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#1 GMO

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Posted 17 February 2016 - 11:41 AM

I cannot be the first person to have this problem...

 

Years ago on an audit, we had raised as an issue that we didn't do a practice mass balance trace on film.  We spoke to the customer after the audit who said "no, don't bother, do it on labels" so we did.

 

We then had another auditor from the same company who raised the same issue.

 

Now our problem is that we can be using the same film batch for months.  Our systems aren't automated so tracing what has been used is manual.  We could be going through hundreds of pieces of paperwork to confirm what was used where.

 

Our systems aren't automated, they are backflushed so it makes actual film usage on the system not related to actual use in the factory.  Assumptions are made.  We can't change this system because it is becoming obsolete and no longer supported by the manufacturer.  Going forward, the new system should help this issue.

 

Because of our production, it's not as simple either to say "this product was made with x film" because there are multiple lines a product can be made on and they use different film widths which may be different batches so to know how much product was made with film x is not a simple task either.  Had it been I could have had a simple calendar which said when each film batch started and stopped being used and compare this with amount made (which is automated).  Simples.  Our system (rightly) though can't tell the difference between a product made on line 1 or line 2 (why would it need to?)

 

I have to admit I've now got a bit bogged down with this.  I asked our (new) technical contact at the retailer who just asked us to write it down from the film code.  Well that's what we do.  I explained why that doesn't work and I got this kind of response.

 

:dunno:

 

Is anyone doing something which would help us?  I have the feeling there is an incredibly simple answer here that I'm missing.


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#2 Simon

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Posted 17 February 2016 - 01:07 PM

Hi GMO, surely the film supplier provides a unique identification number on each reel as well as the batch number. 

 

In my experience film suppliers provide a label on the reel (and sometimes in the core also) with batch ID, Mother reel number, mother reel position, reel number, quantity, supplier item code, customer item code, product description, date of manufacture. If you have this then you can think about what you record per order for raw material usage e.g. what actual reel and what qty.

 

What do you get?

 

Regards,

Simon


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#3 QAGB

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Posted 17 February 2016 - 01:52 PM

I cannot be the first person to have this problem...

 

Years ago on an audit, we had raised as an issue that we didn't do a practice mass balance trace on film.  We spoke to the customer after the audit who said "no, don't bother, do it on labels" so we did.

 

We then had another auditor from the same company who raised the same issue.

 

Now our problem is that we can be using the same film batch for months.  Our systems aren't automated so tracing what has been used is manual.  We could be going through hundreds of pieces of paperwork to confirm what was used where.

 

Our systems aren't automated, they are backflushed so it makes actual film usage on the system not related to actual use in the factory.  Assumptions are made.  We can't change this system because it is becoming obsolete and no longer supported by the manufacturer.  Going forward, the new system should help this issue.

 

Because of our production, it's not as simple either to say "this product was made with x film" because there are multiple lines a product can be made on and they use different film widths which may be different batches so to know how much product was made with film x is not a simple task either.  Had it been I could have had a simple calendar which said when each film batch started and stopped being used and compare this with amount made (which is automated).  Simples.  Our system (rightly) though can't tell the difference between a product made on line 1 or line 2 (why would it need to?)

 

I have to admit I've now got a bit bogged down with this.  I asked our (new) technical contact at the retailer who just asked us to write it down from the film code.  Well that's what we do.  I explained why that doesn't work and I got this kind of response.

 

:dunno:

 

Is anyone doing something which would help us?  I have the feeling there is an incredibly simple answer here that I'm missing.

 

 

Hi GMO,

 

I'm trying to follow your process, and I think I mostly understand what you are doing.

 

For each line, you should have a film roll batch sheet or change log. The sheet should indicate the following at time of changeover when a new film roll is placed on the line:

 

  • Film Supplier
  • Line
  • Date
  • Operator
  • Product Running
  • Lot Number of Product
  • Film Batch Number, PO Number, or other identifying information from film roll
  • Other information necessary to your process

I would then suggest, as you get the film roll changeover records, that this information gets manually stored in a spreadsheet or database (probably easier to use for sorting and queries). If you have to trace it, you would just search for the information you need at the time you need it.

 

I hope I understood your process well enough to help.

 

 

QAGB


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#4 GMO

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Posted 18 February 2016 - 11:04 AM

Hi GMO, surely the film supplier provides a unique identification number on each reel as well as the batch number. 

 

In my experience film suppliers provide a label on the reel (and sometimes in the core also) with batch ID, Mother reel number, mother reel position, reel number, quantity, supplier item code, customer item code, product description, date of manufacture. If you have this then you can think about what you record per order for raw material usage e.g. what actual reel and what qty.

