Options following

divestiture

15 © Ortho-Clinical Diagnostics, Inc.

What & How Maximo

16 © Ortho-Clinical Diagnostics, Inc.

OCD Pencoed Equipment

Automated Packaging Line

• Assembly and labelling of components (RPAM)

• Foil bagging and labelling of components

• Cartoning of foil bag (FPA)

• Adding of package inserts

• Labelling of carton

• Case packaging of cartons and labelling

17 © Ortho-Clinical Diagnostics, Inc.

Maximo – Maintenance Only

18 © Ortho-Clinical Diagnostics, Inc.

How Maximo is Used

Asset Management and Scheduling of Calibration

Preventative and Reactive Maintenance

Standard work processes

Movement of assets

Reporting

– Work Orders

– Look ahead

– Compliance

0

10

20

30

40

50

60

70

80

90

100

2011 2012 H1 2012 H2 2013 H1 2013 H2 2014 H1

Sc

he

du

le A

dh

ere

nc

e (

%)

Maintenance Period

Schedule Adherence Historic Trending

Calibration

Calibration Off Site

Preventative Maintenance

Service Contract

19 © Ortho-Clinical Diagnostics, Inc.

Maximo Calibration

20 © Ortho-Clinical Diagnostics, Inc.

Maximo Calibration

Related data can be accessed and also stored

securely

Transcription errors reduced

Paperless

Works Order approved with electronic signatures

Prompt response with Non-Conformance and

Corrective Action Preventive Action for calibration

failures

Related functionality and benefits with maintenance

21 © Ortho-Clinical Diagnostics, Inc.

Calibration Implementation

OCD Engineering Project Managed

Exponential learning on software for Operations

Engineering & Information Management

Design based upon experience and quality requirements

Minimal customisation

Qualification protocols written and executed

Introduced for new Pencoed site only

Training Modules written and service provider training

completed

22 © Ortho-Clinical Diagnostics, Inc.

Calibration Specification Justification

23 © Ortho-Clinical Diagnostics, Inc.

Maximo Calibration Module

24 © Ortho-Clinical Diagnostics, Inc.

ME2 Progress

25 © Ortho-Clinical Diagnostics, Inc.

Enterprise CMMS

26 © Ortho-Clinical Diagnostics, Inc.

Why eCMMS Maximo 7.5

J&J eCMMS

Introduction of a standard platform for 3 sectors of

J&J: MD&D, Pharma and Consumer.

37 sites in Phase 1 migrating from several different

systems.

The strategic target end state for CMMS was to go

to 1 single common IT platform.

Benchmark sites and ability to measure

performance.

27 © Ortho-Clinical Diagnostics, Inc.

The Challenge

Site X

Knowns: - Using a CMMS system to

manage maintenance processes - CMMS system rules defined by

local Site practices -System configuration -Reports/Reporting -System functions -Usability - Abiding by established local

procedures and Quality program

Enterprise Platform

Driving Standards: - Best Practice foundation - Business processes -Maintenance -Calibration -Spare parts/inventory - Centralized CMMS -System configuration -Reporting/Reports -System function/capabilities - Quality/compliance

28 © Ortho-Clinical Diagnostics, Inc.

Site Readiness Considerations

Business Process Readiness

– Adaptation to new standards for business processes designed within CMMS platform (e.g. work types, work priorities, roles, nomenclatures, workflow, reports, etc...)

Maximo 7.5 CMMS Readiness

– New technical platform

– New functionality/capability

– New reporting capabilities

Quality/Compliance Readiness

– Documentation (SOPs, Work Instructions, etc...)

– Local Site procedures consideration

Training

– Business processes

– Maximo 7.5 (System)

Reporting/Reports & Value

29 © Ortho-Clinical Diagnostics, Inc.

Conclusion

30 © Ortho-Clinical Diagnostics, Inc.

Conclusion

• Quality and Compliance.

• Electronic – remove need for paper.

• Standardisation (site & globally).

• Data analysis for productivity improvements.

• Efficient scheduling, reduce downtime and increase capacity.

• Automatic verdict of Calibration.

• Improved tracking and reporting.

• Centralised system management.

• Steep learning curve for Maximo calibration.

• Service providers’ reference devices or solutions.

• Sites at different levels of maturity.

• Turnaround for changes and improvements.

• Issues with reporting.

• Too much and not enough application access!

• Enterprise vision can conflict with Site practicalities.

• Migration of data for non Maximo software.

• Latency - Slow at times for calibration.

31 © Ortho-Clinical Diagnostics, Inc.

Next Steps and Summary

Next Steps

Johnson and Johnson divestiture

– 2 Ortho Clinical Sites share the MD&D and Consumer platform – UK and USA

– 1 Ortho-Clinical Diagnostic site shares the Pharma platform – USA

Facilities department

Continuous Improvement

Inventory

Summary

Maximo and Maximo Calibration has provided a platform that link OCD’s

robust processes and continuous improvement values that promotes

‘Excellence through Technology’ in asset management.