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Assurance Qualité, Eco-conception et Développement Durable 1

Organisation of the course

• 14h Lectures (7 sequences) • 10h exercises (5 sequences) – 2 examinations To be completed for students in GIPI2 next year.

Course outline

• 4 sequences on Quality managament.

• 3 sequences on sustainable development and eco-design.

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?

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

The Concept



Multiple dimensions



Variety of phenomena



Changing through time



Changing with the activity sector



Different from author and place

Quality …. An Approach

Efficiency Responsibility Loyalty Assessment Client Warranty Planning Needs Ethics Zero defects Control Value Expectations Effectiveness Conformance Rights Satisfaction Duties

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?

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?

Quality in different areas of society

Area

Airlines Health Care Food Services Postal Services Academia Consumer Products Insurance Military Automotive Communications

Examples

On-time, comfortable, low-cost service Correct diagnosis, minimum wait time, lower cost, security Good product, fast delivery, good environment fast delivery, correct delivery, cost containment Proper preparation for future, on-time knowledge delivery Properly made, defect-free, cost effective Payoff on time, reasonable cost Rapid deployment, decreased wages, no graft Defect-free 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, Feigenbaum) engineering, manufacturing and maintenance through which the product and service in use will meet the expectations by the customer (Armand 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: • Product-based definition: product attributes excellence quantities of • 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?

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?

  

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 Quality of Conformance

• •

Conformance to specifications Cost Consumer ’s Perspective Quality of Design

• •

Quality characteristics Price Marketing Fitness for Consumer Use

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.

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).

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.

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

Focus :The century of Quality

1920 - Inspection

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Industrial Revolution

  

mass production unit verification defective product

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Taylor's conception of work

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Measurement, comparison and verification activities

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Focus on the quantity produced

1930 – Statistical Control

  

Sampling inspection Use of statistical tools First concerns regarding prevention:



identification of causes for defective products

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Focus on the finished product

1930 – Statistical Control



Seven Basic Quality Tools:



Flowcharts and Process Maps

     

Check lists Cause-effect diagrams Pareto diagrams Histograms Scatter diagrams Control charts

1960 – Quality Warranty

    

First quality standards Customers ’ specifications Preventive actions System ’s approach

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Started the concern about involving everyone in the organization Focus on the manufacturing process

1970 – Quality Management Programs

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Evolution from the Quality Warranty phase

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Integration of quality on global management

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Quality Circles Audit Focus on the work process

1980 – Total Quality



Management Principles:

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Responsibility delegation

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Staff autonomy

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Satisfaction of needs and

   

expectations Struggle for improvement Adaptation needs Change management Focus on the organizational process

1980 – Total Quality

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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

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Horizontal vision within the organization, from top management to staff

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Includes all the concerned parts Continuous learning and adaptation to change

1980 – Total Quality



Tools and methodologies:

     

Re-engineering QFD – Quality Function Deployment Benchmarking Inquiries: clients and staff Brainstorming Balanced Scorecard

1990 - ... – Excellence Models

  

Orientation guide Flexible and adaptable instrument Self-assessment and continuous improvement models

 

Support on the pathway to excellence Focus on customer

• • • • •

Quality: 2 schools of thought

Deterministic School Vision:

–

Deterministic, 1 good way, Pratiques principales:

–

To be conform with the requirements,

– –

Customer focus, Lead corrective actions, Concepts:

–

Inspection, AQ, 0 failure, Contributors:

–

Taylor, ISO, Crosby, Targets:

–

Quality cost, lack of top management involvement.

• • • • •

Continuous improvement school Vision :

–

Not a unique way, multiple paths 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:

–

Deming, Juran, Ishikawa, Shewhart Targets:

–

All profits linked with Quality, top management involvement.

A new theoretical Framework

10 8 6 4 2 0 Zero failure Quality Inspection Deterministic school Culture TQM, quality management Quality control Process Continuous improvement school Product

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)

Why he is famous?

• Zero defect concept • Non quality estimated between 15 to 20% of the overall turnover.

Why he is famous?

Shewhart Walter A. (1891-1967)

• •

Control charts.

Statistical point of view,

Why he is famous?

Juran Joseph M. (1904-1987?)

