natgillin/translations-raw huggingface dataset:
c. The evaluation procedures and results; and d. The disposition of the affected product. 
c. Procedure procjene i rezultate; i d. Izdvajanje neispravnog proizvoda.
(Refer to VIII. 
(Vidi VIII.
Above) 
gore)
CFR 318.308(d) and 381.308(d)). 
CFR 318.308(d) i 381.308(d)).
IPP are to: 
IPP-ovi trebaju:
Verify that an appropriate alternative process schedule was used (318.302(a) 
Provjeriti da je korišten odgovarajući alternativni terminski plan (318.302(a)
c. Is available for review by IPP; or 
c. Dostupan je za pregled od strane IPP-a; ili
Verify that the product involved has been placed on hold and that the deviation is being evaluated by a processing authority; and 
Provjeriti da je predmetni proizvod stavljen na čekanje i da nadležno tijelo trenutno procjenjuje odstupanje; te
Deviations of this type would be submitted to PDD for review per 9 CFR 
Odstupanja ove vrste trebaju se podnijeti PDD-u na pregled sukladno 9 CFR
318.308(d) and 381.308(d). 
318.308(d) i 381.308(d).
IPP are to request assistance from PDD through supervisory channels when needed. 
IPP-ovi trebaju zatražiti pomoć od PDD-a putem nadzornih kanala u slučaju potrebe.
Does not have alternative documented procedures that will ensure only safe and stable product is shipped in commerce; 
Nema alternativne dokumentirane procedure koje će osigurati otpremu u trgovine samo sigurnog i stabilnog proizvoda;
a. A complete description of the deviation along with all supporting documentation; 
a. Cjelokupan opis odstupanja zajedno s čitavom popratnom dokumentacijom;
The form is located in Outlook under Public Folders/Agency Issuances/Forms. 
Obrazac se nalazi u Outlooku, pod Public Folders/Agency Issuances/Forms.
Attach the required data and distribute the form as follows: 
Priložiti potrebne podatke i poslati obrazac kako slijedi:
a. Send the completed form and required data to PDD either by mail, fax, or through askFSIS http://askfsis.custhelp.com/. 
a. Poslati ispunjeni obrazac i potrebne podatke PDD-u poštom, faksom ili putem askFSIS http://askfsis.custhelp.com/.
When sending the information through askFSIS the subject line is to read: 
Ako se podaci šalju putem askFSIS-a, naslov treba glasiti:
Contact PDD at 800-233-3935 if you need assistance; 
Obratite se PDD-u na 800-233-3935 ako vam je potrebna pomoć;
c. Retain a copy in the government office file. 
c. Sačuvati kopiju u datoteci vladinog ureda.
PDD will make a recommendation to the DO based upon all data and information evaluated. 
PDD će dati preporuku DO-u na temelju svih procijenjenih podataka i informacija.
A HACCP plan for canned product that addresses hazards associated with microbiological contamination; 
HACCP-ov plan za konzervirane proizvode koji se bavi rizicima povezanima s mikrobiološkom kontaminacijom;
Alternative documented procedures that will ensure that only safe and stable product is shipped in commerce; or 
Alternativne dokumentirane procedure koje će osigurati otpremu u trgovine samo sigurnog i stabilnog proizvoda; ili
Following the regulations per 9 CFR 318.309(d) and 381.309(d) for incubation of shelf-stable canned product. 
Praćenje uredbi 9 CFR 318.309(d) i 381.309(d) za inkubaciju trajnih konzerviranih proizvoda.
Once disposition is complete, IPP are to release control of normal appearing product containers if USDA Retain Tags were applied. 
Nakon što je izdvajanje dovršeno, IPP-ovi trebaju osloboditi od kontrole spremnike koji izgledaju normalno ako su primijenjene USDA oznake zadržavanja.
Retain abnormal containers that are swollen, leaking or exhibit signs of spoilage pending laboratory analysis; 
Zadržati nepravilne spremnike koji su nabubreni, cure ili pokazuju znakove kvarenja prije izvršene laboratorijske analize;
The amount of product retained will be a minimum of 2 hours of continuous production. 
Količina zadržanih proizvoda istovjetna je barem količini proizvedenoj u dva sata neprekidne proizvodnje.
There is no maximum. 
Nije određena maksimalna količina.
Depending on the cause of the abnormal containers, the amount of product retained may include product from one or more retorts. 
Ovisno o uzroku nepravilnih spremnika, količina zadržanih proizvoda može uključivati proizvode iz jedne ili više retorti.
