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Based on eight quality management principlesLeadershipProcess approachInvolvement of peopleSystem approach to ManagementContinual improvementFactual approach to decision makingMutual beneficial supplier relationship Customer focus

Principle 1

Principle 2 Leaders must set the direction of the organization

Leaders must create and maintain internal environment that encourages people to achieve the organizations objectives

Principle 3 Must help people to develop and use their abilities

Must encourage the involvement of people at all level

Principle 4Activities+ResourcesInputOutput A desired result is more efficiently achieved when resources and activities are managed as a processControl

Process AProcess BProcess DInputOutputControlProcess CProcesses understand interaction

ProcessAny activity that takes inputs and converts them to outputsThe systematic identification and management of these activities and the interaction between activities.

Example - Purchasing Process

Performance MeasurementsDelivery status On-time, On spec, etcSupplier evaluation OutputsReceipt of Material on right conditionRight Quality Right QuantityRight Time

Principle 5Identifying , understanding and managing a system of interrelated process for a given objective improves the organization effectiveness and efficiency

Demings wheel (P.D.C.A.)ISO9000PLANDO

ACTCHECK

ContinualImprovementCustomer FocusContinual improvement of the organization's overall performance should be a permanent objective of the organization. Principle 6

The Plan-Do-Check-Act Cycle(Demings Cycle)

Principle 7Effective decisions are based on the analysis of data and information

Principle 8An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value

Continual improvement of theQuality Management SystemCUSTOMERSManagementResponsibilityMeasurement,Analysis andImprovementResourceManagementRequirementsSatisfactionCUSTOMERS

The Structure0 Introduction1 Scope2 Normative reference3 Terms and definitions4Quality management system requirements5Management responsibility6Resource management7Product realization8Measurement, analysis and improvement

System Requirements / Structure of the Standard4 Quality Management System

4.1 General requirements

Establish , document , implement and maintain a QMS and continually improve its effectiveness in accordance with the standard

4.1 General RequirementsDetermine the processes necessary for QMS

Determine the sequence and interaction of processes

Determine criteria & methods to ensure effective operation & control of the processes

Ensure availability of resources and information needed to support the operation & monitoring of the processes

Measure , monitor and analyze processes

Implement action necessary to achieve planned results & continual improvement

4.2 Documentation RequirementsExtent Size and type of organizationComplexity and interaction of processesCompetence of personnel

Note3 (Documentation may be in any type of media)To IncludeDocumented procedures required by standardDocuments required by organization to ensure effective operation and control process

Note 1 (Where the term documented procedure appears)General

4.2.2 Quality ManualThe organization shall establish a Quality Manual that include:Scope of QMSDocumented procedures or reference to themDescription of interaction between the process of QMS4.2 Documentation Requirements

4.2 Documentation Requirements4.2.3 Control of DocumentsDocumented procedures to:Approve documents prior to issueReview , update as necessary and re-approve documentsTo identify the changes and the current revision status of documentsTo ensure documents remain legible , readily identifiableEnsure relevant versions of applicable documents are available at points of useEnsure that the documents of external origin are identified and distribution controlledObsolete documents are prevented from unintended use and identified if kept for any reasonDocuments required by the quality management system shall be controlled

4.2 Documentation Requirements4.2.4 Control of RecordsRecords must be established and maintainedRecords must be legible , readily identifiable and retrievableDocumented procedure for control of identification , storage , retrieval ,retention time and disposition of quality records

5.1Management Commitment

5.2Customer Focus

5.3Quality policy

5.4Planning5.4.1Quality objectives5.4.2 Quality Planning

5.5Responsibility, authority and communication 5.5.1 Responsibility & authority5.5.2 Management representative 5.5.3 Internal communication 5.6 Management Review5.6.1 General5.6.2 Review input5.6.3 Review output

5.1 Management CommitmentProvide evidence of commitment to the development and improvement of QMS by:

Communicating the importance of meeting customer and legal/regulatory requirements.Establishing quality policy and objectives.Management ReviewsProvision of resources.

5.2 Customer FocusTop Management shall ensure that customer needs & expectations are determined, converted into requirements & fulfilled with the aim of achieving customer satisfaction

5.3 Quality PolicyAppropriate to the purpose of organization.Commitment to meeting requirements and continual improvementsFrame work for establishing and reviewing quality objectivesCommunicated and understood at appropriate levelsIs reviewed for continuing suitability

Establish quality objectives at relevant functions and levelsObjectives must be measurable and consistent with the quality policy including the commitment to continual improvementInclude those needed to meet requirements for product5.4 Planning5.4.1 Quality Objectives (Cont)

5.4 Planning5.4.1 Quality Objectives (Cont)Quality Objectives should be:SetMeasurableAchievableRealisticTimed

5.4.2 Quality Management System PlanningIdentify and plan processes needed to achieve quality objectives

Plan the development of QMSPlan the implementation of QMSPlan the improvement of QMS

5.5 Responsibility, Authority and Communication5.5.1 Responsibility and authority

Functions and their interaction, responsibilities and authorities shall be defined and communicated to facilitate effective quality management

5.5.2 Management RepresentativeMember of the management who has responsibility and authority for ensuring that processes of the QMS are established and maintainedReporting on performance of QMS including needs for improvementPromoting awareness of customer needs and requirementsNote: Responsibilities may include liaison with external parties in relation to QMS

5.5.3 Internal CommunicationEnsure communication between various levels and functions regarding the processes of the QMS and their effectiveness

5.6 Management Review5.6.1 GeneralReview of QMS by top management at planned interval to;ensure QMS suitability, adequacy and effectivenessEvaluate the need for changes to QMS including policy and objectives

Records from Management Reviews shall be maintained (see 4.2.4).

