Functions approving document changes

The change does not need to be reviewed and approved by the same individuals who reviewed and approved the original document. The important factor is that the same functions or organizations review and approve the change. The reason is to subject the document to the same scrutiny as the original by personnel as qualified as those who examined the original. Providing your procedures specify the review and approval authorities in terms of functions or positions and not names, the requirement is easily satisfied. 

RTAP has prepared decision-point review documents for the Safety Function Status Trees that document the basis for technical data and numerical values used in the EOPs. The documents have been reviewed and approved by Reactor Safety Research, Reactor Operations Department, and Reactor Technology Department. The documents are not identified by a specific document number, but are part of the procedure package for DPS0L-105-MC-29-K, Rev. 2, "Vital Safety Function Monitoring-Emergency Condition" (Reference 3), presented for review and approval by the Operations and Maintenance Review and Approval Committee (OMPRAC). The documents become part of the procedure history file and are formally documented. Changes to the documents will not be tracked and reviewed since the documents are for historical purposes only. Administrative controls are required to ensure that all values in the EOPs are adequately maintained and revised as necessary. The staff determined that the EOP-decision point review documents provide the basis for the EOPs, but lack the... 

The standard requires that changes to documents and data be reviewed and approved bp the same functions/organizations that performed the original review and approval unless specificallp designated otherwise. 

How do you ensure that changes to documents are approved by the same functions or organizations that performed the original approval ... 

Changes to documents shall be reviewed and approved by the same function that performed the original review unless specifically designated otherwise. 

It is equally important to identify and test for functionality what should not happen as well as checking that the system works as expected e.g., in a workflow that involves parallel review followed by approval, the test should check that the document is not forwarded to the Approver until all the parallel reviews have been completed. Unless the users have been provided with a test EDMS, this will be the first time the full system is available to the project team and so there may be a tendency to try to make improvements to the system as it is tested. The project team must be clear whether such enhancements, or in the systems integrator s language functionality creep, will be implemented with the associated cost and delays or whether only major concerns such as noncompliant GxP functionality will be corrected. If faults are found during OQ it is better to complete the full protocol, if possible, in order that all required changes are identified and resolved prior to running the OQ again. 

Reference the Optional Template - MOOC Review and Approval Form referenced in this required standard as an example that may be used to document a MOOC. Very complex changes may require a more in depth assessment and such documentation may be used in lieu of this MOOC template. In such cases, the team conducts the hazard review functioning similarly to a PHA team. The documentation from such reviews is processed with the change request. 

Is revised, amended, reviewed, and approved under the control of an information control scheme - 19.2.8 The following is maintained as up-to-date documentation -19.2.9 a. Hazard and risk assessment results and related assumptions SIS equipment with its safety requirements Organization responsible for maintaining functional safety Procedures necessary to achieve and maintain functional safety of the SIS Modification information for all changes to the SIS - (MOC)... 

Documentation should be controlled in a consistent, compatible manner throughout the plant and the operating organization. This includes the preparation, change, review, approval, release and distribution of documentation. Lists and procedures for these functions should be prepared and controlled. 

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