Assurance Qualité,
Eco-conception et
Développement
Durable 1
[email protected]
1
Organisation of the course
• 14h Lectures (7 sequences)
• 10h exercises (5 sequences)
– 2 examinations
To be completed for students in GIPI2 next
year.
2
Course outline
• 4 sequences on Quality managament.
• 3 sequences on sustainable development
and eco-design.
3
Quality management
course outline
•
•
•
•
•
Meaning of Quality
Quality history
Quality tools
ISO 9001:2008
Quality Audits
4
Meaning of Quality
 Webster’s Dictionary
 degree of excellence of a thing
 American Society for Quality
 totality of features and characteristics that
satisfy needs
 Consumer’s and Producer’s Perspective
5
What is Quality?
6
What is Quality?
•
•
•
•
•
•
•
•
Meeting specifications
Meeting customer needs /
expectation
Transparency of service
delivery
Process control
Achieving desired results
Continuous Improvement
Competitive advantage
Added value for society
•
Best value for price
•
Cost effectiveness
•
Performance measurement
•
More for less
•
Satisfaction of stakeholders
•
Doing the right things
•
Doing things right
•
Doing the right things right
7
The Concept
 Multiple dimensions
 Variety of phenomena
 Changing through time
 Changing with the activity
sector
 Different from author and place
8
Quality …. An Approach
Assessment Client
Warranty
Planning
Ethics
Needs
Zero
defects
Control
Value
Efficiency
Effectiveness
Responsibility
Conformance
Rights
Loyalty
Expectations
Satisfaction
Duties
9
What does the word “quality”
mean to you?
• Think about your past experiences staying
at various hotels. Did you stay at a
“quality” hotel? What about the experience
made it a “quality” experience for you?
• Think about a product you bought. How
can you define its “quality”?
10
Dimensions of Quality
Garvin (1987)
1. Performance:
– Will the product/service do the intended job?
2. Reliability:
– How often does the product/service fail?
3. Durability:
– How long does the product/service last?
4. Serviceability:
– How easy to repair the product / to solve the
problems in service?
11
Dimensions of Quality
5. Aesthetics:
–
What does the product/service look/smell/sound/feel
like?
6. Features:
–
What does the product do/ service give?
7. Perceived Quality:
–
What is the reputation of the company or its
products/services?
8. Conformance to Standards:
–
Is the product/service made exactly as the
designer/standard intended?
12
Quality in different areas of
society
Area
Examples
Airlines
On-time, comfortable, low-cost service
Health Care
Correct diagnosis, minimum wait time, lower
cost, security
Food Services
Good product, fast delivery, good environment
Postal Services
fast delivery, correct delivery, cost containment
Academia
Proper preparation for future, on-time
knowledge delivery
Consumer Products
Properly made, defect-free, cost effective
Insurance
Payoff on time, reasonable cost
Military
Rapid deployment, decreased wages, no graft
Automotive
Defect-free
Communications
Clearer, faster, cheaper service
13
What is Quality?
• Conformance to specifications (British Defense
Industries Quality Assurance Panel)
• Conformance to requirements (Philip Crosby)
• Fitness for purpose or use (Juran)
• A predictable degree of uniformity and dependability, at
low cost and suited to the market (Edward Deming)
• Synonymous with customer needs and expectations (R
J Mortiboys)
• Meeting the (stated) requirements of the customer- now
and in the future (Mike Robinson)
• The total composite product and service characteristics
of marketing, engineering, manufacturing and
maintenance through which the product and service in
use will meet the expectations by the customer (Armand
Feigenbaum)
14
What is Quality?
• “The degree to which a system, component, or process
meets
(1) specified requirements, and
(2) customer or users needs or expectations” – IEEE
• The totality of features and characteristics of a product or
service that bears on its ability to satisfy stated or implied
needs” – ISO 8402
• Degree to which a set of inherent characteristics fulfils
requirements – ISO 9000:2000
15
Definitions of Quality
• Transcendent definition: excellence
• Product-based definition: quantities of
product attributes
• User-based definition: fitness for intended
use; meeting or exceeding user
expectations
• Value-based definition: quality vs. price
• Manufacturing-based definition:
conformance to specifications
16
More about Quality
• Realistic but demanding STANDARDS;
• Getting things RIGHT FIRST TIME; ‘It
costs less to prevent a problem than it
does to correct it’
• Influences the relationship with
CUSTOMERS;
• Influences how COMPLAINTS are dealt
with;
• Something to do with how things LOOK 17
and FEEL.
Meaning of Quality:
Consumer’s
Perspective
 Fitness for use
 how well product or
service does what it is
supposed to
 Quality of design
 designing quality
characteristics into a
product or service
 A Mercedes and a Ford are
equally “fit for use,” but with
different design dimensions
3-18
Dimensions of Quality:
Manufactured Products
 Performance
 basic operating characteristics of a product; how
well a car is handled or its gas mileage
 Features
 “extra” items added to basic features, such as a
stereo CD or a leather interior in a car
 Reliability
 probability that a product will operate properly
within an expected time frame; that is, a TV will
work without repair for about seven years
3-19
Dimensions of Quality:
Manufactured Products

Conformance


degree to which a product meets pre–established
standards
Durability


how long product lasts before replacement
Serviceability

ease of getting repairs, speed of repairs, courtesy
and competence of repair person
20
Dimensions of Quality:
Manufactured Products
 Aesthetics
 how a product looks, feels, sounds,
smells, or tastes
 Safety
 assurance that customer will not suffer
injury or harm from a product; an
especially important consideration for
automobiles
 Perceptions
 subjective perceptions based on brand
name, advertising, and the like
21
Dimensions of
Quality:
Service
 Time and Timeliness
 How long must a customer wait for service,
and is it completed on time?
 Is an overnight package delivered overnight?
 Completeness:
 Is everything customer asked for provided?
 Is a mail order from a catalogue company
complete when delivered?
22
Dimensions of
Quality:
Service (cont.)
 Courtesy:
 How are customers treated by employees?
 Are catalogue phone operators nice and are
their voices pleasant?
 Consistency
 Is the same level of service provided to each
customer each time?
 Is your newspaper delivered on time every
morning?
23
Dimensions of Quality:
Service
 Accessibility and convenience
 How easy is it to obtain service?
 Does a service representative answer you calls quickly?
 Accuracy
 Is the service performed right every time?
 Is your bank or credit card statement correct every month?
 Responsiveness
 How well does the company react to unusual situations?
 How well is a telephone operator able to respond to a customer’s
questions?
Meaning of Quality:
Producer’s
Perspective
 Quality of Conformance
 Making sure a product or service is
produced according to design
 if new tires do not conform to specifications, they
wobble
 if a hotel room is not clean when a guest checks
in, the hotel is not functioning according to
specifications of its design
25
Meaning of Quality:
A Final Perspective
 Consumer’s and producer’s
perspectives depend on each other
 Consumer’s perspective: PRICE
 Producer’s perspective: COST
 Consumer’s view must dominate
26
Meaning of Quality
Meaning of Quality
Production
Producer’s Perspective
Consumer’s Perspective
Quality of Conformance
Quality of Design
• Conformance to
specifications
• Cost
• Quality characteristics
• Price
Marketing
Fitness for
Consumer Use
27
History of Quality
Methodology
• Reach back into antiquity, especially into China,
India, Greece and the Roman Empire : skilled
crafstmanship.
• Industrial Revolution (18th century): need for more
consistent products that are mass-produced and
needed to be interchangeable. Rise of inspection
after manufacturing completed and separate quality
departments.
28
History of Quality
Methodology
• World War II: Acceptance of statistical quality-control
concepts in manufacturing industries (more sophisticated
weapons demanded more careful production and
reliability); The American Society for Quality Control
formed (1946).
• Quality in Japan: W.E. Deming invited to Japan to give
lectures; G. Taguchi developed “Taguchi method” for
scientific design of experiments; The Japanese Union of
Scientists and Engineers (JUSE) established “Deming
Price” (1951); The Quality Control Circle concept is
introduced by K. Ishikawa (1960).
29
History of Quality
Methodology
• Quality awareness in U.S. manufacturing industry during
1980s: “Total Quality Management”; Quality control
started to be used as a mangement tool.
• Malcolm Baldrige National Quality Award (1987)
• International Standard Organization’s (ISO) 9000 series
of standards: in 1980s Western Europe began to use;
interest increase in US industry in 1990s; Became widely
accepted today: necessary requirement to world-wide
distribution of product and a significant competitive
advantage.
30
History of Quality
Methodology
• Quality in service industries, government,
health care, and education
• Current and future challenge: keep
progress in quality management alive
• To sum up: A gradual transition
Statistical
Quality
Control
Quality
Assurance
Quality
Management 31
2000 - ...
1990 - … - Excellence Models
1980 – Total
Quality
1970 – Quality Management
Programs
1960 – Quality Warranty
1930 – Statistical Control
1920 –
Inspection
1900 –
Supervision
1900 – Manpower predominance
Focus :The century of Quality
32
1920 - Inspection
 Industrial Revolution
 mass production
 unit verification
 defective product
 Taylor's conception of work
 Measurement, comparison and
verification activities
 Focus on the quantity produced
33
1930 – Statistical Control
 Sampling inspection
 Use of statistical tools
 First concerns regarding
prevention:
 identification of causes for
defective products
 Focus on the finished product
34
1930 – Statistical Control
 Seven Basic Quality Tools:
 Flowcharts and Process Maps
 Check lists
 Cause-effect diagrams
 Pareto diagrams
 Histograms
 Scatter diagrams
 Control charts
35
1960 – Quality Warranty
 First quality standards
 Customers’ specifications
 Preventive actions
 System’s approach
 Started the concern about
involving everyone in the
organization
 Focus on the manufacturing
process
36
1970 – Quality Management Programs
 Evolution from the Quality
Warranty phase
 Integration of quality on global
management
 Quality Circles
 Audit
 Focus on the work process
37
1980 – Total Quality
 Management Principles:
 Responsibility delegation
 Staff autonomy
 Satisfaction of needs and
expectations
 Struggle for improvement
 Adaptation needs
 Change management
 Focus on the organizational
process
38
1980 – Total Quality
 Quality Management System:
a set of organisational measures which transmit
maximum confidence that a given quality level is
being achieved with the adequate resource
consumption
 Characteristics:
 External focus: at the client
 Global approach and as an integral component
of the organization strategy
 Horizontal vision within the organization,
from top management to staff
 Includes all the concerned parts
 Continuous learning and adaptation to change39
1980 – Total Quality
Tools and methodologies:
 Re-engineering
 QFD – Quality Function Deployment
 Benchmarking
 Inquiries: clients and staff
 Brainstorming
 Balanced Scorecard
40
1990 - ... – Excellence Models
 Orientation guide
 Flexible and adaptable instrument
 Self-assessment and continuous
improvement models
 Support on the pathway to
excellence
 Focus on customer
41
Quality: 2 schools of thought
Deterministic School
•
Vision:
Continuous improvement school
•
– Deterministic, 1 good way,
•
Pratiques principales:
– Not a unique way, multiple paths
•
– To be conform with the
requirements,
– Customer focus,
– Lead corrective actions,
•
Concepts:
– Inspection, AQ, 0 failure,
•
•
Targets:
– Quality cost, lack of top
management involvement.
Pratiques principales:
– Continuous improvement;
– Customer satisfaction and
employees involvment,
– Continous and potential improvment
in all the sectors,
•
Concepts:
– Quality throughout the global
company, TQM
Contributors:
– Taylor, ISO, Crosby,
Vision :
•
Contributors:
– Deming, Juran, Ishikawa, Shewhart
•
Targets:
– All profits linked with Quality, top
management involvement.
42
A new theoretical Framework
10
Culture
Zero failure
TQM, quality management
6
4
Quality
Quality control
Process
2
Inspection
0
Deterministic school
Product
Continuous improvement
school
43
Focus on practices
Development level
8
What does Total Quality Management
encompass?
TQM is a management philosophy:
• continuous improvement
• leadership development
• partnership development
Cultural
Alignment
Customer
Technical
Tools
(Process
Analysis, SPC,
QFD)
44
Why he is famous?
• Zero defect concept
• Non quality estimated between 15 to
20% of the overall turnover.
45
Why he is famous?
46
Why he is famous?
Shewhart Walter A. (1891-1967)
• Control charts.
• Statistical point of view,
47
Why he is famous?
Juran Joseph M. (1904-1987?)
• Show the importance of leadeship
and continuous improvement,
• Wrote the « Quality Control
Handbook » (1951).
48
Why he is famous?
Kaoru Ishikawa
• Set up tools easy to use, that
are still used in the everyday
life of a quality engineer.
49
Contributors…
•
Frederick W. Taylor wrote Principles of Scientific Management in 1911.
•
Walter A. Shewhart used statistics in quality control and inspection, and
showed that productivity improves when variation is reduced (1924);
wrote Economic Control of Manufactured Product in 1931.
•
W. Edwards Deming and Joseph M. Juran, students of Shewhart, went
to Japan in 1950; began transformation from “shoddy” to “world class”
goods.
•
In 1960, Dr. K. Ishikawa formalized “quality circles” - the use of small
groups to eliminate variation and improve processes.
•
In the late ‘70’s and early ‘80’s:
– Deming returned from Japan to write Out of the Crisis,
and began his famous 4-day seminars in the United States
– Phil Crosby wrote Quality is Free
– NBC ran “If Japan can do it, why can’t we?”
– Motorola began 6 Sigma
50
Contributors…
Deming’s Concept of “Profound Knowledge”
 Understanding (and appreciation) of Systems
- optimizing sub-systems sub-optimizes the total system
- the majority of defects come from systems, the responsibility of
management (e.g., machines not in good order, defective material,
etc.
 Knowledge of Statistics (variation, capability, uncertainty in data,
etc.)
- to identify where problems are, and point managers and workers
toward solutions
 Knowledge of Psychology (Motivation)
- people are afraid of failing and not being recognized,
so they fear how data will be used against them
 Theory of Knowledge
- understanding that management in any form is a prediction, and
is
based on assumptions
51
The Quality Gurus – Joseph Juran
Quality is “fitness
for use”
Pareto Principle
Cost of Quality
General
management
approach as well as
statistics
1904 - 2008
1951
52
The Quality Gurus – Edward Deming
Quality is
“uniformity and
dependability”
Focus on SPC and
statistical tools
“14 Points” for
management
PDCA method
1900-1993
1986
53
Deming’s 14 Principles.
1.
“Create Constancy of Purpose”




