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1

ISO 9001

Chapter 7

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7 PRODUCT REALIZATION

7.1 Planning of product realization

7.2 Customer-related processes

7.3 Design and development

7.4 Purchasing

7.5 Production and service provision

7.6 Control of monitoring and measuring equipment

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THE PROCESS MAP DEFINITION

CORE BUSINESS

Firstlevel processes

MAIN PROCESSES

(Level 0)

SUPPORT PROCESSES

(Level 0)

. .

Second level processes

Firstlevel processes

Second level processes

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4

Quality policy and objectives

7

ProductRealization

Organizativechoices

Management review

Planning results

Realization activities planning

Design input definition

Customer requirements definition and review

Communication methods with the customer

Design and development results

Design verification and review

Purchasing material and data

Inter

nal

commun

ication

methodsandrules

Product, services and their documentation

MissionandVision

Market needs

Customer needs

Stakeholder needs

Customer returns

Improvement activity results

Benchmarking

QualityMa

nag.

Sys.

Tech. and manag. knowhow (design guides)

Laws,tech

nicaland

econom.p

rocedures

Tech. and manag. knowhow (design guides)

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5

7.2 Customer

related processes

7.3 Design and

development7.4 Purchasing

7.5 Production

and service

provision

7.1 Product

realization

planning

Process

Costraint /

Objective

Input Output

ResourcePolicy and strategyconcerning

technology,

economical and

human resources

Mission and Vision

Quality objectivesWho makes what, how, when, where, with which instruments

and methodologies, which data must be manage and in which

format...

7.6 Control of

monitoring and

measuring of

equipment

THE PRODUCT REALIZATION PROCESS

VS

THE PARAGRAPH OF THE CHAPTER 7 OF THE NORM

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7. 1 Planning of product realization

The organization shall plan and develop the processes needed for product realization. Planning

of product realization shall be consistent with the requirements of the other processes of the

quality management system (see 4.1).

In planning product realization, the organization shall determine the following, as appropriate:

a) quality objectives and requirements for the product;

b) the need to establish processes and documents, and to provide resources specific to the

product;

c) required verification, validation, monitoring, measurement, 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).

The output of this planning shall be in a form suitable for the organizations method of

operations.

NOTE 1 A document specifying the processes of the quality management system (including the

product realization processes) and the resources to be applied to a specific product, project or

contract, can be referred to as a quality plan.

NOTE 2 The organization may also apply the requirements given in 7.3 to the development of

product realization processes.

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THE PLANNING OF THE SINGLE PROCESS

1. IDENTIFICATION OF CUSTOMER NEEDS

2. TRANSLATION IN GOALS (THE PROCESS

OBJECTIVES)

3. DEFINITION OF: METHODS OF EXECUTION,

RESPONSIBILITY, RESOURCES4. IDENTIFICATION OF INDICATORS OF PROCESS

AND RELATED RESULTS CORRELATED WITH

GOALS

5. DEFINITION OF SYSTEM FOR MONITORING THEPROCESS

7

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THE PROCESS

INPUT PROCESSO OUTPUT

material

instructions

data

people

documents

tranformation(value added)

CHECKPOINT

CHECKPOINT

CHECKPOINT

8

material

instructions

data

people

documents

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7.2 Customer-related processes

7.2.1 Determination of requirements related to the product

The organization shall determine

a) requirements specified by the customer, including the

requirements for delivery, and for post-delivery activities,

b) requirements not stated by the customer but necessary forspecified or intended use, where known,

c) statutory and regulatory requirements applicable to the product,

and

d) any additional requirements considered necessary by theorganization.

NOTE Post delivery activities include, for example, actions under warranty provisions,

contractual obligations such as maintenance services, and supplementary services such

as recycling or final disposal.

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Customer needs

Directly esplicited by the customer or

Implicit needs

They should be supplemented byaspects and characteristics

which may give acompetitive advantage

(something additional, innovative, winnin

include the requirements arising from PRACTICE, TYPICAL USE,

FEATURES

that the customer do not always explicit but hes waiting for

(the market offers normally

for that class of product) 10

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Product or

service

typologies

A single job,

project,prototypic plant

For the market,

large series

Requirements definition

MarketingContract/order acquisition

Customer specific and

Specifications

(general conditions)

Product/Service Technical Specific

Marketing Specific (4P)

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MARKETING

Function which plays a connecting role

between market and company

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MARKETINGACTIVITIES

Highlighting the needs

Definition of market demand and the productvariables" (price, performance, consumption, safety,

reliability, maintainability, aesthetics , ...)

Determination of distribution channels

Definition of promotional activities

Definition of a system of monitoring and return of

information from the market (improvement)

4 P:

- PRODUCT- PRICE- PLACE- PROMOTION

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To know the customers needs

Market analysis Analysis of Specialist Publication

Development of technology and knowledge

Customer specific requests

New legislation or regulations

Analysis arising from complaints, guarantees databases

Customers losses, offers not follow by orders

Analysis of products / services and benchmarking Results of direct investigations (questionnaires, interviews,

CSI)

Meetings with Groups (panel) of customers

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Typical activities of the MARKETING

MARKET

RESEARCH

To know what a

potential customerdesires

MARKET TEST

To know if the product

has the characteristics

defined in the marketresearch

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The data provided by Marketing are

translated into a series of specificationsthat form the basis for the development of

product / service design and production

process

The SPECIFICATIONS(or specifics)

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MARKETING

SPECIFICATION

Defines the market and productrequirements that make it possible

to assess the rightness of theproject and the opportunity to

dedicate resources ( "the four P)

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CONTRACTUAL

PRESCRIPTIONS

GENERALREQUIREMENTS

TECHNICALSPECIFIC

TECHNICALREFERENCE

NORMSAre legal

prescriptions,usually standard

for all the product

Are technicalrequirements

Are referenceprescriptions

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7.2 Customer-related processes

7.2.2 Review of requirements related to the product

The organization shall review the requirements related to the product.

