What's New Unreplied Topics Membership About Us Contact Us Privacy Policy
[Ad]

Clause 4.11.8 Environmental Monitoring of Closed areas

Started by , Apr 14 2019 10:28 PM
9 Replies

Hi Again

 

BRC issue 8 really got me busy 

 

With regards to 4.11.8b- enivronmental monitoring - the statement indicates all production areas with open and ready to eat prodcuts so am I correct in saying that if the production area is an enclosed area - no contact low risk plant this cause will not apply?

 

Kind Regards

 

Share this Topic
Topics you might be interested in
SQF Clause 5.2.1 - Artwork customer approval BRCGS Storage and Distribution - Clause 1.1.9 BRCGS Clause 3.11.3 - Incident management test must include a recall test? Clause 8.5.1.2 - Characteristics of raw materials, ingredients and product contact materials FSSC 22000 Clause 2.5.1 - Management of Services and Purchased Materials
[Ad]

Hi Again

 

BRC issue 8 really got me busy 

 

With regards to 4.11.8b- enivronmental monitoring - the statement indicates all production areas with open and ready to eat prodcuts so am I correct in saying that if the production area is an enclosed area - no contact low risk plant this cause will not apply?

 

Kind Regards

 

Note the Heading -

 

Risk-based environmental monitoring programmes shall be in place for pathogens or spoilage organisms. At a minimum, these shall include all production areas with open and ready-to-eat products.

 

The design and structure of this programme will depend on the nature of the products being handled and the potential hazards
associated with them. Sites are not expected to ‘opt out’ of this requirement by determining that they have a low-risk product or
environment; completion of a risk assessment (clause 4.11.8.1) will identify relevant hazards, suitable monitoring techniques and
appropriate monitoring frequencies. #### Jack; JV Legal Alliance

In our BRC training (from BRC not a third party supplier), they said that was a typo. It is supposed to read "production areas with open and/or ready-to-eat products". Our plant is a closed system and is a not RTE ingredient, but we are still doing Environmental Monitoring. 

I believe you are interpreting this wrong. It is not if your production area is enclosed, it is if your product is enclosed in packaging that will protect it from the environment. I also agree with thatparksgal, it should read and/or in my opinion. The only way that this should not apply is if you are only storing sealed product. once product is exposed to the environment of the processing area, environmental monitoring should be performed to ensure food safety. 

from BRC8 -

 

ENCLOSED PRODUCT AREAS
An enclosed product area is defined as an area of the factory where all of the products are fully enclosed and therefore not vulnerable to environmental contamination (e.g. foreign bodies or micro-organisms). This includes areas where:

•  the product is fully enclosed within packaging (e.g. raw material and finished product storage and dispatch areas)
•  the product is fully enclosed within equipment shielding the product from physical or microbiological contamination from the production equipment during production – this may include enclosure within transfer pipework and fully enclosed equipment, and also where the equipment maintains its own environment to protect the product (e.g. aseptic filling equipment).

Whenever product lines are entered, for example for cleaning, maintenance or sampling, documented processes must be in place to ensure that the potential for contamination is minimised and the line is returned to the correct standard to maintain the enclosed product status.

 

Dear Nassu

I think:

In production at open or enclosed area so the factory must control environmental.

The standard: according to the standard of finished product.

Thanks

Hi Nassu,

 

If your products are enclosed in the production area then environmental monitoring is stil required but clearly there is less risk than in 'open and RTE product' production areas.

 

BRC Standard & Guidance:

4.11.8 ENVIRONMENTAL MONITORING
Risk-based environmental monitoring programmes shall be in place for pathogens or spoilage organisms.
At a minimum, these shall include all production areas with open and ready-to-eat products.
Interpretation
The aim of the environmental monitoring programme is to identify any potential risks in the production and open-product areas so that they can be appropriately managed and prevented from becoming the source of product contamination (which could lead to non-conforming product, a customer complaint or other incidents).
An effective programme can, for example, be used to:
• confirm the effectiveness of cleaning and hygiene activities and identify any areas that require further activity
• prevent product contamination by acting as an ‘early warning’ – identifying potential contamination from the site facilities before they affect products.