2.
“Adopt A New Philosophy”




3.
Define the problems of today and the future
Allocate resources for long-term planning
Allocate resources for research and education
Constantly improve design of product and service
Quality costs less not more
Superstitious learning
The call for major change
Stop looking at your competition and look at your customer
instead
“Cease Dependence On Inspection For Quality”




Quality does not come from inspection
Mass inspection is unreliable, costly, and ineffective
Inspectors fail to agree with each other
Inspection should be used to collect data for process control
54
Deming’s 14 Principles.
4.
“End Proactive Awarding Of Business Based On PriceAlone”




5.
“Improve Every Process Constantly / Forever”




6.
Price alone has no meaning
Change focus from lowest inital cost to lowest cost
Work toward a single source and long term relationship
Establish a mutual confidence and aid between purchaser and
vendor
Quality starts qith the intend of management
Teamwork in design is fundamental
Forever continue to reduce waste and continue to improve
Putting out fires is not improvement of the process
“Institute Training”




Management must provide the setting where workers can be
succesful
Management must remove the inhibitors to good work
Management needs an appreciation of variation
This is management’s new role
55
Deming’s 14 Principles.
7.
“Adopt And Institute Leadership”



8.
“Drive Out Fear”




9.
The common denominator of fear:
Fear of knowledge
Performance appraisals
Management by fear or numbers
“Break Barriers Between Staff Areas”


10.
Remove barriers to pride of workmanship
Know the work they supervise
Know the difference between special and common cause of
variation
Know your internal suppliers and customers
Promote team work
“Eliminate Slogans, Exhortations And Targets”


They generate frustration and resentment
Use posters that explain what management is doing to improve
the work environment
56
Deming’s 14 Principles.
11.
“Eliminate Numerical Quotas”



12.
“Remove Barriers That Rob Pride Of Workmanship”




13.
Performance appraisal systems
Production rates
Financial management systems
Allow people to take pride in their workmanship
“Institute Programs For Education And Self Improvement”



14.
They impede quality
They reduce production
The person’s job becomes meeting a quota
Commitment to lifelong employment
Work with higher education needs
Develop team building skills
“Put Everybody In The Company To Work For This
Transformation”



Struggle over the 14 points
Take pride in new philosophy
Include the critical mass of people in the change
57
QUALITY DOES NOT
OCCUR BY ACCIDENT
• What does the customer actually
want?
– Identify, understand and agree
customer requirements
• How are you going to meet those
requirements?
– Plan to achieve them
58
Deming’s Cycle
What are we trying to
accomplish?
AIM
How will we know that a
change is an improvement?
What change can we make
will result in improvement?
that
MEASURE
Selecting Change
Plan
Plan
P
P
Act
Do
A
D
A
A
P
D
Do
D
C
C
C
Check
Check
59
Quality Management
Quality Management System: Management system to direct and
control an organisation with regard to quality – ISO 9000:2000
Quality Management
Quality Planning
Quality Assurance
Quality Control
Criteria driven
Prevention driven
Inspection driven
60
Quality Management
Components
• Quality Planning
– It identifies the standards and determines how to satisfy
those standards.
– It lays out the roles and responsibilities, resources,
procedures, and processes to be utilized for quality control
and quality assurance.
• Quality Assurance
– It is the review to ensure aligning with the quality
standards. An assessment will be provided here.
– Planned and systematic quality activities.
– Provide the confidence that the standards will be met.
61
Quality Control – Inspection
Driven
• Quality Control
– It addresses the assessment conducted
during Quality Assurance for corrective
actions.
– Measure specific results to determine that
they match the standards.
– Use of Statistical Process Control (SPC) : a
methodology for monitoring a process to
identify special causes of variation and signal
the need to take corrective action when
appropriate.
62
– SPC relies on control charts.
Quality-related costs
• Prevention costs
– activities to keep unacceptable products from
being generated and to keep track of the
process
• Appraisal costs
– activities to maintain control of the system
• Correction costs
– activities to correct conditions out of control,
including errors
63
Prevention costs
•
•
•
•
•
•
•
Quality planning and engineering
New products review
Product/process design
Process control
Burn-in
Training
Quality data acquisition and analysis
64
Appraisal costs
•
•
•
•
Inspection and test of incoming material
Product inspection and test
Materials and services consumed
Maintaining accuracy of test equipment
65
Correction costs
1. Internal Failure Costs:
–
–
–
–
–
–
–
Scrap
Rework
Retest
Failure analysis
Downtime
Yield losses
Downgrading (off-specing)
66
Correction costs
2. External Failure Costs:
–
–
–
–
–
Complaint adjustment
Returned product/material
Warranty charges
Liability costs
Indirect costs
67
Cost of implementing quality
management, accreditation and
quality assurance
correction
c
o
s
t
quality management
and assurance
total
time
68
Internal and External Benefits
of Quality
Internal Benefits
Reduces costs
Increases dependability
Increases speed
Boosts moral
Increases customer retention
Increases profit
External Benefits
Customer gets correct
product or service
Correct specifications
Appropriate intangibles
Customer satisfaction
Customer retention
69
Drawbacks
• Long way to establish in the organisation
• QM design not always fit for purpose (loss
of cost effectiveness)
• Substantial efforts
• Maintain system, otherwise reject it.
70
Quality
Quality Improvement
Traditional
Time
71
Continuous improvement philosophy
1. Kaizen: Japanese term for continuous
improvement. A step-by-step improvement of
business processes.
2. PDCA: Plan-do-check-act as defined by Deming.
Plan
Do
Act
Check
3. Benchmarking : what do top performers do?
72
Tools used for continuous improvement
1. Process flowchart
73
Tools used for continuous improvement
2. Run Chart
Performance
Time
74
Tools used for continuous improvement
3. Control Charts
Performance Metric
Time
75
Tools used for continuous improvement
4. Cause and effect diagram (fishbone)
Machine
Man
Environmen
t
Method
Material
76
Tools used for continuous improvement
5. Check sheet
Item
-------------------
A
B
C
√√
D
E
√
√√√
√√√
√√
√
√√
F
√
√
√
G
√
√√
77
Tools used for continuous improvement
6. Histogram
Frequency
78
Tools used for continuous improvement
7. Pareto Analysis
100%
75
%
50
%
25
%
0%
50
40
30
20
10
A
B
C
D
E
Percentage
Frequenc
y
60
F
79
Summary of Tools
1. Process flow chart
2. Run diagram
3. Control charts
4. Fishbone
5. Check sheet
6. Histogram
7. Pareto analysis
80
Case: shortening telephone waiting
time…
• A bank is employing a call answering service
• The main goal in terms of quality is “zero waiting time”
- customers get a bad impression
- company vision to be friendly and easy access
• The question is how to analyze the situation and improve
quality
81
The current process
Custom
er A
Custom
er B
Operator
Receiving
Party
How can we reduce waiting
time?
82
Fishbone diagram analysis
Absent receiving
party
Working system of
operators
Absent
Out of office
Too many phone
calls
Lunchtime
Not at desk
Not giving
receiving party’s
coordinates
Complaining
Customer
Absent
Lengthy talk
Does not know
organization
well
Leaving a
message
Does not
understan
d customer
Makes
custom
er wait
Takes too much time
to explain
Operator
83
Reasons why customers have to wait
(12-day analysis with check sheet)
Daily
average
Total
number
A
One operator (partner out of office)
14.3
172
B
Receiving party not present
6.1
73
C
No one present in the section receiving call
5.1
61
D
Section and name of the party not given
1.6
19
E
Inquiry about branch office locations
1.3
16
F
Other reasons
0.8
10
29.2
351
84
Pareto Analysis: reasons why customers
have to wait
Frequency
Percentage
300
87.1%
250
71.2%
200
49%
150
100
0%
A
B
C
D
E
F
85
Ideas for improvement
1. Taking lunches on three different shifts
2. Ask all employees to leave messages when leaving
desks
3. Compiling a directory where next to personnel’s
name appears her/his title
86
Results of implementing the
recommendations
…After
Before…
Percentage
Frequency
Percentage
Frequency
100%
87.1
%
300
300
71.2
%
200
Improvemen
t
200
49
%
100
100
100%
0%
A
B
C
D
E
F
0%
B
C
A
D
E
F
87
In general, how can we monitor quality…?
By observing
variation in
output measures!
1. Assignable variation: we can assess the cause
2. Common variation: variation that may not be possible
to correct (random variation, random noise)
88
Taguchi’s Contribution
• In the early 1980s, Prof. Genechi
Taguchi introduced his approach to
using experimental design for
1) Designing products or processes so that they are robust to
environmental conditions.
2) Designing/developing products so that they are robust to
component variation.
3) Minimizing variation around a target value.
• By robust, we mean that the product or process performs
consistently on target and is relatively insensitive to factors that
are difficult to control.
89
Taguchi Philosophy
•
3 stages in a product’s (or process’s)
development:
1) System design: uses scientific and
engineering principles to determine
the basic configuration.
2) Parameter design: specific values for the system
parameters are determined.
3) Tolerance design: determine the best tolerances for
the parameters.
90
Taguchi Philosophy
• Recommends: statistical experimental
design methods have to be used for
quality improvement, particularly
during parameter and tolerance
design phases.
• Key component: reduce the variability around the
target (nominal) value.
91
What is a Control Chart?
• A control chart is a presentation of data in
which the control values are plotted
against time.
• Control charts have a central line, upper
and lower warning limits, and upper and
lower action limits.
• Immediate visualisation of problems.
92
Control chart
-illustration of construction
Central line
X-chart
Copper
Action limit
Warning limit
1.3
1.2
1.1
1.0
0.9
0.8
0
10
20
30
40
50
60
70
80
90
100
Control value
93
When to Take Action?
• One point plots outside the Action Limits.
• Two consecutive points plots between the
Warning and Action Limits
• Eight consecutive points plot on one side
of the Center Line
• Six points plots steadily increasing or
decreasing
• When an unusual or nonrandom pattern is
observed
94
When to Take Action?
4
3
2
1
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
-1
-2
-3
-4
Month
95
When to Take Action?
4
3
2
1
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
-1
-2
-3
-4
Month
96
When to Take Action?
4
3
2
1
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
-1
-2
-3
-4
Month
97
What is Quality?












Small improvements in processes
Identifying and describing processes
Quality control to meet specifications
Quality control and financial control are
divided.
Customer orientation
Improvement of results
Improvement of management & Organisation
Balanced steering of management
Focus of potential customer
Improvement of staff development
Improvement of flexibility of the organisation
Results in terms of added value for society
ISO 9000: 2000
98
Comparison
Sector
Business
Management
Quality
Management
Social sector
Rehabilitation
Framework
Guidelines
Standards for QM
Standards for
service provision
Principles of
Excellence
Emphasise
Innovation &
learning
Control & assurance
Control & assurance
Performance
improvement &
learning
Method
Self evaluation +
external audit
External audit
External audit
Self evaluation +
External audit
Orientation
Business Excellence
Process and quality
control
Performance,
process & quality
control
Excellence in service
provision
Recognition
Europe
Global
Europe
Europe
Strategic option
Flexibility
Efficiency
Efficiency
Effectiveness
99
Assurance Qualité, Eco-conception et
Développement Durable 1
ISO 9001:2008
History and clauses
[email protected]
100
Discussion Topics
 Introduction
to Standardization
 Evolution
of Quality Management System
(ISO 9000)
 Quality
Management System - Requirements
(ISO 9001:2008)
 Implementing
a QMS
Customer Satisfaction
“ Degree to which the customer’s requirements have been
fulfilled ”
Performance
Satisfaction =
Expectation
< 1 - Dissatisfaction
= 1 - Satisfaction
> 1 - Delight
Standardization
The process of developing and agreeing upon Standards.
Aims of Standardization