This review shall be conducted prior to the organizations

commitment to supply a product to the customer (e.g. submission

of tenders, acceptance of contracts or orders, acceptance ofchanges to contracts or orders) and shall ensure that:

a) product requirements are defined,

b) contract or order requirements differing from those previously

expressed are resolved, and

c) the organization has the ability to meet the defined

requirements.

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7.2 Customer-related processes7.2.2 Review of requirements related to the product

.

.

Records of the results of the review and actions arising from the

review shall be maintained (see 4.2.4)

Where the customer provides no documented statement ofrequirement, the customer requirements shall be confirmed by the

organization before acceptance.

Where product requirements are changed, the organization shall

ensure that relevant documents are amended and that relevant

personnel are made aware of the changed requirements.

NOTE In some situations, such as internet sales, a formal review is impractical for

each order. Instead the review can cover relevant product information such as

catalogues or advertising material.

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REQUIREMENTS REVIEW

We knowwhat we have

to do ??

ORDER

OFFER??

We are able to dowhat is asked in the

order ??

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It is applied to:

Supplies of job / project /prototypical product

Supplies by catalogue orfrom stores (large series)

Offer

Imply actions during:

Order acceptance

Planning of the

execution activities

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REQUIREMENTS REVIEW

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During the requirements review we haveto examine this kind of aspects:

- Design aspects

- Commercial aspects

- Purchasing

- Production

- Quality control

- Logistics

- Financial aspects- Research aspeects

- Respect of laws, rules, practical implication

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7.2 Customer-related processes

7.2.3 Customer communication

The organization shall determine and implement

effective arrangements for communicating with

customers in relation to:

a) product information,

b) enquiries, contracts or order handling, including

amendments, and

c) customer feedback, including customer complaints.

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COMUNICATION

FIRM CUSTOMER

(Product information)

3 TIMES

BEFORE THE PURCHASING

AFTER SALE

DURING PURCHASING

(Complaints, satisfaction data)

(Order management)

F C

F C

F C

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Product / Service information

Login methods

Service characteristics

Costs

Customer role(contribution) for the

quality level of theservice

.

PRODUCT SERVICE

Finding methods

Product

characteristics

Costs

Use instructions

.

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Data from the use of the product

Analysis of defects and waste, problems encounteredin the production and delivery and installationactivities (testing, commissioning and start-up ...)

Back from assistance and maintenance services Number of spare parts, replacements, guarantees

intervention, complaints, lawsuits

Inspections and Monitoring activities on some

Products / Services Reliability databases

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7.3 Design and Development

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DESIGN AND

DEVELOPMENTSet ofprocesses that transforms requirements into specified

characteristics or into the specification of a product, process

or system.

Note 1 The terms "design" and "development" are sometimes used

synonymously and sometimes used to define different stages of

the overall design and development process.

Note 2 A qualifier can be applied to indicate the nature of what is

being designed and developed (e.g. product design anddevelopment or process design and development).

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PROJECT

Unique process, consisting of a set of coordinated and controlled activitieswith start and finish dates, undertaken to achieve an objective conforming

to specific requirements, including the constraints of time, cost and

resources

PROJECT OR JOB OR PROJECT RESULTS

The object (product / service / system) of a set of design activities or more

generally productive activities or a their part (a study, a construction, an

installation, a maintenance service)"

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DESIGN AND DEVELOPMENT

TODAY

Design (the traditional meaning, the "what") Development (industrialization, the "how")

Analysis and evaluations (including economic)

Planning activities and scheduling

Studies (from marketing to production,maintenance, logistics internal and externalsecurity and the environment, studies ofreliability, qualification, process ...)

Establishing instructions, procedures, manuals

Software development

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Project typical phases

Needs analysis

New product requirements

definition

Function analysis and

project definition

Project Planning activities Identification and control of

the interfaces

Preliminary design

Feasibility Study

Choice solution

Optimizing project

parameters

Analysis of producibility

Design reviews

Design detail: draft system

Design detail: component

desing

Engineering

Assessment (DesignReview)

Classification of the

project

Pre-production

Full production and use

Assessment (DesignReview)

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D&D PLANNING

GENERAL PLANNING

SPECIFIC PLANNING: DESIGN

PLAN (OR SCHEDULE) (for a

specific product or project)

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Management(the system)

Technical(the know-how)

Procedures

Standarddocuments

Organizative and

informative

system

Design guide

Similar and passedproject

Qualified people,methods, codes andsoftware

Project modularityand standartization

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D&D PLANNING

GENERAL

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The general management level

D&D planning

HAS THE PURPOSE OF DEFINING, BEFORE

THE PROJECT ACTIVITIES START, SOMEORGANIZATIONAL AND

METHODOLOGICAL ASPECTS AND THE

OPERATING METHODS IN DETAIL WITH

WHICH THE STAGES OF KEY DESIGN

WILL BE CARRIED ON

Wh t b t ?

