Assistant Quality Lead- Change Control, Band 5

The Pathology Quality Assistant and Change Control Officer (PQA\&CCO) is an exciting opportunity to support the Pathology Quality Management Systems, with a focus on supporting Change Control processes across Pathology.

The role is to provide specialist Quality Management Systems (QMS) support and direction to each of the pathology disciplines; with the aim of achieving and maintaining all regulatory and accreditation requirements from external organisations including UKAS, MHRA, HFEA and HTA, as well as complying with Trust Policies and meeting Trust reporting requirements. This includes a particular focus on Change Control i.e. following internal processes to ensure that all changes within the department are managed correctly and aligned with Trust change requirements.

The role provides this specialist support by advising on the various aspects of Quality Management such as change control, document control, auditing, and non\-conformity management to a large Pathology service, working in several distinct clinical areas i.e., Clinical Biochemistry, Haematology, Cellular Pathology, Microbiology, Phlebotomy, Point of Care Testing, Pre\-Analytical areas and Mortuary – many of which are replicated on both hospital sites.

The post holder is often the first point of contact for any Change Control and Quality Management issues within Pathology. The post holder’s specialist Change Control and Quality Management knowledge will be used throughout the duties below to continually support, advise and direct colleagues, to ensure that the Change Control and QMS processes are maintained and used correctly. Whilst supported by the Quality Manager, the post holder must use their own initiative and expertise to advise and support colleagues, independently of the Quality Manager. To carry out these duties, the post holder will be communicating verbally and in writing to staff throughout Pathology and the Trust, with key links being the Quality Leads within each department, Laboratory Managers, and colleagues in the Trust Digital teams. The post holder will need to plan their time and activities effectively.

• Communicating regularly with all Pathology Department staff, at all levels, across both sites.


• Works with trust and digital colleagues to ensure all change activity is delivered as an integrated piece of change covering people, process, data, and technology and effective documentation of all areas of change affecting Pathology staff, services and processes are in place to meet regulatory requirements in line with current legislation.


• Builds relationships and maintain effective networks throughout the Trust to maintain a conscious awareness of high\-quality pathology QMS and change control.


• Maintain a customer\-focused approach to all pathology colleagues requiring help and advise with aspects of Change Control and the QMS.


• Liaise with external software companies regarding any issues, upgrade or maintenance.


• To communicate information verbally and in writing; presenting information, which may be sensitive and/or confidential.


• Attends meetings where required.


• Deputise for the Quality Manager as required, including attending management meetings.


• Liaise with the UKAS assessment manager and UKAS finance team as needed.


• Follow HR policies such as leave, sickness, and appraisal.

The post holder will be responding reactively to queries, as well as communicating pro\-actively in the form production of data reports, training, and writing procedures (SOPs) and guidance documents when needed.

Clear, precise, accurate and timely information from the post holder is essential in ensuring that pathology colleagues are managing Change and using the QMS appropriately. The post holder needs to be clear with the message of requirements, in a manner that is sensitive to other pressures on colleagues, and keeps staff engaged with the quality team.

Areas that the post holder may be required to advise and support in are most commonly:

• Change Control processes within Pathology and the wider Trust


• The content of Pathology Policies and SOPs


• The content of ISO 15189 and Transfusion Good Practice Guidelines


• Document Control


• Audit


• Non\-conformance


• Record Keeping, including for Assets and Training \& Competence


• Referral lab and supplier accreditation


• QMS database use and functionality


• UKAS visits, documentation and evidence

To achieve the above the post holder must stay up to date with Pathology QMS Policies and Procedures, relevant Trust Policies and procedures, as well as external regulations and standards.

In addition, the post holder will identify problems within the QMS, such as information flow problems, contradictions, duplications, inadequate quality, and investigate further as required; suggesting and implementing solutions appropriately. Understanding a problem and finding solutions may require tenacity and research.

Change Control

• Coordinate and manage change control activities associated with pan\-pathology changes to ensure all relevant governance requirements are met including risk assessments, action planning, verification planning and evidence collation.


• Collaborate with Pathology Quality Leads to support documentation for Clinical Safety Cases to alignment with Digital Clinical Safety Standards DCB0129 and DCB0160\.


• Act as a source of knowledge providing guidance and support to pathology staff, digital teams and other Trust teams as to pathology change control processes and verification evidence requirements.


• Compile reports regarding issues and incidents raised because of Pathology changes for the purposes of submission to external regulators and internal Pathology and Divisional Boards.


• Ensure a full record of change documentation is available on both the IT incident software QMS database, maintaining an audit readiness status and are aligned to the timing of the change being made.


• Using information from multiple sources such to maintain a log of all change activities relating to the Pathology Information Managements System, or LIMS, ensuring it is kept current and available for inspection when required.


• Work collaboratively with Digital Team colleagues, ensuring all digital changes affecting Pathology are captured on the Pathology QMS, liaising with Pathology Systems Team to ensure documentation meets required regulator and accreditor standards and is in place before changes are made to digital systems.


• Manage IT incident logging for Transfusion Medicine on the Pathology QMS database, liaising with the Transfusion Medicine Laboratory Manager.

Whereas the focus of this post is Change Control, any of the duties below may also be required.

Suppliers

• Monitor the accreditation status of pathology suppliers.


• Ensure that supplier information is kept up to date on the QMS database.

QMS Database:

• Become an expert user of the QMS database. This is an advanced IT system requiring particular skills in order to manipulate significant volumes of data, on an almost daily basis. Using detailed knowledge of the functionality and configuration of the database to:


• Be responsible for the production of statistical reports from all modules, on a regular basis. Precisely follow SOPs and re\-write SOPs as reports change.


• Query the system to produce new reports.


• Act as a first point of contact, providing help desk support for the QMS database users – responding to a range of issues from simple enquiries through to more complex functionality issues.


• Ensure the system is appropriately managed.


• Investigate any issues with the use of the QMS software, to uncover the root cause.


• Work with colleagues to develop the use of all Modules; planning and leading these projects, and making decisions regarding set\-up and process.


• Liaise with the relevant pathology disciplines about any changes to the software.


• Carry out regular database management tasks; for example, keeping the Managed Lists, Reference Group and individual Users up to date.

Regulations and Standards

• Be familiar with the content of relevant regulation and standards – e.g., BSQR and ISO 15189 – and be able to find and cite relevant information to advise colleagues.


• Work with the Quality Manager to establish gaps in the department where the regulations/standards are not being met.

Reporting

• Prepare reports (monthly) for the Pathology Management Board, to show the status of the QMS within each pathology discipline. This includes extracting and manipulating data from both the QMS database and Datix, and requires the handing of sensitive and confidential information.


• Create additional reports, e.g., trending – both routine and ad\-hoc.


• Assess reports produced to check for accuracy and anomalies – any issues found must be investigated and addressed.


• Reports are used by the Pathology management and also for external readers.

Auditing

• Plan and document audit schedules with the discipline Quality Leads.


• Carry out detailed complex internal audits independently within Pathology, deciding on non\-conformities when found.


• Review internal audits of pathology colleagues, for quality of content, and give feedback.


• Advise on the management of non\-conformities, observations and recommendations arising from audits.


• Ensure that all audits are processed in line with the Quality Management Systems policies and procedures regarding audits.


• Review and re\-write audit training materials, including the use of research methodologies.

External visits, accreditation and finance

• Make all preparatory arrangements for visits from external inspectors/assessors, i.e., accommodation, catering, personnel availability, and availability of records.


• Identify and prepare the pre\-visit documentation.


• Respond to any findings from visits, specific to the post holder’s duties. Support the Quality Manager and

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