![Concept of PDCA / PDSA Cycle
Concept of PDCA / PDSA Cycle
PLAN:
Design or revise business
process components to
improve results
DO:
Implement the plan and
measure its performance
CHECK/ STUDY :
Assess the measurements and report the results to decision makers [or Study
the results]
ACT: 6+
Decide on changes needed to improve the process](https://image.slidesharecdn.com/fortrainingqualityinternalauditing-241221123144-2c2b56f6/85/For-training-quality-internal-auditing-ppt-27-320.jpg)
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- 1. What is Quality? • Quality is fitness for use. • Meet/satisfy customer/user requirements, needs, and expectations. • Degree to which a set of inherent characteristics fulfills requirements.
- 2. Management System A management system is the structure of processes and procedures used to ensure that an organization can fulfill all tasks required to achieve its objectives. Examples of management system standards include: • ISO 9001 Quality Management System • ISO 22000 Food Safety Management System • PS:3733-2010 Halal Food Management System
- 3. What is Audit? • A Systematic and independent examination to determine whether Quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.
- 4. The purpose of an audit is ... to collect objective evidence to permit an informed judgment about the status of the quality management system
- 5. What is Objective Evidence? • Records • Statements of fact • Other information Which are relevant to the audit criteria and verifiable OR • Findings during an Audit
- 6. What is Audit Findings? • Results of the evaluation of the collected audit evidence against audit criteria.
- 8. What is Auditor? • Person with the competence to conduct an Person with the competence to conduct an audit. audit.
- 9. Auditor’s Responsibilities • Communicating and Clarifying audit requirements • Planning and Carrying Out assigned responsibilities efficiently • Documenting the findings • Reporting the audit results • Verifying the effectiveness of corrective actions in internal audits • Safeguarding records and confidential information • Cooperating with audit team
- 10. Auditor – Personal Attributes • Fair, Truthful, Honest and Discreet Fair, Truthful, Honest and Discreet • Willing to consider alternative ideas Willing to consider alternative ideas • Clear Point of view Clear Point of view • Tactfully dealing with people Tactfully dealing with people • Actively observing physical surrounding and Actively observing physical surrounding and activities activities • Aware and able to understand situations Aware and able to understand situations • Determined, Focus on achieving objectives. Determined, Focus on achieving objectives. • Able to reach timely conclusions based on Able to reach timely conclusions based on logical reasoning and analysis. logical reasoning and analysis. • Able to act and function independently whilst Able to act and function independently whilst interacting effectively with other. interacting effectively with other.
- 11. Auditor – Knowledge & Skills • Audit Process, Responsibilities, Procedure & Techniques Audit Process, Responsibilities, Procedure & Techniques • Management System & References Documents Management System & References Documents • Organizational Situations Organizational Situations • Applicable Laws Applicable Laws • Understand the Risks Understand the Risks
- 12. What is Auditee? • Organization • Department • Person being audited
- 13. Responsibilities of Auditee • Informing employees about the Objectives and Scope of the Audit • Establishing a Professional, Positive Attitude about the audit among the members of the audited Organization. • Providing the Relevant Material and Resources to the audit team • Correcting or Resolving Deficiencies cited by the audit team • Appointing Guides to accompany auditors • Providing a Response to the Audit Report
- 14. Types of Audits Internal Audit • First Party Auditing your own organization using a planned schedule and trained internal auditors. External Audit • Second Party Audit is initiated by client i.e. your purchaser • Third Party Audit performed by independent organization or regulatory body, e.g. ISO 9001:2000 registrar. Example SGS, URS, Moody Int. etc.
- 15. Why Internal Quality Audits • Internal Quality Audits is a requirement of ISO. • Internal Quality Audits Prepares an organization and it staff for assessment and identify problems before the external auditor. • Internal Quality Audit records indicates that a system is adequately working. • Internal Quality Audit help in staff development and leads to the improvement in organization’s performance.
- 16. What is Audit Plan? • Description of the activities and arrangements Description of the activities and arrangements for an for an audit. audit.
- 17. What is Audit Scope? • Level and boundaries of an audit.