5.6.2 Review InputReview performance and improvement opportunities related to:Audit resultsCustomer feedbackProcess performance and product conformanceStatus of preventive and corrective actionsFollow up actions from earlier reviewsChange that could affect the QMSRecommendations for improvement

5.6.3 Review OutputOutput to include actions related to improvement of the effectiveness QMS and its processesimprovement of product related to customer requirementsresource needs

6.1Provision of resources6.2Human resources6.2.1General6.2.2Competence, awareness and training6.3 Infrastructure6.4Work environment

6.1 Provision of ResourcesThe organization shall determine and determine the resources needed for :implement and maintain the QMS and continually improve its effectiveness.Enhance customer satisfaction by meeting customer requirements.

6.2 Human Resources6.2.1 GeneralThose who have responsibilities defined in the QMS must be competent on the basis of appropriate education, training, skills and experience

6.2.2 Competency, Awareness and TrainingIdentify competency needsProvide required trainingEvaluate the effectiveness of training providedEnsure staff is aware of relevance and importance of their activities and contribution to achieving quality objectivesMaintain appropriate records of education, training, qualification and experience

6.3 InfrastructureIdentify, provide and maintain the infrastructure needed to achieve product conformity This shall include :Workspace & associated utilitiesEquipment, hardware and softwareSupporting services (transport or communication)

6.4 Work EnvironmentThe organization shall determine and manage the work environment needed to achieve conformity to product requirements.

7.1Planning of product realization7.2 Customer related processes7.3 Design & development7.4 Purchasing7.5 Production & service operation7.6 Control of measuring & monitoring devices7 Product Realization

7.1Planning of Product RealizationSequence of process to achieve productConsistent with QMS and documented to suit method of operationsQuality objectives and requirements for the productThe need for processes, documentation, resources and facilities specific to the productVerification and validation activities and acceptance criteriaRecords

7.2Customer Related Processes7.2.1Determination of requirements related to the product7.2.2Review of product requirements7.2.3Customer communication

7.2.1 Determination of requirements related to the productProduct requirements specified by the customer including requirements for delivery and post-delivery activitiesRequirements not specified but necessary for intended or specified useObligations related to product, including regulatory and legal requirements any additional requirements determined by the organization

7.2.2Review of requirements related to the product Review identified requirements and ensure before commitment to supply product that;Product requirements are definedFor verbal orders requirements are confirmedDifference between tender and contract are resolvedOrganization has ability to meet the requirements

Records of the results arising from the review shall be recorded.

7.2.3 Customer CommunicationIdentify and implement arrangements for communication with customers relating to:product informationinquiry, contract or order handling, including amendmentsCustomer feedback including complaints

7.3 Design & Development7.3.1 Design & development planning7.3.2 Design & development inputs7.3.3 Design & development outputs7.3.4 Design & development review7.3.5 Design & development verification7.3.6 Design & development validation7.3.7 Control of design and development changes

7.4 Purchasing7.4.1Purchasing process

7.4.2Purchasing information

7.4.3Verification of purchased product

7.4.1 Purchasing ProcessPurchased product meets requirementsType & extend of control depends on effect purchased product may have on realization processes and their outputSelects suppliers based on their ability to supply conforming productDefine criteria for selection and periodic evaluation and re-evaluation of suppliersResults of evaluation and follow up actions must be recorded

7.4.2 Purchasing InformationPurchasing information shall describe the product to be purchased, including where appropriate:

Requirements for approval of product,procedures, processes and equipment.

Requirements for qualification of personnel.

Quality management system requirements.

7.4.3 Verification of Purchased ProductIdentify and implement activities needed to verify purchased productWhere organization or its customer purpose verification at supplier premises, organization must specify in purchasing information:verification arrangementsmethod of product release.