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The Organizational Structure for D&D Definition of "Interfaces" internal and external

Exchange of technical information between the various groups or persons, both internaland external

Standardization and management of technical documents (writing, review, approval,distribution, change ...)

Collection and storage of design documents

Supervision at the Governing level Training of personnel involved in the design

Identification of data input

Determination of levels of quality, acceptance criteria and documentation for parts orcomponents

Implementation of reviews of design and verifications

Execution of audits on design activities

Availability of data, information, test results, codes of calculation Control of changes in design process

Preparing the draft documents

Relations with control bodies, suppliers, customers and client in respect of design activities

Development of specific phases of design activities, including: preliminary or conceptualprojects, construction projects ...

What about ?

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THE DEFINITION OF ROLES, RESPONSIBILITIES AND LINES OF

COMMUNICATION WITHIN THE DESIGN GROUP

Typical organizative structure:

MATRIX

FUNCIONAL

INTEGRATED (Platform, Room, )

TASK-FORCE

The organizative aspects

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INTERFACES

INTERNAL

Relations between differentpeople or groups design of

the same organization

EXTERNAL

Relations between differentpeople or groups design of

different organizations

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THE PROCEDURES

To do planned and systematic design activities To mantain a suitable know-how into the firm

The design results could be in a series ofDOCUMENTS

Is necessary that

The layout

The contents

The management method

Must be preventiveestablished in suitable

PROCEDURES, STANDARDOR COMPANY PRACTICES

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TECHNICAL SPECIFICATION

It defines, in the most possible precise and

detailed way, the characteristics andattributes of a particular product, process

or service

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SPECIFICATION OF A PROCESS

It defines the characteristics of production

(processes) to create a product conform tothe technical specification.

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PURCHASING SPECIFICATION

Developed during the D&D process to define

those components that is not economical todesign or produce internal to the firm.

(For example: a specific purchase of an electric

motor)

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TECHNICAL REPORT

There are exposed: the development of

preliminary studies, draft projects, applied

research, parts of executive projects, the

justification of decisions, the developing of

passed experiences usable for subsequent

applications.

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Typical contents in a technical report

Title

Name of the author

Contents

Introduction

Technical specification (eventually)

Introducing to the descripted problems

Development of the solutions

Conclusions

References

Appendexes

List of symbols

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CALCULUS NOTES

Describe methods of calculation (formulasapplicable criteria, etc. ...), exposing insequential steps for obtaining the result.

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GRID OR QUALITY CONTROL PLAN

It consists of one or more sheets, in tabular formatmatrix, where the stages of monitoring and

measurement (inspection, testing, or generically"controls") are listed in sequence at the point where

the component is realized.

In the frequently case, that it shows also the stages ofmanufacture in correspondence of which the check

activities must be done, it is called Manufacture andControl Plan

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Other typical documents

DRAWING

DIAGRAMS, FLOWSHEET

SCHEDULING DOCUMENTS

INSTRUCTIONS

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SYSTEMS

Sub-systems

components

THT FUNCTIONAL CLASSIFICATION

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A functional classification is important to:

Make reliability analysis

Establish an identification and traceability

system

Control the configuration

Give a different level of importance to the

elements

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Product Data Management andEngineering Document Management

It is an application platform thatallows you to identify, create,edit and store PARTS

(documents) relating to aproject or product and relatedinformation and define, modifyand perform the procedures forapproval and issuance of

documents (in particular areequipped with tools formanaging Images)

THE PART

THE DOCUMENT

THE PDM SYSTEM

THE EDM SYSTEM

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WORK BREAKDOWN

STRUCTURE

The overall project is split into sub-

projects and visualized through a tree

The scheduling is done on individual

elements componing the overall project

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Product

System BSystem A System C

Subsystem B.2Subsystem B.1 Subsystem B.3

Component B.2.2Component B.2.1 Component B.2.3

Sub-componentB.2.2.2.2.2.1

Sub-componentB.2.2.2.2.2.2

Sub-componentB.2.2.2.2.2.3

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THE KNOW-HOW

(the technical memory)

The rapidly

changing market

requires the

reduction of

development time ofnew products

The process ofdevelopment of newproducts progressesthrough the creation

and exchange ofinformation

THEREFORE IS FUNDAMENTAL TO STORE ANDINCREASE INFORMATION ACQUIRED ASSET

Th t t l k h i

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The most common cause to lose know-how isthe SUBJECTIVITY of the information and data

To make objective know-how informationthe management of data must be done

through:

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D&D PLANNING

SPECIFIC PLANNING

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DESIGN AND DEVELOPMENT

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DESIGN AND DEVELOPMENT

Set of processes that transforms requirements intospecified characteristics or into thespecification of a product, process or system.

Requirements /input

data

phaseA

validation

Design review

phaasen

verification

phase A

verification

phase n

Outputelements

Inputelements

Productspecification and

processesproduction

specification

Prototype orproduct

DEFINTION ISO 9000:2005

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DESIGN (project) PLAN

One or more documents prepared before issuing,use a document and / or start a project.

