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Recall for glass found in product and can't locate the source


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#1 Brendar1

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Posted 14 October 2019 - 10:42 PM

i everyone,

I received a customer complaint from a customer that indicated they found glass in product. The object was returned and it is in fact glass.  We are a frozen dough manufacturer. We have a glass and brittle plastics registry and aside from lights that are encased in shatter proof casing we do not have glass in the facility.  We determined that we would recall all lots for that dough produced on the production date in question.  I can't clearly define root cause and don't see a way the contaminant originated in our facility.  (I reached out to our suppliers and they have indicated that they have not received any customer complaints and records of sifting/ foreign object detection are in order)  I have to complete an FDA report defining root cause, action plan and verification of effectiveness.  I also have to submit this information to SQF.  I am at a loss as to how to come to a root cause and corrective action to put into place when we still don't know how it entered the facility.  Any guidance or assistance would be greatly appreciated!

 

 

Thank you for your time,

Brenda



#2 SQFconsultant

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Posted 14 October 2019 - 10:57 PM

It would be written up as source unknown base on the preventors that  you have in place and that all employee, visitor and contactor GMPs are followed that prevent people from bringing glass in, etc. and the recall is being done on an over-cautious standpoint.

 

The only issue would be could this be malicious, could one of your employees, contractors, visitors etc have put the glass into the product or a supplier for economic gain, damage etc.

 

Sometimes its not as easy as just a recall review.


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Glenn Oster
 
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#3 Ryan M.

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Posted 15 October 2019 - 03:18 PM

Also, do not count out the customer.  Customers do in fact tamper with food products they purchase for economic gain, notoriety, or because they are bored and need some "drama" in their lives.  I have come across it a few times in my experience.

 

Can you determine if this may have been a possibility?



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#4 Jain

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Posted 15 October 2019 - 03:55 PM

Also, do not count out the customer.  Customers do in fact tamper with food products they purchase for economic gain, notoriety, or because they are bored and need some "drama" in their lives.  I have come across it a few times in my experience.

 

Can you determine if this may have been a possibility?

 

Is there any provision or guidelines that helps determine possibility of tampering by "customer"?

 

Provisions of physical hazards control including glass, plastic, metal, stone, wood, hairs etc. are applicable to a manufacturer, but can all be introduced by a customer (albeit crazy). It would be almost impossible to prove that the foreign matter was introduced by "complaining customer" himself. Hence, if there is a customer complaint for foreign matter presence, the onus entirely will be on manufacturer to investigate and audit entire operation to find the root cause and corrective measures, if any. Probably the over cautious approach would guide and lead to recall of the entire batch, putting on huge financial burden.

 

If the foreign material introduction is result of lack of controls at operational levels on part of the manufacturer, the provisions surely serve as a measure for check. However, if this was result of a prank by a crazy customer, the manufacturer is burdened with huge financial losses.

 

But then as the saying goes - Customer is the King.



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#5 QSDA

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Posted 15 October 2019 - 05:24 PM

Have you had the glass analysed to try and identify possible source, I had one complaint which turned out to be pyrex (none on site) and eventually traced to previous breakage in complainants' kitchen. 

May also rule out the plant if motor glass etc



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#6 Ryan M.

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Posted 15 October 2019 - 07:00 PM

Is there any provision or guidelines that helps determine possibility of tampering by "customer"?

 

Provisions of physical hazards control including glass, plastic, metal, stone, wood, hairs etc. are applicable to a manufacturer, but can all be introduced by a customer (albeit crazy). It would be almost impossible to prove that the foreign matter was introduced by "complaining customer" himself. Hence, if there is a customer complaint for foreign matter presence, the onus entirely will be on manufacturer to investigate and audit entire operation to find the root cause and corrective measures, if any. Probably the over cautious approach would guide and lead to recall of the entire batch, putting on huge financial burden.

 

If the foreign material introduction is result of lack of controls at operational levels on part of the manufacturer, the provisions surely serve as a measure for check. However, if this was result of a prank by a crazy customer, the manufacturer is burdened with huge financial losses.

 

But then as the saying goes - Customer is the King.

 

What do you mean by provision?  It can happen.  If a company can show that it came from the customer they can save themselves lots of time, effort, and money.  I've had a number of instances which were traced back to the consumer.

