8 replies to this topic

[Dan E]

Greetings,

 

I am attempting to get my company's traceability program to function within the required 4-hour window, as we are currently struggling with this. We have implemented a number of corrective actions to fix the problem, but it just feels like there is too much data to collect in that period of time. I would appreciate any help with the subject.

 

Background:

• Dry grain processing facility
• Process raw product from the field through to finished product packaging
• Product has very long shelf life
• Product can be reworked indefinitely
• Working towards BRC
• BRC Start! Intermediate audit in a few months
• Small company, ~10 full time employees

Issues:

• I am not certain if I am selecting the correct point in the process to trace back to or forward from. Depending on the point selected it can dramatically affect the scope of a trace.
• If I trace an order back to the level of raw product receiving, and then attempt to trace forward from that point, the traceability chain is seemingly unending. If a recall were initiated for a single order, it could implicate 10x as much raw product, and the subsequent forward trace could easily add another factor of 10. A 10,000 lb order could easily implicate 1,000,000 lbs of shipped finished product, anywhere from 1 lb stand up pouches to 2,200 lb totes.
• Are we required to trace retail products forward to the customer? I would imagine grocery stores are not required to do this, and it would likely be impossible due to the nature of the sale. Would it be sufficient for a trace exercise to know how many packages/lbs of retail product were shipped and how many remained on site, as opposed to identifying individual recipients?
• Because my product can be reworked over and over again, I may use product left over from a blend in another blend, so the entire trace exercise has to be performed all over again for each tote included that was previously part of another blend. An example of this can be seen in the attached image.
• I have all of the information I need to trace everything fully, but the task is completely overwhelming.
• What quantity is the mass balance performed on? If I use totes for an order, would I confirm where all product from those totes went? Is the mass balance performed on all orders that each tote went into, or just the order in question?

I have attached an image of a web diagram that shows how a trace would go were I to run it using our current methodology. The red "O" indicates the order selected for the trace exercise, the red arrows show the path of backward traceability, and the blue arrows show the path of forward traceability.

 

Any input is greatly appreciated!

Attached Files

•  Traceability Web Example.pdf   198KB   107 downloads

Edited by Dan E, 09 June 2022 - 04:49 PM.

[Scampi]

You are required to go one step back (your supplier) and one step forward (your customer(s)

 

Yes, your recall amounts will be huge by the very nature of your business which is why it is essential that your traceability be crystal clear, performed in real time and conclusive.  Ideally in your situation, electronically filed via a batch record of some sort

 

The batch record would have production dates , all inputs (in kgs or lbs or tons etc.)  listed by their lot numbers --if they don't arrive with any lot identifiers, you need to do that (could be simple like type/date received/weight   C(corn)6-22 (june 6) 27586 (pounds)   or C62227586.

Issue a batch # to that blend

 

 

Then you need to list on a production record ALL of the finished products that batch went into

 

Then file all that data electronically by BATCH NUMBER

 

Also, your sales order needs to include the BATCH NUMBER that you sent to EACH customer

File that electronically

 

It sounds like alot--but once you develope the spreadsheets or database-it will become easier and old hat really quickly

 

Then when you do a trace, all of the data you need will be easier to find AND in one place

[Dan E]

You are required to go one step back (your supplier) and one step forward (your customer(s)

 

Yes, your recall amounts will be huge by the very nature of your business which is why it is essential that your traceability be crystal clear, performed in real time and conclusive.  Ideally in your situation, electronically filed via a batch record of some sort

 

The batch record would have production dates , all inputs (in kgs or lbs or tons etc.)  listed by their lot numbers --if they don't arrive with any lot identifiers, you need to do that (could be simple like type/date received/weight   C(corn)6-22 (june 6) 27586 (pounds)   or C62227586.

Issue a batch # to that blend

 

 

Then you need to list on a production record ALL of the finished products that batch went into

 

Then file all that data electronically by BATCH NUMBER

 

Also, your sales order needs to include the BATCH NUMBER that you sent to EACH customer

File that electronically

 

It sounds like alot--but once you develope the spreadsheets or database-it will become easier and old hat really quickly

 

Then when you do a trace, all of the data you need will be easier to find AND in one place

 

Scampi,

 

Thank you for your reply. Unfortunately we already have everything you mentioned in place. Everything is tracked by lot number and tag number for individual units. Each time product is handled, all identifying information is tracked and tied to any new production information. We have electronic records of everything, everything is searchable by lot identifiers, order numbers, etc. It still takes well over 4 hours to complete the trace, forwards and backwards, for all product and packaging.

 

Perhaps my database is structured poorly?

