+----------------+-----------------+-----------------+-----------------+
| DEPARTMENT OF  |                 |                 |                 |
| HEALTH AND     |                 |                 |                 |
| HUMAN SERVICES |                 |                 |                 |
|                |                 |                 |                 |
| FOOD AND DRUG  |                 |                 |                 |
| ADMINISTRATION |                 |                 |                 |
|                |                 |                 |                 |
| **PROCESSING   |                 |                 |                 |
| IN STEAM IN    |                 |                 |                 |
| CONTINUOUS     |                 |                 |                 |
| AGITATING      |                 |                 |                 |
| RETORTS**      |                 |                 |                 |
|                |                 |                 |                 |
| **(Retort      |                 |                 |                 |
| Survey)**      |                 |                 |                 |
+----------------+-----------------+-----------------+-----------------+
| > **           |                 |                 |                 |
| INSTRUCTIONS** |                 |                 |                 |
| >              |                 |                 |                 |
| > Complete the |                 |                 |                 |
| > question     |                 |                 |                 |
| > blocks       |                 |                 |                 |
| > below.       |                 |                 |                 |
| > Narrative    |                 |                 |                 |
| > responses to |                 |                 |                 |
| > each item    |                 |                 |                 |
| > can be       |                 |                 |                 |
| > entered in   |                 |                 |                 |
| > the item's   |                 |                 |                 |
| > "comments"   |                 |                 |                 |
| > area or\     |                 |                 |                 |
| > where        |                 |                 |                 |
| > otherwise    |                 |                 |                 |
| > prompted.    |                 |                 |                 |
| > Draw a       |                 |                 |                 |
| > diagram of   |                 |                 |                 |
| > the retort   |                 |                 |                 |
| > or obtain    |                 |                 |                 |
| > one from the |                 |                 |                 |
| > firm and     |                 |                 |                 |
| > attach it to |                 |                 |                 |
| > the EIR as   |                 |                 |                 |
| > an exhibit.\ |                 |                 |                 |
| > Report all   |                 |                 |                 |
| > pipe sizes   |                 |                 |                 |
| > as inside    |                 |                 |                 |
| > diameter     |                 |                 |                 |
| > (ID). Refer  |                 |                 |                 |
| > to 21 CFR    |                 |                 |                 |
| > Part         |                 |                 |                 |
| > 113.40(c)    |                 |                 |                 |
| > and pp 28-30 |                 |                 |                 |
| > of LACF      |                 |                 |                 |
| > Guide Part   |                 |                 |                 |
| > 2.           |                 |                 |                 |
| >              |                 |                 |                 |
| > If problems  |                 |                 |                 |
| > are found    |                 |                 |                 |
| > with the     |                 |                 |                 |
| > firm's       |                 |                 |                 |
| > retort       |                 |                 |                 |
| > equipment or |                 |                 |                 |
| > processing   |                 |                 |                 |
| > system,      |                 |                 |                 |
| > refer the    |                 |                 |                 |
| > reader to    |                 |                 |                 |
| > the          |                 |                 |                 |
| > narrative    |                 |                 |                 |
| > Turbo EIR\   |                 |                 |                 |
| > under        |                 |                 |                 |
| >              |                 |                 |                 |
| "Objectionable |                 |                 |                 |
| > Conditions   |                 |                 |                 |
| > and          |                 |                 |                 |
| > Management's |                 |                 |                 |
| > Response,"   |                 |                 |                 |
| > and include  |                 |                 |                 |
| > a narrative  |                 |                 |                 |
| > explanation  |                 |                 |                 |
| > of specific\ |                 |                 |                 |
| > problems and |                 |                 |                 |
| > evidence     |                 |                 |                 |
| > under the    |                 |                 |                 |
| > subheading   |                 |                 |                 |
| > "Supporting  |                 |                 |                 |
| > Evidence and |                 |                 |                 |
| > Relevance."  |                 |                 |                 |
| > Submit the   |                 |                 |                 |
| > completed    |                 |                 |                 |
| > form as\     |                 |                 |                 |
