Gap Analysis 

Gap analysis assessments are conducted  to identify any variances between the current state of your organization's system, processes or performance to that required or expected by an external or internal authority. 

Many organizations want to determine the exact level of conformance to objectives or requirements and the efforts needed to achieve their goals. This is true particularly for those organizations interested in meeting compliance requirements such as  those of ISO 9001:2000, ISO 13485:2003, or FDA's QSR. This is useful especially to those clients that have either some form of an existing QMS or other formal system of documentation and can be used in conjunction with Process Mapping. 

Other organizations might be interested in analyzing their performance to internal goals and objectives relating to employee hiring and training, customer service, productivity, or inventory.  The resulting information can help an organization make decisions regarding resource allocation, strategic   planning, and operational structure.

Conduct Gap Analysis

We will conduct a comparison of current documents, records and practices to the requirements set forth in the Standards,Regulations or other specified requirements. A tour of your facilities will be taken and interviews with management and all relevant personnel will be conducted.  Cost is dependent on the time required for analysis based on the physical size, number of locations and number of personnel. 

Deliverables:

         Detailed report on Current System Status

         Corrective Action Plan  

Set Aims and Goals of the Project with Management

Upon completion of the Gap Analysis, a detailed report on the Current System Status and a Corrective Action Plan will be presented at a meeting with Client management in order to determine specific goals or objectives of the project, to define milestones, establish progress meeting points, allocate internal resources and assign responsibilities.  The Consultant and Management or Project Team will then establish a project plan utilizing a project planning chart such as a Gantt chart for implementing the QMS and review external costs.

Deliverables:

Detailed Project Plan

Project Team Assignments

Matrix of Responsibilities