Operational Excellence in

Biopharmaceuticals
5. Six Sigma, Kaizen, Analyse Phase, 5S
Jim McKiernan

October 2014

Content

Six

Sigma, continued

Continuous
Analyse
Root
5S

Improvement - Kaizen

Phase

Cause Analysis (RCA)

Course Outline and Timings

Introductions

Date

Event

Content

Timing

16 Sept 11-1

Face to
Face

Intro, Business Context, Operational Excellence Overview, LSS

Structure, DMAIC, Project selection and initiation

2 hours

2 Oct 12-13

Face to
Face

The Define phase, Benefit definition

1 hour

2 Oct 13-14

Face to
Face

Measure phase, Process mapping, data types and measurement.

Intro to stats

1 hour

21 Oct 11-13

Face to
Face

Measure phase, Process mapping, data types and measurement.

Intro to stats

2 hours

28 Oct 11-12

Webinar

Six Sigma, Analyse Phase, Kaizen, 5S

1 hour

10 Nov 11-12

Webinar

Analysis Phase, Six Sigma, Root cause analysis

1 hour

17 Nov 11-12

Webinar

Data analysis, Design of experiments

Improve phase

1 hour

25 Nov 11-13

Face to
Face

Change management, team dynamics and team leadership, Control

phase, project follow-up and ensuring sustainability

2 hours

28 Nov 9-10

Webinar

Test preparation, course review and open questions

1 hour

11 Dec 12-14

Test

Multiple choice, open-book

2 hours

Six Sigma and Customer Focus

The first question in any Six Sigma project is Who is the

Customer?
Patients, doctors, wholesalers, pharmacies, hospitals
FDA, IMB, EMA
Fill/Finish, Warehouse, Customer Service

Six Sigma and Customer Focus

Then we ask What do they want from us?

Physical Product
In which configuration?
Information
What, where, when, how?

Operational Excellence Concepts

Why is Six Sigma so successful?

Strong Customer Focus

Senior management involvement (Top Down)

Rigorous, disciplined approach with a common language
Short duration projects (3-6 months)
Clearly defined measures of success (bottom line)
Promotes learning culture
Infrastructure for developing key people
Very adaptable, fits well with other programmes

What if?

Applying Six Sigma

You could select one of your biggest problems . . . ?

Identify some of your best people to work on it . . . ?
Provide those people with all the training, tools, and
resources they needed to fix it . . . ?
Guarantee them uninterrupted time and focus to
work on it . . . ?
And then get a well thought out and data driven
solution . . . ?

Challenge the conventional wisdom

Challenge the conventional wisdom
But thats the way weve always done it

In God
God We
We Trust,
Trust, The
The Rest
Rest Bring
Bring Data
Data .. .. ..
In

Six Sigma
A Practical Approach to Continuous Improvement

The precise definition of Six Sigma is

not important; the key ingredients are
Scientific:
Structured approach.
Quantitative data.
Show me
the money

Show me
the data

Practical:
Emphasis on financial result.
Start with the voice of the customer.

All improvement takes place project by project, and in no other way

Dr. Joseph M Juran

Kaizen
Kaizen

is a Japanese word :

Operational Excellence Concepts

Kaizen (Continuous Improvement)

What is Continuous Improvement?

Benefits

Tools and Rules

Implementation techniques

Kaizen

Operational Excellence Concepts

What is Continuous Improvement?

Ongoing improvement brought about by a never-ending series of small changes

Complements innovative improvement strategies
Emphasises small gradual changes rather than larger scale changes that can often
paralyze the workplace
An ongoing process rather than a once-off project

Kaizen

Operational Excellence Concepts

Benefits of Continuous Improvement

Can eliminate the need for large scale quantum shifts

Evolutionary rather than revolutionary
Focus on Simple and constructive rather than complex solutions
Involves employees, usually front line, in getting things right
Complements innovative leaps and breakthroughs
Reduces cost, and improves performance
A can do attitude becomes a way of workplace life

Kaizen
Making it work

Ongoing Top Management commitment and support with a clearly articulated and
understood vision for the business
Strong focus on customers
Management by facts
Empowered and engaged workforce learning by doing

Making KAIZEN a process and not a project

Creating a KAIZEN culture and managing the culture change

Seeing employees as part of the solutions and not causes of problems (No Blame!)

Involving all employees and training employees on teamwork and problem solving tools

Fostering and facilitating teamwork

What is a Kaizen Activity

Kaizen Event - Approach

Operational Excellence Concepts

Kaizen

Basic Rules for Kaizen

Do not spend money for KAIZEN, use your wisdom.

Wisdom is brought out when faced with hardship

Ask WHY? five times and seek root causes.

Seek the wisdom of 10 people rather than the knowledge of one.

