5. 1. CUSTOMER FOCUS 2. LEADERSHIP 8 MANAGEMENT PRINCIPLES ISO 9001 3. INVOLVEMENT OF PEOPLE 4. PROCESS APPROACH 5. SYSTEM APPROACH 6. CONTINUAL IMPROVEMENT 7. FACTUAL APPROACH 8. MUTUAL BENEFICIAL SUPPLIER RELATIONSHIPS
6. 6 LEVEL 1 - QUALITY MANUAL Quality Policy Quality Objectives Requirement Standard Other Statutory and Regulatory Requirements
7. LEVEL 2 - QUALITY PROCEDURES Control of Documents Control of Records Internal Quality Audits Control of Non-conforming Products Corrective Action Preventive Action 7
8. 8 LEVEL 3 - QUALITY PLAN Incoming Inspection Plan In-Process Inspection Plan Final Test Report/ Inspection Plan Work Instruction
9. 9 LEVEL 4 - FORMS / FORMATS/RECORDS Testing Report forms Commissioning Report Forms Inspection forms Check Sheets/Check List Miscellaneous Documentation Forms
10. Management Review Competence, Training and Awareness Planning and Production Review of Requirement Related to Product Design and Development Input 10 23 MANDATORY RECORDS
11. 11 23 MANDATORY RECORDS Design and Development Output Design and Development Review Design and Development Verification Design and Development Validation Control of Design and Development Changes
12. 12 23 MANDATORY RECORDS Purchasing Process Availability of Monitoring and Measuring Equipment Preservation of Product Customer Property Control of Monitoring and Measuring Equipment Standards used for Calibrating Monitoring and Measuring Equipment
13. 13 23 MANDATORY RECORDS Identify and Enable Calibration Result of Calibration and Verification Internal Audit Monitoring and Measurement of Product Control of Non-conforming Product Corrective Action Preventive Action
15. QA/QC Concepts Quality Assurance Quality Assurance (or QA) covers all activities from design, development, production, installation, servicing and documentation.
16. QA/QC Concepts Quality Control Quality control refers to the process, most often implemented in manufacturing, monitoring the quality of finished products through statistical measures and an overall corporate commitment to producing defect-free products.
17. QA/QC Concepts Organizational Level. At the organizational level, QA activities ensure that the program or organization is successful by overseeing the system implementation necessary for individual projects in the program, and making sure activities have the resources they need to be successful.
18. QA/QC Concepts Project Level (Design, Estimate and Initiation) At the project level, QA activities support the success of an individual project by ensuring that accurate information is channeled to the right people at the right time so that decisions can be made during project implementation.
19. QA/QC Concepts Technical Level. At the technical level, QA activities ensure that the individual technical activities that generate, process, or synthesize data (or other information) for the decision process are performing within accepted limits.
21. Roles of QA/QC Department Verify that requirements are followed, Verify that controlling and checking an activity have been done, Ensure that approved working methods are established, Evaluate the reported principal causes of non-conformances; Evaluate the effectiveness of corrective action, and Determine where improvements are required 21
22. Quality Control Role of Quality Controller includes: monitoring, Inspection, reduction of variation, elimination of known causes, and 22
26. The Organization President Vice President QA/QC Manager Engineering Manager QA/QC Officer Project Manager Auditors Quality Controllers (Project Engineers) 26
27. FUNCTIONS President Vice President Quality Activities Function Construction Work Function QA/QC Officer Project Manager Auditors Quality Controllers (Project Engineers) 27
28. CONSTRUCTION WORK FUNCTIONS President Vice President Project Manager QA/QC Site Project Engineers (Site Supervision) Subcontractors CAD 28
29. QUALITY WORK FUNCTIONS President Vice President QA/QC Site Manager Project Site Manager Project Engineers (Quality Control) Subcontractors CAD 29
33. Quality Management Objectives zero defect (no defects on project hand-over) identify and solve problems before customer does establish true quality control by making quality “built in” and not “inspected in”. 33
34.
35.