• Show the importance of leadeship and continuous improvement, • Wrote the « Quality Control Handbook » (1951).

Why he is famous?

Kaoru Ishikawa

• Set up tools easy to use, that are still used in the everyday life of a quality engineer.

•

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

The Quality Gurus – Joseph Juran



Quality is “fitness for use ”

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Pareto Principle

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Cost of Quality

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General management approach as well as statistics 1904 - 2008 1951

The Quality Gurus – Edward Deming



Quality is “uniformity and dependability ”

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Focus on SPC and statistical tools

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“14 Points” for management

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PDCA method 1900-1993 1986

Deming ’s

14 Principles

 “Create Constancy of Purpose” 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   “Adopt A New Philosophy” 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

 “End Proactive Awarding Of Business Based On PriceAlone” 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   “Improve Every Process Constantly / Forever” 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

10.

 “Adopt And Institute Leadership” Remove barriers to pride of workmanship   Know the work they supervise Know the difference between special and common cause of variation “Drive Out Fear”  The common denominator of fear:   Fear of knowledge Performance appraisals  Management by fear or numbers “Break Barriers Between Staff Areas”   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.

12.

13.

14.

 “Eliminate Numerical Quotas” They impede quality   They reduce production The person ’s job becomes meeting a quota “Remove Barriers That Rob Pride Of Workmanship”  Performance appraisal systems   Production rates Financial management systems  Allow people to take pride in their workmanship “Institute Programs For Education And Self Improvement”   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?

How will we know that a change is an improvement?

What change can we make AIM MEASURE Selecting Change Plan P Plan P Act A D Do A A P D Do D C C Check C Check

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.

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.

– 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

c o t s

Cost of implementing quality management, accreditation and quality assurance

correction quality management and assurance total time

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

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.

Quality Improvement Time Traditional

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?

Tools used for continuous improvement 1. Process flowchart

Tools used for continuous improvement 2. Run Chart Performance Time

Tools used for continuous improvement 3. Control Charts Performance Metric Time

Tools used for continuous improvement 4. Cause and effect diagram (fishbone) Machine Man Environmen t Method Material

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

Tools used for continuous improvement 7. Pareto Analysis 60 50 40 30 20 10 100% 75 % 50 % 25 % 0% A B C D E F

Summary of Tools 1. Process flow chart 2. Run diagram 3. Control charts 4. Fishbone 5. Check sheet 6. Histogram 7. Pareto analysis

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

The current process Custom er A Custom er B Operator Receiving Party How can we reduce waiting time?

Fishbone diagram analysis Absent receiving party Out of office Not giving receiving party ’s coordinates Complaining Customer Working system of operators Absent Lunchtime Not at desk Too many phone calls Lengthy talk Does not know organization well Leaving a message Operator Absent Does not understan d customer Makes custom er wait Takes too much time to explain

Reasons why customers have to wait (12-day analysis with check sheet)

A B C D E F One operator (partner out of office) Receiving party not present No one present in the section receiving call Section and name of the party not given Inquiry about branch office locations Other reasons Daily average 14.3

6.1

5.1

1.6

1.3

0.8

29.2

Total number 172 73 61 19 16 10 351 84

Pareto Analysis: reasons why customers have to wait Frequency Percentage 300 250 200 150 100 87.1% 71.2% 49% 0% A B C D E F

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

Results of implementing the recommendations Before… …After Percentage Frequency Frequency 300 200 100% 87.1

% 71.2

% 49 % 300 200 Percentage t Improvemen 100 100 100% 0% 0% A B C D E F B C A D E F

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)

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.

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.

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.

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.

Control chart -illustration of construction

1.3

1.2

1.1

X-chart Copper 1.0

0.9

0.8

0 10 20 Warning limit 30 40 50 60 Control value Central line Action limit 70 80 90 100

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 -2 -3 -4 1 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Month

When to Take Action?

-2 -3 -4 4 3 2 1 0 -1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Month

When to Take Action?

