purpose of purporting to evidence the U.S. grade of any processed product. (2) Wilful violation of the regulations in this subpart. Wilful violation of the provisions of this part of the Act. (3) Interfering with an inspector, inspector's aid, or licensed sampler. Any interference with, obstruction of, or attempted interference with, or attempted obstruction of any inspector, inspector's aide, or licensed sampler in the performance of his duties by intimidation, threat, assault, bribery, or any other means-real or imagined. [38 FR 25170, Sept. 12, 1973. Redesignated at 42 FR 32514, June 27, 1977 and at 46 FR 63203, Dec. 31, 1981] § 52.55 Political activity. All inspectors and licensed samplers are forbidden, during the period of their respective appointments or licenses, to take an active part in political management or in political campaigns. Political activities in city, county, State, or national elections, whether primary or regular, or in behalf of any party or candidate, or any measure to be voted upon, are prohibited. This applies to all appointees or licensees, including, but not limited to, temporary and cooperative employees and employees on leave of absence with or without pay. Wilful violation of this section will constitute grounds for dismissal in the case of appointees and revocation of licenses in the case of licensees. § 52.56 Purchase of commodity samples for review. Employees are authorized to purchase commodity samples for review. Employees must pay and obtain receipts for such purchases and keep receipts subject to inspection by supervisory or other authorized Department employees. [48 FR 12330, Mar. 24, 1983] $52.57 Compliance with other laws. None of the requirements in the regulations in this part shall excuse failure to comply with any Federal, State, county, or municipal laws applicable to the operation of food processing es tablishments and to processed food products. § 52.58 Identification. Each inspector and licensed sampler shall have in his possession at all times and present upon request, while on duty, the means of identification furnished by the Department to such person. § 52.59 OMB control numbers assigned pursuant to the Paperwork Reduction Act. The information collection requirements contained in this part have been approved by the Office of Management and Budget (OMB) under the provisions of 44 U.S.C. Chapter 35 and have been assigned OMB control no. 0581-0123. (44 U.S.C. Ch. 35) [49 FR 23826, June 8, 1984] REQUIREMENTS FOR PLANTS TO BE APPROVED AND FOR PLANTS USING CONTRACT IN-PLANT INSPECTION SERVICES 1 SOURCE: Sections 52.81 to 52.83 appear at 38 FR 25170, Sept. 12, 1973, unless otherwise noted. Redesignated at 42 FR 32514, June 27, 1977 and at 46 FR 63203, Dec. 31, 1981. § 52.81 Plant survey. Prior to a plant being approved, or the inauguration of in-plant inspection services, and at such intervals as may be deemed necessary or appropriate, the Administrator will make, or cause to be made, a survey and inspection of the plant where such inspection services are to be performed to determine whether the plant and methods of operation are suitable and adequate for the performance of such service in accordance with: (a) The regulations in this part, including, but not limited to, the requirements contained in §§ 52.81 through 52.83; and 1 Compliance with the above requirements does not excuse failure to comply with all applicable sanitary rules and regulations of city, county, State, Federal, or other agencies having jurisdiction over such plants and operations. (b) The terms and provisions of any contract pursuant to which the service is to be performed: Provided, That, such survey(s) shall be repeated at least yearly. § 52.82 Basis of survey and plant inspection. The plant survey and inspection will be based on the Regulations issued under the Federal Food, Drug, and Cosmetic Act-Human Foods; Good Manufacturing Practice (Sanitation) in Manufacture, Processing, Packing, or Holding (21 CFR Part 110)-as may be modified or augmented by the Federal Food and Drug Administration, U.S. Department of Health, Education, and Welfare or the Administrator of the Agricultural Marketing Service. (c) Provide a statistical procedure for determining compliance of a variable, which may be any measurable product characteristic, with a specified requirement. § 52.202 Options. These standards provide for three options, any one of which may be applied to determine compliance of a variable. These options are based on procedures employing the use of: (a) Conventional averages; (b) The median; or (c) Moving averages. § 52.203 Requirements for application. These standards are written in general terms to be applied to any variable. Therefore, in order to use these standards it will be necessary to predetermine: (a) The sampling allowance code; (3) Reject limits; and (4) Maximum range, when requested. DEFINITIONS § 52.204 Definitions. Statistical and inspection symbols and terms and their respective definitions which are pertinent to the understanding and application of these standards follow. (a) Symbols defined. LRL-The lower reject limit for individual measurements. The lowest value an individual measurement may have without causing the production to be rejected for failure to meet prescribed requirements for individual measurements. LRL-The lower reject limit for subgroup averages or medians. The lowest value the average or median of a subgroup may have without causing the production to be rejected