Table of Contents
Deviation Management end-user requirements #
The deviation management module will enable the company to efficiently manage deviations and non-conformances related to the organization’s quality management system. Level 0 x module end-user requirements.
Level 1 – Deviation Management end-user requirements #
| Ref. ID | End-User Requirement (Theme / Epic level) |
|---|---|
| X.1 | As a quality manager, I want to implement a deviation management module as part of the quality management system so that all relevant deviations can be easily managed, tracked, and resolved, leading to improved quality management processes. |
Level 1 – Deviation Management end-user requirements Acceptance Criteria. #
| Ref ID. | Acceptance Criteria |
|---|---|
| X.1.1 | The deviation management module should be designed to support a range of deviation types, including product, process, and system deviations. |
| X.1.2 | The module should be capable of handling a large number of deviations and non-conformances. |
| X.1.3 | The module should have the ability to automatically assign deviations to responsible individuals or teams. |
| X.1.4 | |
| X.1.5 | |
| X.1.6 | |
| X.1.7 | |
| X.1.8 | |
| X.1.9 |
Level 2 – Deviation Management end-user functional requirements #
| Ref ID. | End-user functional requirements (User Story ) | Criticality |
|---|---|---|
| X.2.1 | As a quality manager, I want to be able to create deviation records and assign them to appropriate individuals, so that deviations can be investigated and resolved in a timely manner. | High / Low |
| X.2.2 | As an investigator, I want to be able to document my findings and recommendations for corrective and preventive actions, so that deviations can be addressed and prevented from recurring. | High / Low |
| X.2.3 | As a reviewer, I want to be able to approve or reject the proposed corrective and preventive actions, so that effective actions can be implemented. | High / Low |
| X.2.4 | High / Low | |
| X.2.5 | High / Low | |
| X.2.6 | High / Low | |
| X.2.7 | High / Low | |
| X.2.8 | High / Low | |
| X.2.9 | High / Low | |
| X.2.10 | High / Low |
Level 3 – Deviation Management non-functional system requirements #
Visit our non-functional system requirements page for an overview of non-functional system requirements.