Fitness for purpose
Interchangeability
Variety reduction
Compatibility
Guarding against factors that affect the
health and safety of consumers
Environmental protection
Better utilization of resources
Better communication and
understanding
Better communication and
understanding
Removal of trade barriers
Standard?
Standards are documented agreements
containing technical specifications or
precise criteria to be used consistently as
a guideline of characteristics, to ensure
that materials, products, processes and
services are fit for their intended purpose.
TYPES OF STANDARDS
Vocabulary standards:
Glossaries, signs and symbols; A few examples are Paper Vocabulary, List
of Equivalent Terms Used in the Plastic Industry, Vocabulary for the Refractory
Industry and Vocabulary of Information Processing.
Measurement standards:
Material measure or physical property that defines or reproduces the unit of
measurement of a base or derived quantity. Such as units of measures; The
seven basic units of the SI system e.g. meter, Kg, Ampere etc.
Product standards:
Cover specifications for dimensions, performance, health, safety,
environmental protection and documentation; Standards for inspection, test
methods and analysis.
Management Standards:
Standards that focus on organization, such as for logistics, maintenance,
inventory management, quality management, project management and
production management such as ISO 9000, ISO 14000, ISO 17025, SA 8000,
HACCP etc.
Attributes of a standard
A standard generally has three attributes:
1.
Level: such as at the company, national or international level.
1.
Subject: such as engineering, food, textile or management.
1.
Aspect: such as specification, testing and analysis, packaging and
labeling (more than one aspect may be covered in a single standard: a
standard may include specification of items such as the product, its
sampling and inspection, related tests and analysis, packaging and
labeling).
Renowned Standardization
Bodies
ISO
ASTM
DIN
EN
International Organization for Standardization
American Society for Testing and Materials
Deutsches Institut für Normung
European Norms
IEC
BSI
International Electrotechnical Commission
British Standards Institute
Certification
1.
2.
3.
Means Compliance with a standard or
specification (e.g. Systems or Product
Standards).
May be general in the scope of recognition
Considers total business .
Accreditation
1.
2.
3.
It means recognition of competence in a
specific area and scope.
Its scope is highly specific.
Evaluates people, skills and knowledge.
Evolution of Quality Management
System – ISO 9001:2008
1987
First Published – ISO 9001, 9002 & 9003
1994
First revision – ISO 9001, 9002 & 9003
2000
Second revision - ISO 9001
2008
2015
Third revision – ISO 9001
Fourth version – new version
Quality Management System
Management System to direct & control an organization
with regard to quality.
The Early Days
In 1946, delegates from 25
countries met in London and decided
to create a new international organization, of which the
object would be "to facilitate the international
coordination and unification of industrial standards".
The new organization, ISO, officially began operations
on 23 February 1947.
ISO is a network of the national standards institutes of
156 countries, on the basis of one member per
country, with a Central Secretariat in Geneva,
Switzerland, that coordinates the system.
(http://www.iso.org)
Who and what is
ISO?
ISO is the (International
Organization for Standardization)
and is the world's largest developer of
standards. Because "International Organization for
Standardization" would have different abbreviations in
different languages ("IOS" in English, "OIN" in French
for Organisation internationale de normalisation), it
was decided at the outset to use a word derived from
the Greek ISOS, meaning "equal". Therefore,
whatever the country, whatever the language, the
short form of the organization's name is always ISO.
What does ISO
do?
The International
Standards which ISO develops
are very useful. They are useful to
industrial and business organizations of all types, to
governments and other regulatory bodies, to trade
officials, to conformity assessment professionals, to
suppliers and customers of products and services in
both public and private sectors, and, ultimately, to
people in general in their roles as consumers and end
users.
ISO makes the world
better
ISO standards contribute to
make the development,
manufacturing and supply of products and services
more efficient, safer and cleaner. They make trade
between countries easier and fairer. They provide
governments with a technical base for health, safety
and environmental legislation. They aid in transferring
technology to developing countries. ISO standards
also serve to safeguard consumers, and users in
general, of products and services - as well as to
make their lives simpler.
Benefits to the Society from
Standards
• For businesses
–
–
suppliers can base the development of their products and services on specifications that have
wide acceptance in their sectors
free to compete on many more markets around the world
• For customers
–
–
worldwide compatibility of technology
wide choice of offers & competitor prices
• For governments
–
health, safety and environmental legislation
• For trade officials
–
level playing field for all competitors
–
technical barriers to trade
• For developing countries
–
–
international consensus of technological know-how
right decisions in investing their scarce resources
• For consumers
–
provides assurance about their quality, safety and reliability
• For everyone
–
quality of life in general
• For the planet
–
International Standards on air, water and soil quality, and on emissions of gases and radiation
Examples of Benefits
• Standardization of screw threads helps to keep chairs, children's
bicycles and aircraft together
• freight containers, international trade would be slower and more
expensive without standards
• public transport and buildings is a problem if the dimensions of wheelchairs and entrances are not standardized
• Standardized symbols to provide danger warnings and information
across linguistic frontiers.
• Standardized protocols allow computers from different vendors to
"talk" to each other
• More than half a million organizations in more 60 countries are
implementing ISO
Administration of ISO
• Membership of ISO is open to national standards institutes or similar
organizations most representative of standardization in their country
 Member bodies
 Correspondent members
 Subscriber members
 individuals or enterprises are not eligible for membership
 ISO's national members pay subscriptions that meet the
operational cost of ISO's Central Secretariat
 ISO standards are developed by technical committees comprising
experts on loan from the industrial, technical and business sectors
which have asked for the standards, and which subsequently put
them to use.
Definitions
• Certification : refers to the issuing of written assurance
(the certificate) by an independent, external body that has
audited an organization's management system and
verified that it conforms to the requirements specified in
the standard.
• Registration: means that the auditing body then records
the certification in its client register
• Accreditation: refers to the formal recognition by a
specialized body - an accreditation body
• Certification is not compulsory
ISO 9001:2008 – Periodic
Review
• ISO 9001, like all standards is subject to periodic review
to determine whether it is still relevant, whether it needs
to be updated or whether it should be discarded
• The review period is around 5-6 years and for ISO 9001
it is designed such that whenever there are significant
changes to be done (major revision) the next revision will
be less significant (minor)
• Since the revisions issued in 2000 (implemented in
2003) were major, the 2008 one is minor; changes are
more based on the clarification of the existing
requirements rather than including new ones
New version released on the
15th of November 2008
ISO 9000:2000 Family
Annexes A & B for
information only
Quality management
systems Fundamentals &
ISO
ISO
10012
Measurement 10012
ISO
9000
Audits
ISO
19011
vocabulary
Guidelines
Quality management
systems Guidelines for
performance
improvement
ISO
9004
ISO
9001
Technical
Reports
Quality management
systems Requirements
ISO 9001:2000 Process
PROCESS
ApproachEFFECTIVENESS
CONTROLS
Extent to which planned
activities are realized and
planned results achieved
PROCESS
INPUT
“set of interrelated or
interacting activities
which transforms
inputs into outputs
OUTPUT
PRODUCT
PROCESS EFFICIENCY
RESOURCES
Relationship between the
result achieved and the
resources used
A desired result is achieved more efficiently
when activities and related resources are
managed as a process
ISO 9001:2000 System
approach to management
Identifying,
understanding and
managing interrelated
processes as a
system contributes to
the organization’s
effectiveness and
efficiency in
achieving its
objectives
R
R
O
Process
A
I
I
R
I
C
I
I
O
R
C
=
=
=
=
R
I
Process
C
INPUT
OUTPUT
RESOURCES
CONTROLS
O
Process
B
C
C
O
I
Process
D
C
O
Concept of integration
► ISO 9001:2008, ISO 14001:2004 & OHSAS 18001:2007 standards
based on PDCA concept, therefore having similar structure:

Policy

Planning

Implementation and operation

Performance assessment

Improvement

Management review
Quality management
Principles
1. Customer focus
2. Leadership
3. Involvement of people
4. Process Approach
5. System approach to management
6. Continuous Improvement
7. Factual approach to decision making
8. Mutually beneficial supplier
relationships
Quality Management Principle No.1
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.
Application of this principle is reflected in
ISO 9001:2008 clauses 5.2, 7.2.3 and 8.2.1
Customer Focus...





Application of this principle involves :
Researching and understanding customer needs
and expectations.
Ensuring that the objectives of the organization are
linked to customer needs and expectations.
Communicating customer needs and expectations
throughout the organization.
Measuring customer satisfaction and acting on the
results
Systematically managing customer relationships.
Ensuring a balanced approach between satisfying
customers and other interested parties (such as
owners, employees, suppliers, financiers, local
communities and society as a whole)
Quality Management Principle No.2
Leadership
 Leaders
establish unity of purpose and
direction of the organization. They
should create and maintain the internal
environment in which people can
become fully involved in achieving the
organization’s objectives.
This principle is reflected in ISO
9001:2008 clauses 5.3, 5.4, 5.5, 6.1, 6.2
Leadership...
Application of this principle involves:
 Considering the needs of all interested parties including
customers, owners, employees, suppliers, financiers,
local communities and society as a whole.
 Establishing a clear vision of the organization’s future.
Setting challenging goals and targets.
 Creating and sustaining shared values, fairness and
ethical role models at all levels of the organization.
 Establishing trust and eliminating fear.
 Providing people with the required resources, training
and freedom to act with responsibility and accountability.
 Inspiring,
encouraging and recognizing people’s
contributions.
Quality Management Principle No.3
Involvement of people
People at all levels are essence of an
organization and their full involvement enables
their abilities to be used for the organization’s
benefit. This principle is reflected in ISO
9001:2008
clauses
5.3(d)
and
6.2.
Involvement of people...



Application of this principle involves:
People understanding the importance of their
contribution and role in the organization.
People identifying constraints to their performance.
People accepting ownership of processes and
problems and their responsibility for solving them.
Involvement of people...




People evaluating their performance against their
personal goals and objectives.
People actively seeking opportunities to enhance their
competence, knowledge and experience.
People freely sharing knowledge and experience.
People openly discussing problems and issues.
Quality Management Principle No.4
Process Approach
A desired result is achieved more efficiently when
activities and related resources are managed as a
process.
This principle is reflected in almost all clauses of
ISO 9001
Process Approach...
Application of this principle involves:



Systematically defining the activities necessary to
obtain a desired result.
Establishing clear responsibility and accountability for
managing key activities.
Analyzing and measuring of the capability of key
activities.
Process Approach...



Identifying the interfaces of key activities within and
between the functions of the organization.
Focusing on the factors - such as resources,
methods, and materials - that will improve key
activities of the organization.
Evaluating risks, consequences and impacts of
activities on customers, suppliers and other
interested parties.
Quality Management Principle No.5
System approach to management
Identifying, understanding and managing inter-related
processes as a system contributes to the
organization’s effectiveness and efficiency in
achieving its objectives. This principle is reflected in
ISO 9001:2008clauses 4.1& 4.2.
System approach to management...
Application of this principle involves:
 Structuring a system to achieve the organization’s
objectives in the most effective and efficient way.
 Understanding the inter-dependencies between the
processes of the system.
 Structured approaches that harmonize and integrate
processes.
System approach to management...




Proving a better understanding of the roles and responsibilities
necessary for achieving common objectives and thereby reducing crossfunctional barriers.
Understanding organizational capabilities and establishing resource
constraints prior to action.
Targeting and defining how specific activities within a system should
operate.
Continually improving the system through measurement and evaluation.
Quality Management Principle No.6
Continual Improvement
Continual improvement of the organization’s overall
performance should be a permanent objective of the
organization.
This principle is reflected in ISO 9001 clause 8.5.
Continual Improvement...


Application of this principle involves:
Employing a consistent organization-wide approach
to continual improvement of the organization’s
performance.
Providing people with training in the methods and
tools of continual improvement.
Continual Improvement...



Making continual improvement of products,
processes and systems an objective for every
individual in the organization.
Establishing goals to guide, and measures to track,
continual improvement.
Recognizing and acknowledging improvements.
Quality Management Principle No.7
Factual approach to decision making
Effective decisions are based on the
analysis of data and information.
This principle is reflected in ISO 9001:2008
clauses 5.4.1, 5.6.2, 7.3 and 8.4
Factual approach to decision making
Application of this principle involves:
 Ensuring that data and information are sufficiently
accurate and reliable.
 Making data accessible to those who need it.
 Analyzing data and information using valid methods.
 Making decisions and taking action based on actual
analysis, balanced with experience and intuition
Quality Management Principle No.8
Mutually beneficial supplier relationships
An organization and its suppliers are interdependent and a mutually beneficial
relationship enhances the ability of both to
create
value.
This principle is reflected in ISO 9001:2008
clause 7.4
Mutually beneficial supplier relationships




Application of this principle involves:
Establishing relationships that balance short-term
gains with long-term considerations.
Pooling of expertise and resources with partners.
Identifying and selecting key suppliers.
Clear and open communication.
Mutually beneficial supplier relationships



Sharing information and future plans.
Establishing joint development and improvement
activities.
Inspiring, encouraging and recognizing improvements
and achievements by suppliers.
ISO 9000 standards
Three important standards in the family of ISO 9000
International Standard are:

ISO 9000:
Concepts, Principles, Fundamentals and
Vocabulary

ISO 9001:

Sets the QMS Requirements to be met
ISO 9004:
Provides guidance for Continual
improvement of
organization’s overall
performance
ISO 9001:2008

Internationally accepted management standard that
has become a world benchmark for good
management practice

Generic standard i.e. any industry sector viz.
manufacturing or service (education, hospitals,
hotels, banks, transport, accountancy, etc.) can use
it.

