18 replies to this topic

[PQAManager]

We have added a new line and the new product is slightly different from what we were (still are) running.  The product is a syrup, but different from our previous syrups this product has pulp.  With the pulp, we are unable to put the in-line screen like on our other product.  With our current product the CCP is visually inspect screen, insert, and sign off.  What are alternative solutions?

[Brothbro]

So a foreign material CCP? If a screen is not an option you may need to invest in a magnetic trap or some kind of metal detector. I'm more familiar with MD systems for examining individual packages, but I think systems which monitor fluids in-line also exist. A magnetic trap would definitely be cheaper, but lacks the advantage of warning you when you've caught something. It also can only catch magnetic material, which not all FM is.

 

Depending on the size/nature of the pulp, there may also be a mesh screen size that can capture FM but allow pulp to pass.

Edited by Brothbro, 19 September 2023 - 08:08 PM.

[PQAManager]

So I cannot do a risk assessment for this?  I have to find an alternate solution.

[Scampi]

what did your decision tree say?

[PQAManager]

Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control? ->No->Not a CCP

 

Could Occur> Product Recall>Medium Risk

 

No In-line Screen Risk Assessment

Date: 09/19/23

Location/Event: In-line hose Screen for Syrup

Identification of possible introduction of foreign object (risks):

• Ceiling
• Lights
• Tanks are open
• Human contamination
• Introduction of a piece of bag from when ingredients were cut open to be mixed in the batch, or anything that slips by the visual inspection.

Hazard: Foreign material may find itself in the product, unless caught by visual inspection (CCP1).  Since Foreign contamination could occur and if it did it would cause a recall this would be a medium risk.  So since there is no sufficient likelihood of occurrence and severity there is nothing to warrant a control.

Control Step: Proper education though GMPs, HACCP training, and Foreign Material Prevention training, Monitoring CCPs, and SQF practices (trained upon hire and yearly).  Ceilings and Lights are maintained in a clean and sanitary state.  Tanks are only open to ceiling and lights.  Any batch that has to set for an extended period of time is covered.

Note: Screens are only left out on orders with pulp, seeds…that will clog up the screen.

Edited by PQAManager, 19 September 2023 - 09:41 PM.

[jfrey123]

Your decision tree should lead you to determining whether you need a critical control point on the new line.  If your hazard analysis identified the same risks as your other line with a screening CCP for FM, you'll need something to counter the FM that came up in this new hazard analysis.

 

What FM are you looking to control?  If it's metal produced by the machines in the line, post MD might be needed.  If it is something else, you might have to try and mitigate it before it enters your system.  We can help spitball more ideas if you describe the process in a little more detail.

[PQAManager]

Ingredients dumped in tank, Blended by propeller and there are no other parts in tank and propellers are large.  Then pumped by pump and hose to filler.  Filler fills bottles and they are capped and sealed syrups.

[PQAManager]

If we do a metal detector it only detects metal, what about other foreign material?  If I followed the decision tree down and decided it was a CCP then wouldn't I have to consider all foreign material?  What would be the other preventative measure or control point for the other foreign material other than metal?  What do other plants do that sale juice?  We could get a screen with larger holes, but where could I get validation on that?

[SerenityNow!]

Would you be able to change the screen size depending on the FM risk? Maybe more screens @ a larger size, or can you screen at an earlier phase; maybe at dumping?

[kingstudruler1]

Are you trying to use the same HACCP/PC plan for both lines?   

 

In general changing a CCP/PC just because it doesn't fit product flow parameters, doesn't make sense to me. 

 

If the foreign material from your supplemental risk assessment are what you are trying to control (paper, ceiling, human, lights) is what you are trying to control with a CCP, those are not items that I expect to have a CCP for control.   What FM is indicated as needing to be controlled in the original HACCP plan?   It seems to me that the agitator or pump could  be a bigger risk.  

 

I produced juice for a several years.  Our filler heads had screens.   I don't remember is we removed them after milk to run juice.   however in either case the screen was not a CCP.   Right or wrong we didn't have a CCP for FM.   

 

I dont think that your supplemental risk assessment "works" in terms of HACCP.  You would need to review / redo your HACCP hazard analysis.   If you still determine that a hazard needs a preventative control / CCP then you will need to find a solution(s) that controls those hazard(s)

[Scotty_SQF]

Metal Detectors may have the term 'metal' in it, but it doesn't just pick up metal.  They are more or less density detectors and detect a difference in density to pick up an issue.  In a previous role, we found things such as plastic, small pebbles and other items from kick outs from a metal detector that were not metal.  Having said that, to my knowledge, there may still be items it wouldn't pick up. Mainly items that may be close to the density of the product you are producing.  Glass is one that I do not believe they could easily pick up, though I may be mistaken.  Just wanted to throw this out there as many people always think metal detectors only pick up metal.  To be clear though, that really is their main objective and hence why you test it with metal pieces, but again, they can pick up other items.

