1 Presents a: Two Hour ISO/TS 16949:2002 Executive Overview
Presented by: Date: Your Company
Slide 2
2 Outline TS 16949:2002 Executive Overview Quality Management
Principles Process Approach New/Changed Requirements related to
Management Responsibility
Slide 3
3 TS 16949 Is... A process approach for: Implementing an
effective quality management system, and Enhancing customer
satisfaction through continual improvement Based on ISO
9001:2000
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4 What does ISO 9000 accomplish? Gives the organization
confidence that customer requirements are being met; Gives the
customer confidence that products and services are consistent;
Provides or sustains market entry; and Helps an organization
achieve, sustain, and improve product/service quality by managing
the processes that create them.
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5 Goals for TS 16949 Provide a model for continual improvement
in the automotive supply chain, emphasizing defect prevention and
reduction of variation ; Define fundamental quality system
requirements AND customer specific requirements (i.e. TS 16949
plus) uniquely applicable to the automotive industry; and Avoid the
need for multiple certification audits.
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6 Why Standardize Quality Management Systems? Provides a common
basis for doing business and managing quality, globally; Allows
diverse companies to exchange products and services with greater
confidence; and Reduces the need to satisfy multiple (often
contradictory) standards.
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7 ISO 9000 is the Most Successful Standard in ISO History Over
500,000 registrations world-wide in over 160 countries from all
continents Over 40 sectors or industry classifications led by:
electrical/optical equipment, metal products, construction,
machinery, wholesale/retail trade but growing in acceptance by many
others, including: engineering, information technology,
health/social work, utilities, transportation, public
administration, education, and other services.
Slide 8
8 Why did the ISO 9001/2:1994 Standards Need Revision? Bias
Wording/terms biased towards manufacturing Problems with the 20
element model Difficult for small businesses to adapt Flow
incompatible with how companies do business Incompatible with other
models (ISO 14000 EMS e.g.) Not sufficiently forward looking Does
not smoothly facilitate the move from baseline quality to
performance excellence required by evolving user and customer needs
(MBNQA, e.g.).
Slide 9
9 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
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10 The Performance Pyramid Competitive Advantage Efficient
Quality Management System Effective Quality Management System
Business Vision Performance Excellence Malcolm Baldrige Criteria
Performance Improvement TS 16949 Baseline Performance: ISO
9001:2000 # 1
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11 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
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12 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.
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13 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.
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14 Process Approach Monitor more than process output:
(typically through inspection activities) Monitor inputs and
transformation activities as well: (i.e. define/control input,
develop controls and mechanisms to manage the activity, and
define/measure output in terms of desired results that are linked
to established the organizations performance and improvement
objectives)
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15 What is a Process? Activity that transforms input into
output Activity InputOutput Resources: People Facilities/Equipment
Material Methods Results: Products Services Performance
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16 How is a Process Managed? Activity InputOutput Right
Resources: Qualified People Right Facilities/Equipment Correct
Materials Proven Methods Desired Results: Quality Products Quality
Services Customer Satisfaction Monitor & Measure the Process
make sure the inputs are right, the transformation activities
consistently work, and the desired results are achieved, then -
improve the process as needed
Slide 17
17 How is a Process Measured? Activity InputOutput Right
Resources: Qualified People Right Facilities/Equipment Correct
Materials Proven Methods Desired Results: Quality Products Quality
Services Customer Satisfaction Efficient No Waste Effective Desired
Results Achieved
Slide 18
18 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
Slide 19
19 Benefits of the System Approach Clear understanding of
processes and their interactions with other processes Better
control of linkages between related processes and people who
perform them Facilitates continual improvement
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20 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
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21 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)
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22
Slide 23
23 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
Slide 24
24 Continual Improvement Continual improvement of the
organizations overall performance should be a permanent objective:
improvement activities must planned (take action to achieve a
desired result) and monitored for effectiveness Continual
Continuous
Slide 25
25 Plan Do Act Check QMS Results Baseline Performance
Improvement Objective Improve Process through PDCA Cycle
Measure/Monitor Results Against Objectives - Improve Process and
Change QMS as Needed to Achieve and Sustain Desired Results The QMS
Sustains the Gains of Continual Improvement
Slide 26
26 Factual Approach to Decision Making Effective decisions are:
based on the analysis of data and information.
Slide 27
27 Performance Against Desired Results Actions are taken when
targets/goals NOT achieved, especially as they may relate customer
targets/goals for: Zero Defects (PPM) Capability (Cpk, Ppk)
Efficiency (thruput, scrap, waste) On-Time Delivery (schedule
adherence) Expediting Costs (premium freight)
Slide 28
28 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.