| > an EIR       |                 |                 |                 |
| > attachment.  |                 |                 |                 |
+----------------+-----------------+-----------------+-----------------+
| **RETORT       |                 |                 |                 |
| DESCRIPTION**  |                 |                 |                 |
+----------------+-----------------+-----------------+-----------------+
| RETORT NO.     | \*CAN SIZE      | COOKER CAPACITY | STEPS/REEL      |
|                |                 |                 |                 |
|                |                 |                 |                 |
+----------------+-----------------+-----------------+-----------------+
|                | NO. OF          | NO. OF PRESS    | NO. OF AMOS.    |
|                | PRECOOKERS      | COOLERS         | COOLERS         |
|                |                 |                 |                 |
|                |                 |                 |                 |
+----------------+-----------------+-----------------+-----------------+
| \* List the    |                 |                 |                 |
| Can Size       |                 |                 |                 |
| covered during |                 |                 |                 |
| the            |                 |                 |                 |
| inspection.    |                 |                 |                 |
+----------------+-----------------+-----------------+-----------------+
| **COMPUTER     |                 |                 |                 |
| CONTROLS**     |                 |                 |                 |
+----------------+-----------------+-----------------+-----------------+
| > DOES A       |                 |                 |                 |
| > COMPUTER     |                 |                 |                 |
| > CONTROL ANY  |                 |                 |                 |
| > OF THE       |                 |                 |                 |
| > RETORT       |                 |                 |                 |
| > FUNCTIONS?   |                 |                 |                 |
| > Yes No       |                 |                 |                 |
| >              |                 |                 |                 |
| > EXPLAIN:     |                 |                 |                 |
| >              |                 |                 |                 |
| >              |                 |                 |                 |
+----------------+-----------------+-----------------+-----------------+
| > 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   |                 |                 |                 |
| >              |                 |                 |                 |
| > COMMENTS:    |                 |                 |                 |
| >              |                 |                 |                 |
| >              |                 |                 |                 |
+----------------+-----------------+-----------------+-----------------+

+-----------------------------------------------------------------------+
| **INDICATING MERCURY-IN-GLASS THERMOMETER (113.40(a)(1))**            |
+-----------------------------------------------------------------------+
| > IS THE RETORT EQUIPPED WITH AT LEAST ONE MERCURY-IN-GLASS (MIG)     |
| > THERMOMETER? Yes No                                                 |
| >                                                                     |
| > COMMENTS:                                                           |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE RETORT EQUIPPED WITH ANOTHER TYPE OF TEMPERATURE INDICATING  |
| > DEVICE? Yes No                                                      |
| >                                                                     |
| > IF YES, DESCRIBE THE INDICATOR:                                     |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+
| > ARE SCALE DIVISIONS EASILY READABLE TO 1°F (.5°C)? Yes No           |
+-----------------------------------------------------------------------+
| > NO. OF DEGREES F OR C/IN. OF GRADUATED SCALE:[     ]{.underline} .  |
| > *(TEMP. RANGE MUST NOT EXCEED 17°F(8°C)\                            |
| > PER INCH (4°C/CM) OF GRADUATED SCALE. SEE LACF GUIDE, P. 14.)*      |
| >                                                                     |
| > DATE LAST TESTED FOR ACCURACY:                                      |
| >                                                                     |
| > *(THERMOMETERS **SHALL** BE TESTED FOR ACCURACY AGAINST A KNOWN     |
| > ACCURATE STANDARD THERMOMETER\                                      |
| > UPON INSTALLATION AND AT LEAST ONCE A YEAR THEREAFTER; RECORDS OF   |
| > ACCURACY CHECKS THAT SPECIFY\                                       |
| > DATE, STANDARD USED, METHOD USED, AND PERSON PERFORMING THE TEST    |
| > **SHOULD** BE MAINTAINED. EACH THERMOMETER **SHOULD** HAVE A TAG,   |
| > SEAL, OR OTHER MEANS OF IDENTITY THAT INCLUDES THE DATE IT WAS      |
| > LAST\                                                               |
| > TESTED FOR ACCURACY.)*                                              |
| >                                                                     |
| > STANDARD USED FOR THE TEST:\                                        |
| >                                                                     |
+-----------------------------------------------------------------------+
| > NAME AND TITLE OF PERSON WHO PERFORMED TEST:\                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE LAST TEST DATE IDENTIFIED ON THE THERMOMETER? Yes No         |
| >                                                                     |
| > WERE CALIBRATING TEST RECORDS PREPARED/MAINTAINED? Yes No           |
| >                                                                     |
| > *(SHOULD REQUIREMENT)*                                              |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DESCRIBE THE FIRM'S ACTIONS REGARDING MIG THERMOMETERS THAT WERE    |
| > OUT OF CALIBRATION:\                                                |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE MERCURY UNDIVIDED? Yes No                                    |
| >                                                                     |
| > *(A THERMOMETER THAT HAS A DIVIDED MERCURY COLUMN OR THAT CANNOT BE |
| > ADJUSTED TO THE STANDARD\                                           |
