THERMAL PROCESSING 

TRAINING 

Module 20. Process Deviations 

and Abnormal Containers 

Thermal Processing for Meat and 

Poultry Products Training 

1 
 

 

 

 

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Objectives 

 Identify common types and causes of process 

deviations 

 Describe regulatory requirements and 

processor responsibilities for identifying, 

managing, and documenting process 

deviations, corrective actions, and abnormal 

containers 

 Understand verification procedures to follow 

when process deviations occur or abnormal 

containers are found in official establishments 
 

 

 

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Definitions – 9 CFR 431.1 

 Process Schedule (PS) 

• Thermal process requirements and critical factors 

that ensure canned products are commercially sterile 

and shelf stable 

 Critical Factor (CF) 

• Any characteristic, condition, or part of a product, 

container, or procedure affecting adequacy of PS 

(e.g., IT, RT, Bb) 
 

 

 

 

 

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Additional Definitions 

 Process Deviation (PD) 

• Detected in-process or through record review 

• Thermal operating parameters not met 

• Any CF fails to meet specified PS requirements 

• Process applied is less than PS 

 Alternative Documented Procedures 

• Other documented procedures addressing 

process deviations 

 Alternate Process Schedule 

• Process schedule on file used to reprocess 

product in lieu of original process schedule 
 

 

 

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Operating Process Example 

 Operating Process Schedule 

• Voluntary thermal process schedule that typically 

exceeds minimum PS requirements 

• Operating process schedule a “buffer” for critical 

factors identified in approved process schedule 

Example 

- Approved Process Schedule 

IT = 100°F, Bb = 50 min. @ RT = 250°F 

- Operating Process Schedule 

IT = 100°F, Bb = 52 min. @ RT = 252°F 
 

 

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Handling Process Deviations – 9 

CFR 431.9(b)(1)(2)(3) 

 All process deviations handled through... 

(1) Canning HACCP plan addressing biological 

food safety hazards OR 

(2) Alternative documented procedures OR 

(3) Paragraph (c) in §431.9 
 

 

 

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Handling Process Deviations - 9 

CFR 431.9(c)(1)(i)(ii) 

 Processor options for handling process 

deviations identified in-process: 

(i) Immediately reprocess product under 

original process schedule OR 

(ii) Reprocess product using on file alternate 

process schedule approved by a PA 
70m 

 

In-Process PD: Original Process 

Schedule Example - §431.9(c)(1)(i) 

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250° 

248° 

250° 

50 m 

Original PS applied 

JDL 

PS=100°IT/70Bb/250°RT 

Retort temperature 

dropped to 248°F @ 50 

min. but 15 minutes later 

recovered to 250°F 

Processor immediately

reprocessed product from

time of recovery using 

original process schedule 

8 
50m 

248° 

 

In-Process PD: Alternate Process 

Schedule Example - §431.9(c)(1)(ii) 

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250° 

25 m 

Alternate schedule 

applied

JDL 

PS=100°IT/70Bb/250°RT 

Retort temperature dropped 

to 248°F @ 50 min. and 

remained at 248°F 

Processor applied alternate 

process schedule on file 

provided by PA for that 

product 

Alt. PS=100°IT/75Bb/248°RT 
 

 

 

 

 

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Handling Process Deviations - 9 

CFR 431.9(c)(1)(iii)(A)(B)(C) 

 Hold product involved until process deviation 

evaluated by PA for product safety and stability 

 Upon completion of PA evaluation, processor 

must provide inspector: 

(A) Complete process deviation description and 

all necessary supporting documentation 

(B) Copy of written PA evaluation report 

(C) Description of any product disposition 

actions taken or proposed 
 

 

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Product Not Shipped – 9 CFR 

431.9(c)(1)(iv) 

 Product handled under §431.9(c)(1)(iii) is not 

distributed until “the Program” has also 

reviewed all information submitted and 

approved product disposition actions 
 

 

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Further Evaluation – 9 CFR 

431.9(c)(1)(v) 

 Establishment must set aside product for 

further evaluation by PA and PDS if: 

