Allergens control in research and development
I have a question that I need some insight into. My company produces food grade packaging and we are SQF certified. Our audit is coming up at the end of October. Our R&D group is starting to develop peanut butter products that are prototypes. They want to grind peanuts to create this peanut butter product. They will be grinding the peanuts under a hood. This is a prototype, so it will not be sold.
The R&D testing lab is attached to the QA lab with no barrier in between. The labs have limited access but QA technicians frequently go back and forth to the production floor. The production floor has zero allergens. We are looking at risk factors and have to mediate the risks but I am highly concerned with this new project.
The R&D group does not go to the production floor and can wear smacks etc. We have a foot bath to sanitize shoes. We also control the waste and trash. My biggest concern is the dust and contaminating the lab area that can then transfer to the floor.
Our scope does not include food products, only food packaging. Are we ok to do this if we are not selling food products only testing and developing them?
Thank you in advance for any insights and direction as this is new territory.
What an odd one.
Seems to me your scope now includes food products if you do this. Not only food products, an allergen, and to me the scariest allergen to deal with.
I don't see how you can just go ahead with this as is without building it into your SQF system. At least a hazard analysis and display of controls? Something. But maybe you can get away with it if it's in the lab? I don't know, but it would make me hella nervous.
I'll be interested to hear an auditor chime in on what they'd say if they are doing an audit and walk into your lab to find a peanut party. Maybe Glen can give you some idea what the fallout would be, if any.
I personally wouldn't allow that to happen at our food grade packaging facility. Just too many variables to contend with and just an unnecessary risk.
What an odd one.
Seems to me your scope now includes food products if you do this. Not only food products, an allergen, and to me the scariest allergen to deal with.
I don't see how you can just go ahead with this as is without building it into your SQF system. At least a hazard analysis and display of controls? Something. But maybe you can get away with it if it's in the lab? I don't know, but it would make me hella nervous.
I'll be interested to hear an auditor chime in on what they'd say if they are doing an audit and walk into your lab to find a peanut party. Maybe Glen can give you some idea what the fallout would be, if any.
Thanks. Since we have done limited tests on peanut butter with no grinding it is included in my HACCP plan for allergen control. My concern is the new element of grinding and mixing of the peanuts. It is making me very nervous.
. They will be grinding the peanuts under a hood. ...
Are we talking bio/chem containment negative pressure ventilation hood, or a simple overhead kitchen vent?
Are we talking bio/chem containment negative pressure ventilation hood, or a simple overhead kitchen vent?
I am going to test but I believe it is a negative pressure hood. My thought was to test areas in the lab with allergen swabs to confirm the hood is containing the particles.
Way too many red flags here.
Can this be done off-site or can your company rent a portable building that can go up on your property?
I just don't see how a non-food company can work with a high allergen in an allergen free environment regardless of risk analysis workups without having massive issues.
Man, this sounds sticky. A non-food facility looking into producing food. I'd wager none of your current storage/handling SOP's nor sanitation play towards the risks of any food in your facility, and to add one of the worst allergens into the mix... As a side question, is your company planning on starting food manufacturing at the same plant if you end up with a successful product? Major revisions to your program and building would be required.
If you could wholly segregate the R&D area away from any potential cross traffic, come up with some isolated storage for the peanuts (and I don't think anywhere in your current storage space would fly), you might be able to get away with doing these tests on site. The area would have to be indicated on your facility maps, you'd have to declare the operation outside of your current scope, and the auditor will still want to walk through it to verify it is as safe as your RA's indicate.
In your shoes, I'd be proposing the R&D take this project off site. But if they won't go for it, it'll be up to you to tell them what they need to make it safe.
Man, this sounds sticky. A non-food facility looking into producing food. I'd wager none of your current storage/handling SOP's nor sanitation play towards the risks of any food in your facility, and to add one of the worst allergens into the mix... As a side question, is your company planning on starting food manufacturing at the same plant if you end up with a successful product? Major revisions to your program and building would be required.
If you could wholly segregate the R&D area away from any potential cross traffic, come up with some isolated storage for the peanuts (and I don't think anywhere in your current storage space would fly), you might be able to get away with doing these tests on site. The area would have to be indicated on your facility maps, you'd have to declare the operation outside of your current scope, and the auditor will still want to walk through it to verify it is as safe as your RA's indicate.
