Medical Device Agile Quality Demo

Industry specific cover image

INSERT CUSTOMER LOGO

Quality Demo – screenshots – medical equipment

Todd Hein – Sr. Director, Medical Devices - Life Sciences IBU

Copyright ©2008, Oracle. All rights reserved. Oracle & [customer] Confidential 2

FDA Requirements in one common datatbase:

AgileMD Enterprise Quality Management (EQM)Differentiation – Leveraging PLM functionality across the enterprise

Design Controls

MaterialControls Records,

Documents, &Change Controls

Equipment & Facility Controls

Production & Process Controls

Corrective &Preventive

Actions

Management

FDA Quality System Audit

“Support Claims with Evidence”

Integrated Quality Event Management

The only true close loop system linking quality events to all enterprise records

Global Product, Document, & Change Management

All QMS/DHF/DMR/Submission records in one enterprise solution

1

2

Synchronized Project & Portfolio Management

All regulated projects linked with global document & quality system

3

Enterprise Quality Analytics & dashboards

Comprehensive DW schema to support Enterprise Quality Management Reviews

4

Open Standards based IT architecture

Support integration across the enterprise IT platform

5


ERP

Agile CAPA Management

Customer Complaints

Create CAPA

Analyze Root Cause

Inventory Levels

Customers

Quality Analyst

Support

Close & Notify

Create CCs

Analyze SR Trends

Analyze Cycle Time

Prompt Actions/Alerts

Quality Analytics

Publish Product SRs

Engineering Change Analyst Manufacturing Staff

Containment Action

Change ManagementImplement Change

Notify Customer

Cross System CAPA process / data flow

Stop Ship

Ship to Locations

Replicate CCs

NCR’s Supplier IssuesAudits CAPA 8D

SOP’s DCO’s

Documents

Product

ECO’s


1.0 Custom er Com plaint 2.0 Internal NCMR 3.0 Supplier Issue 5.0 Internal Audit

M D R

D H F D M R Q /A -R /A D o cs

ERP/BI Interface6.0

4.0 8-D CAPA

Q u a lity E ve n tS o u rce

Agile Quality Demo ScenarioDemo scenarios numbered



M D R


ERP/BI Interface6.0

4.0 8-D CAPA



Agile “Compliant Dataset”


7.0 Comprehensive Reports8.0 Enterprise Audit Mgmt


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ERP/BI Interface6.0

4.0 8-D CAPA




Demo Script – General Navigation

• Script Overview– CFR Part 11 Compliance– Global process with local needs– Search capabilities

• Business Issue– Ability to meet regulatory requirements for electronic signature and audit

traceability– Ability to standardize processes while supporting local requirements– Ability to provide quick and easy access to data

• Benefits to Philips– Meets external audit requirements and reduces compliance activities– Provides a platform for a common process with flexibility to meet local

requirements– Simplifies access to data for better decision making



M D R


ERP/BI Interface6.0

4.0 8-D CAPA


Agile Quality Demo Scenario – 1.0 Customer Complaints

Scenario – “screen flicker”CC – auto link to Final P/N & revisionQ/A Define disposition & monitor statusAuto create feature


Customer

Customer Complaint Cover PageCaptures details, severity, disposition and action taken


Customer complaint linked to specific product AND revision


Customer Complaint – workflow and sign-off history


Customer Complaint related to CAPA with “smart rule”


Demo Script 1 – Log a Customer Complaint

• Script Overview– Initiate a Customer Complaint (CC) and identify product (and revision)

affected– Select failure code and document immediate action taken– Route to Quality team for disposition– Provide disposition, approve and monitor CC until disposition has been

completed

• Business Problem– Document a customer issue so that corrective action may be taken– Monitor corrective action to ensure it is completed

• Benefits to Philips– Reduced cycle time to act on CCs– 360 degree view of quality history– Ability to monitor trends and recurring issues over time



M D R


ERP/BI Interface6.0

4.0 8-D CAPA


Agile Quality Demo Scenario – 2.0 Internal NCMR

Scenario – “screen flicker” at functional test Q/A – auto link to sub assy P/N & revisionSupplier notificationAuto Product Risk assessment


Non Conformance Material Report Cover page


NCMR linked to specific sub assembly AND revision


NCMRE workflow with supplier notification


NCMR linked to CAPA with “smart rule” and test results attached for evidence


Demo Script 2 – Log a Non-Conformance Report

• Script Overview– Initiate a Non-Conformance Report (NCR)– Identify immediate containment action and route for approval– Provide disposition, approve and monitor NCR until disposition has been

completed

• Business Problem– Document an internal quality issue– Ensure exposure to additional material defects are addressed– Determine disposition with proper approvals– Monitor corrective action to ensure it is completed

• Benefits to Philips– Reduced cycle time to act on NCRs– 360 degree view of quality history– Ability to monitor trends and recurring issues over time



M D R


ERP/BI Interface6.0

4.0 8-D CAPA


Agile Quality Demo Scenario – 3.0 Supplier Issue

Scenario - “screen flicker”NCMR – copy & saveAuto supplier request & input


Supplier NCMR cover page – with action details


SNCMR linked to specific sub-assembly and revision


Supplier NCMR workflow with supplier activity


NCMR linked to CAPA with “smart rule” and test results attached for evidence, plus a link to a associated website


Demo Script 3– Log a Supplier Issue

• Script Overview– Initiate a Supplier Issue

– Identify follow-up action requested and notify supplier

– Receive feedback from supplier and monitor NCR until follow-up has been completed

