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<strong>Operational</strong> <strong>Excellence</strong><br />

<strong>Indica<strong>to</strong>rs</strong> <strong>as</strong> <strong>response</strong> <strong>to</strong> <strong>cost</strong><br />

pressures at Takeda<br />

Prepared by Joerg W<strong>as</strong>senhoven


Introduction:<br />

Jörg W<strong>as</strong>senhoven<br />

Direc<strong>to</strong>r <strong>Operational</strong> <strong>Excellence</strong>, OPX<br />

Takeda Pharmaceuticals International GmbH<br />

Thurgauerstr<strong>as</strong>se 130<br />

8152 Glattpark-Opfikon (Zurich)<br />

Switzerland<br />

Mobile +49 (0) 151 14630559<br />

Email joerg.w<strong>as</strong>senhoven@takeda.com<br />

2 OpEx <strong>Indica<strong>to</strong>rs</strong> <strong>as</strong> <strong>response</strong> <strong>to</strong> <strong>cost</strong> pressures at Takeda


3 OpEx <strong>Indica<strong>to</strong>rs</strong> <strong>as</strong> <strong>response</strong> <strong>to</strong> <strong>cost</strong> pressures at Takeda


4 OpEx <strong>Indica<strong>to</strong>rs</strong> <strong>as</strong> <strong>response</strong> <strong>to</strong> <strong>cost</strong> pressures at Takeda


5 OpEx <strong>Indica<strong>to</strong>rs</strong> <strong>as</strong> <strong>response</strong> <strong>to</strong> <strong>cost</strong> pressures at Takeda


<strong>Operational</strong> <strong>Excellence</strong> Organisation CCO:<br />

Operations<br />

Exec<br />

Central<br />

OPEX<br />

Coaching,<br />

training and<br />

men<strong>to</strong>ring Blueprints Reposi<strong>to</strong>ry<br />

Central OPEX team M<strong>as</strong>ter Blackbelts sit on Regional Management teams<br />

Coaching,<br />

training and<br />

men<strong>to</strong>ring<br />

Liquids<br />

region<br />

Solids<br />

region<br />

LATAM<br />

region<br />

Functions E<br />

M & others<br />

Blackbelts at site sit on Management teams<br />

Blackbelts co-ordinate with<br />

Greenbelts & Yellowbelts around active project execution<br />

6 OpEx <strong>Indica<strong>to</strong>rs</strong> <strong>as</strong> <strong>response</strong> <strong>to</strong> <strong>cost</strong> pressures at Takeda


Regula<strong>to</strong>ry Pressures and Cost Pressures in the<br />

Pharmaceutical Industry “<br />

Backround<br />

•On August 2012 CFCD Japan (Takeda corporate finance) h<strong>as</strong> kicked off a<br />

Global Capital Management project that covers the world wide Takeda<br />

organization in full and requires an Extended Value Stream Mapping approach.<br />

Company<br />

Business Unit<br />

Plant<br />

Department<br />

Equipment<br />

7 OpEx <strong>Indica<strong>to</strong>rs</strong> <strong>as</strong> <strong>response</strong> <strong>to</strong> <strong>cost</strong> pressures at Takeda


KPI Driver Tree<br />

“Regula<strong>to</strong>ry Pressures and Cost Pressures<br />

in the Pharmaceutical<br />

Industry “<br />

Demand<br />

Forec<strong>as</strong>t<br />

COGS<br />

Reduction<br />

Inven<strong>to</strong>ry<br />

Optimization<br />

Capital<br />

Expenses<br />

Quality<br />

Labour<br />

Utilization<br />

Thoughput<br />

time<br />

Machine<br />

Capacity<br />

Utilization<br />

OEE<br />

Yield/Scrap<br />

Quality Grade<br />

Production time<br />

Performance Grade<br />

Setup Time<br />

Availability Grade<br />

Downtime Time<br />

Root Causes<br />

8 OpEx <strong>Indica<strong>to</strong>rs</strong> <strong>as</strong> <strong>response</strong> <strong>to</strong> <strong>cost</strong> pressures at Takeda


