THERMAL PROCESSING 

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Module 23. Process Verification 

and Assessment 

Thermal Processing for Meat and Poultry 

Products Training 

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Purpose and Objectives 

 Purpose of Module 24 

• Provide methods for monitoring processes 

and assessing canneries. 

 Performance Objective 

• Ability to use appropriate methods to 

successfully verify processes at canning 

establishments and perform assessments 

of the establishment’s Food Safety System. 

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FSAs 

 It is important that the EIAO/CSI understand 

the approach to food safety assessments 

(FSAs) to verify the establishment is in 

compliance with the meat and poultry canning 

regulations and that the establishment 

responds appropriately to the results of the 

FSA. 

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FSA/Initial Inspection Steps 

 Before the FSA: 

• Prepare 

• Review prior history (CSI to if possible) 

 During the FSA: 

• Meet with management (CSI entrance meeting) 

• General walk through (CSI after entrance meeting) 

• Review temperature distribution report and 

scheduled process documentation (CSI also) 

• Request for records (EIAO before walk through) 

• Conduct the FSA 

• Write observations 

• Review observations and obtain management's 

4 response 
 

 

 

 

 

 

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FSA Procedures 

 Preparation for the FSA 

• Review of previous FSA reports 

• Review the FSA tool questions and PHRE 

findings to identify specific areas of focus 

• Contact previous EIAOs if necessary 

• Review the establishment’s HACCP system 

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Recommended References 

 9 CFR Part 431– Meat and Poultry Canning 

Regulations 

 FSIS Canning Reference Manual 

 Review specific information on products 

 Procedures specified in FSIS Directive 5100.1 

- EIAO Food Safety Assessment Methodology 

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GMA Bulletins 

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 NFPA Bulletin 26L for 

metal containers 

 Other NFPA bulletins: 

• 30L for glass 

containers 

• 44L for rotary 

sterilizers 

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Establishment Equipment Needed 

for Demonstrating Compliance 

 Stopwatch 

 Handheld 

thermometer 

 Drill bits 

 Tape measure 

 Dial caliper 

 Can teardown 

equipment 

 pH paper 

 Dividers 

 Head space gauge and 

other CF measuring 

instrumentation 

 Method to test cooling 

water chlorine 

(sanitizer) level 

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Dividers 

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 Dividers are used to 

measure times on 

temperature curves. 

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Drill Bits 

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 Drill bits are 

used to 

measure 

holes in 

steam 

spreaders 

and water 

spreaders. 

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Tape Measure 

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 Tape 

measures are 

used to 

measure retort 

diameters and 

pipe length. 

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Dial Calliper 

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 Dial callipers are 

used to measure 

inside and outside 

pipe diameters. 

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Seam Teardown Equipment 

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Sanitary 

Can 

Opener 

Tin 

shears 

Seam 

Micrometer 

Nippers 13 

 Need some way 

to tear down 

cans to observe 

seams. 

 Possibilities 

include can 

opener, nippers, 

and seam 

micrometer. 
 

 

 

pH Paper 

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 A narrow range pH 

paper works best. 

• Should be able to 

determine if the 

food is acidified 

with the pH paper. 

 pH meters can be 

used if available. 

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Headspace Gauge 

Gauge in 

16th of an 

inch from 2 

to 16 16ths 

 Gauge sets on 

top of the 

container. 

 When a prong 

touches the 

product, it 

turns opaque. 

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@ ) AT.I.) WATER-Cl/EX 

COLOR COMPARISON CHART 

WATER-CHf)(TM CHLORINE 

Chlorine RANGE, 0.11 ppm (Caralog No 00200) 

A t.p \ht,,, ~• .,t -tlU,111' ,ilillt wtt cM1. ,a:;..Mtlll,11\,n,, ~11111,tL 

TEST UNIT P~M ...... Pl'AI 

0 4 8 

■ 5 9 

2 6 10 

3 7 11 

 

 

 

Method to Determine Cooling Water Chlorine Level 

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 Change in color 

compared to 

chart. 

 Pool test kit can 

be used. 

 Low level test 

strips are 

available. 

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FSA Procedures 

 Assess and evaluate the establishment’s 

comprehensive food safety system 

 Follow instructions in FSIS Directive 5100.1 

and use the FSA tool 

 Choose a product and production line that 

represents one of the most difficult to control 

 Do not try to cover all products and production 

lines during one FSA 

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FSA Procedures (2) 

 Four basic areas of concern: 

• Establishment of the process 

• Delivery of the process 

• Documentation of the process 

• Container integrity 

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FSA Procedures (3) 

 Establishment scheduled processes, including 

documentation from a process authority 

• Temperature distribution test 

• Minimum requirement is a letter from a 

processing authority 

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FSA Procedures (4) 

 Delivery of the scheduled process: 

• Does the establishment's equipment and 

operating procedures deliver the scheduled 

process? 

