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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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Organizative choices
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)
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
Who makes what, how, when, where, with which instruments and methodologies, which data must be manage and in which format...
7.4 Purchasing
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3.
4.
5.
THE PROCESS
INPUT
material
instructions data documents people CHECK POINT CHECK POINT CHECK POINT
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PROCESSO
OUTPUT
material
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
Contract/order acquisition
Marketing
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MARKETING
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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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MARKET TEST To know if the product has the characteristics defined in the market research
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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
REQUIREMENTS REVIEW
ORDER
OFFER ??
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REQUIREMENTS REVIEW
It is applied to: Supplies of job / project / prototypical product Imply actions during: Offer
Order acceptance
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COMUNICATION
FIRM CUSTOMER BEFORE THE PURCHASING (Product information) F C
3 TIMES
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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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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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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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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 DEFINITION OF ROLES, RESPONSIBILITIES AND LINES OF COMMUNICATION WITHIN THE DESIGN GROUP
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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 layout
The contents The management method
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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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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INSTRUCTIONS
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Sub-systems
components
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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 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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Set of processes that transforms requirements into specified characteristics or into the specification of a product, process or system.
phase A
Output elements
Input elements
phaase n
verification phase n
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- Document lists
- flowsheet - block diagrams
- forms
- reticular diagram - matrix tables
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DOCUMENT LIST
(ENGINEERING SCHEDULE)
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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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CONTRACTUAL REQUIREMENTS
GENERAL REQUIREMENTS
Are legal prescriptions, usually standard for all the product
TECHNICAL SPECIFIC
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)
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DOCUMENTS OF SCHEDULING
LIST EQUIPMENT AND COMPONENTS PROCEDURES, INSTRUCTIONS SPECIFICATIONS, MANUALS, PROCEDURES / INSTRUCTIONS FOR THE CONSERVATION, TRANSPORT, SERVICE 65
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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 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
QUALIFICATION
VALIDATION
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GENERAL REQUIREMENTS==>
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
FMEA Failure tree analysis (FTA) Risk analysis Tests on prototype, models or samples Alternative calculus Comparison with similar project
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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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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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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
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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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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")
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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4 5
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DIRECT SELECTION
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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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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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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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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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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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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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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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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Typical documents for planning and controlled management of the production activities for a manufactured product
BILL OF MATERIALS OPERATION SCHEDULE (WORKING SCHEDULE)
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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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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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
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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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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