| > **[SHALL]{.underline}** BE REPAIRED OR REPLACED.)*                  |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > WHEN MIG THERMOMETERS ARE FOUND TO BE PROVIDING READINGS ABOVE THE  |
| > ACTUAL TEMPERATURES, DOES THE FIRM EVALUATE PRODUCTS PRODUCED USING |
| > THOSE THERMOMETERS? Yes No                                          |
| >                                                                     |
| > DESCRIBE THE FIRM'S PROCEDURES:\                                    |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE THERMOMETER LOCATED WHERE IT IS EASY TO READ ACCURATELY? Yes |
| > No                                                                  |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENT)*                             |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > THE SENSOR BULB IS LOCATED IN THE Retort Shell , or External Well   |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENT)*                             |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DIAMETER OF OPENING FROM RETORT TO EXTERNAL WELL:                   |
| > [     ]{.underline} BLEEDER SIZE: [     ]{.underline}               |
| >                                                                     |
| > *(OPENING **[SHALL]{.underline}** BE AT LEAST 3/4-IN. DIA) (BLEEDER |
| > **[SHALL]{.underline}** BE AT LEAST 1/16-IN. DIA.)*                 |
+-----------------------------------------------------------------------+
| > DOES THE BLEEDER EMIT STEAM CONTINUOUSLY DURING PROCESSING? Yes No  |
+-----------------------------------------------------------------------+
| > *(**[SHALL]{.underline}** REQUIREMENT)*                             |
| >                                                                     |
| > IF NO, EXPLAIN (OR ANY OTHER COMMENT):\                             |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IF A MUFFLER IS USED ON BLEEDER(S), WHAT EVIDENCE DOES THE FIRM     |
| > HAVE THAT IT DOES NOT RESTRICT FREE\                                |
| > FLOW OF STEAM?                                                      |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+
| > *(**[SHALL]{.underline}** REQUIREMENT -- 113.87(g))*                |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE MERCURY THERMOMETER USED AS THE REFERENCED INSTRUMENT DURING |
| > PROCESSING? Yes No                                                  |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENT)*                             |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **TEMPERATURE RECORDING DEVICE (113.40(a)(2))**                       |
+-----------------------------------------------------------------------+
| > IS THE RETORT EQUIPPED WITH A TEMPERATURE RECORDING DEVICE? Yes No  |
| >                                                                     |
| > TYPE OF TEMPERATURE RECORDER Round Circular Chart Strip Chart Other |
| >                                                                     |
| > IF OTHER, EXPLAIN:\                                                 |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DO THE CHART SPECIFICATIONS MEET THE REQUIREMENTS OF PART 113? Yes  |
| > No                                                                  |
| >                                                                     |
| > *(GRADUATIONS ON THE TEMPERATURE-RECORDING DEVICE SHALL NOT EXCEED  |
| > 2°F (1°C) WITHIN A RANGE OF 10°F*                                   |
| >                                                                     |
| > *(5.5°C) OF THE PROCESSING TEMPERATURE. EACH CHART SHALL HAVE A     |
| > WORKING SCALE OF NOT MORE THAN 55°F/IN*                             |
| >                                                                     |
| > *(12°C/CM) WITHIN A RANGE OF 20°F (10°C) OF THE PROCESSING          |
| > TEMPERATURE -- 113.40(b)(2). ALSO, SEE P. 14 OF LACF*               |
| >                                                                     |
| > *FIELD GUIDE - PART 2.)*                                            |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE TEMPERATURE CHART ADJUSTED TO AGREE AS NEARLY AS POSSIBLE    |
| > WITH BUT NOT HIGHER THAN THE KNOWN ACCURATE MERCURY-IN-GLASS        |
| > THERMOMETER DURING THE PROCESSING PERIOD? Yes No                    |
| >                                                                     |
| > *(SHALL REQUIREMENT -- NOTE ANY DIFFERENCE BETWEEN THE RECORDING    |
| > THERMOMETER AND THE MERCURY-IN­-GLASS THERMOMETER AND WHICH READING  |
| > IS HIGHER.)*                                                        |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THERE A MEANS FOR PREVENTING UNAUTHORIZED ADJUSTMENTS? Yes No    |
| >                                                                     |
| > *(A MEANS OF PREVENTING UNAUTHORIZED CHANGES IN ADJUSTMENTS         |
| > **[SHALL]{.underline}** BE PROVIDED. A LOCK OR NOTICE FROM          |
| > MANAGEMENT STATING "ONLY AUTHORIZED PERSONS ARE PERMITTED TO MAKE   |
| > ADJUSTMENTS" & POSTED AT OR NEAR THE RECORDING DEVICE IS A          |
| > SATISFACTORY MEANS FOR PREVENTING UNAUTHORIZED CHANGES.)*           |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE CHART DRIVE TIMING MECHANISM ACCURATE? Yes No                |
| >                                                                     |
| > IF NO, EXPLAIN:\                                                    |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE RECORDER COMBINED WITH A STEAM CONTROLLER? Yes No            |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > THE TEMPERATURE SENSING BULB IS INSTALLED IN THE Retort Shell , or  |
| > External Well                                                       |
| >                                                                     |
| > *(THE TEMPERATURE-RECORDER BULB **[SHALL]{.underline}** BE          |
| > INSTALLED EITHER WITHIN THE RETORT SHELL OR IN A WELL\              |
| > ATTACHED TO THE SHELL.)*                                            |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DOES THE TEMPERATURE RECORDER BULB WELL HAVE A 1/16-IN. DIA. OR     |
| > LARGER BLEEDER THAT EMITS STEAM CONTINUOUSLY DURING THE PROCESSING  |
| > PERIOD? Yes No N/A                                                  |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENT)*                             |
| >                                                                     |
