Tim Mohn pres
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11/22/2010 1 IVT Change Control – Holistic EQMS IVT Change Control Holistic EQMS Presented on November 16, 2010 Tim Mohn Industry Principal – Sparta Systems [email protected] 732-217-0499 Agenda •Enterprise Quality Management System – visioning •How does Auditing fit in? •Sample company evolution over time •Sample company evolution over time 2
Transcript of Tim Mohn pres
11/22/2010
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IVT Change Control – Holistic EQMSIVT Change Control Holistic EQMSPresented on November 16, 2010
Tim MohnIndustry Principal – Sparta [email protected]
Agenda
•Enterprise Quality Management System – visioning•How does Auditing fit in?•Sample company evolution over time•Sample company evolution over time
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Enterprise Quality Management Visioning
Enterprise Quality Management Solutions from every angle.
What is a Quality Management Solution?
DataTracking
& trending
ControlConsistent approach
Workflow managementAny process
approach
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EQMS Snapshot
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Segmented point solutions
Integratedholistic
solutions
Quality Management Is Evolving to Meet Changing Business Requirements
Location/department
deployments
Quality driven
Utilitarian
Global enterprise
deployments
IT, quality, business,
driven
Mature, feature rich solutions
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2005 2012
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EQMS: A Broad Scope of Usage
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EQMS: A Broad Scope of Usage
Discussion point: what are best practices? Who defines them?
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Key Manufacturing and Quality Systems
ERP EQMS DocumentManagement
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Regulated Industry Trends
Cost pressures – especially in companies with limited top-line growthIncreased regulatory scrutiny, globallyIncreased regulatory scrutiny, globallyHealth care reform – what does it mean for companies?Companies are increasingly risk averse
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Industry Specific Trends
How many of your companies have more than 1 location?Of those, how many have been acquired from otherOf those, how many have been acquired from other companies?
One key distinction of device vs. pharma
Pharma companies have historically been more centralized, while devices have been managed as business units
1 Device companies drive revenue by managing product changes
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1. Device companies drive revenue by managing product changes2. To optimize design changes, companies allowed divisions to run ~
independently3. With the increased cost pressures and time to market for new
products, device companies are shifting to increased centralization
Trends Lead to
Stronger corporate oversightDesire to eliminate redundant systems and processesAcceleration of companies on IT & process maturityAcceleration of companies on IT & process maturity path
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IT & Process Maturity Path
Integrated Enterprise Systems
PaperPaper + electronic tracking
Electronic point solution (NC, CAPA, doc control)
Best of breed system (QMS, ERP, doc control)
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But Why Integration?
Companies are continuing to realize that no one system can do it allThey are investing in scalable, enterprise systems thatThey are investing in scalable, enterprise systems that are best-of-breed and then integrating to othersCompanies that pursue one system to do everything are finding that its simply too costly and not flexible enough to accommodate their needs
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Integration with Leading Enterprise Systems
Enterprise Document Management System
Integrated change f
Enterprise Resource Planning
Product/material/f
ERPmanagement workflowAccess to controlled documentation
Laboratory InformationManagement System
Automated initiation of lab investigations
Manufacturing Execution
vendor informationBatch releaseReturn/repair processing
Customer Relationship Management
Customer master dataAutomated complaint initiation
Product Lifecycle
CRM
PLMLIMS
EDMS
EQMS
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Manufacturing Execution System
Automated initiation of deviations/nonconformances
Product Lifecycle Management
Change controlDocument management integrations/overlapMES
Need for Integration
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Old Model – Point to Point
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New Model – Service Oriented Architecture (SOA)
Modern Common integration layerCommon integration layer
Standards basedReusable parts
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What makes integration projects different?
Web services and SOA are new technologies for many EQMS teams
Where does the master data live?How clean is it?Is it replicated in
How will the EQMSteam interact with the interfaced systems?
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Enlist help from the experts (internal or external)
Is it replicated in other systems that must also be cleaned up?
Change control?
Integration Details: SAP – EQMS
Release
User-entered V lid t d I iti t i id t
Master data integration
Di iti
Place onhold
Updatedisposition
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User enteredproduct
information
Validated data
Initiate incidenton batch
Dispositionincident
EQMSEQMS
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Integration Details: SAP – EQMS
Release
Di iti
Place onhold
Updatedisposition
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DispositionincidentAuto-create NC
EQMSEQMS
Multiple ERPs
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EQMSEQMS
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Integration Details: Customer Relationship Management (CRM) – EQMS
Auto-create complaint Investigation
Up-to-date records & cross reference
Regulatory reportable complaints
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investigation status & info
eMDR to FDAEQMSEQMS
Laboratory Information Management System (LIMS) & EQMS
Auto-create OOS Investigation
Investigation result
OOSidentified
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investigationInvestigation
result
EQMSEQMS
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How does auditing fit in?
Enterprise Quality Management Solutions from every angle.
