Keeping Your Quality System Trim: Lean Principles for GMPs

Keeping Your Quality System Trim: Lean Principles for GMPs

James Shore

QUALITY LEAN SOLUTIONS

“Simplified Sustainable Solutions ™”

Abstract

Some of the most successful medical device

manufacturers are using the Lean Principles it to

improve their bottom line while ensuring quality. You

may already be using some of these principles but

just have not heard of the names before, such ask

“kanban, heijunka and muda.”

In this session, you’ll learn how to use lean

management principles to increase quality, reduce

waste (and costs), and increase output – all without

losing sight of your compliance responsibilities.

15th Annual Medical Device Quality CongressQuality Lean Solutions, Copyright March 2018 2

Why

Lean?

• Compliance

• Product Safety

• Efficiencies

• Utilization

• Observe the process

• Listening to the people– Flowchart -VSM

– Material at the source - Kanban replenishment

– Organization - 5S

– Muda - Removing waste

15th Annual Medical Device Quality Congress Quality Lean Solutions, Copyright March 2018 3

House

of

Lean

Quality Lean Solutions, Copyright March 2018 4

Build on trust, listening and respect for the people

The 3 S rules

• Solutions – we need to know the problem before the changes are made • Start with why – Simon Sinek

• Sustainable (and scalable)- “right-sized” for the company size and material

•Simple – has to be understood by those who are using the information, can’t be complex or it won’t be followed

• The Goal - Eliyahu Goldratt

Simple Sustainable Solutions ™

6

Approach to incremental improvement

Flowchart -VSM

1

Material at the source - Implementing Kanban replenishment

2

Organization - 5S

3

Muda - Removing waste

4

7

Receiving Inspection

743

Assemble cylinder

assembles

Shop order package

Parts sent in from

supppliers

Assemble Cuff Assemby

Quotation received from customer Approval Return to customer

Electrical testing

Final QC

Pack and ship

Accept?

No

No

Yes

Order material

Ultrasanically weld to

assemblies to together

Ship to customer

Inventory

Start with the process map


SIPOC process map


Value

Stream

Mapping

• Visualize the process

• Identify the delay

• Shows where the “bottlenecks” are

• Shows where your inventory is accumulating

Why?

• The demand of the customer should set the level of the production

• Don’t want a push process

• Process should be level loaded without big delays


15th Annual Medical Device Quality Congress


Production Control

SupplierCustomer

`

Assemble cylinder

assembly

Assemble cuff

assembly

Electrical test/QC

Pack/Shipping

Ultrasonic weld

C/T – sec

C/O – min

Uptime –

2 Shifts

43,000 sec available

C/T = 45 Sec

C/O = 10 mins

Uptime –

2 Shifts


C/T = 600 Sec

C/O = 240 mins

Uptime –

2 Shifts


C/T =720 Sec

C/O = 240 mins

Uptime –

2 Shifts


C/T =120 Sec

C/O = 120 mins

Uptime –

2 Shifts


I

Inv – days

I

Inv – days

I

Inv – days

I

Inv – days

I

Inv – days

Improve

Improve

Improve

66 days30 days

12 days10 days

Cost of carrying inventory ~ additional 15%

of part cost, more for finished product



Push vs. Pull

Push (MRP)

• Planning-the purchasing of raw

materials upon projected

demand regardless whether

consumption is taking place or

not.

Pull (Kanban)

• Raw materials are given

a predetermined quantity

to keep on hand and

consumption triggers

replenishment.