| > COMMENTS:                                                           |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IF A MUFFLER IS USED ON THE BLEEDER, DOES THE FIRM HAVE DOCUMENTED  |
| > EVIDENCE THAT IT DOES NOT BLOCK\                                    |
| > THE FLOW OF STEAM? Yes No N/A                                       |
| >                                                                     |
| > *(SHALL REQUIREMENT -- 113.87(g))*                                  |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **PRESSURE GAGE (113.40(a)(3))**                                      |
+-----------------------------------------------------------------------+
| > IF A PRESSURE GAGE IS PRESENT ON THE RETORT COOKER SHELL, IS IT     |
| > GRADUATED IN DIVISIONS OF 2 LBS. OR\                                |
| > LESS? Yes No                                                        |
| >                                                                     |
| > *(**[SHOULD]{.underline}** REQUIREMENT)*                            |
| >                                                                     |
| > IS THE PRESSURE COOLING SHELL EQUIPPED WITH A PRESSURE GAGE? Yes No |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IF THE COOKER SHELL IS CONNECTED BY TRANSFER VALVES TO A PRESSURE   |
| > COOLING SHELL, IS THE PRESSURE IN\                                  |
| > THE COOLER LESS THAN THE PRESSURE IN THE COOKER? Yes No             |
| >                                                                     |
| > *(THE PRESSURE IN THE PRESSURE COOLER SHOULD BE AT LEAST 2 PSIG     |
| > LESS THAN THE PRESSURE IN THE COOKER\                               |
| > TO PREVENT BACKFLOW OF COOLING WATER INTO THE COOKER.)*             |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **STEAM CONTROLLER (113.40(a)(4))**                                   |
+-----------------------------------------------------------------------+
| > IS THE STEAM CONTROLLER AUTOMATIC? Yes No                           |
| >                                                                     |
| > *(EACH RETORT **[SHALL]{.underline}** BE EQUIPPED WITH AN AUTOMATIC |
| > STEAM CONTROLLER TO MAINTAIN THE RETORT\                            |
| > TEMPERATURE.)*                                                      |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE STEAM CONTROLLER TEMPERATURE OR PRESSURE ACTUATED? Temp.     |
| > Press.                                                              |
| >                                                                     |
| > *(THE STEAM CONTROLLER MAY BE ACTUATED BY A TEMPERATURE SENSOR      |
| > POSITIONED NEAR THE MERCURY-IN-GLASS*                               |
| >                                                                     |
| > *THERMOMETER; A STEAM CONTROLLER ACTIVATED BY THE STEAM PRESSURE OF |
| > THE RETORT IS ACCEPTABLE IF IT IS*                                  |
| >                                                                     |
| > *CAREFULLY MAINTAINED SO IT OPERATES SATISFACTORILY.)*              |
+-----------------------------------------------------------------------+
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > REPORT THE **MANUFACTURER**, **MODEL**, **TYPE** AND **SIZE** OF    |
| > THE AUTOMATIC STEAM CONTROL VALVE:\                                 |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IF THE TEMPERATURE (STEAM) CONTROLLER IS AIR OPERATED, DOES THE     |
| > SYSTEM HAVE AN ADEQUATE FILTER TO\                                  |
| > ASSURE A SUPPLY OF CLEAN, DRY AIR? Yes No                           |
| >                                                                     |
| > *(AIR OPERATED TEMPERATURE CONTROLLERS **[SHOULD]{.underline}**     |
| > HAVE ADEQUATE FILTER SYSTEMS TO ASSURE A SUPPLY OF\                 |
| > CLEAN, DRY AIR 113.40(C)(2).)*                                      |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| > **BLEEDERS (113.40(c)(5))**                                         |
+-----------------------------------------------------------------------+
| > ARE BLEEDERS (EXCEPT THOSE FOR THERMOMETER WELLS) 1/8-INCH OR       |
| > LARGER IN DIAMETER? Yes No                                          |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENT)*                             |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > ARE THESE BLEEDERS LOCATED ALONG THE TOP OF THE RETORT NO MORE THAN |
| > 8 FT. APART AND WITHIN\                                             |
| > APPROXIMATELY 1 FT. OF THE OUTERMOST LOCATION OF CONTAINERS AT EACH |
| > END? Yes No                                                         |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENT)*                             |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > ARE THE BLEEDERS ARRANGED SO THE OPERATOR CAN OBSERVE THAT THEY ARE |
| > OPERATING PROPERLY?\                                                |
| > Yes No                                                              |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENT)*                             |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > ARE THE BLEEDERS WIDE OPEN DURING THE ENTIRE PROCESS INCLUDING THE  |
| > COME-UP TIME? Yes No                                                |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IF A MUFFLER IS USED ON BLEEDERS, DOES THE FIRM HAVE DOCUMENTED     |
| > EVIDENCE THAT IT DOES NOT RESTRICT\                                 |
| > FREE FLOW OF STEAM? Yes No N/A                                      |
| >                                                                     |
| > *(SHALL REQUIREMENT -- 113.87(G))*                                  |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| > **VENTING & CONDENSATE REMOVAL (113.40(c)(5&6))**                   |
+-----------------------------------------------------------------------+
| > IS THE RETORT VENTED TO REMOVE AIR PRIOR TO PROCESSING? Yes No      |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENT)*                             |
| >                                                                     |
| > NUMBER OF VENTS: [     ]{.underline} DIAMETER: [     ]{.underline}  |
| > LENGTH: [     ]{.underline}                                         |
| >                                                                     |
| > LOCATION:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > WHAT IS THE TYPE OF VENT VALVE? Gate Plug Cock Other                |
| >                                                                     |