• Alternate process schedule not on file with 

inspector is used OR 

• Alternate process schedule is immediately 

calculated and used 
 

 

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Continuous Rotary (Agitating)

Retort PD - 9 CFR 431.9(c)(1)(vi) 

 Process deviations handled per §431.9(c)(1)(iii) 

and (iv) OR 

 §431.9(c)(1)(vi)(A) if an emergency reel stop 

 §431.9(c)(1)(vi)(B) if a temperature drop 
 

 

 

 

 

 

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CRR Emergency Stops – 

9 CFR 431.9(c)(1)(vi)(A)(1)(2) 

Jams or Breakdowns 

(1) All containers, including containers in retort 

intakes and transfer valves between retort 

shells, given emergency still process on file 

before retort is cooled OR 

Retort promptly cooled, all containers removed, 

then either reprocessed, repacked and 

reprocessed, or destroyed 

(2) Retort reel stop time and time retort used for 

emergency still process documented 
 

 

 

 

 

 

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CRR Temperature Drops – 9 CFR 

431.9(c)(1)(vi)(B)(1) 

Temperature Drop <10°F: 

(i) All containers given emergency still process on 

file before reel restarted OR 

(ii) Container entry to retort prevented and 

emergency agitating process on file given 

before container entry to retort restarted OR 

(iii) Containers prevented entry to retort, retort 

emptied, and discharged containers 

reprocessed, repacked and reprocessed, or 

destroyed 
 

 

 

 

 

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CRR Temperature Drops – 9 CFR 

431.9(c)(vi)(1)(B)(2) 

Temperature Drop ≥10°F: 

 Container entry to retort prevented 

 All containers given emergency still process on 

file before reel restarted AND 

 Reel stop time and time retort used as still retort 

noted OR 

 Reel restarted, retort emptied, and discharged 

containers reprocessed, repacked and 

reprocessed, or destroyed 
 

 

 

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Process Deviations - 9 CFR 

431.9(c)(2) 

 Process deviations identified during record 

review of processing and productions records 

required by §431.8(a) and (b) must be 

reviewed and evaluated by PA and PDS before 

involved product shipped from establishment 
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Process Deviation File - 9 CFR 

431.9(d) 

 Maintained in separate file or log 

• Processing and production records 

• Description of corrective actions taken 

• Evaluation procedures and results 

• Disposition of affected product 

 Retained in accordance with §431.8(e) 
 

 

 

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Pop Quiz 

A plant using an operating process has a 

temperature drop in the retort, but the 

temperature is not below the minimum 

retort temperature established in the 

process schedule. 

Is this a process deviation? 

Yes No 

19 
 

 

 

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Pop Quiz 

The biggest concern with reprocessing 

product that has already received a 

thermal process is that the product may 

become mushy and not saleable. 

False True 

20 
 

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Process Deviations -

Detection, Correction, and Handling 

 PD types and causes 

 Plant responsibilities 

• In-process PD detection and handling 

• Record review PD detection 

• Product reprocessing 

• Reporting process deviation to PA 

• Evaluation results and product dispositions 

 CSI responsibilities 

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Types of Process Deviations – 

Directive 7530.1 

 Mechanical 

• Still retorts 

• Batch agitating retorts 

• Continuous rotary agitating Retorts 

• Aseptic Processing Systems, including Surge 

Tanks 

• Hydrostatic Retorts 

 Product Related 

 Human Element 
 

 

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Process Deviations Impacting 

Heating Parameters 

 Low initial temperature 

 No or improper vent procedure used 

 Insufficient venting time 

 Low venting/CUT temperature 

 Inconsistent retort temperature 

• Down spikes (no measurable duration) 

• Drops (measurable duration) 

• Excessive fluctuations 

 Shortened process time 
 

 

 

 

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Steam Retort Process Deviations 

- Mechanical 

 Blown retort door gasket 

 Contaminated or ruptured air lines 

 Leaky or stuck air or water valves 

 Ruptured steam valve diaphragm 

 Thermometer failures 

 Steam or water spreader problems 

 Venting issues (e.g., divider/crate open area, 

piping valves, diameter, and obstructions) 

24 
 

 

 

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Steam Retort Process Deviations 

– Mechanical (cont.)

