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Internal Quality Auditing Terminologies

Internal Quality Auditing Terminologies. TERMINOLOGIES. *Fitness for use Conformance to specification Delighting the customer Towards zero defects Free from defects Degree of excellence

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Internal Quality Auditing Terminologies

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  1. Internal Quality Auditing • Terminologies

  2. TERMINOLOGIES *Fitness for use Conformance to specification Delighting the customer Towards zero defects Free from defects Degree of excellence Right fist time all the time

  3. Quality Inspection State (QI) Inspection is:- • Conformity evaluation by observation and judgment accompanied as appropriate by measurement, testing or gauging (3..8.2) • After-the-event screening process • Application point within the process • Thirty party inspection or operator sell inspection • Decision scrap, rework, medication, concession • No prevention content-does not provide any basis for process improvement

  4. Outline • Definition of quality and other related terms • Historical development of quality management • Functions affecting quality • Achieving quality assurance

  5. Historical Development of QM The development of quality annulment can be defined in four stages: • Quality inspection stage (QI)-1920s • Quality control stage (QC) - 1950s; • Quality assurance stage (QA) - 1970s; • Total quality management (QM) stage

  6. Quality Assurance Stage (QA) Quality Assurance is:- • Part of quality management focused on providing confidence that quality requirements will be fulfilled (3.1.11) • Issues of progression from QC to QA -Change n emphasis from production to process • Third level of quality development -Represents a shift from detection to prevention -Planed and systematic actions defined • Existence of motive quality system –ISO 9000 • Gender use of QM tools – SPC, QFD, FMEA • Quality performance and costs • Major customer approval

  7. The ISO 9000 Concept…. • Represents an international consensus on good management practices for a systematic and generic application of principles and practices based on quality • ISO 9000 is a written standard that defines the system that organizations should use to ensure that their products and / or services meet or exceed customer expectations • A set of standardized requirements for quality management systems and is applicable to any organization regardless of it’s size or whether public or private sector

  8. Quality Defined: ISO 9000:2000 • Degree to which a set of inherent characteristic fulfils requirements (3.11) -Characteristic – distinguishing feature, i.e. physical, sensory, temporal or functional etc (3,5,1) -Requirement –need or expectation that is stated or implied or obligatory, i.e. custom or common practices for you (3.1.2)

  9. Total Quality Management Stage • Represents the most advanced stage of quality development today (TQM was first used in 1985 to describe the Japanese style at quality improvement – Naval Air Command System – UK) • A Management philosophy • Company wide approached centred on application of QM to all aspects of business -Focused on the requirements of the customer satisfaction -Participation of all employees -Recognized the important of suppliers -Aimed at long term success for • Development of organization culture • Continue improvement • Benefit of all employees, stakeholders and society

  10. The ISO 9000 Concept … • ISO 9000 is seen as a vehicle towards TQM • The principal goal of the ISO 9000 Standards is to demonstrate quality assurance • “Quality culture” refers to the degree of awareness, commitment, collective attitude and behaviour of the organization with regard to quality

  11. What is Quality Management? • Quality Management (QM) • Coordinated activities to direct and control an organization with regard to quality (3,2,8) • Management System (SM) • System to establish policy and objectives and to achieve those objectives (3,2,2) • Quality Management System (QMS) • Management system to direct and control and organization with regard to quality (3,2,2)

  12. Quality: Meeting Requirements • Specifications are imprecise means of conveying subjective aspects i.e. -Not everything is measurable, e.g. courtesy or friendliness • Thus, conformance to requirements is not necessarily all there is to achieving quality

  13. QUALITY CLASSIFICATION Product quality may be classified into two categories; Quality of design • Quality of conformance

  14. FUNCTIONS AFFECTING QULTITYQUALITY LOOP

  15. Quality: Customer Satisfaction • Customer Satisfaction or is it meeting requirements? • Only true measure of acceptable quality ... -Takes account of both subjective and objective interpretations of needs and expectations -Correct interpretation of needs and expectation.. Acceptable quality

  16. TERMINOLOGIES • QUALITY POLICY Overall intentions and direction of an organization related to quality as formally expressed by top management QUALITY OBJECTIVES Something sought, or aimed for, related to quality

  17. ACHIEVING QUALITY ASSURANCE The organization’s concern is to provide quality products / services To succeed the company must offer products that fulfill the following objectives. • Meet well define need, use or purpose • Satisfy customer’s expectations • Comply with applicable standards and specifications • Comply with statutory requirements • Are made available to competitive prices • Are provided at a cost that will yield profits

  18. TO MEET THIS OBJECTIVES The company must organize itself in a way that:- The technical ) Administrative ) Control Human factors ) Hence the need for a quality system

  19. Internal Quality auditing to ISO 19011: 2000

  20. Definitions (1) Audit A systematic and independent examination to determine whether quality activities and related results comply with the planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve the objectives