| > IF OTHER, SPECIFY:\                                                 |
| >                                                                     |
+-----------------------------------------------------------------------+
| > ARE VENTS FULLY OPEN DURING VENTING? Yes No                         |
| >                                                                     |
| > IF NO, EXPLAIN:\                                                    |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DOES THE FIRM HAVE ON FILE DOCUMENTARY PROOF DEMONSTRATING THAT     |
| > ADEQUATE VENTING IS ACHIEVED?\                                      |
| > Yes No                                                              |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENT -- 113.40(c)(6); HEAT         |
| > DISTRIBUTION DATA AND/OR A LETTER FROM A COMPETENT PROCESS*         |
| >                                                                     |
| > *AUTHORITY DOCUMENTING THE LAST HEAT DISTRIBUTION TEST PERFORMED ON |
| > THE RETORT (DATE OF TEST, WHO*                                      |
| >                                                                     |
| > *PERFORMED THE TEST, THE RESULTING VENT SCHEDULE, ETC) WOULD BE     |
| > ACCEPTABLE DOCUMENTATION.)*                                         |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS A STEAM BY-PASS VALVE USED DURING VENTING? Yes No                |
| >                                                                     |
| > IF YES, EXPLAIN:\                                                   |
| >                                                                     |
+-----------------------------------------------------------------------+
| > *(NOTE: VENTING PROCEDURES AND ARRANGEMENTS MUST BE THE SAME AS     |
| > USED DURING THE TEMPERATURE\                                        |
| > DISTRIBUTION STUDY THAT WAS CONDUCTED ON THE RETORT TO ESTABLISH    |
| > THE VENT SCHEDULE.)*                                                |
+-----------------------------------------------------------------------+
| > IF VENTS ARE EQUIPPED WITH MUFFLERS, SPECIFY TYPE AND PERFORMANCE   |
| > CHARACTERISTICS. DOES THE FIRM\                                     |
| > HAVE DOCUMENTED EVIDENCE THAT THE MUFFLER ALLOWS ADEQUATE VENTING?  |
| > Yes No                                                              |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENT -- 113.87(G))*                |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > WHEN THE STEAM IS TURNED ON, IS THE DRAIN OPENED FOR A TIME         |
| > SUFFICIENT TO REMOVE STEAM CONDENSATE\                              |
| > FROM THE RETORT? Yes No                                             |
| >                                                                     |
| > *(**[SHOULD]{.underline}** REQUIREMENT)*                            |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > HAS PROVISION BEEN MADE FOR CONTINUAL OR AUTOMATIC DRAINAGE OF      |
| > CONDENSATE DURING RETORT OPERATION?                                 |
| >                                                                     |
| > Yes No                                                              |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENT; A CONDENSATE TRAP OR BLEEDER |
| > LOCATED AT THE BOTTOM OF THE RETORT WOULD BE*                       |
| >                                                                     |
| > *SUFFICIENT TO ASSURE CONTINUAL CONDENSATE REMOVAL.)*               |
| >                                                                     |
| > DESCRIBE THE PROCEDURES USED FOR CONDENSATE REMOVAL:\               |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE RETORT EQUIPPED WITH A CONDENSATE TRAP? Yes No               |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THERE A CONDENSATE BLEEDER IN THE BOTTOM OF THE RETORT SHELL     |
| > THAT SERVES AS AN INDICATOR OF                                      |
| >                                                                     |
| > CONTINUOUS CONDENSATE REMOVAL? Yes No                               |
+-----------------------------------------------------------------------+
| > IF SO, IS THIS BLEEDER VISIBLE TO THE RETORT OPERATOR? Yes No       |
| >                                                                     |
| > *(SHALL REQUIREMENT)*                                               |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DOES THIS CONDENSATE BLEEDER CONTINUOUSLY EMIT STEAM DURING THE     |
| > THERMAL PROCESS? Yes No                                             |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENT)*                             |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE CONDENSATE BLEEDER CHECKED WITH SUFFICIENT FREQUENCY DURING  |
| > RETORT OPERATION TO ASSURE\                                         |
| > ADEQUATE REMOVAL OF CONDENSATE? Yes No                              |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENT)*                             |
| >                                                                     |
| > ARE THESE OBSERVATIONS RECORDED AT THE TIME THEY ARE MADE? Yes No   |
| >                                                                     |
| > *(SHALL REQUIREMENT -- 113.100(a))*                                 |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IF THE CONDENSATE BLEEDER IS NOT VISIBLY MONITORED, IS IT EQUIPPED  |
| > WITH AN AUTOMATIC ALARM SYSTEM THAT\                                |
| > SERVES AS A CONTINUOUS MONITOR OF CONDENSATE FUNCTIONING? Yes No    |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENT)*                             |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IF AN AUTOMATIC ALARM IS USED TO MONITOR CONDENSATE FUNCTIONING,    |
| > DOES IT WORK ADEQUATELY?\                                           |
| > Yes No                                                              |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| > **RETORT SPEED TIMING (113.40(c)(7))**                              |
+-----------------------------------------------------------------------+
| > IS THE ROTATIONAL SPEED OF THE RETORT ADJUSTED AND RECORDED WHEN    |
| > THE RETORT IS STARTED, AT ANY TIME A\                               |
| > SPEED CHANGE IS MADE, AND AT INTERVALS OF SUFFICIENT FREQUENCY TO   |
| > ENSURE THAT THE RETORT SPEED IS\                                    |
| > MAINTAINED AS SPECIFIED IN THE SCHEDULED PROCESS? Yes No            |
