HACCP Services

HACCP Consulting Services

HACCP is a tool that was originally developed for the seafood industry to determine potential hazards in your production process that might critically effect the quality of your end products. At the current time, HACCP is required for the food industry under the new FDA food safety regulations and ISO 22000.

HACCP is a preventive, not reactive, management tool used to assure that the manufacturing process addresses all potential hazards of a product. HACCP is not a zero-risk system, but it is designed to minimize the risk of potential hazards. Understanding, proper implementation and monitoring can only be beneficial to your company.

mdi Consultants provides the following HACCP services:

Please read our article published in the Journal of cGMP Compliance – HACCP Inspectional Approach for Medical Device Manufacturers

1. HACCP TRAINING: WHAT IS HACCP?

HACCP is an acronym for Hazard Analysis and Critical Control Points. When used properly, the HACCP approach of evaluating your products and the production process could provide assurance that you have determined the hazards associated with the product and its processes. You will also have to determine the CRITICAL CONTROL POINTS, those points that are used to either eliminates or reduces the Hazard and you have to define how you would be controlling these points.

Our staff will provide in-house training on HACCP, what it is, how it is to be used for your products and processes and most importantly how to do a HACCP ANALYSIS and PLAN.

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2. HAZARD ANALYSIS OF YOUR PRODUCT AND SYSTEM

mdi will work with your staff to prepare a flow chart of your operations and to perform a Hazard Analysis of your products and processes following the FDA guidelines for performing such analysis. Each product and process will be evaluated as to their potential Hazard as it relates to Biological, Chemical or Physical Hazard.

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3. DEFINING CRITICAL CONTROL POINTS (CCP)

Working closely with your staff, we will assist in identifying the CRITICAL CONTROL POINTS of the process as well as establish the critical limits for preventive measures associated with each CCP identified. We will then set up a program to monitor each CCP (establish procedures for using monitoring results to adjust the process and maintain control), establish corrective actions to be taken when a critical limit deviation occurs and finally establish a record keeping system.

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4. HACCP IMPLEMENTATION

Once the HACCP PLAN has been established, our staff will assist with the implementation of the plan to assure that it is fully understood and can be implemented with minimum difficulty and confusion. KISS is our motto (Keep It Simple Stupid). If not implemented properly, the HACCP PLAN has no value and could be a potential liability.

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5. AUDITING THE HACCP PLAN

Once the plan has been implemented, our staff will monitor the PLAN on a periodic basis to make sure that it is functioning properly and being properly controlled and adhered to. We will make recommendations of corrective actions to bring the PLAN into better compliance.

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6. INTERFACE WITH THE FDA ON YOUR PLAN

If you are interested in working with the FDA on your PLAN, our staff will provide an interface between your organization and the FDA to assure that the PLAN is understood, address any FDA issues and be available to meet with the FDA concerning any area that cannot be rectified without a face-to-face meeting. Our staff’s high level of integrity is recognized by the Agency and we are able to understand and work with the agency in a professional manner while still advocating your needs and requirements.

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7. BE AVAILABLE DURING FDA AUDITS OF YOUR HACCP PLAN

Once your PLAN has been accepted, the FDA will want to audit the PLAN. Our staff will be available to be present during these audits to assure correct interpretation, address any deficiencies immediately, and to assure that the audit is fair and follows the FDA guidelines.