Any type (private, public, government enterprise,
etc) and any size of enterprise can use it (big, small
or tiny)
PDCA Methodology
Plan
Act
Do
check
Model of Process based Quality Management System
Continual Improvement of the quality
management system
C
U
S
T
O
M
E
R
R
E
Q
U
I
R
E
M
E
N
T
S
Management
responsibility
Measurement,
analysis &
improvement
Resource
management
Product
realization
Product
C
U
S
T
O
M
E
R
S
A
T
I
S
F
A
C
T
I
O
N
ISO 9001:2008
Quality Management System - Requirements
1.0 Scope
2.0 Normative References
3.0 Terms and Definitions
4.0 Quality Management System Requirements
5.0 Management Responsibility
6.0 Resource Management
7.0 Product Realization
8.0 Measurement, Analysis & Improvement
ISO Clause
Number
0
0.1
0.2
0.3
0.4
1
1.1
1.2
2
3
4
4.1
4.2
4.2.1
4.2.2
4.2.3
4.2.4
5
5.1
5.2
5.3
5.4
5.4.1
5.4.2
5.5
5.5.1
5.5.2
5.5.3
5.6
5.6.1
5.6.2
5.6.3
6
6.1
6.2
6.2.1
6.2.2
6.3
6.4
ISO Clause Name
INTRODUCTION
General
Process Approach
Relationship with ISO 9004
Compatibility with Other Management Systems
SCOPE
General
Application
NORMATIVE REFERENCES
TERMS AND DEFINITIONS
QUALITY MANAGEMENT SYSTEM
General Requirements
Documentation Requirements
General
Quality Manual
Control of Documents
Control of Records
MANAGEMENT RESPONSIBILITY
Management Commitment
Customer Focus
Quality Policy
Planning
Quality Objectives
Quality Management System Planning
Responsibility, Authority, and Communication
Responsibility and Authority
Management Representative
Internal Communications
Management Review
General
Review Input
Review Output
RESOURCE MANAGEMENT
Provision of Resources
Human Resources
General
Competence, Training, and Awareness
Infrastructure
Work Environment
ISO Clause
Number
7
7.1
7.2
7.2.1
7.2.2
7.2.3
7.3
7.3.1
7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7
7.4
7.4.1
7.4.2
7.4.3
7.5
7.5.1
7.5.2
7.5.3
7.5.4
7.5.5
7.6
8
8.1
8.2
8.2.1
8.2.2
8.2.3
8.2.4
8.3
8.4
8.5
8.5.1
8.5.2
8.5.3
ISO Clause Name
PRODUCT REALIZATION
Planning of Product Realization
Customer-related Processes
Determination of Requirements Related to the Product
Review of Requirements Related to the Product
Customer Communication
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
Design and Development Changes
Purchasing
Purchasing Process
Purchasing Information
Verification of Purchased Product
Production and Service Provision
Control of Production and Service Provision
Validation of Processes for Production and Service
Provision
Product Identification and Traceability
Customer Property
Preservation of Product
Control of Monitoring and Measuring Equipment
MEASUREMENT, ANALYSIS AND IMPROVEMENT
General
Monitoring and Measurement
Customer Satisfaction
Internal Audits
Monitor and Measurement of Processes
Monitoring and Measurement of Product
Control of Nonconforming Product
Analysis of Data
Improvement
Continual Improvement
Corrective Actions
Preventive Actions
Quality Management System
CUSTOMERS
Feedback
8.2 Monitoring Customer
Satisfaction
8.2 Internal Audits
Shipping &
Delivery
8.3 Control of
Nonconforming Product
Covering the entire QMS is:
4.2.3 DOCUMENT
CONTROL AND
4.2.4 RECORDS
CONTROL
8.4 Analysis of Data
(Suppliers, Process,
Product, Customer)
7.4 Purchasing &
Receiving
7.3 Design
7.1 Planning
8.0 MEASUREMENT,
ANALYSIS AND
IMPROVEMENT
6.0 RESOURCE
MANAGEMENT
8.5 CONTINUAL
IMPROVEMENT
5.0 MANAGEMENT
RESPONSIBILITY
7.5 Production Control
8.5 Corrective &
Preventive Action
7.0 PRODUCT
REALIZATION
7.6 Monitoring &
Measuring Devices
5.6 Management Review
5.4 Quality Objectives
5.3 Quality Policy
5.1 Management
Commitment
6.2 Human Resources
(Training)
6.3 Infrastructure
6.4 Work Environment
Bids, Quotations,
Orders, and Contracts
CUSTOMER REQUIREMENTS
CUSTOMERS
Quality Management System - 1
4.1 General Requirements
a) Identification of the processes for the QMS
b) Determine the sequence of these processes
c) Determine criteria for effective operation &
control of these processes
d) Ensure the availability of resources
e) Monitor, measure (where applicable) and
analyze these processes
f) Implement actions necessary for achieving
planned results and continual improvement
Quality Management System - 2
4.2
Documentation Requirements - 1
4.2.1 General
The QMS Documentation shall include:
a) Quality Policy & Quality Objectives
b) Quality Manual
c) Documented procedures and records
required by this Standard
d) Documents needed for planning, operation
and control of processes
e) Records required by this Standard
Quality Management System - 3
4.2
Documentation Requirements - 2
4.2.2 Quality Manual
a) Scope of QMS / Justification of the
Exclusions
b) Documented procedures or reference to them
c) Description of interaction between the
processes of the QMS
Quality Management System - 4
4.2 Documentation Requirements - 3
4.2.3 Control of documents
Establish documented procedure to define method
to:
a) Approve documents
b) Review, update and re-approve documents
c) Identify the revision status / changes
d) Ensure availability of relevant versions at point
of use
e) Ensure documents are legible and readily
identifiable
f)
g)
Identification and Control the external documents
Identification and Control of obsolete documents
Quality Management System - 5
4.2
Documentation Requirements - 4
4.2.4 Control of records
a) Establish / Maintain records to demonstrate
conformity to this International Standard
b) Keep records legible, readily identifiable and
retrievable
c) Establish documented procedure for
identification, storage, protection, retrieval,
specify retention time and their disposition
Documentation Requirements
Clause 4
Documents
Quality manual
Flow chart of major processes and their
interaction
Document control procedure
Record control procedure.
Description of out sourced services and their
control procedure.
Records
Document updating records
Disposal of quality records
Management Responsibility - 1
5.1 Management Commitment
a) Communication to the organization the
importance of meeting customer, statutory
and regularity requirements
b) Establish Quality Policy & Quality Objectives
c) Conducting Management Reviews
d) Ensuring the availability of resources
5.2 Customer Focus
Determine and meet the customer requirements
for enhancing customer satisfaction
Management Responsibility - 2
5.3 Quality Policy
a) Is appropriate to the purpose of the
organization
b) Includes a commitment to comply with and
continually improve the QMS
c) Provides framework of establishing and
reviewing Quality Objectives
d) Is communicated and understood within
organization
e) Is reviewed for continuing suitability
Management Responsibility - 3
5.4
Planning - 1
5.4.1 Quality Objectives
a) Needed to meet the requirements of the
product are established at relevant functions
within the organization
b) Are measurable and consistent with the
Quality Policy
Management Responsibility - 4
SMART Objectives
Specific
Measurable
Achievable
Results orientated
Time bound
Management Responsibility - 5
5.4
Planning - 2
5.4.2 Quality Management System Planning
Top Management shall ensure that
a) Planning is done for meeting the requirements
of this standard (4.1) and Quality Objectives
b) Integrity of the QMS is maintained when
changes to QMS are planned and implemented
Management Responsibility - 6
5.5 Responsibility, Authority and Communication
-1
5.5.1 Responsibility and Authority
Are defined and communicated
5.5.2 Management Representative
The Management Shall appoint a Management
Representative responsible to :
a) Ensure that processes for QMS are established,
implemented and maintained
b)
Reporting to top management on performance of QMS
and any need for improvement
c)
Ensure the promotion of awareness of customer
requirements throughout the organization
Management Responsibility - 7
5.5 Responsibility, Authority and Communication
-2
5.5.3 Internal Communication
Top management shall ensure that
appropriate communication processes are
established within the organization and that
communication takes place regarding the
effectiveness of quality management system.
Management Responsibility - 8
5.6
Management Review - 1
5.6.1 General
The management shall review the QMS at
planned intervals to ensure it’s continued
suitability, adequacy and effectiveness
The review shall include :
a) Assessing opportunities for improvement
and need for changes to the QMS
b) Review of the Quality Policy and Quality
Objectives
Records of the reviews must be kept
Management Responsibility - 9
5.6
Management Review - 2
5.6.2 Review Inputs
The Inputs shall include information on:
a) Results of audits
b) Customer feedback
c) Process performance and product conformity
d) Status of preventive and corrective action
e) Follow-up actions from previous
management review
f) Changes which could affect the QMS
g) Recommendations for improvement
Management Responsibility - 10
5.6
Management Review - 3
5.6.3 Review Outputs
The Outputs shall include any decisions and
actions on:
a) Improvement of the effectiveness of quality
management system and processes,
b) Improvement of product related to customer
requirements
c) Resources needs
Documentation Requirements
Clause 5
Documents
Quality objectives at organizational and
functional level.
Organization structure and responsibilities of
management representative and key
functionaries whose job affects product quality.
Description of internal communication channel. (
This could be specified in quality manual)
Procedure for management review
Records
Evidence of quality planning
Record of management review
Resource Management - 1
6.1
Provision of Resources
The Organization shall determine and provide
resources needed to :
a) Implement and maintain the QMS and
continually improve its effectiveness
b) Enhance customer satisfaction by meeting
customer requirements.
Resource Management - 2
6.2
Human Resources
6.2.1 General
Competent persons should perform work effecting quality
6.2.2 Competence, awareness and training
a) Determine the necessary competence for the
personnel performing work effecting quality
b) Provide training and take action to satisfy these
needs
c) Evaluate the effectiveness of the action taken
d) Ensure that its personnel are aware of relevance and
importance of their activities and how they contribute
to the achievement of the quality objectives
e) Maintain appropriate records of education, training,
skills and experience
Resource Management - 3
6.3
Infrastructure
The organization shall determine, provide and
maintain the infrastructure needed to achieve
product conformity, it includes:
a) Building, workplace and associated utilities
b) Process equipment (both hardware and
software)
c) Supporting services(such as transport or
communication)
Resource Management - 4
6.4
Work Environment
The organization shall determine and manage
the work environment needed to achieve
conformity to product requirements
Documentation Requirements
Clause 6
Documents
Specific requirement of qualification and
competence of personnel
Procedure for identifying training needs and
yearly training plan
List of special facilities or work environments
affecting quality
Procedure for maintenance of buildings
equipment and facilities
Record
Record of training and experience of personnel
Maintenance record
Product Realization - 1
7.1
Planning of Product Realization
Organization shall plan and develop the processes
needed for product realization, while considering the
Following factors as appropriate:
a) Quality objective and requirements for the product
b) Need to establish processes, documents, and
provide resources specific to the product
c) Required verification, validation, monitoring,
inspection and test activities specific to the product
and the criteria for product acceptance
d) Records needed to provide evidence that the
realization processes and resulting product meet
requirements (see 4.2.4)
Product Realization - 2
7.2
Customer Related Processes - 1
7.2.1 Determination of requirements related to the product
The organization shall determine:
a) Requirements specified by customer including
(delivery conditions & post Delivery activities)
b) Requirements not stated but necessary for the
intended use, where known
c) Statutory & regulatory requirements related to
product
d) Any additional requirement determined by the
organization
Product Realization - 3
7.2
Customer Related Processes - 2
7.2.2 Review of Requirements Related to the Product
Review following before the acceptance of contract :
a)
Product requirements are defined
b)
Contract or order requirements differing from those
previously expressed are resolved
c)
The organization has the ability to meet the defined
requirements.
Results of the reviews must be maintained
Any change in requirements is communicated to all
Product Realization - 4
7.2
Customer Related Processes - 3
7.2.2 Customer Communication
The organization shall define and implement
Effective arrangements for communicating with
customers in relation to :
a) Product information
b) Enquiries, contracts or order handling,
including amendments, and
c) Customer
feedback,
including
customer
complaints
Product Realization - 5
7.3
Design and Development - 1
7.3.1 Design and Development Planning
Organization shall determine the
a) Design and development stages,
b) Review, verification and validation that are
appropriate to each design and development
stage, and
c) Responsibilities and authorities for design
and development Planning output shall be
updated, as appropriate, as the design and
development progresses
Product Realization - 6
7.3
Design and Development - 2
7.3.2 Design and Development Inputs
Inputs related to product requirements including following
shall be determined,
a) Functional and performance requirements,
b) Applicable statutory and regulatory requirements,
c) Where applicable, information derived from previous
similar design, and
d) Other requirements essential for design and
development
The requirements must be complete, unambiguous and
not in conflict in each other
The requirements must be reviewed for adequacy and
records must be maintained
Product Realization - 7
7.3
Design and Development - 3
7.3.3 Design and Development Outputs
The design and development outputs shall:
a) Meet the input requirements for design and
development
b) Provide
appropriate
information
for
purchasing, production and for services
provision
c) Contain or reference product acceptance
criteria
d) Specify the characteristics of the product
that are essential for its safe and proper use
Product Realization - 8
7.3
Design and Development - 4
7.3.4 Design and Development Review
Reviews by representatives of the functions
concerned shall be performed in accordance with
planned arrangements (see 7.3.1) to :
a)
Evaluate the ability of the results of design
and development to meet requirements, and
b) Identify
any
problems
and
propose
necessary actions.
Records of reviews and any necessary actions
shall be maintained
Product Realization - 9
7.3
Design and Development - 5
7.3.5 Design and development verification
Verification shall be performed in accordance
with planned arrangements (7.3.1) to ensure
that design and development outputs have
met the design and development input
requirements.
Records of the results and any actions shall
be maintained.
Product Realization - 10
7.3
Design and Development - 6
7.3.6 Design and development validation
Validation shall be performed in accordance
with planned arrangements (7.3.1) to ensure
that Resulting product is capable of meeting
requirements for intended use, where known.
Where practicable, validation shall be
completed prior to the delivery or
implementation of the product
Records of the results and any actions shall
be maintained.
Product Realization - 11
7.3
Design and Development - 7
7.3.7 Control of design and development changes
The changes will be reviewed, verified and
validated as appropriate and approved before
implementation.
The review for change shall include evaluation
of the effects of the change on constituent
parts and product already delivered.
Records of the changes and any actions shall
be maintained.
Product Realization - 12
7.4
Purchasing - 1
7.4.1 Purchasing Process
The
organization
shall
ensure
that
purchased product conforms to specified
purchase requirements
The type and extent of control applied shall
be dependent upon the effect on the final
product
Product Realization - 13
7.4
Purchasing - 2
7.4.2 Purchasing Information
Purchasing information shall describe the
purchased product, including where appropriate:
a)
Requirement for approval of product,
procedures, process and equipment
b) Requirement for qualification of personnel
c)
Quality management system requirements
Product Realization - 14
7.4
Purchasing - 3
7.4.3 Verification of the Purchased Product
Establish and implement the inspection
activities
necessary
for
ensuring
conformance of purchased product to
purchase information.
Where verification at the supplier’s premises
is required by organization / customer, it
shall be indicated so in the purchase
information.
Product Realization - 15
7.5
Production and Service Provision - 1
7.5.1Control of Production and Service Provision
Production and service provision shall be carried out
under controlled conditions, as applicable:
a) Availability of information that describes the
characteristics of the product,
b) Availability of work instructions, as necessary,
c) Use of suitable equipment,
d) Availability and use of monitoring and measuring
devices,
e) Implementation of monitoring and measurement, and
f)
Implementation of release, delivery and post-delivery
activities.
Product Realization - 16
7.5
Production and Service Provision - 2
7.5.2Validation of processes for production and service
provision
Validation of process shall be done where the resulting
output cannot be verified by subsequent monitoring or
measurement, the following shall be addressed:
a) Defined criteria for review and approval of the
processes
b) Approval of equipment and qualification of personnel
c) Use of specific methods and procedures
d) Requirements for records
e) Revalidation
Product Realization - 17
7.5
Production and Service Provision - 3
7.5.3Identification and Traceability
Identification of product by suitable means
throughout product realization
Identification of the product status with
respect to the monitoring and measurement
requirements
Where
traceability
is
required
the
organization shall control and record the
unique identification of the product
Product Realization - 18
7.5
Production and Service Provision - 4
7.5.4Customer Property
The organization shall
a)
Identify, verify, protect
customer property
and
safeguard
b) In case of loss, damage or unsuitable for use
customer must be informed
c)
Records must be maintained
Product Realization - 19
7.5
Production and Service Provision - 5
7.5.5Preservation of Product
The organization shall preserve the
conformity of product during internal
processing and delivery to the intended
destination.
This preservation shall include identification,
handling, packing, storage and protection.
Preservation shall also apply to the
constituent parts of product
Product Realization - 20
7.6
Control of Monitoring and Measuring Equipments
The equipments Shall be:
a) Calibrated or verified at specific intervals, or prior to use,
against measurement standards traceable to international
or national measurement standards, where no such
standards exist, the basis used for calibration or verification
shall be recorded
b) Adjusted or re-adjusted as necessary
c) Identified to enable the calibration status to be determined
d) Safeguarded from adjustments that would invalidate the
measurement result
e) Protected from damage and deterioration during handling,
maintenance and storage
f) Records shall be maintained
Documentation Requirements
Clause 7
Documents
Quality plan or other documents showing how
quality is planned in products/projects
Method of capturing customer requirements
Review of orders or contracts to assess
capability to meet customer’s requirements
Specifications for company’s products
Procedure for design and development
Specifications for purchased materials
Documentation Requirements
Clause 7 contnd..
Documents
Procedure for selection and approval of
suppliers
Procedure for review of suppliers performance
Procedure for verification of purchased products
and dealing with non conforming supplies.
Procedures or work instruction for critical
processes.
Procedure for assessing process capability and
approval of processes.
Qualification of operators and processes where
quality cannot be verified after work is
finished.
Documentation Requirements
Clause 7 contd…
Documents
Procedure for maintenance of critical equipment.
Procedure for identification and traceability of
materials (where required).
Inspection and testing plans/instructions.
Procedure for showing inspection/test status of
materials/equipment.
Procedure for calibration measuring devices.
Procedure for handling customer property.
Procedure for preservation, packaging and
storage of product.
Documentation Requirements
Clause 7
Records
Contract review of major contracts
Design review record
Results of design verification/validation
Inspection results of purchased materials.
Record of qualification of operators and
processes where output cannot be assessed for
non conformity.
Inspection and testing records
Record of rework and rejection
Calibration record of measuring devices.
Record of damaged or lost customer property
(where applicable).
Measurement, Analysis and Improvement - 1
8.1
General
Organization must plan and implement the
monitoring measurement, analysis and
improvement processes needed to :
a) Demonstrate conformity of the product
b) Ensure conformity of the QMS
c) Continually improve the effectiveness of QMS
Determine applicable method including Statistical
Techniques and extent of their use
Measurement, Analysis and Improvement - 2
8.2
Monitoring & Measurement - 1
8.2.1 Customer Satisfaction
Establish a method for obtaining and using
the information about customer perception
as to whether the organization has met
customer requirements
Measurement, Analysis and Improvement - 3
8.2
Monitoring & Measurement - 2
8.2.2 Internal Audit
Documented procedures Shall be established and
internal audits shall be conducted at regular intervals
to determine whether the QMS :
a) Conforms to standard and other requirements
determined by organization
b) Is effectively implemented and maintained
Audit shall be:
1. Planned, Criteria / Scope / Frequency and method be
defined.
2. Selection / conduct of audit shall ensure impartiality
3. Follow-up activities shall be performed
4. Records shall be maintained
Measurement, Analysis and Improvement - 4
8.2
Monitoring & Measurement - 3
8.2.3 Monitoring and measurement of processes
Apply methods for monitoring and where
applicable measurement of QMS processes.
Methods shall demonstrate the ability of the
processes to achieve the planned results.
In case planned results are not obtained
Corrective / Preventive actions must be taken
to ensure the conformity to the product.
Measurement, Analysis and Improvement - 5
8.2
Monitoring & Measurement - 4
8.2.4
Monitoring and measurement of product
Monitor the characteristics of the product at
appropriate stages in accordance with
planned arrangements (see 7.1)
Evidence of conformity and acceptance
criteria must be defined.
No product or service delivery shall not
proceed until the planed arrangement are
satisfactorily completed and approved by
authorized person.
Records shall also be maintained.
Measurement, Analysis and Improvement - 6
8.3 Control of Nonconforming Product - 1
The nonconforming products must be
identified and controlled to prevent unintended
use or delivery.
Documented procedure stating responsibility
and authority to deal with nonconforming
products shall be defined.
Measurement, Analysis and Improvement - 7
8.3 Control of Nonconforming Product - 2
The organization shall deal with nonconforming products
by :
a) Taking action to eliminate the detected non
conformity
b) Authorizing its use, release / acceptance under
concession by relevant authority if allowed by
customer.
c) Take action to prevent its original intended use
Records and actions taken shall be recorded.
Incase of rework product shall be re-verified
Incase the product has been delivered appropriate
actions shall be taken
Measurement, Analysis and Improvement - 8
8.4
a)
b)
c)
d)
Analysis of Data
Determine, collect and analyze appropriate data
to demonstrate the suitability and effectiveness
of the QMS and to evaluate where continual
improvement of the QMS can be made.
Analysis of data shall provide information
relating to:
Customer Satisfaction (see 8.2.1)
Conformity of product requirements (see 7.2.1)
Characteristics and trends of processes and
and products including opportunities of
Corrective action
Suppliers
Measurement, Analysis and Improvement - 9
8.5
Improvement - 1
8.5.1 Continual Improvement
The organization shall continually improve the
effectiveness of QMS through the use of :