-2 -3 -4 0 -1 2 1 4 3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Month

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

Comparison

Sector Framework Emphasise Method Orientation Recognition Strategic option Business Management Guidelines Innovation & learning Self evaluation + external audit Europe Quality Management Standards for QM Control & assurance Social sector Standards for service provision Control & assurance External audit Business Excellence Process and quality control Global External audit Performance, process & quality control Europe Rehabilitation Principles of Excellence Performance improvement & learning Self evaluation + External audit Excellence in service provision Europe 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 < 1 - Dissatisfaction Satisfaction = = 1 - Satisfaction Expectation > 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 precise criteria specifications to be used consistently or 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

environmental protection and documentation; Standards for inspection, test methods and analysis.

for dimensions, performance, health, safety,

Management Standards:

Standards that HACCP etc.

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,

Attributes of a standard

A standard generally has three attributes: 1.

Level

: such as at the company, national or international level.

Subject

: such as engineering, food, textile or management.

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).

ISO ASTM DIN EN

Renowned Standardization Bodies

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

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

It means recognition of competence in a specific area and scope.

Its scope is highly specific .

Evaluates people, skills and knowledge.

1987 1994 2000

2008 2015

Evolution of Quality Management System – ISO 9001:2008

First Published – ISO 9001, 9002 & 9003 First revision – ISO 9001, 9002 & 9003 Second revision - ISO 9001 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 wheel chairs 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 Measurement ISO ISO 10012 10012 Quality management systems Fundamentals & ISO 9000 Audits ISO 19011 vocabulary Guidelines Quality management systems Guidelines for performance improvement ISO 9004 ISO 9001 Quality management systems Requirements Technical Reports

ISO 9001:2000 Process Approach

PROCESS EFFECTIVENESS CONTROLS

Extent to which planned activities are realized and planned results achieved

INPUT PROCESS “set of interrelated or interacting activities which transforms inputs into outputs OUTPUT PRODUCT RESOURCES PROCESS EFFICIENCY

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 I R Process A I C I = INPUT O = OUTPUT R = RESOURCES C = CONTROLS O I Process C C I R O Process B I C R I O R 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 contributions.

and recognizing people ’s

Quality Management Principle No.3

Involvement of people People benefit.

at organization and their full involvement enables their abilities to be used for the organization ’s 9001:2008 This all levels principle clauses are is essence reflected 5.3(d) and of in an ISO 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 organization ’s a system effectiveness contributes and to efficiency the 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 cross functional 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 inter dependent 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 E N T S R E Q U I R E M Resource management Management responsibility Product realization Measurement, analysis & improvement Product C U S T O M E R T I O N S A T I S F A C

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

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 Number

0 INTRODUCTION 0.1

0.2

0.3

0.4

1 1.1

General Process Approach

ISO Clause Name

Relationship with ISO 9004 Compatibility with Other Management Systems SCOPE General 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

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

ISO Clause Name

PRODUCT REALIZATION 7.1

7.2

7.2.1

Planning of Product Realization Customer-related Processes Determination of Requirements Related to the Product 7.2.2

7.2.3

7.3

7.3.1

7.3.2

7.3.3

7.3.4

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 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

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

CUSTOMERS Shipping & Delivery 7.6 Monitoring & Measuring Devices 7.5 Production Control 7.4 Purchasing & Receiving 7.3 Design 7.1 Planning Quality Management System Feedback 8.2 Monitoring Customer Satisfaction 8.2 Internal Audits 8.3 Control of Nonconforming Product 8.4 Analysis of Data (Suppliers, Process, Product, Customer) 8.5 Corrective & Preventive Action 8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT Bids, Quotations, Orders, and Contracts 6.0 RESOURCE MANAGEMENT 6.2 Human Resources (Training) 6.3 Infrastructure 6.4 Work Environment CUSTOMER REQUIREMENTS Covering the entire QMS is: 4.2.3 DOCUMENT CONTROL AND 4.2.4 RECORDS CONTROL 8.5 CONTINUAL IMPROVEMENT 5.6 Management Review 5.4 Quality Objectives 5.3 Quality Policy 5.1 Management Commitment CUSTOMERS

Quality Management System - 1 4.1 General Requirements a) b) c) d) e) f) Identification of the processes for the QMS Determine the sequence of these processes Determine criteria for effective operation & control of these processes Ensure the availability of resources Monitor, measure (where applicable) and analyze these processes Implement actions necessary for achieving planned results and continual improvement