A. Abnormal containers may be observed by import inspection personnel while conducting inspection on a lot of imported product. 
A. Nepravilne spremnike mogu uočiti zaposlenici inspekcije uvoza tijekom provođenja inspekcije serije uvezenih proizvoda.
If a lot includes one or more abnormal containers (critical defect), import inspection personnel are to retain the lot pending laboratory analysis. 
Ako serija sadrži jedan ili više nepravilnih spremnika (kritični nedostaci), zaposlenici inspekcije uvoza trebaju zadržati seriju do završetka laboratorijske analize.
When import inspection personnel observe abnormal containers during inspection of a lot, they are to: 
Kada zaposlenici inspekcije uvoza uoče nepravilne spremnike tijekom inspekcije serije, trebaju:
If a condition of container or incubation TOI was not assigned, enter an unscheduled TOI for condition of container and then reject the TOI in the AIIS; and 
Ako stanje spremnika ili inkubacije TOI-a nije dodijeljeno, unijeti neraspoređen TOI za stanje spremnika, a zatim odbiti TOI u AIIS-u, te
SUBMITTING SAMPLES FOR LABORATORY ANALYSIS 
PODNOŠENJE UZORAKA ZA LABORATORIJSKU ANALIZU
D. If the Import Inspection Division (IID) determines the lot should be Refused Entry because of past history, no samples are to be submitted, and import inspection personnel are to follow the instructions for lots refused entry in FSIS Directive 9020.1. 
D. Ako Odjel za inspekciju uvoza (eng. Import Inspection Division, IID) odredi da seriji treba zabraniti ulazak zbog prošlih događanja, ne treba predavati uzorke, a zaposlenici inspekcije uvoza trebaju slijediti upute za serije kojima je zabranjen ulazak iz FSIS-ove Direktive 9020.1.
Inspection personnel are to submit both abnormal and normal appearing containers. 
Zaposlenici inspekcije trebaju podnijeti i nepravilne spremnike i spremnike koji izgledaju normalno.
G. When submitting samples, IPP and import inspection personnel are to: 
G. Prilikom podnošenja uzoraka, zaposlenici IPP-a i inspekcije uvoza trebaju:
FSIS Directive 7530.1, Revision 1, Handling Process Deviations and Abnormal 
FSIS-ova Direktiva 7530.1, 1. prerađeno izdanje koje se bavi odstupanjima od procesa i slučajevima nepravilnih
Whenever the actual process is less than the process schedule, or when any critical factor does not comply with the requirements for that factor as 
Kad je stvaran proces kraći od terminskog plana za taj proces, ili kad neki od kritičnih čimbenika ne udovoljava zahtjevima za taj čimbenik kako je
Verify that the product was reprocessed using a full process schedule; or 
Provjeriti da je proizvod dodatno obrađen korištenjem cjelokupnog terminskog plana; ili
and (b) and 381.302(a)and (b) and is; 
i (b) i 381.302(a)i(b) te;
Not met the corrective action requirements in 9 CFR 417.3(b); or 
Nije udovoljila zahtjevima korektivnih radnji iz 9 CFR 417.3(b); ili
Access the Automated Import Information System (AIIS) data program and reject the assigned Type of Inspection (TOI) (condition of container or incubation) for the lot represented by the abnormal containers pending laboratory analysis. 
Pristupiti programu s podacima Automated Import Information System (AIIS) i odbiti dodijeljenu Vrstu inspekcije (TOI) (stanje spremnika ili inkubacije) za seriju koju predstavljaju nepravilni spremnici do završetka laboratorijske analize.
A. When IPP and import inspection personnel observe abnormal containers that need 
A. Kada zaposlenici IPP-a i inspekcije uvoza uoče nepravilne spremnike koje treba
Laboratory; and 
Laboratory; i
Place abnormal containers under refrigeration before mailing to prevent rupture and to preserve their contents. 
Staviti nepravilne spremnike u hlađeni prostor prije slanja kako bi se spriječilo probijanje i kako bi se sačuvao njihov sadržaj.
Do not freeze either the abnormal containers or normal appearing containers. 
Nemojte zamrzavati nepravilne spremnike niti one koji izgledaju normalno.
