Professional Documents
Culture Documents
Presents a:
Date:
Outline
TS 16949:2002 Executive
Overview
Quality Management Principles
Process Approach
New/Changed Requirements related to
Management Responsibility
TS 16949 Is . . .
A process approach for:
Implementing an effective quality
management system, and
Enhancing customer satisfaction
through continual improvement
emphasizing defect
prevention and reduction of
variation;
Bias
One World
One Quality System
QS 9000 standards contain loopholes
Too many companies have only sought to meet
minimum requirements and then only by
twisting the intent of the existing standards
There is a growing demand for
performance excellence
QS 9000 is not sufficiently performance oriented
ISO 9001:2000 is process/performance oriented,
but by itself is not yet viewed as a performance
excellence standard for automotive manufacturers
9
#1
Performance Excellence
Malcolm Baldrige Criteria
Competitive
Performance Improvement
TS 16949
Efficient
Baseline Performance:
ISO 9001:2000
Advantage
Effective
Quality Management System
10
ISO 9001:2000
Quality Management Principles
Customer Focus
Leadership
Involvement of People
Process Approach
System Approach
Continual Improvement
Factual Approach to Decision Making
Mutually Beneficial Supplier Relationships
11
Customer Focus
Organizations depend on their
customers and therefore should:
understand current and future customer
needs;
meet customer requirements; and
strive to exceed customer expectations.
12
Leadership
Leaders should:
establish unity of purpose and
direction of the organization, and
create and maintain the internal
environment in which people can
become fully involved in
achieving the organizations
objectives.
13
Process Approach
INPUT
ACTIVITY
OUTPUT
14
What is a Process?
Activity that transforms input into output
Input
Activity
Output
Resources:
Results:
People
Facilities/Equipment
Material
Methods
Products
Services
Performance
15
Input
Activity
Right Resources:
Qualified People
Right Facilities/Equipment
Correct Materials
Proven Methods
16
Output
Desired Results:
Quality Products
Quality Services
Customer Satisfaction
Input
Effective
Activity
Output
Right Resources:
Desired Results:
Qualified People
Right Facilities/Equipment
Correct Materials
Proven Methods
Quality Products
Quality Services
Customer Satisfaction
17
System Approach
Identify, understand, and manage
interrelated processes (system)
the output of one process is the
input to one or more subsequent
processes in the system
these interfaces must be managed to ensure
the outputs of a process meet the input
requirements of related process(es) that
follow
18
TS 16949 implements
the PDCA improvement cycle
Plan
Clause 5. Management responsibility - everything
flows from Management who define the requirements for
the system
Clause 6. Resource management - from these
requirements the resources will be identified and
management must ensure they are provided and applied
within the system
Do
Clause 7. Product (and/or service) realization - the
necessary process are established and carried out
20
TS 16949 implements
the PDCA improvement cycle
Check
Clause 8. Measurement, analysis and
improvement - processes and products will be
monitored and measured against policies, objectives and
requirements for the product and results/opportunity for
improvement reported
Act
Clause 8. Measurement, analysis and
improvement - acting upon data reported in the check
cycle, improvement actions can be taken - directly, or as
an output of the Management Review process (Clause
5.6)
21
C
U
S
T
O
M
E
R
R
E
Q
U
I
R
E
M
E
N
T
S
Management
Responsibility
Resource
Management
Measurement
Analysis &
Improvement
Product
Realization
Input
Product
Output
22
C
U
S
T
O
M
E
R
S
A
T
I
S
F
A
C
T
I
O
N
Involvement of People
People at all levels are the essence of
an organization, and
their full involvement enables . . .
their abilities to be used . . .
for the organizations benefit
23
Continual Improvement
Continual
Continuous
Plan
Act
QMS
25
Results
Do
Check
Factual Approach
to Decision Making
Effective decisions are:
26
Performance Against
Desired Results
Actions are taken when targets/goals
NOT achieved, especially as they may
relate customer targets/goals for:
Mutually Beneficial
Supplier Relationships
An organization and its suppliers
are inter-dependent so:
a mutually beneficial relationship
enhances the ability of both
to create value.