Quality Policy
Quality Objectives,
Audit Results
Analysis of data,
Corrective and Preventive Actions
Management Review
Measurement, Analysis and Improvement - 10
8.5
Improvement - 2
8.5.2 Corrective Action
Corrective actions shall be taken to eliminate
causes
of nonconformities to prevent their recurrence.
Documented procedure shall be established to
define requirements for:
a) Reviewing
nonconformities
(including
customer complaints)
b) Determining the causes of nonconformities
c) Evaluating the need for action to ensure that
nonconformities do not recur
Measurement, Analysis and Improvement - 11
8.5
Improvement - 3
d) Determining and implementing action needed
e) Records of the action taken results
f) Reviewing corrective action taken
Measurement, Analysis and Improvement - 12
8.5
Improvement - 4
8.5.3 Preventive Action
Preventive actions shall be taken to eliminate
causes
of potential nonconformities to prevent their
occurrence. Documented procedure shall be
established to define requirements for:
a) Determining potential nonconformities and
their causes
b) Evaluating the need for action to prevent
occurrence of nonconformities
c) Determining and implementing action needed
Measurement, Analysis and Improvement - 13
8.5
Improvement - 5
d) Records of results action taken
e) Reviewing preventive action taken
Documentation Requirements
Clause 8
Documents
Procedure for measurement and monitoring of
processes for effective control.
Methods for use of statistical techniques for
process control and data analysis for
improvement.
Procedure for inspection and release of final
product.
Procedure for dealing with non conforming
product and use of material under concession.
Procedure for monitoring customer satisfaction
and dealing with customer complaints.
Documentation Requirements
Clause 8 contnd..
Documents
Procedure of internal audit of QMS, along with
check list.
Procedure for corrective and preventive action.
Procedure for collection and analysis of data for
effectiveness and improvement of QMS.
Records
Process monitoring data and corrective action
taken for process control
Record of product non conformities and
products accepted on concession.
Documentation Requirements
Clause 8 contnd..
Records
Data analysis and activities for continual
improvement.
Result of internal audits and follow up action.
Data on customer feedback and action taken on
customer complaints.
Quality Management System
CUSTOMERS
Feedback
8.2 Monitoring Customer
Satisfaction
8.2 Internal Audits
Shipping &
Delivery
8.3 Control of
Nonconforming Product
Covering the entire QMS is:
4.2.3 DOCUMENT
CONTROL AND
4.2.4 RECORDS
CONTROL
8.4 Analysis of Data
(Suppliers, Process,
Product, Customer)
7.4 Purchasing &
Receiving
7.3 Design
7.1 Planning
8.0 MEASUREMENT,
ANALYSIS AND
IMPROVEMENT
6.0 RESOURCE
MANAGEMENT
8.5 CONTINUAL
IMPROVEMENT
5.0 MANAGEMENT
RESPONSIBILITY
7.5 Production Control
8.5 Corrective &
Preventive Action
7.0 PRODUCT
REALIZATION
7.6 Monitoring &
Measuring Devices
5.6 Management Review
5.4 Quality Objectives
5.3 Quality Policy
5.1 Management
Commitment
6.2 Human Resources
(Training)
6.3 Infrastructure
6.4 Work Environment
Bids, Quotations,
Orders, and Contracts
CUSTOMER REQUIREMENTS
CUSTOMERS
Implementing a Quality
Management System
• Embrace the Eight Quality Management Principles
• Engage Top Managers
• Answer the question “Why do we need a formal
Quality Management System?”
• Conduct a gap analysis
• Determine where you are compared to where you
want to be
• Identify areas for improvement
Adapted from: Cianfrani, Tsiakais, West, ISO 9001:2008 Explained, 3rd edition, ASQ Quality Press, 2009
Implementing a Quality
Management System (cont)
• Review or create:
–
–
–
–
Quality objectives that align with business objectives
Quality Policy
Quality Manual (Level I document)
SOPs (Level II documents)
• Need to address a minimum of 6 areas
– Work Instructions (Level III documents)
– Forms (Level IV documents)
•
•
•
•
•
Create QMS performance metrics
Begin Management Review Meetings
Conduct Internal Auditor training
Perform internal audits
Respond to internal audits and fill gaps
Focus on document control, recordkeeping,
continual improvement and management review
3rd Party Certification
• Research and select a 3rd party registrar
• Optional Pre-assessment meeting (you
actually get some consulting)
• Will need at least two Management Review
meetings
• Will need a full cycle of internal audits
• Practice certification
• Respond to gaps
• Formal certification
Some questions to ask 3rd Party
Registrars
• Are you accredited by a signatory to the
International Accreditation Forum?
• Are you qualified to audit in our industrial
class?
• Can you accommodate our expected
registration date?
• May I speak to some of your current
customers to get a feel for your customer
service?
Adapted from: “Registrar Search Simplified”, Craig Cochran, Quality Digest, February 2006
Some questions to ask 3rd Party
Registrars
• Ask to interview the lead auditor who will
be assigned:
– Can you tell me about your experiences working
in our industry?
– How are major nonconformities handled?
– How do you feel about disagreements when they
arise between you and the customer?
– Can you tell me about an audit situation when
you and a customer had a disagreement on
interpretations and how the disagreement was
resolved?
– What are the three most important things I should
know about you?
Some questions to ask 3rd Party
Registrars
• Understand all the costs:
– What is the fee per auditor day?
– Will we be billed for travel time?
• (Of course you will be charged for actual
travel, lodging and meals)
– Get a list of all other fees:
• Application fee
• Admin fee
• Report writing fee
• Maintenance fee
• Use of logo fee
Possible Project Planning
If You have already embraced the 8 Quality Management Principles
and
you have already engaged the Top Managers
Description
Kickoff meeting
Select 3rd party registrar
Gap Analysis
Document review
Create QMS metrics
Mgt Review Meetings
Pre-Assessment meeting
Internal Auditor training
Internal Audits Round 1
Practice certification
Internal Audits Round 2
Formal certification
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Typical 3rd Party Certification
Costs
• Assume $1300 per auditor
day
• 1st year certification
–
–
–
–
–
–
–
Admin fee
Pre-Assessment fee (2 days)
Pre-Assessment travel
Practice certification fee (3 days)
Practice certification travel
Formal certification fee (5 days)
Formal certification travel
$ 500
$2600
$1000
$3900
$1200
$6500
$1600
• 2nd year surveillance
– Admin fee
– Surveillance fee (2 days)
– Surveillance travel
$ 500
$2600
$1000
• 3rd year recertification
– Admin fee
– Recertification (5 days)
– Recertification travel
• THREE YEAR TOTAL
$ 500
$6500
$1600
$30000
7. Quality Management System Summary
1. Say what you do
2. Write it down in standard format
3. Do what you say
4. Keep excellent records
5. Audit to verify
6. React to gaps
7. Review at Top Management level
8. Build in continual improvement
L ’AUDIT
du SMQ et du SQSE
1ère Partie : La technique
d ’audit
• 1 - QU'EST-CE QUE L'AUDIT ?
• 2 - EN QUOI CONSISTE L'AUDIT ?
• 3 - QUI EST CONCERNE? QUI
INTERVIENT ?
• 4 - COMMENT SE DEROULE UN AUDIT ?
I .1/4 - QU'EST-CE QUE L'AUDIT?
• LA QUALITE ET LE GISEMENT DE NON
QUALITE
• L'AUDIT C'EST ... CE N'EST PAS
• DEFINITIONS AUDIT ET DIAGNOSTIC QUALITE
• PLACE DE L'AUDIT DANS LA DEMARCHE
QUALITE
I.1. 1/8 - La Qualité
GASPILLAGE
réalisation
besoins
du client
Qualité
+
Q
Sur
Qualité
INSATISFACTIONDéfaut
ILLUSION
spécifications
Savoir écouter est un art. Epitecte
I.1 2/8 - Gisement de Non-Qualité
Coûts apparents
3 à 8 % du CA
Coûts cachés
10 à 20 % du CA
ATTAQUE DE LA NQ
Erreurs
Retards
Traitement des plaintes
FACILE
Révision de dossiers
(sans investissement)
Changements de fournisseur identifiés
Paperasseries sur équipement
Temps perdus
Dépenses inutiles
Changements de fournisseurs non perçus
Image dégradée
ACCESSIBLE
(dépenses faibles)
DIFFICILE
(cout élevé)
INACESSIBLE
I.1. 3/8 - L ’audit,...
C'est ...
un outil de progrès
une évaluation par rapport
à un référentiel
une méthodologie claire
un compte-rendu
Ce n'est pas....
une inspection
un auto-diagnostic
l'imprévu ou une impression
I.1. 4/8 - L ’audit,...
AUDIT QUALITE
DIAGNOSTIC QUALITE
• Examen méthodique et normalisé
• Examen méthodique, méthode spécifique
ou consultant
• Champ: système, procédé, produit, service • Champ: entreprise, politique commerciale,
sociale, etc...
• Référentiels (dispositions préétablies & • Pas de référentiel
objectifs à atteindre)
• Détermine la conformité ou
la non-conformité au système qualité
• Est un constat, une photographie
• Révèle en audit interne
les domaines d'amélioration possible
• Recherche des points forts et faibles
• Propose des solutions
I.1. 5/8 - L ’audit,...
Norme
ISO
19011
Processus systématique, indépendant et
documenté en vue d ’obtenir des preuves d ’audit
et de les évaluer de manière objective pour
déterminer dans quelle mesure les critères
d ’audit sont satisfaits.
(preuves : enregistrements, énoncés de fait, ou autres informations,
critères : politiques, procédures, exigences auxquelles les preuves
sont comparées,…)
I.1. 6/8 - Les différents types d ’audit et objec
AUDIT INTERNE
(par première partie
Améliorer le fonctionnement et
accroître la confiance en interne
système/processus/procédure/
produit)
AUDITS
AUDIT CLIENT
(par deuxième partie
Donner la confiance au client
système/processus/procédure/
produit)
AUDIT DE
CERTIFICATIO
N (par ex. AFAQ,
BVQI, Tüv,
Lyods, etc..)
(par tierce
partie
Système)
Prouver à l'ensemble des
clients
nationaux et internationaux
qu'ils peuvent avoir confiance.
I.1. 8/8 - Trois questions posées par
l ’audit
PROCEDE-T-ON COMME IL EST PREVU ?
LE REFERENTIEL EST-IL ADAPTE AUX OBJECTIFS?
A T ’ON LES MOYENS
POUR ATTEINDRE LES RESULTATS ?
Définition
AUDIT QUALITE : Examen méthodique, indépendant et documenté
en vue de déterminer si les activités et résultats relatifs à la Qualité
satisfont aux dispositions préétablies, si ces dispositions sont
mises en œuvre de façon efficace, et si elles sont aptes à atteindre
les objectifs.
OUTIL POUR AMELIORATION DU SYSTEME QUALITE
Les objectifs
ISO 9001
Déterminer la conformité ou non-conformité des éléments
du Système de Management de la Qualité aux exigences
prescrites.
Déterminer l’efficacité du Système de Management de la
Qualité mis en œuvre à satisfaire aux objectifs définis.
Donner à l’audité l’occasion d’améliorer son Système de
Management de la Qualité.
Permettre l’enregistrement du Système de Management
de la Qualité de l’organisme audité.
Les objectifs
REFERENTIEL
(norme)
Recherche de
conformité
Recherche de
conformité
LES PRATIQUES
(ce qui est
réalisé)
SYSTEME
QUALITE
(ce qui est
prévu)
Recherche de conformité
Recherche d’efficacité & Amélioration continue
Les différents types
L’AUDIT DE SYSTEME QUALITE
L’AUDIT DE PROCESSUS
L’AUDIT DE SERVICE
L’AUDIT DE PRODUIT
Les différentes natures
L’audit interne ou audit 1ière partie
- Inter-services / Inter-fonctions L’audit externe ou audit 2ème partie
- Client / Fournisseur L’audit tierce partie
- Organisme certificateur -
Les acteurs
Client
Auditeur
Personne ayant
les compétences
pour réaliser un
audit
Personne ou
organisme
demandant un
audit
Audité
Personne ou
organisme qui est
audité
Les intervenants
Client
Audit Interne
Direction
Audit Externe
Client
Audit Tierce Partie
Audité
(organisme)
Auditeur
Audité
RQ et/ou auditeurs
Toute fonction recevant
formés
l’auditeur
Propres auditeurs ou
tierce partie
Organisme indépendant
Fournisseur
Organisme
Les exigences normatives
Audit Interne
Méthode d’audit
Formation des
auditeurs
Client / Fournisseur
Interne
ISO 19011 (2002) ou
Chapitre 8.2.2 de la
ISO 19011 (2002)
méthode client
norme ISO 9001
Qualification selon la
ISO 19011 ou formation
norme ISO 19011
à l’audit sans
(2002)
qualification
Tierce Partie
Formation interne ou
externe
Responsable du
Définition des
actions correctives
Suivi
Organisme audité
Fournisseur
domaine soumis à
l’audit
Organisme chargé de l’audit doit tenir informé le
Mise en œuvre et
client d’avancement des AC
mesure d’efficacité
L ’AUDIT:
1ère Partie : La technique
d ’audit
• 1 - QU'EST-CE QUE L'AUDIT ?
• 2 - EN QUOI CONSISTE L'AUDIT ?
• 3 - QUI EST CONCERNE? QUI
INTERVIENT ?
• 4 - COMMENT SE DEROULE UN AUDIT ?
I.2/4 - EN QUOI CONSISTE L'AUDIT ?
• PLACE DE L ’AUDIT DANS LE
MANAGEMENT
• PRISE EN COMPTE DU REFERENTIEL DE
L ’ENTREPRISE
• OBJECTIF DE L ’AUDIT
• REGLES POUR LES AUDITS
I.2. 1/10 - Place de l ’audit dans le manageme
MANAGEMENT
PRODUIT
ou
SERVICES
FOURNITURES
EXTERIEURES
Processus
Transverses
PROCEDE
MAIN
D'OEUVRE
CONTRAINTES EXTERNES
Sur tout ou partie
des systèmes
qualité, environnemental
et sécurité
A
P
C
D
I.2. 2/10 - Qu ’est-ce qu ’un référentiel ?
REFERENTIEL
Réglementation
Normes
Etat de l'art
Cahier des charges
Procédures
Modes opératoires
Manuel qualité
ce qu'on doit faire
le référentiel est-il
adapté au but à
atteindre ?
REALITE
procède-t-on
comme prévu?
Ce qui est fait
Mise en oeuvre
Procédés
Objet
ce qui est fait
OBJECTIFS DE L ’ENTREPRISE
Réduction des coûts de nonqualité
Amélioration d'un
produit/procédé
Certification
ce qu'on veut faire
Homologation
s'est-on donné
le moyen des
résultats
à atteindre (efficacité)?
I.2. 3/10 - Quel référentiel pour l ’entreprise ?
•
•
•
•
EXIGENCES REGLEMENTAIRES, CLIENTS, PARTIES
INTERESSEES
Législation, (arrêtés, décrets, … )
Normes ISO - 9000/14000/…., normes produits, ...
Ecoute Clients et parties intéressées (Documents d ’interfaces
avec l'extérieur, études marchés, cahier des charges, contrats,
commandes,…)
DOCUMENTATION D ’ORGANISATION ET OPERATIONNELLE
organisation, documents descriptifs du fonctionnement, systèmes
qualité, environnemental, etc… documents opératoires, ...
I.2. 4/10 - Objectifs de l ’audit ?
• CONSTATER UNE SITUATION
PREVENTIF
• VERIFIER L ’ABSENCE DE
DERIVE / SITUATION
CORRECTIF
ANTERIEURE
• ANALYSER LES CAUSES D'UN
MESURE
PROBLEME
• EVALUER L ’EFFICACITE
mais, en
cas, pour FAIRE UN AUDIT de
D aucun
’ACTIONS
PLUS CORRECTIVES
!...
I.2. 5/10 - Les REGLES de l ’audit
• LES NORMES
INTERNATIONALES
• L'ORGANISATION DE
L ’ENTREPRISE AUDITEE
I.2. 6/10 - Intégration en audit ?
ISO 10011 - 1 : L ’Audit
1 - DOMAINE D'APPLICATION
2 - REFERENCES NORMATIVES
3 - DEFINITIONS
4 - OBJECTIFS DES AUDITS ET RESPONSABILITES
5 - AUDIT
6 - ACHEVEMENT
7 - SUIVI D'ACTIONS CORRECTIVES
0011 - 2 : Qualification des Auditeurs
1. 2. 3. - DOMAINE D'APPLICATION, REFERENCES
NORMATIVES DEFINITIONS
4 - ENSEIGNEMENT
Lignes directrices pour l ’audit environnemental
ISO 14010 - principes généraux
ISO 14011 - Procédures d ’Audit
ISO 14012 - Critères de qualification pour
les auditeurs environnementaux
1234-
5 - FORMATION