INVENTORY

R YOTNEVNI

Material Flow – Kanban



Kanban KanbanFinished

GoodsSupplier Customer

Level loading across the entire supply chain

Kanban process



Lower Limit - Trigger

Upper limit – Max Inventory

Re – Order

Buffer

Kanban calculation can be applied to anything



Daily Demand 1 soda/day

Supplier Lead Time 14 days

Package Quantity 12 pack

Supplier OTD % 100%

1 14Daily Demand Lead Time

12Package Quantity

1Cards Needed

1.16 – round up or down

10

Process Map – current process



Lost Cards

Delay in signal

Forget to signal

Order too much inventory

66 steps, 1 person (shipping and receiving)

Walking ~ 7 miles/year



eKanban software

(Synchrono)Kanban is

consumed

Supplier notified via

email

Material ShippedMaterial

receivedProduct is

built

Elimination of walking

Real time signals

No lost cards

54 hours gained back to improve process

Real time status

Bar code – eliminate data errors/10 second transaction

Bar code

Traceability and “right sized inventory”



12 pack

Kanban #1

12 pack

Kanban #2

Visual Factory – 5S activities


What you need is there

What is there is what you need

Visual Factory – 5S

activities

Process is

simple but

difficult

• Implement

• Sustain

Requires

respect for

everyone

15th Annual Medical Device Quality CongressQuality Lean Solutions, Copyright March 2018 20

How Pull Systems Reduces Waste (Muda)



• Defects

• Overproduction

• Waiting

• Non-Value Added

• Transportation

• Inventory

• Motion

• Employee Underutilization

Too many items can spoil!

Summary

Lean principles can be

implemented to increase quality,

reduce waste and increase

output

without compromising

compliance

Knowledge is power!

Start your lean journey now


Quality Lean Solutions, Copyright March 2018

Thank you!!

Jim Shore

[email protected]

www.qualityleansolutions.com

Follow me on Twitter - @Qualityleansoln

508.726.0574

23

mailto:[email protected]

http://www.qualityleansolutions.com/



If you can read this thank a teacher

If you like your freedom, thank a Veteran by supporting them

“Son, on behalf

of a grateful

Nation…”

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501(3)(c) Non-Profit Organization 100% of the royalties are donated to Veteran Services

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Quality Lean Solutions, Copyright March 2018

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https://asq.org/q

uality-

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item?item=H1509

100 % of royalties are

donated to Veteran

Services

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Reference informationProactive Supplier Management in the Medical Device Industry – James Shore and John

Freije


Start with Why – Simon Sinek

https://www.amazon.com/Start-Why-Leaders-Inspire-

Everyone/dp/1591846447/ref=sr_1_3?ie=UTF8&qid=1521993062&sr=8-

3&keywords=start+with+why&dpID=51fRj1bsD5L&preST=_SY291_BO1,204,203,200_QL40

_&dpSrc=srch

The Goal: A Process of Ongoing Improvement – Eliyahu Goldratt

https://www.amazon.com/Goal-Process-Ongoing-

Improvement/dp/0884271951/ref=sr_1_1?s=books&ie=UTF8&qid=1521993131&sr=1-

1&keywords=the+goal+by+eliyahu+goldratt&dpID=519C2Gz-

v2L&preST=_SY291_BO1,204,203,200_QL40_&dpSrc=srch

Value Stream Mapping

http://blog.gembaacademy.com/2008/02/24/lets-create-a-current-state-value-stream-map/

5S information

https://www.creativesafetysupply.com/content/education-

research/5S/index.html?utm_source=leansixsigmadefinition

http://leansixsigmadefinition.com/glossary/5s/




https://www.amazon.com/Start-Why-Leaders-Inspire-Everyone/dp/1591846447/ref=sr_1_3?ie=UTF8&qid=1521993062&sr=8-3&keywords=start+with+why&dpID=51fRj1bsD5L&preST=_SY291_BO1,204,203,200_QL40_&dpSrc=srch

https://www.amazon.com/Goal-Process-Ongoing-Improvement/dp/0884271951/ref=sr_1_1?s=books&ie=UTF8&qid=1521993131&sr=1-1&keywords=the+goal+by+eliyahu+goldratt&dpID=519C2Gz-v2L&preST=_SY291_BO1,204,203,200_QL40_&dpSrc=srch

http://blog.gembaacademy.com/2008/02/24/lets-create-a-current-state-value-stream-map/

https://www.creativesafetysupply.com/content/education-research/5S/index.html?utm_source=leansixsigmadefinition

http://leansixsigmadefinition.com/glossary/5s/

Keeping Your Quality System Trim: Lean Principles for GMPs

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