DFSS

Poka - Yoke
(Mistake Proofing)

SPC

Operational Method
Sheets (OMS)

Written Instructions

Verbal Instructions

Step 12
Introduction to Control

AMOUNT OF CONTROL

Amount of Effort Expended by the Process

Six Sigma Methodology

Step 12 - Control Phase

Implement Process Controls

How do we make sure it stays fixed?

The Xs you have determined as vital, their settings, and other actions you
have taken to make the improvement must be:
Nailed down
Set in concrete
Fully implemented (NOT just agreed to)
Put into a rigorous audit schedule
BEFORE you can say a project is closed!

Six Sigma Breakthrough Steps

Define
Measure

Analyze

Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Step 7

Improve

Step 8
Step 9
Step 10
Step 11

Control

Step 12

- Select Output Characteristic

Identify Process Input/Output Variables

Define Performance Standards
Validate Measurement System
Establish Process Capability
Define Performance Objectives
Identify Variation Sources
Screen Potential Causes
Discover Variable Relationships
Establish Operating Tolerances
Validate Measurement System
Determine Process Capability
Implement Process Controls

Real World Scenario:

Example
Your team has managed to work their way though
a tough problem using Six Sigma Breakthrough
Strategy. The team has managed to learn and
understand the technical concepts. The Black Belt
is reporting projected savings based on todays
data, based on todays accomplishments.
How can the Black Belt walk away and be
confident that the gains will be sustained?

Quality System Introduction Agenda

Class Brainstorming Exercise
What is a Quality System?
How does the Six Sigma Breakthrough Strategy
assist the Quality System?
Why should Black Belts want a good Quality
System?

Class Brainstorming Exercise

Exercise: Write down three very specific actions
that you will take to ENSURE the gains from your
project are sustained PERMANENTLY when you
walk away.
Results: Each individual will share ONE action
with the class.
Are you sure this action will PERMANENTLY fix
the problem?

DFSS

Poka - Yoke
(Mistake Proofing)

SPC

Operational Method
Sheets (OMS)

Written Instructions

Verbal Instructions

Aspects of Control

AMOUNT OF CONTROL
Amount of Effort Expended by the Process

Employ the Control Technique that ensures the Greatest Control

with the Least Amount of On-Going Effort from the Process

What is a Quality System?

A Quality System is an organizations agreed upon
method of doing business
It is not to be confused with a set of documents
that are meant to satisfy an outside auditing
organization (e.g. ISO/TS 16949 )
This means a Quality System represents the
actions, not the written words of an organization

Elements of a Quality System

Quality Policy
Organization for Quality (does not mean Quality Department!)
Management review of Quality
Quality Planning (how to launch and control products and processes)
Design Control
Data Control
Purchasing
Approval of materials for on-going production
Evaluation of suppliers
Requirements are aimed
Verification of Purchased Product (does not mean incoming
primarily at achieving
inspection!)
customer satisfaction by
PREVENTING nonconformity
at all stages from design
through servicing

Elements of a Quality System

Product identification and traceability
Process Control
Government Safety and Environmental Regulations

Designation of Special Characteristics

Preventative Maintenance
Process Monitoring and Operator Instructions

Preliminary Capability Studies (how to turn on a process)

Ongoing process performance requirements (how to run a process)
Verification of set-ups

Inspection and Testing

Requirements are aimed

primarily at achieving
customer satisfaction by
PREVENTING nonconformity
at all stages from design
through servicing

Elements of a Quality System

Control of Inspection , Measuring, and Test Equipment

Calibration
Measurement System Analysis

Control of Nonconforming Product

Corrective and Preventative Action
Handling, Storage, Packaging, Preservation, and Delivery
Control of Quality Audits (do what we say we do?)
Training
Requirements are aimed
primarily at achieving
Service
customer satisfaction by
Use of Statistical Techniques
PREVENTING nonconformity
at all stages from design
through servicing

Breakthrough Strategy - Quality System

Specifics from ISO/TS 16949 as they apply to us
Section 4.1.2.1 - define and document organizational freedom
and authority to:

a) Initiate action to prevent the occurrence of any

nonconformitys relating to the product, process and
Quality System;
b) Identify and record any problems relating to the
product, process, and Quality System;
c) Initiate, recommend or provide solutions through
designated channels;
d) Verify the implementation solutions

Breakthrough Strategy - Quality System

Specifics from ISO/TS 16949 as they apply to us
4.11.2
a) select appropriate inspection, measuring and test equipment that is
capable of the necessary accuracy (calibration) and precision (gage

studies);
4.14.1
The supplier shall establish and maintain documented procedures
for implementing corrective and preventative action.
Any corrective or preventative action taken to eliminate the
causes of actual or potential nonconformitys shall be to the
degree appropriate to the magnitude of problems and
commensurate with the risks encountered.
The supplier shall implement and record any changes to the
documented procedures resulting from corrective and preventive
action.

