Quality Business Processes

PURPOSE 

The University of Limerick’s Health Research Institute (HRI), founded in 2014, has a prime role in fostering and delivering health research in Limerick and nationally. As it continues to develop, both the breadth and impact of research undertaken by its members are increasing. The HRI has developed a unique transdisciplinary approach to health research, focusing on translational outputs with direct relevance to health practice, and delivering research excellence and impact in the health domain through a vibrant membership and supportive ecosystem. 

The HRI has been built upon the unique blend of research disciplines which has emerged during the development of health-related teaching and activity across the University. These disciplines are encapsulated in our ‘Priority Research Areas’ and ‘Underpinning Areas of Excellence’, Ageing, Cancer, Physical Activity for Health, Food Diet and Nutrition, Participatory Health Research, Digital Technology & Advanced Data Analytics and Implementation Research. These Priority Research areas and Underpinning Areas of Excellence group the Institute’s researchers into resonant research areas, with a high degree of interconnected areas of collaboration and knowledge exchange. 

The HRI has an interdisciplinary ethos with a focus on collaboration. This collaborative approach is supported by our position as the bridge between clinically based and university-based researchers.  

Our research strategy is closely aligned with the strategic goals of the University of Limerick (UL). 

The HRI has developed a Quality Management System suitable for a small entity, called QMS Essential. 

HRI activities are primarily based on the University Strategic objectives, the HRI Strategy, feedback from HRI Members and other internal and external stake holders and the HRI Executive committee requirements. 

Core activities include: 

1. Management of institutional (core team) compliance with all UL policies 
2. Regular and relevant communication with all Members 
3. Provision of support to the HRI Members- Full Member Academic, Full Member Clinical, Full Member ECR (Early Career Researcher), Postgraduate and Postdoctoral.
4. Organisation of events and activities to promote collaboration and networking. 
5. Organisation of Learning and Development opportunities 
6. Management of the Members’ Database 
7. Management of the Quality Management System 
8. Compilation and dissemination of Annual Reports 
9. Preparation and organisation for Quality Reviews 
10. Policy, Process and Operational Procedure development 
11. Administration of Records and Personal Data Inventory according to the UL Records Management and Retention policy 
12. Social Media activity 
13. Website Management 
14. Support for research funding applications 
15. Clinical Research Support in the Clinical Research Support Unit (CERC-UHL) 
16. Internal Funding administration and management 
17. Maintenance and management of the HRI Risk Register 
18. SharePoint development and management 

The HRI has an Implementation Plan (WIP- February 2024) which is updated on an annual basis or more regularly as required. This plan is based on the HRI strategic objectives, stake holder feedback, Risk Register future controls, HRI Management Team and HRI Executive committee requirements. The plan will be available as an operational procedure on SharePoint. The HRI has an annual meeting schedule, for both internal core team members and for the wider membership. These meetings are entered into the Operations and Members SharePoint calendars as appropriate. The HRI has a monitored Risk Register, a Personal Data Inventory and a Records Retention and Management log. SharePoint is the central repository for all HRI documentation. 

The purpose of this document is to outline the key activities of the HRI. The finer detail is available in the HRI Operational Procedures folder stored on SharePoint. 

RESPONSIBILITY 

The Institute is led by the Director who has overall responsibility for its management. 
The Operations Manager manages the daily activities of the Institute and ensures that the Implementation plan reflects the HRI strategy and that it is actioned effectively. 

The Operations Manager has responsibility for this process and its implementation. 

PROCEDURE 

Executive Committee 

 The HRI Executive Committee has responsibility for all aspects of the Institute’s governance, strategic planning and implementation and for ensuring alignment between the agreed strategy and operational planning.  

The objectives, therefore, of the Executive Committee are to facilitate the continual development, implementation, evaluation, and review of the Institute’s research strategy in conjunction with the External Advisory Board (to be developed) and to ensure that all requirements are in place and updated as required. 

All members are expected to represent their particular area of responsibility and ensure appropriate communications between their respective units and the Committee, as required. 

The HRI adheres to all principles laid down by the UL (University of Limerick) Human Rights - Equality, Diversity, and Inclusion policies in relation to Executive Committee composition. 

