Chapter 5Quality Systems and Quality Systems Auditing

Dr. Ayham Jaaron

Objectiveslist and discuss the elements of a quality management systemunderstand the basic elements of the major quality management systemsunderstand the basics of the ISO 9001 standardunderstand the basics of the MBNQA processlist and discuss the objectives of quality auditslist and discuss the types of quality auditsdiscuss the quality system audit processdiscuss the scope and objectives of quality information systemsdiscuss the importance of ensuring data accuracy and integritydiscuss quality documentation systemsunderstand the basics of a quality information system, document control, and information flows

Quality Systems & Quality Systems AuditingA system is any set of interdependent parts that perform a function or set of functions.Quality Management Systems include:PlansActivitiesEvents

Quality Systems & Quality Systems AuditingQuality AuditsAre a part of the evaluation and assessment processShould be systematic and independent to identify the activities and resultsAre a form of performance auditNeed the desired state documented

Quality Management SystemsElements of a Quality Management SystemPlanningPerformanceMeasurementImprovement

Quality SystemsA quality system is the collective plans, activities and eventsthat are provided to ensure that a product, process, or servicewill satisfy given needs.The best evidence for theexistence of a quality systemis the quality manual.

Quality ManualThe quality manual providesevidence that:a process has beendefinedthe procedures areapprovedthe procedures areunder control

Quality ManualThe quality manual providesNO evidence that:the system hasbeen implementedImplementation is verified throughquality audit

Formal Guidelines (Approaches) to Quality ControlISO 9001ISO/TS 16949MBNQAQS-9000

ISO 9001ISO 9000is a series of standards, developed and published by theInternational Organization for Standardization(ISO), that define, establish, and maintain an effective quality assurance system for manufacturing and service industries

ISO/TS 16949Aims to the development of aquality management systemthat provides for continual improvement, emphasizingdefectprevention and the reduction of variation and waste in thesupply chain. It is based on theISO 9001and the first edition was published in March 2002 as ISO/TS 16949:2002.

QS-9000QS9000is a qualitystandarddeveloped by a joint effort of the "Big Three"automakers,General Motors,ChryslerandFord. It was introduced to the industry in 1994. It has been adopted by several heavytruckmanufacturers in theU.S.as well. Essentially all suppliers to the domestic automakers need to implement a QS9000 system.

Quality Management SystemEach approach has the goal of providing a framework through which a quality control program can be:IdentifiedDesignedDevelopedImplementedEnhanced

Quality Management Systems

ISO 9000

ISO 9000 FamilyThere are many standards in the ISO 9000 family, including:ISO 9000:2005 - covers the basic concepts and language of how to build a quality system.ISO 9001:2008 - sets out the requirements of a quality management systemISO 9002: same as 9001 but it does not cover product realization requirements (now obsolete).ISO 9004:2009 - focuses on how to make a quality management system for long term success. Not meant for certification rather how to build strategy of quality.ISO 19011:2011 - sets out guidance on internal and external audits of quality management systems.

Popular StandardsISO 14000Environmental managementISO 3166Country codesISO 26000Social responsibilityISO 50001Energy managementISO 31000Risk managementISO 22000Food safety managementISO 27001Information security managementISO 20121Sustainable events

Quality Management SystemsEight Management Principles that are the basis for ISO 9000 standards:Customer focusLeadershipInvolvement of peopleProcess approachSystems approach to managementContinual improvementFactual approach to decision makingMutually beneficial supplier relationships

ISO 9000 Process approach

Quality Management SystemsEight Steps for ISO 9000Determine the needs and expectations of customers and other constituents

Establish quality policy and quality objectives for the organization

Determine the processes and responsibilities necessary to attain the quality objectives

Determination and provision of the resources necessary to attain the quality objectivesISO Audit Checklist

Quality Management SystemsEight Steps for ISO 9000 continuedEstablish measures for the effectiveness and efficiency of each process

Application of these measures to determine the effectiveness and efficiency of each process

Determination of means of preventing nonconformities and eliminating their causes

Establishment and application of a process for continual improvement of the quality management system

Quality Management SystemsSelf-Assessment and Improvement Path for ISO 9000

Comprehensive self-assessment to review actual processes and result of the quality policies and objectives

Identification of areas for improvement based on the results of the internal audit

Quality Management SystemsSelf-Assessment and Improvement Path for ISO 9000

Establishment of objectives for the improvement efforts

Development of improvement plans

Implementation of the improvement plan

Re-audit to assure the improvement plans achieved the desired resultsSelf-Assessment tool

Quality Management SystemsQS-9000QS-9000-specialized standard for U.S. Automotive suppliers.