It can be constituted by:

- Document lists

- flowsheet

- block diagrams

- forms

- reticular diagram

- matrix tables

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DOCUMENT LIST

(ENGINEERING SCHEDULE)

Sequential list of documents which are expected to be

necessary to issue or use, with an indication of:

Responsibility (writing, approval, interfaces)

Input / output (links with other documents)

Assessment design points (verification, design review,

qualification, validation)

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FLOWSHEET

Sequential flow of the development of design,with an indication of:

Individual activities or actions (calculations,

analysis and technical assessments and

economic issue design documents, studies

process, etc)

Responsibilities

Documents issued / used (inputs, outputs,interface)

The assessment activities

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7.3.2 Design and development inputs

Inputs relating to product requirements shall be determined and

records maintained (See 4.2.4). These inputs shall include

a) functional and performance requirements,

b) applicable statutory and regulatory requirements,

c) where applicable, information derived from previous similar

designs, andd) other requirements essential for design and development.

The inputs shall be reviewed for adequacy.

Requirements shall be complete, unambiguous and not in conflict

with each other.

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CONTRACTUAL

REQUIREMENTS

GENERALREQUIREMENTS

TECHNICALSPECIFIC

TECHNICALREFERENCE

NORMSAre legal

prescriptions,usually standard

for all the product

Are technicalrequirements

Are referenceprescriptions

MARKETING SPECIFICATION

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MARKETING SPECIFICATION(Requirements Form, Concept Plan)

PRODUCT SPECIFICATION(Product Brief)

It defines the characteristics of the product to answer to

the customers needs

It defines the market and product requirements that makepossible to assess the goodness of the project and the

opportunity to dedicate resources ( "the four P")

PRODUCT SPECIFICATION

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PRODUCT SPECIFICATIONcontents example

1. PURPOSE

2. APPLICATION3. DEFINITIONS AND ABBREVIATIONS4. REFERENCE DOCUMENTS5. REQUIREMENTS OF MARKET

5.1. Life cycle (commercial) of theproduct

5.2. Segment the concerned market5.3. Customer requirements

6. FEATURES OF OPERATION6.1. Operating conditions andenvironmental6.2. Ergonomic needs

6.3. The period of life-cycle6.4. Decommissioning (year-end)

7. FEATURES7.1. Aesthetics7.2. Design7.3. Materials

8. MANUFACTURE

8.1. Productive processes8.2. Time development8.3. Costs

9. INSTALLATION AND USE9.1. Transportation9.2. Maintenance

10. PACKAGING ANDCONSERVATION

11. APPLICABLE LAWS

12. Q.A. REQUIREMENTS

12.1. Documentation12.2. Security12.3. Tests

13. RELIABILITY14. LEGAL ASPECTS

Attachments

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7.3.3 Design and development outputs

The outputs of design and development shall be in a form suitable forverification against the design and development input and shall be

approved prior to release.

Design and development outputs shall

a) meet the input requirements for design and development,

b) provide appropriate information for purchasing, production and for

service provision,

c) contain or reference product acceptance criteria, and

d) specify the characteristics of the product that are essential for its safe

and proper use.

NOTE Information for production and service provision may include

details for the preservation of product.

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Main DOCUMENTS: design anddevelopment outputs

DRAWINGS

TECHNICAL SPECIFICATIONS

TECHNICAL REPORTS AND NOTES OF CALCULATION

STUDIES AND PROCESS SPECIFICATIONS

PURCHASING SPECIFICATIONS

PLANS AND PROCEDURES / INSTRUCTIONS FOR PRODUCTION AND /

OR CONTROL AND MAINTENANCE EQUIPMENT

DIAGRAMS, FLOW SHEET

DOCUMENTS OF SCHEDULING

LIST EQUIPMENT AND COMPONENTS

PROCEDURES, INSTRUCTIONS

SPECIFICATIONS, MANUALS, PROCEDURES / INSTRUCTIONS FOR THE

CONSERVATION, TRANSPORT, SERVICE

D&D i ifi ti d lid ti

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D&D review, verification and validation

7.3.4 Design and development review

At suitable stages, systematic reviews of design and development shall be performed in accordancewith planned arrangements (see 7.3.1)

a) to evaluate the ability of the results of design and development to meet requirements, and b) toidentify any problems and propose necessary actions.

Participants in such reviews shall include representatives of functions concerned with the designand development stage(s) being reviewed. Records of the results of the reviews and any necessaryactions shall be maintained (see 4.2.4).

7.3.5 Design and development verification

Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure thatthe design and development outputs have met the design and development input requirements.Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4).

7.3.6 Design and development validation

Design and development validation shall be performed in accordance with planned arrangements

(see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for thespecified application or intended use, where known. Wherever practicable, validation shall becompleted prior to the delivery or implementation of the product. Records of the results ofvalidation and any necessary actions shall be

maintained (see 4.2.4).

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DESIGN REVIEW AND VERIFICATION

They concern specific aspects of theproject (choices, assumptions,calculations) and a maximumsingle document

There are several

They may consist of alternativecalculations, testing, independentverification, comparison withsimilar projects

They concern the whole projectand therefore all documents

produced

Few

They are carried out at certain

stages of project development

DESIGNVERIFICATION

DESIGNREVIEW

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Design verification methods

Comparative methods like alternative calculations toverify the correctness of calculations and performedanalyses

Independent verification to check the correctness of theoriginal calculations and / or other design activities

Tests, simulations or experiments

Comparison of the new project with an similar alreadyexperienced

Examination of documents before issuing

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DESIGN REVIEW

Systematic and documented reviews of the

design results.

They have the objective to identify and

anticipate inadequacies of the project might

cause problems, to begin corrective action to

ensure that the final project complies with therequirements of the customer.