• Business Problem– Document a supplier quality event

– Determine follow-up actions with proper approvals

– Monitor corrective action to ensure it is completed

• Benefits to Philips– Reduced cycle time to act on NCRs

– 360 degree view of quality history

– Ability to monitor trends and recurring issues over time



M D R


ERP/BI Interface6.0

4.0 8-D CAPA


Agile Quality Demo Scenario – 4.0 CAPA (8D process)

•Scenario – aggregate Q/A events (CC/NCMR/Supplier Issue)•Auto CAPA triggers w/rules for risk assessment•Auto Linked to DHF/DMR archive•Synchronized Root cause change mgmt -evidence•Stop ship for ERP-SAP


CAPA cover page


AgileMD Enterprise Quality Management (EQM)Quality Event Scenarios

Need this view updated for cover page on previous slide


CAPA with aggregated quality events and affected documents requiring action defined by CAPA


CAPA workflow and status


All CAPA activity managed in one systems including:

•Associated CC/NMCR/SNCMR with smart rules•Associated DHF, DMR, work instructions, Product risk assesment documents and change activity• Stop ship notification for ERP system


CAPA with attached documents and websites to support CAPA investigation


Complete history of CAPA activity provides realtime status and auditable archive





M D R


ERP/BI Interface6.0

4.0 8-D CAPA


Agile Quality Demo Scenario – 5.0 Internal Audit

Scenario –internal auditSite specific controlsLink to DMS system w/chg mgmt


Site Audit Cover page


QMS Procedures selected to be audited – site specific


Audit workflow with and reviewers/approvers identified below


Demo Script 5 – Initiate Internal Audit of a Document

• Script Overview– Initiate an Internal Audit

– Identify audit findings

– Monitor until follow-up has been completed

• Business Problem– Ensure internal processes are being followed

– Document an internal audit and findings

– Monitor follow-up to ensure it is completed

• Benefits to Philips– Reduced cycle time to prepare and conduct audits

– 360 degree view of quality history

– Ability to monitor trends and recurring issues over time



M D R


ERP/BI Interface6.0

4.0 8-D CAPA


Agile Quality Demo Scenario – 6.0 ERP/BI Interface

• Complete• Open• Integrated


OracleBI Server

ProactiveDetectionand Alerts

DisconnectedAnalytics

Ad-hoc Analysis

MS OfficePlug-in

Reporting & Publishing

Interactive Dashboards

OLTP & ODSSystems

Data WarehouseData Mart

SAP, OracleCustom Apps

FilesExcelXML

BusinessProcess

Multidimensional Calculation and Integration Engine

Intelligent Caching Services

Simplified Business Model and Abstraction Layer

Intelligent Request Generation and Optimized Data Access Services

Key capabilitiesConsolidate and

standardize BI toolsSeamless user

experience across products

Conditional navigations

Unified metadata and shared services

Oracle BI Suite Enterprise EditionOracle BI Suite Enterprise Edition

AgileMD – Leveraging enterprise quality dataAutomatically consolidating quality across the IT platform


Enterprise Value – AgileMD/ERP IntegrationSynchronizing design/mfg & regulatory content with change/quality history

As Designed As Built

ERPAgile

DMR / Item Master Integration

(Proto - Commercial)

Design Analysis(Quality & Change Mgmt)

Automating the Prototype – Commercialization process to provide compliance integrity & business efficiency

MBR/DHR(Lot Info)

Sale/ShipInfo

Procurement ($$ / Lead-time)

Router&

Inventory Pick

NPD/DHF

QMS

Reg. Sub

Design Change


Stop ship notification automatically triggers ERP system from CAPA workflow


Deviation notification automatically triggers ERP system from CAPA workflow




M D R


ERP/BI Interface6.0

4.0 8-D CAPA


Agile Quality Demo Scenario – 7.0 Reporting

•Scenario – Quality reporting & analytics• KPI – threshold filters and triggers• Drill down capability



Out-of-the Box dashboard provides comprehensive view of all quality events, status, and performance


QMS Analytics 200+ Out-of-the Box analytic reports enable pro-active management of quality with notification filters, dynamic drill-down analysis, and KPI’s


Comprehensive search capabilities to analyze impact of change,


Demo Script 6– Reporting, Dashboard, Workflows and Web UI

• Script Overview– Show standard reports, dashboard and analytics capabilities– Demonstrate workflow capabilities– Demonstrate web user interface

• Business Problem– Ability to find data needed for decision making– Ability to tailor views of data for specific users– Ability to present results with little effort– Ability to configure workflows to meet specific process requirements

• Benefits to Philips– Reduce access time to data– Reduce manual collection and formatting of data for reports– Improve decision making with more timely data– Ability to monitor trends and recurring issues over time




M D R


ERP/BI Interface6.0

4.0 8-D CAPA


Agile Quality Demo Scenario – 8.0 External Audit Mgmt

Scenario External audit managementOne system for docs/parts change mgmt & qualityLink to DMS & Cobra system













PLM Process Dependencies

CustomerComplaint

CAPA

Stop Ship

ChangeOrder

Deviation

Non-Conformance


Quality“triage”

Close-loop quality/change analysis with DMS

End

CC & NCR

Identified

CAPA initiated

On NPI&L

Initiate Design Control Audit

Review associated

DHF/DMRDefine

changes

requiredRoot cause

Analysis

Monitor changes

• Proactive Change mgmt driven by quality

• One auditable archive for all regulatory documents (QMS/DHF/DMR/Reg Submittals)

• Comprehensive enterprise analysis• Close loop quality & change process

Close out

Corrective Action

QuarterlyQuality Review


Enterprise Quality Management EffectivenessVisibility is the key!

• Quality icon makes everyone aware of quality events associated with Part/process/procedures in AgileMD compliant dataset. Blah blah blah…..

Technology

Medical Device Agile Quality Demo