6 - EXPERIENCE
7 - QUALITES PERSONNELLES
67-
8 - APTITUDE AU MANAGEMENT
9 - ENTRETIEN DES COMPETENCES
10 - LANGUE
11 - CHOIX DU RESPONSABLE D'AUDIT
ISO 10011 - 3 : Gestion des programmes d ’Audit
1. 2. 3. - DOMAINE D'APPLICATION, REFERENCES
NORMATIVES DEFINITIONS
4 - MANAGEMENT DES PROG. D'AUDITS
 Organisation - normes - qualification - équipe
d'audits
 surveillance maintien performances des auditeurs
 conditions de fonctionnement - audits conjoints
 amélioration du programme d'audit
5 - CODE DE DEONTOLOGIE
ISO 19011 :
Lignes directrices pour
l ’audit des systèmes
de management de la qualité et
de management environnemental
depuis fin 2002
I.2. 7/10 - ISO 19011
Lignes directrices pour l ’audit des systèmes de management
de la qualité et de management environnemental
• 1. 2. 3. - DOMAINE D'APPLICATION,
REFERENCES NORMATIVES DEFINITIONS
• 4 - Principes essentiels
• 5 - Management d ’un programme
d ’audit
I.2. 8/10 - Obligation d ’une procédure
d ’audit
Exemple
• ORGANISATION DES AUDITS
Prise en compte des demandes
établissement, validation, gestion
du programme
règles sur la fourniture des compterendus
bilan et connexion au Plan d'actions
Q.
• CONDUITE DES AUDITS
I.2. 9/10 Exemple établissement et suivi programme
audit
DEMANDEURS
Expression du besoin
1 d'audit
Cellule d'audits
2
Préparation Prog.
d'audits
Hiérarchie
3
validation
Priorités
Resp. Audit
4
Conduite des audits
Demandeur
5
Actions correctives
Plan d'amélioration
D/AQ
6
Analyse des
Audits
Cell.+Hiér.+
Dem
Efficacité des
7audits
I.2. 10/10 Exemple procédure de conduite des audits
D/AQ
1
Référentiel
Validation du Prog.
Resp. Audit
2
Programme
Organisation
contact demandeur
Resp. Audit
3
Préparation visite
Resp. Audit
4
Visite d'audit
Resp. Audit
5
Compte rendu
Compte rendu
d'audit
6
Demandeur
Suivi des actions
correctives
1ère Partie : La technique
d ’audit
• 1 - QU'EST-CE QUE L'AUDIT ?
• 2 - EN QUOI CONSISTE L'AUDIT ?
• 3 - QUI EST CONCERNE? QUI
INTERVIENT ?
• 4 - COMMENT SE DEROULE UN AUDIT ?
I.3/4 - QUI EST CONCERNE ?
• LES ACTEURS
• LES REGLES DU JEU
• L'AUDIT TIERCE PARTIE
• L'AUDIT CLIENT
• L'AUDIT INTERNE
I.3. 1/5 - Les acteurs
Demandeurs ou commanditaires
(ils initient)
Auditeurs
Audités
« L ’Equipe d ’Audit »
(ils participent, ils proposent)
(ils animent)
HIERARCHIE
(ils coordonnent, valident, valorisent)
I.3. 2/5 - Les règles du jeu
A respecter par tous !
1. le savoir être
2. le savoir faire
I.3. 3/5 – Le savoir-être
ECOUTE
NEUTRALITE
OBJECTIVITE
POSITIVISME
CONFIANCE
ADAPTATION
FORMATION
CONSEIL
DYNAMISME
ENTRAINEMENT
EVOLUTION
ENTHOUSIASME
ENCOURAGEMENT
HUMILITE
MODESTIE
I.3. 4/5 – La déontologie de l’auditeur
CODE DE BONNE CONDUITE DE L'AUDITEUR
 Correction, respect de l'interlocuteur
 Respect scrupuleux de la déontologie,
 Etre attentif autant à la forme qu'au fond,
 Etre rigoureux mais souple (points clés)
 Garder une attitude positive
 Montrer de l'empathie
 Etre attentif aux "diversions" (téléphone, secrétaire,...)
 Intervenir sous forme de questions appropriées
 S'appuyer sur l'accompagnant pour la prise de notes,
 Ne pas alimenter les conflits internes,
 Constater les écarts
 Observations fondées sur des preuves tangibles donc des constats de faits,
sinon accorder le bénéfice du doute
 Ecarts en rapport direct avec l'objectif et l'objet de l'audit
 Indiquer et localiser des difficultés liées à l'organisation et/ou aux moyens en vue du progrès
I.3. 5/5 – La déontologie de l’auditeur
CODE DE BONNE CONDUITE DE L'AUDITEUR
 Présentation physique négligée
 Etre "flic" ou "prof",
 Faire comme chez soi
 Etre rigide (liste de questions-type,..)
 Vouloir absolument trouver un écart
 Montrer de la sympathie
 Accepter de" petits cadeaux", de bons repas,...
 Occuper 50% (voire plus !) du temps de parole
 Garder le nez dans ses notes
 Ne pas assurer un climat propice à la communication
 Proposer des solutions
 Recueillir des opinions
 Interroger ou demander des éléments concernant des points qui sortent de l'objet de l'audit
 Mettre en cause des personnes
 Faire passer un examen
L ’AUDIT:
1ère Partie : La technique
d ’audit
• 1 - QU'EST-CE QUE L'AUDIT ?
• 2 - EN QUOI CONSISTE L'AUDIT ?
• 3 - QUI EST CONCERNE? QUI
INTERVIENT ?
• 4 - COMMENT SE DEROULE UN AUDIT ?
I.4/4 - COMMENT SE DEROULE UN AUDIT ?
•
PREPARATION DE L'AUDIT
- Les intervenants
- Le planning
- l ’aspect documentaire
•
CONDUITE DE L'AUDIT SUR LE TERRAIN
•
LE RAPPORT D'AUDIT
•
L'APRES AUDIT
I.4. 1/15 - Le savoir-faire
ORGANISATION-PREPARATION : étude du référentiel, questionnaire
fermé, calendrier, réservation des locaux, réunion de lancement
PRESENTATION-CONTRAT : ouverture par une présentation
puis acceptation du but, du champ, des critères à examiner, des rôles
INTERVIEWS : sur le terrain, de préférence entretiens individuels
VALIDATION : à chaud, Premières conclusions
COMPTE-RENDU D'AUDIT : Formalisme de l ’entreprise
- des faits tangibles, non-conformités, remarques, observations
SUIVI D'ACTIONS : programme d'actions, bilan 6 mois/1an après
I.4. 2/15 - Le Savoir Faire = La Norme
Déclenchement de l ’audit
Revue initiale des documents
Préparation pour les activités sur site
Activités sur site
Rendre compte de l ’audit
Achèvement de l ’audit
I.4. 3/15 – Préparation de l’audit
Le questionnaire fermé
• EX : Référentiel 50CQA
• chap. 7
• "des mesures doivent
être prises
• en vue d'identifier et
de tenir sous
• contrôle les articles"
?
QUESTIONS FERMEES
Les articles sont-ils identifiées ?
Avez-vous une procédure
d'identification des articles?
Connaissez-vous les écarts pour non
identification des produits?
Avez-vous mis en place des actions pour
que les produits soient tenus sous
contrôle ?
I.4. 4/15 – Préparation de l’audit
le Questionnaire ouvert pour les interviews
• COMMENT ?
• QUAND?
• AVEC QUELS ELEMENTS?
• QUI INTERVIENT?
• QUELLES PROPOSITIONS
D'AMELIORATIONS?
POURQUOI?
Vous êtes vous assuré
que les produits sont
identifiés?
I.4. 5/15
NE PAS PREVOIR,
C'EST DEJA GEMIR
LEONARD DE VINCI
L ’audit : 80% du temps en préparation et compte rendu - 20% en intervie
I.4. 6/15 – Constats des faits
Non - conformités et recommandations
• EXAMENS SUR LE TERRAIN les rôles dans l ’équipe d ’audit
• ECARTS CONSTATES
(PREUVES TANGIBLES)
• RECOMMANDATIONS
EVENTUELLES
•
sur demande du client ou des audités -
•
ne jamais les formuler en terme de solution
I.4. 7/15 - Le rapport
d ’audit
•
1 - OBJECTIF ET CHAMP DE L'AUDIT
•
2 - LE REFERENTIEL
•
3 - DEROULEMENT DE L'AUDIT
•
4 - CONSTATS ET RECOMMANDATIONS
•
5 - CONCLUSIONS
•
6 - DIFFUSION
•
EX. Modèle de rapport utilisé au CEA
I.4. 8/15 - Code de bonne conduite
pour la rédaction du rapport d ’audit
 Appréciation "objective" de l'efficacité des méthodes et moyens
examinés pour atteindre les objectifs de l'activité
 Le rapport contient des faits et des conclusions:
 un rappel des données de l'audit,
 le plan de l'audit, éléments de référence, activités auditées,
"check-list", etc...
 les observations retenues,
les conclusions découlant du constat réalisé, de l'objectif fixé et
des risques encourus
 Notation en Audit Externe, "profil de performance" en interne.
 Prendre les dispositions permettant d'assurer la confidentialité
I.4. 9/15 - CONCLUSIONS - l'après
audit
pour l'auditeur:
 une meilleure connaissance de l'entreprise (ou, en externe, du partenaire)
 une formation permettrant de progresser dans sa propre activité
 l'amélioration continue et la reconnaissance de sa compétence
pour l'audité:
 évaluation de l'efficacité de son système qualité
 certification d'entreprise mais aussi homologation, accréditation,
qualification,....
 identifier des améliorations potentielles
 polariser sur des points importants que "l'oeil neuf" a décelés,
et par la suite,
découvrir d'autres moyens pour maîtriser la Qualité,
Plus globalement, apporter une meilleure réponse aux attentes du clien
I.4. 10/15 - Gestion des audits
GESTION DES AUDITS
N° DEMANDEUR AUDIT EURS (1)
NOM
UNIT E
LIBELLE
DE
L'AUDIT
REFERENT IEL
CHAMP
ECHEANCIER
D'APPLICAT ION
Définir et Mettre en place la couverture du système
par le programme d ’audits !
I.4. 11/15 - Gestion des audits/Quels indicateu
N°
D EM A N D EU R
A U D IT EU RS (1 )
LIBELLE
NOM
DE
U N IT E
L' A U D IT
REFEREN T IEL
CHA M P
EC H EA N C IER
D ' A PPLIC A T IO N
REF. D U
C.R
(1 ) resp o n sab le d e l' au d it so u lig n é
N 1 = N b d e rec o m m an d at io n s f o rm u lées p ar les au d it eu rs
(2 ) U n it é o u IN B
N 2 = N b . d ' ac t io n s c o n c rèt es réalisées su it e à rec o m m an d at io n s
N1
N2
I.4. 12/15 - Quelle mesure d’efficacité ?
Indicateur semestriel:
Nb actions réalisées
Nb de
recommandations
?
Diminution
de la
Non-Qualité
I.4. 13/15 - Exemples d ’indicateurs
F
G
1S99 2S99 1S00 2S00 1S01 2S01
H
1S99 2S99 1S00 2S00 1S01 2S01
1S99 2S99 1S00 2S00 1S01 2S01
Produits
43
60
43
85
50
100
60
78
56
44
96
43
100
X
100
100
100
100
Fournis.
66
X
X
X
X
100
70
X
X
X
X
100
X
X
X
X
X
X
Fonctiont.
75
100
100
100
66
100
100
57
55
68
58
90
X
100
100
92
86
100
Prog.part.
X
X
100
100
X
X
100
83
100
X
X
X
X
100
100
X
X
X
Sécurité
70
60
50
70
60
86
83
53
43
60
63
72
X
85
87
92
95
97
Environt.
64
100
44
100
75
100
100
86
64
67
92
81
X
95
100
100
100
95
F : nombre d ’audits réalisés / nombre d ’audits prévus d ’être réalisés
(*)
G : nombre d ’actions d ’amélioration réalisées / nombre d ’actions
d ’amélioration prévues d ’être réalisées (*)
H : nombre d’actions d’amélioration vérifiées / nombre d ’actions
d’amélioration prévues d’être vérifiées (*)
* : période considérée : entre deux Revues de Direction
I.4. 14/15 - Exemple de suivi de
l ’efficacité d’un programme d’audits
100
Eval Ent
80
GEN
60
SSM
ENV
40
20
0
99 (1s)
99 (2s)
00 (1s)
00 (2s)
01 (1s)
01 (2s)
I.4. 15/15 - Le plan d ’action qualité
suite à audits
QUOI ?
QUAND ?
COMBIEN?
Nature des Objectifs :
actions à
coûts
effectuer
délai,
quantité,
diminution
d'écart...
QUI
?
COMMENT ?
Personnes chargées
de préparer
et d'effectuer les
actions
Mode de suivi:
réunions,
revues de direction,
compte-rendu
Pilote de l'action
QUAND ?
COMBIEN?
Mode d'évaluation
Indicateurs
gains financiers?
L ’AUDIT:
2ème Partie : Mise en situation
• Réussir l'AUDIT, ou comment s'y prendre
pour qu'un audit soit efficace
II .1/4 – Comment s’y prendre ?
de l’audit – satisfaction des attentes client
. Nouvelle logique et dynamisme – le PDCA
. 7 étapes et 14 clés
. Remarques sur l’aspect comportemental
. Rôle
Des attentes à la satisfaction
des besoins: 4 acteurs
exigences
attentes
Auditeurs
Tiers indépendants
société
Réglementatio
SMQSE
Organisme
SMQSE
Fournisseur
externe
utilisateurs
SM
Audit processus
Audit système
satisfaction
PM
Fournisseur
interne
Responsable
Produit/Projet
d’installation
et/ou recherche
Besoins
SM PM
programmes
Client
partenaires
Exploitant
Nouvelle logique de l'audit
L'auditeur vérifie la conformité du produit avec
les exigences du client (explicite, implicite et latente),
et en plus l'auditeur va s'assurer que les activités
réalisées sont efficaces (atteinte des objectifs).
Il utilise la logique
•
•
•
•
Plan : Objectifs, ressources et organisation
Do : Maîtrise de la réalisation des activités
Check : Surveillance et mesures
Act : Action ou réaction
Un audit interne pour quoi faire ?
(ex: CEA ?)
La logique du
PP
appliquée au processus AUDIT
Objectifs
PP
Ressources
L'AUDIT
D
PP
Processus systématique,
indépendant et documenté
en vue d’obtenir
des preuves d’audit
et de les évaluer
de manière objective
pour déterminer
dans quelle mesure
les critères d’audit sont
satisfaits.
Pilotage du processus
Interaction Processus
Données d'entrée
Critères d'audit :
ensemble de
politiques,
procédures ou
exigences
déterminées
comme références.
ISO19011
A
Données de sortie
Preuves d'audit :
enregistrements,
énoncés de faits ou
autres informations,
qui se rapportent
aux critères d'audit
et sont vérifiables.
ISO19011
C
Un audit interne pour quoi faire ?
(ex: CEA ?)
P
Objectifs
P
Ressources
L'AUDIT
D
P
Surveiller
les SMQ
Données
d'entrée
Mesurer
Données
de sortie
Progresser
Références : MQ CEA §9.3
ISO 9001:2000
C
Approche dynamique du Système Audit
Qualité
Système
qualité audit
DSNQ, DIR, centre...
Prévoir
Planifier
Fixer les
objectifs
Besoin d'audits
Vision management
Analyse / Objectifs
Clients
de
l'audit
Améliorations du Processus Audit
Vision opérationnelle
Affecter les ressources
nécessaires
Effectuer
des mesures
sur le produit
& le processus
(auditeurs et budgets)
PROCESSUS
Réalisation
de l'audit
Rapport
Clients
de
l'audit
Audit = miroir
Axe optique
Champ d’audit
Éclairage
Miroir
Auditeurs
Informations
Sujets
Audités
La logique du PDCA
appliquée au processus AUDIT
PP
Objectifs
P
Ressources
PP
Données d'entrée
PROCESSUS
d'AUDIT
D
Données de sortie
C
A
Pilotage du processus
Interaction Processus
Les objectifs d'audit
ISO 9001:2008
Conformité : satisfaction d'une exigence
(audit de conformité d'un produit,
de l'application d'une procédure).
Efficacité : niveau de réalisation des activités
et d'obtention des résultats escomptés
(audit d'efficacité d'un processus, d'un système).
Objectifs
Décrit par l’intitulé de l’audit:
à mentionner en gros au tableau lors de l’audit!
Dans un laps de temps imparti
Ex : Audit d’application du processus
de conduite du projet XYZ dans le cadre
du système de management de la qualité
de l’organisme W de deux jours
Audit du système de management de la qualit
de l’organisme X en cinq jours
Le champ de l’audit
Définis par :
Mesurés par :
relevés,
enregistrements,
indicateurs
Processus et moyens mis
en place pour atteindre
les objectifs qualité
Exigences
clients,
réglementaires
Le parcours de l'auditeur (1)
MQ, procédures,MO,
fiche de poste
Les 7 étapes de l'activité d'audit (ISO 19011)
1 - Déclenchement de l'audit
2 - Revue des documents
3 - Préparation des activités d'audit
4 - Réalisation de l'audit sur site
5 - Préparation, approbation et diffusion du rapport
d'audit
6 - Clôture de l'audit
7 - Suivi d'audit
14 clés pour franchir ces 7 étapes
(1)
•
•
•
•
•
•
•
1 - Négocier le mandat d'audit
2 - Établir la liste des vérifications
3 - Établir le plan d'audit
4 - Bâtir les guides d'entretien
5 - Animer la réunion d'ouverture
6 - Interviewer
7 - Observer, détecter et recueillir les preuves
14 clés pour franchir ces 7
étapes (2)
•
•
•
•
•
•
•
8 - Reformuler
9 - Prendre des notes
10 - Détecter et évaluer les constats
11 - Tenir la réunion de clôture
12 - Rédiger le rapport d'audit
13 - Conserver ou détruire les documents
14 - Apprécier les actions correctives
Clé 1 : Négocier le mandat d'audit
•Capter les attentes
Objectifs : dans quel but, jusqu'où aller ?
Audit d'efficacité, de conformité...
 Champ : l'étendue et les limites de l'audit
Type d'audits : système, processus, produit,
diagnostic
 Critères : Choix du référentiel
Norme, manuel qualité, procédure…
Risque : Ne pas satisfaire au besoin du commanditaire