Quality Management System - 2 4.2.1 General The QMS Documentation shall include: a) b) c) Quality Policy & Quality Objectives Quality Manual d) e) Documented procedures and records required by this Standard Documents needed for planning, operation and control of processes 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) c) Documented procedures or reference to them Description of interaction between the processes of the QMS

Quality Management System - 4 a) b) c) d) 4.2 Documentation Requirements - 3 4.2.3 Control of documents Establish documented procedure to define method to: Approve documents Review, update and re-approve documents e) f) g) Identify the revision status / changes Ensure availability of relevant versions at point of use Ensure documents are legible and readily identifiable 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) c) Keep records legible, readily identifiable and retrievable 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) b) c) d) Communication to the organization the importance of meeting customer, statutory and regularity requirements Establish Quality Policy & Quality Objectives Conducting Management Reviews 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) b) c) d) e) Is appropriate to the purpose of the organization Includes a commitment to comply with and continually improve the QMS Provides framework of establishing and reviewing Quality Objectives Is communicated and understood within organization 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 a) The review shall include : 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) b) c) d) e) Results of audits Customer feedback Process performance and product conformity Status of preventive and corrective action f) g) Follow-up actions from previous management review Changes which could affect the QMS 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) c) Improvement of product related to customer requirements 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

6.1

Resource Management - 1 Provision of Resources The Organization shall determine and provide resources needed to : a) b) Implement and maintain the QMS and continually improve its effectiveness 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) b) Determine the necessary competence for the personnel performing work effecting quality Provide training and take action to satisfy these needs c) d) e) Evaluate the effectiveness of the action taken Ensure that its personnel are aware of relevance and importance of their activities and how they contribute to the achievement of the quality objectives 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) b) c) Building, workplace and associated utilities Process equipment (both hardware and software) 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) b) c) d) Requirements specified by customer including (delivery conditions & post Delivery activities) Requirements not stated but necessary for the intended use, where known Statutory & regulatory requirements related to product 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) c) Contract or order requirements differing from those previously expressed are resolved 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) b) c) Product information Enquiries, Customer complaints contracts or including amendments, and feedback, order including handling, customer

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) c) Review, verification and validation that are appropriate to each design and development stage, and 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) b) c) d) Functional and performance requirements, Applicable statutory and regulatory requirements, Where applicable, information derived from previous similar design, and 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) b) c) d) Meet the input requirements for design and development Provide purchasing, provision appropriate production information and for for services Contain or reference product acceptance criteria 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 necessary actions.

and propose Records of reviews and any necessary actions shall be maintained

7.3

Product Realization - 9 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.

7.3

Product Realization - 10 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, completed prior to validation the implementation of the product shall delivery be or Records of the results and any actions shall be maintained.

7.3

Product Realization - 11 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 procedures, process and equipment product, b) c) Requirement for qualification of personnel Quality management system requirements

Product Realization - 14 7.4

Purchasing - 3 7.4.3 Verification of the Purchased Product Establish activities and implement necessary the for inspection ensuring conformance of purchased purchase information.

product to 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 characteristics of the product, that describes b) c) d) e) f) Availability of work instructions, as necessary, Use of suitable equipment, the Availability and use of monitoring and measuring devices, Implementation of monitoring and measurement, and 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) b) Defined processes criteria for review and approval of the Approval of equipment and qualification of personnel c) d) e) Use of specific methods and procedures Requirements for records 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) b) c) Identify, verify, customer property protect and safeguard In case of loss, damage or unsuitable for use customer must be informed 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

7.6

Product Realization - 20 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) c) Adjusted or re-adjusted as necessary 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) b) c) Demonstrate conformity of the product Ensure conformity of the QMS 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.

Selection / conduct of audit shall ensure impartiality Follow-up activities shall be performed 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) b) c) Taking action to eliminate the detected non conformity Authorizing its use, release / acceptance under concession by relevant authority if allowed by customer.

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

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: a) Customer Satisfaction (see 8.2.1) b) Conformity of product requirements (see 7.2.1) c) Characteristics and trends of processes and and products including opportunities of Corrective action d) 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 customer complaints) (including b) Determining the causes of nonconformities c) Evaluating the need for action to ensure that nonconformities do not recur

8.5

Measurement, Analysis and Improvement - 11 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

8.5

Measurement, Analysis and Improvement - 13 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.