Business Assessment Process<br />

• The BAP is a universal <strong>to</strong>ol<br />

• Establishes Ownership for management & down <strong>to</strong> the process level<br />

• Provides Gap Analysis from Current <strong>to</strong> Future State<br />

• The BAP Generates and Prioritizes an action plan<br />

– Project Portfolio<br />

• OpEx Projects<br />

– Kaizen Events<br />

– BB Projects<br />

– GB Projects<br />

• Other ProjectsCompany<br />

– Identifies local team initiatives<br />

– Sets a time line for improvements<br />

• Establishes true process understanding<br />

Company<br />

Business Unit<br />

Plant<br />

Department<br />

Equipment<br />

BAP is f<strong>as</strong>t, specific and ties directly linked <strong>to</strong> the annual targets and<br />

identifies the who, what and when for process improvement<br />

9 OpEx <strong>Indica<strong>to</strong>rs</strong> <strong>as</strong> <strong>response</strong> <strong>to</strong> <strong>cost</strong> pressures at Takeda


BAP Road Map<br />

10 OpEx <strong>Indica<strong>to</strong>rs</strong> <strong>as</strong> <strong>response</strong> <strong>to</strong> <strong>cost</strong> pressures at Takeda<br />

1


BAP Playbook<br />

Ph<strong>as</strong>e I<br />

(Alignment)<br />

Ph<strong>as</strong>e II<br />

(Plan & Prep)<br />

Ph<strong>as</strong>e III<br />

(BAP)<br />

Ph<strong>as</strong>e IV<br />

(Post BAP)<br />

3-4 Month Prior <strong>to</strong> BAP 1 -3 month Prior <strong>to</strong> BAP Day 1 - 2 30-60-90 Day Plan<br />

Organizational<br />

Alignment &<br />

Identify Key<br />

Value Streams<br />

Strategy<br />

Annual Targets<br />

VOC<br />

Team ID<br />

Critical Y<br />

ROIC<br />

CTQ<br />

KPI`s<br />

Data Collection<br />

Resources<br />

Logistics<br />

Product Lines<br />

Takt Time<br />

Team Assign.<br />

Data Checklist<br />

Data, Data, Data<br />

Current State<br />

Maturity Assessment<br />

Current State VSM<br />

Spaghetti Diagram<br />

C&E Matrix, FMEA<br />

Defect Data<br />

Cycle Time Analysis<br />

Constraint Analysis<br />

Future State<br />

Current EVSM<br />

Future State EVSM<br />

Gap Analysis<br />

Validation <strong>to</strong> Annual Targets<br />

Project Identification<br />

Project Priority<br />

Project Resourcing<br />

& Implementation<br />

Resource Assignments<br />

30-60-90 Day Plan<br />

Project Clusters<br />

BB Projects<br />

GB Projects<br />

Kaizen Events<br />

Future State EVSM<br />

Future State<br />

Throughput Time<br />

Cycle Time<br />

Inven<strong>to</strong>ry €<br />

Resource Plan<br />

Tool Selection/Usage May Vary From One Assessment <strong>to</strong> Another<br />

11 OpEx <strong>Indica<strong>to</strong>rs</strong> <strong>as</strong> <strong>response</strong> <strong>to</strong> <strong>cost</strong> pressures at Takeda


Identification of Key Value Streams<br />

PQ Analysis – initially narrow down opportunities b<strong>as</strong>ed on volume, value<br />

Demand Segmentation – narrow down further and segment b<strong>as</strong>ed on volume, variability,<br />

inven<strong>to</strong>ry level, quality,…<br />

12 OpEx <strong>Indica<strong>to</strong>rs</strong> <strong>as</strong> <strong>response</strong> <strong>to</strong> <strong>cost</strong> pressures at Takeda


