Lead Auditor / Auditor Course For Quality Management .

INSTITUTE OF QUALITYLead Auditor / Auditor CourseFor Quality Management SystemsISO 9001:2008Apr 2010INTRODUCTIONApr 201021

INTRODUCTION OF PARTICIPANTS¾ Participants are requested to find a partner each.¾ You are expected to find out professional information aboutyour partner in 2 minutes. Also enquire his / her keyexpected learning from the programme.¾ Please record your findings. Write down your name and thedetails collected from your partner¾ Each participant would in turn introduce his partner to thegroup and his key expected learning.¾ Hand over your recorded findings to the tutors.Duration : 30 Minutes3Apr 2010COURSE FORMAT¾ FOR A DURATION OF FIVE DAYS¾ COVERS THE REQUIREMENTS OF IRCA / NABET¾ ENABLES SUCCESSFUL CANDIDATES TO REGISTER¾ INCLUDES CLASSROOM SESSIONS, SYNDICATEWORKSHOPS, ROLE PLAY EXERCISES¾ EXTENSIVE EXAMPLES AND CASE STUDIES BASED ONINDUSTRY SITUATIONSApr 201042

COURSE LEARNING OBJECTIVES PURPOSE OF QUALITY MANAGEMENT SYSTEM & 8 QUALITY MANAGEMENTPRINCIPLES STANDARDS – ISO 9000, ISO 9001, ISO 9004, ISO 19011 & THEIRINTERRELATIONSHIPS. INTERPRETATION OF ISO 9001 IN CONTEXT TO THE AUDIT ROLES AND RESPONSIBILITIES OF AUDITORS AND LEAD AUDITORS. PLAN AND CONDUCT AN AUDIT, GATHER OBJECTIVE EVIDENCE VIA VARIOUSMETHODS AND DETERMINE CONFORMITY TO THE REQUIREMENTS AUDIT REPORT WRITING AUDIT FOLLOW UP – EVALUATING THE EFFECTIVENESS OF CORRECTIVEACTION IMPLEMENTATION CERTIFICATION AND ACCREDITATION PROCESSES AUDITOR CERTIFICATION AND ROLE OF IRCA / NABET5Apr 2010COURSE PROGRAMME¾ BLEND OF LECTURES, INTERACTIVE WORKSHOPS ANDPRESENTATIONS¾ ROLE PLAY ON OPENING AND CLOSING MEETINGS¾ INCLUDES PRE-COURSE MATERIAL ANDCOURSE MATERIAL¾ CONTINUOUS ASSESSMENT OF PARTICIPANTS¾ COURSE EXAMINATIONApr 201063

DELEGATE RESPONSIBILITIES¾ COURSE IS INTENSIVE, HENCE FULL ATTENTION ANDDILIGENCE IS REQUIRED¾ TIME SCHEDULES ARE IMPORTANT¾ BE ALERT, INTERACTIVE AND CO-OPERATIVE¾ TAKING NOTES¾ USE OF MOBILE PHONES PROHIBITED¾ DELEGATES APPEAL AND COMPLAINT7Apr 2010EVALUATION PROCESS & CRITERIA CONTINUOUS ASSESSMENT SKILL BASED PRACTICAL WORK¾ TUTOR MARKED¾ PRESENTATION / ROLE PLAY¾ QUIZZES DAILY ASSESSMENT– CONTRIBUTION, QUESTIONING, COMMUNICATION,REPORTING, PARTICIPATION IN TEAM– PERSONAL ATTRIBUTES: ATTITUDE,MANNER,SUITABILITY AS AUDITOR– ATTENDANCE, PUNCTUALITY AND PARTICIPATION¾ RESITTING THE EXAMINATION OR THE COURSE WRITTEN EXAMINATIONApr 201084

ISSUE OF CERTIFICATES¾ SUCCESSSFUL COMPLETION CERTIFICATE WHEN THE DELEGATE HAS PASSSED BOTH THEWRITTEN EXAMINATION AND CONTINUOUSASSESSMENT¾ ATTENDANCE CERTIFICATE WHEN THE DELEGATE HAS NOT PASSSED THE WRITTENEXAMINATION BUT SATISFIES THE CONTINUOUSASSESSMENT AND ATTENDANCE REQUIREMENT¾ LETTER OF ATTENDANCE WHEN THE DELEGATE IS NOT MEETING ANY OF THEABOVE BUT SATISFIES ATTENDANCE REQUIREMENTONLY9Apr 2010SECTION – 1Introduction to QMSApr 2010105

