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Authorisation Log


Document ID	CSC I.003
Revision	2.1.5

1. Purpose and Scope

This document provides a log of the training and competency of CSC staff members for effectively performing activities required in the QMS Standard Operating Procedures.

Master log

Key	Description
T	Trained - Can perform the process with supervision from a competent member of staff
C	Competent - Can perform the process without supervision
P	Process owner Can: - perform process without supervision, - supervise staff, - deliver training, - approve authorisation, - adapt process

Process	Staff Member 1	Staff Member 2
On-Boarding
Read Quality Manual
Project Setup (Documentation)
Clinical Risk Management
XNAT Data Upload
ML model training
Incident Reporting
CAPA
Deployment
Requirements Gathering
Verification and Validation
GitHooks
Github PR review
Change Management
Alert notified Body

Training evidence

On-Boarding


Training materials (link training log, questionnaire etc)	records/training_records/training-onboarding/onboarding.md
No. examples of evidence of completed task required for competence	0

Name	Training	Examples/Evidence
Staff Member 1	Meetings	OnBoardingChecklist_Example.md

Quality Manual Training


Training materials (link training log, questionnaire etc)	quality-manual-Training-log-example.md
No. examples of evidence of completed task required for competence	0

Name	Training	Training test score	Examples/Evidence
Staff Member 1

Project Setup (documentation)


Training materials (link training log, questionnaire etc)	- Questionnaire
No. examples of evidence of completed task required for competence	1 project

Name	Training	Training test score	Examples/Evidence
Staff Member 1

Clinical Risk Management


Training materials (link training log, questionnaire etc)	Stage 1: Training provided online: https://portal.e-lfh.org.uk (Clinical Risk Management Training) Stage 2: Clinical Safety In Person Training Session
No. examples of evidence of completed task required for competence	0

Name	Training	Training test score	Examples/Evidence
Staff Member 1

XNAT Upload


Training materials (link training log, questionnaire etc)
No. examples of evidence of completed task required for competence

Name	Training	Training test score	Examples/Evidence
Staff Member 1

ML Training


Training materials (link training log, questionnaire etc)
No. examples of evidence of completed task required for competence

Name	Training	Training test score	Examples/Evidence
Staff Member 1

Change Management


Training materials (link training log, questionnaire etc)	- Change_Management_Questionnaire.pdf
No. examples of evidence of completed task required for competence	0

Name	Training	Training test score	Examples/Evidence
Staff Member 1

Incident Reporting


Training materials (link training log, questionnaire etc)
No. examples of evidence of completed task required for competence

Name	Training	Training test score	Examples/Evidence
Staff Member 1

CAPA


Training materials (link training log, questionnaire etc)	- Questionnaire
No. examples of evidence of completed task required for competence	1

Name	Training	Training test score	Examples/Evidence
Staff Member 1

Deployment


Training materials (link training log, questionnaire etc)
No. examples of evidence of completed task required for competence

Name	Training	Training test score	Examples/Evidence
Staff Member 1

Requirements Gathering


Training materials (link training log, questionnaire etc)
No. examples of evidence of completed task required for competence	1

Name	Training	Training test score	Examples/Evidence
Staff Member 1

Verification and Validation


Training materials (link training log, questionnaire etc)	- Questionnaire
No. examples of evidence of completed task required for competence	1

Name	Training	Training test score	Examples/Evidence
Staff Member 1

Project Setup and GitHooks


Training materials (link training log, questionnaire etc)
No. examples of evidence of completed task required for competence	1

Name	Training	Training test score	Examples/Evidence
Staff Member 1

GitHub PR risk assessment and review


Training materials (link training log, questionnaire etc)
No. examples of evidence of completed task required for competence	After training

Name	Training	Training test score	Examples/Evidence
Staff Member 1

Alert Notified Body


Training materials (link training log, questionnaire etc)
No. examples of evidence of completed task required for competence	None

Name	Training	Training test score	Examples/Evidence
Staff Member 1