ISO 9001

Chapter 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

MAIN PROCESSES (Level 0)

SUPPORT PROCESSES (Level 0)

First level processes

First level processes

Second level processes

Second level processes

.
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Organizative choices

Laws, technical and econom. procedures

Quality policy and objectives Market needs Customer needs Stakeholder needs Management review Planning results Customer returns Improvement activity results Benchmarking Tech. and manag. knowhow (design guides)

Quality Manag. Sys.

Mission and Vision

Internal communication methods and rules

Realization activities planning Customer requirements definition and review Communication methods with the customer

7 Product Realization

Design input definition Design and development results Design verification and review Purchasing material and data Product, services and their documentation Tech. and manag. knowhow (design guides)
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THE PRODUCT REALIZATION PROCESS VS THE PARAGRAPH OF THE CHAPTER 7 OF THE NORM

Costraint / Objective

Input

Process

Output

Policy and strategy concerning technology, economical and human resources Mission and Vision Quality objectives

Resource

7.1 Product realization planning

Who makes what, how, when, where, with which instruments and methodologies, which data must be manage and in which format...

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 of equipment

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.
3.

TRANSLATION IN GOALS (THE PROCESS

OBJECTIVES) DEFINITION OF: METHODS OF EXECUTION, RESPONSIBILITY, RESOURCES

4.

IDENTIFICATION OF INDICATORS OF PROCESS

AND RELATED RESULTS CORRELATED WITH GOALS

5.

DEFINITION OF SYSTEM FOR MONITORING THE PROCESS

THE PROCESS
INPUT
material
instructions data documents people CHECK POINT CHECK POINT CHECK POINT
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PROCESSO

OUTPUT
material

tranformation (value added)

instructions data documents people

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 for specified or intended use, where known, c) statutory and regulatory requirements applicable to the product, and d) any additional requirements considered necessary by the organization.
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

They should be supplemented by aspects and characteristics Implicit needs which may give a competitive advantage (something additional, innovative, winning
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)

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Requirements definition
Product or service typologies

A single job, project, prototypic plant

For the market, large series

Contract/order acquisition

Marketing

Customer specific and Specifications (general conditions)

Marketing Specific (4P)

Product/Service Technical Specific

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MARKETING

Function which plays a connecting role between market and company

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MARKETING
ACTIVITIES
4 P: - PRODUCT - PRICE - PLACE - PROMOTION

Highlighting the needs Definition of market demand and the product variables" (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)
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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 customer desires

MARKET TEST To know if the product has the characteristics defined in the market research

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The SPECIFICATIONS (or specifics)

The data provided by Marketing are translated into a series of specifications that form the basis for the development of product / service design and production process

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MARKETING SPECIFICATION

Defines the market and product requirements that make it possible to assess the rightness of the project and the opportunity to dedicate resources ( "the four P)

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CONTRACTUAL PRESCRIPTIONS

GENERAL REQUIREMENTS
Are legal prescriptions, usually standard for all the product

TECHNICAL SPECIFIC

TECHNICAL REFERENCE NORMS

Are reference prescriptions
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Are technical requirements

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 of changes 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 processes

7.2.2 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 of requirement, 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 know what we have to do ??

ORDER

We are able to do what is asked in the order ??

OFFER ??

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REQUIREMENTS REVIEW
It is applied to: Supplies of job / project / prototypical product Imply actions during: Offer

Order acceptance

Supplies by catalogue or from stores (large series)

Planning of the execution activities

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During the requirements review we have to 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 BEFORE THE PURCHASING (Product information) F C

3 TIMES

DURING PURCHASING (Order management) F C AFTER SALE (Complaints, satisfaction data) F C

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Product / Service information

PRODUCT Finding methods Product characteristics Costs Use instructions . SERVICE Login methods Service characteristics Costs Customer role (contribution) for the quality level of the service .
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Data from the use of the product

Analysis of defects and waste, problems encountered in the production and delivery and installation activities (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 DEVELOPMENT

Set of processes 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 and development or process design and development).