Extended Value Stream Mapping<br />

Gap Analysis & W<strong>as</strong>te Identification<br />

Jan_08 Feb_08 Mrz_08 Apr_08 May_08 Jun_08 Jul_08 Aug_08 Sep_08 Okt_08 Nov_08 Dez_08<br />

Artikelnr. Produktbezeichnung Tabletten Tabletten Tabletten Tabletten Tabletten Tabletten Tabletten Tabletten Tabletten Tabletten Tabletten Tabletten<br />

1000001 Produkt A01 5% 2% 1% 1% 2%<br />

1000002 Produkt A02 6% 25% 11% 20% 30% 6% 8% 16%<br />

1000003 Produkt A03 20% 8% 10%<br />

1000004 Produkt A04 6% 8%<br />

1000005 Produkt A05<br />

1000006 Produkt A06 6% 11% 30% 6% 8% 16%<br />

1000007 Produkt A07 1% 6% 6% 3%<br />

1000008 Produkt A08 12% 21% 16% 18% 20%<br />

1000009 Produkt A09 24% 43% 30% 26% 40%<br />

1000010 Produkt A10 27% 14% 36%<br />

1000011 Produkt A11<br />

1000012 Produkt A12<br />

1000013 Produkt A13 3% 5% 3% 7% 10% 7% 2%<br />

1000014 Produkt A14 3% 12% 8% 16% 4% 5% 14% 4%<br />

1000015 Produkt A15 5% 22% 17% 33% 7% 35% 33% 9%<br />

1000016 Produkt A16 2% 6% 3% 6% 9% 9% 2% 17% 3% 11% 9% 3%<br />

1000017 Produkt A17<br />

1000018 Produkt A18 4% 4%<br />

Produktionsplanung<br />

1000019 Produkt A19 6% 25% 11% 20% 30% 35% 8% 38% 9% 35% 16% 10%<br />

Total 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100%<br />

ø Chargen 7,18 16,58 4,00 9,09 5,00 3,33 2,86 12,50 2,63 11,11 2,86 6,25 10,00<br />

