Lean Manufacturing in a

Regulated Environment
Joe Ely
VP-Operations
Cook Biotech, Inc.
 Today’s Objectives
• Describe Lean Manufacturing
– Four ways of capturing its practice
• Discuss how it can exist in a regulated
environment
– Critically examine in each of the four ways
 Where did Lean come from?
• Toyota Production
System
• Gained fame due to
Toyota’s success
and openness
What is Lean?
 1. Toyota’s House Diagram
Waste

Quality at the
Make what I
Source
need and no
more

No improvement
w/o standards
 2. Muda, Mura, Muri
• Muda = “Waste” or failures of people or
processes to efficiently deliver product.
• Mura = “Unevenness”, or failures related to
unpredictable or inconsistent outputs.
• Muri = “Overburden”, or failures of
standardization to create efficient process.
 The Seven Wastes
• Overproduction
• Defects
• Waiting
• Inventory (Excess)
• Transportation
• Motion
• Over Processing
 Overproduction
• Producing more than the customer requires.
– Why is it a waste?
• Used up resources (time, people, raw materials) that could have
been used for something that is needed
• Usually leads to waste of Inventory (excess)
– Examples
• Producing product when there are no signals
• Making a pot of coffee at 5pm
• Running 50 samples when 25 would give you enough information
– Countermeasure
• Kanban System
 Defects
• Process/product/service that fails to meet specifications
– Why is this a waste?
• Used up resources (time, people, raw materials) that will be scrapped
• More resources will be used to correct
– Examples
• Incorrect pattern cut in product
• A purchase order without a managers signature
• Spelling and grammatical errors in a report
– Countermeasures
• Poka-Yoke (mistake proofing)
• Line Stops
• Single Piece Flow
 Waiting
• People in a process delayed or stopped.
– Why is this a waste?
• Occupying a human resource that could be performing a value-
added step
– Examples
• Waiting for an intermediate component
• Waiting for a machine to finish
• Waiting for approvals
– Countermeasures
• Single piece flow
• Reduce cycle time
• “Pooling”
 Inventory (Excess)
• Raw materials, purchased parts, WIP, and finished goods not yet sold.
– Why is this a waste?
• Takes up space that could be used for value adding steps
• Tends to hide other problems
– Examples
• Excess intermediate assemblies
• Pens in the paper mill
• Rough drafts of a report
– Countermeasures
• Kanban System
• Water spider routes
• Limiting space
 Transportation
• Movement of materials or other items from one place to
another.
– Why is this a waste?
• Occupies more time of a resource
• Creates more opportunities for damage
– Examples
• Forktrucks moving material
• Bringing a document over for approval
– Countermeasure
• Spaghetti Diagram
• Improving floor layout
 Motion
• Non-value-added movement of a person’s body.
– Why is this a waste?
• Can increase cycle time
• Often leads to Ergonomic issues
– Examples
• Wiping down a laminar flow hood
• Reaching for a computer mouse
• Putting on safety glasses
– Countermeasures
• Ergonomics (body in neutral position)
• Workstation Layout
 Over-Processing
• Work being performed beyond what is required to satisfy
customer.
– Why is this a waste?
• Excess resources used
– Examples
• Using higher grade raw material than required
• Extra approvals on a report
• Typing a Memo, instead of leaving a post-it note
– Countermeasures
• Appropriate technology
• Identifying value from the customer
 2. Muda, Mura, Muri
• Unevenness
– a gyrating schedule not
caused by end-consumer
demand but rather by the
production system, or
– an uneven work pace in
an operation causing
operators to hurry and
then wait.
• Eliminated by managers
through level scheduling
and careful attention to
the pace of work.
 2. Muda, Mura, Muri
• Overburdening
• requiring people or
machines to run at a
higher or harder pace
with more force and
effort for a longer
period of time than
equipment designs
and appropriate
workforce
management allow
 2. Muda, Mura, Muri
• Lean says the solutions rests with Managers
to eliminate waste, unevenness and
overburdening
 3. Five steps of Lean
• “Lean Thinking” by Womack and Jones, 1996
– Value
– Value Stream
– Flow
– Pull
– Perfection
 3. Five steps of Lean
• Value
– Would the
customer pay me
to do this?
– Does it
transform the
material toward
the end result?
 3. Five steps of Lean
• Value Stream
– What is the
sequence of
steps?
– Which add
value?
– What’s the total
cost of value-
adding steps?
 3. Five steps of Lean
• Flow
– Eliminating
pauses between
steps
– Very small Work
in Process
Inventory
 3. Five steps of Lean
• Pull
– Use when you Signal
can’t flow
– Signal to start Production

