Case Study #2: Validation Master Plan

CASE STUDY #2 - VALIDATION MASTER PLAN

Project objective: Maintain facility Validation Master Plan

Project description: Chicago Controls was requested to maintain the facility Validation Master Plan (VMP) due to loss of personnel. The VMP was a lengthy document comprising sections on all aspects of plant activities. The plant manufactured multiple products. The VMP included extensive lists of equipment, utilities, and associated assets.

Chicago Controls project activities: Chicago Controls evaluated the existing VMP. Review of sections indicated inaccuracies and omissions in the document. Chicago Controls facilitated a coordinated effort with plant personnel to successfully correct errors and omissions. The VMP was also not able to be easily used when VMP updates were made. Chicago Controls made suggestions to Management to facilitate VMP usage in regulatory and internal audits. Suggested
changes were implemented resulting in an easily used VMP.

Results: The facility VMP was successfully updated and maintained including document structural enhancements suggested by Chicago Controls.

Customer benefits: There were three significant customer benefits in this project:

1. VMP updates. The VMP was updated to correct inaccuracies and omissions.

2. VMP maintenance. The updated VMP was continually maintained.

3. VMP enhancements. The enhancements to the VMP significantly improved the use of the VMP in regulatory audits.

Summary: The contributions of Chicago Controls enabled successful project completion and exceeded customer expectations.

"The Validation Master Plan is much more easy to use -- much better than the previous system. It will be much easier for an outside auditor to use and find the current updated sections." - Plant Quality Manager