Bringing Quality to Life: The Importance of …...Breaking down silos Patient collaboration Building bridges Processes QIG Internal Monitoring Resource Management Training and Competencies

Bringing Quality to Life:The Importance of Engagement

Piran Sucindran

GCP Quality Specialist

Outline

What is engagement?

Developing a quality culture

Breaking down silos

Patient collaboration

Building bridges

QIGProcessesInternal

Monitoring

Resource Management

Training and Competencies

Knowledge Management

Risk Management

Engagement

BRINGING QUALITY TO LIFE: IMPLEMENTING A QUALITY MANAGEMENT SYSTEM IN FRONTLINE NHS RESEARCHSUCINDRAN 2015

I welcome change as long

as nothing is altered or different

Engagement in investigator sites

Internal and external

Investigator team infrastructure• Physicians

• Research nurses

• Trial co-ordinators and practitioners

• Management

Internal departments• R&D

• Pharmacy

Patients

Sponsors and CROs

Developing a quality culture

Senior management buy-in• Deviation reviews

• CAPA oversight

• Encourage quality improvement

Regular agenda items• Management meetings

• Clinical meetings

Internal quality focus group• Opportunity for engagement

• Voice for frontline staff

• “SOP Committee”

Developing a quality culture

Developing a quality culture – Shared Vision

Developing a quality culture

94% involved in development of QMS• Developing processes – 50%

• Referenced in meetings

• Knowledge sharing

• Active engagement

Accessibility• 90% - SOPs as reference tools

• 60% - reference SOPs to Sponsors

• Availability of SOPs

• Appearance and tone

• QMS as support

Developing a quality culture

80% comfortable with deviation reporting• Get rid of blame culture

• Focus on processes

• Group resolution

• Not their responsibility?

Quality isn’t something we do…

it’s everything we do

Inter-departmental collaboration

Inter-departmental collaboration

The Patient Experience

Link between patient and sponsor

Always listen to sponsor, why not patient?

The Patient Experience

The Patient Experience

22 patients, friends and family

Shared aims

Stories

Collaborative QI techniques• Experience-Based Co-Design

• King’s Fund

• Appreciative Inquiry

Outcomes

Ongoing collaboration

Staff event

• Staff stories

• Reflective practice

• Observations

Patient event

• Patient stories

• Positive experiences

• Improvements

Staff and patient event

• Design improvements

• List actions

• Responsibilities

DIS

CO

VER

DR

EAM

DES

IGN

DEL

IVER

ONGOING COLLABORATION

Building bridges

Building bridges

Bridging the gap

Communication• Managing expectations

• Understanding limitations

• “Language” barrier

QMS mirroring sponsors’• Reassurance

• CAPA management

• Limits variation

• Risk management

Transcelerate• Clinical Quality Management System

The Importance of Engagement

Support from the top

Drive from all levels

Identify stakeholders

Tear down silos

Truly collaborate

Build bridges

Thank you

@superpiran