ISO 9001 ISO Scope. 1 Scope 1.1 General 1.2 Application

Transcription

1 Quality Management System 1 st and 2 nd level requirements 1 Scope 1.1 General 1.2 Application 2 Normative references 3 Terms and definitions 4 Quality management system 4.1 General requirements 4.2 Documentation requirements 5 Management responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.5 Responsibility, authority and communication 5.6 Management review 6 Resource management 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment 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 8 Measurement, analysis and improvement 8.1 General 8.2 Monitoring and measurement 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement 1 Scope 1.1 General 1.2 Application 1 - Scope 1 Scope 1.1 General 1.2 Application 2 Normative General references Aim and motivation for implementing the QMS: 3 Terms -Aim: promotion and definitions of the work quality; demonstration of the quality in the execution of a construction works; - Motivation: Avoid interventions during the warranty period; owner demand. 4 Quality management system 4.1 General requirements Documentation - Application requirements Activities : 5 Management All activities of responsability the organization; activity in a specific department; 5.1 Activities Management performed commitment in certain types of construction works; activity performed in a specific construction project; 5.2 Customer focus 5.3 Territory: Quality policy 5.4 Planning 5.5 Activity Responsibility, performed authority in the entire and communication national territory; activity performed on a certain region; 5.6 Activity Management performed review in a given city;... exclusions are limited to requirements within Clause 7 (Product realization) and must be justified Nuno Marques de Almeida 1

2 2 - Normative references 1 Scope 1.1 General 1.2 Application 2 Normative references 2 Normative references No sub-requirements 3 Terms 2 - Normative and definitions references Examples: 4 Quality management system 4.1 ISO General 9001 (ISO requirements 9004?); 4.2 Organization s Documentation Quality requirements Manual ( construction project); 5 Management Construction project responsability Quality Management Plan ( subcontract); 5.1 EU Management public procurement commitment directives ( public construction projects); 5.2 Customer focus Construction project specifications; Detailed design; 5.3 Quality policy 5.4 Planning 5.5 Responsibility, authority and communication 5.6 Management review 3 - Terms and definitions 1 Scope 1.1 General 1.2 Application 2 Normative references 3 Terms and definitions 3 Terms and definitions No sub-requirements 4 Quality management system 4.1 General requirements 4.2 Documentation requirements 3 -Terms and definitions 5 Management responsability 5.1 Terms Management and definitions commitment ISO 9000:2005; 5.2 Construction Customer focus project specific vocabulary (technical terms, construction schedule, equipment plan, ); 5.3 Quality policy 5.4 Planning 5.5 Responsibility, authority and communication 5.6 Management review Nuno Marques de Almeida 2

3 Requirement 4 - Quality management system 1 Scope 2 Normative references 3 Terms and definitions 4 Quality management system 5 Management responsibility 6 Resource management 4 Quality management system 4.1 General requirements 4.2 Documentation requirements General Quality manual Control of documents Control of records 7 Product realization 8 Measurement, analysis and improvement Requirement General requirements 4 Quality management system 4.1 General requirements 4.2 Documentation requirements 4.1 General requirements Identification of the processes (WHAT IS DONE?) Determine the sequence and interaction of these processes (HOW IS IT DONE?) Determine criteria and methods for process operation and control (HOW TO CONTROL?) Ensure the availability of resources (WHAT SUPPORT?) Monitor, measure and analyze processes (CHECKING IS MANDATORY!) Actions necessary to achieve planned results and continual improvement (FEEDBACK!) Outsourced processes (performed by an external party) that affects conformity shall be controlled by the organization Nuno Marques de Almeida 3

4 Requirement Documentation requirements Manual da Qualidade Empresa 4 Quality management system 4.1 General requirements 4.2 Documentation requirements General Quality manual Control of documents Control of records Establish who and how to... approve; review and update (and reapprove); change and ensure current version status; make available at points of use; remain legible and readily identifiable identify and distribute documents of external origin; prevent the use of obsolete documents. Procedimentos documentados, Instruções de Trabalho e Elementos desenhados Planos da Qualidade (especificam como o SQ é aplicado a um produto, projecto ou contrato) Registos da Qualidade Projecto ou Obra (fornecem evidências objectivas das actividades desenvolvidas ou resultados atingidos) QUALITY PLAN (engineering design or construction project) Records provideevidenceof conformity to requirements Documented procedure shall be establish in view of: Identification Storage Protection Retrieval/recovery Time of retention Disposition of records The importance of a well structured QMS CoQ without a well structured QMS Prevention Inspection costs Costs of failure and rework Failure costs avoided Prevention Inspection costs Costs of failure and rework Added prevention and reduced failures/re-work through effective implementation of QMS Nuno Marques de Almeida 4