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According to the temporal stages of execution, we

distinguish the following types of DESIGN REVIEW

PRELIMINARY DESIGN REVIEW

REQUIREMENTS REVIEW

INTERMEDIATE DESIGN REVIEW (before the

purchasing, a test session)

FINAL DESIGN REVIEW (before production, assembly,

final test, installation)

SUITABILITY TO MARKET INTRODUCING DESIGNREVIEW

NEW QUALIFICATION OF THE PROJECT

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QUALIFICATION AND VALIDATION OF

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Demonstrated capability

to respond to thespecified requirements

Demonstrated

capabiility to respondto the requirements of

use

QUALIFICATION AND VALIDATION OFTHE PROJECT

QUALIFICATION VALIDATION

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PLANT FOR MEDICINES FOR A PHARMACEUTICALI NDUSTRY

GENERALREQUIREMENTS==>

Designqualification

Designvalidation

(performance requirements, tests tobe overcome, the size and interface)

implement all the tests planned to

reproduce the operating conditionsof the plant (facility)

can be made during the installation,making it work with "real" medicines totreat and analyzing the results of testsand inspections carried out during aninitial period of operation set point.

DESIGN VALIDATION FOR A

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DESIGN VALIDATION FOR A

MANUFACTURED PRODUCT

An evaluation of the project carried out at different timesthrough:

ANALYTICAL METHODS

Tests on prototype, modelsor samplesAlternative calculusComparison with similarproject

FMEA

Failure tree analysis (FTA)Risk analysis

VERIFICHE DI PROGETTO

DESIGN REVIEW

FINAL TESTS

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7 3 7 Control of design and development

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7.3.7 Control of design and development

changes

Design and development changes shall be identified and recordsmaintained. The changes shall be reviewed,

verified and validated, as appropriate, and approved before

implementation. The review of design anddevelopment changes shall include evaluation of the effect ofthe changes on constituent parts and product

already delivered.

Records of the results of the review of changes and anynecessary actions shall be maintained (see 4.2.4).

Control of design and development

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Control of design and development

changes

PLANNING METHOD OF APPROVAL OF

CHANGES fairly rigid:

all changes must be identified,registered

reviewed

(in some cases) PROVIDE THE NOTICE TO

CUSTOMER

7 4 PURCHASING

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7.4 PURCHASING

7.4.1 Purchasing process

The organization shall ensure that purchased productconforms to specified purchase requirements. The typeand extent of control applied to the supplier and thepurchased product shall be dependent upon the effect ofthe purchased product on subsequent productrealization or the final product.

The organization shall evaluate and select suppliers basedon their ability to supply product in accordance with theorganizations requirements. Criteria for selection,

evaluation and re-evaluation shall be established.Records of the results of evaluations and any necessary

actions arising from the evaluation shall be maintained(see 4.2.4).

7 4 2 P h i i f i

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7.4.2 Purchasing information

Purchasing information shall describe the product to bepurchased, including where appropriate

a) requirements for approval of product, procedures,

processes and equipment,

b) requirements for qualification of personnel, and

c) quality management system requirements.

The organization shall ensure the adequacy of specified

purchase requirements prior to their communication

to the supplier.

7.4.3 Verification of purchased

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7.4.3 Verification of purchased

product

The organization shall establish and implement the

inspection or other activities necessary for ensuring

that purchased product meets specified purchase

requirements.Where the organization or its customer intends to

perform verification at the suppliers premises, the

organization shall state the intended verification

arrangements and method of product release in the

purchasing information.

PURCHASING ACTIVITIES

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PURCHASING ACTIVITIES

PLANNING

definition of a policy for supplies and an appropriatedevelopment plan

the definition of processes, responsibilities and necessaryresources

establishment of procedures and standards for themanagement and control of activities

developing awareness and training plans of personnel

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THE PURCHASING ACTIVITIES

must consider as a priority final customer needs

must be planned and kept under control

must provide verification methods that result in

benefits for both the supplier and the buyer

must be such as to establish close working

relationship between supplier and buyer and a

system of information return useful for both

PURCHASING DOCUMENTS

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PURCHASING DOCUMENTS

DEFINITION

Defining the requirements of supply, to besent to the supplier in the form of:

SPECIFIC OR SUPPLY CONTRACT

TECHNICAL SPECIFICATIONS

OTHER REFERENCE DOCUMENTS

PURCHASING DOCUMENT

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CONTENTS

LIMITS AND EXTENSION OF SUPPLY

TECHNICAL REQUIREMENTS

Q.A. REQUIREMENTS

RIGHT OF ACCESS FOR THE BUYER TO THE

SUPPLIER PLANTS AND DOCUMENTATION

REQUIREMENTS FOR DOCUMENTATION

Purchasing specification: an

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g p

example of contents

Contents, Foreword, Definitions

The purpose of specific

The function of the specific

Physical and functional interfaces

Documents and references

Terms of installation, use, construction or storage of the product or material Features

Performance (or behaviour)

Life Cycle

Reliability

Monitoring and Quality Assurance

Packaging and shipping

Information from supplier to the user

Service after sales

Documentation

Great series production

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Great series production

Requested documents

Conformity declaration

Configuration design and specificationsUser and maintenance manuals

.