 

What do you get?

 

Regards,

Simon

 

Yes they do. That's not the problem.  The problem is the batch may be used for 100s of production runs and as we have more than one line which can run product (with different film widths, so different batches) finding how much was made is not easy.  Try mass balancing that...


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#5 GMO

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Posted 18 February 2016 - 11:05 AM

Hi GMO,

 

I'm trying to follow your process, and I think I mostly understand what you are doing.

 

For each line, you should have a film roll batch sheet or change log. The sheet should indicate the following at time of changeover when a new film roll is placed on the line:

 

  • Film Supplier
  • Line
  • Date
  • Operator
  • Product Running
  • Lot Number of Product
  • Film Batch Number, PO Number, or other identifying information from film roll
  • Other information necessary to your process

I would then suggest, as you get the film roll changeover records, that this information gets manually stored in a spreadsheet or database (probably easier to use for sorting and queries). If you have to trace it, you would just search for the information you need at the time you need it.

 

I hope I understood your process well enough to help.

 

 

QAGB

 

No, it's not quite right.  Even if I had all that with the database or spreadsheet, it wouldn't show me how much I should have used.


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#6 GMO

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Posted 18 February 2016 - 11:20 AM

Perhaps I've not explained this well.  Ok, take product A.  It can run on line 1 using batch X and line 2 using batch Y.

 

Film batches are recorded as I use the film.

 

Product A is created on our system as it's made but not telling me if it's been run on line 1 or line 2.

 

My production records (a few sheets per run) will tell me if it's run on line 1 or line 2.

 

My suggestion to the team was to put on a calendar when we changed over batches of film, however, to find out which line the product was run on and hence which film was used, I have to wade through pages and pages of production sheets which go on for months for the same batch.  If I went from the daily planning sheets it would take just as long and wouldn't account for if a line had been changed due to a breakdown.

Does that make sense?  In a way I can get around the issue of when we started and stopped using a batch, to be honest as long as you've finished a batch that's easy but due to production flexibility, I can't easily find out how much product was made on which line which is what I need to be able to find out to have the number to compare the mass balance with.


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#7 QAGB

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Posted 18 February 2016 - 02:12 PM

Perhaps I've not explained this well.  Ok, take product A.  It can run on line 1 using batch X and line 2 using batch Y.

 

Film batches are recorded as I use the film.

 

Product A is created on our system as it's made but not telling me if it's been run on line 1 or line 2.

 

My production records (a few sheets per run) will tell me if it's run on line 1 or line 2.

 

My suggestion to the team was to put on a calendar when we changed over batches of film, however, to find out which line the product was run on and hence which film was used, I have to wade through pages and pages of production sheets which go on for months for the same batch.  If I went from the daily planning sheets it would take just as long and wouldn't account for if a line had been changed due to a breakdown.

Does that make sense?  In a way I can get around the issue of when we started and stopped using a batch, to be honest as long as you've finished a batch that's easy but due to production flexibility, I can't easily find out how much product was made on which line which is what I need to be able to find out to have the number to compare the mass balance with.

 

 

Hi GMO,

 

I think I get it, maybe?? So the problem isn't so much the mass balance of film, as it is being able to figure out what products ran with the batches quickly enough.

 

 

 

I'm trying to walk through this one as I go. The mass balance would be one film lot trace (hopefully for your sake), and comparing that to how much film you used, and what you still have in stock. Alright, so if you receive a purchase order that shows you received  3 skids of film rolls with lot ABC; you should know (or be able to find out) how many film rolls are on each skid. Let's say each skid has 20 film rolls. You've got 60 film rolls of that lot number. If you make a changeover log when the film spool empties on each line, that it would be 60 - 1 - 1 - 1 etc. So if you make a database for film, and do a query for lot ABC, and you find that there are 54 records of changeovers for lot ABC between January 1 - May 1, you should have used 54 film rolls, with 6 in stock or presently being used. If you find that there are exactly 6 in your inventory that can be accounted for, you're good with that portion. Note: the changeover log for film does not need product information (I was overthinking the document); it just needs the date, pertinent film roll identification information, and the line running the film.

 

The much harder part of this mass balance as you said, is to figure out what products ran with lot ABC, and how much was run during that 4 month span. Do you have a production record that just shows the following information?