FSIS Form 10,000-2, Laboratory Report; 
FSIS-ov obrazac 10,000-2, Laboratorijski izvještaj;
FSIS Form 10,000-3, Canned Foods--Abnormal Containers; and 
FSIS-ov obrazac 10,000-3, Konzervirani proizvodi--Nepravilni spremnici; te
FSIS Form 7500-1 Canned Food Sample Reporting Form. 
FSIS-ov obrazac 7500-1, Obrazac za izvještavanje o uzorcima konzervirane hrane
I. Import inspection personnel are to complete the following forms: 
I. Zaposlenici inspekcije uvoza trebaju popuniti sljedeće obrasce:
FSIS Form 9540-3, Import Abnormal Container, Chemical, Species, Pathology 
FSIS-ov obrazac 9540-3, Uvoz nepravilnih spremnika, kemikalija, vrsta, analiza
Laboratory Analysis; and 
patološkog laboratorija; i
FSIS Form 7500-1, Canned Food Sample Reporting Form. 
FSIS-ov obrazac 7500-1, Obrazac za izvještavanje o uzorcima konzervirane hrane.
FSIS Form 10,000-3 and 7500-1 are available in Outlook under Public 
FSIS-ovi obrasci 10,000-3 i 7500-1 dostupni su u Outlooku pod Public
FSIS Form 10,000-2 and FSIS 
FSIS-ov obrazac 10,000-2 i FSIS-ov
Form 9540-3 can only be ordered from the Beltsville Service Center. 
obrazac 9540-3 može se naručiti samo putem Beltsville Service Center.
Their DO; and 
njihove DO-ove; i
The PDD canning team. 
PDD-ov tim za konzerviranje.
L. Import inspection personnel are to send one copy of each form, and any additional information requested to: 
L. Zaposlenici inspekcije uvoza trebaju poslati po jednu kopiju svakog obrasca i sve dodatne tražene informacije na:
Regional Import Field Supervisor (RIFS); and 
Regionalnog nadzornika za uvoz (Regional Import Field Supervisor, RIFS); i
PDD canning team. 
PDD-ov tim za konzerviranje.
FSIS Form 10,000-3 and 7500-1 are hard copy forms and will need to be scanned into an electronic file or faxed. 
FSIS-ovi obrasci 10,000-3 i 7500-1 su obrasci u tiskanom obliku i trebat će ih skenirati u elektroničku datoteku ili poslati faksom.
M. IPP and import inspection personnel are to retain one copy of each form in the government office file. 
M. Zaposlenici IPP-a i inspekcije uvoza trebaju zadržati po jednu kopiju svakog obrasca za datoteku u vladinom uredu.
N. Occasionally, the FSIS Western Laboratory may not request samples when the cause of the deviation is known. 
N. Ponekad FSIS-ov laboratorij Western Laboratory ne traži uzorke kad je razlog odstupanja poznat.
The PDD canning team will review the findings and determine whether any further action is needed. 
PDD-ov tim za konzerviranje će pregledati sve nalaze i utvrditi jesu li potrebne daljnje radnje.
DISPOSITION OF AFFECTED LOTS 
IZDVAJANJE PREDMETNIH SERIJA
A. Once the FSIS Western Laboratory completes its analysis of abnormal containers submitted, it will forward the findings to PDD. 
A. Nakon što FSIS-ov laboratorij Western Laboratory dovrši analizu predanih nepravilnih spremnika, proslijedit će svoje nalaze PDD-u.
PDD will review the laboratory analysis and container evaluation findings and issue a disposition recommendation to the program area as indicated below. 
PDD će pregledati analizu laboratorija i procjenu nalaza o spremnicima i izdati preporuku o izdvajanju programskom području kako je dolje naznačeno.
B. The DO is to review PDD's disposition recommendation and any additional information provided by IPP and the Frontline Supervisor (FLS). 
B. DO treba pregledati PDD-ovu preporuku o izdvajanju kao i dodatne informacije koje je dao IPP i pogranični nadzornik (Frontline Supervisor, FLS).
The DO is to make the final ruling on the disposition of the affected product and notify IPP. 
DO treba dati konačnu presudu o izdvajanju predmetnog proizvoda i obavijestiti IPP.
IPP are to follow instructions from their DO and FLS. 
IPP treba slijediti upute svojih DO-ova i FLS-ova.
C. IID Headquarters (HQ) is to review PDD's disposition recommendation and make the final ruling on the disposition of the affected product. 
C. Sjedište IID-a (HQ) treba pregledati preporuku PDD o izdvajanju i donijeti konačnu presudu u vezi predmetnog proizvoda.
