NOTE: Although the pictures in this article demonstrate the functionality implemented in Xfmea, identical capabilities are available in RCM++.

Preparing the First (Original) Version of the Analysis
There are likely to be many modifications to early drafts of an analysis and it may not be necessary to track the exact details of every specific change when preparing the first complete version. In this case, you will use Xfmea or RCM++ in the same way that you always have, with no special Change Log configurations. As it does for all analyses, the software will record the date of the most recent change to each record and, for login secure databases, the name of the user who made that change. At some point, you will finalize the analysis and prepare to submit it, for example, to management, a customer, a regulatory authority, etc. You may run the software’s “Check Analysis” feature to make sure that there are no obvious discrepancies in your analysis (such as Effects without a Severity rating, Failure Modes with no Causes identified, etc.). You will probably generate a print-ready report for distribution of the analysis in Microsoft Word® or Excel® (or even exported from one of those applications to HTML or PDF format). You may also wish to include some charts to demonstrate the analysis graphically (e.g. a bar chart of the top 10 failure causes ranked by RPN, a pie chart of recommended actions by their completion status, etc.) and/or your own custom reports generated with the software’s flexible query utility.

Activating the Change Log and Recording Approvals Electronically
When the first version of the analysis is complete, an authorized user can select Activate Change Log from the System Hierarchy menu in order to put the analysis under formal revision control. The analysis at that point is identified as the “Original” version and the analysis is then “locked” and not editable until the first tracked “Revision” begins.

If appropriate (and only in login secure databases), the user(s) managing the Change Log may choose to assign specific database users to review and approve the Original version of the analysis. If each user has a different role when reviewing and approving the analysis (e.g. Engineering, Documentation, Legal, etc.), this can also be identified in the Change Log record. The software can be configured to automatically send a notification e-mail to all assigned approvers to inform them that the analysis is ready to be reviewed. Each person then must log in to the database, review the analysis and electronically record his/her approval of the version. (Note that if the reviewers determine that changes are required before the version can be approved, the analysis can be re-opened and the process begins again.)

This feature is particularly useful for organizations that are subject to regulatory requirements for electronic record tracking, such as the FDA's 21 CFR Part 11 regulations.

Preparing a Revised Version of the Analysis and Recording the Changes
After all assigned users have electronically recorded their approval of the Original version, the analysis becomes eligible for its first formally tracked “Revision.” When the team is ready to begin updating the analysis, an authorized user can open the Analysis Change Log window and click Start Revision to define the next version with a number, a name and, if desired, optional comments about the purpose or circumstances of the revision. The authorized user can also specify whether the software will require users to enter a “Reason for Change” for each modification to the analysis. (If not, the software will simply record the details of the change with no impact on the way users interact with the software when updating the analysis). The utility will automatically record the following details for each change:

• The Revision in which the change was made.
• The date/time of the change.
• The user who made the change (for login secure databases only).
• The type of change (e.g. add, edit, delete, etc.).
• The type of record that was changed (e.g. item, function, failure, etc.).
• The number and name of the item that the modified record is associated with.
• The number and description of the record that was changed.
• The property that was changed, if applicable (e.g. Cause Description, Initial Occurrence, etc.).
• The value of the property before the change, if applicable.
• The new value of the property, if applicable.
• The reason for change provided by the user (if chosen to be captured).

The following picture shows the Version History and Change Log tables that are maintained for the analysis. Users can view this information within the Analysis Change Log window and also export the reports to Excel, if desired.

Analysis Change Log Window - Click to Enlarge...

Users can also view and export data from the Record Change Log window. As shown next, this window displays a history of the modifications to an individual record since the Change Log was activated (e.g. a particular Effect and its Severity ratings, a particular Cause and its Occurrence and Detection ratings, etc.).

Ending the Revision and Recording Approvals Electronically
When the team has completed the first Revision to the analysis, an authorized user can open the Analysis Change Log window and click End Revision. The analysis at this point in time is identified by the # and name that have been specified for the Revision (e.g. 1.0 – Revision 1) and the analysis is again locked and not editable until the next tracked Revision begins. If users have already been assigned to review and approve this version of the analysis (and the e-mail notifications feature has been enabled), then the software will automatically send an e-mail to inform these users that the analysis is ready to be approved. The next Revision cannot be started until all assigned approvers have electronically submitted their approval of the current version of the analysis and the user(s) who are managing the Change Log may continue to add or delete approvers as necessary during this period. 

At some point, the team may need to prepare another revised version of the analysis. In that case, an authorized user will open the Analysis Change Log window again and click Start Revision to define the next minor revision (e.g. 1.1 – Revision 1.1) or major revision (e.g. 2.0 – Revision 2); the analysis becomes editable again, and so on. This cycle can be repeated as many times as necessary, providing a complete record of all of the changes that have been made to the analysis, within each tracked revision cycle, since the Change Log activation.

Note About Archiving Each Finalized Version of the Analysis
Please note that even when the Change Log is active, the Xfmea/RCM++ software automatically stores only the current version of the analysis in an editable state. Therefore, you may wish to manually archive the analysis as it was at the time when each version was completed. There are several ways to accomplish this depending on your organization’s particular needs. Options include:

• Generate a complete report of the version and link or attach it to the analysis in Xfmea/RCM++ (or store it externally in your organization’s formal document management system).
• Maintain separate “archive” copies of each version of the analysis within the software (e.g. as separate items in the same project or within separate projects). For example, each time you finalize a version of an analysis, you could copy and paste (or export) it into an “Archive” project, which remains locked for editing.
• Use the software’s “Baselines” feature to store and manage complete backups of the database at the time when each version was completed.

All three options would provide an archive of each version of the analysis but only the last two approaches would allow you to “roll back” and work with the analysis in Xfmea or RCM++.

Conclusion
As this article demonstrates, Version 4 of the Xfmea and RCM++ software provides a flexible array of options to control and track modifications to your FMEA or RCM analyses and also to provide electronic approval tracking, if desired. A flowchart of the workflow described in this article is presented to the right. Since processes tend to vary by organization, the software can also be configured to fit other procedures for revision tracking and management. For more information about purchasing or upgrading the software, please visit the product Web sites at http://Xfmea.ReliaSoft.com or http://RCM.ReliaSoft.com.