[PQAManager]

I would like to use our current HACCP plan and incorporate our new line since they are so similar, but I don't know what to do about the screen issue with the new product.

[jfrey123]

If we do a metal detector it only detects metal, what about other foreign material?  If I followed the decision tree down and decided it was a CCP then wouldn't I have to consider all foreign material?  What would be the other preventative measure or control point for the other foreign material other than metal?  What do other plants do that sale juice?  We could get a screen with larger holes, but where could I get validation on that?

 

With this, and your explanation of the process previously, I have to ask what FM risk has triggered the CCP in your HA.  Usually an auditor will tell you the HA has to be specific to the process, and while we all want to avoid FM in our processes, you really have to drill down and determine where FM is likely to cause a health or injury risk.  I've never had an auditor accept "I'm worried about foreign material," they want to know what type and where it could come from to see if I've taken additional measures to control it before final processing.

 

Microsoft PowerPoint - Principle_1_new2019.pptx (tamu.edu)

 

From Texas A&M's PCQI training, page 11 has a great example of a risk matrix.  Generally speaking, if a risk of something happening is remote or low, it won't trigger a CCP in your HACCP plan.  To make an absurd exmaple: if someone put anthrax into anyone's production line, it would be devastating.  But most of us have sufficient PRP's to prevent adulteration and sabotage, so no one includes anthrax type detection as a CCP.

 

I understand the desire to make the new line fit your existing HACCP.  As it is a new line, you should run through it step by step to see if it is a match for the processing steps and the product type.  And kind of along kingstudruler's point, if you're unable to drill down to a specific risk of FM having a high chance of occurring, I'd question whether you need a CCP or not.  You might take the chance to document a review of your current line's CCP monitoring documents, examining for trends in the screen checks.  The material type found on the screen and the frequency at which you're finding it can be used to justify whether or not a screen is necessary in the new line (and dare I say the current line, since you are officially reviewing your HACCP program).

 

But if that review does find FM is being caught at the screen often, then you need to drill down to the root cause and see if you can eliminate it prior to processing if you want to run a pulp line without a screen.  Or a larger screen allowing the pulp to pass through (not a juice guy, not sure if that can be done).  Or some detection after bottling to eliminate the FM.

[PQAManager]

I'm thinking we should get larger mesh screens so pulp flows freely, but the screen would catch a bolt or something to be somewhat useful at minimizing this risk, but not to an acceptable level.  But since the validation is that mesh of a certain size stops the size of choking hazard, but a larger mesh would not be small enough to prevent choking hazard so it would not be completely down to an acceptable level right?  Then that would cause you to have other controls...like an x-ray machine to scan the final product in jugs and boxes.  How much would we be looking for to get an x-ray machine to scan up to gallon jugs and 2'x'2'x9" boxes?  I am worried like someone said about the propeller, pumps, and fillers to make sure no metal makes it's way into product. I really don't think our company can afford a x-ray machine.  Anyone else got any ideas.  I've been through the decision tree and the risk matrix and I am wondering if I could consider this not being a CCP for our old or new line.  Could our HACCP plan exist without the Foreign Material CCP? Anyone currently in the juice industry?  What do you do?

[PQAManager]

Is there an in-line screen 3 mesh?

[Charles.C]

I'm thinking we should get larger mesh screens so pulp flows freely, but the screen would catch a bolt or something to be somewhat useful at minimizing this risk, but not to an acceptable level.  But since the validation is that mesh of a certain size stops the size of choking hazard, but a larger mesh would not be small enough to prevent choking hazard so it would not be completely down to an acceptable level right?  Then that would cause you to have other controls...like an x-ray machine to scan the final product in jugs and boxes.  How much would we be looking for to get an x-ray machine to scan up to gallon jugs and 2'x'2'x9" boxes?  I am worried like someone said about the propeller, pumps, and fillers to make sure no metal makes it's way into product. I really don't think our company can afford a x-ray machine.  Anyone else got any ideas.  I've been through the decision tree and the risk matrix and I am wondering if I could consider this not being a CCP for our old or new line.  Could our HACCP plan exist without the Foreign Material CCP? Anyone currently in the juice industry?  What do you do?

