Lean, team-based medical device manufacturing. David Hurley Associate Director of Operations Alcon Research, Ltd.

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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

Efficiency Improvements 1,000.00 Process 2 900.00 800.00 700.00 600.00 500.00 400.00 300.00

Old Process

New Process Water Spider

New Process Meet Frodo

WIP Racks for Sale

Results and cautions!

WIP (Beware Equivalent Units!)

550,000 Product 1, WIP (Equivalent Units) 500,000 450,000 400,000 350,000 300,000 250,000 200,000 Jan-13 Feb-13 Mar-13 Apr-13 May-13 Jun-13 Jul-13 Aug-13 Sep-13 Oct-13 Nov-13 Dec-13

800,000 Product 1, WIP (Equivalent Units) + 17% 600,000 400,000 200,000 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

800,000 Product 1, WIP (Equivalent Units) 600,000 400,000 200,000 -

Process 1 WIP (Equiv. Units Avg.) 500,000 455,158 450,000 408,315-32% 400,000 350,000 300,000 B A + 12% 278,742 250,000 S 200,000 150,000 100,000 E L I N - 39% 50,000 E 0 2013 2014 2015

Process 2, Product A WIP (Avg.) 400,000 350,000 339,807 300,000 277,731 + 22% 250,000 200,000 150,000 100,000 50,000 B A S E L I N E 60,669-82% 0 2013 2014 2015

Cycle Time

Process 1 Cycle Time (Days) 14 + 11% 12 11 10 9 + 22% 10 8 6 4 2 0 B A S E L I N E - 9% 2013 2014 2015

Process 1 Lot Std. Dev. (Avg. Days) 18 17 16 14 12 B A 10 8 S E L 8-65% 6 I N - 53% 6 4 2 E - 25% 0 2013 2014 2015

Process 1, Max. CT (Days) 400 362 350 300 250 B A S 200 150 100 E L I N 187-48% - 86% 50 E 50-73% 0 2013 2014 2015

400 Process 1, Lots Completed 24 Hrs. (Lot Count) Normal Distribution 350 346 300 250 200 5% 150 100 50 Non-Normal Distribution 0.1% Normal Distribution 0.2% 0 5 14 2013 2014 2015

Cost

$4,500,000 Process 1 Cost and Throughput 2012-2015 (proj.) + 4% 10,000,000 $4,000,000 + 17% 0 % 9,000,000 $3,500,000-1% 8,000,000 $3,000,000 $2,500,000 B A - 15% - 6.5% 7,000,000 6,000,000 $2,000,000 S E -22% 5,000,000 4,000,000 $1,500,000 L 3,000,000 $1,000,000 $500,000 I N E 2,000,000 1,000,000 $- 2012 2013 2014 2015 (Proj.) 0 Cost TH

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 David.Hurley@Alcon.com