KAIZEN ideas are infinite

Source: Kaizen Institute Ltd.

Operational Excellence Concepts

Kaizen and linking to Visual Management

Visual Management

Integral part of Kaizen

Display charts, lists, records of performance

Management and workers aware of elements that make quality, cost and delivery
successful

Problems should be visible

Standards should be visible

Targets should be visible

The Analyze Phase in DMAIC

Analyze is the third phase in the 5-step DMAIC cycle used in Lean
and Six Sigma projects
This phase is all about identifying activities that create value, those
that create waste and the root causes of problems
The M (measure), A (analyze) and I (improve) phases are usually
iterative and not linear
A key step in this phase is to develop detailed current state maps
in order to identify VA (Value-adding) and NVA (non value-adding)
activities
We should also start doing some cause-effect analyses

The Analyze Phase The Toolbox

Tool

Used for

Outputs

Process Maps

Map current processes, identify VA,

NVA

VA/NVA activities

Pareto Analysis

Prioritization

Areas on which to focus (80/20

rule)

5 Whys

Getting subjective, qualitative input to

get to root causes

Root causes

Cause-Effect Matrices

Understand relationships between

dependent and independent variables

Causal relationships

Cause and Effect Charts

(Ishikawa)

Brainstorming causes of problems

usually under 6 headings

Root causes

Charts bar, histograms,

box plots, scatter
diagrams, time series

Visualizing data

Areas for focus, identified trends

ANOVA

Analysis of Variances, Compares

means of different populations

Interpretation of Null Hypothesis

Analyse

Root Cause Analysis - Cause & Effect (fishbone) diagram

Causes (x)
manpower

materials

method

Effect (y)
problem
statement

mother
nature

measurement

machinery

Operational Excellence Concepts

Root Cause Analysis 5 Whys

In Ohnos classic example (From his book on the Toyota Production System):

Why did the machine stop? There was an overload and the fuse blew.

Why was there an overload? The bearing was not sufficiently lubricated.

Why was it not lubricated sufficiently? The lubrication pump was not pumping
sufficiently.

Why was it not pumping sufficiently? The shaft of the pump was worn and rattling.

Why was the shaft worn out? There was no strainer attached and metal scrap got in.

Introduction to 5S

Operational Excellence Concepts

5S Philosophy

Based on 5 Japanese words that begin with s

Focuses on effective work place organisation and standardised work procedures

Simplifies the work environment

Reduces waste and non-value activity

Can improve quality, efficiency and safety

5S

Operational Excellence Concepts

Sort (Seiri) focuses on eliminating unnecessary items from the workplace

Set in order (Seiton) focuses on efficient and effective storage methods

Shine (Seiso) cleaning the whole place and doing this on a daily basis to maintain the
improvement

Standardize (Seiketsu) standardising best practice in the work area involving

employees in the development of such standards

Sustain (Shitsuke) focuses on defining a new status quo and standard of work place
organisation (most difficult to achieve as human nature is to resist change)

5S

5S

Can also be seen as 5C

Clear Out focuses on eliminating unnecessary items from the workplace

Configure focuses on efficient and effective storage methods

Clean and Check cleaning the whole place and doing this on a daily basis to maintain
the improvement

Conformity standardising best practice in the work area involving employees in the
development of such standards

Custom and Practice focuses on defining a new status quo and standard of work place
organisation (most difficult to achieve as human nature is to resist change)

5S

Sort

Identify what is needed and to be kept

Dispose of un-needed items

Each workplace should only have the essentials to do the job

How

Have a tidy-up session and throw out rubbish

Attach red tags to items not required and move to a holding area

Locate items needed close to the point of use

5S

Red Tag Procedure

5S

Set in Order

A place for everything and everything in its place Ship shape

Eliminate searching time

How

Determine locations close to the place required

Organize shelving, cabinets (use pictures, glass doors to assist

visualization

Clearly label each item/storage location

Indicate quantity

5S

5S

Shine

Is the area visibly clean, tidy and safe?

Identify causes of grime, dirt, contamination

Eliminate causes and protect against deterioration

How

Cleanliness is a part of daily activities

Inspect equipment for damage

Repair faults and damage so that equipment is always ready for

use

5S

5S

5S

Standardize

Ensure everyone in the area is aware of standard work required to

maintain the new order

Examples could include

Shelves to store QC samples inbound to lab
Tooling needed on a production line and configuration on a
shadow board

How

Write down the standard (rules, cleaning frequency, ways of

working, SOPs

Assign responsibilities

Train

5S

Sustain

Maintain clarity of senior management commitment

Maintain equipment in a constant state of readiness

5S is the way of working not a project

How

Regular audits and results reporting

Involvement of all

Develop habits that are hard to break

Redefine standards

Review and refine

5S