massimiliano niselli operational excellence coordinator › wp-content › uploads › 2018 › 12...

Massimiliano NiselliOperational Excellence Coordinator

I prossimi 60 minuti

1. Stevanato in breve (5 min)

2. Operational Excellence in Stevanato Group: Lean Six Sigma nella strategia aziendale (15 min)

3. Caso: Riduzione dello Scarto sulla Linea Cliente (30 min)

4. Q&A (10 min)

1. SG in breve

• Mission, Vision & Values

• Organization, Governance& History

• Key Data

• Company structure and business approach

5

Mission

To create systems, processesand services that guaranteethe integrity of parenteral medicines

Stevanato Group Brand Structure

Corporate Presentation

2017

GIOVANNI

STEVANATO

Founded

Ompi

BRATISLAVA

PLANT

Medical Glass

Acquisition

LATINA

PLANT

Alfamatic

Acquisition

MONTERREY

PLANT

Opening

MONTERREY

PLANT

Double its size

ZHANGJIAGANG

PLANT

Foundation

stone

SETE

LAGOAS

PLANT

Foundation

stone

2011

20121993

20161949 2005

2008

BALDA

Acquisition

Company MilestonesPharmaceutical Systems Division


2018

NAGOYA

SALES OFFICE

Opening

FDA

INSPECTION

BALDA

Successful

completion

Engineering

Systems Pharmaceutical

Systems

17% 83%

240288

337

453

2013 2014 2016*2015

NET SALES (in MM Euro) KEY FIGURES

EMPLOYEES >3500

2017 vs 2016: +7%

Key Figures (2017)

* SVM and Balda consolidated from 1 January 2016, Medirio consolidated from the acquisition date (13 May 2016)

including change in WIP

** it considers a different accounting reclassification from previous years


483

2017**

Structured Flexibility: A Close Relationship.A Daily Exchange.


11

Strictly Confidential

Stevanato Group Integrated Capabilities


…and Partner for

Systems & Solutions

TODAY & TOMORROWPharma & Healthcare

Glass Primary Packaging

Supplier & Engineering

Services…

YESTERDAYPharma - Parenteral

2. OpEx in SG: Lean Six Sigma nella strategia aziendale

2014 2015 2016 2017 2018

OpEx function is set

"Coming together is a beginning, staying

together is progress, working together is a

success".

(H. Ford)

The Excellence journey

Set the Foundation

- PCS

- 5S

- Six Sigma training

- …OpEx abroad

Listen to VOC

- Customer @ Center

- Projects on Quality

Steps as Global Program

- Safety

- Quality

- Efficiency

LSS on transactional projects

- Sales Excellence

- Quality Excellence

- Lean the meeting

Industry 4.0

- MES

- Big Data

- SPC

2019

Operational Excellence

We are a multicultural, passionate and sparkling team of change agentssupporting the achievement of Stevanato Group’s long-term strategic goals.

Every day we drive improvements and create value for internal

and external customers, working shoulder to shoulder with SG

people in all processes.

Everywhere we strive for excellence by bringing standards,

methods, and data-driven approach.

Everyone of us brings enthusiasm and contributes to allow SG

people expressing their potential.

Set Foundation: Culture of data

Performance Control System… … results across al our companies

Function B-OEK Yellow Green Black

Operation Director

Continuous Improvement Mgr

TMC

Maintenance Mgr

Infrastructure Mgr

Set-up Team

Maintenance Lab cal aut

Scheduling

Production Manager

Production Dept Leader

Shift Leader

Logistic/Reworking (Cernita)

QC Manager

QC Department Leader

OpEx Manager

OpEx Leader

OpEx Process Engineer

OpEx Process Expert

B-O

EKYe

llow

Bel

tG

reen

Bel

tB

lack

Bel

t

Different training levels… … according to specific functions

Suggested for people who directly have impact on the flow valueContents: Lean thinking, problem solving

Suggested for people who lead Six Sigma projectsContents: Six Sigma Intermediate Statistic Tools utilization

Suggested for people who participate in improvement & Six Sigma projectsContents: DMAIC approach and overview on Quality Tools

Suggested for people who manage Six Sigma projects and evaluate new project opportunities Contents: Six Sigma Advanced Statistic Tools utilization

Set Foundation: Training on LSS

17

Internal Efficiency: Scrap on total height

NUMBER OF CONTROL TIMES NUMBER OF CONTROL TIMES OK % CONTROL TIMES OK

BEGINNING 128 43 34%

END 836 775 93%

Daily average of the Rejected Pieces for Total Height OOS

Table with the Percentage each hour OK Control

New Tools Included

Smarter Visualization

of the Success!!