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PROJECT

Unique process, consisting of a set of coordinated and controlled activities with 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 external security and the environment, studies of reliability, 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 (Design Review) Classification of the project Pre-production Full production and use Assessment (Design Review)

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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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D&D PLANNING GENERAL

Management (the system) Technical (the know-how)

Similar and passed Procedures project Standard Qualified people, documents methods, codes and software Organizative and informative Project modularity and standartization system Design guide
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The general management level D&D planning

HAS THE PURPOSE OF DEFINING, BEFORE THE PROJECT ACTIVITIES START, SOME ORGANIZATIONAL AND METHODOLOGICAL ASPECTS AND THE OPERATING METHODS IN DETAIL WITH WHICH THE STAGES OF KEY DESIGN WILL BE CARRIED ON

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What about ?
The Organizational Structure for D&D Definition of "Interfaces" internal and external Exchange of technical information between the various groups or persons, both internal and 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 or components 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 conceptual projects, construction projects ...
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The organizative aspects

THE DEFINITION OF ROLES, RESPONSIBILITIES AND LINES OF COMMUNICATION WITHIN THE DESIGN GROUP

Typical organizative structure:

MATRIX FUNCIONAL INTEGRATED (Platform, Room, ) TASK-FORCE

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INTERFACES

INTERNAL
Relations between different people or groups design of the same organization

EXTERNAL
Relations between different people 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

Is necessary that

The design results could be in a series of DOCUMENTS

The layout
The contents The management method

Must be preventive established in suitable PROCEDURES, STANDARD OR COMPANY PRACTICES

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TECHNICAL SPECIFICATION

It defines, in the most possible precise and detailed way, the characteristics and attributes 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 to the technical specification.

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PURCHASING SPECIFICATION
Developed during the D&D process to define those components that is not economical to design 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 (formulas applicable criteria, etc. ...), exposing in sequential steps for obtaining the result.

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GRID OR QUALITY CONTROL PLAN It consists of one or more sheets, in tabular format matrix, 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 of manufacture in correspondence of which the check activities must be done, it is called Manufacture and Control Plan

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Other typical documents

DRAWING DIAGRAMS, FLOWSHEET SCHEDULING DOCUMENTS

INSTRUCTIONS

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THT FUNCTIONAL CLASSIFICATION

SYSTEMS

Sub-systems

components

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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 and Engineering Document Management

THE PDM SYSTEM
THE PART It is an application platform that allows you to identify, create, edit and store PARTS (documents) relating to a project or product and related information and define, modify and perform the procedures for approval and issuance of documents (in particular are equipped with tools for managing Images)

THE EDM SYSTEM

THE DOCUMENT
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WORK BREAKDOWN STRUCTURE

The overall project is split into subprojects and visualized through a tree The scheduling is done on individual elements componing the overall project

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Product

System A

System B

System C

Subsystem B.1

Subsystem B.2

Subsystem B.3

Component B.2.1

Component B.2.2

Component B.2.3

Sub-component B.2.2.2.2.2.1

Sub-component B.2.2.2.2.2.2

Sub-component B.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 of new products The process of development of new products progresses through the creation and exchange of information

THEREFORE IS FUNDAMENTAL TO STORE AND INCREASE INFORMATION ACQUIRED ASSET

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

To make objective know-how information the management of data must be done through:

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D&D PLANNING

SPECIFIC PLANNING

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DESIGN AND DEVELOPMENT

DEFINTION ISO 9000:2005

Set of processes that transforms requirements into specified characteristics or into the specification of a product, process or system.

Requireme nts /input data

phase A

Output elements

Input elements

phaase n

Product specification and processes production specification

Prototype or product

verification phase A Design review validation

verification phase n

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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, and d) 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

GENERAL REQUIREMENTS
Are legal prescriptions, usually standard for all the product

TECHNICAL SPECIFIC

TECHNICAL REFERENCE NORMS

Are reference prescriptions
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Are technical requirements

MARKETING SPECIFICATION
(Requirements Form, Concept Plan)

It defines the market and product requirements that make possible to assess the goodness of the project and the opportunity to dedicate resources ( "the four P")

PRODUCT SPECIFICATION
(Product Brief)

