SS2 - SAMPLING SCHEDULE FOR CANNED AND ACIDIFIED FOODS

I. Canned Foods

1. Field Examination
   1. Routinely examine warehouse stock for evidence of leaking cans, wet cases, swollen cans, swarms of fruit flies around isolated pallets, etc.
   2. When the inspectional evidence indicates the probability of under processed lots, or lots with excessive defective units, conduct a visual examination of warehouse stock. Give preference to the examination of the lot that was processed incorrectly. However, any lot produced using the process, and preferably warehoused at least 14 days, should be examined.
   3. A lot to be examined will be one production code.
   4. Each field examination will consist of a maximum of 576 containers. However, a minimum of 192 containers may be examined if 3 or more abnormal containers are found.
      1. Flippers. Only one end is slack or slightly bulged and the end remains flat if pressed in. Cans which bulge when sharply and squarely struck end-down on a flat surface are flippers, provided that the bulged end remains flat when pressed. Flippers result from a lack of vacuum.
      2. Springers. One end of a can bulges. Manual pressure on the bulged end forces the opposite and out or the same end will spring out with release of pressure. If both ends bulge, but only one will remain flat when pressed, the can is a springer. Springers result from moderate positive pressure in the can. Buckling or extensive denting of the side wall may produce a springer.
      3. Swells. Both ends of the can are bulged. Neither end will remain flat without pressure. Soft swells yield to manual pressure, but no impression can
         be made manually on hard swells. Swells result from positive pressure in the can usually because of spoilage of the contents. Some swells, especially in acid products, may result from chemical reaction between the contents and the container. NOTE: Other abnormalities or defects, should be reported on C/R, but not counted as "abnormal containers" for the purposes of the sequential field examination. These other defects include visibly leaking cans, severe dents around seams, gross seam defects, severely rusted containers, etc.
   5. Follow the chart on the next page for the field examination.
   6. Unless the inspectional evidence of improper processing or non-compliance with the GMP's can be related to specific production lots, conduct no field examinations during the inspection. However, if inspectional evidence or other examination results indicate problems, conduct field examinations using the large chart on the next page for guidance.
2. Sample Size
   1. Investigational
      1. Samples for laboratory examination will consist of all abnormal and 12 normal containers. The sample will include as many abnormal containers as were found during your field exam(e.g., if 21 abnormal containers are observed during the examination, the sample will consist of 21 abnormal and 12 normal containers). Do not collect leakers, but report the number noted.
         It may be necessary to collect samples of any other defects noted such as seam defects to support observations and document the severity of the defects. In some cases, photographs may be a suitable substitute for collection of physical subsamples.
      2. Report the results of the field examination in the EIR and as a Field Exam in FACTS. If a sample is collected, on the C/R. Identify, by sub-sample number, the condition of each container in the sample (e.g., sub-sample 1 - flipper; sub-sample 2 - hard swell; --------sub-sample x - normal).
         

         UNCASED CONTAINERS		PACKED 48/CASE		PACKED 24/CASE		PACKED 12/CASE		PACKED 6/CASE
         LOT SZ CONTAIN.	NO. TO EXAMINE	LOT SIZE (CASES)	CASES TO EXAMINE	LOTSIZE (CASES)	CASES TO EXAMINE	LOTSIZE (CASES)	CASES TO EXAMINE	LOT SIZE (CASES)	CASES TO EXAMINE	NUMBER ABNORMAL CONTAINERS TO DISCONTINUE EXAMINATION EARLY*
         192 or less	all	1 - 4	all	1 - 8	all	1 - 16	all	1 - 32	all	3
         193 - 288	192	4 - 6	4	8 - 12	8	16 - 24	16	32 - 48	32	5
         289 - 384	all - 298	6 - 8	6	12 - 16	12	24 - 32	25	48 - 64	all - 50	6
         385 - 576	363	8 - 12	8	16 -24	15	32 - 48	30	64 - 96	61	7
         577 - 912	433	12 - 19	9	24 - 38	18	48 - 76	36	96 - 152	72	8
         913 - 1488	480	19 -31	10	38 - 62	20	76 - 124	40	152 - 248	80	9
         1489 - 3408	529	31 - 71	11	62 - 142	22	124 - 284	44	248 - 568	88	10
         3409 or more	576	71 or more	12	142 or more	24	284 or more	48	568 or more	96	11

