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Lot definition for recall, 24 hour bakery operation


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#1 redwards

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Posted 02 August 2015 - 01:02 AM

Hello,

 

If you have a continuous bakery 24 hour operation during the week with a shut down and sanitation on Fridays.

 

And you run multiple batches, ie different products, during the week.

 

Is the lot for each batch or the whole week, especially pertaining to a recall issues with a batch in the middle of the week or creating COAs for individual batches or one for the weeks lot.

 

What CFR or FDA code would contain the answer.

 

 I have a sense of what the answer is I just cant confirm it with regs.

 

Thanks,

Ray


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#2 Charles.C

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Posted 02 August 2015 - 06:12 PM

Hi Ray,

 

Thanks for yr query and Welcome to the Forum ! :welcome:

 

Coding for continuous production tends to be tricky. There are several baking threads scattered about this forum re-coding/traceability. 

 

I'm not quite clear what you are currently doing for coding so I have given various generic samples below unspecific to continuous/non-continuous processes. And one (last) attachment specific to continuous.

 

IMO, in general, the choice of lot/batch usage issue is semantics, ie arbitrary. Mostly the  l/b terms seem to be interchangeable from a coding POV. But not quite always, eg see  example (ii) below. This interpretation also looks similar to that in the attachment lob3 below.

 

As far as FDA/recall is concerned, I haven’t looked up their specific requirements but the first 2 recall-related attachments below seem to use interchangeability. I followed the CFR ref.given in 2nd one which yielded –

 

Coding. Each container or product shall  be  marked  with  an  identifying code permanently visible to the naked eye.  If  the  container  does  not  permit the  code  to  be  embossed  or  inked,  the label may be legibly perforated or otherwise  marked,  as  long  as  the  label  is securely  affixed  to  the  product  container.   The   required   identification shall specify in code the establishment where  the  product  was  packed,  the product   contained   therein,   and   the year,  day,  and  period  during  which  it was  packed.  The  packing  period  code shall  be  changed  often  enough  to  enable ready identification of lots during their sale and distribution. Codes may be  changed  periodically  on  one  of  the following  bases:  intervals  of  4  to  5 hours;   personnel   shift   changes; or batches, as long as the containers constituting  the  batch  do  not  represent those  processed  during  more  than  one personnel shift.

 

 

Not myself familiar with continuous process but there are several baking related threads here which are.  IIRC, most people are using a mixture of product specific / time periods for coding. One week seems extremely long to me for any coding scenario but it maybe depends on yr product/process.

 

Attached File  lob1 - food recall manual.pdf   951.48KB   40 downloads

Attached File  lob2 - Recall plan MODEL strategy.doc   109.5KB   40 downloads

Attached File  lob3 - batch, lot, FDA, continuous production.pdf   241.22KB   50 downloads

 

 

(i) (m) Lot or batch means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.

http://www.accessdat...ch.cfm?fr=820.3

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(ii) (2) Batch means a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

 

10) Lot means a batch, or a specific identified portion of a batch, having uniform character and quality within specified limits; or, in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits.

http://www.accessdat...ch.cfm?fr=210.3

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(iiii) (1) A production lot is a set of food production consumer units that are from one production shift. Alternatively, a collection of consumer units of the same size, type, and style produced under conditions as nearly uniform as possible, designated by a common container code or marking, constitutes a production lot.

https://www.law.corn.../text/9/317.309

-----------------------------

 

(iv) © "Batch or Lot" means a specific quantity of a finished product or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

(Dietary Expert Group)

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(v) “Lot” means a definitive quantity of a commodity produced essentially under the same conditions.

(Codex)

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(vi) For purposes of this guidance, a production lot or batch is defined as sprouts from a single lot of seed that were started at the same time in a single growing unit (i.e., a single drum or rack of trays).

http://www.fda.gov/F...s/ucm120246.htm

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Not sure if above helps for yr query or not. :smile: Other posters here in baking area may have more specific comments.

 

PS - deleted, misread, not FSMA


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Kind Regards,

 

Charles.C


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