ISO 9000:2000 Clause 7

Product Realization
Analysis and
Implementation
a workshop presented by
Jack West
&
Eduardo del Rio

Integrated process
management
Control

Input

Activity

Activity

Process

Activity

Output

Mechanism
(resources)

Consistent Pair of QMS

Standards

ISO 9001 : QMS - Requirements

ISO 9004 : QMS - Guidance for
performance improvement

One Way to Think about

the Relationship
Results

ISO 9004
ISO 9001

pt
De
h

Breadth

ISO 9004 perspective:

Performance improvement

ISO 9001 perspective:

Quality of product

The Bigger Picture: The Quality Hierarchy

Business
Vision
Competitive
Advantage

The
Baseline
ISO 9001

Performance
Excellence

Efficient
Quality Management System
Effective
Quality Management System

ISO 9004
Performance
Improvement

From material developed by Joe Tsiakals

5

The Consistent Trio

Consistent pair of QMS standards

ISO 9001 : QMS - Requirements

ISO 9004 : QMS - Guidance for performance
improvement

+ Compatible Fundamentals & Terminology

ISO 9000 : QMS - Fundamentals and
Vocabulary
6

Continual Improvement:
Incremental and Breakthrough
Breakthrough Target:
Be 5% Better than Benchmark
Benchmark: Best in Class
In 18 Months
Performance

Incremental Improvements
Over Five Years
UP
Is
good

Breakthrough
in 18 Months

Five Years

TIME

18
Months

Continual Improvement: Incremental

and Breakthrough
Characteristics

Tendency
Incremental
Improvement

Breakthrough
Improvement

People Involved

People working in the

process

Managers, engineers,
consultants

Size of Changes

Small incremental changes

Big changes

Types of Changes

Practices, procedures,
equipment mods,
elimination/simplification of
activities, process foolproofing

Technology, new equipment,

major process upgrades,
process re-engineering

Results

Small improvements

Large jumps in performance

Cost of Projects

Low, generally included in

operating budget

High, may involve capital

investment

Business Basics
Revenue - Cost = Profit

Better Products
Customer Satisfaction

Fewer Rejects
Less Returns =
Less Problems

Maybe You
Get a Bonus

Better Quality
Higher Revenue and Lower Cost

Output matters: Scope

Clause
1.1 Scope

Requirement
This International Standard specifies requirements for
a quality management system where an
organization
a) needs to demonstrate its ability to consistently
provide product that meets
customerrequirements, and
b) aims to enhance customer satisfaction through
the effective application of the system, including
processes for continual improvement of the system
and the assurance of conformity to customer and
applicable regulatory requirements.

20047 ISO

Output matters: Top managers

Clause
5 that customer
5.2 Customer Top management
shall ensure
focus

requirements are determined and are met with

the aim of enhancing customer satisfaction (see
7.2.1 and 8.2.1).

5.3 Quality
policy

Quality policy
Top management shall ensure that the quality
policy

b) includes a commitment to comply with

requirements and continually improve the
effectiveness of the quality management
system,

5.6.3 Review
output

The output from the management review shall include

any decisions and actions related to
b) improvement of product related to customer
requirements.
2000 IS0

Output matters: Resources

Clause 6
6.1 Provision The organization shall determine and provide the
resources needed
of resources

b) to enhance customer satisfaction by meeting

customer requirements.

2000 ISO

Output matters: Product

realizationClause 7 cont.
7.3.6 Design
and
development
validation

Design and development validation shall be

performed in accordance with planned arrangements
(see 7.3.1) to ensure that the resulting product is
capable of meeting the requirements for the
specified application or intended use, where
known.

