Compliance Risk Assessments

In today's ever-changing regulatory environment, pharmaceutical companies must establish a true "Culture of Compliance," where compliance is integrated throughout the organization, is effectively part of the daily operations, and is not a barrier to conducting business.

The purpose behind the Compliance Risk Assessment is two-fold. First, it enables an organization to be proactive, identifying key risk areas before they become unmanageable problems. Second, it enables organizations to minimize potential losses associated with fines and penalties. As a result, these two functions ultimately lead to greater efficiency and profit.

Pharmaceutical manufacturers come in many shapes and sizes, but they all face similar challenges related to compliance. CIS is committed to providing an efficient and affordable means of compliance and risk management that is scaleable to the needs and priorities of your organization. The Compliance Risk Assessment is a low cost means of identifying potential risks and thus saving your organization from fines and penalties. During the Risk Assessment, CIS will perform a 5 Point Diagnostic Evaluation.

CIS utilizes a "Four Step Method" to conduct a needs assessment:

Step 1. PERFORM A "GAP" ANALYSIS.
The first step is to check the actual performance of the organizations and people against existing policies, procedures, standards, guidelines and regulations.

Step 2. IDENTIFY PRIORITIES AND IMPORTANCE.
The first step typically produces a large list of needs for training and development, career development, organization development, and/or other interventions. CIS evaluates these against organizational goals and constraints. This is done to determine if the identified needs are real, if they are worth addressing, and specify their importance and urgency in view of organizational needs and requirements

Step 3. IDENTIFY CAUSES OF PERFORMANCE PROBLEMS AND/OR OPPORTUNITIES.
Having prioritized and focused on critical organizational and personal needs, CIS identifies specific problem areas and opportunities in the organization; we must know what our performance requirements are, if appropriate solutions are to be applied. Two questions need to be asked for every identified need:

  • Are people doing their jobs effectively?
  • Do they know how to do their jobs?

This requires a detailed investigation and analysis of the people, their jobs, and the organization - both for the current situation and in preparation for the future.

Step 4. IDENTIFY POSSIBLE SOLUTIONS AND GROWTH OPPORTUNITIES.
If people are doing their jobs effectively, perhaps we should leave well enough alone. ("If it ain't broke, don't fix it.") However, some training and/or other interventions might be called for if sufficient importance is attached to moving people and their performance into new directions. But if employees ARE NOT doing their jobs effectively:

  • Training may be the solution, IF there is a knowledge problem.
  • Organization development activities may provide solutions when the problem is not based on a lack of knowledge and is primarily associated with systematic change. These interventions might include strategic planning, organization restructuring, procedure revision, system implementation, performance management and/or effective team building.