Clé 2 : Évaluer la faisabilité de l'audit (1)
•
•
•
•
Établir la liste de vérifications
Comprendre les activités, préparer l'audit et l'accepter :
1 : vision large
2 : examen de la politique qualité et les
objectifs associés
• 3 : examen de l'organisation
• 4 : examen global du SMQ ou examen partiel
(audit de processus)
• 5 : notification de l’audit
• Risque : ne pas comprendre l'unité, l'organisme...
Clé 2 : Évaluer la faisabilité de l'audit (2)
• Ressources nécessaires disponibles
•
•
L’équipe d’audit
Constituée de personnes formées et reconnues (exemple forum audits)
– Responsable d’audit : personne d’expérience reconnue ou
personne qualifiée (BEQA,Groupe C)
– Auditeurs (tutorat)
– Expert de l'activité, si nécessaire
– Observateur possible
• Risque : ne pas avoir la compétence suffisante
pour comprendre le métier
Clé 3 : Établir le plan d'audit
• Concevoir le déroulement :

Identifier les fonctions auditées concernées
(ne pas oublier que + de 50% des exigences ISO
9001 concernent le management)

Bâtir le plan d'audit (date, horaire, domaine,
intervenants)

Prévoir les visites de terrain
Risque : ne pas avoir le temps nécessaire
pour mener l'audit correctement
ISO 9001 Version 2000
Plan d’audit
Fonction
X
Exemple fourni par AFAQ
Fonction
Z
Processus réalisation A
3
Ecoute client
1
Fonction
Y
Processus réalisation B
Processus réalisation C
Politique Objectifs Q / Organi.
Processus réalisation D
SMQ
Processus Achats
Processus RH
4
Processus Déploiement, de
pilotage et d’amélioration
2
Processus Communication
Bouclage Processus RH / Com / SI
Analyse et Amélioration
5
Audits
internes
Sat. clients
Actions
correctivespréventives
Processus Traitement Information
Revue de direction
Analyse
Des
données
Clé 4 : Bâtir les guides d'entretien
• Maîtriser le fil conducteur :
 Avec une liste de vérification des points
essentiels à auditer (points critiques à
approfondir)
ou un questionnaire, si besoin (la MQ
nourrit une liste de questions sur intranet)
 Avec
un formulaire d'enregistrements des
informations (rapport d’audit)
 En
utilisant l'approche Processus
systématiquement (données d'entrée/
données de sortie)
Risque : hors sujet, investigation non
pertinente, ne rien voir
Clé 5 : Animer la réunion d'ouverture
• Énoncer "les règles du jeu" :
 fixer
le cadre, rappeler le mandat
 rappeler
tout ce qui doit l'être
 montrer
que la mission est structurée et
organisée (mais souplesse du plan d'audit)
 rappeler
les objectifs : on ne porte pas de
jugement !
• Risque : ne pas donner confiance, ne pas avoir
accès à l'information
Clé 6 : Interviewer
•Questionner et recueillir les informations pour évaluer :
 Écouter PDCA
 Écouter les réponses aux questions : claires,
courtes, pertinentes, ne doivent pas mettre mal à
l'aise
ne doivent pas contenir la réponse
 le vocabulaire : utiliser les mots de votre
interlocuteur
 Le dialogue audités - auditeurs qui est source de
détection de voies de progrès
•Risque : se laisser déborder par
l'information, se faire son propre scénario
par manque d'écoute
Clé 7 : Observer, détecter et recueillir les
preuves tangibles
•Obtenir et confirmer pour évaluer :
 rechercher
des faits jusqu'à la preuve
d'efficacité (recoupement de preuves)
 bannir les impressions, les
sentiments, les interprétations…
•Risque : incapacité à justifier le statut de l'écart
Clé 8 : Reformuler
•Constater à chaud :
 fait
adhérer l'audité au constat de l'écart
 fait
adhérer l'audité à la formulation des
constats
•Risque : avoir des difficultés lors de la réunion de
clôture pour faire accepter l'observation d'audit
Clé 9 : Prendre des notes
•Justifier :
 noter
les preuves, les réponses, les
références…
 utiliser
des supports adaptés
•Risque : avoir des difficultés lors de la réunion de
synthèse, pour prouver en réunion de clôture
et pour rédiger le rapport
Clé 10 : Détecter et évaluer les constats
•Détecter les constats : Tous (en + ou en -)
•Statuer :
 mettre le constat en évidence auprès de l'audité
 essayer de déterminer si le constat est de
caractère systématique ou non
 statuer après une analyse du risque
(synthèse entre auditeurs)