| >                                                                     |
| > *(**SHALL** REQUIREMENT)*                                           |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > ARE THESE ADJUSTMENTS AND RECORDINGS MADE AT LEAST ONCE EVERY 4     |
| > HOURS? Yes No                                                       |
| >                                                                     |
| > *(**[SHOULD]{.underline}** REQUIREMENT)*                            |
| >                                                                     |
| > IF NO, HOW OFTEN?\                                                  |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IF ROTATIONAL SPEED ADJUSTMENTS AND RECORDINGS ARE NOT MADE AT      |
| > INTERVALS OF SUFFICIENT FREQUENCY,\                                 |
| > DOES THE FIRM HAVE A RECORDING TACHOMETER TO PROVIDE A CONTINUOUS   |
| > RECORD OF THE RETORT SPEED?\                                        |
| > Yes No                                                              |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DOES THE FIRM HAVE A MEANS OF PREVENTING UNAUTHORIZED SPEED CHANGES |
| > ON THE RETORT? Yes No                                               |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENT; A LOCK OR NOTICE FROM        |
| > MANAGEMENT POSTED AT OR NEAR THE SPEED ADJUSTMENT\                  |
| > DEVICE THAT PROVIDES A WARNING THAT ONLY AUTHORIZED PERSONS ARE     |
| > PERMITTED TO MAKE ADJUSTMENTS, IS A*                                |
| >                                                                     |
| > *SATISFACTORY MEANS OF PREVENTING UNAUTHORIZED CHANGES.)*           |
| >                                                                     |
| > Adjustment of the reel speed changes the process time and may       |
| > affect the agitation of the product. The reel speed calculated to   |
| >                                                                     |
| > provide the process time would be entered on the FDA 2541a          |
| > (Scheduled Process Filing Form) in Part D column titled "Reel       |
| > Speed" in                                                           |
| >                                                                     |
| > revolutions per minute (rpm). A minimum reel speed (slower than the |
| > reel speed providing adequate-processing time) may be               |
| >                                                                     |
| > determined during process establishment to provide for adequate     |
| > product agitation. This minimum reel speed should be entered on     |
| >                                                                     |
| > Form 2541a, Part D in the column titled "Other" along with an       |
| > explanation of "minimum reel speed". Minimum reel speeds for        |
| > agitation                                                           |
| >                                                                     |
| > may be less than the reel speed established for the process time.   |
| > Reel speeds greater than the established reel speed for process     |
| >                                                                     |
| > time will shorten the process time. Reel speeds slower than the     |
| > minimum reel speed for agitation, may not provide for adequate      |
| >                                                                     |
| > agitation of the product. In cases where a minimum reel speed for   |
| > agitation is not identified by the processing source, determine if  |
| >                                                                     |
| > agitation is critical to the process. Note some processes are       |
| > established without considering agitation. If agitation is critical |
| > to the                                                              |
| >                                                                     |
| > process, the firm should have information that identifies the       |
| > minimum rpm required to achieve adequate product agitation in the   |
| >                                                                     |
| > container. This reel speed may be the same as that established to   |
| > provide for process time.                                           |
| >                                                                     |
| > Reel speed and process time can be determined using the following   |
| > formulas. To use these formulas, known values can be entered        |
| >                                                                     |
| > into the formula to determine unknown values or to check the values |
| > supplied by the firm on the process filing form. The capacity of    |
| >                                                                     |
| > the retort is normally stamped on the end of the cooker reel shaft. |
| > The approximate number of reel steps for the FMC system for each    |
| >                                                                     |
| > container size is provided in the table below. Please be aware that |
| > some reels may be altered. In some cases, the firm may process a    |
| >                                                                     |
| > smaller can size in a reel designed for a larger container (e.g.    |
| > 300 in a 303 x 307 reel).                                           |
| >                                                                     |
| > *CONTAINER SIZE NUMBER OF STEPS PER TURN OF REEL*                   |
| >                                                                     |
| > 211 56                                                              |
| >                                                                     |
| > 300-303 47                                                          |
| >                                                                     |
| > 303-307 42                                                          |
| >                                                                     |
| > 401-404 35                                                          |
| >                                                                     |
| > 603 24                                                              |
| >                                                                     |
| > DETERMINE THE REEL SPEED BY TIMING 10 REVOLUTIONS OF                |
| >                                                                     |
| > THE RETORT REEL AND REPORT RESULTS (IN SECONDS):                    |
