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CSC-PR-022-Control-of-QPULSE-Documents.md

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qms_version 2.2.0
sop_version 2.0.1

Control of Q-Pulse Documents

General
Document ID CSC PR.022
Document Version 2.0.1
Author
Approval
QMS Version 2.2.0
Regulatory References ISO 13485:2016 4.1.3a 4.2.1d, 4.2.4

Purpose

This document described the processes required to ensure that Q-Pulse documents referenced by this QMS remain fit for the purposes of the CSC QMS.

Scope

This document covers all Q-Pulse tracked documents that are referenced by this QMS.

Roles and Responsibilities

Role Responsibility
QMO Ensure the overall validity of the CSC QMS
Quality Representative Conduct review of referenced Q-Pulse documentation in annual Management Review. Raise Change Requests against Q-Pulse documents as required.

Definitions

Term Definition
Q-Pulse Quality management system software used by the Medical Physics department
QMO Quality Management Officer
QR Quality Representative
CSC Clinical Scientific Computing
QMS Quality Management Systems

1. Introduction

The CSC Team is a subsection of the GSTT Medical Physics department and therefore staff are part of the Medical Physics Quality management system ISO 9001, where all protocols, procedure, work instructions etc., are stored in the Q-Pulse software. All CSC staff members have access to Q-Pulse through their Trust PC accounts.

This QMS complies with ISO 13485:2016 but references Medical Physics Q-Pulse documents where specific processes are managed at wider department level. A list of these documents is provided in Table 1.

2. Q-Pulse Documents

Table 1. List of Q-Pulse documents referenced by the CSC-QMS

Q-Pulse Document Title Q-Pulse ID Revision CSC QMS Process
Department Induction procedure D PR.013 1.1 HR
Supplies: Ordering D WI.008 1.0 Purchasing
Supplies Receipt of Goods D WI.009 1.0 Purchasing
Approved Suppliers D I.004 1.1 Purchasing
Supplies: Authorisation List D I.003 1.6 Purchasing
Performance Analysis D PR.010 1.0 Management Review
Suggestions, Praise & Customer Surveys D PR.011 1.0 Continual Improvement

3. Control of Q-Pulse Documents

3.1 Validity Checks

A review of the Q-Pulse documents must be conducted annually as part of the management review to ensure the references document remain fit for purpose.

If the document/procedure revision differs from that listed in table 1, it should be critically reviewed against:

  • CSC QMS processes
  • ISO 13485:2016
  • BS EN 60304:2006

If gaps are found they must be addressed by creating a corresponding procedure for the CSC QMS, controlled by the GitHub repository, or changes can be requested against the document in Q-Pulse.

3.2 Request changes to Q-Pulse documents

In cases where a document in Q-Pulse that is referenced by the CSC QMS is no longer fit for purpose or needs updating for continued use by the CSC Team, updates can be requested against the document within the Q-Pulse application. This is done by right-clicking on the 'Document Number' in Q-Pulse and then selecting "Add Change Request". A comment should be left describing the discrepancy and clear suggestion on how it would be resolved. You will receive a notification from the author if the change has been accepted and integrated.

If change requests are rejected or will not be applied within a reasonable time frame for acceptable use by the CSC QMS, the document should be taken under CSC control and duplicated into the CSC QMS GitHub repository.

3.3 Duplicating a document into the CSC-QMS GitHub repository

If an SOP in Q-Pulse which is used by the CSC QMS becomes non-compliant, and the change request is not accepted, the document must be duplicated into the CSC QMS GitHub repository and with the necessary corrections made.

  • This document must follow the naming conventions described in document and record control.
  • A risk assessment on the document/process should be performed, covering potential failures scenarios when using the documents/process.
  • The author should be a Quality Representative within the CSC. It must be approved by the QMO.
  • If there are significant changes to the document or process, adequate training must be provided to CSC team members who are required to use it.
  • The reference to the now-outdated Q-Pulse document should be removed from the table above, thus removing it from the annual audit.
  • The document reference should be updated in CSC Pl.002 Process Interaction where appropriate.