It defines the characteristics of the product to answer to the customers needs

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PRODUCT SPECIFICATION contents example

1. PURPOSE 2. APPLICATION 3. DEFINITIONS AND ABBREVIATIONS 4. REFERENCE DOCUMENTS 5. REQUIREMENTS OF MARKET 5.1. Life cycle (commercial) of the product 5.2. Segment the concerned market 5.3. Customer requirements 6. FEATURES OF OPERATION 6.1. Operating conditions and environmental 6.2. Ergonomic needs 6.3. The period of life-cycle 6.4. Decommissioning (year-end) 7. FEATURES 7.1. Aesthetics 7.2. Design 7.3. Materials 8. MANUFACTURE 8.1. Productive processes 8.2. Time development 8.3. Costs 9. INSTALLATION AND USE 9.1. Transportation 9.2. Maintenance 10. PACKAGING AND CONSERVATION 11. APPLICABLE LAWS 12. Q.A. REQUIREMENTS 12.1. Documentation 12.2. Security 12.3. Tests 13. RELIABILITY 14. 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 for verification 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 and development 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 65

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 accordance with planned arrangements (see 7.3.1) a) to evaluate the ability of the results of design and development to meet requirements, and b) to identify any problems and propose necessary actions. Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions 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 that the 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 the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see 4.2.4).

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DESIGN REVIEW AND VERIFICATION

DESIGN VERIFICATION
They concern specific aspects of the project (choices, assumptions, calculations) and a maximum single document There are several They may consist of alternative calculations, testing, independent verification, comparison with similar projects

DESIGN REVIEW
They concern the whole project and therefore all documents produced Few They are carried out at certain stages of project development

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Design verification methods

Comparative methods like alternative calculations to verify the correctness of calculations and performed analyses Independent verification to check the correctness of the original calculations and / or other design activities Tests, simulations or experiments Comparison of the new project with an similar already experienced 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 the requirements 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 DESIGN REVIEW

NEW QUALIFICATION OF THE PROJECT

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QUALIFICATION AND VALIDATION OF THE PROJECT

QUALIFICATION

VALIDATION

Demonstrated capability to respond to the specified requirements

Demonstrated capabiility to respond to the requirements of use

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PLANT FOR MEDICINES FOR A PHARMACEUTICALI NDUSTRY

GENERAL REQUIREMENTS==>

(performance requirements, tests to be overcome, the size and interface)

Design qualification

implement all the tests planned to reproduce the operating conditions of the plant (facility) can be made during the installation, making it work with "real" medicines to treat and analyzing the results of tests and inspections carried out during an initial period of operation set point.
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Design validation

DESIGN VALIDATION FOR A MANUFACTURED PRODUCT

An evaluation of the project carried out at different times through:

ANALYTICAL METHODS VERIFICHE DI PROGETTO DESIGN REVIEW

FINAL TESTS

FMEA Failure tree analysis (FTA) Risk analysis Tests on prototype, models or samples Alternative calculus Comparison with similar project

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7.3.7 Control of design and development changes

Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4).

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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

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7.4 PURCHASING
7.4.1 Purchasing process
The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product. The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organizations 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).
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7.4.2 Purchasing information

Purchasing information shall describe the product to be purchased, 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.
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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.
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PURCHASING ACTIVITIES PLANNING

definition of a policy for supplies and an appropriate
development plan

the definition of processes, responsibilities and necessary

resources

establishment of procedures and standards for the

management 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

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PURCHASING DOCUMENTS DEFINITION

Defining the requirements of supply, to be sent to the supplier in the form of: SPECIFIC OR SUPPLY CONTRACT TECHNICAL SPECIFICATIONS OTHER REFERENCE DOCUMENTS

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PURCHASING DOCUMENT 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

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Purchasing specification: an 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

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Great series production

Requested documents
Conformity declaration Configuration design and specifications User and maintenance manuals .