Risk-based environmental monitoring programme
The programme must be based on risk assessment. At a minimum this will include:
• a sampling protocol. It is important to ensure that the sampling method does not inadvertently create false positives (e.g. by allowing post-sampling contamination or growth of organisms) or false negatives (e.g. by killing organisms in the sample before the test is completed). Sampling must be appropriate for the target organisms, test methods and locations sampled; techniques may include swabs, air sampling, water/liquid samples etc.
• identification of suitable test locations, taking into account:
– significance of the area or equipment in terms of the potential to affect food safety; for example, food contact surfaces, non-food contact areas which are in close proximity to open products, and nonfood contact areas some distance away from open products (e.g. floors, walls and drains)
– areas or parts of equipment that are difficult to clean and could harbour pathogens
– areas of the site or equipment which previously tested positive
– areas where scientific literature has identified a specific risk (e.g. drains)
• frequency of tests, taking into account:
– products that support the growth of pathogens. These require a greater frequency of testing than those that do not support growth
– locations with previous positive results or an upward trend towards an action level (clause 4.11.8.2). These are likely to require increased testing to confirm the effectiveness of the action taken
• target organisms. These may include specific pathogens that present a risk to the product or environment (e.g. Listeria spp in wet environments or Enterobacteriacae in dry environments), specific spoilage organisms (e.g. yeast or mould) or indicator organisms (e.g. total plate count, total coliforms)
• test methods. Rapid on-site and laboratory tests are available, and sites should consider the requirements of section 5.6 when deciding which methods and/or laboratories to use
• evaluation of results. The significance of the results and any actions required must be considered (clause 4.11.8.2).

 

Kind regards,

 

Tony

Hi Nassu,

 

If your products are enclosed in the production area then environmental monitoring is stil required but clearly there is less risk than in 'open and RTE product' production areas.

 

BRC Standard & Guidance:

4.11.8 ENVIRONMENTAL MONITORING
Risk-based environmental monitoring programmes shall be in place for pathogens or spoilage organisms.
At a minimum, these shall include all production areas with open and ready-to-eat products.
Interpretation
The aim of the environmental monitoring programme is to identify any potential risks in the production and open-product areas so that they can be appropriately managed and prevented from becoming the source of product contamination (which could lead to non-conforming product, a customer complaint or other incidents).
An effective programme can, for example, be used to:
• confirm the effectiveness of cleaning and hygiene activities and identify any areas that require further activity
• prevent product contamination by acting as an ‘early warning’ – identifying potential contamination from the site facilities before they affect products.

Risk-based environmental monitoring programme
The programme must be based on risk assessment. At a minimum this will include:
• a sampling protocol. It is important to ensure that the sampling method does not inadvertently create false positives (e.g. by allowing post-sampling contamination or growth of organisms) or false negatives (e.g. by killing organisms in the sample before the test is completed). Sampling must be appropriate for the target organisms, test methods and locations sampled; techniques may include swabs, air sampling, water/liquid samples etc.
• identification of suitable test locations, taking into account:
– significance of the area or equipment in terms of the potential to affect food safety; for example, food contact surfaces, non-food contact areas which are in close proximity to open products, and nonfood contact areas some distance away from open products (e.g. floors, walls and drains)
– areas or parts of equipment that are difficult to clean and could harbour pathogens
– areas of the site or equipment which previously tested positive
– areas where scientific literature has identified a specific risk (e.g. drains)
• frequency of tests, taking into account:
– products that support the growth of pathogens. These require a greater frequency of testing than those that do not support growth
– locations with previous positive results or an upward trend towards an action level (clause 4.11.8.2). These are likely to require increased testing to confirm the effectiveness of the action taken
• target organisms. These may include specific pathogens that present a risk to the product or environment (e.g. Listeria spp in wet environments or Enterobacteriacae in dry environments), specific spoilage organisms (e.g. yeast or mould) or indicator organisms (e.g. total plate count, total coliforms)
• test methods. Rapid on-site and laboratory tests are available, and sites should consider the requirements of section 5.6 when deciding which methods and/or laboratories to use
• evaluation of results. The significance of the results and any actions required must be considered (clause 4.11.8.2).

 

Kind regards,

 

Tony

Hi Tony..very much interesting...is there a excel template for this environmental monitoring risk assessment? Please do share if available

1 Thank

Hi

 

But if its a refinery that manufactures edible oil - there is n growth of bacteria - can this be defined in the program and how do we know which risk assessment is required. Is there a template to use

 

Kind Regards


Similar Discussion Topics
SQF Clause 5.2.1 - Artwork customer approval BRCGS Storage and Distribution - Clause 1.1.9 BRCGS Clause 3.11.3 - Incident management test must include a recall test? Clause 8.5.1.2 - Characteristics of raw materials, ingredients and product contact materials FSSC 22000 Clause 2.5.1 - Management of Services and Purchased Materials BRCGS clause 3.5 BRCGS Clause 3.7.5 - Supply Chain Traceability FSSC 22000 Clause 2.5.7 - Environmental Monitoring Programme Addressing clause 6.1 and clause 8.1 in ISO 22000:2018 BRCGS issue 9 Clause 1.1.3 - Food Safety and Quality Objectives