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.
| Procedure | Leader |
|---|---|
| GP-001 Control of documents | JD-004 |
| SP-001-001 eIFU management | JD-004 |
| GP-002 Quality planning | JD-004 |
| GP-003 Audits | JD-004 |
| GP-004 Vigilance system | JD-004 |
| SP-004-001 Product Withdrawal | JD-004 |
| GP-005 Human resources and training | JD-006 |
| SP-005-001 Anti-corruption and anti-bribery | JD-006 |
| GP-006 Non-conformity, Corrective and preventive actions | JD-004 |
| GP-007 Post-market surveillance | JD-004 |
| GP-008 Product requirements | JD-003 |
| GP-009 Sales | JD-002 |
| SP-009-001 How to use CRM | JD-002 |
| SP-009-002 How to use contracts | JD-020 |
| SP-009-003 How to share performance metrics | JD-011 |
| GP-010 Purchases and suppliers evaluation | JD-004 |
| GP-011 Provision of service | JD-005 |
| GP-012 Design, re-design and development | JD-003 |
| SP-012-002 Cybersecurity and transparency requirements | JD-017 |
| 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 |
| SP-018-001 Remote infrastructure control access policy | JD-005 |
| GP-019 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-050 Data protection | JD-020 |
| SP-050-001 Data protection officer manual | JD-020 |
| SP-050-002 Manual of functions and obligations of the staff | JD-020 |
| GP-051 Security violations | JD-020 |
| GP-052 Data Privacy Impact Assesment (DPIA) | JD-020 |
| GP-100 Business continuity and disaster recovery plans | JD-001 |
| GP-101 Information security | JD-007 |
Responsibility matrix
Responsibilities table
| Document | JD-001 | JD-003 | JD-004 | JD-005 | JD-006 | JD-007 | JD-009 | JD-011 | JD-017 | JD-020 | Team members involved |
|---|---|---|---|---|---|---|---|---|---|---|---|
| GP-001 | Approver | Reviewer | Reviewer | Author | |||||||
| R-001-* | Approver | Reviewer | Reviewer | Author | |||||||
| GP-002 | Approver | Reviewer | Reviewer | Author | |||||||
| GP-003 | Approver | Reviewer | Reviewer | Author | |||||||
| SP-004-001 | 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 | |||||||
| SP-018-001 | 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-100 | Approver | Reviewer | Reviewer | Author | |||||||
| GP-101 | Approver | Reviewer | Reviewer | Author | |||||||
| R-002-* | Reviewer & Approver | Author | |||||||||
| R-007-006 | Reviewer & Approver | Author | |||||||||
| GP-004 | Reviewer | Approver | Author | ||||||||
| GP-007 | Reviewer | Approver | Author | ||||||||
| GP-013 | Reviewer | Approver | Author | ||||||||
| GP-015 | Reviewer | Approver | Author | ||||||||
| SP-001-001 | Approver | Author | Author | Reviewer | |||||||
| T-002* | Approver | Author | Author | Reviewer | |||||||
| R-004-* | Approver | Author | Author | Reviewer | |||||||
| GP-008 | Approver | Author | Author | Reviewer | |||||||
| SP-005-001 | Approver | Author | Author | Reviewer | |||||||
| R-010-001 | Approver | Author | Author | Reviewer | |||||||
| R-TF-001-008 | Reviewer | Reviewer | Approver | Author | |||||||
| R-012-* | Reviewer | Reviewer | Approver | Author | |||||||
| GP-051 | Approver | Reviewer | Author | ||||||||
| T-051-* | Approver | Reviewer | Author | ||||||||
| GP-005 | Approver | Reviewer | Reviewer | Author | |||||||
| GP-021 | Approver | Reviewer | Author | ||||||||
| GP-050 | Approver | Reviewer | Author | Author | |||||||
| SP-050-* | Approver | Reviewer | Author | Author | |||||||
| GP-052 | Approver | Reviewer | Author | Author | |||||||
| T-052-* | Approver | Reviewer | Author | Author | |||||||
| REQ* | Approver | Tester | Tester | Tester | Tester | ||||||
| T-012-001 | Approver | Tester | Tester | Tester | Tester | ||||||
| TEST* | Tester | Approver | Tester | Tester | |||||||
| PLAN* | Tester | Approver | Tester | Tester | |||||||
| T-012-003 | Tester | Approver | Tester | Tester | |||||||
| T-012-018 | Tester | Approver | Tester | Tester |
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, JD-004
- Approver: JD-001