5 Requirement 5 - Management responsibility 1 Scope 2 Normative references 3 Terms and definitions 4 Quality management system 5 Management responsibility 6 Resource management 7 Product realization 8 Measurement, analysis and improvement 5 Management responsability 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning Quality objectives Quality management system planning 5.5 Responsibility, authority and communication Responsibility and authority Management representative Internal communication 5.6 Management review General Review input Review output 5 Management responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.5 Responsibility, authority and communication 5.6 Management review How does the top management commit itself? communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements establishing the quality policy establishing quality objectives (% reduction of claims, ) conducting management reviews (req. 5.6) ensuring the availability of resources (financial, material, human) Requirement Management commitment Nuno Marques de Almeida 5

6 5 Management responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.5 Responsibility, authority and communication 5.6 Management review Requirement 5.2 Customer focus 5 Management responsability 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.5 Responsibility, authority and communication 5.6 Management review Requirement Quality policy Nuno Marques de Almeida 6

7 ID Task Name Duration Start Finish 1 ELABORAÇÃO DO PROJECTO 227 days Programa Preliminar 5 days Organização processo de concurso 15 days Abertura do concurso 1 day Apreciação das propostas 30 days Notificação da adjudicação 1 day Assinatura do contrato 15 days Programa Base 20 days Estudo Prévio 30 days Aprovação do Estudo Prévio 5 days Anteprojecto 25 days Aprovação do Anteprojecto 5 days Projecto de Execução 60 days Aprovação do Projecto de Execução 15 days FISCALIZAÇÃO 68 days Organização processo de concurso 15 days Concurso 20 days Apresentação das propostas 1 day Abertura do concurso 1 day Apreciação das propostas 15 days Notificação da adjudicação 1 day Assinatura do contrato 15 days EXECUÇÃO DA OBRA/EMPREITADA 453 days Organização processo de concurso 15 days Concurso 30 days Apresentação das propostas 1 day Abertura do concurso 1 day Apreciação das propostas 15 days Notificação da adjudicação 1 day Assinatura do contrato 10 days Consignação 15 days Execução física dos trabalhos 365 days RECEPÇÃO DA OBRA/EMPREITADA 388 days Pedido de Vistoria 1 day Vistoria 5 days Recepção Provisória 1 day Pedido de Vistoria 365 days Vistoria 15 days Recepção Definitiva 1 day Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Quality in Construction September 2015 Requirement Planning 5 Management responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning Quality objectives Quality management system planning 5.5 Responsibility, authority and communication 5.6 Management review Planning of the QMS to meet requirement 4.1 Plan and implement changes to the QMS Quality objectives shall be measurable Requirement Responsibility, authority and communication 5 Management responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.5 Responsibility, authority and communication Responsibility and authority Management representative Internal communication 5.6 Management review Nuno Marques de Almeida 7

8 Requirement Management review 5 Management responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.5 Responsibility, authority and communication 5.6 Management review General Review input Review output Output from the management review (decisions and actions) improvement of the QMS improvement of product resource needs Plan intervals for reviewing the QMS: assess opportunities for improvement assess need for changes to the QMS Input to management review (information) results of audits customer feedback nonconformities status of preventive and corrective actions follow-up from previous reviews changes that could affect the QMS recommendations for improvement Requirement 6 - Resource management 1 Scope 2 Normative references 3 Terms and definitions 4 Quality management system 5 Management responsibility 6 Resource management 7 Product realization 8 Measurement, analysis and improvement 6 Resource management 6.1 Provision of resources 6.2 Human resources General Competence, training and awareness 6.3 Infrastructure 6.4 Work environment Nuno Marques de Almeida 8

9 Requirement Provision of resources 6 Resource management 6.1 Provision of resources 6.2 Human resources General Competence, training and awareness 6.3 Infrastructure 6.4 Work environment Requirement Human resources 6 Resource management 6.1 Provision of resources 6.2 Human resources General Competence, training and awareness 6.3 Infrastructure 6.4 Work environment Nuno Marques de Almeida 9

10 Requirement Infrastructure 6 Resource management 6.1 Provision of resources 6.2 Human resources General Competence, training and awareness 6.3 Infrastructure 6.4 Work environment 6.3 Infrastructure The organization shall determine, provide and maintain the... buildings, workspace and associated utilities process equipment (both hardware and software) supporting services (transport, communication, ) Requirement Work environment 6 Resource management 6.1 Provision of resources 6.2 Human resources General Competence, training and awareness 6.3 Infrastructure 6.4 Work environment Nuno Marques de Almeida 10