2000 ISO

Clause 4 Quality management system

4.1 General requirements
Establish, implement, document, maintain,
and continually improve the QMS
processes; this includes:

Defining their sequence and interactions

Managing the QMS processes
Establishing criteria and methods to operate and control
the QMS processes
Ensuring availability of information to operate and
monitor the QMS processes
Measuring, analyzing and continually improving the
QMS processes
Provide for control of outsourced processes
14

4.1 General Requirements

The organization shall...
Continually Improve
Maintain
Implement
Document

Quality
Management
System

Establish
15

Quality
Management
System

Identify processes

16

Quality
Management
System

Determine sequence & interaction

17

Quality
Management
System

Determine methods to operate &

control processes

18

Ensure availability of
resources & information

Quality
Management
System

Resources
19

Measure, monitor &

analyze processes

Quality
Management
System

Measure at key points

20

Chart the Basic Processes of the

System
Example Quality Management System
Relationship Map
P
l
a
n
n
i
n
g

Process Design &

Customer-Relationships

Data
Management

&
S
t
r
a
t
e
g
y

Product design

Production Operations

Measurement
and Analysis

Information
Product

Procurement
Validation

Delivery and Service

Corrective Action and

Management Review

Preventive Action

Records Management

There should be a relationship

diagram of the overall system -put it in the quality manual
21

Purpose Of Process
ManagementControl

Understand the
processes and how
they fit together
Understand
relationship between
response and
independent process
variables
Control the process

Y
Response
Variable
Motion of
the Car

Kid With the Control!

22

Clause 5 Management responsibility

5.4 Planning
5.4.1 Quality Objectives
Established at relevant
functions and levels
Measurable
Consistent with policy

5.4.2 Quality management

system planning
Top management must
ensure QMS is planned
to meet clause 4.1
Covers:

processes of QMS
resources needed
continual improvement of
the QMS

23

Clause 5 Management responsibility

5.4.2 Quality planning, continued
Planning shall ensure:

change is controlled
QMS integrity is maintained when
changes are made to it

24

Planning the QMS (Clause 4.1 & 5.4)

Planning

Quality management system planning (clauses 4.1 & 5.4)

Establishing quality objectives (5.4.1)
Planning of quality management system (5.4.2)
to meet requirements given in clause 4.1
to meet quality objectives
Change control of quality management system

Product realization planning (clause 7.1)

25

Clause 7 Product realization

CONTINUAL IMPROVEMENT OF
THE QUALITY MANAGEMENT SYSTEM

Management
responsibility

CUSTOMER

Resource
management

REQURIEMENTS

Input

CUSTOMER

Measurement,
analysis and
improvement

Product
realization

SATISFACTION

Product Output

Key
Value adding activities
Information flow

Figure 1 Model of a process-based quality management system

26

Clause 7 Product realization

Clause 7 contains

7.1 Planning of product realization

7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
7.5 Production and service provision
7.6 Control of monitoring and measuring
devices
27

Clause 7 Product realization

Requirements similar to the 1994

edition, but
Wording is more generic so as to ease
application by all sectors and sizes of
organizations

28

Clause 7.1 Planning of product

realization

Immediately focuses on processes

Planning of realization processes
must be:

consistent with other requirements of the

organizations quality management system
documented in a form suitable to the
organizations operating methods
7.1 covers all realization processes

29

Clause 7.1 Planning of product realization,

continued

In planning realization processes, the

organization must determine:

quality objectives for the contract, project, or product

need for processes and documentation
verification and validation activities and acceptance
criteria
records required to provide confidence of process and
product conformity

Resources and facilities must be determined and

provided
Note 2: may apply 7.3 to development of product
realization processes
30

Planning Product Realization (Clause

7.1)
Planning

Quality management system planning (clauses 4.1 & 5.4)

Product realization planning (clause 7.1)
Determine quality objectives/requirements for product (7.1, 7.3.3)
Establish processes, documentation, and resources (7.1, 7.5.1)
Define criteria for product acceptance and release (7.1, 7.3.3, 7.5.1)
Determine necessary records (7.1)
Determine necessary inspection, test, verification & validation
activities (7.1, 7.5.1, 8.1, 8.2.3, 8.2.4)
31

Typical Planning Outputs

Process Planning
Activity

Examples of
Resulting Documents

Planning the QMS

(4.1, 5.4.1, & 5.42)

Quality Objectives
Quality Manual
Documented Procedures

Planning Product
Realization (7.1)

Quality Plans for Specific

Products or Projects
Work Instructions
32

Discussion Groups
1.
2.

3.