ISO/TS 16949:2000(E)An international quality management system specification for the supply chain.

Quality Management SystemsMalcolm Baldrige National Quality Award (MBNQA)

Created in 1987

Highest recognition a U.S. organization can receive

Quality Management SystemsMBNQA continuedSix categoriesManufacturingServiceSmall businessEducationHealth careNonprofit

Quality Management SystemsSeven Categories of Criteria for MBNQA

Category NumberBusinessEducationHealth Care1LeadershipLeadershipLeadership2Strategic PlanningStrategic PlanningStrategic Planning3Customer and Market FocusStudent, Stakeholder, and Market FocusFocus on Patients, other Customers, and Markets4Measurement, Analysis, and Knowledge ManagementMeasurement, Analysis, and Knowledge ManagementMeasurement, Analysis, and Knowledge Management5Human Resource FocusFaculty and Staff FocusStaff Focus6Process ManagementProcess ManagementProcess Management7Business ResultsOrganizational Performance ResultsOrganizational Performance Results

Quality AuditingA quality audit compares what is available to what is supposed to be.Therefore a quality audit cannot be performed unless whatis supposed to be is properly documented. It is impossibleto determine the degree of compliance with an undefinedstate. For a quality system audit, the quality manual isthe definition of what is supposed to be.Quality Audit can be internal or external

Specific Types of Quality AuditsTunners Generic Types (1990)Policy Auditcompares written policies and procedureswith standards and specificationsPractice Auditcompares actual practices with establishedprocedures.Product Auditcompares performance of a product withits specifications.Policy

Specific Types of Quality Audits..cont.Four Dimensions of Audits (Mills, 1989)

The purpose of the audit-why?The object of the audit-what?The nature of the audit-who? int. vs. ext.The method of the audit-how? On site/report

Audit TypesArters ClassificationFirst-Party AuditSecond-Party AuditThird-Party AuditQuality auditor in your organizationaudits your quality system.Quality auditor in your organizationaudits your suppliers quality system.MBNQA audit team audits yourorganizations quality system.

Performing a Quality Audit (ANSI/ASQC Q1-1986)The above systems list the responsibilities of:

Audit Client Responsibilities: the organization who request the audit (such as government, ISO, MBNQA organisation).Auditee Responsibilities

Auditor Responsibilities

Class taskDiscuss with your group members the expected responsibilities for: the Audit client, Auditee, Auditor?

Audit Client ResponsibilitiesInitiate auditDefine reference standardsReceive audit reportAbstain from any undue interference with audit activitiesDetermine follow up activities

Auditee ResponsibilitiesAppoint someone to accompany auditorProvide access to facilities and evidential materialsProvide adequate working facilitiesCooperate with the auditorsAttend meetingsReview findingsTake corrective actionAbstain from any undue interference with the audit

Auditor ResponsibilitiesComply with applicable audit standardsClarify and articulate the audit objectivesEffectively and efficiently plan and implement the auditReport the audit resultsAudit results of corrective actionsRetain and safeguard audit working papersMaintain independence from organization being audited

Quality Information SystemsInformation Systems are designed to:Collect

Process

StoreAnd Transmit data & information

Quality Information SystemsQuality Information Systems (QIS) can be:Entirely electronicEntirely manualA combination of electronic and manual

Quality Information Systems3 key components

Data

Data Flows

Processing Logic

Problem Identification, Analysis, Reporting, & Corrective Action SystemInformationFlows

Quality Information SystemData Accuracy and SecurityCheck and verify on a regular basis

Improve accuracy by using automatic data entry approaches such as:BarcodesRFIDAutomated measurement systems

Quality Information System (QIS)An information system designed to meet the needs of thequality system. Data accuracy and integrity are musts.INOUTQIS

SummaryExamined:

Quality SystemsQuality Management SystemsQuality AuditsQuality Information Systems

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