Roadmap to Compliance

High Value Manufacturing Consulting develops a comprehensive path to compliance using a five-phase roadmap:

Phase 1:

Quality Audit & Assessment

> Assess the current situation in the manufacturing facility.

> Develop a plan including specific client resource requirements.

> Begin documenting the detailed plan, if time permits.

> Perform initial assessment.

Phase 2:

Activation Plan

> Document detailed plan including sequence of 11+1 Quality Management Strategies and Material Management systems required to be implemented.

> Provide detailed roadmap to creation of Objective Evidence Books and implementation of on-going credible evidence process that incorporates Layered Process Audits to take the stress out of audit preparation.

> Identify specific “Skill Set” and timing for each unique resource.  Implement introductory QMS modules and industry-specific compliance criteria. Document Checkpoint criteria. Finalize client resource commitment.

Phase 3:


Implement specific plan developed and agreed to from Contract #2. Results of Contract #2 plan will be divided into two separate sub-tasks (Contract #3 and #4) so a prioritized segmentation of the work and associated resources can be more easily implemented and managed.

Phase 4:

Assessment & Continued Implementation

Continue implementation of specific plan developed and agreed to from Contract #2 as detailed in sub-tasks.

Phase 5:

Certification Preparation

Provide pre-audit certification risk assessment prior to engaging the certified 3rd party Auditor to complete certification process. HVMC will provide a different person than the one involved in Phases #1 through #4 who will review the completed self-assessment to ensure all objectives have been met and gaps closed. This individual will review Objective Evidence Books, developed in earlier phases, with plant leadership. This pre-audit risk assessment will minimize the time needed for final certification and maximize potential for a successful certification by the 3rd party audit.