Transcript TS 16949:2002 Executive Overview Training Rev 12-15-03

Your Company
Presents a:
Two Hour ISO/TS 16949:2002
Executive Overview
Presented by:
Date:
1
Outline
TS 16949:2002 Executive
Overview
• Quality Management Principles
• Process Approach
• New/Changed Requirements related to
Management Responsibility
2
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
3
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.
4
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.
5
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.
6
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.
7
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.).
8
“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
The Performance Pyramid
Business Vision
Performance Excellence
Malcolm Baldrige Criteria
Performance Improvement
TS 16949
Baseline Performance:
ISO 9001:2000
#1
Competitive
Advantage
Efficient
Quality Management System
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 organization’s
objectives.
13
Process Approach
INPUT
ACTIVITY
OUTPUT
• 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)
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
How is a Process Managed?
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
Input
Activity
Right Resources:
Qualified People
Right Facilities/Equipment
Correct Materials
Proven Methods
16
Output
Desired Results:
Quality Products
Quality Services
Customer Satisfaction
How is a Process Measured?
Efficient
No Waste
Input
Effective
Desired Results Achieved
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
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
19
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
Continual Improvement of the
Quality Management System
Management
Responsibility
Resource
Management
Measurement
Analysis &
Improvement
Product
Realization
Input
Product
Output
The Process-Based Quality
Management System
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 organization’s benefit
23
Continual Improvement
Continual
Continuous
• Continual improvement of the organization’s overall
performance should be a permanent objective:
– improvement activities must planned (take action to
achieve a desired result) and monitored for
effectiveness
24
The QMS Sustains the Gains of
Continual Improvement
Improve Process
through PDCA Cycle
Plan
Act
QMS
25
Results
Do
Check
Measure/Monitor Results Against
Objectives - Improve Process and
Change QMS as Needed to Achieve and
Sustain Desired Results
Improvement
Objective
Baseline Performance
Factual Approach
to Decision Making
• Effective decisions are:
– based on the analysis of
data and information.
26
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)
27
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:
–
–
–
–
–
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)
29
The ISO 9000:2000 standards
include 3 documents...
ISO 9000:2000
Quality Management Systems Fundamentals and Vocabulary
ISO 9001:2000
Quality Management Systems Requirements
ISO 9004:2000
Quality Management Systems Guidelines for Performance Improvements
30
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
31
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
32
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
33
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
34
TS 16949 incorporates all
ISO 9000:2000 standards and ...
ISO/TS 16949:2002
Quality Management Systems - particular
requirements for the application of ISO 9001:2000
for automotive production and relevant service part
organizations
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
35
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. __________________________________________________________
• 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. __________________________________________________________
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
Clause 5 - Management responsibility
• 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:
•communicate importance of meeting
customer (and regulatory/legal)
requirements
•establish quality policy and objectives
•conduct management reviews
•ensure availability of necessary resources
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
39
Clause 5 - Management responsibility
• 5.1.1 Process efficiency – top management shall
review the product realization processes and the
support processes to assure their effectiveness and
efficiency.
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.
40
Clause 5 - Management responsibility
• 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)
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.
41
Clause 5 - Management responsibility
• 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 organization’s 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
QS-9000 1998 Cross Reference: 4.1.1
Note: Policy must include statement on commitment to continually improve QMS.
42
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)
QS-9000 1998 Cross Reference: None
Note: Establish quality objectives for relevant functions and levels; objectives to be measurable.
– 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: 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.
43
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
44
Sample Policy and Objectives
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)
45
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
Plant Manager
Sales
Design
Production
QS-9000 1998 Cross Reference: 4.1.2
Note: Greater flexibility in how responsibility and authority is documented.
46
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.
47
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
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.
– 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.
48
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
49
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.
QS-9000 1998 Cross Reference: 4.1.3, 4.1.3.1
Note: Review expanded to include QMS improvement opportunities and need for changes
– 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. 3.1, 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.
50
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.
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.
– 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.
51
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.
52
EXERCISE #2
• List your organization’s 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 organization’s goals and objectives?
1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________
• How can you use TS 16949 to help deal with business needs and
external challenges?
___________________________________________________________
___________________________________________________________
___________________________________________________________
53
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.”
54
Use of Audits to Assess QMS
Effectiveness has shifted
9001:1994
Internal audit
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
Customer Oriented Processes
This is a process
Ÿ
An interface Organizational/
External environment input (I)
Ÿ
An interface Organizational/
External environment output (O)
O
Organization
I
Notice how this is a literal
application of the process model.
Check input
against
output.
Continual improvement of the quality
Continual improvement of the quality
management system
management system
Management
responsibility
Customers
Customers
Customers
Customers
Measurement,
analysis and
improvement
Resource
management
Satisfaction
Key
Information flow
Value-adding activities
Requirements
56
Input
Product
realization
Product
Output
The Octopus Model
4
3
5
2
6
1
10
7
8
57
9
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
Reviewed by: ISO Management Representative Approved by: Chief Executive Officer
Signature/Date:
Signature/Date:
COP 4.1 Customer-Oriented Process (COP) Model
Sales Manager
.