28
TS 16949:2002
Supplier Expectations
ISO 9001:2000 Registration, and
customer approved processes for:
ISO 9001:2000
Quality Management Systems Requirements
ISO 9004:2000
Quality Management Systems Guidelines for Performance Improvements
30
31
32
33
(and/or service)
realization
Role of TS 16949
Developed as a stand-alone document
Includes ISO 9001:2000 in its entirety
Numerous additional automotive
customer requirements
36
EXERCISE #1
Pick one of the eight quality management principles and list three
of the most important actions you think your organization should
take in applying this principle.
1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________
37
TS 16949
in a nutshell
Clause 4.1 Establish a quality management
system and continually improve its
effectiveness
a) identify processes needed for the QMS
b) determine the sequence and interaction of these
processes
c) determine criteria and methods needed to ensure these
processes are effective
d) ensure availability of resources and information need to
support the operation and monitoring of these processes
e) monitor, measure and analyze these processes, and
f) implement actions need to achieved planned results and
continual improvement of these processes
38
39
40
41
42
5.4 Planning
5.4.1 Quality objectives.
Must be measurable & consistent with quality policy
Must be established at relevant functions and levels in the
organization
Must include those needed to meet product requirements
(identified per Clause 7.1 a)
QS-9000 1998 Cross Reference: None
Note: Establish quality objectives for relevant functions and levels; objectives to be measurable.
43
44
Measurable Objectives
Improve Customer
Satisfaction
Improve Processes
(through teamwork aimed at reducing scrap, rework, waste, cycle time variation, etc.)
(through teamwork aimed at reducing defects, returns, within spec variation, etc.)
45
Design
Production
46
47
48
49
50
51
52
EXERCISE #2
How can you use TS 16949 to help deal with business needs and
external challenges?
___________________________________________________________
___________________________________________________________
___________________________________________________________
53
54
Effectiveness
assessed in
audit report
Management
review
9001:2000/TS 16949
Internal audit
Customer
satisfaction
Other data
55
Management
determines
effectiveness by
analyzing all
available data
and information
Management
review
An interface Organizational/
External environment input (I)
An interface Organizational/
External environment output (O)
Organization
I
Check input
against
output.
Customers
Customers
Customers
Customers
Measurement,
analysis and
improvement
Resource
management
Satisfaction
Key
Informationflow
Valueaddingactivities
Requirements
56
Input
Product
realization
Product
Output
1
10
7
8
57
Examples of COPs
Finished
Prototype
Product
Specifications
Determined
Production Run
and Optimized
Product
Analyzed and
Request for
Change Issued
Prototype
Delivered
Prototype
Requested
Product
Validation
Warranty
Request
Product
Realization
Warranty
Warranty
Request
Accepted
Customer
Feedback
Performance
Reports
Product Design
Order Accepted
Order / Request
Corrective actions,
Preventive actions,
Continual
Improvement
Market Analysis
Bid Awarded
with
Specifications
Bid / Tender
Bid Proposal
Request for
Quote from
Customer
58
Information
about Product
Line(s)
Sales and
Marketing
Research of
Market
59
60
Exercise # 2
1.
2.
3.
4.
61
Process Approach
(Managers Define / Auditors Assess)
1. Process Scope and Boundaries
2. Process Flow, including:
2.1 Inputs used to effect process completion
2.2 Events that start process activity
2.3 Activities required to complete the process
2.4 Validation that process is effective
2.5 Events that signal process completion
2.6 Outputs resulting from process completion
3. Process metrics and statistics (to monitor/measure)
4. Process Change Management
5. Tools used to fulfill process requirements
6. Controlled Documents
7. Quality Records
62
Turtle Diagram
63
Exercise # 3
1.
2.
3.
4.
5.
6.
65
www.iso.org
www.bsi.org.uk/iso-176-sc2
www.asq.org
www.aiag.org
www.qualitymap.com
Other questions?
IsoQual, Inc. Staff
66
Email: isoqual@bellsouth.net
call (502) 299-6122
or