Hi PQA,

 

Not my area at all but this (FDA 2002 !) detailed HACCP analysis for pasteurized Apple Juice puts screen as a CCP ( but cf Post 10) -

 

 Juice_HACCP_Training_Curriculum_First_ed.pdf   646.03KB   8 downloads

 

(added) - but also see -

 

We recommend that consideration of potential hazards associated with metal fragments be a part of your hazard analysis if you conduct operations such as the grinding of fruit, or cutting operations, where metal fatigue or metal to metal contact can occur in your processing equipment. If your process includes such operations, we recommend that you classify metal fragments as a hazard that is reasonably likely to occur in the absence of data or experience about your operation that shows that your process does result in the presence of metal fragments in juice when there are no controls in place. For instance, if you have used a metal detector in your process for a year, and have had no occurrences of metal fragments in your juice, you could conclude that metal fragments are not a hazard that is reasonably likely to occur in your process. If you conclude in your hazard analysis that metal fragments are a hazard that is reasonably likely to occur in your juice, you must establish controls for metal fragments in your HACCP plan.

https://www.fda.gov/...idance-first#iv

 

 

eg  extraction not physical CCP.png   112.78KB   0 downloads

(in this case no screen was in use)

 

In comparison, this (probably non-USA) haccp plan for fresh, extracted, orange juice filled into glass containers has no screen at all with PRPs (including glass audit) handling Foreign materials -

 

 HACCP_Plan_Orange_Juice.pdf   328.82KB   10 downloads

 

Are syrups pasteurised [RTE?] ? Is haccp for syrups equated to "Juices" in USA ? Are you audited by FDA ?

 

My initial impression is that "screen" is most likely to be expected as set as CCP unless strong reasons or data to justify otherwise.

Edited by Charles.C, 21 September 2023 - 05:36 AM.
(added)

[PQAManager]

Thanks Charles C,

 

I completely agree that it should be a CCP where screen is inserted before filler.  No we don't pasteurize, most of our syrups are bar mixes like margarita syrup mix and they have a year expiration date.  I wanted to throw out there different routes because I know my HACCP team.  I need to know what to come back at them with when they buck.  Thanks everyone for all the facts and knowledge shared.  I just recently got PCQI certified, been HACCP, SQF, newbie Quality Assurance Manager for 4 years...your always learning!  I have a Bachelor in Math and a minor in Chemistry....taught High School Algebra II for a year and decided that was not for me:)  Onward journey through our slow season getting our Stuff* together.  This community is the greatest, and I enjoy everyone's professionalism.  Now to look for a 3-5 inch mesh screen or make one...want to make sure no FM can enter larger than 0.3 inches for choking hazard.  That would be more than "reasonably likely to occur, that could be a fatality on the risk matrix definitely putting it in the CCP category. 

[Xoinks]

I'll preface this that I haven't run juice, so my point may be moot if juice HACCP has more specific FM hazard requirements.

 

I've validated metal detector sizes on baked goods before using FDA guidance that 7mm or larger has had regulatory action taken against it for being injurious to human health (choking hazard).  7mm - 25mm.  Reference:  FDA CPG 555.425 Adulteration of foods with foreign material 

 

It also specifies hard or sharp objects, and generally speaking paper or soft plastic bags are not considered hazardous to health under most circumstances (worse for company reputation) and I don't believe most regulatory agencies would insist on a recall for an isolated one-off paper/very soft plastic issue that isn't likely to be harmful to human health. 

 

That may allow you to increase the size of your screen (potentially if that works with your pulp), possibly control with a magnet, or even control exclusively with pre-requisite programs and targeted inspections of health hazards that may fall in (like lights, glass, brittle plastic, knives used to cut bags, etc.)  .  Definitely would want to validate against screen records and customer complaints - if you are routinely getting findings then your screens are truly preventing hazards and you'll need to really figure out an alternative effective control.  Inspections can be an effective alternative IF they are well designed and done by a reliable inspector and acted upon appropriately when there are findings.  

 

Lastly - reach out to your equipment supplier if you haven't (whoever designed or sold the line with the screens) - they likely have worked with companies that package juice with pulp and may have some insight.  

 

If you aren't having metal or hard plastic findings on your screens you have a pretty good potential case for the control not really NEEDING to be a CCP, but obviously need to tread extremely carefully. 

Edited by Xoinks, 21 September 2023 - 09:09 PM.

[G M]

Thanks Charles C,

 

I completely agree that it should be a CCP where screen is inserted before filler.  ..

 

Part of what Charles is getting at is history, what do you have a history for finding as FM?  Anything?  Does this new pulpier juice introduce any more/less risk that your prior experience would indicate?

 

Does your mixing equipment pose any risk of producing metal filings? (probably)  Potentially loose or misaligned parts with a moving metal mechanism are difficult to reduce to zero risk.

 

There are some in-line fluid/batter options for metal detection or x-ray.  It's probably worth calling up a Mettler-Toledo or other brand rep to talk about options just for the sake of knowing.  MT has some mobile demonstration trailers that might be passing through your region, and you and your maintenance manager might find seeing the equipment in person helpful in thinking about how something like that could be integrated.