36. B A Replacement Order Placed Order A B Order Made Order Made B A B B B B B To Customer Delivery Field Testing Delivery Conforming Install Conforming Future repercussions Root Cause A Investigation Non-Conforming B & C B & C B & C Repairs SCRAP QA HOLD Non-Conforming A QA HOLD C C C C C C REPAIR Quality Check Conforming Install To Customer Conforming A Unload Container, Bags, STORAGE Testing Trucks etc Lost Revenue Paperwork/Database Dumping Costs Transport Future Costs (Reclaim/ Environment) A SCRAP Lost Revenue Dumping Costs Future Costs (Reclaim/ Environment) Cost of Quality KEY: NORMAL ADDED ADDED COSTS COSTS COSTS 36
40. Prepared by: Sid Calayag Reference: Quality Management System ISO 9001:2008
Notes de l'éditeur
QUALITY MANAGEMENT PRINCIPLES The quality management principles are a set of comprehensive and fundamental rules or beliefs for leading and operating an organisation. They aim at continually improving performance over long term, by focusing on customers while addressing the needs of all stakeholders.As per the ISO, the following eight quality management principles can facilitate any organisation in creating quality work culture and successful implementation of quality management.1. Customer-focused OrganisationOrganizations depend on their customers. Customer-focused organisations produce products and services that customers need and provide them satisfaction. This can be achieved by the following actions: • Identify customer needs. • Design a product that responds to customer needs. • Produce and deliver the product as per the design. • Enhance after-sales service and handle complaints quickly. • Measure customer satisfaction. • Improve quality to delight the customer.2. LeadershipSenior leaders of an organisation need to set directions and create customer orientation, clear and visible quality values and high expectations. Values, directions and expectations must address all stakeholders. The senior leaders must commit to the development of the entire workforce and should encourage participation, learning innovation and creativity by all employees. Through their personal roles in planning, communications, review or organisation performance and employee recognition, the leaders serve as role models who reinforce values and expectations and build leadership and initiative.3. Involvement of PeopleInvolvement of the people is one way of improving quality and productivity. Involving people at all levels enables their abilities to be used for the benefit of the organisation. This can be done by providing a good corporate work culture, providing an interesting work system and environment, and building the capability of people to perform assigned tasks in the organisation. 4. Process ApproachA desired result is achieved more efficiently when related resources and activities are managed as a process.5. Systems Approach to ManagementIdentifying, understanding and managing a system of interrelated processes for a given objective contributes to the effectiveness and efficiency of the organisation. 6. Continuous ImprovementA permanent objective of the organisation is that it should continuously improve performance by addressing the needs of all the interested parties. 7. Factual Approach to Decision-makingEffective decisions are based on the logical or intuitive analysis of data and information8. Mutually Beneficial Supplier RelationshipThe ability of the organisation and its suppliers to create value is enhanced by mutually beneficial relationships.The main purposes of quality management systems can be summarised as below:• Customer satisfaction/customer delight by assuring the required minimum level of consistent quality.• Satisfying 'internal customers'.• Assuring the management of doing this at minimum possible total cost of quality.• Maximising output to input ratios of processes.• 'Prevention is better than cure' strategy to be implemented.• Improve quality of communication all around.• Develop competent sub-contractors as partners.• Make continual improvement an ongoing feature of the company's culture.
It introduced the sayings "fit for purpose" and "do it right the first time". It includes the regulation of the quality of raw materials, assemblies, products and components; services related to production; and management, production, and inspection processes.
Quality control principles can also be utilized in service industries.
The need for audit Once procedures are established, how can it be ensured that the procedures are being implemented and are effective? What takes the place of inspection in the old system of operation? The answer is a compliance audit.An audit is undertaken to indicate whether a procedure or job instruction is working satisfactorily. Verifying, by audit, that the quality system requirements are being followed throughout the organization and that effective procedures and job instructions are being implemented by all departments or disciplines.Verifying that those responsible for controlling and checking an activity have done so in a systematic manner and that there is objective evidence available to confirm such;Ensuring that all procedural non-conformances are resolved.Ensuring that fundamental working methods are established and that fully approved procedures are developed to cover them and that all departments and personnel are aware of, and have access to, current versions of these procedures.Verifying that all procedures are regularly reviewed and updated as necessary.Determining and reporting the principal causes of quality losses and non-conformances;Determining, with senior management, where improvements are required and, where necessary, recommending the corrective action.
Quality control is the collective term for in-process activities and techniques intended to create specific quality characteristics. These includes monitoring, reduction of variation, elimination of known causes, and efforts to increase economic effectiveness.Quality ControlQuality control refers to the activities associated with the creation of project deliverables. It is used to verify that deliverables are of acceptable quality and that they meet the completeness and correctness criteria established in the quality planning process. Quality control is conducted continually throughout a project and is the responsibility of team members and the project manager.Quality ToolsList any quality-related tools that this project will utilize
Preventing mistakes is much more time and cost-effective than correcting them.
