Manufacturing Change Control Management

Manufacturing operations face significant challenges in managing process changes, particularly when these changes involve multiple departments and stages. Without a clear and unified view of the processes involved, or a way to ensure that changes are compliant with established standards, such as ISO 9001, manufacturing organizations can struggle to remain competitive.

Without an agile system for managing process changes, organizations are unable to quickly adapt to the changing market, resulting in lost revenue or customers. Information silos and tribal knowledge of standard operating procedures (SOPs) can lead to inconsistencies during audit reviews. Without a scalable system in place, it is difficult to enforce standards across new distribution facilities.

Manufacturing Change Control Management (MCCM) provides numerous benefits for manufacturing and distribution organizations, including improved visibility into process changes and agility in adapting these changes. The ability to centralize process changes ensures that each user has access to the necessary information to participate in the process while audit tracking maintains compliance with ISO 9001 requirements. Tasks make it easier for users to prioritize their work, and the flexible nature of MCCM allows administrators to customize the change control process and specify SLAs for individual tasks. MCCM provides the following benefits.

• Centralize information storage/reporting: allows users access to all pertinent information associated with Change Control items via out-of-the-box drillable Dashboards
• Audit: track every facet of the Change Control process to ensure ISO 9001 compliance and enable Process Performance reports
• Assign tasks: automatically route tasks to their owners, communicating urgency and helping users prioritize their work through the use of Service Level Agreements (SLAs)
• Create/tailor processes: provide administrators the flexibility to create tailored Change Control processes including stages, gates, participants/roles/permissions and decision methods for “passing” each gate
• Out-of-the-box process: offers a standard Change Control process with predefined steps