Annex 1 Responsibility matrix
You can find the editable table here: https://docs.google.com/spreadsheets/d/1frDSW3Uq17wUy2TzvBcwhSiq1xceRFtsSzEidRsJyTg/edit?usp=sharing
Procedure leaders
As well as establishing the responsabilities that each job description has over each document, we deemed appropiate to single out a particular job description who we expect to act as a leader of that document. Thus, we have created one very simple table that outlines the one person who is expected to have an especially active role in a document.
The responsibilities for authoring, reviewing and approving Specific Procedures (SPs) are the same as their parent General Procedure (GP). The procedure leader of each SP is also the same as the leader of its corresponding GP.
The responsibilities for templates (T-ZZZ-nnn), records (R-ZZZ-nnn, R-TF-ZZZ-nnn) and other procedure-specific documents (such as design and development nomenclatures in GP-012) are defined within each corresponding General Procedure.
| Procedure | Leader |
|---|---|
| GP-001 Control of documents | JD-004 |
| GP-002 Quality planning | JD-004 |
| GP-003 Audits | JD-004 |
| GP-004 Vigilance system | JD-004 |
| GP-005 Human resources and training | JD-006 |
| GP-006 Non-conformity, Corrective and preventive actions | JD-004 |
| GP-007 Post-market surveillance | JD-004 |
| GP-009 Sales | JD-002 |
| GP-010 Purchases and suppliers evaluation | JD-004 |
| GP-011 Provision of service | JD-005 |
| GP-012 Design, redesign and development | JD-003 |
| GP-013 Risk management | JD-004 |
| GP-014 Feedback and complaints | JD-003 |
| GP-015 Clinical evaluation | JD-005 |
| GP-016 Traceability and identification | JD-004 |
| GP-017 Technical Assistance Service | JD-005 |
| GP-018 Infrastructure and facilities | JD-007 |
| GP-019 Non-product software validation | JD-005 |
| GP-020 QMS Data analysis | JD-004 |
| GP-021 Communications | JD-011 |
| GP-022 Document translation | JD-004 |
| GP-023 Change control management | JD-003 |
| GP-024 Predetermined Change Control Plan | JD-003 |
| GP-025 Usability and Human Factors Engineering | JD-005 |
| GP-026 Packaging and Labelling | JD-004 |
| GP-027 Corporate Governance | JD-001 |
| GP-028 AI Development | JD-003 |
| GP-029 Software Delivery and Commissioning | JD-005 |
| GP-030 Cyber Security Management | JD-005 |
| GP-050 Data protection | JD-020 |
| GP-051 Security violations | JD-020 |
| GP-052 Data Privacy Impact Assessment (DPIA) | JD-020 |
| GP-100 Business continuity and disaster recovery plans | JD-001 |
| GP-101 Information security | JD-007 |
| GP-110 Esquema Nacional de Seguridad | JD-005 |
| GP-200 Remote Data Acquisition in Clinical Investigations | JD-005 |
Responsibility matrix
| Document | JD-001 General Manager | JD-003 Design & Development Manager | JD-004 Quality Manager & PRRC | JD-005 Technical Manager & PRRC | JD-006 Human Resources Manager | JD-007 Technology Manager | JD-009 Medical Data Scientist | JD-011 Communications Manager | JD-020 Privacy and Business Law | Team members involved |
|---|---|---|---|---|---|---|---|---|---|---|
| GP-001 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-002 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-003 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-006 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-009 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-010 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-011 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-012 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-014 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-016 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-017 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-018 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-019 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-020 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-022 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-023 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-024 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-025 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-026 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-029 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-030 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-100 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-101 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-110 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-200 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-004 | Reviewer | Approver | Author | |||||||
| GP-013 | Reviewer | Approver | Author | |||||||
| GP-015 | Reviewer | Approver | Author | |||||||
| GP-051 | Approver | Reviewer | Author | |||||||
| R-018-* | Approver | Reviewer | Author | |||||||
| GP-005 | Approver | Reviewer | Reviewer | Author | ||||||
| GP-021 | Approver | Reviewer | Author | |||||||
| GP-050 | Approver | Reviewer | Author | Author | ||||||
| GP-052 | Approver | Reviewer | Author | Author | ||||||
| GP-028 | Approver | Author & Reviewer | ||||||||
| GP-027 | Author & Approver | Reviewer | ||||||||
| Declaración-de-Aplicabilidad | Approver | Approver | Approver | Author |
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & PRRC
- Approver: JD-001 General Manager