 

Line, date, time of startup, product, lot, quantities:

 

For example:

  • Line 1 ----- 1/1/16 -----7:00 AM ----- Product 1----- Lot 101A ------ 100 cases
  • Line 1 ----- 1/1/16 -----9:30 AM ----- Product 2----- Lot 102A ------ 50 cases
  • Line 1 ----- 1/1/16 -----1:00 PM ----- Product 3----- Lot 103A ------ 200 cases
  • Line 1 ----- 1/1/16 -----3:30 PM ----- Product 4----- Lot 104A ------ 75 cases

 

  • Line 2 ----- 1/1/16 -----7:00 AM ----- Product 1----- Lot 101B ------ 95 cases
  • Line 2 ----- 1/1/16 -----8:15 AM ----- Product 2----- Lot 102B ------ 100 cases
  • Line 2 ----- 1/1/16 -----11:00 AM ----Product 3-----  Lot 103B ------ 400 cases
  • Line 2 ----- 1/1/16 -----3:30 PM ----- Product 4----- Lot 104B ------ 50 cases

 

 

From this information, you could have a separate database just for production dates, lot numbers, products running and quantity made, and the line where the product was produced. Therefore, you can do a search for all products produced between January 1 - May 1, and view quantities made.

 

This also brings up another question: if you are running the same product on both lines, do you give different lot numbers or some sort of differential coding to your products on each line? Otherwise, you won't necessarily know which products would need to be traced, and you would be accounting for all products with the same lot number even if the film roll lot number was different between line 1 and line 2.

 

If you stick to FIFO, and try to use one lot of film at a time (since you said you can use one batch of film for months), you should be able to trace those with two separate databases. If you're pretty good with database, you can link both of those databases together by date and do a query for date of production  and film roll lot; showing results for products produced, lot numbers, and quantities. Then you should be able to get results for the products, and quantities made with lot ABC for film roll made during January 1 - May 1. You also should be able to account for what you are currently running if you're still using the same lot of film. If the date of the mass balance is May 10th, there are 9 days since the last record of changeover. You should be able to find the products made since May 1st, and add that information to your mass balance.

 

In the case of a breakdown, if both lines are still using lot ABC, you should be ok because you should have production quantities of finished product regardless of the line running it. If the lines use different lot numbers (as you said may happen), the process becomes more interesting but still can be done. However, if you're only using 3-4 different batches of film per year, this all should be traceable. If there is still some uncertainty, you can trace a couple of days or so before and after what you think would need to be traced, to make sure you cover it all.

 

This will involve some data entry for sure, but would make tracing easier in the long run. This all works out in my head, but I'm not sure if it would work out for you.

 

QAGB


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#8 GMO

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Posted 18 February 2016 - 02:36 PM

Hi GMO,

 

I think I get it, maybe?? So the problem isn't so much the mass balance of film, as it is being able to figure out what products ran with the batches quickly enough.

 

 

 

I'm trying to walk through this one as I go. The mass balance would be one film lot trace (hopefully for your sake), and comparing that to how much film you used, and what you still have in stock. Alright, so if you receive a purchase order that shows you received  3 skids of film rolls with lot ABC; you should know (or be able to find out) how many film rolls are on each skid. Let's say each skid has 20 film rolls. You've got 60 film rolls of that lot number. If you make a changeover log when the film spool empties on each line, that it would be 60 - 1 - 1 - 1 etc. So if you make a database for film, and do a query for lot ABC, and you find that there are 54 records of changeovers for lot ABC between January 1 - May 1, you should have used 54 film rolls, with 6 in stock or presently being used. If you find that there are exactly 6 in your inventory that can be accounted for, you're good with that portion. Note: the changeover log for film does not need product information (I was overthinking the document); it just needs the date, pertinent film roll identification information, and the line running the film.

 

The much harder part of this mass balance as you said, is to figure out what products ran with lot ABC, and how much was run during that 4 month span. Do you have a production record that just shows the following information?

 

Line, date, time of startup, product, lot, quantities:

 

For example:

  • Line 1 ----- 1/1/16 -----7:00 AM ----- Product 1----- Lot 101A ------ 100 cases
  • Line 1 ----- 1/1/16 -----9:30 AM ----- Product 2----- Lot 102A ------ 50 cases
  • Line 1 ----- 1/1/16 -----1:00 PM ----- Product 3----- Lot 103A ------ 200 cases
  • Line 1 ----- 1/1/16 -----3:30 PM ----- Product 4----- Lot 104A ------ 75 cases

 

  • Line 2 ----- 1/1/16 -----7:00 AM ----- Product 1----- Lot 101B ------ 95 cases
  • Line 2 ----- 1/1/16 -----8:15 AM ----- Product 2----- Lot 102B ------ 100 cases
  • Line 2 ----- 1/1/16 -----11:00 AM ----Product 3-----  Lot 103B ------ 400 cases
  • Line 2 ----- 1/1/16 -----3:30 PM ----- Product 4----- Lot 104B ------ 50 cases

 

 

From this information, you could have a separate database just for production dates, lot numbers, products running and quantity made, and the line where the product was produced. Therefore, you can do a search for all products produced between January 1 - May 1, and view quantities made.