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Prototypical production

Requested documents
Quality manual and plan Specific operative procedures Scheduling of activities document Planning and programming documents Notes of calculus, analysis Quality records

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DOCUMENT PRESCRIPTIONS

FOR IMPORTANT PROJECT may be contained in one or more SUITABLE DOCUMENTS forming an integrated part of the contract documents

IN THE OTHER CASES

May be contained with the contractual documents or with the Q.A. prescriptions

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The contractual aspects (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 control of 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 the organization (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)

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AQ prescriptions
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)

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Graduation of the Q.A. prescriptions (The Item Control Level)

It consists in dividing the subject of supply, such as a product or a service, in its various components, parts or activities in relation to criticality 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
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Graduation criteria
THE COMPLEXITY of the project and / or the production 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)
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AQ graduation prescriptions
Contro level
1 2 AQ PRESCRIPTIONS ISO 9001 + QP + MS + DP + QR

ISO 9001 + DP + QR
ISO 9001 + Changes control ISO 9001 Supplied products control Conformity Declaration Storing and delivery process control
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3
4 5

6
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Suppliers selection methods

Investigation at supplier plant and

capabilities assessment of the supplier and / or its Quality System

DIRECT SELECTION

Product samples verifications

Passed or similar purchased

product experienxe and results

Pubblicized experienxe of other

organizations (Certifications/Qualifications)

UNDIRECT SELECTION

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ASSESSMENT CHECK-LIST
CONCERNS ALL THE ISSUES AND HAS THE PURPOSE OF MAKING A PLANNED AND SYSTEMATIC EVALUATION CAN ASSOCIATE A DIFFERENT WEIGHT TO THE QUESTIONS (MORE CRITICAL ISSUES OF OTHER) CAN BE A REFERENCE FOR A QUESTIONNAIRE FOR PRE-ASSESSMENT OF POTENTIAL SUPPLIERS

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Why a direct assessment ?

Supplier of high importance for quality Conformity with requirements not be found with only checks on the finished product Suppliers taken into consideration for the first time and supplies which require the adoption of a complete Quality System Unavailability of adequate documentation of the Supplier Quality System Not significant or obsolete data on previous experiences of supplier 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

General organization aspects Technical aspects
Quality managment system The ISO 9001 prescriptions or other norms

Dimension Organization Administrative, Design and economical and development methods financial Production capabilities methods, Image and presence insutrments and on the market personnel Partnership characteristics Time to market Service level

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Supplier selection
Effectiveness Capability to supply product conform to the prescripted requirements Efficiency Capability to supply innovative product with competitive costs and in reduced time.

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COMAKER SUPPLIERS
This is a selected and qualified supplier, with which the buyer establishes a partnership based on:

Continuous long-term relation, with training and with involvement in all phases of achieving the product Technical and financial assistance Contracts economically convenient to both parties Involvement in the quality perceived by the end customer

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The inspector (series production)

Evaluate the suitability of supplier for each product line Approve the quality control planning documents (grids of control, QC plans) from the supplier, he is present in some relevant stages Make with the supplier a continuous exchange of information Maintains liaison with technical bodies of their organization to solve quality problems
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Meetings before the start of the activities

CONCERN

Content and meanings of contracts Planning intervention of the buyer to assess

the performance of supplier

Techniques, tests, inspections and special

procedures that the supplier intends to use

Conditions for exchange of information and

documents
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Meetings during the operations

Examine the qualitative trends of the supply Resolve any disputes or failures emerged during the course of supply

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SUPPLY ACCEPTANCE

CHECKS (inspections) AT THE ESTABLISHMENT OF SUPPLIER INSPECTION AT RECEIPT EXAMINATION OF DOCUMENTATION THAT PROVE QUALITY LEVEL FREE-PASS INSPECTION AND TESTS AFTER USE (PROCESSING, ASSEMBLY, INSTALLATION)
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CHECKS (inspections) AT THE SUPPLIER PLANT

The product is vital for reasons of security, reliability, cost, timing .. It is difficult to ascertain the quality after delivery The design, manufacture or testing are complex or unusual

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ACCEPTANCE / QUALIFICATION LEVEL OF THE SUPPLIER

The level of severity to accept their supplied material 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

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INSPECTION AT RECEIPT
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

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What to inspect at receipt

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

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INSPECTION AT RECEIPT

Suitable area to put the products waiting for control / check Use of cards of different shape and color to identify the materials:
- conform - not conform - waiting to acceptance
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ACCEPTANCE METHODS
INSPECTION AT 100%

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)

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ACCEPTANCE THROUGH DOCUMENT ANALYSIS (RECORDS )

Products with elementary design, involving standard materials, processes and tests. The products were previously subject to a feedback of their quality, as required by the Plan of Quality, procedures and / or specifications, through qualification tests, sampling and inspections on batchs.

