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Post by itrainsinside on Mar 30, 2015 16:08:23 GMT -5
It's everyone's favorite BRC thing time!!~ Risk Assessing!!
So I'm updating my risk assessment for v7. 5.3.3 Interpretation Guide says the risk assessment requires
"Identification of potential points of cross-contamination. An 'allergen process flow' diagram or 'allergen map' can be useful in understanding where allergenic ingredients and foods exist in the plant and where they are introduced into the process. This usually takes the form of a site plan, on which are highlighted all the routes each allergenic material can take. This map can subsequently be used to identify areas where cross-contamination between allergenic and non-alleregnic materials (ingredients, intermediates or products) can occur (The map should consider process flow, environmental factors, production activities, shared equipment and people.) Assessment of the risk at each stag identified in the previous step."
Im looking for examples of what you might asses in each category for the bolded points.
Environmental factors = air flow? temperature?
Production activities = ingredient handling? processing? packaging?
Shared equipment (I think I've got this one, lol)
People = training? GMP Inspection? Auditing?
Thanks in advance all!
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Post by cazyncymru on Mar 30, 2015 16:43:27 GMT -5
Yeah, I'd look at air flow or air handling units and even maybe condenser fans (blast chillers etc)
Do you potentially have cleaning that is common (CIP)?
What about lab equipment ? Scales for weighting out ingredients?
Sieves? Sealing units? Another good one I've had is chain mail apron!
Allergen training? Fridge inspection in canteen on GMP? Personal lockers ?
A start for you !
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Post by itrainsinside on Mar 31, 2015 7:21:39 GMT -5
Thanks Caz, I Should have started with our only allergen is "coconut cream" . Comes in liquid form, 400-600 lb. drums. We pump material into an aseptic processing system (Not dumped or splashed).
Ingredient comes to us aseptically packed also.
We have shared lines (but separate cleaning, batching tools) do a 5 log reduction CIP. Caustic, Acid, we titrate final rinses, and also compare pH of rinsing water and final rinse samples. Allergen swabs....
I think I am hung up because ALL of the risks as so low... Im having difficulty thinking of what environmental factors are actually a concern, or even applicable.
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Post by martha on Apr 2, 2015 21:12:56 GMT -5
Thanks Caz, I Should have started with our only allergen is "coconut cream" . Comes in liquid form, 400-600 lb. drums. We pump material into an aseptic processing system (Not dumped or splashed). Ingredient comes to us aseptically packed also. We have shared lines (but separate cleaning, batching tools) do a 5 log reduction CIP. Caustic, Acid, we titrate final rinses, and also compare pH of rinsing water and final rinse samples. Allergen swabs.... I think I am hung up because ALL of the risks as so low... Im having difficulty thinking of what environmental factors are actually a concern, or even applicable. What actually popped into my head was the word "Seagulls", but I don't think they are inside, lol. Sorry, I'm a bit silly on Thursdays. It looks like you have covered all your bases very well.
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Post by Whateves on Apr 2, 2015 22:27:29 GMT -5
Allergens ... Environmental factors = air flow? temperature? Production activities = ingredient handling? processing? packaging? Shared equipment (I think I've got this one, lol) People = training? GMP Inspection? Auditing? Thanks in advance all! Environmental factors - air flow for sure. I made an airflow map with blueprint pdf & visio, you just drag little arrows on it. Bonus : Also used to demonstrate air flow is moving from high risk to low risk and out the factory instead of in. I made people move their personal fans (which have to be on a cleaning schedule and swabbed, because they get SO GROSS, just pay for fucking air conditioning, factory) They have cool little thingys that measure air flow for ilke $15 on grainger. And light! The same thingy measures light intensity and temp & humidity. I think only air flow is really applicable, although the other three can affect the process in non-allergen related ways. Maybe light intensity if it was really dark in an area you needed to identify allergens in? That's a stretch. But I need to have a lux chart anyway to make sure people can see for HSE / Quality reasons anyway, so two birds. Production activities - just like your product flow map but with arrows in a different color to indicate where allergens & non allergens are instead of where raw & finished product go . People - map of factory with arrows showing where people move. Ideally, they do not wade through a pool of seafood and milk then walk over an open vat of dairy free whatevers. Probably already have this for HSE too to indicate where Forklifts & carts move I like making maps. Srsly, does anyone need a map?
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