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Top Management and Quality System Management Representative Business Unit Director Manufacture Engineer Quality Engineer Operations Manager / Department Managers Human Resources Administrator Information Systems Management Responsibility Resource Management Product Realization Measurement Analysis and Improvement Conduct Management Reviews QP-010 (5.6) Maintain & ImproveQMS QP-010 &QP-030 (4.0; 5.0) Provide Resources QP-010 (6.0) Conduct Internal Quality Audits QP-210 (8.2.2) Analyze Internal Quality Audit Data (8.4) DFC 4.1 QMS Deployment Flowchart - Key Processes Identify & Review Product Requirements QP-020 ( 7.2.1; 7.2.2) Manage Customer Communications QP-021 (7.2.3) Monitor & Measure Customer Satisfaction QP-022 (8.2.1) Develop & Maintain Product Realization Schedules & Plans QP-230 (7.1 & 7.3) Establish & Maintain Product Identification & Traceability QP-020 (7.5.3) Plan & Control Manufacturing QP-230 (7.5.1 & 7.3) Qualify & TrainWork Force QP-220 (6.2.2) Plan & Maintain Information Systems QP-040 &QP-200 (4.2.3; 4.2.4; 6.3) Plan & Maintain Facilities QP-186 (6.3; 6.4) Assure Supplier Quality (7.4.1) Control Customer Property and Preserve Product QP-180 (7.5.3; 7.5.4; 7.5.5) Control Monitoring & Measuring devices QP-130 (7.6) Monitor Manufacturing and Control Processes QP-100 (8.2.3 & 8.2.4) Control Nonconforming Product QP-150 (8.3) Analyze Product Realization and Customer Satisfaction Data (8.4) Analyze Manufacturing Processes & Control Data Facilities and Equipment Data (8.4) Analyze Supplier and Purchased Material Data (8.4) Analyze Competency Data (8.4) Analyze Information Systems Data (8.4) Initiate Corrective and Preventive Actions QP-160 (8.5) Analyze Product Quality Data (8.4) Analyze MFG Process Data (8.4) Monitor Product Quality Data QP-240 ( 8.4) Monitor Manufacturing Processes QP-022 (8.2.1) Plan QC Processes and controlPOR QP-230 (7.1 & 7.3) Plan and Implement MFG Process QP-230 (7.1 & 7.3) Need Process or Process Change? No Yes Yes Assure Purchased Material Quality (7.4.2; 7.4.3)

QMS Deployment Flowchart

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Split of responsibility within various departments

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Page 1: QMS Deployment Flowchart

Top Managementand

Quality System ManagementRepresentative

Business UnitDirector Manufacture Engineer Quality Engineer Operations Manager /

Department ManagersHuman Resources

Administrator Information Systems

ManagementResponsibility

ResourceManagement

ProductRealization

MeasurementAnalysis andImprovement

Conduct ManagementReviews

QP-010 (5.6)

Maintain & ImproveQMSQP-010 &QP-030

(4.0; 5.0)

Provide ResourcesQP-010 (6.0)

Conduct Internal QualityAudits

QP-210 (8.2.2)

Analyze Internal QualityAudit Data

(8.4)

DFC 4.1 QMS Deployment Flowchart - Key Processes

Identify & Review Product RequirementsQP-020 ( 7.2.1; 7.2.2)

Manage CustomerCommunicationsQP-021 (7.2.3)

Monitor & MeasureCustomer Satisfaction

QP-022 (8.2.1)

Develop & MaintainProduct RealizationSchedules & PlansQP-230 (7.1 & 7.3)

Establish & Maintain Product Identification &TraceabilityQP-020 (7.5.3)

Plan & ControlManufacturing

QP-230 (7.5.1 & 7.3)

Qualify & TrainWorkForce

QP-220 (6.2.2)

Plan & MaintainInformation SystemsQP-040 &QP-200(4.2.3; 4.2.4; 6.3)

Plan & Maintain FacilitiesQP-186 (6.3; 6.4)

Assure SupplierQuality(7.4.1)

Control Customer Property and Preserve ProductQP-180 (7.5.3; 7.5.4; 7.5.5)

Control Monitoring &Measuring devices

QP-130 (7.6)

Monitor Manufacturing and Control ProcessesQP-100 (8.2.3 & 8.2.4)

Control Nonconforming ProductQP-150 (8.3)

Analyze ProductRealization and Customer

Satisfaction Data(8.4)

Analyze ManufacturingProcesses & Control Data

Facilities and Equipment Data(8.4)

Analyze Supplier andPurchased Material Data

(8.4)

Analyze CompetencyData(8.4)

Analyze InformationSystems Data

(8.4)

Initiate Corrective and Preventive ActionsQP-160 (8.5)

Analyze Product QualityData(8.4)

Analyze MFG ProcessData(8.4)

Monitor ProductQuality DataQP-240 ( 8.4)

Monitor ManufacturingProcesses

QP-022 (8.2.1)

Plan QC Processesand controlPOR

QP-230 (7.1 & 7.3)

Plan and ImplementMFG Process

QP-230 (7.1 & 7.3)

Need Process orProcess Change?

No

Yes

Yes

Assure PurchasedMaterial Quality

(7.4.2; 7.4.3)