The Institute of Medicine of the National Academies of Sciences has released a publication on the Scientific Criteria to Ensure Safe Food. As with previous publications from the National Academies, this publication is expected to have a significant impact on the future of food regulations in the United States.

Congress through the Food and Drug Administration and the USDA/Food Safety Inspection Service requested that the National Academies conduct a study on the recurrent controversy regarding the scientific basis of food safety criteria. This study accomplished the following objectives:

• Defined the terms "performance standard" and "performance criteria."
• Evaluated the scientific basis for existing criteria.
• Defined the science-based process to establish food safety criteria.
• Examined whether current criteria accomplish what they purport to accomplish.
• Reviewed the need for performance standards as measures of process control.
• Recommended changes for improvement.

The publication makes a number of recommendations to the regulatory agencies to improve the development of food safety regulations and criteria.

This publication also makes several recommendations for food processors to implement now. These recommendations include:

• "The committee strongly recommends that the regulatory agencies continue to introduce and audit implementation of HACCP in all sectors of the food industry, as appropriate."
• "The committee recommends the adoption of SPC principles linked to continuous improvement by food processors, as well as incorporation of such principles by the regulatory agencies into food safety regulations and into the agencies' compliance monitoring procedures of food processors."
• "Although microbiological samples provide both the plant and the regulatory agency with a 'score card' for plant performance, if future significant gains in the safety of the US meat and poultry supply are to be realized, meat and poultry establishments need to implement more effective process control measures."
• "Statistical process control linked to continuous improvement must be part of food safety regulations. The concept of 'continuous improvement' is central to food safety."

The report emphasizes that the US food processing industry must move from an inspection based system to a process control based system to ensure the production of safe food

This concept is not new. In 1997 FSIS published a technical amendment to the PR/HACCP regulation, where the E. coli data was to be recorded whether on a process control chart or on a table (Pathogen Reduction/Hazard Analysis Critical Control Point, Systems; Technical Corrections and Amendments, Federal Register Vol 62, No. 93 pages 26211-26219, May 13, 1997). The following supplementary information was published with the FSIS change of rules, "FSIS has concluded that statistical process control will provide experience in 'process thinking' (a central tenet of HACCP), and develop an historical record of performance, and permit evaluation of the long term stability of a process and determination of process capability (that is, how the process is actually working), and track the effectiveness of process improvement actions."

The NAS report makes the following conclusion: "…food safety regulations should incorporate the concepts of SPC linked to continuous improvement, and they should require that food processors analyze and maintain records to ensure that their processes (1) exhibit stable and predictable variation and (2) are capable of meeting performance standards."

It can be expected that voluntary reporting of data on control charts will become mandatory reporting of data on control charts plus providing a process capability analysis of the data. In addition, as the FDA and FSIS develop new performance standards and performance criteria, it can be expected that these new regulations will require the food processor to use SPC linked to Continuous Improvement to demonstrate not only compliance to the regulation but also improvements in the processing system to further improve the safety of the US food supply.

Recommendations for Food Processors

Process Control

All food processors should use Statistical Process Control to monitor all processes. SPC should be linked to continuous improvement. This will allow the food processor to take action to improve processes. Thus, SPC creates a win-win strategy between the stakeholders in the food processing chain including: the food processor, the customer and the regulator.

Benefits in implementing SPC include:

• Safer and higher quality food.
• Decreased production costs.
• Increased processing efficiencies.
• Better regulatory compliance.

When implementing an SPC program, long term cost reductions can be achieved by using a statistical quality control software programs such as Quality Monitor and Quality Analyst to collect and analyze data.

HACCP

All food processing plants should have an internal audit program to ensure the effectiveness of the HACCP program. A number of tools that can help a food processor implement an HACCP audit program. The American Society for Quality has a certification program for HACCP auditors. In addition, ASQ has also published: The Quality Auditor's HACCP Handbook.

Food processors should begin to use SPC to monitor prerequisite areas and HACCP programs.

Web Articles on SPC in the Food Industry

Using SPC to monitor Prerequisite Areas or HACCP programs

• HACCP Integrations
  www.nwasoft.com/press/mag_foodeng_0110.htm
• Integrating HACCP and SPC
  www.nwasoft.com/press/mag_haccp.htm
• Using NWA Quality Monitor For HACCP Data Collection in Food Processing
  www.nwasoft.com/appnotes/haccp.htm
• Analyzing Plant Sanitation Processes using Statistical Process Control
  www.nwasoft.com/appnotes/plantsani.htm

Using SPC to Improve Product Quality

• QC Software Holds the Mustard
  www.nwasoft.com/press/mag_foodengr9907.htm
• An Alternative to Reduce Variables in Cuts
  www.nwasoft.com/press/mag_pork.htm

Implementing SPC

• When it Comes to SPC, People are the Hard Part of the Equation
  www.nwasoft.com/press/mag_weimea_0106.htm
• Choosing and Implementing SQC Software in the Food Processing
  Industries
  www.nwasoft.com/appnotes/food.htm
• Implementing Statistical Process Control
  www.nwasoft.com/appnotes/impspc.htm

Other Sources of Additional Information

American Society for Quality

• ASQ home page
  www.asq.org 
• CQA-HACCP auditor's certification
  www.asq.org/cert/types/cqa-haccp/index.html 
• Quality Auditor's HACCP Handbook can be purchased from ASQ Quality Press at qualitypress.asq.org or by calling ASQ at 1-800-248-1946.

Institute of Food Technologists

• IFT home page
  www.ift.org
• IFT offers a process control short course.
  For more information visit the IFT Continuing Education Department or call IFT at 1-312-782-8424.

National Academies of Sciences

• NAS home page
  www.nas.edu 
• The NAS report on Scientific Criteria to Ensure Safe Food can be read on line or purchased from the National Academies Press at www.nap.edu/catalog/10690.html?se_side.

Food and Drug Administration

• FDA home page
  www.fda.gov 

Food Safety Inspection Service

• FSIS home page
  www.fsis.usda.gov

back to top