 Nonfunctioning or fast running automatic retort 

timers 

 Digital programmer circuit failures 

 Boiler or electrical failures 

 Pump/turbine fan failures 

 Air compressor failures, especially in 

overpressure or air agitation processes 

25 
 

 

 

 

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Continuous Rotary Agitating Retort 

Process Deviations - Mechanical 

 Incorrect RPM (high, low, or none) 

 Slipping or broken drive belts or mechanisms 

in agitating retorts 

 Reel jams/stops 

 Condensate build-up 

 Cooling shell pressure too high 

 Unprocessed containers in inlet and transfer 

valves not separated from processed 

containers following emergency still process 

26 
 

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Hydrostatic Retort Process 

Deviations - Mechanical 

 High water level in steam dome 

 Conveyor speed too fast 

 Temperature drops in water leg(s) not 

considered in process schedule 

 Prolonged container stops in-feed leg(s) 

27 
 

 

 

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Water Cascade/Spray Retort 

Process Deviations - Mechanical 

 Clogged nozzles, plates, filters, strainers, or pump 

suction ports 

 Low water recirculation flow rates 

 Low water level 

 Wrong basket or container load configuration 

 Improper overpressure (low or high) 

 Improper retort control/operation 

28 
 

 

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Process Deviations – Aseptic 

Systems 

 System pressure drops 

 Temperature drop in hold tube 

 Hold tube installed with wrong pitch or length 

too short 

 Water flow rate too fast 

 Low temperature 

 Low sanitizer concentration in bath 

 Clogged spray nozzles 

29 
 

 

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Process Deviations - Product 

Related 

 Different heating method 

 Formulation errors 

• Unauthorized ingredients 

• Inaccurate or incorrect percentages 

• Concentration changes 

 High fill weights/viscosity/pH/water activity, 

wrong container position (if critical factors) 

 Inadequate head space (if agitating) 

 Holding product too long 

30 
 

 

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Process Deviations – Product 

Related (cont.)

 Preparation errors 

• Improper ingredient hydration or blanching 

procedures 

• Frozen ingredients used instead of canned 

ingredients and vice versa 

• Improper mixing of ingredients 

• Incorrect slice thickness or dice size 

• Holding product too long 

31 
 

 

 

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Process Deviations – Human 

Element 

 Improper CF measurements (e.g., IT, RT, Bb, 

pH, fill weight, etc.) 

 Wrong process schedule/product formula used 

 Improper retort control/early shut down 

 Retort by-pass 

 Improper controller/recorder pen settings, pen 

not inked, improperly affixed/wrong recorder 

chart 

 Incorrect, pre-recorded, or falsified record 

32 entries 
 

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Record Deviations 

 Improper controller/recorder pen settings, pen 

not inked 

 Improperly affixed/slipping recorder chart 

 Wrong recorder chart 

 Temperature recorder chart temperature higher 

than accurate indicating temperature device 

 Missing vent time and temperature entries* 

 Tracing skips/blots* 

*NR and PA evaluation may not be required 

33 
Record Deviations – Tracing 

Waviness 

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Record Deviations - Ink Skip 

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Record Deviations - Ink blot 

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Pop Quiz 

The plant measures a low IT prior to applying the 

intended (posted) process schedule to any 

product, switches to the alternate process 

schedule on file, and successfully applies it. 

Is this a process deviation? 

Yes No 

37 
 

 

 

 

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Pop Quiz 

The recording chart stopped 20 minutes into a 

43-minute process. The retort operator 

observed and recorded MIG thermometer 

readings every 1 minute from the time the 

chart stopped until the process was done. 

Is this a process deviation? 

Yes No 

38 
 

 

 

 

 

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Pop Quiz 

While removing the cans from retort baskets, 

the labeling department notices that an extra 

divider plate (double) was used between one 

layer of cans. The heat distribution data does 

not address the use of 2 dividers between 

layers. 

