11 replies to this topic

[lmacfarland]

I am looking for some insight / opinions or examples of product returns being used for rework.

 

Specifically fluid dairy. Some large customers (NOT CONSUMERS) are able to return over order to our facility and we process into rework (pasteurization included). 

 

I am new to the dairy industry and this process, currently I am building a Rework Policy and uneasy with allowing this practice but know it has been this way for 30+ years. 

 

My main concern is how we would prove no loss of confidence in our product that has technically been lost in our supply chain. 

 

We do have several testing completed on this product before being use  (flavour grading, inspection, micro results...) is this enough to allow confidence in product? 

 

Does anyone have experience returned product for rework purposes?

 

 

Thank you! 

[pHruit]

Hi,
This is a question that I'm sure many of us working with raw material products have been asked periodically - the salesperson wants to keep the customer happy and "of course it's still fine".

The "we've always done this" argument seldom seems to have any basis in science or GMP, and is the bane of many QA persons' lives...

 

In the past I've consented to use of returned product that has been shipped in a packed format (as an industrial ingredient - drums, IBCs etc) where the original seals are still intact and we've been able to verify that storage requirements have been maintained.

Obviously you'd need to consider shelf life and limiting factors, storage conditions etc to decide what the potential risk is.
For bulk product it's more complex as you then have the question of how your customer has treated it - are their tanks sufficiently clean, and how can you prove that for yourself? If we buy from a bulk supplier we include their cleaning and hygiene controls in the assessment process so we know they're suitable, but this is not always so easy to accomplish when the "supplier" is your customer.

There's also the question of what else may or may not have got into it, and whether you can actually verify that. I'm sure I'm not the only person who has seen some very curious practices in terms of the way some sites manage stock in bulk storage tanks - not following FIFO, dumping newer loads onto older stock etc - the latter could be fine for the customer as for their traceability they just consider it one larger batch from two (or more) sources, whereas in your position it means you'd have no idea what you're actually getting back or whether it's really your product.

Testing can help, but should only be used in addition to, rather than as a replacement for, proper QA-led controls.

 

It would therefore be useful to know a bit more about the actual supply process - is this product packed, and is the format tamper-evident? Are there specific storage requirements, and do you have any way of verifying that these have been met? If it's bulk, what can you realistically find out about the storage process and associated controls?

[lmacfarland]

Hi,
This is a question that I'm sure many of us working with raw material products have been asked periodically - the salesperson wants to keep the customer happy and "of course it's still fine".

The "we've always done this" argument seldom seems to have any basis in science or GMP, and is the bane of many QA persons' lives...

 

In the past I've consented to use of returned product that has been shipped in a packed format (as an industrial ingredient - drums, IBCs etc) where the original seals are still intact and we've been able to verify that storage requirements have been maintained.

Obviously you'd need to consider shelf life and limiting factors, storage conditions etc to decide what the potential risk is.
For bulk product it's more complex as you then have the question of how your customer has treated it - are their tanks sufficiently clean, and how can you prove that for yourself? If we buy from a bulk supplier we include their cleaning and hygiene controls in the assessment process so we know they're suitable, but this is not always so easy to accomplish when the "supplier" is your customer.

There's also the question of what else may or may not have got into it, and whether you can actually verify that. I'm sure I'm not the only person who has seen some very curious practices in terms of the way some sites manage stock in bulk storage tanks - not following FIFO, dumping newer loads onto older stock etc - the latter could be fine for the customer as for their traceability they just consider it one larger batch from two (or more) sources, whereas in your position it means you'd have no idea what you're actually getting back or whether it's really your product.

Testing can help, but should only be used in addition to, rather than as a replacement for, proper QA-led controls.

 

It would therefore be useful to know a bit more about the actual supply process - is this product packed, and is the format tamper-evident? Are there specific storage requirements, and do you have any way of verifying that these have been met? If it's bulk, what can you realistically find out about the storage process and associated controls?

 

 

The product is packaged in retail packaging, it is a fluid closed product.

 

Part of the process is checking for leaking or damage. If any packages show evidence of leaking or damage that product is not to be used in the reclaim process and is now to be disposed.

 

Storage requirements are set to refrigerated temperatures - so far this is checked with flavour, odour and appearance.

 

Mico is completed to ensure no pathogens and or spoilage bacteria.

 

Self life of finished product containing rework is not adjusted as pasteurization is completed (micro again tested post pasteurization). Only a specified % of rework is approved to be added to a batch with "Like with Like" requirements  

[foodguy63]

Hi,

 

I don't have much experience with reworking bulk ingredients, but from what I understand it sounds like the traceability aspect may be the most difficult followed by customer storage conditions.

Many companies don't completely clean there bulk containers and equipment with every new lot received. This means that reworking bulk ingredients that may have been opened, emptied, and refilled could be a recall nightmare. If you ensure all packaging is still secure and unopened you would probably be okay.

As far as customer storage containers, verifying by organoleptic and microbiological methods may be a good check, but getting a copy of that customer's process might be useful.

Also, have you integrated the rework process into your Food Safety Plan? If not, then I would do that and perform the subsequent hazard analysis.

[pHruit]

The product is packaged in retail packaging, it is a fluid closed product.

 

Part of the process is checking for leaking or damage. If any packages show evidence of leaking or damage that product is not to be used in the reclaim process and is now to be disposed.

 

Storage requirements are set to refrigerated temperatures - so far this is checked with flavour, odour and appearance.

 

Mico is completed to ensure no pathogens and or spoilage bacteria.