  21. Auditing Standard • IS0 19011 : 2002 Guidelines on Quality and / or Environmental Systems Auditing

  22. Outline • Definition of a quality audit • Types of audit • Purpose and objectives of internal audits • Creating an environment for successful audits • Benefits of an effective audit process

  23. Definitions (2) • Quality Audit Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.

  24. Types of audit 3 types • Process audits • Product audits • System audits

  25. Process audits • Evaluation of the content and effectiveness of specific processes and work activities • To confirm the process parameters and improve capability of the process • To ensure the realization of process quality characteristics • To ensure improvement of process control during service provision

  26. Product audits -To identify opportunities for improvement to establish the quality level of units before final inspection and testing -To establish the capability of the inspection function -To determine the usefulness of inspection/tests

  27. Audits are distinguished by the party requesting: • 1st party audit (internal audits) – the auditee audits its own quality system according to a quality standard. • 2nd part audits (supplier audits) – the customer audits the supplier’s quality system • 3rd party audits – these are external certification audits by an independent institution in order to certify the quality system

  28. Products audits Investigation of products conformance to specified characteristics -To obtain additional neutral assessment of product’s level of quality -To obtain additional assurance that specified quality requirements are met

  29. System audits • Evaluation all the elements of the quaity system in order to:- • Verify usefulness, suitability and effectiveness • Verify adequate documentation • Verify compliance with requirements • Determine weak points

  30. Registration / certification audit Verify that the organization's QMS meet the requirements of ISO 9001 : 2000 Internal audit Identify opportunities for improvement Maintain ISO 9001 certification Purpose of audits

  31. Objectives of the Internal audit • To verify conformance to applicable standards • To verify conformance to documented procedures • To verify effectiveness of the processes in the system • To identify opportunities to improve the system

  32. Creating and environment for successful audits (1) • Gaining management support -Documenting audit findings in away that ensures management understands the effect on system -Linking non-conformities to losses especially in income -Making clear the consequence of deviating form system requirements e.g. y quantifying the losses

  33. Benefits of an effective audit process • Reduced operating costs through better efficiency • Improved customer satisfaction • Improved morale • Reduced barriers between departments • Survival through continual improvement

  34. Creating an environment for successful audits (2) • Gaining employees support -Provide basic training so people understand the purpose of the audit -Ensuring people understand their roles -Making clear that the auditees is the customer of the audit not the ‘victim’ -Ensuring that punitive action is not taken based on audit findings

  35. Audit Planning and Scheduling

  36. Audit Planning and Scheduling The MR plans the audit • The schedule is drawn by the MR well in advance in consultation with the Management Review Board • The schedule must be comprehensive to ensure that each activity is examined at least once in a year MR has overall responsibility

  37. Drawing an Audit Schedule (2) • Frequency of audits is determined by:- - Status of activity - Importance of activity • Provide for unscheduled audits - Due to failures in the system - Due to new features added to the systme

  38. Outline • Responsibilities for planning and scheduling • Drawing of a schedule • Selecting auditors • Audit cycle

  39. Drawing an Audit Schedule (1) Can be:- • Departmental • Section • Project • Corporate Period covered by schedule usually 12 months

  40. Selecting Auditors Identify independent auditors • Train them to form a pool of auditors • Assign them the audit task

  41. INTERNAL QUALITY SCHEME ABC COMPANY LTD Dsig…. Rev…. Date …..

  42. The Audit Cycle (2) • Identification of deficiencies or non conformance • Proposal and agreement on corrective action • Corrective action taken • Follow up audit to evaluate effectiveness of corrective action • Report to management

  43. Agenda for Management Review Meeting (5,6,2) • Review of audits • Customer feedback • Process performance & product conformity • Status of conformity & preventive action • Follow up action on previous management reviews • Changes that affect the quality management system and • Recommendations for improvement

  44. The Audit Cycle (1) • Identification of the need for the audit (From the management) • Planning and preparation • Internal audits performed as per the schedule

  45. Management Review • Management review meeting (at least annually) • Management issues the internal audit schedule • After audits Management analyses results of the audit

  46. Preparation for an Individual Audit

  47. 2. Establish audit scope 3. Possible ways: • Audit of entire organization at one time • Audit y department, area or product • Audit by process in the quality system

  48. 4. Establish audit basis • Usually a combination of the quality system standard and the system documentation (manual, plans, procedures, work instructions, standard specification, etc)

  49. 1. Establish audit type and purpose Especially if the audits are: • Unscheduled • Occasioned by a problem in the system

  50. 3. Establish audit personnel • Usually appointed by MR • Must be independent of area being audited • Must have sound understanding of area to be audited • Usually from pool of trained auditors • Team leaders should be identified

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