In your shoes, I'd be proposing the R&D take this project off site. But if they won't go for it, it'll be up to you to tell them what they need to make it safe.
Right now they are only doing prototype testing, so nothing will be sold or manufactured. If they do proceed with manufacturing the product, it will be a separate facility. They need to do the formulization first.
Storage of any and all peanuts and ingredients etc f would be locked up nightly and contained to the R&D lab.
Good point on indicating the lab on the site map. Would I need to contact SQFI or just tell the Auditor it is outside our scope?
In your shoes, I'd be proposing the R&D take this project off site. But if they won't go for it, it'll be up to you to tell them what they need to make it safe. EXACTLY :-)
Right now they are only doing prototype testing, so nothing will be sold or manufactured. If they do proceed with manufacturing the product, it will be a separate facility. They need to do the formulization first.
Storage of any and all peanuts and ingredients etc f would be locked up nightly and contained to the R&D lab.
Good point on indicating the lab on the site map. Would I need to contact SQFI or just tell the Auditor it is outside our scope?
In your shoes, I'd be proposing the R&D take this project off site. But if they won't go for it, it'll be up to you to tell them what they need to make it safe. EXACTLY :-)
Not just the map, but any document you can think of that might relate needs to address this. How are the peanuts entering the facility? Are they bringing some retail purchased items through the front door? Better not cross production on the way to the segregated lab. Are they receiving boxes by Fedex at your regular dock door? No go as well (at least to me).
I defended a SQF facility for a couple years where the production area was a segregated part of a warehouse suite, took up maybe 1/3 of the space completely walled off. The rest of the suite was a separate business (same owners), providing storage for all sorts of bad junk. They even had a small mixing area setup for yet another side business that made fire starters out of flammable powders. Even when you label these areas as outside of the scope, if it's under your primary roof, the auditor will demand access to inspect: not only for any perceived risks they can tie to the business, but to ensure you guys are being honest about the non-comingling of goods. The moment an auditor finds a jar of your peanut product outside that marked area or finds any of your primary packaging material in that lab, it's major finding time.
Not just the map, but any document you can think of that might relate needs to address this. How are the peanuts entering the facility? Are they bringing some retail purchased items through the front door? Better not cross production on the way to the segregated lab. Are they receiving boxes by Fedex at your regular dock door? No go as well (at least to me).
I defended a SQF facility for a couple years where the production area was a segregated part of a warehouse suite, took up maybe 1/3 of the space completely walled off. The rest of the suite was a separate business (same owners), providing storage for all sorts of bad junk. They even had a small mixing area setup for yet another side business that made fire starters out of flammable powders. Even when you label these areas as outside of the scope, if it's under your primary roof, the auditor will demand access to inspect: not only for any perceived risks they can tie to the business, but to ensure you guys are being honest about the non-comingling of goods. The moment an auditor finds a jar of your peanut product outside that marked area or finds any of your primary packaging material in that lab, it's major finding time.
Thanks. All good points. We have a meeting next week to discuss. I will bring up every single angle. I am hoping I can change their minds about doing it here but if not, I have to think of every single risk and how to control them. We have an excellent rating on SQF and I do not want to jeopardize that.
. We have an excellent rating on SQF and I do not want to jeopardize that.
It's not your rating you should be worried about
If you cannot control the peanut dust, you could cause anaphylaxis on your employee, and employee where the use your packaging etc etc etc
It's not your rating you should be worried about
If you cannot control the peanut dust, you could cause anaphylaxis on your employee, and employee where the use your packaging etc etc etc
Of course people are the MAIN priority...employees and anyone that could be affected by the product or allergens. I would never imply that they were not the first priority!
I'd just echo what everyone else is saying. R&D should know better and I'm betting they do. At this point, the way I see it, it's basically risking lives, customers, reputation, and dollars for an idea; and all on your shoulders.
Does this involve large scale equipment? If not, why not do it at home? I've done a few things that had allergens we didn't use in our building, but the prospective business was large enough we'd consider adding more allergens to our facility, but I handled the R&D out of my home test kitchen until we nailed down formulation. I was lucky and in the end we got the business and were able to ditch the allergen (celery) by using an artificial flavor. But over my years I've done a few R&D things in my home kitchen before they were brought into work, for various reasons.
I am lucky enough to have two kitchens at home though, so my downstairs kitchen is set up somewhat like a test kitchen, while my upstairs kitchen sink is piled with my kid's cereal bowls daily, lol.