Using the New Change Log Utility in Xfmea
With the release of Version 4,
ReliaSoft has added Change Log functionality to the
This will be of use to organizations that are under a regulatory or
other requirement to strictly control and track modifications to
existing FMEA or RCM analyses. The functionality has been designed to be
flexible enough to fit procedures and requirements that may vary by
organization. This article describes one way that you might use the
softwares new Change Log features to manage and track revisions to a
NOTE: Although the pictures in this article demonstrate the
functionality implemented in Xfmea, identical capabilities are available
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 softwares 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 softwares 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
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,
- The number and name of the item that the modified record is
- 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
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.).
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
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
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 organizations particular needs.
- Generate a complete report of the version and link or attach it
to the analysis in Xfmea/RCM++ (or store it externally in your
organizations 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
- Use the softwares 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++.
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