quality system overview version nov 2012 alfred medical research & education precinct (amrep)...
TRANSCRIPT
Quality SystemOverview
Version Nov 2012
Alfred Medical Research & Education Precinct (AMREP)
Austin Hospital
© Copyright Nucleus Network 2012
Structure & Quality Policy
- Quality Policy
- Quality Manual & Policies
- SOPs
- Quality Records
Intent
Framework
Defines &
Describes
Evidence of
Compliance
Nucleus Network Quality System Overview Version 20-Jan-2009 Copyright Nucleus Network
© Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012
Business Operational Principles
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
Risk ManagementProject Management
Business Operational Principles
© Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Niv 2012
Management Leadership
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
Management Leadership
Customer Focus PlanningManagement
ReviewResource
Management
© Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012
Product Realisation
Product Realisation @ Nucleus Network includes;
Clinical Trial RealisationConsulting Services
© Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012
Facilities, Equipment, Materials & Services
Clinical Trial Realisation
© Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012
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 (F&E)
Facilities, Equipment, Materials &Services
Facility & Equipment
Calibration
Validation
Preventative Maintenance
Procurement
© Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012
Our support systems that ensure effective Product Realisation Document Management Information Management Learning & Development Change Control Vendor Assurance
Support Systems
Change Control
Document Management
Learning & Development (Training)
Vendor Assurance
Information Management
Support Systems
© Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012
Document Management
Nucleus Network Quality System Overview Version 20-Jan-2009 Copyright Nucleus Network
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
© Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012
ALC
OATB
DN
C
Documentation Standards
© Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012
Information & Communication Technology Policy
Validation Master Plan – GxP IT Systems– Back-Up Procedure
Information Technology
© Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012
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
Learning & Development (L&D)
© Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012
Staff
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
© Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012
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
GCP Education & Training
© Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012
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)
Vendor Assurance
© Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012
Continuous Improvement of our systems and Product Realisation processes is a key focus of the organisation
Measurement, Analysis and Improvement activities include;– Internal Audit Program– Corrective & Preventive Actions
(CAPA) Management– GCP Quality Control– Key Performance Indicator monitoring
ContinuousImprovement
Plan
Do
Check
Act
Measurement, Analysis & Improvement
© Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012