Prototypical production

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Quality manual and plan

Specific operative procedures

Scheduling of activities document

Planning and programming documents

Notes of calculus, analysis

Quality records

Prototypical production

Requested documents

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DOCUMENT PRESCRIPTIONS

FOR IMPORTANTPROJECT

may be contained in one ormore SUITABLE

DOCUMENTS formingan integrated part of the

contract documents

IN THE OTHER CASES

May be contained withthe contractual

documents or with

the Q.A.prescriptions

The contractual aspects

(Agreement on Q A )

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(Agreement on Q.A.)

Criteria with which the buyer can obtain Quality

Assurance by the supplier Confidence in Quality System supplier

Presentation during the delivery of specific data

tests, checks and records relating to the controlof the process

Tests, inspections on 100% executed by the

supplier Tests, inspections on the delivered batch of

samples, carried out by the supplier

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follows Agreement on Q.A

Implement a Q.A. system as specified by theorganization (for example, ISO 9001 or more)

Periodic assessment, carried out by the organization

or a third party (Certification) of SQ provider

Inspection at receiving

Internal (in the organization) selection in the course of

(installation, for example)

AQ prescriptions

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Q p p

Contractual constraint

The prescriptions are prepared specially for the

product, service or supplied material, graduate in

relation to the needs ( "tailoring")

Products, services or materials are divided and

grouped into homogeneous groups, who are

associated appropriate A.Q. prescriptions (reported

in special Q.A. Specifications)

Graduation of the Q.A. prescriptions

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It consists in dividing the subject of supply,

such as a product or a service, in its various

components, parts or activities in relation tocriticality and the difficulty of verifying the

quality with checks and establish for each of

them a control level to which associate the

more suitable requirements of quality

assurance

Graduation of the Q.A. prescriptions

(The Item Control Level)

Graduation criteria

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Graduation criteria

THE COMPLEXITY of the project and / or theproduction of component

THE DETECTABILITY of any functional problems

THE PROBABILITY to cause a malfunction THE POSSIBILITIES / EASY TO RESTORE

(accessibility, maintenance difficulties, availability of

spare parts)

The consequences in terms of security and COSTS

(LEGAL or LOSS OF MARKET AND IMAGE)

AQ graduation prescriptions

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Q g p p

Contro levelAQ PRESCRIPTIONS

ISO 9001 + DP + QRISO 9001 + Changes control

ISO 9001

Conformity Declaration

Storing and delivery process control

ISO 9001 + QP + MS + DP + QR1

23

4

56

7

Supplied products control

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ASSESSMENT CHECK-LIST

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CONCERNS ALL THE ISSUES AND HASTHE PURPOSE OF MAKING A PLANNEDAND SYSTEMATIC EVALUATION

CAN ASSOCIATE A DIFFERENT WEIGHTTO THE QUESTIONS (MORE CRITICALISSUES OF OTHER)

CAN BE A REFERENCE FOR AQUESTIONNAIRE FOR PRE-ASSESSMENTOF POTENTIAL SUPPLIERS

Why a direct assessment ?

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Why a direct assessment ?

Supplier of high importance for quality

Conformity with requirements not be found with only checkson the finished product

Suppliers taken into consideration for the first time andsupplies which require the adoption of a complete QualitySystem

Unavailability of adequate documentation of the SupplierQuality System

Not significant or obsolete data on previous experiences ofsupplier

Deficiency in the documentation of the Quality System

supplier Supplier considered of strategic value not only for

conformity, but also for issues of cost, innovation,development time

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Supplier areas evaluated

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Supplier areas evaluatedGeneral

organizationaspects

Technicalaspects

Quality

managmentsystem

Dimension

Administrative,

economical and

financial

capabilities

Image and presence

on the market

Partnership

Organization Design and

developmentmethods

Productionmethods,

insutrments andpersonnelcharacteristics

Time to market

Service level

The ISO 9001

prescriptionsor othernorms

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Supplier selection

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Supplier selection

Effectiveness

Capability to supply

product conform to theprescripted

requirements

Efficiency

Capability to supply

innovative product

with competitivecosts and in reduced

time.

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COMAKER SUPPLIERS

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COMAKER SUPPLIERS

Continuous long-term relation,

with training and with involvementin all phases of achieving theproduct

Technical and financial assistance

Contracts economically convenientto both parties

Involvement in the qualityperceived by the end customer

This is a selected and qualified supplier,

with which the buyer establishes apartnership based on:

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Th i

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The inspector

(series production)

Evaluate the suitability of supplier for eachproduct line

Approve the quality control planning documents(grids of control, QC plans) from the supplier, heis present in some relevant stages

Make with the supplier a continuous exchange ofinformation

Maintains liaison with technical bodies of theirorganization to solve quality problems

Meetings before the start of the activities

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CONCERN

Content and meanings of contracts

Planning intervention of the buyer to assessthe performance of supplier

Techniques, tests, inspections and special

procedures that the supplier intends to use

Conditions for exchange of information and

documents

Meetings before the start of the activities

M ti d i th ti

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Examine the qualitative trends of thesupply

Resolve any disputes or failures emergedduring the course of supply

Meetings during the operations

SUPPLY ACCEPTANCE

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CHECKS (inspections) AT THE

ESTABLISHMENT OF SUPPLIER

INSPECTION AT RECEIPT

EXAMINATION OF

DOCUMENTATION THAT PROVEQUALITY LEVEL

FREE-PASS

INSPECTION AND TESTS AFTER USE(PROCESSING, ASSEMBLY,INSTALLATION)

CHECKS (inspections) AT THE

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CHECKS (inspections) AT THESUPPLIER PLANT

The product is vital for reasons of

security, reliability, cost, timing ..