Audits Across the Enterprise
Example of audits:
− GMP/GLP/GCP − Internal Controls− Business Conduct Standards− Clinical Site Audits− Compliance− Computer Related System − Validation Audits− Contractor Compliance Assessment
I t l Q lit A dit
− Contractor/Supplier/Vendor− Third Party (FDA, ISO & other health)− Pre-Clinical Studies− Processes− Internal Facility Projects− Method Validation Audits
EH&S A dit
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− Internal Quality Audits− Risk Assessments
− EH&S Audits
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Holistic Auditing for the Enterprise
Planning Execution Follow-up
Audit Cycle
Evaluate effectiveness
Enables companies to schedule audits in advance, manage auditor workloads, and ensure FDA requirements are meet
For example: covering all elements of the ‘Quality System’ per procedure
Planning
Allows auditors to document results in real time and provide actionable data for tracking and trending This data enables companies to prioritize resourcesExecution
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tracking and trending. This data enables companies to prioritize resources across audit types for true enterprise management
Ensures appropriate action is taken (such as CAPAs) and audits are closed out once completedFollow-up
Holistic Auditing for the Enterprise
Planning Execution Follow-up
Audit Cycle
Evaluate effectiveness
Evaluate effectiveness
Enables enterprises to:Track & trend across audit programs− Audit statistics
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Audit statistics− Issue patterns for systemic issue identification (for example: supplier
issues or training issues)− Prioritize tasks across audit types throughout the enterprise
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Audit Team Drivers
AuditorsFlexible, easy-to-use authoring
Audit ManagersStandardized data for analysis
Auditors require authoring tools that are:• Flexible• Portable• Easy to use • Familiar
Auditors Managers require data tools that are:• Standardized• Data driven • Analytical• Easy to use
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Key challenge – how do you satisfy both needs?
‘Flexible’ Audit Templates
Templates provide a structure to the standard of the audit while remaining flexible to fit within the corporate audit structures/processes.
Ensures the audits are conducted to the standard• Every audit is conducted to a standard• Every audit is conducted to a standard • Different templates for each standard i.e. each project – 21 CFR part 820, 21 CFR part 11,
ISO 9001, Sarbanes Oxley − Questions are based on standards
Increases uniformity to allow for enterprise-wide audit analytics and prioritization
• Allows classification of issues & resolutions to be consistent across the enterprise• Enables analytics across audit program by leveraging comparisons of similarities
Provides flexibility to adapt the audit to fit within the process of the
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Provides flexibility to adapt the audit to fit within the process of the corporation
• Audits can be designed across a spectrum of highly structured to highly flexible based on audit project and/or auditor
• Flexible templates enable auditors to conduct audits without the need to transfer information (i.e. copy/paste from Word or other applications)
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Audit follow-up best practices
Feeder into CAPA process for internal audits (i.e., escalate to CAPA as appropriate)When interacting with suppliers, companies utilize different
t t istrategies− SCAR – Supplier Corrective Action Request− Email supplier finding and manually track response (not recommended)Best practice – ensure consistent, closed-loop audit monitoring
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Sample Company Evolution over time
Enterprise Quality Management Solutions from every angle.
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CAPA Process Steps
1. Issue Identification and Correction(Nonconformity)
2. Risk Assessment
3. Root Cause Determination
4. Implement CAPA
5. Effectivity Check
4. Implement CAPA
Process questions
Should all NCs be treated equal? (validation deviations, manufacturing issues, procedural deviations, customer complaints, audit deficiencies, etc)deviations, customer complaints, audit deficiencies, etc)
Who should be able to create NCs?
Is there a 1:1 relationship:
−between NCs and Product Dispositions?−NCs and Root Cause Investigations−NC and CAPA?NC and CAPA?−CAPA assignee and who tasks are assigned to
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Process questions continued
When does CAPA start? Before Root Cause identified or after?
When does risk assessment occur? Before Root Cause or after?
Correction vs. Corrective Action vs. Preventive Action
−Based on Risk?−Effectivity Check needed for all?CAPA Due Dates – who determines?
If the company has products that fall under different regulations ( d i d bi l i ) d th f ll th(e.g., device and biologics) do they follow the same process or slightly different?
Sample Business Process and EQMS Evolution
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CC
Site A Site B Site C Site D
CC CC CC
Audit CA
PAAudit CA
PA
Nonconform
ance CAPA
Nonconform
ance CAPA
Complaint Investigation CA
PCom
plaint Investigation CAP
Audit CA
PAAudit CA
PA
Nonconform
ance CAPA
Nonconform
ance CAPA
Complaint Investigation CA
PCom
plaint Investigation CAP
Audit CA
PAAudit CA
PA
Nonconform
ance CAPA
Nonconform
ance CAPA
Complaint Investigation CA
PCom
plaint Investigation CAP
Audit CA
PAAudit CA
PA
Nonconform
ance CAPA
Nonconform
ance CAPA
Complaint Investigation CA
PCom
plaint Investigation CAPPAPA PAPA PAPA PAPA
Audit Deficiency NonconformanceComplaint
Investigation
Risk Evaluation Risk Evaluation Risk Evaluation
R t C R t C R t CRoot Cause Root Cause Root Cause
CAPA
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ComplaintAudit Deficiency Nonconformance
ComplaintInvestigation
Risk EvaluationRisk Evaluation
CAPACAPA
Root Cause
Key learning
Quality systems must be designed with organizational change management in mind
In this example, the company knew they wanted to haveIn this example, the company knew they wanted to have a consistent root cause and risk evaluation process but couldn’t achieve everything in one phaseBy breaking it into 3 phases, over a period of a few years, the organization grew and was pulling for the changes – rather than pushing it to unwilling consumers
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Agenda
•Enterprise Quality Management System – visioning•How does Auditing fit in?•Sample company evolution over time•Sample company evolution over time
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Q&A
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Thank you very much
Any questions, please feel free to contact me:
Tim MohnTim MohnIndustry [email protected]
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