Picker 7-May-99 MRI equipment
The following, deviations from the Device Quality System Regulations were documented:
1) Failure to maintain a design file necessary to demonstrate that the design was developed in accordance with the approved design plan as required by 21 CFR 820.30(j). For example, there is no documentation of any module testing of the gantry control module of the _____ Software. Procedure NENG 2304, 10/15/96, Software Design and Development Control System identifies module testing as a required task.
2) Failure to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation as required by 21 CFR 820.30(b). For example:
(a) Coding conventions, rules or procedures; e.g., addressing requirements for source code clarity, management of source complexity, and proper and safe use of the programming language; were not established for the implementation of the software component of the Axis/Irix Product, Project #NU1078, as indicated by procedure NENG 2304, 10/15/96, Software Design and Development Control System
(b) The Axis/Irix Alpha Test plan and procedures lacks documentation identifying how test cases are mapped to the corresponding element of the specification as required by procedure NENG 2304, 10/15/96, Software Design and Development Control System (8.2).
(c) The MR Work instruction Software Product Design Management, No. E084, lacks requirements for complete software specifications, unit testing, test case identification methodologies which assure testing rigor, and lacks test completion criteria such as test coverage or thoroughness requirements.
3. Failure to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including tile needs of the user and patient, as required by 21 CFR 820.30(c). For example:
(a) The MR division procedure, Design Program Management, No M2803 lacks a mechanism for addressing incomplete, ambiguous or conflicting design requirements.
(b) There is not an autonomous specification for the gantry control module of the Software component for the Axis/Irix devices. Procedure NENG 2304, 10/15/96, Software Design and Development Control System requires a “Software Design Description” which documents software specification (5.2) in sufficient detail to permit coding and module testing (7.3.2).
(c) There is not an autonomous complete software specification for the _____.
(d) The Axis/Irix Product Specification – Base Development Project #NU1078, Product Specification (CP3) – Rev B; states in 17.1, “The _____ software specification is part of the rest of this specification and does not need to be delineated separately.” However, the product specification lacks necessary detail to ensure correct software implementation the thorough software test coverage as illustrated by #2.2.2.1. OVERRIDE/RESET and a user discovered software problem where a cold restart was necessary in order to remove a patient from the device after a camera head hit the patient. This specification covers the functions of the Override/Reset button which failed to function as expected per this complaint, #IR056-99. This specification section contains the ambiguous word “all” which is not further specified elsewhere in this document or in another specification document, nor is there a cross reference to other relevant sections such as any defining the intended software functionality and performance in relation to activation of the contact sensors. There is no information which specifies sensor activation as an interrupt event.
4. Failure to establish and maintain procedures for verifying the device design as required by 21 CFR 820.30(f). For example:
(a)There is no documentation that all of the Axis/Irix _____ Communication Error Messages were exercised by testing.
(b) The only test completion criteria identified in the Axis/Irix Alpha Test Reports is the resolution of all major open problems. Criteria for testing rigor (e.g., identifying appropriate challenges) and/or thoroughness (e.g. structural and functional coverage criteria) are not documented.
(c) The test documentation lacks the necessary detail for objective review, and accurate repetition of tests. For example, “Cause collision throughout several whole body scans and confirm that the scans can be continued” does not identify the precise number of scans, number of collisions, or timing of the collisions. Test results are documented only as Pass or Fail and some comments.
(d) There is no test documentation, e.g., a test plan or actual test results, of the 8.4.15 (8.4E) version of the Odyssey software.