 

Regards,

Daniel

[Scampi]

It could be, but it's an incredible amount of data to manage

 

NOTE: BRC uses the word "should" not must or shall, so you may have some wiggle room on the timing

 

Are you entering all of that data manually?    It may be worth incorporating an inventory/trace management system----some are pretty simple (bar codes are scanned and weights are entered at every step) and then a barcode is issued for finished goods that is scanned every time you ship an order. Then you could just perform a search on a batch code and the system will spit out everything for you (in about 20 minutes)

 

Reach out to whomever audited you previously and ask them how tight the 4 hour window really is

 

From a processing point of view--you may want to take a really good look at "rework"  Is there anyway you can blend to order?  or adjust your batches to match sales history which would reduce the amount of leftover / surplus product you have at the end of a production run.  Adjusting your runs is probably the best way to simplify this process (if you can)

 

Trace exercises are great---they allow you to see where issues exist in your overall process--which is part of the fun!

[Dan E]

It could be, but's an incredible amount of data to manage

 

NOTE: BRC uses the word "should" not must or shall, so you may have some wiggle room on the timing

 

Are you entering all of that data manually?    It may be worth incorporating an inventory/trace management system----some are pretty simple (bar codes are scanned and weights are entered at every step) and then a barcode is issued for finished goods that is scanned every time you ship an order. The you could just perform a search on a batch code and the system will spit out everything for you (in about 20 minutes)

 

Reach out to whomever audited you previously and ask them how tight the 4 hour window really is

 

From a processing point of view--you may want to take a really good look at "rework"  Is there anyway you can blend to order?  or adjust your batches to match sales history which would reduce the amount of leftover / surplus product you have at the end of a production run.  Adjusting your runs is probably the best way to simplify this process (if you can)

 

Trace exercises are great---they allow you to see where issues exist in your overall process--which is part of the fun!

 

Thank you, I will look into the timing issue and ask our auditor. For some reason I was under the impression there was an FDA requirement of 4 hours for trace exercises under FSMA, but I cannot find anything about an FDA requirement for traceability timeframes in my cursory search.

 

For the rework side, we already do blend to order for most products. Typically a single blend goes into a single order for larger quantities, but our smaller items (specifically our 25 lb boxes and anything retail) tend to be produced in lump sums. It does not make sense for us to pack 1, 2, or 10 at a time, so we will do 200. But then that blend will go to 20+ different orders. Even then, the leftover rice from a blend, usually a few hundred lbs, will have trace information tied to it from that blend. So when we go to use small quantities like that it really throws a wrench in the traceability process, but I don't see a way around it. We can't eliminate the small amount of overage we produce when blending, and we can't afford to throw away potentially hundreds of lbs of good saleable product.

 

I agree about trace exercises, I am finding all kinds of problems haha!

[wtheriot]

Oh the days of rice and the huge "rework" bins/lots we would create. Ive been there and done that.

 

From the start...when you take in rough rice from the grower I assume you keep all of that crop in one bin with a Lot number?

 

Once milling are you milling into smaller bins for packaging and assigning that bin a lot number?

 

Then is the customer order being assigned a specific lot number?

In this scenerio you have to trace finished product back to milling record back to rough rice milled.

 

In addition, it sounds like you guys mill more than the specific customer order in which case you have extra. Are you then throwing that into a bin? Dies that bin then end up with dozens of lot numbers as rework sometime in the future?

 

I may be way off...but Im just trying to understand your process that creates the indefinite rework.

[Dan E]

Oh the days of rice and the huge "rework" bins/lots we would create. Ive been there and done that.

 

From the start...when you take in rough rice from the grower I assume you keep all of that crop in one bin with a Lot number?

 

Once milling are you milling into smaller bins for packaging and assigning that bin a lot number?

 

Then is the customer order being assigned a specific lot number?

In this scenerio you have to trace finished product back to milling record back to rough rice milled.

 

In addition, it sounds like you guys mill more than the specific customer order in which case you have extra. Are you then throwing that into a bin? Dies that bin then end up with dozens of lot numbers as rework sometime in the future?

 

I may be way off...but Im just trying to understand your process that creates the indefinite rework.

 

wtheriot,

 

Yes, rice it is. You know the drill!

 

When we receive rice from the grower it is tracked by the truckload with a receiving lot number, then a processing lot number is assigned once the product is ran through the mill (multiple receiving lots may be comingled into one processing lot, only product with the same grower and owner information is comingled), then finished product is graded and bagged off into separate totes all with the associated processing lot plus individual tag numbers per tote.

 

When a customer places an order, we generate an order number. We will either fill the order from stock product (less common) or generate a blend lot number for the order. That lot number is tied to all tags from the order, and our blend report tracks every pound that goes into a blend lot, all that come out, the waste generated from the order, any remaining blended product, and has a built in mass balance calculation. The blend lot is then tied to the order paperwork to complete the chain.