IID-HQ is to notify the import inspection personnel of the disposition of the affected product. 
Sjedište IID-a treba obavijestiti zaposlenike inspekcije uvoza o izdvajanju predmetnog proizvoda.
IID-HQ is to send a copy of the determination to the Regional Import Field Office. 
Sjedište IID-a treba poslati kopiju odluke Regionalnom uredu za uvoz.
When disposition includes sorting or further re-inspection of product, import inspection personnel are to request, through the supervisor, that the AIIS lot inspection assignment be reopened to allow 
Ako izdvajanje uključuje sortiranje ili dodatnu inspekciju proizvoda, zaposlenici inspekcije uvoza trebaju zatražiti, putem nadzornika, da se AIIS pošiljka za inspekciju serije ponovno otvori kako bi se omogućilo
Import inspection personnel are to refer all questions to their supervisor for the disposition of the lot. 
Zaposlenici inspekcije uvoza trebaju uputiti sva pitanja o izdvajanju serije svom nadzorniku.
Refer questions regarding this directive to the PDD through askFSIS at http://askfsis.custhelp.com/ or by telephone at 1-800-233-3935. 
Pitanja vezana za ovu direktivu uputite PDD-u putem askFSIS-a na http://askfsis.custhelp.com/ ili na telefon 1-800-233-3935.
Office of Policy and Program Development 
Ured za razvoj politike i programa
Attachment 1 
Prilog 1
As a resource to inspection personnel, the following, is a list of other types of deviations that may occur. 
Kao pomoćno sredstvo za zaposlenike inspekcije, u nastavku je popis ostalih vrsta odstupanja do kojih može doći.
This list is not meant to be all inclusive. 
Ovaj popis ne obuhvaća sve moguće primjere.
Mechanical Process Deviations 
Odstupanja mehaničkog procesa
•Blown retort door or gasket 
•Pregorjela vrata retorta ili brtve
•Leaky air or water valves - particularly in top steam and bottom vented retorts. 
•Propusni zračni ili vodeni ventili - posebice u gornjim retortama za parenje i donjim retortama s otvorom.
•Nonfunctioning or fast running automatic retort timers 
•Nefunkcioniranje ili prebrzi automatski mjerači vremena retorta
•Digital programmer circuit failures 
•Kvarovi na digitalnom programiranom krugu
•Mercury thermometer failures both I.T. and retort temperature 
•Kvarovi na živinom termometru, temperature I.T.-a i retorte
•Stuck valves 
•Zaglavljeni ventili
•Ruptured steam valve diaphragms 
•Probijene membrane parnih ventila
oDividers - unauthorized use or misuse 
oRazdjelnici- neovlašteno korištenje ili zlouporaba
oCrates - unauthorized use 
oSanduci- neovlašteno korištenje
oPiping changes 
oIzmjene na cijevima
•Boiler failures, electrical failures 
•Kvarovi na parnom kotlu, električni kvarovi
•Air compressor failures, especially water with overpressure, with air agitation 
•Kvarovi na zračnom kompresoru, posebice vode s nadpritiskom, s miješanjem zraka
(pumps or turbine fans) 
(pumpe ili turbinski ventilatori)
•Drive belts or mechanisms on agitating retorts 
•Pogonski remeni ili mehanizmi na retortama za miješanje
Product Related Process Deviations 
Odstupanja procesa koja se tiču proizvoda
•Low initial temperatures 
•Niske početne temperature
•Wrong container orientation, if critical 
•Pogrešan smjer spremnika, ako je kritično
•Unauthorized ingredient change (e.g., sugars, starches, and nitrite) 
•Neodobrena izmjena sastojaka (npr., šećera, škroba i nitrita)
•Heating ingredients differently (e.g., steam blanch instead of oven braising) 
•Nejednako grijanje sastojaka (npr., blanširanje parom umjesto pirjanja u pećnici)
•Re-hydration of ingredients 
•Rehidracija sastojaka
•Cooked frozen, to raw fill, to cooked fill 
•Kuhanje smrznutih sastojaka, punjenje sirovih ili prekuhanih sastojaka
•Using frozen instead of canned ingredients or vice-versa 
•Korištenje smrznutih umjesto konzerviranih sastojaka i obratno
•Change in slice thickness, diced size, or form size 
•Promjena debljine kriški, veličine komada ili oblika
•Different blanch procedures 
•Različite procedure blanširanja
•High pH, if critical to process schedule 
•Visok pH, ako je kritičan za terminski plan procesa
•High water activity, if critical to process schedule 
•Visoka aktivnost vode, ako je kritična za terminski plan procesa
•High fill weights, drain weights, net weights, or inadequate methods 
•Prevelika težina ispune, ocijeđena težina, neto težina ili neodgovarajuće metode