 

One example, when I was in a milk bottling plant we packaged 4-oz cartons of milk.  This was mainly sold to schools and nursing homes.  Customer service got a call about foreign material in the 4-oz carton of milk.  Long story short I had to end up driving to the nursing home to meet with the director and the person complaining.  They pulled out a napkin from inside the carton.  The napkin fully filled up the carton.  During our process of filling the container it is running 300 cartons per minute.  There's no way it came from our process, someone had to have introduced the napkin into the carton.  For an operator to do this they would have had to shut down the line for 15 to 20 minutes.  For that much downtime other persons on the line would have to be involved.  I explained this to the person and the director.  They wouldn't hear it and they wouldn't give me the carton or napkin for further investigation.  I finally asked, what exactly do you want from us?  She said a new walker would be nice.  At that point I excused myself and called my manager explaining the situation and he said, "We'll let our lawyers deal with it if it comes to that."



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#7 Brendar1

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Posted 15 October 2019 - 08:17 PM

Thank you for the responses, I truly appreciate it.  Unfortunately for me at this time the company does not want to pursue sending out the glass for testing.  I am still at a loss for what I should report back to FDA and SQF.  I truly believe that we have our preventive measures and programs in place so still continue to have difficulties writing up a root cause to a problem that we don't believe we have.  Thoughts?



#8 probard

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Posted 16 October 2019 - 01:36 AM

Hi Brendar,

 

Given the financial loss caused by a recall, there is literally no downside to analyze the glass and get the opportunity to know whether it is possible or not that it comes from your plant, why on earth would your company not want to analyze it? 

 

Also, I would advise to analyze not only the chemical composition of the glass, but also its shape. Specialized labs are able to tell if the shape of the object before breaking (plane surface, angle, etc.)

 

Best regards,

Pauline



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#9 DPN

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Posted 16 October 2019 - 06:54 AM

Dear Brenda,

 

Unfortunately, I do not have an answer for you. I agree with our colleagues that it would be best to analyse the glass in a laboratory. 

 

Another thing I would like to add though: You said you do not have glass in your production facilities, so I presume you also have considerd this, but just te be sure: employees could wear glasses.

 

Regards



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#10 Hank Major

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Posted 16 October 2019 - 08:49 PM

Thank you for the responses, I truly appreciate it.  Unfortunately for me at this time the company does not want to pursue sending out the glass for testing.  I am still at a loss for what I should report back to FDA and SQF.  I truly believe that we have our preventive measures and programs in place so still continue to have difficulties writing up a root cause to a problem that we don't believe we have.  Thoughts?

 

Write it up as a probable downstream introduction (this is the root cause). Emphasize that there is no evidence of any missing or broken glass objects where the dough was being made and shipped while under your control. Then say that in spite of the root cause analysis findings, you are doing a Corrective Action (the recall) anyway. 



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#11 QAGB

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Posted 17 October 2019 - 07:54 PM

Agreed with everyone on this. I don't really understand why your company would choose not to have the glass analyzed. This could really save you a lot of headaches. 

 

I have dealt with two customer tampering events in my time - where in both cases it was extremely improbable that an employee could have done what the customer said happened to the product. These things definitely do happen. 



#12 majoy

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Posted 17 October 2019 - 08:16 PM

Proactive recall is good if you have the resources. Seems like your company has it anyway so, i wouldn't fight it with the owners if they want to recall. But i will still send it out just for curiosity and so that if there will be similar complaint in the future, i will have history to look into.

 

But same as everyone else, customers are sometimes bored and there are notorious complainers because they know they can get money, compensation etc. for their complaint.


"Whatever you do, do it well..." - Walt Disney


#13 consulti

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Posted 21 October 2019 - 07:44 AM

Hello Brenda,

 

I would check all the glass in my site ( Size / shape), check the CCTV cameras ( assuming you have the food defense system in place) to ensure no sabotage has happened at site. Visit the customer to understand further details. Visit supplier to ensure they have taken all the precautions. If we do not find any source I think we should  go back to the customer as well as FDA and SQF saying no source found at the production and supplier end.

 

Regards



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#14 BostonCream

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Posted 21 October 2019 - 07:56 PM

i dont see the necessity of a recall in this case. I would rather put it as an "isolate incidence" if no source of glass can be identified through the whole facility. 






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