for failure to meet prescribed requirements for subgroup averages. LWL-The lower warning limit for individual measurements. This value serves as a warning point that the production may have reached a level where the chances of subsequently finding an individual measurement that will fall below the LRL have increased to a degree that the production may be in danger of rejection. LWL-The lower warning limit for subgroup averages or medians. This value serves as a warning point that the quality of the production may have reached a level where the chances of subsequently finding a subgroup average or median that will fall below LRL, have increased to a degree that the production may be in danger of rejection. m-The number of subgroups in a sample. Mi-The median of all the individual measurements in a subgroup. Mi-The median of all the individual measurements or subgroup medians (Mi) in a sample. n-The total number of sample units or measurements in a sample. n=(m) (n.). n.-The number of sample units or measurements in a subgroup. R-A range of measurements, the difference between the highest measurement and lowest measurement within a subgroup. R-The average range of all the subgroup ranges. R-A specified average range value. Rmax-A specified maximum range for a subgroup. s-The standard deviation of the individual measurements. sx-The standard deviation of the averages. URL The upper reject limit for individual measurements. The highest value an individual measurement may have without causing the production to be rejected for failure to meet prescribed requirements for individual measurements. URL-The upper reject limit for subgroup averages or medians. The highest value the average or median of a subgroup may have without causing the production to be rejected for failure to meet prescribed requirements for subgroup averages. UWL-The upper warning limit for individual measurements. This value serves as a warning point that the quality of the production may have reached a level where the chances of individual subsequently finding an measurement that will exceed the URL have increased to a degree that the production may be in danger of rejection. UWL-The upper warning limit for subgroup averages or medians. This value serves as a warning point that the quality of production may have reached a level where the chances of subsequently finding a subgroup average or median that will exceed the URL-have increased to a degree that the production may be in danger of rejection. X-The value of an individual measurement for a variable. X-The average of all individual measurements in a subgroup. X' 'max-A specified maximum lot average value. max X adjusted-X'max plus a sampling allowance. X'min-A specified minimum lot average value. X', 'min adjusted X'min minus a sampling allowance. X-The arithmetic mean of all the individual measurements in a sample. When the average is calculated for each subgroup in a sample for conventional averages, X is also the average of the subgroup averages. (b) Terms defined. Average. The arithmetic mean of two or more values; the sum of all measurements divided by the number of measurements. Median. The median is the middle value with respect to magnitude of all the individual measurements when the number of individual measurements is odd. When the number of individual measurements is even and arranged according to magnitude, the median is the arithmetic mean of the two middle values. Moving average. A scheme under which a series of consecutive measurements are made until such number equals the subgroup size; the average is then determined and recorded; as new data is collected from continuing production, the first measurement of the subgroup is dropped, the next new value is added, and a new average is calculated; this process of adding new measurements, dropping the oldest measurement in the subgroup, and cal culating the average on the new data is continued throughout the production. Example: X1=(5+7+3)/3=5.00 X2 (7+3+4)/3=4.67 X=(3+4+6)/3=4.33 Moving range. The difference between the highest measurement and lowest measurement within a subgroup from which a moving average is obtained. One-sided specification. A specification with rejection limits applicable to only one side of the specified lot average. When only lower reject limits apply, the term "low-sided specification" may be used. When only upper reject limits apply, the term "highsided specification" may be used. Two-sided specification. A specification with both upper and lower rejection limits applicable. Sample. Any number of sample units to be used for inspection of a lot. Sample unit. A container, the entire contents of a container, a portion of the contents of a container, a composite mixture of a product, or any other unit of container or commodity to be used for inspection. Sampling allowance. The amount that the sample quality may deviate from the lot quality due solely to the fact that only a portion has been taken from the whole lot. Subgroup. Generally a small group of sample units representing a portion of a sample. The term "subgroup" is synonymous with the term "sample" when the sample contains only one subgroup. Variable. Any measurable product characteristic. [38 FR 10447, Apr. 27, 1973; 38 FR 12729, May 15, 1973. Redesignated at 42 FR 32514, June 27, 1977 and at 46 FR 63203, Dec. 31, 1981] certain numerical values are recorded in the form of plottings. It is desirable to use both forms. The control chart may be incorporated