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, 3 rd 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

3 Party Certification

• Research and select a 3 rd 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 3

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 3

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 3

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 3

Party Certification

• 1 st 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 • 2 nd year surveillance – Admin fee – Surveillance fee (2 days) – Surveillance travel • 3 rd year recertification – Admin fee – Recertification (5 days) – Recertification travel • THREE YEAR TOTAL $ 500 $2600 $1000 $3900 $1200 $6500 $1600 $ 500 $2600 $1000 $ 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

besoins du client I.1. 1/8 La Qualité GASPILLAGE Qualité + Q Sur Qualité INSA TISFACTION Défaut ILLUSION réalisation 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

Erreurs Retards Traitement des plaintes Révision de dossiers Changements de fournisseur identifiés

ATTAQUE DE LA NQ FACILE (sans investissement) ACCESSIBLE (dépenses faibles)

Paperasseries sur équipement Temps perdus Dépenses inutiles Changements de fournisseurs non perçus Image dégradée

DIFFICILE (cout élevé) INACESSIBLE

I.1. 3/8 - L ’audit,...

C'est ... Ce n'est pas....

un outil de progrès une évaluation par rapport à un référentiel une méthodologie claire un compte-rendu une inspection un auto-diagnostic l'imprévu ou une impression

I.1. 4/8 - L ’audit,...

AUDIT QUALITE

• Examen méthodique et normalisé

DIAGNOSTIC QUALITE

• Examen méthodique, méthode spécifique ou consultant • Champ: système, procédé, produit, service • Champ: entreprise, politique commerciale, sociale, etc...

•

Référentiels (dispositions préétablies & objectifs à atteindre)

• Pas de référentiel •

Détermine la conformité ou la non conformité au système qualité

• Est un constat, une photographie • Recherche des points forts et faibles • Révèle en audit interne les domaines d'amélioration possible • Propose des solutions

I.1. 5/8 - L ’audit,...

Norme ISO 19011

Processus systématique, indépendant et documenté en vue d ’ obtenir des preuves d et de les évaluer de manière objective pour déterminer dans quelle mesure les critères ’ audit 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 objectifs AUDITS AUDIT INTERNE (par première partie système/processus/procédure/ produit )

Améliorer le fonctionnement et accroître la confiance en interne

AUDIT CLIENT (par deuxième partie système/processus/procédure/ produit )

Donner la confiance au client

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.

l I.1. 8/8 ’audit Trois questions posées par 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 : les objectifs.

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 OUTIL POUR AMELIORATION DU SYSTEME QUALITE

Les objectifs

ISO 9001 Déterminer la du Système de Management de la Qualité aux exigences prescrites.

conformité ou non-conformité des éléments 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.

Recherche de conformité

Les objectifs

REFERENTIEL (norme) 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

Auditeur Personne ayant les compétences pour réaliser un audit Client 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 formés Propres auditeurs ou tierce partie Toute fonction recevant l ’auditeur Fournisseur Organisme indépendant Organisme

Les exigences normatives

Audit Interne

Tierce Partie Client / Fournisseur Interne

Méthode d’audit Formation des auditeurs Définition des actions correctives Suivi

ISO 19011 (2002) Qualification selon la norme ISO 19011 (2002) Organisme audité client d ’avancement des AC ISO 19011 (2002) ou méthode client ISO 19011 ou formation à l’audit sans qualification Chapitre 8.2.2 de la norme ISO 9001 Formation interne ou externe Fournisseur Organisme chargé de l’audit doit tenir informé le Responsable du domaine soumis à l ’audit Mise en œuvre et 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 management FOURNITURES EXTERIEURES MANAGEMENT PROCEDE Processus Transverses MAIN D'OEUVRE PRODUIT ou SERVICES Sur tout ou partie des systèmes qualité, environnemental et sécurité A P C D CONTRAINTES EXTERNES

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 ?

procède-t-on comme prévu?