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29 TS 16949:2002 Supplier Expectations ISO 9001:2000
Registration, and customer approved processes for: Advanced Product
Quality Planning (APQP) Production Part Approval Process (PPAP)
Process Control (Control Plan, Flow Diagrams, SPC) Containment
Process Corrective/Preventive Action Process (utilizing 8D or other
disciplined problem solving process) Targeted Improvement; e.g.
quality (PPM), capability (Cpk/Ppk), schedule (on-time delivery),
cost of quality (scrap, rework, etc), efficiency
(productivity/throughput)
Slide 30
30 The ISO 9000:2000 standards include 3 documents... ISO
9000:2000 Quality Management Systems - Fundamentals and Vocabulary
ISO 9004:2000 Quality Management Systems - Guidelines for
Performance Improvements ISO 9001:2000 Quality Management Systems -
Requirements
Slide 31
31 Role of ISO 9000:2000 Defines quality management principles
terms and definitions fundamentals: - systems approach - process
approach - continual improvement ISO 9000:2000 is a normative
reference (i.e. part of the requirements), replaces: ISO 8402:1994
and ISO 9000-1:1994
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32 Role of ISO 9001:2000 Specifies quality system requirements:
for achieving customer satisfaction applicable to entire enterprise
Note:permissible exclusions (like design) must be justified, and
are limited to requirements within Clause 7 - Product Realization
ISO 9001:2000 replaces: ISO 9001/2/3:1994
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33 Role of ISO 9004:2000 Provides guidelines for performance
improvement, based on quality management principles and approaches
defined in ISO 9000, and continual improvement of the quality
management system itself note:however, ISO 9004 is NOT intended as
a guideline for implementing or assessing implementation of ISO
9001 requirements ISO 9004:2000 replaces: ISO 9004-1, 9004-2,
9004-3 & 9004-4
Slide 34
34 ISO 9001 and ISO 9004 are the Consistent Pair Comprised of
the following 8 clauses: 1. Scope 2. Normative references (part of
the requirements) 3. Terms and definitions 4. Quality management
system 5. Management responsibility 6. Resource management 7.
Product (and/or service) realization 8. Measurement, analysis &
improvement
Slide 35
35 TS 16949 incorporates all ISO 9000:2000 standards and...
Customer Requirements / Guidance Advanced Product Quality Planning
(APQP) & Control Plan Failure Mode Effects Analysis (FMEA)
Production Part Approval Process (PPAP) Fundamental Statistical
Process Control (SPC) Measurement Systems Analysis (MSA) Quality
System Assessment (QSA) Checklist ISO/TS 16949:2002 Quality
Management Systems - particular requirements for the application of
ISO 9001:2000 for automotive production and relevant service part
organizations
Slide 36
36 Role of TS 16949 Developed as a stand-alone document
Includes ISO 9001:2000 in its entirety Numerous additional
automotive customer requirements
Slide 37
37 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.
__________________________________________________________ How well
does your organization do each of the actions identified above? 1.
__________________________________________________________ 2.
__________________________________________________________ 3.
__________________________________________________________ How can
top management become more involved in implementing the principles
and requirements associated with TS 16949? 1.
__________________________________________________________ 2.
__________________________________________________________ 3.
__________________________________________________________
Slide 38
38 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
Slide 39
39 5.1 Management commitment - top management must demonstrate
commitment to development and implementation of the quality system
and continually improving its effectiveness through specific
activities: Clause 5 - Management responsibility QS-9000 1998 Cross
Reference: 4.1.1 Note: Management must provide evidence of their
commitment to (i.e. involvement in) the QMS and its continual
improvement communicate importance of meeting customer (and
regulatory/legal) requirements establish quality policy and
objectives conduct management reviews ensure availability of
necessary resources
Slide 40
40 5.1.1 Process efficiency top management shall review the
product realization processes and the support processes to assure
their effectiveness and efficiency. Clause 5 - Management
responsibility QS-9000 1998 Cross Reference: None Note: Management
to review product realization processes for effectiveness and
efficiency; organization may also identify key manufacturing
oriented processes and their associated support processes and
describe how they are managed to achieve and improve effectiveness
and efficiency. Review cost trends and benchmarking of key
processes.
Slide 41
41 5.2 Customer focus - in addition to commitment to specific
activities, top management must: ensure customer needs and
expectations are determined, turned into requirements, and that
those requirements are met customer requirements (identified per
Clause 7.2.1) must be met with the aim of enhancing customer
satisfaction (a perception that must be measured per Clause 8.2.1)
Clause 5 - Management responsibility QS-9000 1998 Cross Reference:
4.3.2 Note: Management must pursue the enhancement of customer
satisfaction; typically this is through appropriate focus on
customer oriented processes (see Section 7.2): i.e. those with
significant input from customers, and describe how they are managed
to enhance customer satisfaction.
