Summary

To meet the challenges of today's food safety issues, the FDA has increased its emphasis toward programs that are proactive and prevention oriented. The most comprehensive, science-based program to date for reducing pathogen contamination in fruit and vegetable products is HACCP. It has become the industry standard for ensuring food safety. Unlike past traditional approaches which relied on end-product testing, HACCP focuses on continuous control and monitoring of CCPs to ensure safety all along the production and processing continuum. Because all product and processing operations tend to vary over time, however, it becomes important to be able to identify and quantify the type of variation present in them. Unfortunately, an inherent weakness of HACCP is that it can neither identify variation within a process nor provide any advanced warning as to when a CCP has a high probability of exceeding its CL, causing loss of control within the safety zone. If HACCP is to be a truly effective prevention tool, it must be linked to appropriate procedures that both monitor and verify that a process can remain in control and safe.

The reliability and effectiveness of HACCP as a safety tool can be greatly strengthened by the incorporation of statistical quality control (SQC) methods, namely SPC and acceptance sampling, into its structure. SPC is an objective, quantitative, and statistically valid means of predicting CCP control during monitoring. In SPC, the data generated can be used on a continuous basis to assess whether any unacceptable trends are developing over a period of time at a CCP and whether the process is in statistical control. In similar fashion, acceptance sampling brings the scientific method to HACCP verification activities. It can validate and verify that a process is not only operating in a safe zone of control but is producing a safe product.

Integration of SPC into a HACCP program will provide several benefits. First, it will bring about a culmination to any processor's/packer's HACCP plan in that statistically valid control charts will demonstrate to customers evidence of product safety. Second, it will provide an on-going and continuous improvement of all processes which will have a positive impact on the company's "bottom line.'' Third, it will satisfy future government regulations that are moving toward the requirement that a fresh produce processor/ packer or fresh-cut processor be able to document compliance with product performance standards.

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