The HRI Executive Committee (the “Committee”) will be comprised of:  

• Institute Director (Chair) 

Representatives from:   

• Faculty of Education & Health Sciences, typically the ADR 
• Faculty of Science and Engineering, typically the ADR 
• University of Limerick Hospital Group, typically the Chief Academic Officer 
• Health Sciences Academy Director (if different to the above) 
• Active Researchers of priority and underpinning research areas x 3, with at least one from each research area type. 
• Representative from the Postgraduate/Postdoctoral membership in an advisory capacity (non-voting) 

Co-opted members (internal and/or external) for defined periods as nominated by the Director and approved by the VPR (Vice President Research) * 

* Representatives who may be invited to participate in specific discussions in an advisory capacity (non-voting). This can include Patient/Public Representatives and Industry. 

Management Team 

The HRI Management Team (the “Team”) has responsibility for the efficient and effective management of the Institute. All management requirements and planning will be dictated by the HRI Executive Committee and by the strategic implementation plan. The Management Team will ensure the effective implementation of the strategic plan and advise the Executive of any barriers or concerns related to this plan. 

The objectives, therefore, of the Management Team are to ensure that the strategic implementation plan and the direction of the Executive Committee are executed. 

The HRI Management Team will be comprised of: 

1. Institute Director (Chair) 
2. Operations Manager  
3. Clinical Research Operations Manager  
4. HRI Research Funding Officer  
5. 4 x Research active academics from HRI Research areas- at least one from the Priority Research Areas and one from the Underpinning Areas of Excellence. 

The Team may include Co-opted members (internal and/or external) for defined periods as nominated by the Director i.e., representatives who may be invited to participate in specific discussions in an advisory capacity (non-voting). 

Core Operational Team 

The HRI Core Operational Team which has responsibility for the day-to-day activities of the Institute comprises: 

• Operations Manager- overall responsibility for the operational management of the HRI.   
• Clinical Research Operations Manager- manages all aspects of the HRI-CRSU.  
• Research Funding Officer - provides support to HRI members for external research funding.   
• Senior Administrator – HRI Research Centres and Groups - provides administrative support to Research Centres and Groups 
• Biostatistician- provides bio-statistical expertise to HRI Members, University of Limerick Hospital   Group and Mid-West Community Healthcare Organisation colleagues. 
• Projects Coordinator- provides co-ordination support for HRI projects.   
• Senior Administrator- manages specific areas e.g., social media, internal funding calls, membership application and renewal. 
• HRI Administrator- provides administrative support to the Institute with 50% of time spent as Personal Assistant (PA) to the HRI Director.   
• Quality and Regulatory Clinical Research Associate.  
• Clinical Nurse Managers who provide research nursing support in the HRI-CRSU.   
• CRSU Administrator- provides administrative support in the CRSU.  

DOCUMENTATION 

The HRI Operational Procedures provide the background detail to this process. Linked are the HRI Procedure and Policy Processes PaPPs . 

RECORDS 

Records are held by the HRI for the period defined by individual processes. All members of staff operate in accordance with the University’s Records Management Policy. Any personal data that is used as part of this process is processed in accordance with the General Data Protection Regulation (GDPR) / Data Protection Acts 1988-2018 and the University of Limerick’s Data Protection Policy   

PROCESS VERIFICATION 

The HRI verifies the effectiveness and accuracy of this key business process on a regular basis by: 

• Internal/ QMS audits 
• Stake Holder feedback including surveys. 

REVISION HISTORY 

PURPOSE 

The purpose of this process is to ensure that there is effective, succinct and clear communication both within the Health Research Institute and with all internal and external stakeholders. 

RESPONSIBILITY 

Overall responsibility for this process lies with the Operations Manager; however, all staff are responsible for maintaining good communications with all stakeholders.  

PROCEDURE 

The Operations Manager is committed to ensuring that all staff are given the opportunity to understand and contribute to the activities of the unit. The communications process forms an integral part of this commitment.  

Communication within the Health Research Institute 

There are several strategies in place to ensure effective communication within the Health Research Institute. 

• Unit-Level Meetings: Unit-level meetings include: 
• Individual meetings between direct line managers and team members. Weekly or every fortnight. 
• Operations Meeting 
• Monthly with Operations Manager and the core Administration Team 
• Quarterly with the entire Operations Team 
• CRSU Team meeting- every two weeks. 
• HRI Executive Committee Meeting- three monthly. 
• Management Team Meeting- monthly. 
• Events co-ordination Meeting- every two weeks. 

• SharePoint: SharePoint is used as a central repository of information for all unit-level documents. All staff members have access to SharePoint.  

• Open-door Policy: Informal communication is ensured by the unit’s open-door policy. Staff members are free to drop into any office at any time. When working remotely, staff members can organise a video call easily with each other or with their line manager. 