OBJECTIFS DE L

’

ENTREPRISE

Réduction des coûts de non qualité Amélioration d'un produit/procédé

REALITE

Ce qui est fait Mise en oeuvre Procédés Objet

ce qui est fait

s'est on donné le moyen des résultats à atteindre (efficacité)?

Homologation

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 ANTERIEURE

CORRECTIF

• ANALYSER LES CAUSES D'UN

MESURE

PROBLEME • EVALUER L ’EFFICACITE D ’ACTIONS CORRECTIVES

I.2. 5/10 Les REGLES de l ’audit

• LES NORMES INTERNATIONALES • • L'ORGANISATION DE L ’ ENTREPRISE AUDITEE y compris sa procédure

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

ISO 10011 - 2 : Qualification des Auditeurs Lignes directrices pour l ’audit environnemental ISO 14010 ISO 14011 ISO 14012 principes généraux Procédures d ’Audit Critères de qualification pour les auditeurs environnementaux

1 2 3 4 -

1. 2. 3. - DOMAINE D'APPLICATION, REFERENCES NORMATIVES DEFINITIONS 4 - ENSEIGNEMENT 5 - FORMATION 6 - EXPERIENCE 7 - QUALITES PERSONNELLES 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 d'audits équipe    surveillance maintien performances des auditeurs conditions de fonctionnement - audits conjoints amélioration du programme d'audit

5 - CODE DE DEONTOLOGIE

6 7 -

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 d ’ audit ’ un programme • 6 - Activités de l ’ audit

I.2. 8/10 - Obligation d d ’audit Exemple ’une procédure

• ORGANISATION DES AUDITS  Prise en compte des demandes  établissement, validation, gestion du programme  règles sur la fourniture des compte rendus  bilan et connexion au Plan d'actions Q.

• CONDUITE DES AUDITS – Particularités de l ’ entreprise

I.2. 9/10 Exemple établissement et suivi programme audit DEMANDEURS 1 Expression du besoin d'audit 2 Cellule d'audits Préparation Prog.

d'audits 3 Hiérarchie validation Priorités Resp. Audit 4 Conduite des audits Demandeur 5 Actions correctives Plan d'amélioration 6 D/AQ Analyse des Audits Cell.+Hiér.+ Dem Efficacité des 7 audits

I.2. 10/10 Exemple procédure de conduite des audits D/AQ 1 Validation du Prog.

2 Resp. Audit Organisation contact demandeur Programme Référentiel Resp. Audit 3 Préparation visite 4 Resp. Audit Visite d'audit Compte rendu 5 Resp. Audit 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 « L ’Equipe d ’Audit » (ils animent) Audités (ils participent, ils proposent) 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

QUESTIONS FERMEES

chap. 7 "des mesures doivent être prises en vue d'identifier et

de tenir sous contrôle les articles"

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?

Vous êtes vous assuré que les produits sont identifiés?

POURQUOI?

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 interviews !

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 d ’audit Le rapport

• • • • • •

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 client

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 D'APPLICAT ION ECHEANCIER

Définir et Mettre en place la couverture du système par le programme d ’audits !

I.4. 11/15 Gestion des audits/Quels indicateurs?

N° DEMANDEUR NOM UNITE AUDITEURS (1) LIBELLE DE L'AUDIT REFERENTIEL CHAMP D'APPLICATION ECHEANCIER REF. DU C.R

N1 N2

(1) responsable de l' audit soulignй (2) Unitй ou INB N1 = Nb de recommandations formulйes par les auditeurs N2 = Nb. d' actions concrиtes rйalisйes suite а recommandations

I.4. 12/15 Quelle mesure d ’efficacité ?

Indicateur semestriel: Nb actions réalisées Nb de recommandations

de la

Diminution Non-Qualité

I.4. 13/15 Exemples d ’indicateurs Produits Fourn is.

Fonctiont.

Prog.part.

Sécurité Environt.

