This is what the Guidance for SQF8 Manufacturing states -
What does it mean?
An environmental monitoring program must be in place for food processes that are handled, exposed,
stored, processed or packed. This program should be included for food processes of all risk levels. This
element outlines the specific conditions required in areas where foods are processed or handled. Conditions
like these may contain pathogenic microorganisms and will support the formation of toxins or growth of
pathogenic microorganisms, and has a likelihood of growth causing illness or injury to a consumer if not
properly produced, processed, distributed and/or prepared for consumption. It may also apply to a food
that is deemed high risk by a customer, declared a risk by the relevant food regulation or has caused a
major foodborne illness outbreak (refer SQF Code, Appendix 2: Glossary).
What do I have to do?
The process flow is particularly relevant for high risk processes where the product is subject to handling or
exposure after a “kill-step.” This includes (refer to 11.7.1) segregation of the post-process end from the raw
material end of the process; controlling pedestrian walkways to avoid personnel contamination; dedicated tools
and equipment post-process; dedicated staff servicing the post-process end; and dedicated uniforms for staff
The reference to the environmental monitoring program is self-explanatory, but is worth repeating as it is
considered mandatory for areas in which high risk food is processed, handled or exposed. Failure to have an
effective environmental monitoring program will result in a major non-conformance.
An environmental monitoring program (EMP) is a program which includes pathogen swabbing to detect risk in the
sanitary conditions of the processing environment and is a verification of the effectiveness of the pathogen
controls that a management site has in place for high risk foods (refer Appendix 2: Glossary of Terms).
Swabbing must include not only the smooth, accessible parts of the process, but also the transfer points,
bearings, etc., where product is likely to build up.
To my understanding, "risk-based" refers to the sampling/analysisng procedure (eg zoning) used in the monitoring function of EMP, ie not to the estimated intrinsic, so-called, risk "status" of the product. (the Guidance confusingly [IMO] mixes the 2 terminologies together).
To my understanding (eg "red" above), the Guidance requires an EMP to be implemented regardless of the product's "risk" status.
One thread here reported that their auditor essentially "matched" the Guidance by insisting that the presence of multiple "shall" words in the Code necessitated implementing an EMP. Period.
Other auditors (eg Posts 2,3) seem to be ignoring the Guidance + "shall' and interpreting "risk" as referenced to the Product's risk status.
As per my above opinion I found the content of Posts 2,3 incomplete however the appropriate SQF auditors obviously thought otherwise.
IMO the audit for clause 2.4.8 has currently become somewhat of a "Lottery".
PS - to illustrate an alternative interpretation, consider this extract -
Determination of Need for PEMP
Not every food manufacturing facility needs to have a PEMP. More testing does not necessarily equal more safety. Rather, the judicious use of food safety resources requires interventions and verifications to be targeted to the most appropriate areas for the greatest risk reduction. A thorough risk evaluation should be conducted to lead the food safety team to a determination of whether or not a PEMP is necessary, which organism or indicator group to monitor, and the degree of stringency of the PEMP. Any type of sampling and testing has the potential for “false” results. This is especially true for microbial testing. Therefore, if a product or process can be designed that precludes the need for a PEMP; this option should be carefully balanced with other considerations such as product safety and quality, consumer acceptance, regulatory requirements, and production expense. An example of a process change that could eliminate the need for a PEMP is to eliminate product exposure to the plant environment (hot filling or aseptic filling versus cold or ambient temperature filling) or pasteurization of the product in its final package. Another example is the reformulation of a product or changing distribution from refrigerated to frozen to prevent the growth of L. monocytogenes.
The next component is a complete evaluation of the science-based food safety risk. We have designed a simple decision tree that can be used as a first step to aid in this risk evaluation. This decision tree has been used for hundreds of products in numerous production facilities and has been found to work well for most products/processes. However, it is meant to be used as a tool to assist in completing the risk evaluation and not used to replace a complete evaluation.
(A rather ingenious-looking, generic, decision tree is included in the sub-link)(the tree was possibly designed to attempt to match FSMA's more specific "risk" requirements)
Edited by Charles.C, 14 June 2019 - 08:52 AM.