16 replies to this topic

[ladytygrr]

Good morning,

 

I came in this morning to find out that a chunk (have not yet seen how large) of the stainless steel die on the corner of our extruder came off. This was found during pre-operational inspections. I'm told the piece of steel was found and fitted to the missing area and they were a perfect match (as far as we can tell). They took the die out, filed down the sharp corners and are cleaning and sanitizing it along with the rest of the extruder prior to starting operations.

 

We do not have a metal detector or x-ray machine.

 

Given no metal detector or x-ray, are there any steps that we could/should be taking that we're not thinking of in order to ensure we are operating at the highest level of safety possible?

 

In my head, we should be looking at obtaining a new die because small pieces could be chipping off and it would be nearly impossible for us to tell - am I headed in the right direction with that thought? If I am right, I don't see management being too happy with that - what are other reasons to get a new one? Could the chunk out somehow be more of a harbor for microbial growth if it's still stainless steel and we're still cleaning and sanitizing the whole thing?

 

Thanks in advance,

 

~Emily~

[brianweber]

Get a new one. Once a die breaks or chips it is time to replace. The structure has been compromised. As for microbial growth, I wouldn't think so as long as it is filed down smooth with no crevices that are not cleanable.

[ladytygrr]

Thanks, Brian. I just found out it's actually like the only piece on the whole extruder that is NOT stainless and is, instead, aluminum.

 

I'm quite worried that we are going to decide NOT to replace it (in other words, that I'm going to be overruled). The piece is on the side and "nowhere near a food contact surface" per our ops mgr but that is not letting me breathe easier. Grrrr. 

[brianweber]

It's a struggle, but you just stand firm and DOCUMENT what you recommended to them.

[Simon]

Hi Emily, did you say you found all pieces?

If so and it is fitted back and cleaned and polished and working then I don't see a risk.

 

The only other thing I would be interested in is what was the root cause of it coming off, which if can be identified should be addressed to prevent reoccurrence.

 

Great it was found during pre-operational inspections.

 

Regards,

Simon

[Simon]

OK I am the boss with the wallet. 

Can you tell me why I need to spend money replacing it...what is the risk?

[dv8dawn]

Boss, If I were in this position, I would rather compare the die cost v/s x-ray machine and metal detector then will buy a metal detector to convince the Management by cost wise and Operations by quality wise…. 

[ladytygrr]

Simon,

 

We weren't able to fit the piece back in. It is sheared off to the point that I can see layers of material on the sheared off piece. The die itself where the piece came off was filed down/polished and put back into the extruder.

 

My reasoning behind paying money for a new die: the piece may be on the side, but when it was put back and the extruder put back together, I couldn't see where the piece had come off. That means if pieces start to shear off again, they will likely be small flakes and it will be entirely possible that we will miss that happening and, since we don't have metal detection (which won't work on aluminum anyway) or x-ray on our line, we could have aluminum flakes, shards, needle-like pieces in our product and NEVER KNOW IT. That is not a risk that I want my name attached to; why would we want our company's name attached to a risk like that?

 

How's my reasoning, boss?

[Scampi]

it may help to estimate the cost of a recall, plus the bad press associated with it and add that to your argument. Is anyone positive it somehow didn't end up in  the product? Sometimes scare tactics work to encourage management to spend money. If it's the corner of the extruder, how can it possibly be non food contact?

[ladytygrr]

it may help to estimate the cost of a recall, plus the bad press associated with it and add that to your argument. Is anyone positive it somehow didn't end up in  the product? Sometimes scare tactics work to encourage management to spend money. If it's the corner of the extruder, how can it possibly be non food contact?

Thanks, Scampi. 

 

Your point of if it's the corner of the extruder, how can it be non food contact is spot on and my take, as well. They put it back together before I could look at it but the fact that we can't see where the aluminum came off when the die was reinstalled and the extruder put back together is adding to my concern.

 

The fact they found the piece during pre-op checks and everything was filed/polished, cleaned, and sanitized before starting operations makes me comfortable that nothing got in the product from the initial issue. I am concerned about continuing operations, though.

 

Love the idea of estimating the cost of a recall and bad press. I'll have to get working on that so I can present to the appropriate individuals over here.

 

Thank you!!

[Simon]

Sounds logical Emily.

Machinery and equipment must be maintained in good repair. That said replacing the die in itself still does not address the root cause, buy a new one and the same or similar thing could happen to this or another part. And as you say no means of detection.

There are many case studies of recalls for metal contamination you could use to show your boss how exposed you are to risk and cost without adequate detection on the line.

 

Regards,

Simon

[ladytygrr]

Thanks, Simon.

 

I used to work in a machine shop and am still on good terms with my old coworkers. I have a call in to one of them to discuss aluminum and the likelihood of continued shearing off of pieces of the die.

 

I asked about why it happened and I could not get a straight answer. I will keep pursuing (and documenting!) what I find.

 

Along the lines of documentation...what do people usually do to document stuff like this wherein we've suggested or requested things/changes for the sake of food safety but it was turned down? Do I send myself an email? Start a document I house on my own computer? We aren't planning on having a food safety team or HACCP team meeting to discuss this so there won't be any meeting minutes I can document this in.

[Charles.C]

 

Along the lines of documentation...what do people usually do to document stuff like this wherein we've suggested or requested things/changes for the sake of food safety but it was turned down? Do I send myself an email? Start a document I house on my own computer? We aren't planning on having a food safety team or HACCP team meeting to discuss this so there won't be any meeting minutes I can document this in.

 

Hi Emily,

 

It's called a Corrective Action Form.

 

Used to be more dramatically called a N.U.O.C.A. (Notice of Unusual Occurrence and Corrective Action)

 

 Copy of ChewingGumHACCP.xls   123KB   25 downloads

(just an example, the details are debatable)

 

As per  post #5, the lever for Action is the "Root Cause" portion of  the Form.

[ladytygrr]

Thanks, Charles. My quality background is fairly limited; I'm familiar with Corrective Action forms but we've historically only been using them for customer complaints and/or our complaints re: repeat, provable/known vendor issues rather than stuff like this. 

 

Our "CA" forms are a spreadsheet with column headings. I'll have to think on this. 

 

Many thanks to everyone - have a great night!!

 

~Emily~

[Simon]

You often see a separate "Food Safety Incident Report" aside from customer complaints and internal quality defect forms.  It will still have many of the same fields such as date, description of incident, product batches involved, personnel involved, what was done to correct the situation, what was the root cause and action taken to prevent a recurrence and of course a sign off as complete.  Something like that.

 

Regards,

Simon

[Agnieszka]

You often see a separate "Food Safety Incident Report" aside from customer complaints and internal quality defect forms.  It will still have many of the same fields such as date, description of incident, product batches involved, personnel involved, what was done to correct the situation, what was the root cause and action taken to prevent a recurrence and of course a sign off as complete.  Something like that.

 

Regards,

Simon

Hi Emily, 

You may want to use basic incident report template (like the one attached) and build the report as per Simon's post to cover what has happen and what decisions have been made.

Attached Files

•  incident report template.docx   30.11KB   21 downloads

[ladytygrr]

Hi Emily, 

You may want to use basic incident report template (like the one attached) and build the report as per Simon's post to cover what has happen and what decisions have been made.

Wow, Agnieszka - thank you! I'm working on developing many records that we need to have and this is a fantastic template!

 

Thanks a bunch and Happy Friday Eve!

 

~Emily~