HACCP and ISO: Is it the Right Combination?

From the regulatory standpoint, prior to implementing any federal program in which ISO and HACCP are in combination, the feasibility of rearranging task codes that are included in the generic Inspection System Program (ISP) might be important to the success of the combination. There are tasks, which are now considered other consumer protection tasks, and which might be more efficiently placed into following the task codes: 03 (HACCP), 01 (sanitation), 06D01 (sanitation performance standards) or 05 (pathogen reduction).1 Such a revision would give a tighter vision of food safety and would enable better oversight in each of these categories, and it would also identify quality areas that may or may not be relevant to food safety but are certainly important in considering consumers.

Food safety would of course be under the auspices of HACCP, and there would be critical control points.1 Food quality would be under the auspices of ISO, and there would be quality control points, as noted by Dr. John Surak.2 If this takes place, there are two possibilities for incorporating both HACCP and ISO in establishments. The first situation is one in which plants have already been operational, have consequently been under HACCP, and would only need to implement ISO 9000 and up. Those starting after September 2004 would come under the umbrella of ISO 22000, as this considers both ISO and food safety management. Both plans will be included in this paper.3,4

In designing this plan, it is important to keep in mind that both HACCP and ISO need to be generic, so that establishments have the opportunity to demonstrate how they are managing their process. If a plant has a HACCP plan in place, the following will be implemented:

Using HACCP and ISO 9000 (or above) Standards

• Reassessment of HACCP plan with the modifications above and the seven steps that are required by regulation to be completed. In the recordkeeping step, shipping records must be made available to the regulators.
• A quality assessment or analysis and a mapping of various quality control points with in the establishment.
• Verification of those points in the flow
• Within these points would be quality operating limits. These limits determine control, and are additive or cumulative during the day for the tests performed. Cusum, used now for finished product standards, may be used, or another acceptable approved statistical program for maintaining the limits may be used.
• Design monitoring points for each QCP, being specific
• Design verification points for each QCP, again being specific
• Design corrective actions and further planned actions in the case that the limits for the QCPs are exceeded.
• Recordkeeping of each of the QCPs. Records must be accessible to regulators.(This is based on the Q Pro Con System, set up by Jeff Chilton at the following Web site: www.chiltonconsulting.com5, 10)

If a plant is starting after September, 2004, the following would be implemented, using ISO 22000, which incorporates both HACCP and ISO 9000 standards:

• Define management responsibilities
• Define resources and how these will be managed
• Define process flow, with control points labeled and defined
• Do a hazard analysis on all aspects of the plant
• Design the HACCP plan following the steps as promulgated in 9CFR417.2 and in the Final Rule listed in the Federal Register, Vol. 61, No. 144, July 25, 1996, pages 38805-38989.
• Define CCPs
• Define critical limits for each CCP
• Define monitoring procedures
• Define verification procedures
• Define corrective actions (including further planned action) in the event that the limits of any CCP are exceeded
• Design recordkeeping for each CCP
• Design supporting safety measure (SSM) program, listing all prerequisite programs and defining the location and purpose of the quality control points (QCPs)
  1. Define QCPs
  2. Define quality operating limits for each QCP
  3. Define monitoring procedures
  4. Define verification procedures
  5. Define corrective actions (including further planned action) in the event that the limits of any QCP are exceeded
  6. Design recordkeeping for each QCP
• Determine how and why things are measured and how the plan will be updated
• Validate the system (Food safety management: combining HACCP and SSM)
• Verify the system
• Update the system as needed

(This is based on a system designed by Dr. John G. Surak, Clemson University, in his paper, “HACCP and ISO: Development of a Food Safety Management Standard.” It can be accessed by www.saferpak.com.2,8)