Learning ObjectivesBy the end of the session successful students willbe able to : Explain the purpose and business benefits of a qualitymanagement system. Explain the 8 principles of quality management. Explain the process approach to management systems.11Apr 2010CertificationandrecognitionStreamliningthe systemsPurpose ofQMSImprovementinperformanceApr 2010Benefitsto stakeholdersEnhancedmarketstanding126

BENEFITS OF QUALITY MANAGEMENT¾ CUSTOMER CONFIDENCE¾ CONSISTENCY IN QUALITY¾ REDUCTION IN WASTE AND REWORK¾ EMPLOYEE PARTICIPATION¾ REDUCTION IN LIABILITIES¾ IMPROVEMENT IN PROFIT¾ CONTINUAL IMPROVEMENT13Apr 2010Activity on understanding QMPsGroup exercise :Relate the following QMPS withorganizations with the attribute most identifiable to themProcess ApproachFactual decisionmakingCustomer FocusContinual improvementSystems ApproachSupplier relationshipInvolvement of peopleLeadershipDuration 15 min.Apr 2010147

PRINCIPLES OF QUALITYMANAGEMENT¾ TO LEAD AND OPERATE AN ORGANIZATIONSUCCESSFULLY, IT IS NECESSARY TO DIRECT ANDCONTROL IT IN A SYSTEMATIC ANDTRANSPARENT MANNER¾ MANAGING AN ORGANIZATION ENCOMPASSESQUALITY MANAGEMENT AMONGST OTHERMANAGEMENT DISCIPLINES¾ EIGHT QUALITY MANAGEMENT PRINCIPLES HAVE BEENIDENTIFIED AND THEY FORM THE BASIS OF ISO 9001 :2008 STANDARD15Apr 2010PRINCIPLES OF QUALITYMANAGEMENT QUALITY MANAGEMENTPRINCIPLE 1QUALITY MANAGEMENTPRINCIPLE 2 “CUSTOMER FOCUSEDORGANIZATION”“LEADERSHIP” ORGANIZATIONS DEPEND ON THEIRCUSTOMERS AND THEREFORESHOULD UNDERSTAND CURRENTAND FUTURE CUSTOMER NEEDS,MEET CUSTOMER REQUIREMENTSAND STRIVE TO EXCEED CUSTOMEREXPECTATIONS.Apr 2010LEADERS ESTABLISH UNITY OF PURPOSEAND DIRECTION OF THE ORGANIZATION.THEY CREATE THE INTERNAL ENVIRONMENTIN WHICH PEOPLE CAN BECOME FULLYINVOLVED IN ACHIEVING THEORGANIZATION’S OBJECTIVE168

PRINCIPLES OF QUALITYMANAGEMENT QUALITY MANAGEMENTPRINCIPLE 3QUALITY MANAGEMENTPRINCIPLE 4 “INVOLVEMENT OF PEOPLE”“PROCESS APPROACH” A DESIRED RESULT IS ACHIEVED MOREEFFICIENTLY WHEN RELATEDRESOURCES AND ACTIVITIES AREMANAGED AS A PROCESSPEOPLE OF ALL LEVELS ARE THEESSENCE OF AN ORGANIZATIONAND THEIR FULL INVOLVEMENTENABLES THEIR ABILITIES TO BEUSED FOR THE ORGANISATION’SBENEFIT17Apr 2010PRINCIPLES OF QUALITYMANAGEMENT QUALITY MANAGEMENTPRINCIPLE 5QUALITY MANAGEMENTPRINCIPLE 6 “SYSTEM APPROACH TOMANAGEMENT”“CONTINUAL IMPROVEMENT” IDENTIFYING, UNDERSTANDINGAND MANAGING A SYSTEM OFINTERRELATED PROCESSES FORA GIVEN OBJECTIVE IMPROVESTHE EFFECTIVENESS ANDEFFICIENCY OF THEORGANIZATIONCONTINUAL IMPROVEMENT SHOULD BEA PERMANENT OBJECTIVE OF THEORGANIZATIONApr 2010189