formuler de manière à susciter
le changement (valeur ajoutée)
•Risques : passer à côté de constats qui
existent, ou identifier des constats non
justifiés
Clé 11 :
Tenir la réunion de clôture
•Conclure avec les audités (dont la hiérarchie):
 rendre
compte des points forts et des
points à améliorer
 présenter les constats (concision) et les
argumenter
 discuter en séance les recommandations
d'amélioration (caractère non contraignant)
 conclure sur l'atteinte des objectifs du
commanditaire
•Risque : refaire l'audit lors de la réunion de clôture
Clé 12 : Rédiger le rapport d'audit
•Conclure avec le client de l'audit :
 C'est
la seule trace qui restera (synthèse
attractive : lisibilité à court, moyen et long
terme)
 Pertinence et cohérence du rapport
 Diffuser le rapport
 Répondre à l'objectif du mandat
 Dégager
des axes d'amélioration
•Risques : un rapport à VA nulle qui discrédite l'auditeur
- divergence par rapport aux conclusions
de la réunion de clôture
Le rapport est facile à lire!
• Par le commanditaire, et l’audité
• Par les autres participants à l’audit (auditeur,
observateur, expert,…)
• Par les membres du bureau du BEQA qui peuvent
avoir à l’examiner
• Par ceux qui vont mettre en œuvre les actions
d’amélioration
• Le style est libre, mais néanmoins factuel (on peut
employer le temps présent)
Le rapport est cohérent avec la
pratique de l’organisme
• Utilisation du modèle de rapport d’audit préconisé,
reflet de la culture de l’organisme
• Sa diffusion est maîtrisée, une note d’envoi du
responsable d’audit vers le client, avec suggestions
et commentaires sur le déroulement de l’audit, peut
aider à la compréhension
• Les actions:
– De capitalisation: les écarts +
– D’amélioration: traitement puis solde des écarts –
Seront aussi aisément que possibles mises en
œuvre, le suivi tracé!
Cohérence du rapport d’audit
• De la première page: cadre, champ,
unité référentiel, acteurs et
fonctions,dates, références,…libellé
explicite de l’audit (de SM, de
processus)…
• Des aides à la lecture: page
d’explications
• De la page de synthèse: contexte,
points forts, points à améliorer
• Du tableau de synthèse des items
examinés, avec le repère des écarts
Un libellé des écarts factuel
• C’est le constat des faits:
– Ex: Il n’existe pas de document qui
explicite le programme d’audits internes de
l’organisme.
• Ce ne sont pas des recommandations
ou pire des directives: ex l’audité doit….
• C’est formulé par rapport aux exigences
et attentes:
– De la norme
– Du client
…a bien identifier (références!.. de la norme,
Le rapport est concis
• Certains organismes n’utilisent que les fiches d’écart,
avec une page de présentation….un peu
juste!…d’autres pratiquants font un laïus…!
• 1 page (5 au total): présentation, aide à la lecture,
synthèse, tableau de synthèse, liste des documents
• Quelques pages pour le corps du rapport
• 1 page par fiche d’efficacité (+ et -)
• Le total doit être compris entre 5/6 pages et moins de
20!….au delà on peut douter de la lecture!
Clé 13 : Clôture de l'audit
•Convenir de :

Conserver ou détruire les documents relatifs à
l'audit.
L'audit est fini lorsque toutes les activités du plan d'audit
ont été réalisées et que le rapport d'audit approuvé a été
diffusé.
Clé 14 :
Apprécier les actions correctives
•Évaluer pour faire évoluer :
 pertinence
correctives
 le
des propositions d'actions
suivi des actions par le commanditaire
•Risques : des actions de changement qui génèrent
l’immobilisme,
•audits non exploités.
Évaluation du risque
Remarque ou non-conformité ?
• Remarque : Concerne une façon de procéder qui ne répond
pas totalement aux exigences pour le critère considéré
(défauts de maîtrise ou insuffisance de formalisme), mais qui
est sans conséquence sur la qualité du produit ou de la
prestation.
• Non-conformité : Caractérise un écart par rapport au
référentiel ou aux exigences spécifiées pour le critère
considéré, qui a ou qui pourrait avoir des conséquences sur
la qualité du produit ou de la prestation et qui nécessite
impérativement une action corrective et/ou préventive.
• Pour l'appréciation des conséquences, l'auditeur prendra, si
besoin, l’avis d’un expert du domaine audité.
 Évaluation par rapport aux conséquences
La valeur ajoutée de l'audit
. participer au changement
. participer à la simplification du
système en place
. non à l'alignement, oui à la cohérence
et l'harmonie
. contribuer à mettre en résonance :
l'organisation, le système qualité et les
modes de management - QSE
L ’auditeur et l'organisme audité
Etre attentif aux caractéristiques du SQ en place
. Efficience, efficacité
. Originalité
. Pertinence
. Capacité d ’amélioration
Essuyer ses "lunettes" et remettre en cause
. Ses intimes convictions
. Ses habitudes
. Ses marottes ...
Etre "OK"
. Enveloppe culturelle
. Compétences
. Mode de communication
Etre un acteur dynamique de l'évolution du SQ en place
Le mode de communication des
auditeurs
confiance de soi
gestion de soi
relation aux autres
intelligence sociale
CONCLUSION :
« Dans notre rôle d'auditeur, nous touchons
à l'ensemble du "mystère
de l'être humain" et des organisations,
tout en abordant
des réalités extrêmement concrètes »
(Moody Certification)
The Basics of ISO 14001
Environmental
Management
Systems –
Requirements with
Guidance for Use
What is ISO 14001?
• It is an Environmental Management
System (EMS) that uses a continual
improvement approach in achieving and
demonstrating sound environmental
performance.
• The goal is for organizations to control
the impacts that their activities, products
and services have on the environment.
• ISO 14000 is the standard, and ISO
14001 is the document containing the
requirements.
Why become ISO 14001 registered?
• Organizations are becoming increasingly concerned in
achieving & demonstrating sound environmental
performance, often delivering cost savings.
• Marketing Tool: Shows customers, shareholders,
vendors, etc. that you are a “Good Corporate Citizen”
“It is Everyone’s Job to Protect the Environment”
“Protect the land, the air, and the water by
preventing or reducing pollution”
Overview of the
Requirements
of the ISO 14001 Standard
Plan – Do – Check - Act
Copyright ©2008 Lorne Duquette  Distributed by 14000 Store
Requirements: General
• The organization must develop an effective system that
meets the requirements of the Standard.
• Document, implement and maintain the system.
• The EMS documents need to be controlled.
• Follow a Plan-Do-Check-Act approach.
– Plan - Establish the objectives and processes needed to
deliver the results (in line with the EMS).
– Do - Implement the needed processes of the EMS.
– Check - Check the processes against the policy, objectives,
targets, regulations, and report on the results. (Auditing)
– Act - Take actions that will continually improve the EMS.
Requirements (Plan):
Management
• Top Management must be committed to and involved in
the design and implementation of the EMS.
• They will write the Environmental Policy and be
responsible for making sure it is communicated and
implemented.
• Many specific responsibilities are assigned to Top
Management to ensure their input and participation.
• After implementation Management will conduct
management review to ensure continued effectiveness
of the system.
Requirements (Plan):
Resources
• The EMS must clarify what resources,
human and physical are required to
create safe products and operations.
• During development of the system you
will determine how to ensure competent
personnel, identify training that is
required, and identify the infrastructure
and work environment required
Requirements (Plan): Form
EMS
• Your organization will need to plan all of
the processes that go into making your
product to ensure safe conditions.
• You will need to state of scope of the EMS
and clearly identify the products and
define the locations or sites that are part
of the EMS.
Requirements (Do):
Environmental Review
• An initial environmental review will be
needed.
• An assessment of environmental aspects
and their Impacts will have to be
performed.
• Regulatory, legal and other requirements
will need to be identified.
Requirements (Do): Create
EMS
• Environmental programs with targets and
objectives will need to be established,
implemented and evaluated on an
ongoing basis.
• Emergency preparedness procedures will
be required to address potential accidents
and emergencies.
Requirements (Do): Create
EMS
• Measuring and monitoring of product and
process characteristics that can have an
impact on the environment will be
required.
- Measuring and monitoring equipment will need to be
controlled and calibrated.
- A process will be needed for the Environmental Safety
Team to evaluate compliance to legal and other
requirements.
Requirements (Check):
Control Nonconformities
• Establish and document a system for
controlling nonconformities.
– When specified product and process limits
are exceeded potentially unsafe conditions
must be identified, assessed, controlled and
dispositioned appropriately.
– Identify corrections and corrective actions to
mitigate environmental impacts and to
eliminate the nonconformity and its cause.
Requirements (Check):
Audit System and Control Records
• Establish the internal audit process.
- Train auditors, and plan internal audits to establish an
audit program that will determine if the EMS is effective
and up to date.
• Control the records associated with the
EMS.
• Conduct regular management reviews to
ensure effectiveness of the EMS.
Requirements (Act): Improve your EMS
• Continually improve the EMS
through the use of:
– Management reviews
– Internal audits
– Corrective actions
– Analysis of data / results
– Update the EMS
ISO 14001 Implementation
Steps
ISO 14001:
Environmental Management
Systems
Implementation Timeline
• You will need to develop an
implementation plan that covers:
– Education on the contents of the standard
– Determine your position with regards to the
environment and the requirements of ISO
14001
– Analyze the shortcomings and close the gaps.
– A timeline of the implementation steps based
on the gap analysis
– Time to run the Environmental Management
System, collect records and make
improvements before your registration audit.
Implementation Timeline
Task 19 - ISO 14001:2004 EMS TIMING CHART for :________________________________________ ISO REP: _______________________
ISO DEVELOPMENT WORKSHOP TASKS
A. Preparation Phase-from Tasks 1-13
1
2
3
4-5
6-7
8-9
10-11
12
13
Train
Audit
14
15
16
Feb
Mar
Apr
2010
1. Describe your organization
. Decide on ISO management system
. Select ISO Management Rep + Committee
7. Conduct Environmental Team meetings
. Formulate Quality Policy / Objectives
. State Scope of QMS
13. Assign improvement actions
B. Development Phase-from Tasks 14-23
14. Provide ISO training - Exercise A-E
. Perform environmental assessment
. Identify legal and other requirements
. Identify environmental programs
. Manage implementation project
. Collect existing documents
. Do financial study - Costs vs Benefits
. Reconfirm ISO decision
23. Promote & practice teamwork
C. Implementation Phase-ref Tasks 24-28
24. Obtain / Review EMS Model/Template
. Draft EMS documentation - use Model
Approve Quality Manual
Approve Procedures & Instructions
. Implement Procedures & Instructions
. Train auditors & conduct Internal Audit
28. Perform management review
D. Registration Phase-from Tasks 29-30
29. Select a registrar
Perform documentation review
Perform final Registration audit
30. Receive ISO certificate / CELEBRATE !!
Significant Dates
Jan-09
Feb
Mar
Ap-May Ju-Jul Au-Sep Oc-Nov Dec 09 Jan 10
Implementation: Conduct the
Environmental Gap Analysis
1. You must determine your position with
regards to the environment:
–
–
–
–
Are there GAPS that need to be bridged?
What are they and where are they located?
How can they be improved?
Who will be taking corrective / preventive actions?
2. Your environmental position needs to
be analyzed so that the GAPS can be
bridged / closed.
Implementation: Conduct the
Environmental Gap Analysis
3. Conduct a Gap Analysis – Complete a
series of assessments in the following
order:
–
–
–
–
Perform Initial Environmental Review
Perform Environmental Assessment – Aspects/Impacts
Identify Legal and Other Requirements
Identify Environmental programs with objectives and targets
4. Based on the results of the
assessments, implement Improvement
Implementation:
Form a Team
• Appoint a Management Representative
- This individual will be the ISO project manager.
• Assign a Environmental Safety Team
– This team will be active in the design and development of the
EMS and participate in the on going operation of the system.
• Assign a Management Team
- This team will be providing the direction and guidance for the
development and implementation of the EMS.
Implementation: Form a Team
• The Management Team will act as a steering team for
the project, assigning responsibilities, providing
resources and coordinating the project.
– The Management Team can assign task
teams to work on specific processes that
must be designed and documented for the
EMS.
Implementation: Form a Team
• Each task team will evaluate the current process that
they are assigned to and the requirements of the
standard.
– A new or modified process will be developed,
documented and submitted to the
Management Team for review and approval.
Implementation: Execute your plan
• After the task teams have designed and
documented a new or modified
process, it must be implemented.
• Train all employees that are involved in
the process
• When the required processes have
been implemented, start your internal
audit program and management review
meetings.
Implementation: Audit
• Use information / results from internal audits and
management review to make improvements to the EMS.
• Run your system long enough to generate records for the
Registrar to audit.
• Make sure all employees are trained on ISO 14001
• Have a Registrar conduct your Registration Audit.
Tools to help your implementation:
• The ISO 14001 Workbook
– This is a series of 30 detailed checklists,
exercises and instructions that take you
through 30 systematic tasks for your
organization to consider and complete.
• EMS Manual, Procedures and Forms.
– Move your project along with our
professionally designed documentation.
– This package provides Microsoft Word
templates to use as a foundation for your
EMS.
– Customize this Environmental Manual
including procedures, forms, and tables to
save time and ensure an efficient, effective
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