Breakthrough Strategy - Quality

System
Specifics from ISO/TS 16949 as they apply to us
4.14.2
The procedures for corrective action shall include:
a) The effective handling of customer complaints and reports of
product nonconformity's; (data collection system)
b) Investigation of the cause of nonconformities relating to
product, process, and Quality System, and recording the results of
the investigation; (project selection)
c) Determination of the corrective action needed to eliminate
the cause of nonconformity's; (measure, analyze, improve)
d) Application of controls to ensure that corrective action is
taken that it is effective. (control)

Breakthrough Strategy - Quality

System
Specifics from ISO/TS 16949 as they apply to us
4.14.3
The procedures for preventive action shall include:
a) The use of appropriate sources of information such as processes
and work operations which affect product quality, concessions, audit
results, quality records, service reports and customer complaints to
detect, analyze and eliminate potential causes of nonconformity's;
(potential causes are identified by FMEA)
b) Determination of the steps needed to deal with any problem
requiring preventive action;
c) Initiation of preventive action and applications of controls to ensure
that it is effective;
d) Ensuring that relevant information on actions taken is submitted
for management review. (Black Belt project reviews)

Breakthrough Strategy - Quality

System
Specifics from ISO/TS 16949 as they apply to us
4.18
The supplier shall establish and maintain documented procedures for
identifying training needs and provide for the training of all personnel
performing activities affecting quality. (what personnel do not affect
quality?)

4.20
4.20.1 Identification of need: The supplier shall identify the need for
statistical techniques required for establishing, controlling and
verifying process capability and product characteristics.
4.20.2 Procedures: The supplier shall establish and maintain
documented procedures to implement and control the application of
the statistical techniques identified in 4.20.1.

Why Should BBs want a Quality System?

Quality System certifications are becoming a customer
requirement as well as a requirement to engage in new
business opportunities. Your project area can be a show place
for the rest of the organization.
A solid Quality System can provide the means through which
your project will sustain its gains, long-term.
The control phase of Black Belt training requires that a solid
Quality System be employed in your immediate project area.

Control Methods Agenda

Integrating with Lean Manufacturing
Ranking Control Methods (The Strategy)
Types of Control Methods
Product vs. Process
Automatic vs. Manual
Control Plan

Control Methods are a Form of Kaizen

Based on the Toyota Production System
Pre-Control
Xbar-R Charts
P & NP Charts
C & U Charts
Mistake Proofing
I-MR Charts
EWMA
Cusum
Realistic Tolerancing

Standardized Work

Kan Ban
We can not
sustain Kan Ban
without Kaizen

Kaizen

We can not sustain Kaizen

(Six Sigma) without
Standardized Work
We cannot sustain Standardized
work without the Visual Factory

Visual Factory

We can not sustain a visual factory without 5S

5S Work Place Organization

SPC Control Methods

SPC on (Xs) or (Ys) without proper
training = WALL PAPER
Warning Signal used to attempt to detect
defects. Operators will learn to ignore or
disconnect the warning signals once
production becomes #1 priority. PEOPLE
ACT ON WHAT THEY ARE MEASURED ON!!!
S.O.P is implemented to attempt to detect
defects. If action is not taken, the SPC is
not sustainable short-term or long-term.

Worst

SPC Control Methods (continued)

SPC on (Xs) or (Ys) with fully trained
operators. The operators have been
trained and understand the rules of
SPC, but management will not
empower them to stop or
investigate.
Operators using SPC without
management support are essentially
doing inspection. They are looking for
defects, not the causes.

Better

SPC Control Methods (continued)

SPC on (Xs) or (Ys) with fully trained
operators and staff who respects the rules.
Once a chart signals a problem everyone
understands and agrees to shut down for
special cause identification/elimination.
Properly applied SPC that detects an error
condition will act as a flag and shut down the
equipment so defect will not move forward.
In the best situation, SPC will predict an error
before it occurs, defect will never be created.
Best

Types of Control Methods

Types of Control Methods
Product Monitoring SPC Techniques (on Ys)

Pre-Control (manual or automatic)

Xbar-R or I-MR Charts (manual or automatic)
P & NP Charts (manual or automatic)
C & U Charts (manual or automatic)

Process Control SPC Techniques (on Xs)

Mistake Proofing (automatic)

Xbar-R or I-MR (manual or automatic)
EWMA (automatic)
Cusum (automatic)
Realistic Tolerancing (manual or automatic)

The Control Plan

A living document which is used to document
all you process control methods.
*Definition: The control plan is a written
description of the systems for controlling parts
and processes (or services). The control plan
is a living document and should be updated to
reflect the addition / deletion of controls
based on experience gained by producing
parts (or providing services).

The Goal and The Vision

The immediate GOAL of the Quality System (QS):

During the Control Phase of the QS Methodology:

The TEAM should 5S the project area
The TEAM should develop Standardized Work instructions
The TEAM should understand and assist with the
implementation of process and product control systems
The TEAM should document all of the above and live by
what they have documented

The Goal and The Vision

The Long-Term VISION of the Quality System:

The COMPANY and all of its suppliers have a Quality
Systems that govern the ways in which products and services
are bought, sold, and produced.
The COMPANY should be 5S all areas.
The COMPANY should develop Standardized Work
instructions and procedures
The COMPANY should understand and assist with the
implementation of process and product control systems
The COMPANY should document all of the above and live by
what they have documented