6 replies to this topic

[LECHUMI]

Hi all,

 

Good day!

 

In relevance to the requirement of Clause 2.5.7 Environmental Monitoring as in FSSC 22000, could anyone guide me on how to do the risk based assessment for EMP? Should the assessment consider all possible hazards including biological, chemical, physical and allergen that covers all the areas of swabbing? 

 

Any sample of risk assessment document would be really helpful as a guidance. 

 

Thank you for your help. 

[Tony-C]

Hi LECHUMI,

 

The requirement you are referring to comes from FSSC 22000 Scheme Version 5.1 published in November 2020

PART 2 Requirements for Organizations to be Audited

Section 2.5 FSSC 22000 Additional Requirements

2.5.7 Environmental Monitoring (Food Chain Categories C, I & K)

The organization shall have in place:

a) Risk-based environmental monitoring program;

b) Documented procedure for the evaluation of the effectiveness of all controls on preventing contamination from the manufacturing environment and this shall include, at a minimum, the evaluation of microbiological and allergen controls present;

c) Data of the monitoring activities including regular trend analysis.

 

To meet these requirements, I consider Microbiological and Allergen Controls, Chemical and Physical I would cover under verification of Food Hazard Controls and Prerequisite Programmes which should be eliminating Chemical and Physical hazards.

 

So, for microbiological risk based monitoring first, the thing to consider is the proximity to the product which will have a large influence on the likelihood of contamination.

 

You can use a numerical system if you like but in this example I have used colour coding.

 

 PRP 11.5A Environmental Monitoring Planning.pdf   1MB   819 downloads

 

Environmental Monitoring Priorities - Priority Order for Environmental Sampling:

Open product areas:

High risk (chilled and frozen)
High care (chilled and frozen)

Ambient high care

Low risk

Flow & entrances to the above areas
Enclosed product areas:

Warehouses

Storerooms

Flow & entrances to the above areas

Non-product areas:

Canteens

Laundries

Offices

Flow & entrances to the above areas

 

Key Areas are Open Product and Filling/Processing Areas

Environmental Monitoring Priorities - Priority Order for Environmental Sampling:

Food Contact Surface – Inside Storage Tank

Food Contact Surface – Filler Nozzle

Food Contact Surface – Foil Lidding

Non-Food Contact Surface – Inside Door Filler Cabinet

Non-Food Contact Surface – Cleaning Equipment

Non-Food Contact Surface – Floor under Filler

Non-Food Contact Surface – Outside Storage Tank

Non-Food Contact Surface – Drain

Non-Food Contact Surface – Wall

Non-Food Contact Surface – Floor near Entrance

Non-Food Contact Surface – Hand Wash Sink

 

So, to summarise for Environmental Monitoring – Key Areas are Open Product and Filling/Processing Areas:

The priority will then be food contact surfaces, then surfaces that could contaminate product such as from condensation or from packaging contact surfaces.

Next will be filling equipment parts then other environmental areas.

These planning diagrams help you understand typical environmental surveillance.

 

There is also an Example Environmental Monitoring Area Plan and Schedule, both are colour coded as well.

 

Moving on to Allergens, Section 2.5 FSSC 22000 Additional Requirements:

2.5.6 MANAGEMENT OF ALLERGENS (FOOD CHAIN CATEGORIES C, E, FI, G, I & K)

The organization shall have a documented allergen management plan that includes:

a) Risk assessment covering all potential sources of allergen cross-contamination and;

b) Control measures to reduce or eliminate the risk of cross-contamination.

 

In this case, to comply with 2.5.7 Environmental Monitoring you will have to plan to monitor your allergen control measures. A point here that is different about allergen control to microbiological control. In raw areas such as mixing microbiological cross-contamination may be insignificant because the product is going to be processed and have a subsequent step that eliminates the microbiological hazard. For allergen cross-contamination in a raw area it is highly unlikely that a subsequent step will reduce/eliminate that hazard and so monitoring will be important in this area as well as subsequent food contact areas such as filling.