•High viscosity 
•Visoka viskoznost
•Low machine vacuum, if critical to the process schedule 
•Nedovoljan vakuum iz stroja, ako je kritičan za terminski plan procesa
•Products held too long - thickening 
•Preduga obrada proizvoda - zgušnjavanje
•Pump failures causing inadequate circulation of water or steam-air mixtures 
•Kvarovi na pumpi koji uzrokuju nedovoljnu cirkulaciju vode ili mješavine pare i zraka
•Formulation percentage changes 
•Izmjene postotaka u formuli
•Headspace control, if critical to the process schedule 
•Headspace kontrola (headspace=tehnika pri kojoj se pare u plinu nalaze iznad krutog ili tekućeg uzorka), ako je kritičan za terminski plan procesa
•Improper dispersion (mixing) of starches (orbitort retort) 
•Nepravilna disperzija (miješanje) škroba (orbitort retorta)
Human Element Process Deviations 
Odstupanja procesa uzrokovana ljudskim faktorom
•Retort by-pass 
•Obilaženje retorte
•Wrong process selection (temperature, time, product, container size, retort method) 
•Krivi odabir procesa (temperature, vremena, proizvoda, veličine spremnika, metode retorte)
•Vent valve not fully opened 
•Ventil za ispuštanje pare nije posve otvoren
•Cold water and air line valves not properly closed (steam retorts) 
•Ventili za hladnu vodu i zrak nisu ispravno zatvoreni (parne retorte)
Usually requires process abort, re-vent, and retiming the process 
Obično je potreban prekid procesa, dodatno ispuštanje pare i ponovno određivanje trajanja procesa
•Venting deviations: 
•Odstupanja u ispuštanju pare:
oProblems with obstruction of valves, manifolds, headers, and pipes, re- venting if temperature drops below 212ºF on steam retorts 
oProblemi sa začepljenjima ventila, cjevovoda, sabirnika i cijevi, dodatno ispuštanje pare ako temperatura padne ispod 100º C u retortama za parenje
•Improper record entries, missed or omitted record entries, wrong recorder chart 
•Neispravan unos podataka, propušteni ili izostavljeni unosi, nepravilan dijagram bilježenja
•Errant measurements of pH, weights, headspace, and other critical factors 
•Pogrešna mjerenja pH vrijednosti, težine, headspacea i ostlaih kritičnih čimbenika
•Bleeders closed 
•Zatvoreni razdjelnici
•Pre-recorded or falsified entries 
•Prethodno uneseni ili krivotvoreni unosi
•Mistakes in retort log entries 
•Pogreške u unosima u evidenciju rada retorte
•Failure to properly affix the recorder chart 
•Nemogućnost ispravnog pričvršćivanja dijagrama bilježenja
•Misuse of steam by-pass causing early activation of process schedule automatic timer before the vent cycle is completed 
•Zlouporaba parne premosnice koja uzrokuje preranu aktivaciju automatskog programatora terminskog plana procesa prije dovršetka ciklusa ispuštanja pare
•Misformulation 
•Netočna formulacija
•Not inking the recorder 
•Nedostatak tinte u snimaču
•Boredom 
•Dosada
•I.T. not correctly measured 
•I.T. nije ispravno izmjeren
Process Deviations Unique to Water Retorts 
Odstupanja procesa jedinstvena za retorte za vodu
•Low water level 
•Niska razina vode
•Failure of circulation systems 
•Kvar na cirkulacijskim sustavima
•Addition of cold water 
•Dodavanje hladne vode
•Overpressure, if critical for retort pouches and semi-rigid containers 
•Nadpritisak, ako je kritičan za otvore u retorti i polukrute spremnike
Process Deviations for Batch Agitating Retorts 
Odstupanja procesa za retorte za miješanje smjese
•Low or high reel speeds 
•Niska ili visoka brzina okretaja
•Broken drive belts 
•Slomljeni pogonski remeni
•Unauthorized rotation mode 
•Neodobren način okretanja
•Unauthorized reel speeds from heat distribution aspects 
•Neodobrene brzine okretaja s obzirom na raspodjelu topline
Deviations for FMC Sterilmatics (continuous rotary retorts) 
Odstupanja za FMC Sterilmatics (neprekidno rotirajuće retorte)
•Reel speed 
•Brzina okretaja
•Segregation of transfer valve and intake valve cans when still emergency process has been applied followed by cooling 
•Razdvajanje prijenosnog ventila i konzervi usisnih ventila prilikom primjene procesa mirovanja u slučaju nužde nakon kojeg slijedi hlađenje
•Prolonged stops of reel 
•Dugotrajno zaustavljanje okretanja
•I.T. problems with product in in-feed conveyor or between closing machine and intake valve 
•I.T. problemi s proizvodom na transportnoj vrpci za unos ili između stroja za zatvaranje i ventila za dovod.