Nur Produkt „A“<br />

Lieferant<br />

Tabl./min<br />

5000,00<br />

4500,00<br />

4000,00<br />

3500,00<br />

3000,00<br />

2500,00<br />

2000,00<br />

1500,00<br />

1000,00<br />

500,00<br />

0,00<br />

Wartezeit<br />

WIP<br />

MRP-System<br />

Wartezeit<br />

WIP<br />

Wartezeit<br />

WIP<br />

Unter dem<br />

Kundentakt<br />

Wartezeit<br />

WIP<br />

Ungenauigkeiten im<br />

„Rolling Forec<strong>as</strong>t“ von<br />

Venezuela<br />

Kunde<br />

2 Kampagnen<br />

10 Chargen<br />

Kundennachfrage<br />

Kundennachfrage<br />

1 Kampagne = 5 Chargen<br />

1 Charge = 500000 Tabl= 100kg API<br />

5000000 Tabl./Monat<br />

Verfügbare Arbeitszeit<br />

Tage/Monat<br />

21<br />

168 h/Monat<br />

8 h/Tag<br />

0,5 h Pause/Tag 10,5 h/Monat<br />

157,5 h/Monat<br />

Verfügbare Arbeitszeit 9450 min/Monat<br />

567000 sek/Monat<br />

Kundentakt Kalkulation<br />

Kundennachfrage 5000000 Tabl./Monat<br />

157,5 h/Monat<br />

Verfügbare Arbeitszeit 9450 min/Monat<br />

567000 sek/Monat<br />

31746 Tabl./h<br />

Kundentakt 529 Tabl./min<br />

1 Tonne 5<br />

Chargen<br />

max. 3 Tage<br />

Wiegen<br />

2 1<br />

CT = 105 min<br />

TT = 4762 Tabl./min<br />

CTT = 529 Tabl./min<br />

max. 5 Chargen<br />

Tage<br />

Mixer<br />

1 1<br />

CT = 600 min<br />

TT = 833 Tabl./min<br />

CTT= 529 tabl./min<br />

max. 5 Chargen<br />

Tage<br />

Kilian RTS 23<br />

Tablettenpresse<br />

1 1<br />

Kilian RTS 20<br />

Tablettenpresse<br />

1 1<br />

CT = 390 min<br />

max. 5 Chargen<br />

Tage<br />

Lackierung<br />

1 1<br />

CT = 510 min<br />

TT = 980 Tabl./min<br />

CTT = 529 Tabl./min<br />

IPC<br />

5 Chargen<br />

14 Tage<br />

Abfüllung +<br />

Konfektionierung/<br />

1Blister<br />

3 2<br />

CT = 1152 min<br />

Abfüllung +<br />

Konfektionierung/2<br />

Blister<br />

3 2<br />

CT = 772 min<br />

TT = 647 Tabl./min<br />

CTT = 529 Tabl./min<br />

...<br />

20 Tage<br />

Rechtzeitiger<br />

Bestand von<br />

Fertigprodukten<br />

im Lager<br />

unflexibel<br />

TT = 1282 Tabl./min<br />

TT = 434 Tabl./min<br />

7.5 h/Schicht/MA (exkl.<br />

Pausen)<br />

54.000 sek verfügbar<br />

1 Rüsten für 5 Chargen<br />

1,5 h Rüsten (SOLL)<br />

Rüsten .. (IST)<br />

SOLL-Fertigungszeit 8 h<br />

für 5 Chargen<br />

7.5 h/Schicht/MA (exkl. Pausen)<br />

54.000 sek verfügbar<br />

1 Rüsten für 5 Chargen<br />

SOLL-Fertigungszeit 5 h für 1 Charge<br />

SOLL-Fertigungszeit 25 h für 5<br />

Chargen<br />

SOLL-Rüstzeit 4h<br />

IST-Rüstzeit ..<br />

CTT = 529 Tabl./min<br />

7.5 h/Schicht/MA (exkl. Pausen)<br />

27.000 sek verfügbar<br />

SOLL-Fertigungszeit 7h/Charge<br />

IST-Fertigungszeit 5.25 h<br />

SOLL-Rüstzeit 11h<br />

IST-Rüstzeit 13.5h; Ende der Kampagne<br />

SOLL-Rüstzeit 2h; IST-Rüstzeit 1.25 h;<br />

zwischen den Chargen<br />

...<br />

<br />

<br />

<br />

<br />

<br />

...<br />

TT = 529 Tabl./min<br />

...<br />

<br />

<br />

<br />

<br />

<br />

...<br />

Taktzeit Kalkulation exkl. Endreinigung<br />

Abfüllung und Abfüllung und<br />

Konfektionierung<br />

500000 Wiegen Mischen Tablettierung Lackieren Konfektionierung<br />

h 1,75 10,00 6,50 8,50 19,20 12,87<br />

min 105 600 390 510 1152 772,2<br />

