Quality Management

Introduction

The overall structure of the GMC's quality framework as it applies to pharmaceutical medicine is illustrated in the diagram below.

qual management pic

The GMC is solely responsible for Quality Assurance (QA) matters whilst the National Deanery is responsible for Quality Management (QM) matters and the LEPs for Quality Control (QC) matters. The GMC's Quality Improvement Framework provides detailed information about QA, QM and QC in postgraduate medical education and specialty training.

Processes of Quality Management

Under domain 2 of the GMC's Standards for postgraduate training, postgraduate training "must be quality managed, monitored, reviewed, evaluated and improved." The National Deanery is responsible for ensuring that this process is undertaken.

The Senior Specialty Adviser (SSA) has responsibility for overseeing the PMST programme followed by trainees both within a Local Education Providers (LEP) (a trainee's place of work) and across several LEPs.

The role of the SSA is a joint appointment of the Faculty and Lead Postgraduate Dean and s/he will normally be responsible for all trainees at a particular company or location (if the company is large and has several locations).

The SSA will normally be a Fellow of the Faculty, experienced at a senior level in pharmaceutical / regulatory medicine as well as in staff supervision, appraisal and assessment, and is committed to continuing professional development in general with a particular emphasis on PMST.

Other than meeting with the trainee at the enrolment meeting or prior to the start of PMST, to agree the training programme, there are no set rules as to when and how often a trainee should meet with their SSA. However, most trainees will meet or correspond with their LEP's SSA once or twice a year.

The standards expected of a LEP are set out in domains 5, 6, 7 and 8 of the GMC's Standards for postgraduate training.

The National Deanery maintains the following lists:

LEPs which have delivered, are delivering, pharmaceutical medicine training (and so deemed by SAC-PM to meet the required standards).
Trainees undertaking PMST at the current date, with a National Training Number.
SSAs.
Educational Supervisors (ESs) and Associate Educational Supervisors (AESs).

The Faculty, through the Director of Education and Training (DET), is responsible for the appointment, induction and training of ESs and AESs. ESs and AESs undergo an initial induction training, an annual training day and additional ad hoc / refresher training as required.

The ES will normally be located at the LEP - the trainee's place of work. The ES is responsible for facilitating provision of training and monitoring trainees' achievement and progress through the PMST programme to standards set within a framework of assessment, appraisal and review.

The SSA represents the National Deanery and is responsible for the evaluation, review and monitoring of designated training organisation(s) and PMST programme(s) in accordance with standards in item 1. above.

The SSAs, on behalf of the National Deanery, quality manages LEPs. The SSAs will usually quality manage their assigned LEP through review of JRCPTB Form A and conducting an assessment of the LEP, on an ongoing basis and specifically at the enrolment and subsequent induction of each trainee commencing training at the organisation, and at meetings during the year between SSA, ES and trainee. The DET and the SAC-PM Chairperson review training organisations at production of a new JRCPTB Form A.

The SSA, with the ES, provides induction to PMST and monitors achievement and progress in the programme through the review process. The DET and/or SAC-PM Chair review delivery of the PMST curriculum, through JRCPTB Form B, on an ongoing basis and, specifically, at the point of enrolment of each specialty trainee.

The SSA also serves to advise and assist the trainee(s) in the event of changes to or difficulties in achieving the training programme. Difficulties in achieving the training programme at organisational or other levels are reported to the SAC-PM, where they are discussed and actions decided. Lack of resolution will result in action by the Postgraduate Dean who may see fit to suspend training and/or trigger a GMC visit to the location/site.

Opportunities for review of standards is ongoing through:

ARCPs and RITAs.
National Deanery (Lead Postgraduate Dean, Faculty and JRCPTB) meetings & committees.
GMC National Training Surveys.
GMC programme of visits (QA).
Advice and assessment of examinations and courses (External Module Courses) by Faculty Board of Examiners and PMST Courses QM Group respectively.

The National Deanery's Curriculum and Assessment Working Group (CAWG) reviews the PMST curriculum. The CAWG is usually convened when the National Deanery must submit its revised curriculum to the GMC, and at such other times when periodic review of aspects of the curriculum take place.

The Faculty's PMST Courses QM Group quality manages the approved external courses for PMST on an annual (cyclical) basis to ensure that courses meet the Faculty's standards, and cover the Module Items of the PMST curricula through lectures, interactive workshops and post-course assignments (assessments).

Regulation of specialty training

The management and regulation of specialty training in the UK is contained in the following documents. The ‘Orange Guide' is applicable to trainees following the HMT curriculum.