18

Listen to VOC (1): Alcali Release Conclusion

19

Listen to VOC (2): Adhering drop

New development of wetting

Confirmed wetting phenomenon

Production site

Packaging provider

Glass supplier

ONAOMPI

MexicanItalianMexicanItalian

GermanyBrazilGermanyBrazilGermanyBrazilGermanyBrazil

4,0

3,5

3,0

2,5

2,0

Men

iscu

s H

eig

ht

Individual Value Plot of Meniscus HeightTime = T3

Further development of

wetting phenomenon

observed at T2 already

20

Listen to VOC (3): Scrap on a customer line

Time series plot - Typical 6072 Batch Time series plot - TL Optimized batch

Batch B0000559901

Note: Measurements are taken before annealing process

Reduced «between exit variability»

Higher cpk

More centered process

Less distance from nominal value

Elimination of “border” cartridges

Reduced variability introduced by on-line 100% measurement

system

21

Listen to VOC (4): Complaints from the market

Accept H1The CTQ before the project is different compared the CTQ after project

2% defective – Power report2% defective – summary report

LSS on transactional process: Sales Excellence (1)

124 Opportunities

identified

WAR ROOM

As is process

Documents/tools used

Lead time

LSS on transactional process: Sales Excellence (2)

LSS on Behaviours: Lean the Meeting (1)

1st Quartile 0,41667

Median 0,700003rd Quartile 1,00000

Maximum 6,16667

0,76775 0,89520

0,64477 0,75000

0,64715 0,73748

A-Squared 28,25

P-Value <0,005

Mean 0,83147

StDev 0,68935Variance 0,47521

Skewness 3,1903

Kurtosis 14,7520

N 452

Minimum 0,00000

Anderson-Darling Normality Test

95% Confidence Interval for Mean

95% Confidence Interval for Median

95% Confidence Interval for StDev

6543210

Median

Mean

0,900,850,800,750,700,65

95% Confidence Intervals

Summary Report for Real duration


1st Quartile -8,000


Maximum 100,000

-0,034 3,691

0,000 3,000

18,440 21,080

A-Squared 7,38

P-Value <0,005

Mean 1,828


Skewness 0,15132

Kurtosis 3,07042

N 431

Minimum -70,000





9060300-30-60

Median

Mean

43210


Summary Report for Finish Delay [min]

1st Quartile 2,0000


Maximum 69,0000

6,2928 8,2424

5,0000 5,0000

9,5921 10,9742

A-Squared 33,06

P-Value <0,005

Mean 7,2676


Skewness 2,9131

Kurtosis 14,3354

N 426

Minimum -30,0000





604530150-15-30

Median

Mean

8,07,57,06,56,05,55,0


Summary Report for Start Delay [min]

26


27

SG Steps: lo Stevanato Progression System

5S

Performance Control System

FI

FO

CU

SE

D

IMP

RO

VE

ME

NT

A

M

AU

TO

NO

MO

US

MA

INT

EN

AN

CE

PM

PL

AN

NE

D

MA

INT

EN

AN

CE

QM

QU

AL

ITY

MA

INT

EN

AN

EM

EA

RL

Y

MA

NA

GE

ME

NT

T&

E

TOT

PM

OF

FIC

ES

SA

FE

T

Y

5S

Performance Control System

FI

FO

CU

SE

D

IMP

RO

VE

ME

NT

AM

AU

TO

NO

MO

US

MA

INT

EN

AN

CE

PM

PL

AN

NE

D

MA

INT

EN

AN

CE

QP

QU

AL

ITY

PR

OG

RE

SS

ION

E&

T

ED

UC

AT

ION

&

TR

AIN

ING

S

SA

FE

TY

28

Sviluppi futuri: LSS e i primi approcci Industry 4.0

Big data Analytics SPC

L’idea è di applicare l’analisi dei big data per

comprendere maggiormente il processo di formatura.

Alcune fasi necessarie per un progetto di questo tipo

sono:

- Digitalizzazione e raccolta delle informazioni

necessarie, sia direttamente dalla macchina che da

processi manuali (es. ispezione a fine linea)

- Catalogazione delle informazioni raccolte

La raccolta dati può andare avanti per mesi per creare il

necessario set di informazioni.