Transcript Nucleus Network Quality System Audit Overview Nov2012

Quality System
Overview
Alfred Medical
Research & Education
Precinct (AMREP)
Austin Hospital
Version Nov 2012
© Copyright Nucleus Network 2012
Nucleus Network Quality System Overview Version Nov 2012
© Copyright Nucleus Network 2012
Structure & Quality Policy
ent
Int
m
Fra
- Quality Policy
ork
ew
- Quality Manual & Policies
&
es s
n
i
f
De cribe
s
e
D
- SOPs
f
eo
c
n
nce
ide
Ev plia
m
Co
Nucleus Network Quality System Overview Version 20-Jan-2009
- Quality Records
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Nucleus Network Quality System Overview Version Niv 2012
© Copyright Nucleus Network 2012
Business Operational Principles
Business Operational Principles
Project Management
Risk Management
We have adopted two key business operational principles that
are applied to all organisational processes and activities
Project Management
– As the process of combining resources, systems, processes, and people to
complete a project to meet the established goals within the constraints of
time, cost and quality
Risk Management
– As a process for the identification and management of significant risks
– Supporting a scientific and practical approach to our decision-making
process
– Adopted AS/NZS 31000:2009 Risk management – principles and guidelines
as the standard framework
Nucleus Network Quality System Overview Version Nov 2012
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Management Leadership
Management Leadership
Customer Focus
Planning
Resource
Management
Management
Review
 Management Leadership through Customer Focus,
Planning, Resource Management and Management
Review processes
– Quality System Steering Committee (QSSC)
• Comprises of Senior Management
• QSSC Purpose;
– Provide leadership in regards to the effectiveness of the Quality System
– Conduct Management Review
– Prioritise and facilitate Continuous Improvement/CAPA Management
– Monitor Internal and External Audits
Nucleus Network Quality System Overview Version Nov 2012
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Product Realisation
Product Realisation @ Nucleus Network
includes;
 Clinical Trial Realisation
 Consulting Services
Nucleus Network Quality System Overview Version Nov 2012
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Clinical Trial Realisation
Facilities, Equipment,
Materials & Services
Nucleus Network Quality System Overview Version Nov 2012
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Facilities & Equipment (F&E)
Supporting Trial Realisation;
Facilities & Equipment Policy
 Validation Master Plan – F&E
– Defines Calibration, Validation and
Preventive Maintenance
requirements for all equipment
 Asset Register
– All critical equipment listed
 F&E Group exists to
oversee this process
Facilities, Equipment, Materials &
Services
Facility & Equipment
Calibration
Validation
Preventative Maintenance
Procurement
Nucleus Network Quality System Overview Version Nov 2012
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Support Systems
Our support systems that
ensure effective Product
Realisation
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Document Management
Information Management
Learning & Development
Change Control
Vendor Assurance
Support Systems
Document Management
Information Management
Learning & Development (Training)
Change Control
Vendor Assurance
Nucleus Network Quality System Overview Version Nov 2012
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Document Management
Document Distribution and Control
 Controlled copies of all Policies & SOPs are available in
separate physical document libraries throughout each
facility
 All official controlled copies printed on blue paper
 SOPs and forms are also made available online
(Intranet)
 Online SOPs are scanned versions of the signed
master
 Master documents are locked away under control of the
Quality Department
Nucleus Network Quality System Overview Version 20-Jan-2009
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Nucleus Network Quality System Overview Version Nov 2012
Documentation
Standards
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Nucleus Network Quality System Overview Version Nov 2012
Information Technology
Information & Communication
Technology Policy
 Validation Master Plan – GxP IT Systems
– Back-Up Procedure
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Nucleus Network Quality System Overview Version Nov 2012
© Copyright Nucleus Network 2012
Learning & Development (L&D)
Learning & Development Policy

Learning & Development Group
–
Drives the L&D process
– Monitors and tracks L&D achievements
 All new employees attend;
–
Corporate Induction
– L&D Handbook Training session
•
•
Employee L&D Lifecycle
Enables each employee to facilitate own
training
Nucleus Network Quality System Overview Version Nov 2012
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L&D Training Matrix
Requirements
All requirements
are assessed for
each position
type;
•Mandatory
•Desirable
•Not Required
Tracks status for
each staff
member;
•Trained/Met
•Gap
Each employee
has own
individuals views
of the matrix
Staff
Nucleus Network Quality System Overview Version Nov 2012
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GCP Education & Training
Commitment to Good Clinical Practice
(GCP) Education of our employees
 All staff are provided GCP Training as part of
Nucleus Network Induction upon commencement
 In addition, all permanent employees attend a
minimum of a 2 day Good Clinical Practice
Nucleus Network Quality System Overview Version Nov 2012
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Vendor Assurance
Vendor Assurance Program
– Classification of each vendor based on risk
– Approved Vendor List
– Strong relationships with key vendors e.g.
• Clinical Trial Pharmacy
• Hospital Pathology
• BioMedical Engineering
• Recall Australia (Archiving)
Nucleus Network Quality System Overview Version Nov 2012
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Measurement, Analysis & Improvement
Continuous Improvement of our
systems and Product Realisation
processes is a key focus of the
organisation
Plan
Act
Continuous
Improvement
Check
Measurement, Analysis and
Improvement activities include;
– Internal Audit Program
– Corrective & Preventive Actions
(CAPA) Management
– GCP Quality Control
– Key Performance Indicator monitoring
Do
Nucleus Network Quality System Overview Version Nov 2012
Nucleus Network Quality System Overview Version Nov 2012
Centre for Clinical Studies
Centre for Clinical Studies
AMREP
Austin
Alfred Medical Research and Education Precinct
© Copyright Nucleus Network 2012