F 1S99 2S99 1S00 2S00 1S01 2S01

43 66 60 X 43 X 85 X 50 X 100 100 75 X 70 64 100 X 60 100 100 100 50 44 100 100 70 100 66 X 60 75 100 X 86 100

G 1S99 2S99 1S00 2S00 1S01 2S01

60 70 78 X 56 X 44 X 96 X 43 100 100 100 83 100 57 83 53 86 55 100 43 64 68 X 60 67 58 X 63 92 90 X 72 81

H 1S99 2S99 1S00 2S00 1S01 2S01

100 X X X 100 X 100 X 100 X 100 X X X X X 100 100 85 95 100 100 87 100 92 X 92 100 86 X 95 100 100 X 97 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

l I.4. 14/15 Exemple de suivi de ’efficacité d’un programme d’audits

100 80 60 40 20 0 99 (1s) 99 (2s) 00 (1s) 00 (2s) 01 (1s) 01 (2s) Eval Ent GEN SSM ENV

I.4. 15/15 Le plan d ’action qualité suite à audits QUOI ? Nature des actions à effectuer QUAND ?

COMBIEN?

Objectifs : coûts 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 ?

. Rôle de l’audit – satisfaction des attentes clients . Nouvelle logique et dynamisme – le PDCA . 7 étapes et 14 clés . Remarques sur l ’aspect comportemental

Des attentes à la satisfaction des besoins: 4 acteurs

exigences attentes

Auditeurs

Tiers indépendants société Réglementation SMQSE SMQSE

Fournisseur

externe SM

PM Organisme

Responsable

Produit/Projet

d’installation et/ou recherche SM

utilisateurs

Besoins

programmes

Client

Audit processus Audit système

Fournisseur interne partenaires Exploitant satisfaction

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 • • •

: Maîtrise de la réalisation des activités

Check Act

: : Surveillance et mesures Action ou réaction

Un audit interne pour quoi faire ?

(ex: CEA ?)

La logique du appliquée au processus AUDIT P P P P

Objectifs Ressources

P P

Données d'entrée

Critères d'audit : ensemble de politiques, procédures ou exigences déterminées comme références.

ISO19011

L'AUDIT

A 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 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 ?)

Données d'entrée

Objectifs Ressources L'AUDIT

Surveiller les SMQ D P

Données de sortie

Mesurer Progresser Références : MQ CEA § 9.3

ISO 9001:2000 C

Approche dynamique du Système Audit Qualité Système qualité audit DSNQ, DIR, centre...

Besoin d'audits Prévoir Planifier Fixer les objectifs Clients de l'audit Vision management Analyse / Objectifs Améliorations du Processus Audit Vision opérationnelle Affecter les ressources nécessaires

(auditeurs et budgets)

PROCESSUS Réalisation de l'audit Effectuer des mesures sur le produit & le processus Clients de l'audit Rapport

Miroir

Auditeurs

Audit = miroir

Axe optique

Champ d’audit

Éclairage Sujets

Audités Informations

La logique du PDCA appliquée au processus AUDIT

P P

Données d'entrée

P P

Objectifs PROCESSUS d'AUDIT Ressources

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

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 qualité

de l ’organisme X en cinq jours Le champ de l ’audit

Mesurés par

relevés, enregistrements, indicateurs

Processus et moyens mis

en place pour atteindre les objectifs qualité Exigences

clients, réglementaires

Définis par

: MQ, procédures,MO, fiche de poste

Le parcours de l'auditeur (1)

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 Fonction Y Fonction Z

Exemple fourni par AFAQ Processus réalisation A

Processus réalisation B Ecoute client Processus réalisation C

Politique Objectifs Q / Organi.

SMQ Processus réalisation D Processus RH

Processus Déploiement, de pilotage et d ’amélioration 2

Processus Communication Processus Traitement Information Processus Achats 4

Bouclage Processus RH / Com / SI Analyse et Amélioration

Audits internes Sat. clients Actions correctives préventives Analyse Des données

Revue de direction

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

•Statuer :  : Tous

(en + ou en -)

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

points à améliorer

et des

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 (codification…NC1, R2,…)

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, des exigences client)

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 des propositions d'actions correctives  le 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

pas totalement aux exigences

pour le

ne répond

est sans critère considéré (défauts de maîtrise ou insuffisance de formalisme), mais qui 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



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. 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 1 Jan-09 2 Feb 3 Mar 4-5 6-7 8-9 10-11 12

Train

Audit

Ap-May Ju-Jul Au-Sep Oc-Nov Dec 09 Jan 10 14 Feb 15 Mar 16 Apr 2010

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 actions.

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 system.