11 Requirement 7 - Product realization 1 Scope 2 Normative references 3 Terms and definitions 4 Quality management system 5 Management responsibility 6 Resource management 7 Product realization 8 Measurement, analysis and improvement 7 Product realization 7.1 Planning of product realization 7.2 Customer-related processes Determination of requirements related to the product Review of requirements related to the product Customer communication 7.3 Design and development Design and development planning Design and development inputs Design and development outputs Design and development review Design and development verification Design and development validation Control of design and development changes 7.4 Purchasing Purchasing process Purchasing information Verification of purchased product 7.5 Production and service provision Control of production and service provision Validation of processes for production and service provision Identification and traceability Customer property Preservation of product 7.6 Control of monitoring and measuring equipment 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 Requirement Planning of product realization Nuno Marques de Almeida 11

12 7 Product realization 7.1 Planning of product realization 7.2 Customer-related processes Determination of requirements related to the product Review of requirements related to the product Customer communication 7.3 Design and development 7.4 Purchasing 7.5 Production and service provision 7.6 Control of monitoring and measuring equipment Requirement Customer-related processes Requirement Design and development 7 Product realization 7.1 Planning of product realization 7.2 Customer-related processes 7.3 Design and development Design and development planning Design and development inputs Design and development outputs Design and development review Design and development verification Design and development validation Control of design and development changes 7.4 Purchasing 7.5 Production and service provision 7.6 Control of monitoring and measuring equipment organization shall determine: design and development stages the review, verification and validation of each stage the responsibilities and authorities Systematic reviews shall be performed to evaluate the ability of the design/construction works to meet requirements Ensure that the design/construction requirements are met (comparison with known cases,, calculation, testing) Ensure that the resulting product is capable of meeting the requirements for the specified application or intended use (APROVED) AEC design and development activities Designer Supervision Constructor Execution of design Constructability review of the design Technical assistance Approval of design by the constructor Changes to design Changes to design Design errors and omissions Design errors and omissions... Change orders Luís Alves Dias, Nuno Marques... de Almeida Constructability review of the design (example1? example2?); Design of the construction site (temporary installations, infrastructures for water and energy supply, sewers, waste); Design for provisional structures (formworks and shoring systems, scaffolding, stairs); Variants to the engineering design;... Nuno Marques de Almeida 12

13 7 Product realization 7.1 Planning of product realization 7.2 Customer-related processes 7.3 Design and development 7.4 Purchasing Purchasing process Purchasing information Verification of purchased product 7.5 Production and service provision 7.6 Control of monitoring and measuring equipment Requirement Purchasing Requirement Purchasing process (supply chain)??? (Example: Request of subcontractor approval?) Nuno Marques de Almeida 13

14 Requirement Verification of purchased product (standard samples) (Example: Request for approval of materials?) Requirement Verification of purchased product (materials, equipment) Example (before pouring concrete): concrete oriented? structure oriented? Example (while pouring concrete): delivery of pre-mixed concrete? Example (after pouring concrete): testing? Nuno Marques de Almeida 14

15 7 Product realization 7.1 Planning of product realization 7.2 Customer-related processes Identification 7.3 Design and development Aim: Enable the identification of the product status with 7.4 Purchasing respect to monitoring and measurement requirements 7.5 Production and service provision throughout product realization Control of production and service provision Example: Label showing the status (waiting inspection, rejected, Validation of processes for production and service provision approved) of products (sand, etc.) Identification and traceability Customer property Preservation of product 7.6 Control of monitoring and measuring equipment Requirement Production and service provision Identification andtraceability Movable products: marking of product enabling traceability (e.g. premolded concrete elements). Nonmovable products: marking of product or documented records Traceability Aim: Enable the identification of origin of materials and parts, trace the processing history and the final application or location of product. Example: Traceability of rebar in a structural concrete slab (origin of steel bars, details of the control process during delivery in the construction site, details of cutting and bending process, details of the placing process, details of checking conformity to design). Example? 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 Requirement Control of monitoring and measuring equipment Notes Determine the monitoring and measurement to be undertaken, plus the equipment that is required. Ensure that all monitoring and measuring equipment is properly calibrated and in proper working condition (constructor, subconstructor, suppliers) Example of procedure? Examples Geotechnical measurements (inclinometer, measurement of anchor forces, pore water pressure sensor, soil pressure sensor, ) Concrete structures (Extensometer, temperature sensor, ) Tape measure (adequate storage of reference tape measure); Topographic equipment Water related equipment (pressure instruments, flow measurement, ) Electrical (digital multimeters, ) Post-tensioning systems (jacks, load cells, );... Nuno Marques de Almeida 15