| > [     ]{.underline}                                                 |
|                                                                       |
| **. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
| . . . . . . . . . . . . . . . . . . . . . .**                         |
|                                                                       |
| > CALCULATE THE ACTUAL PROCESS TIME USING THE FORMULA:                |
| >                                                                     |
| > *SECONDS FOR 10 REVS = (10 RVS) X (60 SECS) X (REEL STEPS) X        |
| > (PROCESS TIME)/CAPACITY*                                            |
| >                                                                     |
| > ACTUAL PROCESS TIME = [     ]{.underline} MIN.                      |
|                                                                       |
| **. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
| . . . . . . . . . . . . . . . . . . . . . .**                         |
|                                                                       |
| > IS THE ACTUAL PROCESS TIME AT LEAST EQUAL TO THE MINIMUM PROCESS    |
| > TIME FILED WITH FDA Yes No                                          |
|                                                                       |
| **. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
| . . . . . . . . . . . . . . . . . . . . . .**                         |
|                                                                       |
| > CALCULATE THE PROCES SPEED IN CONTAINERS/MIN USING THE FORMULA:     |
| >                                                                     |
| > *CONTAINERS PER MINUTE = CAPACITY/PROCESS TIME (MIN)*               |
| >                                                                     |
| > CONTAINERS PER MINUTE = [     ]{.underline}                         |
|                                                                       |
| **. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
| . . . . . . . . . . . . . . . . . . . . .**                           |
|                                                                       |
| > CALCULATE THE REEL SPEED AS REVOLUTIONS PER MINUTE (RPM) USING THE  |
| > FORUMLA:                                                            |
| >                                                                     |
| > *RPM = CAPACITY/(REEL STEPS) X (PROCESS TIME)*                      |
| >                                                                     |
| > REEL SPEED (RPM) = [     ]{.underline}                              |
|                                                                       |
| **. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
| . . . . . . . . . . . . . . . . . . . . .**                           |
|                                                                       |
| > IS THE REEL SPEED CALCULATED ABOVE AS CONTAINERS PER MINUTE AND/OR  |
| > REVOLUTIONS PER MINUTE AT LEAST                                     |
| >                                                                     |
| > EQUAL TO THE MINIMUM REEL SPEED FILED WITH FDA? Yes No              |
| >                                                                     |
| > *(IF NO, THE LOT COULD BE UNDER PROCESSED AND SHOULD BE HANDLED AS  |
| > A PROCESS DEVIATION. )*                                             |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
| . . . . . . . . . . . . . . . . . . . . .**                           |
|                                                                       |
| > ALTERNATE FORMULAS WHICH CAN BE USED TO DETERMINE SECONDS FOR 10    |
| > REVOLUTIONS OF THE REEL:                                            |
| >                                                                     |
| > *(10 REV) X (60 SECS) X (#REEL STEPS)/(CPM)*                        |
| >                                                                     |
| > *(10 RVS) X (60 SEC)/RPM*                                           |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **EMERGENCY STOPS (113.40(c)(8)**                                     |
+-----------------------------------------------------------------------+
| > IF EMERGENCY STOPS ARE NOT OBSERVED DURING PROCESSING OR REVIEW OF  |
| > RECORDS, ANSWER THE FOLLOWING\                                      |
| > QUESTIONS BY REVIEW OF WRITTEN SOPS OR INTERVIEW WITH MANAGEMENT.   |
| > INDICATE HOW THIS INFORMATION WAS\                                  |
| > OBTAINED:                                                           |
| >                                                                     |
| > Processing Observation Review of Processing Records Review of Sops  |
| > Interview with Management                                           |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IN THE CASE OF A JAM OR BREAK DOWN DURING PROCESSING OPERATIONS     |
| > NECESSITATING COOLING THE RETORT, IS\                               |
| > THE RETORT OPERATED IN SUCH A WAY THAT ENSURES THAT THE PRODUCT IS  |
| > COMMERCIALLY STERILE?\                                              |
| > Yes No                                                              |
| >                                                                     |
| > *(THIS CAN BE ACHIEVED BY REPROCESSING OR REPACKING &               |
| > REPROCESSING.)*                                                     |
| >                                                                     |
| > IF NO, IS THE PRODUCT DESCARDED? Yes No                             |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENTS)*                            |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IF OPERATED AS A STILL RETORT, ARE ALL CONTAINERS GIVEN A FULL,     |
| > STILL RETORT PROCESS BEFORE THE RETORT\                             |
| > IS COOLED? Yes No N/A                                               |
| >                                                                     |
| > IF SO, IS THE STILL PROCESS SCHEDULE READILY AVAILABLE TO THE       |
| > RETORT OPERATOR? Yes No                                             |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENTS)*                            |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IF ANY CONTAINERS ARE IN THE RETORT INTAKE VALVE OR IN TRANSFER     |
| > VALVES BETWEEN COOKER SHELLS AT THE\                                |
| > TIME OF BREAKDOWN, ARE THE CONTAINERS REPROCESSED, REPACKED AND     |
