1 reply to this topic

[Charles.C]

Dear All,

This is not an ISO 22k submission although I found it during an on-going attempt to understand why I22k uses the term “operational prerequisites” when, as far as I can see, they are “intended” by ISO to not be prerequisites (not in the Codex sense anyway).

Regardless, "Prerequisites" used to approx. = GMP and my searching found an interesting discussion which I thought might be usefully shared (although not necesarily agreed!) so here is part of it –

"GMP vs CCPs

Q1. When does an “established” programme (e.g. chemical residue suspect list procedures) have to be included in a HACCP plan rather than be represented as a prerequisite programme?

A1. Ideally, all hazards identifiable with the raw material, inputs and process steps should be considered in the development of the HACCP plan. This would include those chemical hazards associated with identified chemical suspect residues. While an “alreadyestablished programme” may be seen to be delivering an appropriate level of control under GMP as it does under HACCP, application of HACCP principles is required to ensure that this is in fact the case. Also it may be found that controls are more effective if included in an integrated HACCP plan. If treated separately, it does mean that the approach to hazard identification and control for raw material hazards is going to be fragmented (with some in prerequisite programmes and some in the HACCP plan) and an auditor would be obliged to check the prerequisite programme as well as the HACCP plan for completeness.

Q2. How are prerequisite programmes and CCPs differentiated? Can a control measure that is covered by a prerequisite programme be made a CCP, e.g. chilling?

A2. Prerequisite programmes and CCPs can be differentiated by consideration of performance and impact on the process. A process step such as chilling, that already has documented and effective control mechanisms covered under a prerequisite programme, with appropriate records to support this performance, is unlikely to become a CCP in a HACCP plan. However, if this process step is known to be a problem area, and there is an associated history of nonconformance, then the processor is obliged to consider the impact of this step on the identified food safety hazards when carrying out the hazard analysis of the whole process, and this may result in the step becoming a CCP. A nonconforming water supply, although covered by a prerequisite programme as above, is unlikely to result in water usage becoming a CCP (or several CCPs) in a HACCP plan for a particular product and process. Appropriate actions to be taken are specified in industry standards as regulatory requirements. Further, water usage is not an individual process step but an activity that is usually involved in many process steps. Therefore it is always easier to control water potability separately, before it impacts on the main process itself, e.g. by readjusting an existing prerequisite programme to improve its effectiveness or by having a separate HACCP plan for water potability.

Q3. When are hazards considered to be addressed by GMP/prerequisite programmes?

A3. Hazards are generally considered to be addressed by GMP/prerequisite programmes when the following apply:
- the potential hazard is addressed by existing regulations and standards, e.g. Meat Regulations, MAF manuals, industry standards, circulars, TDs;
-the potential hazard affects the whole process and cannot be addressed at one specific step (e.g. water potability, personal hygiene, cleanup procedures, hygienic processing);
- the potential hazard directly or indirectly impacts on raw material, other inputs, outputs and/or the process but is addressed outside the HACCP plan (e.g. Supplier Quality Assurance programmes, food contact materials, water potability, waste management, vermin control).

Q4. Can certain components of GMP/prerequisite programmes be considered as CCPs?

A4. Certain components of GMP/prerequisite programmes may be considered as CCPs if the potential hazard can be controlled at specific steps of the process and one or more of the following circumstances apply:
 - existing procedures are not effective and/or process failure has occurred;
 - improvement in the process is required and/or can still be achieved;
 - the step is considered to be critical to the process and making it a CCP would increase the focus on control of the hazard and/or increase personnel awareness, and therefore would assist in the achievement of the FSO.

Thus, it is expected that making a component of a GMP/prerequisite programme into a CCP should directly or indirectly result to an improvement in the process and/or food safety outcomes through increased focus on control at that process step.

For the reasons given above, certain steps (e.g. legging, chilling) have been considered as addressed by GMP in some premises whereas others have considered them as CCPs. The CCP status of these steps can be removed when there is sufficient evidence to indicate that existing procedures at the particular step (which are components of a GMP/prerequisite programme) are adequate to consistently control the hazard and that no other improvements in the process and/or food safety outcomes can be achieved by making the step into a CCP.

It should be noted that not all prerequisite programmes can be considered as CCPs because the reasons given above do not apply (e.g. water potability, cleanup procedures, waste management, control of chemicals). If any of these programmes is ineffective then the specific system must still be corrected, e.g. as described in IS 8.

Q5: Are there CCPs that cannot be considered as GMP/prerequisite programmes?

A5: Control measures which are components of GMP/prerequisite programmes generally prevent the transfer and/or redistribution of hazards (e.g. hygienic dressing techniques). However, there are other types of control measures applied at certain steps that are not preventive but rather are designed to reduce or eliminate specific hazards. Examples of these are metal detection, thermal processing, and decontamination methods. In most cases, these operations would be considered as CCPs and would not be adequately covered under GMP/prerequisite programmes."

There is a lot of other HACCP factors discussed in a similar fashion at -
http://www.nzfsa.gov...at/haccp_v1.pdf

Above link has changed. Current link at 17September 2011 is -
http://www.foodsafet...de/haccp_v1.pdf

Rgds / Charles.C



.

[Simon]

Great document Charles, very interesting, if a little old. At the back there is a comparison of the now defunct ISO 9002 and HACCP. Even so most still valid and useful.

Thanks,
Simon