Communication with Internal Stakeholders 

• Website: The website is used to ensure ongoing awareness of all key stakeholders, of the activities undertaken by the Health Research Unit. The website clearly outlines the main research focal areas of the Institute, the team composition and the various activities being undertaken at any given time including Fundamentals of Health Research Series, Members Lunches and Standalone events such as Statistics, Data Research management and Project Management  

• Members: HRI Members are communicated with via: 
• E-Mail. HRI has specific e-mail accounts for such correspondence. 
• SharePoint. A specific SharePoint site for Members which is constantly updated. 
• Newsletter. A monthly update to the Membership. 
• Funding Newsletter. A monthly newsletter focussing specifically on funding opportunities. 
• The Postgrad/ Postdoc Hub Committee which meets monthly. Hub events occur quarterly. 
• Monthly activities for membership which span networking, training and skills development. 

Communication with External Stakeholders 

As outlined above, the website is used as a key communication tool for both internal and external stakeholders. Key external stakeholders of HRI include, but are not limited to, the following: 

• UL colleagues. 
• Partner organisations- mainly University of Limerick Hospital Group and Mid-West Community Healthcare Organisation. 
• Research Participants. 
• Funding Bodies. 
• Communication with all the above is typically direct and via e-mail. 

Feedback is gathered periodically, both formally and informally from both internal and external stakeholders, through customer/stakeholder surveys and by other means (e.g.  focus groups, informal consultation, informal feedback etc.) as appropriate. Feedback is used to enhance service provision. 

Closing the Feedback Loop 

For communication to be effective, it must be a cyclical and reflective process. HRI team members are advocates of closing the feedback loop. This is done in several ways: 

• Annual Report compilation and dissemination. 
• Summary report of any feedback gathered for Executive Committee/ Management Team consideration. 
• Reports, as appropriate, to the contributing stakeholders 
• Continual improvement based on feedback, with communication of changes introduced to the team and the relevant stakeholders.  

COMPLAINTS 

Complaints regarding the activities of the HRI are dealt with through the university’s complaint process and procedures.  

RECORDS 

HRI ensures that webpage content is current and up to date. SharePoint is used as a central repository for all unit-level documentation. Individual PCs are backed up to an ITD managed server. HRI is governed by UL’s Records Management Policy . Any personal data that is used as part of this process is processed in accordance with the General Data Protection Regulation (GDPR) / Data Protection Acts 1988-2018 and the University of Limerick Data Protection Policy  

PROCESS VERIFICATION 

Evaluation of the Communications Process effectiveness is carried out using internal dialogue and QMS audits can be used. Changes to the process are put in place as required and as appropriate.  

REVISION HISTORY 

PURPOSE 

The purpose of this process is to ensure that the correct version of documentation is available at all times. The procedure covers the review and control of all documentation in the Quality Management System. This includes: 

• Key Business Processes 
• QMS Processes 
• Operational Procedures 
• Quality Improvement Plan 
• Forms / Templates / Work instructions 
• Records 

RESPONSIBILITY 

The Operations Manager is responsible for this process. 

PROCEDURE 

All internally controlled QMS documentation is maintained in electronic format. The SharePoint electronic version is regarded as the master copy and is controlled using revision control, where required and with the guidance of the Quality Support Unit. All members of staff have access to SharePoint.  Overall responsibility for publishing the general Quality Management System (QMS) documentation and that outlined below rests with the documentation controller- the HRI Projects Coordinator 

• Key Business Processes  
• Documentation Control Process 
• Training and Development Process 
• Communication Process 

Once finalised on SharePoint the QMS documentation listed above is then published on the website according to the schedule outlined below. 

Scope and Publication of QMS 

The following table outlines the elements of the Quality Management System and where they are published. 

Publishing Documentation 

The procedure for publishing QMS content is as follows: 

1. The requirement for a new process is discussed at unit-level meetings. A process owner is identified, and it is their responsibility to document the process and seek approval from the Head of Unit. 
2. Change to an existing process is discussed with the process owner, either at unit-level meetings or following QMS audits. 
3. The creation of the document or changes made to existing document. 
4. Updating of the document and inclusion of brief details in the revision history tab, where required. 
5. Approval for document new or amended) sought and achieved. 
6. Document forwarded to the documentation controller (Projects Coordinator) for release. 
7. The documentation controller (Projects Coordinator) publishes the document on the web and/or SharePoint and communicates the update to unit staff. 

It is the responsibility of all staff to ensure that any paper material is the current version. Printed material is uncontrolled documentation. 

Naming Convention 

All documents are given a name relevant to their use. (Units decide whether to include revision number on document title). 