Process Deviations for Hydrostatic Retorts 
Odstupanja procesa za hidrostatične retorte
•Excessive conveyor speed 
•Prevelika brzina transportne trake
•High water levels 
•Visoka razina vode
•I.T. problems from prolonged stops with in-feed leg 
•I.T. problemi zbog dugotrajnog zaustavljanja s krakom trake za unos
•Temperature drops in in-feed leg if in-feed leg heat treatment is part of process schedule 
•Pad temperature na kraku trake ako je toplinski tretman dio terminskog plana procesa
FSIS Form 7500-1, Canned Food Sample Reporting Form 
FSIS-ov obrazac 7500-1, Obrazac za izvještavanje o uzorcima konzervirane hrane
FSIS Form 10,000-2, Laboratory Report FSIS Form 10,000-3, Abnormal Containers FSIS Form 10,000-6, Process Deviations 
FSIS-ov obrazac 10,000-2, Obrazac laboratorijskog izvještaja FSIS-ov obrazac 10,000-3, Nepravilni spremnici FSIS-ov obrazac 10,000-6, Odstupanja procesa
This directive is being reissued to provide updated instructions on how IPP are to handle process deviations and on how IPP and the Office of International Affairs (OIA) import inspection personnel are to submit abnormal containers for microbial 
Ova direktiva se izdaje ponovno kako bi dala ažurirane upute o tome kako IPP-ovi trebaju postupati u slučaju odstupanja procesa te kako IPP-ovi i zaposlenici inspekcije uvoza iz Ureda za međunarodnu suradnju (eng. Office of International Affairs, OIA) trebaju predati nepravilne spremnike za mikrobiološku
Only products which have received a full thermal process as determined by the established process schedule are eligible to bear the FSIS mark of inspection and be distributed in commerce. 
Samo proizvodi koji su prošli potpun termički proces kako je utvrđeno ustanovljenim terminskim planom procesa mogu nositi FSIS-ovu oznaku inspekcije i distribuirati se u trgovine.
Canned product is defined in 318.300(d) and 381.300(d) as a meat or poultry food product with a water activity above 0.85 that receives a thermal process either before or after being packed in a hermetically sealed container. 
Konzervirani proizvod definiran je u 318.300(d) i 381.300(d) kao prehrambeni proizvod od mesa ili peradi s aktivnosti vode iznad 0,85 koji je prošao termički proces prije ili nakon pakiranja u hermetički zatvoren spremnik.
Thermally processed products are packed in a variety of different types of containers including rigid and semi-rigid containers, flexible pouches, glass jars, paperboard (e.g. Tetra-Pak), or any other type of container that can hold thermally processed, commercially sterile (canned) product or aseptically processed product. 
Termički obrađeni proizvodi pakirani su u različite vrste spremnika koje uključuju krute i polukrute spremnike, savitljive vrećice, staklenke, karton (npr. Tetra-Pak) ili neku drugu vrstu spremnika koja može sadržavati termički obrađen, komercijalno sterilan (konzerviran) proizvod ili aseptički proizveden proizvod.
A. Process Deviation: 
A. Odstupanje procesa:
specified in the process schedule (9 CFR 318.308(a) and 381.308(a)). 
navedeno u terminskom planu tog procesa (9 CFR 318.308(a) i 381.308(a)).
Critical factors are specific to the process schedule and ensure food safety of the finished product (9 
Kritični čimbenici su usko vezani za terminski plan tog procesa i osiguravaju sigurnost hrane konačnog proizvoda (9
For the purpose of this directive, a process deviation is specific to the process schedule. 
Za potrebe ove direktive, odstupanje procesa je usko vezano za terminski plan tog procesa.
information on Causes of Process Deviations. 
informacije o Uzrocima odstupanja procesa.