Whether you need to prepare your organization for the next level of growth and success, bring your quality system into compliance, drive a small-focused effort to improve a process, or bring in valuable subject experts, APEX has the knowledge, experience, and resources to support your business in its pursuits. The first step in APEX “meeting the organization where it’s at in its journey”, is to evaluate or assess the organization as related to:
Potential for Growth
- Process-focused positioning of an organization for growth beyond current capabilities and management practices.
- Development and application of a business model as framework for a holistic approach of managing the organization.
- Process architecture development around organizational key value stream(s) (key product or service).
- Aligning vision/mission to process metrics and actionable improvement opportunities meeting requirements.
- Creating a Culture of Fact-Based Process Execution
- Deep and Broad process understanding to gain rich insight into problems and solutions, based on facts not opinions.
- Alignment of Demand Requirements, TAKT time, current process performance and efficiency to determine KPI Goals for Monitoring, Process Capacity, and Improvement Opportunities.
- Providing insight into how much improvement organizations NEED, vs how much they can get.
Ability of the Organization and the Quality Management System to meet Regulatory Requirements
- Operationalizing requirements into well-defined, executable processes that can be measured and improved.
- Multi-tier documentation structuring (architecture) providing for policy-setting and “floor” execution.
- Quality Manual development meeting ISO standards, yet tailored for specific organizational needs and Quality philosophy.
- Timely Regulatory Remediation and Execution
- Translating audit findings/observations into actionable process-focused resolution.
- Product knowledge translated into Critical to Safety/Quality attributes in a compliant Design History File.
- Process development integrating foundational documentation practices, process controls, and Lean/Six Sigma tools.
Availability of Resources and Team Management
- Individual subject matter expert contribution for a focused effort
- Team leadership/project management for a focused work group to achieve specific goals or deliverables.
