On the heels of the relocation of the Gateway Analytical facility, a discussion on Change Control seems appropriate.
Change control is a formal process within the quality management system that ensures significant changes and related execution activities are identified, captured and recorded within a controlled system. The objective of a solid Change Control system is to ensure that the integrity of the quality management system is maintained when significant changes occur. It is important to have discussions with all areas of the organization to ensure that the change control record and planned activities are comprehensively addressed.
Change control records should include the following:
- Detailed description of the change
- Justification for the proposed change
- Evaluation of work/ tasks to be performed
- Customer notification
- Impacted documents and areas
- Approvals (to include relevant management and QA)
Change control records should also include an approved closure report that verifies all planned activities were completed. Any deviations that occurred from the original plan must also be described and justified.
In regard to the relocation of Gateway Analytical, (although certainly not an exhaustive list) three (3) key quality areas that required a detailed plan and timeline for completion were identified as follows:
- Equipment re-qualification/ re-calibration: All equipment had to be re-qualified/re-calibrated after relocation and prior to use. This required scheduling with field service engineers well in advance to minimize instrument down-time.
- Customer notification: All customers had to be formally notified via a letter and in some cases a personal telephone call. (Always remember to thoroughly review all customer quality agreements to ensure all requirements are fulfilled prior to the move.)
- Internal document changes: All documents containing facility information had to be revised to reflect the current location and facility layout. The Quality Management System Manual and facilities SOP were two (2) of the first documents to undergo such a revision.
Based on our recent relocation experience, the key to a solid change control system is advanced and thorough planning from all areas of the organization.