BRCGS issue 9
4.11.8 Environmental monitoring
Risk-based environmental monitoring programmes shall be established for relevant pathogens or spoilage organisms. These programmes are essential for covering all production areas, especially those dealing with open and ready-to-eat products.
The design of the environmental monitoring programme shall be risk-centric, emphasizing factors such as sampling procedures, pinpointing of sample locations, regularity of tests, identification of target organisms like pathogens or spoilage indicators, and methods of testing such as settle plates or rapid tests. It's crucial that the results are both recorded and evaluated thoroughly. For transparency and accountability, all aspects of this programme, including the associated procedures, must be documented.
Control or action limits shall be distinctly defined within the programme's parameters. Shall the monitored results point towards a deviation from the established controls or display a consistent pattern of positive outcomes, the company is mandated to document corrective measures. A periodic review of this programme, at least once a year, is imperative.
This review becomes even more essential when there are changes in processing conditions, introduction of new scientific data, failures in the programme's identification process, positive test results in products, or a consistent record of negative results. The latter might suggest a need to revisit the programme's testing zones, methods, or the very organisms it targets.
IFS version 8
5.6 Product testing and environmental monitoring
Testing and monitoring plans for both internal and external analyses shall be documented and implemented, taking a risk-based approach to ensure the aspects of product safety, quality, legality, authenticity, and specific customer requirements.
The scope of these plans shall encompass raw materials, semi-finished products (where relevant), finished products, packaging materials, contact surfaces of processing equipment, and particular parameters concerning environmental monitoring. The importance of recording all test results is stressed.
Moreover, criteria pertaining to the environmental monitoring programme shall be established, documented, and maintained, guided by the potential risks associated with the operation.
2.5.7 ENVIRONMENTAL MONITORING
The organization shall establish a risk-based environmental monitoring program aimed at the identification and management of relevant pathogens, spoilage, and indicator organisms. In line with this, it is imperative to have a documented procedure in place that evaluates the efficacy of controls, particularly those preventing contamination from the manufacturing environment. This evaluation shall, at its core, focus on microbiological controls, ensuring adherence to both legal and specific customer requirements.
Furthermore, comprehensive data records pertaining to environmental monitoring activities shall be maintained. This encompasses consistent trend analysis that provides insights into the changing patterns and potential risks in the environment.
It is also essential for the environmental monitoring program to undergo periodic reviews, ensuring its ongoing effectiveness and relevance. Such a review shall be conducted at least once annually.
However, more frequent evaluations might be necessary based on certain triggers. These triggers include notable shifts related to products, processes, or legislation; extended durations of time without any positive testing results; trends indicating off-spec microbiological results that connect back to environmental monitoring; repeated pathogen detections during routine assessments; and any alerts, product recalls, or withdrawals directly linked to the products manufactured by the organization.