FSMA Compliance
Gap Analysis
Gap Analysis
The Food and Drug Administration (FDA)’s Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4, 2011. Its purpose is to shift the emphasis from reacting to instances when they occur to a more proactive preventative approach. Numerous standards and procedures have been established to comply with the new requirements.
Not sure if your current practices and procedures meet the applicable FSMA requirements? Many companies start by conducting a gap (or needs) analysis. The analysis starts with a review of the company’s written policies, procedures, and practices. These documents describe the company’s goals and how the company intends to satisfy these goals using standardized processes.
A gap analysis is a mechanism that allows companies to see where they are today verses where they need to be in the future. Companies can then adjust their policies, procedures, and practices to be on the proper path to success.
FSQP offers gap analysis services, which are a benchtop review of your FSMA process. They are done remotely (saving you from travel expenses) but can be done on-site at your request. The gap analysis will:
- Define the requirements that need to be met.
- Benchmark the current state.
- Find areas for improvement that would bring your process into compliance with requirements
- Prepare a written report that includes items on which action should be taken.
A gap analysis is not consultation. As an independent body, FSQP will not dictate specific
solutions to found issues. Rather, FSQP can explain the requirements and general approaches that
can be used to resolve problems.