sek 6300 36000 23400 30600 69120 46332<br />

Tabl./h 285714,29 50000,00 76923,08 58823,53 26041,67 38850,04<br />

Tabl./min 4761,90 833,33 1282,05 980,39 434,03 647,50<br />

Tabl./sec 79,37 13,89 21,37 15,29 7,23 10,79<br />

Takt Tabl./h 31746,00 31746,00 31746,00 31746,00 31746,00 31746,00<br />

Takt Tabl./min 529,00 529,00 529,00 529,00 529,00 529,00<br />

Takt Tabl./sek 9,00 9,00 9,00 9,00 9,00 9,00<br />

Daten von allen<br />

Produkten<br />

Verfügbarkeit<br />

Verfügbare Zeit 21T x 8h = 168 h<br />

Pausen 21T x 0,5h = 10,5 h<br />

Rüsten ( %) = ... h<br />

Stillstand = ... h<br />

Frei (ca. ..%) = h<br />

Summe Verfügbarkeit = ... h/m<br />

Verfügbarkeit von ... %<br />

Leistung<br />

Theoretisch max. .. Tabl./h<br />

SOLL-Leistung ..... Tabl./h<br />

IST-Leistung .. Tabl./h<br />

Geplante Leistung ...%<br />

IST-Leistung ...%<br />

Qualität<br />

Volumen Input ...Tabl<br />

Volumen Output ...Tabl<br />

Qualitätskennziffer .%<br />

Overall Equipment Efficiency<br />

Verfügbarkeit %<br />

Leistung<br />

%<br />

Qualitätskennziffer ....%<br />

Verfügbarkeit<br />

Verfügbare Zeit 21T x 8h = 168 h<br />

Pausen 21T x 0,5h = 10,5 h<br />

Rüsten ( %) = ... h<br />

Stillstand = ... h<br />

Frei (ca. ..%) = h<br />

Summe Verfügbarkeit = ... h/m<br />

Verfügbarkeit von ... %<br />

Leistung<br />

Theoretisch max. .. Tabl./h<br />

SOLL-Leistung ..... Tabl./h<br />

IST-Leistung .. Tabl./h<br />

Geplante Leistung ...%<br />

IST-Leistung ...%<br />

Qualität<br />

Volumen Input ...Tabl<br />

Volumen Output ...Tabl<br />

Qualitätskennziffer .%<br />

Overall Equipment Efficiency<br />

Verfügbarkeit %<br />

Leistung<br />

%<br />

Qualitätskennziffer ....%<br />

Verfügbarkeit<br />

Verfügbare Zeit 21T x 8h = 168 h<br />

Pausen 21T x 0,5h = 10,5 h<br />

Rüsten ( %) = ... h<br />

Stillstand = ... h<br />

Frei (ca. ..%) = h<br />

Summe Verfügbarkeit = ... h/m<br />

Verfügbarkeit von ... %<br />

Leistung<br />

Theoretisch max. .. Tabl./h<br />

SOLL-Leistung ..... Tabl./h<br />

IST-Leistung .. Tabl./h<br />

Geplante Leistung ...%<br />

IST-Leistung ...%<br />

Qualität<br />

Volumen Input ...Tabl<br />

Volumen Output ...Tabl<br />

Qualitätskennziffer .%<br />

Overall Equipment Efficiency<br />

Verfügbarkeit %<br />

Leistung<br />

%<br />

Qualitätskennziffer ....%<br />

Verfügbarkeit<br />

Verfügbare Zeit 21T x 8h = 168 h<br />

Pausen 21T x 0,5h = 10,5 h<br />

Rüsten ( %) = ... h<br />

Stillstand = ... h<br />

Frei (ca. ..%) = h<br />

Summe Verfügbarkeit = ... h/m<br />

Verfügbarkeit von ... %<br />

Leistung<br />

Theoretisch max. .. Tabl./h<br />

SOLL-Leistung ..... Tabl./h<br />

IST-Leistung .. Tabl./h<br />

Geplante Leistung ...%<br />

IST-Leistung ...%<br />

Qualität<br />

Volumen Input ...Tabl<br />

Volumen Output ...Tabl<br />

Qualitätskennziffer .%<br />

Overall Equipment Efficiency<br />

Verfügbarkeit %<br />

Leistung<br />

%<br />

Qualitätskennziffer ....%<br />

Verfügbarkeit<br />

Verfügbare Zeit 21T x 8h = 168 h<br />

Pausen 21T x 0,5h = 10,5 h<br />

Rüsten ( %) = ... h<br />

Stillstand = ... h<br />

Frei (ca. ..%) = h<br />

Summe Verfügbarkeit = ... h/m<br />

Verfügbarkeit von ... %<br />

Leistung<br />

Theoretisch max. .. Tabl./h<br />

SOLL-Leistung ..... Tabl./h<br />