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CONFORMITY DECLARATION (STATEMENT) Declare the quality of the delivered product in accordance with the requests, "guaranteed" by the "controls" ( "System") to which the product was submitted by supplier

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 Nonconformities It is signed by a responsible function of the supplier It is written according to an appropriate procedure

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INSPECTION AND TEST AFTER THE USE

It is difficult or impossible to verify the
quality 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 the product are visible only during its use
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FREE-PASS
The absence of acceptance checks requires that the supplier has at least the following requirements:

Quality oriented approach Competence and technical capabilities on materials and 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
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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 first supplied batches) The product is accompanied usually by a document that guarantees the quality according to the characteristics required by the customer (statement of conformity) or according to the conducted tests (qualification)
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7.5 PRODUCTION AND SERVICE PROVISION

7.5.1 Control of production and service provision

The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable
a) the availability of information that describes the characteristics of the 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-delivery activities.
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7.5.2 Validation of processes for production and 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.
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7.5.3 Identification and traceability

Where appropriate, the organization shall identify the product by suitable means throughout product realization. The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization. Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records (see 4.2.4).
NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained.

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7.5.4 Customer property

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 or incorporation 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.
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7.5.5 Preservation of product

The organization shall preserve the product during internal processing and delivery to the intended 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.

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Typical documents for planning and controlled management of the production activities for a manufactured product
BILL OF MATERIALS OPERATION SCHEDULE (WORKING SCHEDULE)

CONTROL GRID OR QUALITY CONTROL PLAN

PROCEDURES AND OPERATIVE INSTRUCTIONS TO WORK AND CONTROL FORMS TO COLLECT DATA
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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 a component of a product or system

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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 great series not follows the product at different realizative stages used in the initial stage of production

Prototypical production follows the product during the productive process it is the reference for the execution of all the operations
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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
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

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CONTROL PLAN
For each phase (dimensional verification, chemical analysis, ultrasound control ) should be indicated:

The reference documentation (specific rule, procedure) for values and acceptance criteria Responsibilities (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)
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PROCESS CONTROL
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

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Who controls the process ?

The check can be made by:

the same operator

which makes operation others

with automatization procedures
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Methods to control the process

The process control uses:
statistics (Statistical Process Control) and/or procedures (eventually qualified) and/or consolidated practices (the recipes")
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Validation
Confirmation, supported by objective evidence, that the requirements for a specific use or purpose have been satisfied

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Qualification / Validation
Tests conducted to develop and demonstrate the suitability of a process so-called special (heat treatment, welding, sterilization, cooking.) Analysis, studies, real or simulated tests to identify the best conditions for implementing and demonstrate the conformity of a production process (assembly, machining, chemical transformation.) or of a service provision (maintenance, reception desks to a customer, providing a lesson in a class, running a laboratory test)
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Control, identification and traceability of product or materials

Conformity of the materials before being placed in the processes 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) of a part, material or product made by marking or labeling maintained from receipt to installation

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Identification
Purchased product
IDENTIFICATION AT RECEPTION

Product
IDENTIFICATION DURING THE PRODUCTION

Finished product
TRACEABILITY DURING STORING, DELIVERING AND INSTALLATION (USE)

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IDENTIFICATION CODES

Physical localization Functional Referring to drawing, manuals and parts list Removable

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IDENTIFICATION CODES
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 the product/component/material

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7.6 Control of monitoring and measuring equipment

The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements. The organization shall establish processes to ensure that monitoring and measurement can be carried 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 measurement standards traceable to international or national measurement standards; where no such standards 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 results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4). When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary. NOTE Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.
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