on the same sheet with the X and R data sheet. However, one of these forms may be used in lieu of both as desired at the option of the packer. (b) X and R data sheets. A separate data sheet shall be maintained for each item. When a single item is simultaneously produced on more than one processing line, it is desirable to maintain one data sheet for the item. In such instances, the processing line designation shall be recorded with the corresponding data. The X and R data sheets shall provide for recording the following information: (1) The time a sample unit or subgroup has been drawn; (2) The X values; (3) The total values of all the X values in the subgroups when conventional averages are used; (4) The values for Mi, R, R, Mi, X, and X. (c) X and R control charts. Control charts consist of an X chart and may consist of an R chart. When both are used they are contained on the same sheet with the limits for the X chart on the top portion and the limits for the R chart on the lower portion with a space separating the two such that plottings from one does not overlap those of the other. Separate control charts shall be maintained for each item. More than one day's production of an item may be plotted on a single control chart. (1) X charts. (i) The X charts for two-sided specifications shall consist of lines and values properly representing both the upper and lower reject and warning limit(s), and may require the use of minimum and maximum specification lot averages. (ii) The X chart for one-sided specifications shall consist of lines and values properly representing, as applicable, the upper or lower reject and warning limit(s), and the minimum or maximum specification lot average. (2) R charts. When the R chart is used, it shall consist of lines and values properly representing R', Rmax' and the lower limit for R. For subgroup sizes of 6 or less the value of the lower limit for R will always be zero. [38 FR 10447, Apr. 27, 1973; 38 FR 12729, May 15, 1973. Redesignated at 42 FR 32514, June 27, 1977 and at 46 FR 63203, Dec. 31, 1981] PROCEDURE § 52.206 Sampling. (a) General. In order to obtain the most reliable results, sampling should be performed at a point where no further change in the variable can occur. Sample units or subgroups shall be drawn separately for each code, container size, and style. (b) Subgroup sampling. Sampling by subgroups consists of drawing more than one sample unit at approximately the same time. This type of sampling is required in the use of the conventional X and R determinations for variables. When a single code is processed on more than one line sumultaneously, it is desirable to obtain a subgroup representing a single line, alternating the lines each time a subgroup is drawn for that code. If the processing procedure prohibits obtaining a subgroup representing a single line, it shall be necessary to sample by code only, omitting line identity. Each subgroup thus obtained will generally represent more than one line and consequently reflect variations in the code as a whole but not variations for a single line. (c) Sample unit sampling. This procedure consists of drawing a single sample unit at random at specified intervals from a production. This type of sampling may employ the use of a moving average and is applicable to a variable or a process when subgroup sampling is not feasible. § 52.207 Measurements, calculations, and recording data. (a) General. Immediately after the sample unit or subgroup has been taken, measurements and calculations shall be made and recorded on the appropriate form as required. (b) Recording data on the X and R data sheet. The data to be recorded on the X and R data sheet is as follows: (1) The time the sample unit or subgroup is taken; (2) The value for each individual measurement (X value); (3) The total value for all the X values in the subgroup, when applicable; (4) The average value (X) for each subgroup, when applicable; (5) The Mi value for each subgroup, when applicable; (6) The range value (R) for each subgroup, when applicable; (7) The sample median value (Mi) when the median is used; (8) The sample average value (X) when required; and (9) The average range value (R) when applicable. (c) Recording data on the X and R control chart. The data to be recorded on the X and R control chart is as follows: (1) Individual measurements (X values). The values representing the individual measurements of each subgroup (X value) shall be plotted on the X chart. The distance between the smallest and largest value of the individual measurements in the subgroup may be used for R in lieu of plotting the range on the R chart. It is desirable to plot all the values for a subgroup on the same linear segment of the chart. Identical values are plotted adjacently in such a manner as to associate such values with the subgroup in which they occur. (2) The median. When the median option is used, the median for each subgroup shall be identified on the X chart in such a manner as to make it readily distinguishable from the rest of the value in the subgroup. When a subgroup consists of an even number of individual measurements, the median represented by the arithmetic mean of the two middle values shall also be plotted on the X chart in such a manner as to associate it with the subgroup from which it was calculated. When the median option is used for a particular production, it is not permissible to change to the option for conventional averages during the same shift. |