         *For a given lot size, when the specified number of abnormal containers is found, discontinue the examination and collect the abnormals ONE NORMAL CONTAINER TAKEN FROM EACH OF 12 CASES. Open additional cases, if necessary, to meet this requirement. When the maximum number of containers/cases have been examined, always collect a sample as directed above, if one or more abnormal containers have been found. IT IS ABSOLUTELY NECESSARY TO INCLUDE ON THE COLLECTION REPORT THE LOT SIZE, THE NUMBER CONTAINERS EXAMINED, AND THE NUMBER OF ABNORMAL CONTAINERS FOUND BY TYPE (E.G., HARD SWELLS)
   2. Official

      NOTE: Products in 55 gallon drums, or similar large containers, either aseptically filled or heat processed should not be sampled while the shipment is enroute unless the owner accepts responsibility for the portion remaining in the opened containers. Arrange sampling of these products at the consignee (user) so the remaining portion can be immediately used or stored under refrigeration. Always use ASEPTIC TECHNIQUE when sampling these types of products. A lot is defined as one production code.

      1. Filth, Micro, etc. (Includes 702(b) [21U.S.C.372(b)] portion)

         Collect each subdivision to duplicate from a separate case, if possible. Mark subs 1a, 1b, 2a, 2b, etc. Collect as follows:

         	Size of Lot	Min total cans	Cans/case
         906 gm (2 lbs.) Net weight and smaller	Up to 50 cases	48	2 from 24
         	More than 50 cases	96	2 from 48
         Over 906 gm (2 lbs)	Up to 600 cases	48	2 from 24
         	More than 600 cases	72	2 from 36

      2. Standards Assay (Includes 702(b) portion)

         NOTE: Sample sizes listed below are based upon the requirements of the Standards (21 CFR 145.3)When sampling products, which are likely to be non-uniform throughout the lot because of variations from standards of quality, identity, fill-of-container, grade, etc., collect each subdivision in the triplicate from a separate case. Mark subs 1a, 1b, 1c, 2a, 2b, 2c, etc. Collect as follows:

         	Number of cans or packages	Min total cans	Cans/case
         1 kg (2.2 lbs) Net weight or less	4800 or less	48	3 from 16
         	4801 to 24,000	72	3 from 24
         	24,001 to 48,000	96	3 from 32
         	48,001 to 84,000	144	3 from 48
         	84,001 to 144,000	264	3 from 88
         	144,001 to 240,000	384	3 from 128
         	Over 240,000	600	3 from 200
         Greater than 1 kg (2.2lbs), but less than 4.5 kg (10 lbs.)	2400 or less	48	3 from 16
         	2401 to 15000	72	3 from 24
         	15001 to 24000	96	3 from 32
         	24001 to 42000	144	3 from 48
         	42001 to 72000	252	3 from 88
         	72001 to 120,000	384	3 from 128
         	Over 120,000	600	3 from 200
         Greater than 4.5 kg (10 lbs)	600 or less	48	3 from 16
         	601 to 2000	72	3 from 24
         	2001 to 7200	96	3 from 32
         	7201 to 15000	144	3 from 48
         	15001 to 24000	252	3 from 88
         	24001 to 42000	384	3 from 128
         	Over 42000	600	3 from 200

   3. Acidified(Metal or Glass)

      A lot is defined as one production code.

      Samples must be collected randomly from the entire lot. Sample size does not include 702(b) portion .

      # 10 size containers - Randomly select 1 normal container from each of 12 randomly selected cases (if available) in the lot.

      # 2 and smaller - Randomly select 2 normal containers from each of 12 randomly selected cases (if available) in the lot. Sample size is 24 containers.

      For acidified products, the equilibrium pH determines whether the product will support organisms of public health significance. Spoilage in such products is usually due to inadequate heat treatment to kill spoilage organisms. When abnormal containers of acidified products are found during domestic plant inspections, the Investigator should determine the cause of spoilage through inspectional observations and/or record review. It will not ordinarily be necessary to collect samples of abnormal containers of domestic acidified products, unless the reason for the abnormality has potential health hazard significance; the reason cannot be determined; or , the lot contains 1% or more abnormal containers and is intended for shipment or has already been partially shipped. However, since inspectional follow-up is not practical for imported acidified products, always collect abnormal containers to serve as a basis for determining progressive decomposition or product adulteration.

      When collection of abnormal containers is indicated, conduct an examination following the sequential plan provided for canned foods. Collect all abnormal containers (up to a maximum of 24) in addition to the normal containers collected for pH determination. Indicate on the C/R the total number of containers examined and the number of each type of abnormality and defect observed. Also indicate the estimated percentage of abnormal containers in the lot.