16 Record for monitoring the support equipment and accessories Requirement 8 - Measurement, analysis and improvement 1 Scope 2 Normative references 3 Terms and definitions 4 Quality management system 5 Management responsibility 6 Resource management 7 Product realization 8 Measurement, analysis and improvement 8 Measurement, analysis and improvement 8.1 General 8.2 Monitoring and measurement Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of product 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement Continual improvement Corrective action Preventive action Nuno Marques de Almeida 16

17 8 Measurement, analysis and improvement 8.1 General 8.2 Monitoring and measurement 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement Requirement General 8 Measurement, analysis and improvement 8.1 General 8.2 Monitoring and measurement Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of product 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement Requirement Monitoring and measurement Nuno Marques de Almeida 17

18 Requirement Monitoring and measurement Execution procedure? Requirement Monitoring and measurement Examples of monitoring and measurement records? Nuno Marques de Almeida 18

19 Requirement Control of nonconforming product 8 Measurement, analysis and improvement 8.1 General 8.2 Monitoring and measurement 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement NÃO-CONFORME NONCONFORMITY Correction Corrigir until até / / Aceite Accepted for para Rejeitado Rejected Registered Registado por by Verificado Checked by por Nonconformity and defects Nonconformity non-fulfilment of a requirement Defect non-fulfilment of a requirement related to an intended or specified use / / / / Requirement Improvement 8 Measurement, analysis and improvement 8.1 General 8.2 Monitoring and measurement 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement Continual improvement Corrective action Preventive action Corrective action Versus Preventive action Corrective action action to eliminate the cause of a detected nonconformity or other undesirable situation (taken to prevent recurrence) Correction: action to eliminate a detected nonconformity Preventive action action to eliminate the cause of a potential nonconformity or other undesirable potential situation (taken to prevent occurrence) Records of the results of improvement actions: Nonconformance report Example 1? Nonconformance report Example 2? Nuno Marques de Almeida 19

20 Written/documented procedure What is a procedure? Specified way to carry out an activity or a process (procedures can be documented or not) What is a documented procedure? Procedure that is established, documented, implemented and maintained Organization (Example of index) 1 Goal 2 Revision status 3 Description of the procedure 4 Responsibilities 5 Reference documents 6 Records Annexes (if aplicable) Mandatory documented procedures Only 6 procedures (other examples?) 1 - Control of documents (4.2.3) (Example?) 2 - Control of records (4.2.4) (Example?) 3 - Internal audit (8.2.2) 4 - Control of nonconforming product (8.3) (Example?) 5 - Corrective action (8.5.2) 6 - Preventive action (8.5.3) Nuno Marques de Almeida 20

21 Example of common non-mandatory documented procedures in construction projects Documented procedures Procurement and Logistics Procedure (commercial sensitive) Codification of Documents and Drawings (Doc. Control procedure?) Design and Production Procedure (Design, Design-Build, ) Subcontracting Procedure (qualification, evaluation, ) Temporary Works Procedure (safety sensitive, design, construction, ) Management of Plant & Equipment (maintenance plans, inspection regimes, ) Handover, As-Built and Completion Procedure (handover of records to Client, ) Inspection and Quality Control Procedure (framework for site inspections, ) Surveying and Setting out Procedure Material Approvals (first-party inspected, Client approval, ) Reporting Procedure (format, frequency, ) Cost Control Procedure Administration & Correspondence Calibration Procedure Assessing Client satisfaction Request for Information Procedure (changes, clarifications, ) Design Field Change Procedure Training Procedure 59 Mandatory records (1/2) Records provide evidence that requirements are fulfilled and that the QMS is being implemented Only 19 mandatory records (some may not be applicable) 1 - Management review (5.6.1); 2 - Competence, training and awareness (6.2.2); 3 - Evidence that the realization processes and resulting product meet requirements (7.1); 4 - Review of requirements related to the product (7.2.2); 5 - Design and development inputs (7.3.2); 6 - Design and development review (7.3.4); 7 - Design and development verification (7.3.5); 8 - Design and development validation (7.3.6); 9 - Control of design and development changes (7.3.7); ( ) Nuno Marques de Almeida 21