Form small groups of three to five

Discuss what can you do to improve the
planning process
We will call on some to report to the
whole group

33

Clause 7.2 Customer-related processes

7.2.1 Determination of requirements related to the
product

completeness of requirements: availability, delivery,

support
requirements necessary but not specified
regulatory, and statutory obligations

7.2.2 Review of requirements related to the product

requirements clearly defined

confirm unwritten requirements
verify differences from tender
ensure ability to meet requirements
results of review and follow-up recorded

34

Clause 7.2 Customer-related processes

7.2.3 Customer communication

implement arrangements for customer

communications
product information
enquiry/order handling
customer feedback, including complaints

35

8.2.1 Customer
satisfaction
Customer
satisfaction
data

Quality
Management
System

Management
Review

Use
customer data
36

8.2.1 Customer satisfaction

Measuring

Monitoring

Customer
satisfaction
data

Analyzing

Improving

Define how data are used

37

One Approach

Start by asking questions :

What customer information do you
have?
What customer information do you
want?
Do you want your own internal
customer study capability?
Do you want to selectively go to the
outside for specific research projects?

38

Examples of the Voice of the Customer

Want an ongoing
process to gather,
understand, and satisfy
needs of customers.
Want to use customer data to
increase market penetration.
Want an ongoing process
to monitor and measure
market trends.
Want to understand
how to write survey
questions.
Want a way to focus our
sales force on the
markets that have the
greatest immediate
potential.

Want to measure
potential sources of
customer
dissatisfaction.

Want to develop
capabilities so that we
can meet ISO 9001:2000
Clause 8.2.1 on
customer satisfaction
and other related
clauses.
Want to develop a
robust survey process
that can be handled
internally.
Want to train our sales
force so that they
develop a market
intelligence capability.

Want to monitor
customer satisfaction to
see if existing customers
are experiencing
dissatisfaction with
existing products and
services.
Want to train our sales
force in gathering
market intelligence
followed by actual
application of the
training in the real
world.
Want assistance in
designing and
administering a
customer survey.
Want to receive new
orders as a result of our
market intelligence
project.
39

Sources of Customer Satisfaction Data

Active

Methods
Methods of
of
Gathering
Gathering

Receptive

Indirect

Surveys
Focus groups
Site visits
Interviews
Complaints
Warranty costs
Allowances
Letters
Articles
Trade Shows
Repeat business
40

Key
Measures

Sales
Calls

Credits &
Returns

Trade
Shows
Surveys

Complaints

R&D

Articles

Customer
Ratings

Often our customer data is like an incomplete puzzle

41

Key
Measures

Sales
Calls

Trade
Shows

R&D

Surveys

Articles

Credits & Complaints

Returns

Customer
Ratings

Get the pieces to fit together

42

Discussion Groups
1.
2.

3.
4.

Form small groups of three to five

Do you really know your customers
requirements, needs, wants? How well
do you meet them?
What can you improve?
We will call on some to report to the
whole group

43

Clause 7.3 Design and development

Design and development planning

Design and development inputs
Design and development outputs
Design and development review
Design and development verification
Design and development validation
Control of design and development changes

44

Clause 7.3 Design and development

7.3.1 Design and development planning

Requires determination of:

stages of the process

required review, verification, and validations at
each stage
responsibility and authority for these activities

Interfaces between groups involved must be

managed
Project plans must be kept updated
45

Clause 7.3 Design and development

7.3.2 Design and development inputs

Define and document requirements

functional/performance
regulatory/statutory
information from previous designs
other essential requirements

Review inputs
Resolve incomplete, ambiguous, or
conflicting requirements
46

Clause 7.3 Design and development

7.3.3 Design and development outputs

Document in a format that allows for

comparison with input requirements
Output shall

meet input requirements

relate to product acceptance criteria
define characteristics essential to safe and proper
use

Approve output documents prior to release

47

Clause 7.3 Design and development

7.3.4 Design and development review

Systematic review(s) at suitable stages in

the design process

evaluate ability to fulfill requirements

Identify problems & propose follow-up

Include representatives of functions

concerned with the design
Record results of reviews and followup

48

Clause 7.3 Design and development

7.3.5 Design and development verification

ensures design output conforms to

requirements
record verification results and follow-up

7.3.6 Design and development validation

confirm product is capable of meeting the

intended use (examples: pilot run or test)
where practical, complete prior to product
release
record validation results and follow-up
49