Is this a process deviation? 

Yes No 

39 
 

 

 

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Process Deviations -

Plant Responsibilities 

 Detect and handle all process deviations: 

• As described in a canned product HACCP 

plan OR 

• As described in alternative documented 

procedures OR 

• In accordance with §431.9(c) 

 Reprocess or rework product under original 

or alternate schedule authorized by PA 

40 
 

 

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Process Deviations -

Plant Responsibilities (cont.)

 Maintain a separate PD file or log with: 

• Description of each deviation 

• Description of corrective actions 

• Associated processing/production records 

• Evaluation procedures and results 

• Disposition of affected product 

The most egregious deviation is an 

establishment not properly handling a PD and 

distributing that product in commerce! 

41 
 

 

 

 

 

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Process Deviations -

Processor Detection and Correction 

 Once detected, a process deviation must be 

handled by: 

• Immediately reprocessing affected product per 

§431.9(c)(1)(i) or (ii) if found in-process OR 

• Holding affected product for evaluation by PA to 

assess safety and commercial sterility in 

accordance with §431.9(c)(1)(iii) or (2) OR 

• Condemning and destroying product - 9 CFR 

Part 314 or §381.95 

42 
 

 

 

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Process Deviations - Corrected 

In-Process 

 Unless a documented reprocessing schedule 

or alternate process schedule is met, PA 

evaluation of the process deviations is required 

 Corrective actions documented 

• Retort malfunctions (e.g., air or cold-water 

intrusion) jeopardize corrective actions 

• PA may simulate temperature distribution 

• Worst-case scenario 

• No reliability of “assumptions” 

43 
 

 

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Process Deviations - Corrected 

In-Process (cont.)

 Calculation of new or alternate process 

schedule not on file during PD require PA 

evaluation 

 Corrective actions documented 

• Implemented emergency procedures may 

change process parameters following 

calculations 

44 
Process Deviations - Corrected 

In-Process (cont.)

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 Arbitrary corrections can be applied but 

product must still be evaluated by PA 

45 
 

Process Deviations - Correcting 

From Record Reviews 

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 Final chance to detect PD 

 Examine records more frequently when 

excessive record process deviations identified 

• Complications with isolating commingled 

product 

46 
 

Process Deviations - Isolating 

Affected Product 

THERMAL PROCESSING 

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 Product isolation documentation 

 Continuous system consequences for improper 

isolation 

 Product bracketing – last good check 

• Critical factor deviations 

• Retort malfunction 

47 
 

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Process Deviations -

Reprocessing Concerns 

 Valid reprocess schedule 

• Original or alternate process schedule 

 Heat penetration rate differences 

• Binders, extenders, thickeners 

 Storage effects 

• Viscosity changes 

• Product swelling 

48 
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Process Deviations -

Reprocessing Concerns (cont.)

 Potential S. aureus enterotoxin 

• Gross under-processing 

• Heat resistant enterotoxin 

 Rework 

• Level limit 

• Procedure 

• Ex. - 110 Bb original/180 Bb reprocess 

 Appropriate documentation 

49 
 

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Process Deviations -

Critical Role of Processing Authority 

 Adequate evaluation methods 

• Consequences of failure 

 Evaluates each incident individually 

 Advises processors 

• Identifies deviations requiring evaluation 

• Deviation prevention 

50 
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II Ii i i ii II 

I © I 

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II Ii ii II ii II 

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Process Deviations -

Records Submitted to PA 

THERMAL PROCESSING 

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 Product identification 

 Type of container and code 

 Production date 

 Processing vessel identification 

 Process cycle or time span 

 Quantity held 

 Nature/cause of deviation 

 Corrective actions taken 

 Copies of pertinent records 

 Disposition of product 

51 
 

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Process Deviations - Documenting 

Inadequate Information Submittals 

 Records not submitted per §431.9(d) 

• No critical factor records 

 Insufficient detail provided 

• Cause of temperature drop not identified 

• Product disposition unknown 

 Irrelevant QC biological sample results 

52 
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Process Deviations - Handling 