– Minimal
inventory
– Build to order
Inventory
 3. Five steps of Lean
• Perfection
– Relentlessly
Improve
– Measure
– Cut waste in half,
stabilize, cut it in
half again.
 4. Four Rules of Lean
• “Decoding the DNA of the Toyota Production System,”
Spear and Bowen, HBR, Sept-Oct 1999
– Rule 1: All work shall be highly specified as to content,
sequence, timing, and outcome.
– Rule 2: Every customer-supplier connection must be direct,
and there must be an unambiguous yes or no way to send
requests and receive responses.
– Rule 3: The pathway for every product and service must be
simple and direct.
– Rule 4: Any improvement must be made in accordance
with the scientific method, under the guidance of a
teacher, at the lowest possible level in the organization.
 4. Four Rules of Lean
• Rule 1: All work
shall be highly
specified as to
content,
sequence, timing,
and outcome.
 4. Four Rules of Lean
• Rule 2: Every
customer-supplier
connection must be
direct, and there
must be an
unambiguous yes or
no way to send
requests and receive
responses.
 4. Four Rules of Lean
• Rule 3: The
pathway for
every product
and service must
be simple and
direct.
 4. Four Rules of Lean
• Rule 4: Any
improvement
must be made in
accordance with
the scientific
method, under
the guidance of
a teacher, at the
lowest possible
level in the
organization.
How does Lean fit within a
regulated Environment?
 1. Toyota’s House Diagram
Waste. Not a
concern.

Quality at the
Indifferent. Source.
Regulations are Good…increases
silent. reliability, lowers
risk

Regulators LOVE
this!! Core to
their interest
This raises a concern if
change is not well controlled
 2. Muda, Mura, Muri
• Muda = “Waste” or • Muda = “Waste” . Not a
failures of people or big issue
processes to efficiently
deliver product. • Mura = “Unevenness”
• Mura = “Unevenness”, Of some interest but
or failures related to only as related to risk of
unpredictable or error.
inconsistent outputs. • Muri = “Overburden”, A
• Muri = “Overburden”, significant concern, due
or failures of to adequate capacity
standardization to for quality.
create efficient process.
 3. Five steps of Lean
• “Lean Thinking” by – Value
Womack and Jones, 1996 • Moderate interest in
filling needs
– Value – Value Stream
– Value Stream • High interest, esp in
vendors
– Flow – Flow
– Pull – Pull
• Indifferent, except as
– Perfection effects quality
– Perfection
• Want improvement
but well-controlled
 4. Four Rules of Lean
• “Decoding the DNA of the Toyota Production System,”
Spear and Bowen, HBR, Sept-Oct 1999
– Rule 1: All work shall be highly specified as to content,
sequence, timing, and outcome.
– Rule 2: Every customer-supplier connection must be direct,
and there must be an unambiguous yes or no way to send
requests and receive responses.
– Rule 3: The pathway for every product and service must be
simple and direct.
– Rule 4: Any improvement must be made in accordance
with the scientific method, under the guidance of a
teacher, at the lowest possible level in the organization.
 4. Four Rules of Lean
• Rule 1: All work shall be highly specified as to
content, sequence, timing, and outcome.
– Very favorable—standard work, which can be
evaluated
• Rule 2: Every customer-supplier connection
must be direct, and there must be an
unambiguous yes or no way to send requests
and receive responses.
– Favorable – clarity and “digital” response
 4. Four Rules of Lean
• Rule 3: The pathway for every product and
service must be simple and direct.
– Favorable. Allows clear metrics and visibility of
quality.
• Rule 4: Any improvement must be made in
accordance with the scientific method, under the
guidance of a teacher, at the lowest possible level
in the organization.
– Preferred approach to improvement, with emphasis
on data in a scientific method.
 Today’s Objectives
• Describe Lean Manufacturing
– Four ways of capturing its practice
• Discuss how it can exist in a regulated
environment
– Critically examine in each of the four ways
Thank you for your attention!

Joe Ely
VP-Operations
Cook Biotech, Inc.