11 replies to this topic

[anw314]

Hello All!

    I am trying to revamp our Foreign Material program to be more specific in how we handle foreign material events. Specifically corrective actions. It's pretty obvious when you find foreign material in the product you throw it out, put stuff on hold from the last good check if needed, and find the source to stop the bleeding. Where I get stuck and have struggled with in my past experiences has been when you're in sanitation and during a routine PM or after you remove a piece of equipment, oops! you find it's missing a piece. What is the best practice performing a risk assessment. Me (being QA) immediately send myself into a frenzy running around in circles saying "put everything on hold!!" (I'm only half way kidding). I've also seen my upper management throw their hands in the air and say, how are we supposed to know when it came off, the last time we looked at it was a year ago?!

 

My goal is to be able to construct an action plan when these types of events present themselves to remove emotional freak outs and the unknowns out of the equation and look at it from a risk and probability assessment. My problem is I've never been part of an effective assessment and reading about them only half way helps me because I always get caught up in the side questions. I found a really cool form here in a related chain (attached) as I was digging for information, but it reads like it's only when found inside the product. Am I looking at this wrong? What if you're not entirely sure it's in the food? Or when it happened? Or what if the material you found were shavings (metal/plastic/paper/whatever).

 

I tend to be overly cautious, which is not good either when you're trying to get Production to buy in. I need to find a way to make it a solid, factual, practical conversation. Having an outline or guide would be SO helpful to make sure we're coming up with the right decision. So there's my next question, how do you hold those conversations? You collect the information and facts in the moment, make sure you have any effected product contained, and start your risk assessment? I make sure I have my upper management involved or at minimum in the know and have my maintenance manager/supervisor, production supervisors, and QA with me. I have had heated arguments trying to get my point across that if we don't know when it happened we need to establish a conservative time frame based on our facts and not assumptions. Am I out of line, being too conservative, or being too impractical?  

 

 

I super love coming into these forums for advice. You all are so awesome!

 

 

Attached Files

•  Foreign Material Investigational form.xlsx   14.63KB   383 downloads

[Scampi]

Is this happening alot?

 

Can you also add your PM schedule?  I think alot of this should be handled as preventative maintenance (so it isn't a year since machine last inspected)

 

If I were you....i would start by reviewing and beefing up the PM plan.......management will find the $$ for that.....that is relatively inexpensive compared to rework/hold/unfulfilled customer orders etc

 

 

Your assumption MUST be that it's in the food......always. And yes, you are going to have to be the heavy.....no production is not going to like it when stuff is on hold........that will never change.......upper management needs to be shown a better way to manage this

[Ryan H.]

anw314: You really need to get Maintenance and Upper Management on board to help you mitigate this issue. A meeting with those parties and yourself so that additional precautions can be taken. In the event your missing pieces of equipment, etc. your right in being careful and putting things on HOLD in the event you suspect it could be in the food. There are many recalls due to foreign contaminates. Remind them of that.. They might hear you then.. 

 

Good Luck to you. 

 

Scampi is right, you will have to be the "heavy" in this. Hopefully support will follow. 

[Kylo]

Hi anw314
Our way is check easily wear and tear machine/equipment parts like gasket, loose teflon tape etc daily during pre-op.
All sharp object include sieve, filter etc is checked before use and after cleaning daily. Any broken found must report immediately by incident manager.

Having planned pm schedule.

Define design standard and allowable temporary repair materials. Brief to department of concern.

Screw, nut, bolt etc check daily after final metal detection if the product still expose.

Machine/equipment repair by maintenance, upon return to production/qa, the following shall check prior accept.
- operating condition
- any potential hazard to process or worker
a) cleanliness
b) any left over foreign body
*this apply to maintenance team vs vendor.

All the above is documented.
Hope it may helps some.

Rgds.

Sent from my vivo 1609 using Tapatalk

[anw314]

I agree with you guys. We have our Food Safety Team Meeting next week where I would like to really nail this program down.

I have been reviewing FDA 483 and recall events to help demonstrate the scope of what a recall would look like for us and the severity of our actions when we play the naïve card.  

 

Are there any members that have been in the driver's seat during a recall involving foreign material that would be willing to share their story to help me drive this home?

 

Or maybe an auditor or food lawyer that could help me explain the financial implications when we look the other direction and "hope" nothing happens.  

 

Thank you again for your support and advice.

[Scampi]

The implication is utter and complete bankruptcy if the company is found to have known there was an issue and did nothing to prevent/correct it.
 
If the company produces "adulterated foods" and sends them out of sale.....they are breaking the law
 
Read the Jack in the Box story about ecoli
 
XL Foods Canada 
https://www.osler.co...five-drivers-of
 
Common Injuries that a Court Will Award Money Damages  www.legalmatch.com/law-library/article/foreign-objects-in-food-lawyers.html
If you do find an unexpected object in your food, you may be able to sue for your injuries.  Typical injuries that the courts award damages for include:

• Cuts in the mouth and throat and damaged teeth
• Illness due to ingestion of the object
• Allergic reactions by ingredients that were not suppose to be in the food
• Lacerations by sharp objects found in the food that were not expected by the customer

https://www.raglandj...ect-injury.html
https://www.thestar....od_roseman.html
 
All of this from page 1 of a google search........
 
The company you work for is making me very nervous...............................
 
Look the other way is something HACCP is supposed to prevent

[anw314]

Don't be nervous. I would not be with my company if I was being told to look the other direction or believe we were sending out adulterated product in any fashion. I'm just trying to bulk up my tools and resources to better evaluate situations as they come our way.