PRINCIPLES OF QUALITYMANAGEMENT QUALITY MANAGEMENTPRINCIPLE 7QUALITY MANAGEMENTPRINCIPLE 8 “FACTUAL APPROACH TO“MUTUALLY BENEFICIALSUPPLIER RELATIONSHIP”DECISION MAKING” EFFECTIVE DECISIONS AREBASED ON THE ANALYSIS OFDATA AND INFORMATIONAN ORGANISATION AND ITSSUPPLIERS ARE INTERDEPENDENTAND A MUTUALLY BENEFICIALRELATIONSHIP ENHANCES THEABILITY OF BOTH TO CREATE VALUE19Apr 2010PDCA APPROACH¾ CONCEPT INTRODUCED BY DR.SHEWHART INEARLY 40’S¾ POPULARIZED BY DR. DEMING IN THE 1950’S¾ BECAME KNOWN AS DEMING CYCLE¾ PDCA STANDS FOR PLAN, DO, CHECK AND ACT¾ PDCA CYCLE CAN BE APPLIED AT ALL LEVELS WITHINTHE ORGANIZATIONApr 20102010

PDCA CyclePDCA cycle can be applied at all levels within the organization21Apr 2010Activity on PDCAGroup exercise Apply Plan, Do, Check and Act oncommon activities like Making Tea Organizing a Picnic Home budgeting Reaching Place of workDuration 30 min.Apr 20102211

PROCESSSET OF INTERRELATED OR INTERACTING ACTIVITIES WHICHTRANSFORM INPUTS INTO OUTPUTS (ISO 9000-2008)¾ OUTPUTS FROM ONE PROCESS ARE TYPICALLY INPUTSINTO OTHER PROCESSES,¾ PROCESSES MAY BE INTERRELATED ORINDEPENDENT,¾ OVERALL AIM IS TO ADD VALUE BY PLANNING ANDCONTROLLING PROCESSES23Apr 2010BASIC PROCESS MODELCON TROL / P R OC ED UR ESMA N AG EM ENTDESIREDCU STOM ERINP U TCU STOM ERSATISFA C TIO NPROCESS ACTIVITIESOUTPU TSEN ABLER S(RESU LTS)MO N ITO R ING M EASU REM EN TSApr 20102412

PRODUCT¾ THE RESULT OF A PROCESS (ISO 9000-2008)¾ 4 GENERIC PRODUCT CATEGORIESTANGIBLE PRODUCTS HARDWARE PROCESSED MATERIAL SOFTWARE SERVICE¾ MOST PRODUCTS ARE COMBINATION OF THESE25Apr 2010PROCESSAN ACTIVITY USING RESOURCES, AND MANAGED IN ORDER TOENABLE THE TRANSFORMATION OF INPUTS INTO OUTPUTS,CAN BE CONSIDERED AS A PROCESS. OFTEN, THE OUTPUTFROM ONE PROCESS DIRECTLY FORMS THE INPUT TO THENEXT PROCESSPROCESS APPROACHTHE APPLICATION OF A SYSTEM OF PROCESSES WITHINAN ORGANIZATION, TOGETHER WITH THE IDENTIFICATIONAND INTERACTIONS OF THESE PROCESSES AND THEIRMANAGEMENT, CAN BE REFERRED AS THE PROCESSAPPROACHApr 20102613

DOCUMENTING A PROCESS DOCUMENTING A PROCESS INVOLVES : IDENTIFY THE PROCESS OWNER IDENTIFY INPUTS AND EXPECTED OUTPUTS / RESULTS DEFINE THE CHARACTERISTICS OF INPUTS AND OUTPUTS DEFINE THE BOUNDARIES OF THE PROCESS DETERMINE THE ACTIVITIES AND THE SEQUENCE IDENTIFY RESOURCES AND RESPONSIBILITIES DETERMINE THE CRITERIA AND METHODS TO ENSURE THEOPERATION AND CONTROL ARE EFFECTIVE (SOPs ANDCHECKING POINTS) DETERMINE PROCESS PERFORMANCE MEASURES27Apr 2010QMS PROCESSESQMS TYPICALLY INCLUDES PROCESSES FOR¾MANAGEMENT ACTIVITIES¾PROVISION OF RESOURCES¾PRODUCT REALIZATION¾MEASUREMENTProcesses are not restricted to productionor service delivery activities onlyApr 20102814