Engineering Manager
.
Contracting Officer
Market Analysis
and Sales
.
Production Manager
.
Quality Manager
.
Shipping Manager
.
Rev: 12/15/03
Servicing Manager
Bid / Quote
Submission
Order / Release
Processing
Product and/or
Manufacturing
Process Design
Yes
New / Changed
Product or Mfg
Process?
No
Post Delivery
Servicing?
No
Customer
Feedback and
Complaint
Processing
59
Invoicing and
Payment
Processing
Yes
Production
Inspection and
Test
Delivery
Warranty Work
or Post Delivery
Servicing
.
Customer
Oriented
Processes
(COPs)
Market Analysis and Sales
Bid / Quote Submission
Order / Release Processing
Product or Manufacturing Process Design
Product or Mfg Process Validation
Production
Inspection and Test
Delivery
Warranty Work or Post Delivery Servicing
Invoicing and Payment Processing
Customer Feedback and Complaint Processing
60
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
OP 8.3, Control of Nonconforming Product
OP 8.2.4, Monitoring and Measurement of Product
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
OP 8.5, Continual Improvement
OP 8.2.2, Internal Audit (includes QSA)
OP 5.6, Management Review
OP 4.2.4, Control of Records
X
X
X
X
X
OP 4.2.3, Control of Documents
X
OP 8.2.3, Monitoring and Measurement of Processes
OP 8.2.1, Customer Satisfaction
OP 8.1, Statistical Techniques (includes SPC)
OP 7.6, Control of Monitor/Meas. Devices (includes MSA)
OP 7.5.5, Preservation of Product
OP 7.5.4, Control of Customer Supplied Property
OP 7.5.3, Product Identification and Traceability
OP 7.5.2, Validation of Product Realization Processes
OP 7.5.1, Job Planning and Control
OP 7.4.2, Purchasing
OP 7.4.1, Supplier Evaluation
OP 7.3, Design and Development (includes FMEA, PPAP)
X
X
X
X
X
X
X
X
OP 7.2.2, Product Requirements
OP 7.1, Product Quality Planning (includes APQP)
OP 6.3, Facilities and Equipment Maintenance
OP 6.2.2, Competence, Awareness and Training
Support
Oriented
Processes
(SOPs)
Management
Oriented
Processes
(MOPs)
X
X
X
X
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
organization’s 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.
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
WHAT
WHO
Material
What are the supplied materials?
Do they contribute to the making of nonconforming materials?
How do you know the supplied parts are meeting requirements?
Directly Involved Parties
Who is setting the job up? Who is producing product?
Who is determining the (inspection) status of the product?
Who is determining the disposition of nonconforming product?
Who is the process ‘owner’ (responsible for managing the process)?
Process Equipment/Tools
How were the equipment/tools selected for the process?
Are the equipment/tools for the job adequate and available when needed?
How are equipment/tools for the job identified, controlled and maintained?
Linkages/Interfaces with Other Involved Parties
What Support Process personnel are involved? How?
What supplier, customer or other external personnel are involved? How?
What else needs to be in place prior to commencing the job?
How is competency determined for all parties involved?
OUTPUT
INPUT
Identify what the customer wants/needs.
PROCESS
Identify what the customer gets.
Name/Description
List COP or Other Process Title
Output Requirements (criteria and records)
Input Requirements (specifications)
Steps/Activities
List Key Process Steps/Activities
List sources of product requirements (i.e. customer,
organization & regulatory requirements documents).
What output criteria are used to determine if what
should have been produced … has been produced?
What measures are used to demonstrate or ensure
product compliance? (see measures) Consider:
- ppm
- delivery performance
- response time
- time for returned product test/analysis
- quality cost
How were these requirements collected and reviewed
for accuracy and completeness?
HOW
MEASURES
Who decides what measures to use to judge this process?
What are the metrics used to show if the process is effective?
Why were these measures selected?
How is data collected? Who does the analysis? How is it reported?
How is data used to identify and resolve/prevent problems?
What actions are taken based on the data collected?
How are actions tracked to assess their impact?
Has the corrective action worked?
Procedures/Control Documents
How are the process control conditions defined (i.e. what work instructions,
inspection instructions, control plans, procedures governing the control of
nonconforming material, etc., exists)?
Are they available and used?
Where is the control methodology breaking down ?
Support Processes
What processes/systems are needed to support the work? (i.e. maintenance,
housekeeping, logistics, storage, packaging, measuring, data analysis, etc.)
Have any nonconforming materials been traced to support processes
Turtle Diagram (Guide), WI 8.4-2
Rev 12-15-03
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.
65
Where can I obtain more
information?
• On the world-wide web:
ISO web site
TC 176 web site
ASQ web site
AIAG website
IsoQual, Inc.website
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: [email protected]
call (502) 299-6122
or