• Includes product preparation, filling, 

closing, thermal processing, and post 

process handling 

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FSA Procedures (5) 

 Documentation of process delivery: 

• Do the establishment records reflect the 

operations in the establishment? 

• Are the records accurate and complete? 

 Are process deviations recognized and 

handled correctly? 

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FSA Procedures (6) 

 How are records selected for the review? 

• Randomly select 13 production day records 

from the preceding 60 days. 

• Use random number generator. 

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iii. Random Number Generator 

1 

14 

7 

f Gener ate Random Number( s) ! 

t .............................................................................................................. [ 

Random Number( s ): 

2, 4, 5, 6, 8, 12, 13 

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Random Number Example 

Example Production Dates 

Oct 10 = 1 Nov 3 = 8 

Oct 12 = 2 Nov 7 = 9 

Oct 14 = 3 Nov 14 = 10 

Oct 22 = 4 Nov 18 = 11 

Oct 25 = 5 Nov 22 = 12 

Oct 27 = 6 Nov 27 = 13 

Nov 1 = 7 

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FSA Procedures: Container Integrity 

 Are the containers protected from post 

processing contamination? 

 Are container closures examined and the 

results recorded? 

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FSA Procedures: Warehouse 

 Examine product for signs of leaking and 

swollen containers. 

 Examine the distressed goods area for signs 

of problems. 

 Determine why lots are on hold. 

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FSA Procedures: Containers 

 Examination of containers: 

• Follow appropriate FSIS Directive 7520.2. 

• Handle swollen containers with care and 

follow FSIS Directive 7530.1. 

 Hard swells may need to be refrigerated (not 

frozen). 

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fl.00 12 

0 

ll 

~ 'II) 

'Ul 

l 'i!if~ 

ill ' 

1(1 

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Sample Schedule Chart 

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Common Problems Noted 

 Failure to recognize and handle process 

deviations. 

 Failure to identify and control critical factors. 

 Out of specification container seams. 

 Use of computer systems with no validation. 

 MIG thermometer broken or not checked for 

accuracy. 

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Common Problems Noted (2) 

 No information to support process schedule 

development. 

 No information to support retort operation to 

achieve adequate temperature distribution. 

 Processing records do not include all critical 

factors. 

 Use of retort system other than what was 

identified on process schedule. 

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Determining Noncompliance 

 Review the regulations for the retort system 

being inspected (§431.6). 

 Review the regulations before attempting to 

write a list of observations. 

• Observation items should reflect the regulations. 

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FSA Procedures 

 Plan FSA flow. 

• Following the product flow usually works 

best. 

 Ask establishment personnel to conduct the 

required measurements on the retort system 

for pipe sizes, bleeder holes, etc. 

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Key to FSA/Inspection 

 Adequate time must be spent on the cannery 

floor to observe the operation. 

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Reporting the Observations 

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 Discussion of observations with the 

establishment. 

• Provide information about observations. 

• Obtain establishment management's 

response to FSA observations. 

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Example Observation Item 

 “There is no written documentation on hand to 

support your vent procedure of venting to at 

least 212°F that ensures that all the air is 

removed from the retort prior to the beginning 

of the timing of the process for sterilization.” 

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Example Inspection Report 

FDA LACF INSPECTION REPORT

 1 SUMMARY OF FINDINGS

 2 HISTORY OF BUSINESS

 3 PERSONS INTERVIEWED

 4 INDIVIDUAL RESPONSIBILITY

 5 PROCESS ESTABLISHMENT, FILING AND SCHEDULES

 6 

HAS THE FIRM REGISTERED WITH FDA AND FILED A PROCESS FOR ALL LACFS PROCESSED 

AT THIS FACILITY, AND FOR FOREIGN FIRMS, ALL PRODUCTS PROCESSED AND SHIPPED TO 

THE U.S.? YES [] NO [] 

REMARKS:

 7 HAVE PROCESSES BEEN ESTABLISHED FOR ALL LACFS PROCESSED AT THIS FACILITY? 

113.83 YES [] NO [] 

REMARKS:

 8 LIST THE FIRM’S PROCESS AUTHORITIES.

 9 ARE THE PROCESS AUTHORITIES THE SAME AS THAT FILED WITH FDA?

 YES [] NO [] 

REMARKS: 

10 

DOES THE FIRM HAVE A PROCESS LETTER OR OTHER PROCESS SOURCE DOCUMENTATION 

LISTING CRITICAL FACTORS NECESSARY TO CONTROL IN THE ATTAINMENT OF 

COMMERCIAL STERILITY? YES [] NO [] 

REMARKS: 

11 

DO CRITICAL FACTORS/LIMITS LISTED IN SOURCE DOCUMENTS MATCH CRITICAL 

FACTORS/LIMITS FOR SELECTED PRODUCTS AND PROCESSES FILED WITH FDA?

 YES [] NO [] 

NOTE - CRITICAL FACTORS MAY EXIST WHICH THE FIRM CONTROLS BUT HAVE NOT BEEN 

IDENTIFIED IN THE PROCESS FILING AND/OR HAS FAILED TO IDENTIFY AND DOES NOT 

CONTROL) 35 REMARKS: 
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Example Retort Survey Form 

PROCESSING IN STEAM IN STILL RETORTS 

INSTRUCTIONS 

COMPLETE THE QUESTION BLOCKS BELOW. EACH BLOCK IS EXPANDABLE TO ACCOMMODATE 

NARRATION AS NEEDED. DRAW A DIAGRAM OF THE RETORT OR OBTAIN ONE FROM THE 

FIRM. ATTACH THE DIAGRAM TO THIS SURVEY REPORT. REPORT ALL PIPE SIZES AS 

INSIDE DIAMETER (ID). CROSS-SECTIONAL AREA = 3.14R2 (R = 1⁄2 DIAMETER). MAKE A 

HARD COPY OF THE COMPLETED FORM AND ATTACH TO THE LACF INSPECTION REPORT.

RETORT DESCRIPTION 

RETORT NO. TYPE OF RETORT: VERTICAL [] 

HORIZONTAL [] 

VERTICAL (CRATELESS) [] 

LENGTH OR HEIGHT DIAMETER 

FOR VERTICAL RETORTS, BOTTOM CRATE SUPPORTS ARE PRESENT. YES [] NO [] 

ARE BAFFLE PLATES PRESENT IN THE BOTTOM OF RETORT? YES [] NO [] 

ARE THERE ANY PROTRUSIONS INSIDE THE RETORT OR THE RETORT DOOR CASING WHICH 

COULD DAMAGE CONTAINERS DURING LOADING/UNLOADING OF CRATES? YES [] NO [] 

COMPUTER CONTROLS 

DOES A COMPUTER CONTROL ANY OF THE RETORT FUNCTIONS? YES [] NO [] 

DOES THE FIRM HAVE DOCUMENTATION ON HAND THAT INDICATES THAT THE COMPUTER 

SYSTEM HAS BEEN VALIDATED? YES [] NO [] 

EXPLAIN: 

IS RECORD KEEPING PART OF THE COMPUTER FUNCTION? YES [] NO [] 

IF YES, DOES THE RECORD KEEPING COMPLY WITH 21CFR PART 11 YES [] NO [] 

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Retort Diagram 

 A description of the retort system should be 

available for review. 

 If it does not: 

• Obtain simple diagram from the 

establishment. 

• Draw a diagram. 

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2" Li.ne: 

1"'" Cross-type 

Spreader 

Recorder/Concroller ----t"il O I 

0 0, 

?at, 11 Bleeder w/mufflcr 

:Probe for 

(;ontrollei;. 

~----t-1⁄2;" Bleeder w/ 

~ --- .u<H~_. muffler 

6tt X 6 11 

Well 

lJ( 11 Line 

ll,;" Bypass 

llt" Control-++ m 

Valve 

Li.ne 

2 11 Line 

(l) - Cate Valve 

® • Clobe Valve 

lit" Line 

Manifol d 8" Header 

Example Retort Diagram 

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THERMAL PROCESSING 

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Key Points 

 Follow instructions in FSIS Directive 5100.1. 

 Acquire references and prepare for the FSA. 

 Use this presentation for additional pointers 

for conducting an FSA in a canning 

establishment. 

 Ensure that the establishment has the tools 

needed and ensure they know how to use 

them (e.g., seam teardown tools, etc.). 

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Key Points (2) 

 Procedures for FSAs require planning and 

organization. 

 Observations should be reported to 

establishment management. 

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Questions 

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Questions?

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