Slide 42
42 5.3 Quality policy - this clause follows on from the general
requirements for top management and requires them to establish
quality policy that: is appropriate for the organizations purpose,
includes a commitment to meeting requirements and continually
improving the QMS by: establishing and periodically reviewing the
quality policy for continuing suitability, establishing and
reviewing measurable quality objectives for achievement, and
communicating policy and objectives at appropriate levels
throughout the organization Clause 5 - Management responsibility
QS-9000 1998 Cross Reference: 4.1.1 Note: Policy must include
statement on commitment to continually improve QMS.
Slide 43
43 Clause 5 - Management responsibility 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) 5.4.1.1 Supplemental top
management shall define quality objectives and measurements that
shall be included in the business plan and used to deploy the
quality policy QS-9000 1998 Cross Reference: None Note: Establish
quality objectives for relevant functions and levels; objectives to
be measurable. QS-9000 1998 Cross Reference: 4.1.4 & 4.1.5
Note: Business Plan requirements much less prescriptive; a process
should be in place to create, disseminate and monitor quality
objectives in Business Plan. The objectives should be customer
focused, stipulated and deployed, measurable, measured, used to
facilitate an effective and efficient review by management and
utilized for corrective action and continual improvement. Quality
objectives should address customer expectations and be achievable
within a defined time period.
Slide 44
44 Clause 5 - Management responsibility 5.4 Planning
(continued) 5.4.2 Quality management system planning. Top
management must plan to ensure that the QMS meets the requirements
of clause 4.1 The integrity of the QMS must be maintained when
changes are planned and implemented QS-9000 1998 Cross Reference:
4.2.3.1 Note: Management to plan for changes when changes to the
business occur; preparation of quality plans (see Section 7.1) not
specified
Slide 45
45 Quality Policy Statement Deliver High Quality Products
On-Time at Competitive Prices through Process Management and
Continual Improvement Measurable Objectives Improve Customer
Satisfaction (satisfy new customers, achieve higher levels of
satisfaction of loyal customers) Improve Supplier Performance
(through timely supplier corrective action and supplier development
activities) Improve Processes (through teamwork aimed at reducing
scrap, rework, waste, cycle time variation, etc.) Improve Product
Quality (through teamwork aimed at reducing defects, returns,
within spec variation, etc.) Improve On-Time Delivery Performance
(through better planning and resource management) Sample Policy and
Objectives
Slide 46
46 Clause 5 - Management responsibility 5.5 Responsibility,
authority and communication 5.5.1 Responsibility and authority.
Responsibilities and authorities must be defined and communicated
with the organization QS-9000 1998 Cross Reference: 4.1.2 Note:
Greater flexibility in how responsibility and authority is
documented.
Slide 47
47 Clause 5 - Management responsibility 5.5 Responsibility,
authority and communication 5.5.1.1 Responsibility for Quality
Management with responsibility and authority for corrective action
need to be promptly informed of products and process
nonconformities People responsible for product quality must have
the authority to stop production for quality problems All shifts
must have people responsible for ensuring product quality QS-9000
1998 Cross Reference: 4.1.2.1.a, 4.1.2.2, 4.1.2.5 Note: :
Documentation requirements for identifying and recording quality
problems removed; added requirements to: identify responsibility
for stoppage of production to correct quality problems, and to
provide accountability across all shifts.
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48 Clause 5 - Management responsibility 5.5 Responsibility,
authority and communication (cont.) 5.5.2 Management
representative. Top management shall appoint a member of management
to Ensure QMS processes are established & maintained Report to
top mgmt on QMS performance Ensure organizational awareness of
customer requirements 5.5.2.1 Customer Representative. Top
management must appoint someone to ensure that customer
requirements are addressed. QS-9000 1998 Cross Reference: None
Note: Management to designate personnel to ensure customer needs
are met by QMS. The customer rep should participate in decision
points related to product release, engineering release and
activities related to customer requirements. QS-9000 1998 Cross
Reference: 4.1.2.3 Note: Representative to also ensure promotion of
awareness of customer requirements. The management representative
can also act as liaison with external parties on matters related to
QMS.
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49 Clause 5 - Management responsibility 5.5.3 Internal
communication. Top management must ensure processes are established
to communicate effectiveness of the QMS. QS-9000 1998 Cross
Reference: None Note: Management to ensure internal communication
processes are created and used to address QMS effectiveness; also
see clause 7.2.3 regarding customer communications
Slide 50
50 Clause 5 - Management responsibility 5.6 Management review
5.6.1 General. Top management must review the suitability,
effectiveness, and adequacy of the QMS at planned intervals; and
must evaluate the need for change, including changes to policy and
objectives. 5.6.1.1 QMS Performance. Reviews shall include all QMS
requirements and performance trends; monitoring of quality
objectives; reporting and evaluation of cost of quality; and
evidence (records) of achievement of quality objectives and
customer satisfaction. Evidence includes quality objectives
specified in the business plan. QS-9000 1998 Cross Reference:
4.1.3, 4.1.3.1 Note: Review expanded to include QMS improvement
opportunities and need for changes QS-9000 1998 Cross Reference:
4.1. 3.1, 4.1.5 Note: Must go beyond company level data; i.e.
review evidence of achievement of business plan quality objectives
and customer satisfaction; benchmarking and competitive data
comparisons not specified. Examples of measurement include gap
analysis, timeliness, error rates and corrective action
effectiveness. Cost of quality includes both internal and external
costs.