Design & Development Planning 7.3.1

Design verification 7.3.5

Customer
needs
7.2.2

Design
inputs
7.3.2

Design
process
phases and
reviews
7.3.4

Design
outputs
7.3.3

Product

Risk analysis and preventive action

Design validation 7.3.6

50

Use Appropriate Tools ISO 9004:2000

Clause 7.3.1

Failure Modes and Effects analysis

FMEA
Many find FMEA the
Fault tree analysis
most powerful of
these tools for
Reliability prediction
preventing problems.
Relationship diagrams
Ranking techniques
Simulation techniques
51

Using Failure Mode and Effects Analysis

List each potential failure mode(s) for each potential

failure
Describe failure mode for each potential effect that
such a failure could have
Estimate (on a scale of 1 to 10 with 10 being worst)
severity, probability (or frequency) of occurrence,
detectability (ability to detect the potential cause and
prevent the failure)
Multiply rankings to give a risk priority number
(RPN)
RPN is used to prioritize preventive actions
52

Clause 7.3 Design and development

7.3.7 Control of design and

development changes

Identify, document and control changes

Evaluate the effect of changes on

other parts of the product (e.g., other parts,

software)
delivered products

Verify and validate the changes as

appropriate
Record results of change review and
subsequent actions
53

Discussion Groups
1.
2.

3.

Form small groups of three to five

Discuss what can you do to improve the
design and development process in your
organizations
We will call on some to report to the
whole group

54

Clause 7.4 Purchasing

Purchasing process
Purchasing information
Verification of purchased product

55

Clause 7.4 Purchasing

7.4.1 Purchasing process

Control to ensure purchased product conforms to

requirements
Type and extent of control to depend on effect on
subsequent processes and their output
Define supplier selection and periodic evaluation
criteria
Evaluate and select suppliers based on ability to
meet requirements
Record results of evaluations and follow-up

56

Clause 7.4 Purchasing

7.4.2 Purchasing information

Purchasing documents must include

approval/qualification requirements for
product, procedures, processes, equipment,
and personnel
quality management system requirements
Ensure adequacy of purchase document
requirements prior to their release

57

Clause 7.4 Purchasing

7.4.3 Verification of purchased product

Identify and implement inspection or other

activities to ensure product meets
requirements
Provide for verification at the suppliers
premises and for product release

58

Discussion Groups
1.
2.

3.
4.

5.

Form small groups of three to five

What % of the cost of goods sold in your
organization is purchased material? (In some
organizations it is over 50%!!)
What about outsourced processes?
Are the controls exercised over the purchasing
process in balance with the importance of
purchased material to quality perceptions of
your products by your customers?
We will call on some to report to the whole
group
59

Clause 7.5 Production and service provision

7.5.1 Control of production and service

provision
7.5.2 Validation of processes for production
and service provision
7.5.3 Identification and traceability
7.5.4 Customer property
7.5.5 Preservation of product

60

Clause 7.5 Production and service provision

7.5.1 Control of Production and service

provision
Carry out production and service provision
under controlled conditions through:

availability of product/service specifications

availability of work instructions as needed
use of suitable equipment
monitoring and measuring equipment
monitoring and measurement
release, delivery, and post delivery activities

61

Clause 7.5 Production and service

provision

7.5.2 Validation of processes for

production and service provision

Validate processes where output cannot

be verified prior to delivery
Demonstrate production and service
processes can achieve planned results

62

Clause 7.5 Production and service provision

7.5.2 Validation of processes for

production and service provision
(Continued)

Define controls as applicable:

define criteria for review and approval
qualification of process and/or equipment
use of procedures and defined methods
requirements for records
re-validation

63

Use clause 7.1 note 2

Apply the notions for design and

development of products to the processes
for production and service provision
processes
Conduct process design in parallel with
product design