 

I will definitely check out that legal match. Thank you for the tip.

[Charles.C]

The implication is utter and complete bankruptcy if the company is found to have known there was an issue and did nothing to prevent/correct it.
 
If the company produces "adulterated foods" and sends them out of sale.....they are breaking the law
 
Read the Jack in the Box story about ecoli
 
XL Foods Canada 
https://www.osler.co...five-drivers-of
 
Common Injuries that a Court Will Award Money Damages  www.legalmatch.com/law-library/article/foreign-objects-in-food-lawyers.html
If you do find an unexpected object in your food, you may be able to sue for your injuries.  Typical injuries that the courts award damages for include:

• Cuts in the mouth and throat and damaged teeth
• Illness due to ingestion of the object
• Allergic reactions by ingredients that were not suppose to be in the food
• Lacerations by sharp objects found in the food that were not expected by the customer

https://www.raglandj...ect-injury.html
https://www.thestar....od_roseman.html
 
All of this from page 1 of a google search........
 
The company you work for is making me very nervous...............................
 
Look the other way is something HACCP is supposed to prevent

 

 
Hi anw/Scampi,
 
There is QA Safety Risk Assessment.
 
And there is (seemingly/cynically[?]) "Business" Safety Risk Assessment.

[anw314]

Here's an example I pulled from a Food Safety Magazine Article Foreign Materials in Foods: Control and Evaluation. https://www.foodsafe...and-evaluation/

 

"And one of the oldest and best GMPs is still used by many: inspection of the lines. There are many operations that conduct detailed line inspections after cleanup to ensure that the processing lines are intact and undamaged. A small operation that is grinding or chopping a product might not have a metal detector, but that business should know that its chopping operation could pose a contamination risk if it got out of alignment. A post clean-up inspection might reveal scoring within the system, which would pose the question “Where did those metal fragments go?” One of the companies with which I worked had a policy in which a detailed inspection was done on-line up to the fillers. They occasionally discovered that gaskets had broken and vanished, which meant that day’s run was suspect. They continued their daily inspections but adopted a more rigorous program to change out gaskets before breakage occurred. In addition, they changed gasket colors to make them easier to find in product. Their products were soy-sauce based and they originally used dark-gray or black gaskets. Switching to white gaskets made them easier to find."

 

My question is this: what is the process you follow when the gasket is reported missing. The day's run is suspect, you don't know where the gasket is right? My knee jerk gut reaction is to put the whole day's production (to the last good check) on hold for disposal because I know that's the right thing to do. (Assume, in this scenario, you can't reprocess to filter out the foreign material because that's an easy solution) You have now put several thousand cases + on hold, extended an already tight run, and potentially shorted orders going out that week. None of that matters right, because it's the right thing to do. I know that.

 

In my experience (7 years now between two medium sized manufacturing companies) it's like the fight between the front of the house and the back of the house in a restaurant. I've seen and I've heard discussions in food safety conferences this battle between the QA Safety Risk Assessment and the Seemingly/Cynically questioned Business Safety Risk Assessment. It can't just be me who's experienced this.

 

Questions I've heard: 

- How are we supposed to know where the metal fragments went?

- How do you know the gasket was in there when we started?

- How do you know the gasket didn't fall out when it was reassembled or even put back in? 

 

Basically a "prove it" type mentality, right?

 

So in the example above, what if you're dealing with a weeks' worth of product, or a month? They want to make sure we're not throwing product away that wasn't involved. I get it. It's a hard call to make to say you just produced a weeks worth of garbage. All you know is that the material is missing and we expect that procedures are followed to clean and install the equipment, so you have to expect it's now in the product. Right? As elementary as it might appear, I'm just looking for peer support that proves I'm not being irrational and am on the right track. 

 

I feel the need to explain that these are proactive scenarios that run through my head.  I like to be able to describe these to my team to support our culture of prevention and reasons why we do what we do.

[Ryan H.]

Your looking at it right, but also be rantional. Depending on where the breakage of material was, is it really a possibility it is in the product? You will ha e to ask yourself. It it close to the line, or near a open process step, etc. if it’s not near the product line, you could probably rule out contamination, maybe.... If yes. than you will want to be throuogh with how you deal with it. And put it on HOLd for final disposition.

I would also suggest making sure per your SOP in your HOLd policy that if it’s a food safety hold that your in control of the disposition.. that way your able to objectively make your descion.

Your goal here is to stop the breakage or missing pieces from occurring. Maintenance must perform better PMs and your Upper Management must provide the funds.

I would be very interested in an update on your situation after you go back to Upper Management with this!

Good luck to you!

[FurFarmandFork]

To add to Ryan's point, a lot of my foreign material investigations have ended with "oh! I saw that bolt on the floor and just threw it away".

 

Training your line workers to report when they find bits of plastic/equipment/metal on the floor or equipment during their shift can go a long way from "EVERYTHING ON HOLD" to "oh, there it is".

 

Your facility shouldn't have a bunch of machine parts on the floor that makes it normal noise to find screws/nuts/o rings on the floor. If you can include training that says "the line lead needs to know if you find anything that looks broken/machine like that isn't attached, or save it so we can see it later!".

 

Cuts your holds wayyy down when you can find all the missing pieces.

 

-Austin

[anw314]

_{Meeting is tomorrow. You all have been a big help. Thank you!}