PROCUREMENT PROCESS Procure material as perrequired specs and atrequired date Improve quality of incomingmaterial Improve turn over Optimise inventory Cost reduction Timely payment of vendorsActions on vendor relatedquality problem Improvement project with Training needs of dept.vendorPersonnel & vendorsPA Review of pending payments beyondagreed timeReview incoming material go ratew.r.t. goal (item wise)Chronic vendor problemsCost reduction achievement reviewStatus of inventory item wise &reduction of prod. Lead Time. (itemwise)Review of matl. With MaterialRequirement Planning % (MRP)delivery adheranceReview inspection cycle timeincoming (itemwise SRV)DC Vendor selection andevaluationCost reduction projectallotmentProcure products as per drgand tech specs.Periodic process audit andperiodic RatingProcessing of bill/invoiceInventory managementDisposal of receipt rejection29Apr 2010EVALUATING A PROCESS WITHIN THE QMSINCLUDES AUDIT OF : PROCESS INPUTS, OUTPUTS & RESULTS PROCESS MEASURES, LINKAGE WITH QUALITY OBJECTIVES& MEASURES FOR CONTINUAL IMPROVEMENTTHROUGH THE 4 BASIC QUESTIONS IS THE PROCESS IDENTIFIED & APPROPRIATELY DEFINED ? ARE RESPONSIBILITIES ASSIGNED ? ARE THE PROCEDURES IMPLEMENTED & MAINTAINED ? IS THE PROCESS EFFECTIVE IN ACHIEVING THE REQUIREDRESULTS?PROCESSES MAY OR MAY NOT BE DEFINED BYDOCUMENTATIONApr 20103015

Activity on understanding and documentingProcess ApproachTeam exerciseIdentify the inter-linkages of a tutor givenProcess of an organization with the otherrelevant processesPresent on Flip ChartsDuration 30 min.31Apr Apr 20103216

SECTION – 233Apr 2010Learning Objective By the end of the session successful studentswill be able to :¾ Explain the purpose, content & interrelationship of ISO 9000, ISO 9001 & ISO 9004Apr 20103417

Session 2aPurpose, content & inter – relationshipof ISO 9000 family of StandardsApr 201035Activity on identifying the Purpose ofISO 9000 Series of Standards Read section 0.1 of ISO 9000:2005 of Precourse reading material In your syndicate groups discuss and listdown the purpose of ISO 9000 series ofStandards for an organizationDuration 20 min.Apr 20103618

ISO 9000 FamilyISO 9000:2005 – Quality Management Systems - Fundamentals AndVocabularyISO 9001:2008 – Quality Management Systems - RequirementsISO 9004:2009 – Managing for Sustained success of an organization – aquality management approachISO 19011 : 2002 – Guidelines On Quality And / Or Environmental ManagementSystems Auditing37Apr 2010IS O 9 0 0 4ISO 9001 PerspectiveQuality of product and customersatisfaction (effectiveness)I SO 90 0 1ISO 9004 PerspectiveWider focus on quality management than ISO 9001.Addresses the needs and expectations of all relevantInterested parties.Systematic and continual improvement of theorganization's overall performance.Apr 20103819

ISO 9001 & 9004 : Relationship diagramApr 201039OAuditing Standards (Guidelines)Guideline Standards originally published by ISOQuality Management119 01 ISO 10011-1:1990 Guidelines for auditing quality systems -- Part 1: Auditing ISO 10011-2:1991 Guidelines for auditing quality systems -- Part 2: Qualification criteria forquality systems auditors ISO 10011-3:1991 Guidelines for auditing quality systems -- Part 3: Management of auditprogrammesEnvironmental Management deeserOSIydbupsISO 14011:1996Guidelines for environmental auditing -- Audit procedures -- Auditing ofowmanagementenvironmentalsystemsNISO 14012:1996 Guidelines for environmental auditing -- Qualification criteria forISO 14010:1996 Guidelines for environmental auditing -- General principlesenvironmental auditorsApr 20104020