2 replies to this topic

[limmm]

Hi, i would like to request on an example of EMP of FSSC 22000, there are a lot of explanation from internet source but i could not find for a template or case study as well. Thanks in advance.

[Tony-C]

Hi limmm,

 

 

Welcome to the IFSQN forums.

 

Any Environmental Monitoring Programme will need to be based on risk and the controls in place. It would be useful to know your product category? as this is key to risk/controls and receiving relevant advice. FSSC requirements are posted below for clarification.

 

FSSC 22000 Certification Scheme Version 6.0 cover the requirements for an EMP in Part 2 | Requirements for Organization to be Audited Section 2.5.7 ENVIRONMENTAL MONITORING (FOOD CHAIN CATEGORIES BIII, C, I & K). The requirements are:

‘The organization shall have in place:

a) A risk-based environmental monitoring program for the relevant pathogens, spoilage, and indicator organisms;

b) A 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 controls present; and shall comply with legal and customer requirements.

c) Data of the environmental monitoring activities, including regular trend analysis; and

d) The environmental monitoring program shall be reviewed for continued effectiveness and suitability, at least annually, and more often if required, including when the following triggers occur:

i. Significant changes related to products, processes, or legislation;

ii. When no positive testing results have been obtained over an extended period of time;

iii. Trend in out of specification microbiological results, related to both intermediate and finished products, linked to environmental monitoring;

iv. A repeat detection of pathogens during routine environmental monitoring; and

v. When there are alerts, recalls or withdrawals relating to product/s produced by the organization.’

 

Kind regards,

 

Tony

[GMO]

I've seen EMP programmes built in various different ways. As Tony has written, risk assessment is key. Do that first. You can base it on risk of production facility (e.g. high / low risk), product category and which part of the plant. Then food contact or not. Ultimately how often you swab will be linked to how much your product will be put at risk of whatever pathogen is a concern and then how likely it is to turn up in the environment. Then as Tony has included also linking in indicator and spoilage organisms.

 

Once you've conducted your risk assessment, you then need to produce a schedule based on that. So the highest risk areas need to be swabbed most often and the lowest risk least often.

You need to then decide what you do if you have a failure and write the process and what happens if it fails into a procedure.

 

Then this will be part of your HACCP verification so how do you make it "live" in your process? One of the best ways I've seen for that is to hotspot mapped swab completion and swab failures for pathogen swabs onto a factory map in the highest risk areas then review that once a week or month depending on swab frequency. You don't have to do that (it can be a lot of work or better still, automate it) but it's good practice.

 

Lastly as Tony says you need to review it. Your hotspot mapping can be part of that but also it needs some prompts. A reasonably regular micro meeting (1-3 months frequency dependent on risk) is a good idea to have in the diary where you can go into more detail than a normal monthly KPI review. In that you can look at things like other trends, pareto on equipment, any areas you're getting consistent passes, perhaps even a look and go see at a specific area which is consistently failing (or passing suspiciously often). Not that we just do this for audits but an auditor will be looking for evidence that you are robust in reviewing the data and doing something with it. That actions get completed etc. And I'd include both product results and EMP results into this plan as sometimes depending on when you take swab results, product results may point to an issue that swabs miss. For example, in one factory I worked in, we had a consistent trend on a product which WAS down to cleaning in the end but the swabs said otherwise. We found out later that the swabs were always being taken early in the day and the poor cleaning wasn't becoming apparent until the machine had run on longer.