Slide 51
51 Clause 5 - Management responsibility 5.6 Management review
5.6.2 Review input. Specific review inputs are required including
performance trends related to audit results, customer feedback,
product conformance, process performance, changes that could affect
the QMS, and status of actions taken, as well as recommendations
for improvement. 5.6.2.1 Supplemental. Review input shall include
analysis of actual and potential field failures and their impact on
quality, safety, and the environment QS-9000 1998 Cross Reference:
4.14.2.1, 4.14.3 Note: If the products is manufactured or
distributed in a number of markets, the organization must ensure
that there is a defined structure and decision process for info on
field failures and/or product returns. Information should be
collected in one central location and then disseminated and acted
upon at all affected locations. QS-9000 1998 Cross Reference: None
Note: Specifies information on sources to be included in review.
See Clause 7.3.4.1 - Monitoring must be included in management
review.
Slide 52
52 Clause 5 - Management responsibility 5.6 Management review
5.6.3 Review output. Decisions and actions as well as resource
needs to carry them out must be documented. QS-9000 1998 Cross
Reference: None Note: Specifies information on sources to be
included as outputs.
Slide 53
53 EXERCISE #2 List your organizations three most significant
challenges or business needs over the next 2-3 years (consider any
external changes that will affect your organization): 1.
__________________________________________________________ 2.
__________________________________________________________ 3.
__________________________________________________________ What are
your organizations goals and objectives? 1.
__________________________________________________________ 2.
__________________________________________________________ 3.
__________________________________________________________ How can
you use TS 16949 to help deal with business needs and external
challenges?
___________________________________________________________
Slide 54
54 Quality System Attributes Words of wisdom from Victor Schur
(Sears): A Quality System must be S.E.D.A. -- - Suitable-
Documented - Effective- Auditable Words of wisdom from Ian Durand
(US Technical Advisory Group to ISO TC 176): The basis of a quality
system is to say what you do, do what you say, record what you did,
check the results, and act on the difference.
Slide 55
55 Use of Audits to Assess QMS Effectiveness has shifted
9001:1994 Internal audit Effectiveness assessed in audit report
Management review 9001:2000/TS 16949 Customer satisfaction
Management determines effectiveness by analyzing all available data
and information Management review Internal audit Other data
Slide 56
56 Customer Oriented Processes
Slide 57
57 The Octopus Model
Slide 58
58 Examples of COPs
Slide 59
59
Slide 60
60
Slide 61
61 Exercise # 2 1.Map what you perceive to be the customer
oriented process (COP) model for your organization. 2.Identify
support oriented processes (SOPs) in place to aid in effective
implementation of your organizations COPs. 3.Identify management
oriented processes (MOPs) in place to aid in achieving management
objectives or requirements of ISO/TS 16949:2002 and related
customer requirements documents. 4.Present your COP/SOP/MOP model
to the group and explain how this structure can aid in helping the
organization establish/implement and effective continual
improvement program.
Slide 62
62 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
Slide 63
63 Turtle Diagram
Slide 64
Turtle Diagram (Guide), WI 8.4-2 Rev 12-15-03
Slide 65
65 Exercise # 3 1.Map a customer oriented process (COP) using
the deployment flowcharting technique from a pre-determined start
and stop point. 2.Complete a TURTLE DIAGRAM (or Process Assessment
Worksheet) of this COP (use tool of choice using the form and
instructions included as course handouts). 3.Identify key process
performance measures that are (or could be) applicable to this COP.
4.Document (or estimate) current COP performance. 5.Determine if
current performance is acceptable or in need of improvement. If in
need of improvement, establish a measurable improvement objective
for this COP (i.e. can be tracked and achieved within a specified
time frame), a list of recommended actions to achieve the
objectives, and required resources. 6.Participate in a (mock)
management review meeting presenting summary results of your COP
data analysis, including fact based justification for
recommendations.
Slide 66
66 Where can I obtain more information? On the world-wide web:
ISO web sitewww.iso.org TC 176 web sitewww.bsi.org.uk/iso-176-sc2
ASQ web sitewww.asq.org AIAG website www.aiag.org IsoQual,
Inc.websitewww.qualitymap.com Other questions? IsoQual, Inc.
StaffEmail:[email protected] or call (502) 299-6122