| > REPROCESSED, OR DISCARDED?\                                         |
| > Yes No                                                              |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENT -- (113.40(c)(8)(i)*          |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS BOTH THE TIME AT WHICH THE REEL STOPPED AND THE TIME THE RETORT  |
| > WAS USED FOR A STILL RETORT PROCESS\                                |
| > MARKED ON THE RECORDING CHART AND ENTERED ON OTHER PRODUCTION       |
| > RECORDS? Yes No N/A                                                 |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENT -- (113.40(c)(8)(ii)*         |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IF THE RETORT IS COOLED FOLLOWING AN EMERGENCY STOP, ARE SUBSEQUENT |
| > HANDLING METHODS USED FOR\                                          |
| > CONTAINERS IN THE RETORT AT THE TIME OF STOPPING AND COOLING        |
| > ENTERED ON PRODUCTION RECORDS?\                                     |
| > Yes No N/A                                                          |
+-----------------------------------------------------------------------+
| > *(**[SHALL]{.underline}** REQUIREMENT -- (113.40(c)(8)(ii)*         |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DESCRIBE ANY INCIDENCES OF EMERGENCY STOPS THAT WERE NOT HANDLED    |
| > ACCORDING TO 113.40(c)(8):\                                         |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **TEMPERATURE DROPS (113.40(c)(9)**                                   |
+-----------------------------------------------------------------------+
| > IF TEMPERATURE DROPS ARE NOT OBSERVED DURING THE INSPECTION OR      |
| > REVIEW OF PROCESSING RECORDS,                                       |
| >                                                                     |
| > ANSWER THE FOLLOWING QUESTIONS BY REVIEW OF THE FIRM'S SOPS OR      |
| > INTERVIEW WITH MANAGEMENT. INDICATE                                 |
| >                                                                     |
| > HOW THIS INFORMATION WAS OBTAINED:                                  |
| >                                                                     |
| > Processing Observation Review of Processing Records Review of Sops  |
| > Interview with Management                                           |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IF THE TEMPERATURE OF THE RETORT DROPS BELOW THE TEMPERATURE        |
| > SPECIFIED IN THE SCHEDULED PROCESS\                                 |
| > WHILE CONTAINERS ARE IN THE RETORT, IS THE REEL STOPPED PROMPTLY?   |
| > Yes No                                                              |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENT)*                             |
| >                                                                     |
| > IF YES, IS AN AUTOMATIC DEVICE USED TO STOP THE REEL? Yes No        |
| >                                                                     |
| > *(**[SHOULD]{.underline}** REQUIREMENT)*                            |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > BEFORE THE RETORT IS RESTARTED, ARE ALL CONTAINERS IN THE RETORT    |
| > GIVEN A COMPLETE SCHEDULED STILL\                                   |
| > RETORT PROCESS IF THE TEMPERATURE DROP WAS 10°F OR MORE BELOW THE   |
| > SPECIFIED TEMPERATURE?\                                             |
| > Yes No N/A                                                          |
| >                                                                     |
| > IF YES, ARE BOTH THE TIME AT WHICH THE REEL STOPPED AND THE TIME    |
| > THE RETORT WAS USED FOR A STILL\                                    |
| > RETORTPROCESS MARKED ON THE RECORDING CHART AND OTHER PRODUCTION    |
| > RECORDS?\                                                           |
| > Yes No N/A                                                          |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENTS)*                            |
| >                                                                     |
| > ALTERNATIVELY, IF THE TEMPERATURE DROP IS 10°F OR MORE, IS          |
| > CONTAINER ENTRY TO THE RETORT STOPPED AND\                          |
| > THE REEL RESTARTED TO EMPTY THE RETORT? Yes No N/A                  |
| >                                                                     |
| > IF YES, ARE THE DISCHARGED CONTAINERS EITHER:                       |
| >                                                                     |
| > Reprocessed Repacked & Reprocessed , or Discarded ?                 |
| >                                                                     |
| > ARE SUBSEQUENT HANDLING METHODS USED FOR CONTAINERS IN THE RETORT   |
| > AT THE TIME OF THE TEMPERATURE\                                     |
| > DROP ENTERED ON PRODUCTION RECORDS? Yes No N/A                      |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENTS)*                            |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IF THE TEMPERATURE DROP IS LESS THAN 10°F, IS THE PRODUCT GIVEN AN  |
| > AUTHORIZED EMERGENCY STILL PROCESS\                                 |
| > BEFORE RESTARTING THE RETORT REEL? Yes No                           |
| >                                                                     |
| > IS CONTAINER ENTRY INTO THE RETORT STOPPED AND AN AUTHORIZED        |
| > EMERGENCY AGITATING PROCESS USED\                                   |
| > BEFORE CONTAINER ENTRY TO THE RETORT IS RESTARTED? Yes No           |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENTS)*                            |
+-----------------------------------------------------------------------+
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DURING AN EMERGENCY AGITATING PROCESS, ARE CONTAINERS PREVENTED     |
| > FROM ENTERING THE RETORT?\                                          |
| > Yes No N/A                                                          |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > WHEN EMERGENCY PROCEDURES ARE USED, ARE PROCESSES AND PROCEDURES    |
| > NOTED ON PRODUCTION RECORDS?\                                       |
| > Yes No N/A                                                          |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DESCRIBE ANY INCIDENCES OF TEMPERATURE DROPS THAT WERE NOT HANDLED  |
| > ACCORDING TO 113.40(C)(9):\                                         |
| >                                                                     |
+-----------------------------------------------------------------------+