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HACCP and ISO: Is it the Right Combination?
Rearranging Task Codes in a Manner to Better Accommodate the Combination of HACCP and ISO
by Lydia Guillot
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)
- Define QCPs
- Define quality operating limits for each QCP
- Define monitoring procedures
- Define verification procedures
- Define corrective actions (including further planned action) in the event that the limits of any QCP are exceeded
- 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)
The standards of ISO 9000 and ISO 22000 are available at the following sites:
- http://isotc.iso.ch/livelink/ (for ISOTC 34)6 and http://iso.ch/ (for ICS 67.120.20, which are standards for poultry but which are at present not available for public review or ICS 67.120.10 which are available but only pertain to red meat standards.).3
- http://secure/websitecomplete.com/iso9000surviva/shop/ is also available.7
ISO standards are important and will become more important in the future in terms of globalization and world trade. While food industry in the United States believes that these standards are unnecessary, they will find this is not the case. For one thing, ISO standards are independently auditable. What this means is that with ISO standards, an establishment can have a third party come in to certify or accredit them, or at least define the validity of the programs in their establishment. That third party can determine if the establishment needs to upgrade its program. Also, products produced in an ISO system establishment are more marketable globally and domestically because ISO standards are used more often than not in terms of meeting trade requirements worldwide. Each establishment that has chosen ISO standards must adhere to them regardless of what country with which one is trading. As well, while each country has only one member of the ISO standardizing body, certainly each establishment would have an opportunity to express their opinion as a corresponding member or at least advisors to members themselves. ISO is voluntary and independent of government, but some governments have chosen to incorporate standards within their regulatory framework. Not only this, but ISO standards are based on consensus of the standardizing body as described above.9
The purpose behind using ISO in conjunction with HACCP is to bring into focus various aspects that are available to inspection, but are not under the same degree of enforcement or weight as those tasks that are considered “Food Safety,” such as zero tolerance, or time and temperature parameters. It is obvious from the previous article (A Perfect Blend, Part 3: Risk Management Considerations if and when HACCP and ISO are Combined, Food Quality, February/March issue) that there are other parameters resulting in recalls, which are becoming as if not more important than microbiological parameters. It becomes necessary that these be addressed as well, and that can be accomplished by ISO. While microbial counts appear to be decreasing, the amount of recalls due to microbial causes has shown inconsistency. A way to consider this issue is to address the dressing defects that are under the finished product standards, but that may still contain aspects that might be linked to the presence of harmful pathogens. This is the reason for the rearrangement of task codes, in a manner that would better accommodate the combination of HACCP and ISO.
- HACCP Regulatory Process For HACCP-Based Inspection. Reference Guide. Published by USDA/FSIS Human Resource Development Staff. January 1998.
- www.saferpak.com Paper on ISO 22000 by Dr. John Surak, Clemson University; and paper on standardizing bodies by Dr. Martha Petro, Secretary-General of ISO/TC 34, food products.
- www.iso.ch/iso/ ISO Web site
- USDA, 1996, Pathogen Reduction: Hazard Analysis and Critical Control Point Systems; Final Rule, Federal Register, Vol. 61, No. 144, July, 25, 1996, pages 38805-38989.
- www.chiltonconsulting.com Q Pro Con System description
- http://isotc.iso.ch/livelink/ (for ISOTC 34)
- http://secure/websitecomplete.com/iso9000 surviva/shop/ for available ISO standards
- www.saferpak.com/brc.htm Development of ISO 22000 and the BRC.9. http://www.iso.ch/iso/ Certification, General Management, ISO 9000 and 14000 standards.
- www.MeatandPoultry.htm Building Quality on Your Food Safety Foundation. Jeff Chilton Meat and Poultry Quarterly May 1999.
Lydia Guillot is a veterinary medical officer/public health veterinarian for USDA. Reach her at LGuil42909@aol.com.