Missing Entries on Records 

 Computerized recordkeeping failures 

• Manual retort operator logs 

• No PD if MIG or digital thermometer readings 

 Missing temperature tracings, log entries 

• Pressure tracings for steam 

• Concerns with worst case evaluation 

• Simulations based on no venting 

 

 

 

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Process Deviations - PA Evaluation 

Concerns 

 Evaluation without original test data 

 Limits of original data stretched to cover 

conditions 

 Reluctance to conduct additional studies 

• Reliance on experience and suppositions 

without data 

 Incubate, sort, and ship disposition without 

evaluation 

54 
 

 

 

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Process Deviations -

PA Evaluation Reports 

 Evaluation must be written 

 Essential contents of report: 

• Processing conditions causing deviation 

• Processing parameters used 

• Method employed (Ball, Stumbo, other) 

• Resulting sterilizing value (F0) 

• Summary of records utilized 

• Statement if process meets CS or minimum 

health values 55 
 

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PA Evaluation Reports – 

Product Disposition 

Commercial Sterile 

 Product free of viable organisms of public 

health and non-health significance which are 

capable of reproducing under normal nonrefrigerated storage and distribution 

environmental conditions 

56 
 

 

 

 

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PA Evaluation Reports – 

Product Disposition (cont.)

Above Minimum Health 

 Product received a thermal process that 

rendered it free of microorganisms of potential 

public health significance 

Below Minimum Health 

 Product may contain microorganisms of 

potential public health significance 

57 
 

 

 

 

 

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PA Evaluation Reports – 

Product Disposition (cont.)

 Recommended PA disposition procedures for 

product not commercially sterile 

• Above minimum health 

 Reprocess to commercial sterility 

 100% incubation and sort (evaluate for 

swollen containers) 

• Below minimum health 

 Reprocess to CS as above or destroy 

product 

58 
 

 

 

 

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Pop Quiz 

The disposition of thermally processed product that 

may contain spoilage microorganisms capable of 

reproducing under normal non-refrigerated 

conditions but has been rendered free of 

microorganisms of potential public health 

significance would be: 

Commercially Sterile 

Above Minimum Health 

Below Minimum Health 

59 
 

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Process Deviations -

Product Release Criteria 

 Affected product distribution contingent on 

acceptable PA evaluation 

 Written response required for each incident 

• Verbal release not in compliance 

 Detailed PA deviation reports and plant actions 

taken maintained in file/log 

60 
 

 

 

 

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FSIS Directive 7530.1 (Rev. 4) 

“Handling a Process Deviation or Abnormal 

Container of Thermally Processed,

Commercially Sterile Canned Product” 

 Identifies abnormal containers and causes of 

process deviations 

 Identifies procedures IPP to follow when PD 

or abnormal containers found 

 Addresses PDS evaluation of process

deviations and FSIS laboratory analysis of 

abnormal containers 
 

 

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Process Deviations - CSI 

Responsibilities 

 Verify the plant handles process deviations 

through either: 

• A HACCP plan as written, documenting 

corrective actions and reassessing the 

HACCP plan if necessary, OR 

• An alternate process schedule authorized by 

a PA and on file if required for product 

reprocessing OR 

• Alternative documented procedures 

62 
 

 

 

 

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Process Deviations - CSI 

Responsibilities (cont.)

 If a plant follows canning regulations and has 

no alternative documented procedures for 

handling a PD, verify that: 

• If the PD was detected in-process, product 

was immediately reprocessed under a original 

process schedule OR 

• A PA developed alternate process schedule 

on file before the PD occurred was used OR 

• Product involved was placed on hold until PD 

was evaluated by a PA 63 
 

 

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Process Deviations -

CSI Responsibilities (cont.)

 Verify that: 

• Each process deviation was evaluated by the 

plant, a PA, or PDS as necessary 

• All process deviation evaluations and required 

records are maintained in a separate file or 

log 

• All process deviation evaluations and 

corrective actions documented 

64 
 

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Process Deviations - CSI 

Responsibilities (cont.)

