Lean, team-based medical device manufacturing · 2015-10-21 · Lean, team-based medical device manufacturing David Hurley ... •Standard Work ... Water Spider . New Process –

Lean, team-based medical device manufacturing

David Hurley

Associate Director of Operations

Alcon Research, Ltd.

Agenda

• Alcon

• Starting our Lean journey

• Our Lean Change Process

– Lean Production

– Lean Management

Agenda

• Our Improvements – Looking beyond surface

metrics

• Telling your story - Our advice

Alcon, Huntington WV

• Size: 296,000 ft.²

• Employees: More than 750

• Key Products: AcrySof® Intraocular Lenses

(IOLs), PMMA Intraocular Lenses, Monarch IOL

Delivery System (LDS)

• Annual Volume: 5 million IOLs, 9 million LDSs

Alcon-North, Lesage

• Size: 130,000 ft²

• Employees: More than 200

• Key Products & Processes:

– Manufacturing: Monarch IOL Delivery System (9 million annually)

– Sterilization, Packaging, and Distribution of all product lines (15 million annually)

Starting our Lean journey

Lean...Again...Really?

• Failed past initiatives:

– Support from top

– Involvement from

bottom-up

– Change agents

from middle

management

– People who

understand Lean

Why Now?

• New General Manager (Support from top+)

• Involvement from bottom-up (Ready and waiting)

• Change agents from middle management (Me+)

• People who understand Lean (Operational Excellence+)

The Process

We need help!

To The Rescue!

Alcon Operational Excellence

Greg Stehle, April Young, Stephanie Williams

The Process

– Lean Production

– Lean Management

The Process

• Communications and support from the top

• Technicians involved at every step

• Priorities for improvements

– Safety (Ergonomics)

– Quality (Poka-Yoke)

– Productivity (Fixtures)

– Cost (Will take care of itself)

The Process

• Operational Excellence Support

– Lean road map

– Facilitate Gemba Kaizen Events

– Technical support for Lean tools

– Education of support staff

• Change Agents (Middle Managers) develop

technical lean knowledge to lead and facilitate

Lean Production

• Creating Continuous Flow

– Who is your customer? Your supplier?

– What is the distance between stations?

– Is one-handed delivery possible?

– Identification of Product vs. Process oriented

layouts

– What is a work cell? Is a cell possible?

– Takt Time

Lean Production

• CONWIP & Pull System Supermarkets

• Standard Work

• Value Stream Mapping

Lean Production

• Process Improvement Teams (P.I.T.)

– Q.A.

– Mfg.

– Eng.

Lean Management

• Day-by-Hour Charts

• Staffing Grids

• Tier Meetings @ Tier Boards

– Tier 1: For Technicians, by Technicians

– Tier 2: Supervisors and dedicated support (PIT Teams)

– Tier 3: Value Stream Manager and Staff Members

The Kick-Off

Gemba Kaizen Events

Value Stream Mapping

Load Charting

Spaghetti Chart

New Layouts

Lean Management System

The Improvements

New Process – Meet Penny

New Process – Meet Sheldon

New Process – Meet Howard

From Batch

To Flow

300.00

400.00

500.00

600.00

700.00

800.00

900.00

1,000.00

Process 2

Efficiency Improvements

Old Process

New Process – Water Spider

New Process – Meet Frodo

WIP Racks for Sale

Results

and cautions!

WIP (Beware Equivalent Units!)

200,000

250,000

300,000

350,000

400,000

450,000

500,000

550,000

Jan-13 Feb-13 Mar-13 Apr-13 May-13 Jun-13 Jul-13 Aug-13 Sep-13 Oct-13 Nov-13 Dec-13

Product 1, WIP (Equivalent Units)

200,000

400,000

600,000

800,000

Jan-13 Feb-13 Mar-13 Apr-13 May-13 Jun-13 Jul-13 Aug-13 Sep-13 Oct-13 Nov-13 Dec-13 Jan-14 Feb-14 Mar-14 Apr-14 May-14 Jun-14 Jul-14

Product 1, WIP (Equivalent Units)

+ 17%

-

200,000

400,000

600,000

800,000

Product 1, WIP (Equivalent Units)

408,315

455,158

278,742

0

50,000

100,000

150,000

200,000

250,000

300,000

350,000

400,000

450,000

500,000

2013 2014 2015

Process 1 WIP (Equiv. Units Avg.)

+ 12%

- 39%

- 32%

B

A

S

E

L

I

N

E

277,731

339,807

60,669

0

50,000

100,000

150,000

200,000

250,000

300,000

350,000

400,000

2013 2014 2015

Process 2, Product A WIP (Avg.)

+ 22%

- 82%

B

A

S

E

L

I

N

E

Cycle Time

9

11

10

0

2

4

6

8

10

12

14

2013 2014 2015

Process 1 Cycle Time (Days)

+ 22%

- 9%

+ 11%

B

A

S

E

L

I

N

E

17

8

6

0

2

4

6

8

10

12

14

16

18

2013 2014 2015

Process 1 Lot Std. Dev. (Avg. Days)

- 53%

- 25%

- 65%

B

A

S

E

L

I

N

E

362

187

50

0

50

100

150

200

250

300

350

400

2013 2014 2015

Process 1, Max. CT (Days)

- 48%

- 73%

- 86%

B

A

S

E

L

I

N

E

5 14

346

0

50

100

150

200

250

300

350

400

2013 2014 2015

Process 1, Lots Completed ≤ 24 Hrs. (Lot Count)

0.2%

5%

0.1%

Normal Distribution

Non-Normal Distribution

Normal Distribution

Cost

0

1,000,000

2,000,000

3,000,000

4,000,000

5,000,000

6,000,000

7,000,000

8,000,000

9,000,000

10,000,000

$-

$500,000

$1,000,000

$1,500,000

$2,000,000

$2,500,000

$3,000,000

$3,500,000

$4,000,000

$4,500,000

2012 2013 2014 2015 (Proj.)

Process 1 Cost and Throughput 2012 - 2015 (proj.)

Cost TH

- 1%

- 15% - 6.5%

+ 4%

+ 17% 0 %

B

A

S

E

L

I

N

E

-22%

Putting it all together

Put it all together to tell the story

Our Advice on your Lean Journey

• Support from the top

• Start small

• It doesn’t need to be pretty

• Celebrate success – big and small

• Beware of quick automation, Lean first

• Involve everyone, even the grumpy ones

Our Advice on your Lean Journey

• Be transparent

• Take pictures to tell your story

• Involve the right people

• Avoid scope creep – get early wins

Thank You!

Please complete the session survey at:

www.ame.org/survey

Session: WP/24

Lean, team-based medical device

manufacturing

David Hurley

Alcon

[email protected]