Quality Management

System

Quality ManagementQuality Management System System

QMS RequirementsQMS Requirements QMS Integration / QMS Integration /

DevelopmentDevelopment QMS ProcessingQMS Processing QMS SummaryQMS Summary

QMSRequirement

s

QMS Requirements Ability to Create, Modify, and Store Inspection Plans

(Specifications, Samples, Tests) within BPCS

Ability to keep past versions of Inspection Tests and Descriptions

Ability to assign Inspection Specifications to each item / manufacturer

Ability to inspect and record results for both Lot controlled items and non-Lot controlled items (sequence)

Ability to Snap-Shot the Specification (Samples, Tests) for each item / lot or item / sequence

QMS Requirements

Ability to perform inspections and record results as product is being assembled

Ability to enter Notes for each Test during results recording and ability to append to those notes while protecting previous notes

Ability to create ad-hoc Tests during inspection

Ability for extensive Reporting

Ability to handle Non-Conformance Reporting

QMSIntegration / Development

QMS IntegrationQMS Integration

(QMS)Quality

Management

(INV)InventoryControl

(API)AdvancedProcess

(PUR)Purchasing

(SFC)Shop Floor

Control

Development FlowDevelopment Flow

(QMS135)Sampling

Rules

(QMS120)SampleMaster

(QMS125)Test

Master

(QMS115)Specification

Approval

(QMS100)Manufacturer

Master

(QMS105)Manf / Item

Master

Specification Development

Specification Attachment

(QMS165)Item

Master

(QMS115)Specification

Master

QMSProcessing

ManufacturerItem

Master

Spec

SampleMaster

TestMaster

TestDesc

Lot/Sequence Level

SampleRequire

ResultEntry

Lot/SeqTest

Lot/Seq Test

Notes

Lot/Seq TestDesc

EnterResults

Lot/Sequence Disposition

QMS Detail ProcessingQMS Detail Processing

QMSTriggered

Event

Purchase OrderReceipt

Test (Pass / Fail)

Test & Samples@ Lot/Sequence

Level

Trigger QualitySpecification

Test & Samples@ Lot/Sequence

Level

(QMS545)Result Entry

Lot/Sequence StatusUpdated

Test (Pass / Fail)

Shop Order Release

(QMS550)Lot/Sequence

Disposition

Lot/Sequence Processing

Lot/Sequence Disposition

Triggered Activity

QMS Processing

Incoming InspectionIncoming Inspection

QMS Triggered by PO Receipt (PUR550)QMS Triggered by PO Receipt (PUR550) Item Lot/Sequence Inspection Created at Item Lot/Sequence Inspection Created at

ReceiptReceipt Item Lot/Sequence Status “Q”Item Lot/Sequence Status “Q”

Specification Plan LaunchedSpecification Plan Launched Based on Manufacturer (Vendor) / ItemBased on Manufacturer (Vendor) / Item

Inspection and Results recordingInspection and Results recording Disposition (Accept = Status “A” Disposition (Accept = Status “A”

Reject = Status “R”)Reject = Status “R”)

In-Process InspectionIn-Process Inspection

QMS Triggered by Shop Order ReleaseQMS Triggered by Shop Order Release Item Lot/Sequence Inspection Created at Item Lot/Sequence Inspection Created at

ReleaseRelease Item Lot/Sequence Status “Q”Item Lot/Sequence Status “Q”

Specification Plan LaunchedSpecification Plan Launched Based on Manufacturer / ItemBased on Manufacturer / Item

Inspection and Results recordingInspection and Results recording Disposition (Accept = Status “A” Disposition (Accept = Status “A”

Reject = Status “R”)Reject = Status “R”)

QMSSummary

Advantages of using QMSAdvantages of using QMS

Improved inventory controlImproved inventory control Central control of sample and test recordsCentral control of sample and test records Central control over quality documentationCentral control over quality documentation On line visibility of data and documentsOn line visibility of data and documents Central Reporting and TraceabilityCentral Reporting and Traceability All within the BPCS SystemAll within the BPCS System