 

This also brings up another question: if you are running the same product on both lines, do you give different lot numbers or some sort of differential coding to your products on each line? Otherwise, you won't necessarily know which products would need to be traced, and you would be accounting for all products with the same lot number even if the film roll lot number was different between line 1 and line 2.

 

If you stick to FIFO, and try to use one lot of film at a time (since you said you can use one batch of film for months), you should be able to trace those with two separate databases. If you're pretty good with database, you can link both of those databases together by date and do a query for date of production  and film roll lot; showing results for products produced, lot numbers, and quantities. Then you should be able to get results for the products, and quantities made with lot ABC for film roll made during January 1 - May 1. You also should be able to account for what you are currently running if you're still using the same lot of film. If the date of the mass balance is May 10th, there are 9 days since the last record of changeover. You should be able to find the products made since May 1st, and add that information to your mass balance.

 

In the case of a breakdown, if both lines are still using lot ABC, you should be ok because you should have production quantities of finished product regardless of the line running it. If the lines use different lot numbers (as you said may happen), the process becomes more interesting but still can be done. However, if you're only using 3-4 different batches of film per year, this all should be traceable. If there is still some uncertainty, you can trace a couple of days or so before and after what you think would need to be traced, to make sure you cover it all.

 

This will involve some data entry for sure, but would make tracing easier in the long run. This all works out in my head, but I'm not sure if it would work out for you.

 

QAGB

 

It's a massive amount of work for what is essentially no risk, yes it would be easier going forward but this is to do a "tick box" once a year audit.  If we genuinely had an issue with film meriting a recall, we'd recall everything which could be made on the line.  No we don't have the line info but you have made me wonder about another question on whether we could get line counts in another way from our metal detectors.
 

We don't give a product a different code from a different line currently.  It's rare we'd switch lines during a run anyway and to be honest the information you get back from consumers or can use in a recall / withdrawal is just the BB date, everything else gets ignored.

 


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#9 QAGB

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Posted 18 February 2016 - 02:54 PM

It's a massive amount of work for what is essentially no risk, yes it would be easier going forward but this is to do a "tick box" once a year audit.  If we genuinely had an issue with film meriting a recall, we'd recall everything which could be made on the line.  No we don't have the line info but you have made me wonder about another question on whether we could get line counts in another way from our metal detectors.
 

We don't give a product a different code from a different line currently.  It's rare we'd switch lines during a run anyway and to be honest the information you get back from consumers or can use in a recall / withdrawal is just the BB date, everything else gets ignored.

 

 

 

Hi GMO,

 

I absolutely agree with you in the massive undertaking this would be and the low risk as well. We also use film rolls for one of our processing areas, and we recently had to do a traceability exercise for film rolls. It was not much fun, but we got it done. It's easier for us because that system is mostly electronic, but we have film changeover logs which help us figure out how much we need to trace.

 

It would help to maybe label product as zzz-A and zzz-B for lot codes or something similar to signify different lines. I do agree that if you had a recall, you'd probably be recalling everything in that time frame if the film is the culprit.

 

You're probably more likely to be recalling an entire film lot if the supplier notifies you of some serious issue with that lot, rather than from the customer end

(unless you were able to do some serious investigation on a customer complaint (or complaints) which would have led you back to the film).

 

 

QAGB


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#10 GMO

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Posted 18 February 2016 - 04:23 PM

Ultimately I think what we will do is chose a line to do an internal mass balance on where the product can't change lines.  It's totally wrong, it covers a tiny part of our production but it ticks the auditor box.   :thumbdown:

 

I hate doing that.


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#11 QAGB

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Posted 18 February 2016 - 06:22 PM

Ultimately I think what we will do is chose a line to do an internal mass balance on where the product can't change lines.  It's totally wrong, it covers a tiny part of our production but it ticks the auditor box.   :thumbdown:

 

I hate doing that.

 

Hi GMO,

 

There are parts to everyone's process that are harder to trace than others. We'd never been asked to track film rolls before until last year. The auditor made it out to be a big deal and wanted to make sure we could trace the packaging in a timely manner. It may come to a point where someone asks it of you, and you should be prepared if you can be (as cliche as that sounds).

 

QAGB


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#12 carine

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Posted 13 May 2016 - 08:57 AM

Hi GMO, 

 

I encounter same problem as you on film traceability, appreciate  if you could further elaborate on mass balance way, thanks in advance. 


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