 

Self life of finished product containing rework is not adjusted as pasteurization is completed (micro again tested post pasteurization). Only a specified % of rework is approved to be added to a batch with "Like with Like" requirements  

 

Ok, that all makes your life somewhat easier.

For the procedure I'd look to document the process of inspecting to make sure product is still sealed, and you'll still have your own original batch coding on the packs for full traceability. I suppose from a food defence perspective you should possibly consider the potential for the product to be substituted with a forgery and it being this that's returned to you, but unless it's an unusually high value ingredient I don't feel that this would be a huge risk.

 

Is there any way you can verify that the chill chain has been maintained?

That'd be a solid extra point to cover, since it seems to be arguably the highest risk step of the overall sale/customer/return process. Even if it's just a written assurance obtained from your customer as part of your procedure for managing the overall system. Micro testing helps, but you won't be testing every ml returned so a broader solution backed up by the testing would probably give you the best position for this.

[Scampi]

May I ask how "over deliveries" are occurring in the first place?  If you're talking about 2-3 dozen cartons or bags of milk, I can understand that, but if you're talking about 2-3 skids always being returned from either A) the same customer or B) because a sales person is entering an order knowing it's larger than customer requests then those/that practice should be adjusted.

 

There are lots of reasons.....not just the integrity of the supply chain and any adulteration of the product; freight and handling, the labour involved in rework, the cost of the labour and packaging to create the product to begin with etc etc etc

 

You're rework procedure is solid, it's the business practice that needs examined.

 

If you are constantly reworking product like with like, eventually it will skew the real production #'s..............and given Canada's quota system there may be other reasons the rework is the standard practice

[foodguy63]

Ok, that all makes your life somewhat easier.

For the procedure I'd look to document the process of inspecting to make sure product is still sealed, and you'll still have your own original batch coding on the packs for full traceability. I suppose from a food defence perspective you should possibly consider the potential for the product to be substituted with a forgery and it being this that's returned to you, but unless it's an unusually high value ingredient I don't feel that this would be a huge risk.

 

Is there any way you can verify that the chill chain has been maintained?

That'd be a solid extra point to cover, since it seems to be arguably the highest risk step of the overall sale/customer/return process. Even if it's just a written assurance obtained from your customer as part of your procedure for managing the overall system. Micro testing helps, but you won't be testing every ml returned so a broader solution backed up by the testing would probably give you the best position for this.

 

If you truly wished to verify the chill chain you could request you customers temperature recording records before you accept receipt of the rework. This would be a pretty strict and cumbersome step but it would verify the chain. Otherwise, they may make temperature-sensitive indicators like packaging or stickers? This seems a bit like overkill to do on all shipments, assuming you aren't talking about an abundance of rework. If you are, I agree with Scampi's point about the business inefficiency of constant rework.

 

At the end of the day, we as quality professionals need to accept we may not get an absolute verification every time and employ some amount of trust (gasp right?). You have all the best indicating aspects of the returned goods quality verified and if can you get some assurance from the customer returning the ingredient that it has been stored properly, I think you'd have a very robust plan.

[pHruit]

At the end of the day, we as quality professionals need to accept we may not get an absolute verification every time and employ some amount of trust (gasp right?).

 

I sometimes forget that many of you aren't subject to the peculiarities of the UK market and particularly the whims of the UK retailers, and thus still have these concepts like "trust". I have a vague memory of it and I think it was a positive thing, but it's been long-since outlawed here so I'd struggle to say what it really meant

[foodguy63]

 

I sometimes forget that many of you aren't subject to the peculiarities of the UK market and particularly the whims of the UK retailers, and thus still have these concepts like "trust". I have a vague memory of it and I think it was a positive thing, but it's been long-since outlawed here so I'd struggle to say what it really meant

 

This is quite the tangent from the original post so I'll keep this short and sweet:

 

Unfortunately, we are inevitably going to start paralyzing our food systems. When (not if) we get to the point where every process has to be verified back to empirical data, we need to have complete automation from farm to table i.e. no human involvement. That's the only way a system could truly be free of "trust". This is neither positive or negative, only what will happen.

[FSQA]

Are you opening the returned product and using it as a raw material with your new batches or is it kept in the retail packaging and sold to another customer?

 

If its kept in the retail packaging, Temperature control and food defense can be your biggest concerns, as mentioned above.

[lmacfarland]

Are you opening the returned product and using it as a raw material with your new batches or is it kept in the retail packaging and sold to another customer?

 

If its kept in the retail packaging, Temperature control and food defense can be your biggest concerns, as mentioned above.

 

Product that is returned and all other reclaim that is collected from production is treated as a raw product. It is all removed from packaging and % standard set is batched into new product. 

[Tony-C]

20 years ago there were major issues in the UK dairy industry because of this practice. Stores were returning products which may have been short life (scrupulous stores opened short life products and claimed they were leakers) or damages and they were being reworked. There was potential for the returned product to affect product quality/safety or be maliciously contaminated.

 

Systems were out of control and something needed to be done. Because of the sheer amount of work required to ensure adequate control of product from 400+ customer stores, all returned product was subsequently designated animal feed and not reworked. This then meant wastage increased significantly but what that did do was increase focus on returns from customers and genuine issues which were causing problems with product quality (leakers etc.).

 

Despite this I would consider rework of returns where there is a hygienic rework process, systems are in place (including tamper evidence, traceability and temperature control) to ensure product quality & safety and there was sufficient volume to make it practical.

 

One other thing, by reworking your process is selecting organisms and enzymes that can survive pasteurization and affect product quality, particularly shelf life. It is good practice to break this chain periodically by stopping all rework for a number of days, say each month or so.

 

Kind regards,

 

Tony