It is difficult to ascertain the qualityafter delivery

The design, manufacture or testing are

complex or unusual

ACCEPTANCE / QUALIFICATION LEVEL OF THE

SUPPLIER

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SUPPLIER

The level of severity to accept their suppliedmaterial depends on:

Declaration of conformity of the batch by the supplier

Supplier assessment / qualification (Second Part) Certification of the supplier (Third Part)

Verifications carried out at the supplier plant

Experience (past) available about the supplier

INSPECTION AT RECEIPT

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The design, manufacture or testing of the

product are simple or common

The qualitative characteristics are visible even

on the finished product with common or

automated testing or inspections The inspection at reception is not critic to the

integrity, the functions or to preserve the

product

What to inspect at receipt

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Completeness of the product in all its components

Efficacy of protective packaging, conditioning methods

Absence of broken or deforming

Check the most significant size / dimension

Level of the lubricants Freedom of rotating parts movement

Other controls applicable (and non-destructive testing,

chemical analysis on samples ...)

Documentation / Record provided

INSPECTION AT RECEIPT

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S C O C

Suitable area to put the products waiting forcontrol / check

Use of cards of different shape and color to

identify the materials:

- conform

- not conform

- waiting to acceptance

ACCEPTANCE

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ACCEPTANCE

METHODS

INSPECTION AT 100%

SAMPLING ACCEPTANCE

SAMPLING ACCEPTANCE

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SAMPLING ACCEPTANCE

The number of samples in the batch to be

examined depends:

- the level of acceptable quality (LQA)

- the adoption of systems capable of

providing an adequate level of confidence of

conformity with the specified requirements

(qualification level of the supplier)

ACCEPTANCE THROUGH DOCUMENT

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ACCEPTANCE THROUGH DOCUMENT

ANALYSIS (RECORDS )

Products with elementary design, involvingstandard materials, processes and tests.

The products were previously subject to afeedback of their quality, as required by thePlan of Quality, procedures and / orspecifications, through qualification tests,

sampling and inspections on batchs.

CONFORMITY DECLARATION (STATEMENT)

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It allows the identification of products and related

requirements

Indicates deviations from requirements, precises

causes and adopted methods with whom were

assessed and resolved exemptions and Non-conformities

It is signed by a responsible function of the supplier

It is written according to an appropriate procedure

Declare the quality of the delivered product inaccordance with the requests, "guaranteed" bythe "controls" ( "System") to which the product

was submitted by supplier

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INSPECTION AND TEST

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AFTER THE USE

It is difficult or impossible to verify thequality of a product, if not after the

assembly, installation and / or putting into

service The product should be implemented to or

placed within an integrated system

The functional characteristics of theproduct are visible only during its use

FREE-PASS

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Quality oriented approach

Competence and technical capabilities on materialsand utilized processes

Structure that "guarantee" the quality through

suitable systems of prevention and control

Possibility by the customer, to conduct checks on

Management System for Quality

The absence of acceptance checksrequires that the supplier has at least

the following requirements:

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FREE-PASS

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FREE PASS

Pre-requirements: Preventive assessment resulted positive of

the supplier

Objective evidence on the quality of the

supply (ex: check 100% on the firstsupplied batches)

The product is accompanied usually by adocument that guarantees the quality

according to the characteristics requiredby the customer (statement of conformity)or according to the conducted tests(qualification)

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7.5 PRODUCTION AND SERVICE PROVISION

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7.5.1 Control of production and service provision

The organization shall plan and carry out production andservice provision under controlled conditions.

Controlled conditions shall include, as applicable

a) the availability of information that describes the characteristics ofthe product,

b) the availability of work instructions, as necessary,

c) the use of suitable equipment,

d) the availability and use of monitoring and measuring equipment,e) the implementation of monitoring and measurement, and

f) the implementation of product release, delivery and post-deliveryactivities.

7.5.2 Validation of processes for production and

service provision

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service provision

The organization shall validate any processes for production

and service provision where the resulting output cannot be

verified by subsequent monitoring or measurement and as a

consequence, deficiencies become apparent only after the

product is in use or the service has been delivered.

Validation shall demonstrate the ability of these processes to

achieve planned results. The organization shall establish

arrangements for these processes including, as applicable

a) defined criteria for review and approval of the processes, b) approval of equipment and qualification of personnel,

c) use of specific methods and procedures,

d) requirements for records (see 4.2.4), and

e) revalidation.

7.5.3 Identification and traceability

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Where appropriate, the organization shall identify theproduct by suitable means throughout productrealization. The organization shall identify theproduct status with respect to monitoring andmeasurement requirements throughout productrealization. Where traceability is a requirement, theorganization shall control the unique identification ofthe product and maintain records (see 4.2.4).

NOTE In some industry sectors, configuration management is a means bywhich identification and traceability are maintained.

7.5.4 Customer property

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C p p y

The organization shall exercise care with customer

property while it is under the organizations control

or being used by the organization. The organization

shall identify, verify, protect and safeguard

customer property provided for use orincorporation into the product. If any customer

property is lost, damaged or otherwise found to be

unsuitable for use, the organization shall report this

to the customer and maintain records (see 4.2.4).

NOTE Customer property can include intellectual property and personal

data.

7.5.5 Preservation of product

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The organization shall preserve the productduring internal processing and delivery to theintended destination in order to maintain

conformity to requirements. As applicable,preservation shall include identification,handling, packaging, storage and protection.Preservation shall also apply to the constituent

parts of a product.