22 Mandatory records (2/2) Purchasing process (7.4.1); 11 - Validation of processes for production and service provision (7.5.2); 12 - Identification and traceability (7.5.3); 13 - Customer property (7.5.4); 14 - Control of monitoring and measuring equipment (7.6); 15 - Internal audit (8.2.2); 16 - Monitoring and measurement of product (8.2.4); 17 - Control of nonconforming product (8.3); 18 - Corrective action (8.5.2); 19 - Preventive action (8.5.3). 62 Mandatory records (2/2) Purchasing process (7.4.1); 11 - Validation of processes for production and service provision (7.5.2); 12 - Identification and traceability (7.5.3); 13 - Customer property (7.5.4); 14 - Control of monitoring and measuring equipment (7.6); 15 - Internal audit (8.2.2); 16 - Monitoring and measurement of product (8.2.4); 17 - Control of nonconforming product (8.3); 18 - Corrective action (8.5.2); 19 - Preventive action (8.5.3). 63 Nuno Marques de Almeida 22

23 We know about quality standards! what s next? What is the goal? To implement a QMS in the organization? design company; supervision body; construction company. To implement a QMS in a specific context? engineering or architectural design activities; supervision of construction works; execution of construction works; construction project. Interaction of various QS/QP in a construction project QS / QP Designer QS / QP Supervision QS / QP Contractor Internal records; 1st and 2nd part audit reports; Minutes of meetings;. Internal records; 1st and 2nd part audit reports; Minutes of meetings;. Internal records; 1st and 2nd part audit reports; Minutes of meetings;. Avoids duplications Monitoring and measuring records; Control of monitoring and measuring equipment; Nonconformance records;. Nuno Marques de Almeida 23

24 Implementing a QS in construction-related organizations or construction projects It consists of... Identification and production of system documentation Quality Manual (applicable to Organizations); Quality Plan (applicable to design/construction projects); Execution procedures/work instructions (How is it done?); System procedures (Who does what and when?) Quality records (What are the evidences of what was done?) (example contractor?) Communication and application of what is established by the system Promote training actions at different levels (cascade!); Schedule dates for the application of what is establishes; Make the Quality Policy visibly known;... Hierarchy of QMS documents - Construction company - Quality Manual Documented procedures, Work instructions, Drawings, Technical specifications Specifications (requirements) Guides (recommend. / sugest.) Quality Plan (Detailed description for applying the QMS to a product, project or contract) Quality Records (provide objective evidence of undertaken activities or achievedresults) Nuno Marques de Almeida 24

25 Hierarchy of QMS documents - Supervision bodies - Quality Manual Documented procedures, Work instructions, Drawings, Technical specifications Specifications (requirements) Guides (recommend. / sugest.) Quality Plan (Detailed description for applying the QMS to a product, project or contract) Quality Records (provide objective evidence of undertaken activities or achievedresults) Example of organization of a Quality Manual /Plan Promulgation Order (Date of implementation) Index 1 - Introduction 1.1 Title, objective and application Title (QM, QP, ) Goal (activity or department in the organization, type of construction projects covered, geographical are, ) Application (exclusions that are justified and acceptable - limited to requirements within clause 7) 1.2 Documents of reference (standards, regulations mentioned in the document) 1.3 Terms and definitions (annex A), and abbreviations (annex B) 1.4 Revisions (revision description of changes date) 1.5 Distribution (record of copies / controlled copies; non-controlled copies) 2 Presentation of the company (or project or construction work) 3 Policy and quality objectives 4 Quality Management System 5 Management responsibility 6 Resource Management 7 Product realization 8 Measurement, analysis and improvement Annexes Nuno Marques de Almeida 25

26 Example of organization of a Quality Manual /Plan Promulgation Order (Date of implementation) Index 1 - Introduction 1.1 Title, objective and application Example of contents of Quality Plans for construction projects: Title (QM, QP, ) 1) Management Responsibility Goal (activity or department in the organization, type of construction projects 2) Documented covered, geographical Quality Management are, ) System Application (exclusions that are justified and acceptable - limited to requirements 3) Design Control within clause 7) 1.2 Documents of reference (standards, regulations mentioned in the document) 4) Document Control 1.3 Terms and definitions (annex A), and abbreviations (annex B) 5) Purchasing 1.4 Revisions (revision description of changes date) 6) Product Identification and 1.5 Distribution (record of copies / controlled copies; non-controlled copies) Traceability 2 Presentation of the company (or project or construction7) work) Process Control 3 Policy and quality objectives 8) Inspection andtesting 4 Quality Management System 9) Inspection, Measuring, and Test Equipment 5 Management responsibility 10) Inspection andtest Status 6 Resource Management 11) Nonconformance 7 Product realization 12) Corrective Action 8 Measurement, analysis and improvement 13) Quality Records Annexes 14) Quality Audits 15) Training Nuno Marques de Almeida 26