Simplify and Improve Workflow
Home > Simplify and Improve Workflow
Current workflows can create unnecessary compliance issues, inconsistencies, systemic gaps, and time to a process.
Malcom’s assessment and process mapping solution provides an objective/outside perspective to identify potential systemic, procedural, and inter-relational gaps with recommendations to simplify the workflow and improve efficiencies.
Our consultants work closely with the client subject-matter-experts (SMEs) to understand the current processes, systems, and workflow to:
- Compare and contrast inputs/outputs
- Identify steps/tasks performed
- Identify internal work-arounds/customization developed by SMEs to get process to work
- Identify interfaces with other systems
- Develop and verify ‘As-Is’ process map(s) and workflow
- Confirm gaps in the ‘As Is’ process
- Develop ‘To-Be’ future state process map(s) and workflow
- Incorporate industry ‘best practices’ that can be applied for consistency and added simplicity
- Confirm potential improvements for the ‘To Be’ future state process map(s)
- Identify SOP/documentation red-lines to support the ‘To Be’ process
- Identify training/skill sets required to simplify and maintain simplified workflow
Areas where we have simplified and improved workflows: (not inclusive)
- Batch Record
- Batch Record Review and Release Process
- Batch Record Issuance
- 510(K) Submission and Supporting Processes
- Label Issuance and Reconciliation
- Customer Order and Service
- Process/MES Workflow
- Change Control Routing and Approval
- In-process Sample Chain of Custody
Contact Us today to learn how Malcom Associates can help your organization simplify and improve its workflow and take a look at our workflow case study to learn more about our capabilities and expertise.