 Verify the plant maintains full records for 

handling each process deviation in a separate 

file or log, including: 

• Appropriate processing and production 

records 

• Full descriptions of corrective actions 

• Evaluation procedures and results 

• Disposition of affected product 

65 
 

 

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Process Deviations Submitted 

to PDS 

• Corrective action requirements of §417.3 not met 

• Alternative documented procedures not used 

• Alternate process schedule not on file used, or 

alternative process schedule on file immediately 

calculated and used 

• Process deviation in a continuous rotary retort not 

handled per §431.9(c)(1)(vi) 

• Process deviation found through records review 

• IPP concerns - FSIS Form 10,000-6 

66 
e

 

 

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Process Deviations Not 

Evaluated by PDS 

 PDS will not usually review a process 

deviation when: 

• The plant addressed microbial food safety 

hazards in a HACCP plan and implemented 

corrective actions 

• The plant used an alternative documented 

procedure for handling process deviations 

• No process deviation handling concerns 

67 
e

 

 

 

 

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Process Deviations Not 

Evaluated by PDS (cont.)

• Process deviation found in-process not usually 

evaluated by PDS when plant: 

Immediately reprocessed product using 

original process schedule 

Used approved alternate process schedule 

on file 

Handled emergency stops/temperature 

drops in continuous rotary retort per 

§431.9(c)(1)(vi) 

68 
 

 

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Abnormal Containers – 9 CFR 

431.10(a) 

 Processor handles finished product inspections 

according to: 

• HACCP plan addressing biological hazards 

OR 

• FSIS-approved TQ control system OR 

• Alternative documented procedures OR 

• §431.10(b) 
 

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Abnormal Containers – 9 CFR 

431.10(b)(1) 

(i) Incubation facilities - temperature/time recording 

and indicating temperature devices, air 

circulation, restricted entry 

 “Program” responsible for incubator security 

(ii) Incubation temperature 95±5°F (35±2.8°C) 

 If temperature <90°F (32°C) or >100°F (38°C) 

but <103°F (39.3°C), adjust to range, extend 

incubation time containers out of temperature 

 If temperature ≥ 103.5°F >2 hours, test 

terminated and new containers incubated 
 

 

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Abnormal Containers – 9 CFR 

431.10(b)(1) (con’t.)

(iii) Shelf stable product requiring incubation: 

(A) Low acid products - §431.1 

(B) Acidified low acid products - §431.1 

(iv) Incubation samples: 

(A) Still or agitation batch type retort – one 

container each load 

(B) Continuous rotary, hydrostatic, other

continuous-type retort – one container 

per 1,000 

(C) Normal appearing containers only 
 

 

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Abnormal Containers – 9 CFR 

431.10(b)(1) (con’t.)

(v) Incubation time >10 days/240 hours 

(vi) Incubation checks and record maintenance 

• Designated employees visually check all 

incubating containers each working day 

• CSI notified when abnormal containers found 

• All abnormal containers cooled before final 

decision on condition made 
 

 

 

 

 

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Abnormal Containers – 9 CFR 

431.10(b)(1) (con’t.)

(vi) (con’t.) 

• Document at least product name, container 

size/code, number of containers incubated, 

in/out dates, incubation results 

• Retain records, including temperature/time 

recording charts and initial distribution 

(vii) Retain at least code lot involved if abnormal 

containers found in incubation samples 

(viii) No product shipped from establishment 

before required incubation period completed 
 

 

 

 

 

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Abnormal Containers – 9 CFR 

431.10(c) 

(1) Establishment only ships normal-appearing 

containers determined by sampling plan or 

other acceptable means 

(2) Inspector informed if abnormal containers 

detected by other than incubation and affected 

lot not shipped until Program determines 

product safety and suitability 

 Cause and level of abnormals 

 Product disposition actions taken or 

proposed 
 

 

 

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Abnormal Containers - CSI 

Responsibilities 

 IPP verify notification received when 

processors following canning regulations 

detects abnormal containers: 

• During finished product incubation -

§431.10(b) OR 

• By any means other than incubation -

§431.10(c)(2) 
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Abnormal Containers - CSI 

Responsibilities (con’t.)

