Our Services

SOP, Policy and Documentation Creation

S Woolston Consultancy (SWC) has over 15 years’ experience in writing SOP’s and Policies within the healthcare setting for both Clinical and Commercial services, ensuring adherence to all relevant regulatory bodies such as the ABPI, Care Quality Commission, Scottish Care Inspectorate, Regulation and Quality Improvement Authority and UK GDPR. For those services specifically focused on Patient Support Programmes (PSP), SWC has extensive experience in supporting clients define the PSP scope, creating bespoke suites of documents and providing training to those who are delivering the PSP.

SWC can support organisations in developing in-house Document Management Systems and provide expert advice on documentation management (version control, revision and implementation).

Incident Management

SWC has supported organisations in understanding the importance of learning from mistakes and fostering a no blame culture. Identifying when a particular SOP or Policy has been breached is the first step in creating a better process. SWC can help organisations in evolving existing incident and deviation reporting mechanisms to increase reporting levels for better data analysis.

Root Cause Analysis and CAPA Management

SWC can support organisations in identifying why issues or incidents have occurred and therefore help facilitate a Corrective and Preventative Action plan to prevent reoccurrence. An essential component to service improvement, SWC has extensive experience in CAPA management and has utilised this methodology multiple times to create service improvements to a variety of systems and processes.

Clinical Governance Support

SWC has played an active part in over 15 clinical regulatory inspection from the Care Quality Commission, the Scottish Care Inspectorate and the Regulation and Quality Improvement Authority, over 50% of these directly as the registered manager for the organisation. SWC is proficient in the CQC new Single Assessment Framework methodology and is able to support organisations with registration and inspection preparation for all 3 of the clinical governing bodies of England, Northern Ireland and Scotland.

SWC recognises the importance of internal audit in ensuring the adherence to regulatory governing bodies and has extensive experience in developing internal audit schedules, creating audit tools and performing internal audits to support organisations in identifying gaps.

Other areas of expertise within SWC include clinical risk management, pharmacovigilance processing and management in line with MHRA requirements and compliance with UK GDPR with respect to patient data, Subject Access rights and patient consent.