Website Management 

The HRI uses the website as a means of communicating with the key users of our services, with SharePoint being the primary means. Information is organised under relevant categories. The website has links to certain elements of our Quality Management System namely 

• Key Business Processes  
• Documentation Control Process 
• Training and Development Process 
• Communication Process  

The website is hosted on an ITD server and is edited locally. The documentation controller (Projects Coordinator) or a delegate in their absence, is responsible for publishing the documentation outlined above on the website. HRI aims to review site content annually in conjunction with the QMS review process.to ensure it is current and relevant. All operational procedures (QMS Essential) are stored on SharePoint. 

Review of Documentation 

HRI carries out an annual process review co-ordinated by the Projects Co-Ordinator. The purpose of this review is three-fold: 

1. To consider current unit-level procedures (individually and as a suite) in the context of continued relevance and fitness for purpose. 
2. To identify any new procedures required. 
3. To review all new University-level policies published over the previous year and assess their impact/relevance for unit-level procedures. 

Revision Control 

All relevant QMS documentation is given a revision control number, starting with revision 1 for ‘Initial Release’.  This is conducted under the guidance of the Quality Support Unit. The revision history, where used, is maintained at the end of each document. For forms, a revision date is sufficient. The aim is that copies of old versions of documents are not normally maintained, once version control is being used. 

RECORDS 

Records are held by the HRI for the period defined by individual processes. All members of staff operate in accordance with the University’s Records Management Policy  Any personal data that is used as part of this process is processed in accordance with the General Data Protection Regulation (GDPR) / Data Protection Acts 1988-2018 and the University of Limerick’s Data Protection Policy .  

PROCESS VERIFICATION 

Evaluation of process effectiveness is carried out using Internal/QMS audits. 

REVISION HISTORY 

PURPOSE 

The purpose of this process is to ensure that an effective process is in place for the identification and provision of training requirements for each member of staff in the HRI. The requirements identified for each individual are based on the individual’s competence, qualifications and experience. 

PROCEDURE 

On commencement of employment, the Head of Unit, through the Project’s Co-Ordinator, will arrange a general induction programme for all new staff. Typically, induction training for new staff will include: 

• Introduction to staff within the Unit. 

• Introduction to HR and supply of staff ID number. 

• Advice regarding how to request a parking permit from Buildings and Estates. 

• Brief tour of the building. 

• Overview of the key business processes and associated operational procedures. 

• Overview of the quality management system. 

• Overview of SharePoint site. 

• Request to HR for inclusion in the next HR induction programme. 

• Overview of Core Portal and Agresso – if required for role 

• Overview of other software as applicable to the role 

• Introduction to HRI and other meetings schedule 

• Sign posting to important documentation and training requirements 

On commencement of employment, a ‘Staff Training Record’ is compiled for each new member of staff. Any training undertaken in conjunction with HR is automatically recorded on the staff training record on CORE portal. HRI maintains a supplementary record on SharePoint which includes areas that may not be recorded on core portal. 

Planning Training / PDRS 

The HRI adheres to the Performance and Development Review System (PDRS), details of which are available on the HR website. The PDRS is a process defined by HR, which stipulates that the Director/Manager must meet with each staff member, on an annual basis, with a view to improving performance and enhancing professional / career development. Any identified training is included in the PDRS record. Formal training requests are copied to the Learning and Development Manager, HR. Once training has been undertaken, a record of the training is entered into the Staff Training Record. A review of all formal training undertaken is conducted as part of the annual PDRS review.  

Training and development opportunities may be identified outside of the formal PDRS process as needs or opportunities arise.  

Training records are held on SharePoint. Evaluation of the usefulness of formal training is provided to director/manager at PDRS or in the intervening period, as required. 

RECORDS 

Individual training needs for a particular year are recorded on individual staff PDRS form, in consultation with the director/manager. The director/manager is responsible for retaining the completed PDRS forms for each member of staff. Each individual keeps a copy of their own form. The HR Division keeps a central record of all training completed by staff members on courses organised by HR (CORE Portal). The HRI Administrator maintains a ‘Staff Training Record’ in which defined UL/HRI-related formal and informal training is recorded. In the CRSU, there is a Training record for all clinical staff. Any personal data that is used as part of this process is processed in accordance with the General Data Protection Regulation (GDPR) / Data Protection Acts 1988-2018, the University of Limerick Data Protection Policy.   

PROCESS VERIFICATION 

Evaluation of process effectiveness is carried out using Internal/QMS audits.  

REVISION HISTORY