- 18. What is ISO 9001:2008 QMS? • ISO = International Organization for Standards • 9001 = code to denote QMS Family • 2008 = year of last revision • Is a family of standards for implementing a Quality Management System (QMS)
- 19. ISO 9000 Family ISO 9000:2005 QMS- Fundamentals & Vocabulary ISO 9001:2008 QMS- Requirements ISO 9004:2000 QMS- Guidelines for performance Improvement ISO 19011:2002 Guidelines for QMS &/or EMS Auditing Only ISO 9001:2008 can be used for certification
- 20. Quality Management 8 Principles Customer Focus Leadership Involvement of People Process Approach System Approach to Management Continual Improvement Factual Approach to Decision Making Mutually Beneficial Supplier Relationships
- 21. 1. Customer Focus • Organizations depend on their customers; therefore they should Know their current and future needs Meet their requirements Exceed their expectations Get their feedback
- 22. 2. Leadership • Leaders create common purpose and direction; therefore they should Maintain a healthy internal environment Inspire workforce to excel management management responsibility responsibility
- 23. 3. Involvement of People • People are the essence of an organization; therefore They should be fully involved Their abilities should be used for organization benefits resource resource management management
- 24. 4. 4. Process Approach Process Approach . Any activity that takes “inputs” and converts them to “outputs ” . The systematic identification and management of these activities and the interaction between activities . . A desired result is more efficiently achieved when resources and activities are managed as a process
- 25. 5. System Approach to Management • Managing interrelated processes as a system helps the organization in achieving its objectives in an effective and efficient manner
- 26. 6 6 Continual Improvement: Continual Improvement: Continual improvement of the organization's overall performance should be a permanent objective of the organization
- 27. Concept of PDCA / PDSA Cycle Concept of PDCA / PDSA Cycle PLAN: Design or revise business process components to improve results DO: Implement the plan and measure its performance CHECK/ STUDY : Assess the measurements and report the results to decision makers [or Study the results] ACT: 6+ Decide on changes needed to improve the process
- 28. 7. Factual Approach to Decision-Making • Effective decisions are based on the analysis of data and information
- 29. 8. Mutually Beneficial Supplier Relationship An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value
- 31. Session 2 ISO 9001:2008 explored and understood
- 32. The ISO 9001:2008 Model Continual Improvement of the QMS Input Output value adding activities info. flow info. flow CUSTOMER REQUIREMENTS CUSTOMER SATISFACTION management responsibility product realization resource management meas, analysis improvement product clause 4 clause 5 clause 6 clause 8 clause 7 value adding activities
- 33. Structure of ISO 9001:2008 • 1. Scope • 2. Normative References • 3. Terms & Definitions • 4. Quality Management system • 5. Management Responsibility • 6. Resource Management • 7. Product Realization • 8. Measurement, Analysis & Improvement
- 34. 1. Scope 1.1 General: • Product Consistently meets Customer and applicable statutory and regulatory requirements • To enhance Customer Satisfaction, including Continual Improvement of the system and assurance of conformity to Customer and applicable statutory & regulatory requirements.
- 35. 1. Scope 1.2 Application: • Generic Requirements applicable to all organization, regardless of types, size and product provided • Exclusion can be considered if certain requirements no applicable. • Exclusion allowed only from Section 7
- 36. 2. Normative References • The following referenced documents are indispensable for the application of this documents. • For dated references only the edition cited applies. • For undated references the latest edition of referenced document (including any amendments) applies. ISO 9000:2005, Quality Management Systems – Fundamentals and vocabulary
- 37. 3. Terms & Definitions • For the purpose of this documents the term and definition given in ISO 9000 apply. • Throughout the text of this international standard whenever the term Product occur it can also mean Services.
- 38. 4. Quality Management System 4.1 General Requirements: Examples • Departmental Procedures • Training with HRD • Quality objectives • Policy Documentation with company management
- 39. 4. Quality Management System 4.2 Documentation Requirements: 4.2.1 General • Documented statements of a Quality Policy and Quality Objectives. • A Quality Manual • Documented Procedures and records required by ISO 9001:2008. • Documents including records determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.