IST-Leistung .. Tabl./h<br />

Geplante Leistung ...%<br />

IST-Leistung ...%<br />

Qualität<br />

Volumen Input ...tabl<br />

Volumen Output ...tabl<br />

Qualitätskennziffer .%<br />

Overall Equipment Efficiency<br />

Verfügbarkeit %<br />

Leistung<br />

%<br />

Qualitätskennziffer ....%<br />

OEE=VxLxQ<br />

....%<br />

OEE=VxLxQ<br />

....%<br />

OEE=VxLxQ<br />

....%<br />

OEE=VxLxQ<br />

....%<br />

OEE=VxLxQ<br />

....%<br />

13 OpEx <strong>Indica<strong>to</strong>rs</strong> <strong>as</strong> <strong>response</strong> <strong>to</strong> <strong>cost</strong> pressures at Takeda


OEE Standardization<br />

• Blueprints:<br />

– OEE & TEEP available<br />

– Next blueprint under development<br />

• Best Practice Sharing / Training<br />

14 OpEx <strong>Indica<strong>to</strong>rs</strong> <strong>as</strong> <strong>response</strong> <strong>to</strong> <strong>cost</strong> pressures at Takeda


GAMED – How does it work?<br />

Vizualisation<br />

Server PC<br />

Controlling<br />

Client PCs<br />

Planning<br />

Global<br />

Functions<br />

Integration<br />

Client/Server<br />

Machine PC<br />

tabletting<br />

Production signal from<br />

PLC or sensor (24V)<br />

Buffer<br />

Machine PC<br />

Packaging<br />

Material flow<br />

good<br />

Local<br />

operation<br />

Logon product A<br />

(Terminal or PLC)<br />

High<br />

Low<br />

Product A<br />

scrap<br />

Production signal<br />

Setting-up<br />

Production<br />

Downtime<br />

Production<br />

Machine status<br />

Time<br />

15 OpEx <strong>Indica<strong>to</strong>rs</strong> <strong>as</strong> <strong>response</strong> <strong>to</strong> <strong>cost</strong> pressures at Takeda


His<strong>to</strong>rical Background<br />

# of Licenses<br />

90<br />

80<br />

70<br />

60<br />

Currently covering production lines / machines like<br />

•Filling/packaging lines<br />

•Tabletting lines<br />

•Inspection lines<br />

•BFS machines<br />

•Coating and granulation equipment in progress<br />

Radar Screen<br />

Mexico, Cerano, Russia,...<br />

34 Lines in preparation<br />

Oranienburg<br />

Brazil<br />

50<br />

40<br />

30<br />

20<br />

10<br />

8 Licences<br />

Linz<br />

5 Pilot Lines<br />

Brüssel<br />

Elverum<br />

Singen<br />

Lyszkovice<br />

Roskilde<br />

46 Lines<br />

Brüssel<br />

Elverum<br />

Singen<br />

Lyszkovice<br />

Roskilde<br />

Asker<br />

Oranienburg<br />

Status January 2013<br />

Request for 59 new<br />

lines within Europe<br />

2007<br />

12/2009<br />

05/2011<br />

12/2012<br />

Today<br />

Time<br />

16 OpEx <strong>Indica<strong>to</strong>rs</strong> <strong>as</strong> <strong>response</strong> <strong>to</strong> <strong>cost</strong> pressures at Takeda


“coming from theory <strong>to</strong> practice”<br />

17 OpEx <strong>Indica<strong>to</strong>rs</strong> <strong>as</strong> <strong>response</strong> <strong>to</strong> <strong>cost</strong> pressures at Takeda<br />

“It’s a kind of Magic”


Thank you very much for your attention!<br />

18 OpEx <strong>Indica<strong>to</strong>rs</strong> <strong>as</strong> <strong>response</strong> <strong>to</strong> <strong>cost</strong> pressures at Takeda

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