quality system overview version nov 2012 alfred medical research & education precinct (amrep)...

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


Product Realisation

Product Realisation @ Nucleus Network includes;

Clinical Trial RealisationConsulting Services


Facilities, Equipment, Materials & Services

Clinical Trial Realisation


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


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


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


ALC

OATB

DN

C

Documentation Standards


Information & Communication Technology Policy

Validation Master Plan – GxP IT Systems– Back-Up Procedure

Information Technology


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)


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


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


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


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


Nucleus Network Quality System Overview Version Nov 2012

Centre for Clinical Studies

Austin

Centre for Clinical Studies

AMREPAlfred Medical Research and Education Precinct

© Copyright Nucleus Network 2012

Nucleus Network Quality System Overview Version Nov 2012

quality system overview version nov 2012 alfred medical research & education precinct (amrep)...

Documents

quality risk management

resource management

risk management principles

activities project management

senior management qssc

equipment asset

critical equipment

decisionmaking process