 

Your monitoring system for allergens will be based on your Risk Assessment of Cross-contamination in Operations. Your will prioritise monitoring based on the risk. This may be verification of cleaning after allergen production before change over to a non-allergen product. Examples of verification methods include ELISA tests and ATP Tests. The may be other areas that need monitoring such as rework of product, product labelling, verification of batch mixes and measures taken by staff handling allergens to prevent cross-contamination.

 

Kind regards,

Tony

Edited by Tony-C, 31 May 2022 - 04:45 AM.

[Charles.C]

Hi Tony,

 

Many thanks for the highly detailed analysis/example. ( the "absence" requirement for pathogens might be usefully replaced by "not detected" and some units might assist [maybe covered elsewhere]).

 

It is sad that the OP contains zero Product/Process context rendering a directly meaningful answer somewhat  impossible.

 

For EMPG/micro, a zoning approach as frequently utilised in the Literature might allow a simplified presentation. ?

 

(Based on other fssc22000 threads/contributions on this Forum, I suspect that fsc22000 auditors neither anticipate nor reward  elegance in responses to Clauses in the Standard. Not to decry the potential benefits from a Company's POV of course).

 

I don't understand why fssc22000 included Allergen issues in 2.5.6 when such seems to be fully handleable via 2.5.7. (Desire to maximise paperwork ?)

[Tony-C]

Thank you Charles.

 

Zoning is reflected in slides 2 and 8.

 

2.5.6 MANAGEMENT OF ALLERGENS didn’t include monitoring of control measures, it probably should have been added there and would be less confusing.

 

Or it could have been in 2.5.12 PRP VERIFICATION but that focuses on inspections in order to comply with the GFSI Benchmarking Requirements version 2020 GMP requirement for Site inspections/checks:

A programme of site inspections / checks shall be established, implemented and maintained to ensure the site environment and processing equipment are maintained in a suitable condition to ensure food safety, as applicable to the activity of the site.

 

Kind regards,

Tony

[Umie]

Hi LECHUMI,

 

The requirement you are referring to comes from FSSC 22000 Scheme Version 5.1 published in November 2020

PART 2 Requirements for Organizations to be Audited

Section 2.5 FSSC 22000 Additional Requirements

2.5.7 Environmental Monitoring (Food Chain Categories C, I & K)

The organization shall have in place:

a) Risk-based environmental monitoring program;

b) Documented procedure for the evaluation of the effectiveness of all controls on preventing contamination from the manufacturing environment and this shall include, at a minimum, the evaluation of microbiological and allergen controls present;

c) Data of the monitoring activities including regular trend analysis.

 

To meet these requirements, I consider Microbiological and Allergen Controls, Chemical and Physical I would cover under verification of Food Hazard Controls and Prerequisite Programmes which should be eliminating Chemical and Physical hazards.

 

So, for microbiological risk based monitoring first, the thing to consider is the proximity to the product which will have a large influence on the likelihood of contamination.

 

You can use a numerical system if you like but in this example I have used colour coding.

 

PRP 11.5A Environmental Monitoring Planning.pdf

 

Environmental Monitoring Priorities - Priority Order for Environmental Sampling:

Open product areas:

High risk (chilled and frozen)
High care (chilled and frozen)

Ambient high care

Low risk

Flow & entrances to the above areas
Enclosed product areas:

Warehouses

Storerooms

Flow & entrances to the above areas

Non-product areas:

Canteens

Laundries

Offices

Flow & entrances to the above areas

 

Key Areas are Open Product and Filling/Processing Areas

Environmental Monitoring Priorities - Priority Order for Environmental Sampling:

Food Contact Surface – Inside Storage Tank

Food Contact Surface – Filler Nozzle

Food Contact Surface – Foil Lidding

Non-Food Contact Surface – Inside Door Filler Cabinet

Non-Food Contact Surface – Cleaning Equipment

Non-Food Contact Surface – Floor under Filler

Non-Food Contact Surface – Outside Storage Tank

Non-Food Contact Surface – Drain

Non-Food Contact Surface – Wall

Non-Food Contact Surface – Floor near Entrance

Non-Food Contact Surface – Hand Wash Sink

 

So, to summarise for Environmental Monitoring – Key Areas are Open Product and Filling/Processing Areas:

The priority will then be food contact surfaces, then surfaces that could contaminate product such as from condensation or from packaging contact surfaces.

Next will be filling equipment parts then other environmental areas.

These planning diagrams help you understand typical environmental surveillance.

 

There is also an Example Environmental Monitoring Area Plan and Schedule, both are colour coded as well.

 

Moving on to Allergens, Section 2.5 FSSC 22000 Additional Requirements:

2.5.6 MANAGEMENT OF ALLERGENS (FOOD CHAIN CATEGORIES C, E, FI, G, I & K)

The organization shall have a documented allergen management plan that includes:

a) Risk assessment covering all potential sources of allergen cross-contamination and;

b) Control measures to reduce or eliminate the risk of cross-contamination.

 

In this case, to comply with 2.5.7 Environmental Monitoring you will have to plan to monitor your allergen control measures. A point here that is different about allergen control to microbiological control. In raw areas such as mixing microbiological cross-contamination may be insignificant because the product is going to be processed and have a subsequent step that eliminates the microbiological hazard. For allergen cross-contamination in a raw area it is highly unlikely that a subsequent step will reduce/eliminate that hazard and so monitoring will be important in this area as well as subsequent food contact areas such as filling.

 

Your monitoring system for allergens will be based on your Risk Assessment of Cross-contamination in Operations. Your will prioritise monitoring based on the risk. This may be verification of cleaning after allergen production before change over to a non-allergen product. Examples of verification methods include ELISA tests and ATP Tests. The may be other areas that need monitoring such as rework of product, product labelling, verification of batch mixes and measures taken by staff handling allergens to prevent cross-contamination.

 

Kind regards,

Tony

Hi Mr Tony and Mr Charles,

 

Referring to the slides that Mr Tony have attached, may I know how do you set the target levels for the pathogens that you've tested? Also, how do you set the frequency of the environment monitoring? I am in a vegetable processing industry where we process fresh cut veggies to customers. Our current schedule is by quarterly, half-yearly and yearly monitoring but with strict cleaning and sanitation schedule in place (daily). I am wondering if our environment monitoring schedule is adequate. 

 

Appreciate your kind opinion on my concern. Thank you. 

 

Regards, 

Umie

[Tony-C]

Hi Mr Tony and Mr Charles,

 

Referring to the slides that Mr Tony have attached, may I know how do you set the target levels for the pathogens that you've tested? Also, how do you set the frequency of the environment monitoring? I am in a vegetable processing industry where we process fresh cut veggies to customers. Our current schedule is by quarterly, half-yearly and yearly monitoring but with strict cleaning and sanitation schedule in place (daily). I am wondering if our environment monitoring schedule is adequate. 

 

Appreciate your kind opinion on my concern. Thank you. 

 

Regards, 

Umie

 

Hi Umie,

 

You will need to do your own work on site to establish limits. The limits in the slides are for clean surfaces. You may well want to establish limits during production.

 

If your fresh cut veggies are to be cooked then your product is low risk and environmental monitoring standards not so stringent and quarterly monitoring for pathogens may be acceptable if you are not encountering issues when you do swab.

 

I would also be carrying out more regular sampling using indicators - TVC, Enteros and Y&Ms.

 

Kind regards,

 

Tony

[Umie]

Hi Mr Tony, 

 

Seems like a trending analysis will suffice then. Ok, appreciate your opinion. Thank you 

 

Kind regards, 

Umie