64

Design & Development Planning 7.3.1

Design verification 7.3.5

Customer
needs
7.2.2

Design
inputs
7.3.2

Design
process
phases and
reviews
7.3.4

Design
outputs
7.3.3

Product

Risk analysis and preventive action

Design validation 7.3.6

65

Design & Development Planning 7.3.1

Design verification 7.3.5

Customer
needs
7.2.2

Design
inputs
7.3.2

Design
process
phases and
reviews
7.3.4

Design
outputs
7.3.3

Product
&
Process

Risk analysis and preventive action

Design validation 7.3.6

Additional considerations such as:

Resources (capital, equipment, people)
Process capability
PFMEA

66

Analyze Process Data to Find and

Act on OpportunitiesUse Simple
Analytical Tools
materials

methods

machine
Effect

measurement

man

Ishikawa Cause and Effect Fishbone Diagrams

67

Analyze Data to Find and Act on

OpportunitiesUse Simple
Analytical Tools

materials
Feed stock
contamination
Age of
feedstock

methods

Temperature
settings

machine

Manual
controls

Flow rate

Reactor age

Gages out of
calibration

Training

Measurement capability

measurement

Wrong
Viscosity

Experience

man

68

Analyze Data to Find and Act on

OpportunitiesUse Simple Analytical
Tools
Y
Customer
Requirement

X
Process Variable

69

Analyze Data to Find and Act on

OpportunitiesUse Simple Analytical
Tools
Y
Customer
Requirement
Viscosity

Process Variable

X1
Reactor
Temperature

X2
Feedstock
Chemistry
(% Contaminant)

X3
Flow
Rate
GPM
70

Analyze Data to Find and Act on

OpportunitiesUse Simple Analytical
Tools
New Range
(Tolerance)

Y
Customer
Requirement
Viscosity

Range
Customer
Needs
Our
Range
(Tolerance)

Feedstock
Chemistry
(% Contaminant)

71

Analyze Data to Find and Act on

OpportunitiesUse Simple Analytical
Tools
New Range

Y
Customer
Requirement
Viscosity

Range
Customer
Needs
Our
Range
(Tolerance)

Flow
Rate
(GPM)
72

Improvement
Administrative

Distribution representing a reports delivery process > too many

defects (unhappy customers) + mean too high (3.2 weeks): how to
improve within the (green) limits?

Frequency

5 weeks

4 weeks

3 weeks

2 weeks

1 weeks

Exceeds
expectations
unnecessarily

6 weeks

Defects:
Unacceptable to
shareholders who
expect report within 4
weeks max (voice of
customers)

Time to complete quarterly financial report (annual statistics)

73

Improvement
Administrative
2 possible improvements:
1) Mean A to B = Move the mean to the left
2) Curve A to Curve B = Reduce variations
B

Reduce
variability =
Process more
robust =
Process under
control

Frequency

6 weeks

5 weeks

4 weeks

3 weeks

2 weeks

1 weeks

Remove defects

Time to complete quarterly financial report (annual statistics)

74

Six
Sigma
(sigma):

Statistical unit of measurement that defines the standard deviation

of a population. (Definition: Point of inflection on the normal curve.)
Measure of variability or spread of the data, that indicates how
much of the data falls within the customers requirements. The
higher the process sigma, the more of the process outputs, products
and services, meet customers requirements or, the fewer the
defects.
6 Sigma means the population is within the +/- 6 x standard
deviation limits (*). What is not within these limits is called defect.
1
6

* with 1.5 Sigma shift

75

Three Basic Six Sigma Methods

DMAIC

The most common

6 Sigma
To improve an
existing process
Define > Measure >
Analyse > Improve
> Control
Focuses on real
problems directly
related to the
bottom-line
Start realizing
results after 6
months

DMEDI (DFSS)
Focuses

on
development of new
products, services,
processes, and
plants that precisely
meet customer
current and future
needs
Define > Measure >
Explore > Develop >
Implement

Utilizes multiple tools and techniques including

rigorous statistical methods
Sustains improvement over the long-term
Disseminates improvement throughout the
organization
Acts as an agent of change

LEAN

6 SIGMA

An approach & set of

tools to improve supply
chain responsiveness,
as a mix of lean
manufacturing (Kanban,
5S, JIT) and 6 Sigma
5 principles: Value,
Value stream, Flow,
Pull, Perfection
Reduction of lead, cycle
time, throughput, WIP,
waste > Velocity
Can achieve results in
few weeks
7 zeros: Defects,
Excess, Set ups,
Breakdowns, Handling,
Lead times, Surging