 

The remaining blended product, typically a small quantity, is bagged off and retagged with the blend lot number to retain traceability. If that product is used in another blend down the road, the new tag number and the blend lot information will be included on the new blend report. All remaining blends are kept separate, not comingled.

 

I have attached another diagram of forward traceability from a single receiving lot. This does not include any events where remaining blends are used, or when other receiving lots go into the same blend lot, which happens frequently.

Attached Files

•  Traceability Web Example 2.pdf   196.52KB   60 downloads

[Dan E]

Also concerning mass balance, it is not particularly useful for us when considering volumes prior to the "tote" step, at least as concerns traceability.

 

When processed, rice loses somewhere around 50% of the weight it came in with, and a several percentage point margin within that is typical depending on grower and harvesting methodology. If I were to conduct my mass balance on the total lbs received from the grower all the way through to shipped product, I would get something around that 50% figure.

 

We already calculate our recovery numbers for each processing lot (which is a mass balance essentially), but this is to ensure we are not losing product to a waste stream somewhere in the process and that we are meeting or exceeding lab results. From a traceability standpoint the number is meaningless because we accept the value as what it is, a factor of the growing and harvesting practices - it would typically not indicate a failure in traceability.

 

It would also dilute and render meaningless the mass balance we conduct from the tote step through to orders, since we typically exceed 99.7% traceability a several percentage point shift on the raw product side would completely nullify the usefulness of the data and hide any bigger swings on the processing and packing side.

 

Can I do separate mass balances for the two stages of product? Or does anyone have any clever way of dealing with a variable recovery rate on a product?

Edited by Dan E, 10 June 2022 - 07:15 PM.

[Kara S.]

Jumping in a little late to this party, but I believe you are doing too much for the sake of the exercise. 

 

1. I am not certain if I am selecting the correct point in the process to trace back to or forward from. Depending on the point selected it can dramatically affect the scope of a trace.

• ​Your outcome should be the same no matter what you choose. There are basically 3 types of trace exercises. (1) Raw Material - use a raw material lot code and trace it through to finished product. That's it. You end there, I would not begin looking at rework or where it was shipped off to. You are simply showing the auditor you know how your raw material was used. The amount you received in matches the amount consumed. (2) Finished Product - use a lot code of finished product and trace where it went. This should be the sum of what is in-house, what was shipped out to customers, and what you reworked. You should know the lot numbers of where the rework went to, and the location of those. (3) Primary Packaging - Use a lot number of primary packaging and identify which finished product lot numbers used that packaging material. 

2. If I trace an order back to the level of raw product receiving, and then attempt to trace forward from that point, the traceability chain is seemingly unending. If a recall were initiated for a single order, it could implicate 10x as much raw product, and the subsequent forward trace could easily add another factor of 10. A 10,000 lb order could easily implicate 1,000,000 lbs of shipped finished product, anywhere from 1 lb stand up pouches to 2,200 lb totes.

• Yes, unfortunately that is the nature of recalls when you have a large lot size. But if you are asked to trace XXX ingredient from an order number, then you would determine the lot code of XXX ingredient and obtain all the finished product lot codes that ingredient went into. I believe that should be enough for an auditor and that should decrease the time by not then continuing onto finding where that was all shipped. You are only doing 1 step forward - not a full recall which could take a full day or more of work to fully trace adequately. 

3. Are we required to trace retail products forward to the customer? I would imagine grocery stores are not required to do this, and it would likely be impossible due to the nature of the sale. Would it be sufficient for a trace exercise to know how many packages/lbs of retail product were shipped and how many remained on site, as opposed to identifying individual recipients?

• no you do not have to trace to individual consumer. Just where you sold it or shipped it to. 

4. Because my product can be reworked over and over again, I may use product left over from a blend in another blend, so the entire trace exercise has to be performed all over again for each tote included that was previously part of another blend. An example of this can be seen in the attached image.

• Unsure if you add it to a full batch, but you could always create a smaller batch with new batch number for rework. Rather than adding 50# of rework into a 50,000# batch, you can make a smaller batch so there is not 50,000# at risk but 1,000# (example but may not work well with your process). 

 

5. I have all of the information I need to trace everything fully, but the task is completely overwhelming.

• Don't do it by yourself. Look into traceability programs that can run reports if budget allows or ask your current vendor since you mentioned already having electronic records if there is an easier way to search for information. 

 

6. What quantity is the mass balance performed on? If I use totes for an order, would I confirm where all product from those totes went? Is the mass balance performed on all orders that each tote went into, or just the order in question?

• I am honestly unsure. I only had to do a mass balance once for sustainable palm oil and it was quantity received in vs. amount consumed.