- 40. 4. Quality Management System 4.2 Documentation Requirements: Documented Procedures Required for: • Control of Documents • Control of Quality Records • Product Non Conformance • Internal Audits • Corrective Actions • Preventive Actions
- 41. 4. Quality Management System 4.2 Documentation Requirements: 4.2.2 Quality Manual • Scope and justification for exclusion . • Procedures of the QMS or its reference. • Integration between QMS and process.
- 42. 4. Quality Management System 4.2 Documentation Requirements: 4.2.3 Control of Documents • QMS documents shall be controlled. • Appropriates review and approval prior to issue. • Changes in revision are identified. • Available at locations of use. • Legible and identifiable. • External documents are identified and controlled. • Identification of obsolete documents. Example : Quality Manual, QMS Procedure, Departmental Procedure, Work Instruction, Drawing Standard, Machine Manual, Reference Manuals etc.
- 43. 4. Quality Management System 4.2 Documentation Requirements: 4.2.4 Control of Quality Records • Legible readily identifiable and retrievable. • Documented procedure to define the control including retention and disposition. Example : Quality Reports, Audit reports, Out put of Manufacturing Review, Test Report, Corrective and Preventive Action, Customer Surveys, Design reviews, validation, Customer Complaints etc.
Editor's Notes
- #9: from ISO 10011-1
- #14: FIRST-PARTY AUDIT Auditing your own organization using a planned schedule and trained internal auditors. SECOND-PARTY AUDIT Audit is initiated by client who may be your purchaser or other departments in your own organization. THIRD-PARTY AUDIT Audit performed by independent organization or regulatory body, e.g. ISO 9001:2000 registrar. Example QMI, BSI, BvQi, UL, Loyds
- #15: FIRST-PARTY AUDIT Auditing your own organization using a planned schedule and trained internal auditors. SECOND-PARTY AUDIT Audit is initiated by client who may be your purchaser or other departments in your own organization. THIRD-PARTY AUDIT Audit performed by independent organization or regulatory body, e.g. ISO 9001:2000 registrar. Example QMI, BSI, BvQi, UL, Loyds
- #18: Just what is ISO? Not “what”, but “who”! Our standards are often highly technical - and they need to be - but they're developed for people by people. So who we are is a network of the national standards institutes of some 140 countries, with a central office in Geneva, Switzerland, that coordinates the system and publishes the finished standards. Who runs ISO? All strategic decisions are referred to the ISO members, who meet for an annual General Assembly. The proposals put to the members are developed by the ISO Council, drawn from the membership as a whole, which resembles the board of directors of a business organization. Council meets twice a year and its membership is rotated to ensure that it is representative of ISO's membership. Who pays for ISO? ISO’s national members pay subscriptions that meet the operational cost of ISO's Central Secretariat. The dues paid by each member are in proportion to the country's GNP and trade figures. Another source of revenue is the sale of revenue is the sale of standards, which covers 30% of the budget. Source: http://iso.org
- #19: ISO 9000 - fundamentals, vocabulary ISO 9001 - requirements ISO 9004 - continual improvement guidelines (guide to go beyond ISO 9001) ISO/DIS 19011 - auditing guidelines
- #20: Customers play a major role in the future profitability of an organisation. In order to retain customers, the organisation must understand the current requirements and potential future requirements and their customers. Applying the principle of a customer-focused organisation leads to the following actions: Understanding the whole range of customer needs and expectations for products, delivery, price, dependability etc Ensuring a balanced approach among customers and other stakeholders(owners, people, suppliers, local communities and society at large) needs and expectations Communicating these needs and expectations throughout the organisation Measuring customer satisfaction and acting on the results Managing customer relationships Beneficial applications of this principle include: For policy and strategy formulation, making customer needs and the needs of other stakeholders understood throughout the organisation For goal and target setting, ensuring that the relevant goals and targets are directly linked to customer needs and expectations For operational management, improving the performance of the organisation to meet customer needs For human resources management, ensuring the people have the knowledge and the skills required to satisfy the organisation’s customers
- #32: See ISO 9001:2000 Pocket Booklet, page xi.