 When IPP detect abnormal containers: 

• Retain product lot associated with the 

abnormal containers 

• Notify establishment about finding and 

document incident in MOI 
 

 

 

 

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Abnormal Containers - CSI 

Responsibilities (con’t.)

 If establishment handles abnormal containers 

under HACCP plan or documented procedures, 

IPP verify plant: 

• Controls and prevents shipment of affected lot 

– Retain lot if necessary 

• Initiates actions to determine and eliminate 

cause of abnormal containers, including 

§417.3 corrective actions 

 Verify lot safety and stability (review microbial 

results, PA evaluations, incubation records, etc.) 
 

 

 

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Abnormal Containers - CSI 

Responsibilities (con’t.)

 When plant does not handle abnormal 

containers under a HACCP plan or 

documented procedures: 

• Retain product lot associated with abnormal 

containers 

– Minimum amount of 2 hours continuous 

production retained 

• Contact FSIS Western Laboratory by phone 

per Directive instructions 
 

 

 

 

 

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Abnormal Containers - CSI 

Responsibilities (con’t.)

 When IPP observe abnormal containers at 

domestic plant: 

• Contact FSIS Western Laboratory per 

Directive and provide supervisor’s contact 

• Provide lab with all information requested 

• Submit both normal and abnormal samples 

• Refrigerate abnormal containers before 

mailing (DO NOT FREEZE CONTAINERS) 

• Complete FSIS Forms 10,000-2, 10,000-3 
 

 

 

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Abnormal Containers - CSI 

Responsibilities (con’t.)

 When IPP observe abnormal containers at an 

official import establishment: 

• Follow Directive 9900.2, Section XV 

instructions to add a Condition of Container 

type of inspection (TOI) when necessary 

• Provide inspection details to importer of 

record (IOR) 

• Handle abnormal containers same as those 

found at domestic official establishments 

• Follow product disposition instructions 
 

 

 

 

 

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Abnormal Containers - CSI 

Responsibilities (con’t.)

 When IPP observe abnormal containers at 

official import establishments: 

• Follow Directive 9900.2, Section XV to add 

Condition of Container type of inspection 

(TOI) when necessary 

• Follow same procedures for submitting 

domestic samples 

• Complete lab sample Form 8000-21 and 

Abnormal Container TOI questionnaire 

• Send copy to Import Inspection, DO, PDS 
 

 

 

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Abnormal Containers - CSI 

Responsibilities (con’t.)

 Final disposition of abnormal containers 

• DO reviews PDS recommendation and any 

additional findings by IPP and the FLS to 

make final ruling on affected lot disposition 

• IPP notified of any additional actions to take 

through chain of command 

• IPP verify disposition of imported abnormal 

containers per FSIS Directives 9900.2 and 

9900.8 
 

 

 

 

 

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Pop Quiz 

A plant has no HACCP plan addressing microbial 

contamination and no alternative documented 

procedures for handling process deviations. A 

process deviation detected in-process and a 

process not on file is immediately calculated. 

Product is held and a PA evaluates the 

deviation. Upon receiving the PA’s commercial 

sterility disposition, the product is shipped. 

In Compliance 

Out of Compliance 

83 
 

 

 

 

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Pop Quiz 

A plant has no HACCP plan addressing microbial 

contamination and no alternative documented 

procedures for handling process deviations. The 

computer program detected a process deviation 

in-process and calculated/applied an alternate 

process not on file. Should the process deviation 

be submitted to PDS? 

Yes No 

84 
 

 

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Objectives Summary 

 Identify common types and causes of process 

deviations 

 Describe regulatory requirements and 

processor responsibilities for identifying, 

managing, and documenting process 

deviations, abnormal containers, and 

corrective actions 

 Perform verification activities for determining 

plant compliance in handling process 

deviations and abnormal containers 

85 
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Questions?

86