76

Clause 8.2 Monitoring and

measurement
8.2.3 Monitoring and measurement of processes

Apply suitable measures to processes as necessary

to:

meet customer requirements

demonstrate process continuing ability to satisfy its intended
purpose
take appropriate correction and corrective action for
nonconforming processes to ensure conforming product

Measures become an input to improve processes

77

8.2.3 Monitoring and

measurement of
processes

Organization shall monitor & measure

the QMS processes
Do processes achieve results?
Do they perform as intended?
If not, then correct.

Do our processes work?

78

Clause 8.2 Monitoring and

measurement
8.2.4 Monitoring and measurement of
product

Apply suitable measures to characteristics of

products to verify the requirements for the
product are met
Maintain records to:

provide evidence of required measurement, monitoring,

and conformance
indicate authority responsible for release of the product

Release product only after all activities

completed

79

Clause 8 Measurement, analysis,

and improvement
8.3 Control of nonconforming product

Identify and control nonconforming product to

prevent unintended use or delivery
Deal with nonconforming product in one of three
ways:

eliminate the nonconformity

authorize use under concession by relevant authority
take action to preclude original intended use

Take appropriate action regarding consequences

of nonconformity found after product is delivered
or is in use
80

Clause 7.5 Production and service provision

7.5.3 Identification and traceability
Suitable identification throughout
production as appropriate
Identify measuring and monitoring
status of product
Record unique identification where
traceability is required

81

Clause 7.5 Production and service provision

7.5.4 Customer property

Exercise care with customer property

under the organizations control

Identify, verify, protect and maintain

Record and report loss or damage to customer
property

Applies to all customer property not just customer supplied

product considerations include:
Customer provided product
Customer provided tooling, equipment and facilities
Customer provided intellectual property
82

Clause 7.5 Production and service provision

7.5.5 Preservation of product
Preserve conformity of product during
processing and delivery including

identification
handling
packaging
storage
protection

Control extends to constituent parts

83

Clause 7.6 Control of monitoring and

measuring devices

Control, calibrate and maintain

measuring and monitoring
devices used to assure
conformance of product and
service
Measurement carried out in a
way consistent with
requirements

84

Clause 7.6 Control of monitoring and

measuring, continued

Where applicable equipment must be:

Calibrated at intervals using traceable devices;

record calibration results
Adjusted as necessary
Protected from damage and deterioration
Identified to determine calibration status

Take action on equipment and product if

equipment found not to conform

Confirm ability of monitoring and

measurement software prior to use

ISO 10012 may be used as guidance

85

Measurement AccuracyFour
Situations

Centered & Precise Centered But Not

Accurate
Precise
Individual
Low Probability of
Measurements
Accurate Individual
Measurement

Precise
But Not Centered
Low Probability of
Accurate Individual
Measurement

Not Precise
And Not Centered
Low Probability of
Accurate Individual
Measurement

Target center is the actual value

86

Discussion Groups
1.
2.

3.
4.
5.

Form small groups of three to five

Are your product production and service
provision processes consistently
delivering what the customer requires,
needs, wants?
What about outsourced processes?
What needs to be improved?
We will call on some to report to the
whole group
87

Quality management
principles

Customer focus
Leadership
Involvement of people
Process approach
System approach to management
Continual improvement
Factual approach to decision making
Mutually beneficial supplier relationship
88

Quality management principles

Customer Focus
Organizations depend on their
customers and therefore should
understand current and future
customer needs, should meet
customer requirements, and strive to
exceed customer expectations.
89

Customer Focus leads an organization to:

understanding the whole range of
customer needs and expectations for
products, delivery, price, dependability,
etc.
measuring customer satisfaction and
acting on results

90

Some things to think about

Have we identified the processes required for product

realization?

Inputs and outputs

Activities
Measures
Controls
Etc.

Do we really have controlare we managing all the

realization processes and their interactions so that we
meet requirements?
Is everything we do really focused on meeting customer
requirements, needs, wants?
91