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HACCP Services

HACCP is an acronym for Hazard Analysis and Critical Control Points. It is a tool that was originally developed for the seafood industry to determine potential hazards in production processes that might critically affect the quality of an end product. Currently required for food safety; the FDA is making new strides to require medical device companies to comply with HACCP as well, with an eye on the pharmaceutical industry to follow.

A Critical Control Point (CCP) is defined as "a point, step, or procedure in a food process at which control can be applied and, as a result, a food-safety hazard can be prevented, eliminated, or reduced to acceptable levels."

Applying the Strategy

HACCP is a preventive 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. 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. This approach is based on the following seven principles:

1. Conduct Hazard Analysis
2. Determine the CCPs & Define Control
3. Establish Critical Limits
4. Establish Monitoring Procedures
5. Establish Corrective Actions
6. Establish Verification Procedures
7. Establish Record-Keeping & Documentation Procedures

How QPS can help

Using time-tested techniques, QPS provides the consulting and training that clients need to understand hazard analysis and develop the tools needed to create, monitor and improve a controlled process for managing HACCP. Our services give clients the knowledge they need using a comprehensive, empowering method that teaches teams how to manage their HACCP plan in manufacturing through the following courses:

• HACCP Basic Training
• System and Product Hazard Analysis
• Determine and Define CCPs
• Implementing an HACCP Plan
• Auditing an HACCP Plan
• Managing HACCP for FDA

PS will review the HACCP Plan and create an operational flow chart to perform a Hazard Analysis of your products and processes following the appropriate FDA guidelines. We evaluate each product and process for its potential Hazard as it relates to Biological, Chemical or Physical Hazard. We will assist in identifying the CRITICAL CONTROL POINTS of the process and help establish the critical limits for preventive measures associated with each CCP identified. We will then establish procedures to monitor and control each CCP, establish corrective actions required when a critical limit deviation occurs and create a record keeping system. Once established, the QPS team will assist with the HACCP Plan to ensure overall understanding and user-friendly implementation. If implemented improperly, the HACCP Plan has no value and could be a potential liability.

Following successful implementation, QPS will monitor the plan periodically; and make recommendations for corrective actions to bring the plan into better compliance. Once 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 on-site, and to ensure a fair and appropriate audit.

We are well versed in working with certification companies to meet the needs of our clients. QPS takes pride in its attention to detail and ability to provide consistent, quality service to help its clients get what they want, and provide a valuable service at the same time.

Please contact QPS to help you become compliant and at a reasonable cost!