7.5Production & Service Provision7.5.1Control of production and service provision7.5.2Validation of processes for production and service provision7.5.3Identification and traceability7.5.4Customer Property7.5.5Preservation of Product

7.5.1 Control of production and service provisionControl production & services operations through:Availability of information specifying product characteristicsWork instructions available where necessaryUse and maintenance of suitable equipmentAvailability & use measuring and monitoring devicesImplementation of monitoring activitiesImplementation of defined processes for release, delivery and post delivery activities

7.5.2 Validation of Processes Validation arrangements must be defined and must include as applicablequalification of the processqualification of equipment and personneluse of defined methodologies & procedurerequirements for recordre-valuation

7.5.3 Identification & TraceabilityWhere appropriate identify product through all stages of operationsIdentify status with respect to measurement & monitoring requirementsWhere traceability is required control & record unique identification of productI can not remember

7.5.4 Customer PropertyCare for customers property being under organizations control or being used by organizationIdentification, verification, protection & maintenance of customer property provided for use or incorporationAny customer property that is lost, damaged or found un- suitable must be recorded & reported to customerCustomer Property - tangible / intangible

7.5.5 Preservation of ProductPreserve conformity of product during internal processing and final delivery to intended destinationInclude identification, handling, packaging, storage and protectionThis applies to constituent parts of product

7.6Control of monitoring & measuring devicesCalibrate & adjust measuring and monitoring devices at specified intervals as prior to useTraceability to international or national standards. Where no such standard exist record the basisSafeguard MMD from adjustments invalidating calibrationProtect MMD from damage or deterioration during handling, maintenance or storageRecord results of calibrationAssess validity of previous results when devices found to be out of calibration

8Measurement, Analysis and Improvement8.1General8.2Monitoring & Measurement8.2.1 Customer satisfaction8.2.2 Internal audit8.2.3 Monitoring and measurement of processes8.2.4 Monitoring and measurement of product8.3 Control of non-conforming product8.4 Analysis of data8.5 Improvement8.5.1 Continual improvement8.5.2 Corrective action8.5.3 Preventive action

8.1 General

Define, plan & implement measurement and monitoring activities needed to assure conformance and achieve improvement

This include determination of the need and use of applicable methodologies and statistical techniques

8.2 Monitoring and Measurement8.2.1 Customer SatisfactionOrganization shall monitor information on customer satisfaction and /or dis-satisfaction

The methodologies for obtaining and utilizing such information must be determined

8.2.2 Internal AuditConduct periodic internal audit to determine if QMS:Conforms to the requirements of the standardHas been effectively implemented & maintained Plan the audit program considering:Status and importance of the activityresults of previous auditsDefine audit scope, frequency and methodologies performed by personnel not performing audited work

The documented procedure must cover:Responsibilities & authorities for conducting audits Ensuring independenceRecording results and reporting to managementTimely corrective actionsFollow up to verify & report implementation of verification results8.2.2 Internal Audit

8.2.3 Measurement and Monitoring of ProcessesApply suitable methods for measurement and monitoring of those realization processes necessary to meet customers requirements.

Measure & monitor product characteristics to verify conformance at appropriate stages of realization processesEvidence of conformity with the acceptance criteria must be documented, records must indicate the authority responsible for release of productRelease or delivery must not proceed until all the specified activities have been completed unless otherwise approved by the customer8.2.3 Measurement and Monitoring of ProductVERIFIED 19/5/01PASSEDHOLD

8.3Control of Non conforming ProductDocumented procedures for control of non conforming product to prevent unintended use or deliveryNon conforming product shall be correctedRe-verify after correctionIf non-conformance detected after delivery take appropriate actionIt is often required that the proposed rectification be reported for concession to the customer, the end user, regulatory or other body

8.4 Analysis of DataCollect & analyze data, determine suitability and effectiveness of QMS and to identify improvements that can be madeData from measurement & monitoring & other related sourcesAnalyze data provide info on:Customer satisfaction and/or dissatisfactionConformance to customer requirementProcess, product characteristics and their trendsSuppliers

8.5 Improvement8.5.1 Continual improvementPlanning for Continual ImprovementThe organization must plan and manage processes necessary for continual improvement of the QMSFacilitate continual improvement using:quality policyobjectivesaudit resultsanalysis of datacorrective actionspreventive actionsManagement Review

8.5.2 Corrective ActionOrganization must take corrective action to eliminate the causes of non-conformance to prevent recurrenceAction appropriate to the impact of problemDocumented procedures shall define requirements for:identifying non conformitiesdetermine the causesevaluating the need for corrective actiondetermine corrective action needed and implementedRecording results of action

Organization must identify preventive action to eliminate the causes of potential non conformances to prevent occurrencesActions appropriate to the impact of potential problemDocumented procedures must define the requirements forIdentification of potential non-conformances and their causesDetermining and ensuring implementation of preventive action neededRecording results of action taken8.5.3 Preventive Action

Situation Warranting Corrective Action Identification of major non-conformance.Large number of minor non-conformities.The reoccurrence of a problem with a process or activity.Non-conformities observed during audits.Customer Complaints.Non-conforming deliveries from vendors.

Stages of Corrective & Preventive ActionREPORTING INVESTIGATION ACTIONFOLLOWUPCLOSING

EXPECTED BENEFITS

Transparency in working at all level Data availability : Hidden Factors are openCreates AccountabilityPlanning & scheduling improved Rework & Rejection are known and being controlled Customer feedback through regular surveys Employees Participation enhanced Continuos Improvements Program launchedMarket Reputation

Thank You !

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