Know your QMS!
Across
- 4. A Bug state where all work activities except test is done and includes investigation, design, code, documentation etc (6)
- 5. Process of protecting information by preventing, detecting and responding to attacks (13)
- 6. A term used for testing an application with the primary goal of getting the application to fail. It is synonymous with "negative" testing or "exceptions" testing. (11,8)
- 8. The manufacturer’s objective intent for the device and its usage – Intended use (8,3)
- 11. Folder in DHF structure where documentation such as drawings, product documentation, labeling, device specifications, sw documentation etc…..(6,6)
- 13. Any change to product is controlled by a 7 step process (11,6,5)
- 14. Name one of the project outcomes of tollgate meetings where the project is being terminated and the result is documented (4)
- 15. Instruction that outlines how to assign a software safety class based on the risk of harm, defined in the product risk management plan (8,6,14)
Down
- 1. The group that decides to approve or postpone or reject proposed changes for a specific project (6,7,5)
- 2. The Software Hotfix Release process cannot be used for _______________ modifications(10)
- 3. Examination of your task/activities performed at every milestone of your project(6,6)
- 7. One of the activities performed periodically to check if the __________________ is carried out as described in the PMS Plan (4,6,12)
- 9. Name of the procedure in RMED QMS where the ‘Retention Period’ for all the created documents are specified (7,6)
- 10. Defined as any identifiable part of a computer program, i.e., source code, object code, control code, control data, or a collection of these (8, 4)
- 12. QSR Section number related to Design Verification (3,2,1)