Typical documents for planning and controlled

management of the production activities for a

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management of the production activities for a

manufactured product

BILL OF MATERIALS

OPERATION SCHEDULE(WORKING SCHEDULE)

CONTROL GRID OR QUALITYCONTROL PLAN

PROCEDURES AND OPERATIVEINSTRUCTIONS TO WORK ANDCONTROL

FORMS TO COLLECT DATA

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BILL OF MATERIALS

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BILL OF MATERIALS

It is a list of all components (referring to the

finished product or its sub-systems),organized to highlight the parent-child

relationship between them.

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OPERATION

SCHEDULE

List of operations necessary to realize acomponent of a product or system

The operation schedule

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The operation schedule

must

be prepared for each component of the

product

specify the machinery, equipment,instructions, procedures and how much

more necessary for the suitable

implementation of each phase of each

operation

submit a brief description of each stage,

with an explanatory sketch (drawing)

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The operation schedule

Production of greatseries

not follows theproduct at different

realizative stages used in the initialstage of production

Prototypical production follows the productduring the productiveprocess

it is the reference forthe execution of all theoperations

GRID OR CONTROL PLAN

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GRID OR CONTROL PLAN

Prepared for planning control activities

for a specific product

It is a "map" of checks that the

organization must play along the stages

of the operating schedule

It can be used to give "confidence" to the

capacity of the organization

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CONTROL PLAN

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It consists of one or more sheets, in tabular format

matrix, where are listed in sequence the stages of

verification (inspection, testing, testing or control)

expected at the manufacturing activities of a material

or component.

Frequently, it shows the stages of manufacture in

correspondence of which the checks must be done.

Then it is called Manufacture and Control Plan

CONTROL PLAN

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For each phase (dimensional verification, chemical analysis, ultrasound

control ) should be indicated:

The reference documentation (specific rule,

procedure) for values and acceptance criteriaResponsibilities (who performs verification,

accepts.)

The phases under which the buyer or a Third Control

Officer plan to participate with a representative

(phases "binding"), stages "to be notified" ..

The Recording Quality issue (Reports test)

PROCESS CONTROL

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Process capacity assessment

Choice of variables of control

Control may be

Direct (variables and attributes of the process which

materials, machinery and equipment, behaviour, )

Indirect (samples taken from production)

Often control is both directly and indirectly

Who controls the process ?

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The check can bemade by:

with automatization

procedures

others

the same operator

which makesoperation

Methods to control the process

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p

The process control uses:

statistics

(Statistical Process Control)

and/or

procedures (eventually qualified) and/orconsolidated practices (the recipes")

V lid ti

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Validation

Confirmation, supported by objective

evidence, that the requirements for a

specific use or purpose have beensatisfied

Qualification / Validation

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Tests conducted to develop and demonstrate the

suitability of a process so-called special (heattreatment, welding, sterilization, cooking.)

Analysis, studies, real or simulated tests to

identify the best conditions for implementing anddemonstrate the conformity of a productionprocess (assembly, machining, chemicaltransformation.) or of a service provision

(maintenance, reception desks to a customer,providing a lesson in a class, running alaboratory test)

Control, identification and

t bilit f d t t i l

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traceability of product or materials

Conformity of the materials before being placed in theprocesses

Traceability: Relation between a part or material

(identification) and its "history" (supplier, testing,status of verification, use, modification/configuration)

Identification: the "name" and "surname" (unique) ofa part, material or product made by marking or

labeling maintained from receipt to installation

Identification

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Purchased product IDENTIFICATION AT RECEPTION

Product

IDENTIFICATION DURING THE PRODUCTION

Finished product

TRACEABILITY DURING STORING,

DELIVERING AND INSTALLATION (USE)

IDENTIFICATION CODES

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Physical localization Functional

Referring to drawing, manuals and parts

list

Removable

Unique identification

IDENTIFICATION CODES

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Unique identification

The code is associated permanently to

the part/component

Reference for test reports, changes,maintenance activities...

Type of component

Code (alfanumeric) of unique

identification of theproduct/component/material

7.6 Control of monitoring and measuring equipmentThe organization shall determine the monitoring and measurement to be undertaken and the

monitoring and measuring equipment needed to provide evidence of conformity of product todetermined requirements

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determined requirements.

The organization shall establish processes to ensure that monitoring and measurement can becarried out and are carried out in a manner that is consistent with the monitoring and

measurement requirements.Where necessary to ensure valid results, measuring equipment shall

a) be calibrated and/or verified, or both, at specified intervals, or prior to use, against measurementstandards traceable to international or national measurement standards; where no suchstandards exist, the basis used for calibration or verification shall be recorded (see 4.2.4);

b) be adjusted or re-adjusted as necessary;

c) have identification in order to determine its calibration status;

d) be safeguarded from adjustments that would invalidate the measurement result;e) be protected from damage and deterioration during handling, maintenance and storage.

In addition, the organization shall assess and record the validity of the previous measuring resultswhen the equipment is found not to conform to requirements. The organization shall takeappropriate action on the equipment and any product affected. Records of the results ofcalibration and verification shall be maintained (see 4.2.4).

When used in the monitoring and measurement of specified requirements, the ability of computersoftware to satisfy the intended application shall be confirmed. This shall be undertaken prior toinitial use and reconfirmed as necessary.