Study Set Content:
The steps involved in developing a sampling plan are:
- Identify the parameters to be measured, the range of possible values, and the required resolution
- Design a sampling scheme that details how and when samples will be taken
- Select sample sizes
- Design data storage formats
- Assign roles and responsibilities
which represents the lot or batch from which the sample will be taken or withdrawn
N
- represents the random sample size drawn from a lot or a batch.
n
- represents the criteria value or acceptance number.
c
- type of sampling method in which the decision is obtained based after conducting a single sampling procedure
Single sampling plan
- The procedure is to take a random sample of size (n) and inspect each item. If the number of defects does not exceed a specified acceptance number (c), the consumer accepts the entire lot.
Single sampling plan
type of sampling method in which decisions can only be made after a second sampling procedure
Double sampling Plan
- specifies two sample sizes and two acceptance numbers
Double sampling Plan
- consumer randomly selects items from the lot and inspects them one by one
- Each time an item is inspected, a decision is made to (1) reject the lot (2) accept the lot, or (3) continue sampling, based on the cumulative results
- Sequential-Sampling Plan
to determine the number of units to inspect. Each unit is tested individually. The lot on zero defectives is accepted, or, in the case of continuous measurements, the lot is accepted if the average falls within given specifications.
- Square root sampling plan
process of establishing and securing documented evidence that will provide high degree of assurance that a certain specific procedure, process or protocol will persistently produce an end product that meets the pre determined specifications, standards and quality attributes
Validation
are made to ensure the accuracy, specificity, reproducibility and ruggednes comparable to given specified range that the example or analyte will be analyzed
Validation methods
closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value, and the value found
Accuracy
expresses the closeness of agreement (degree of scatter) between a series of measurements obtained from multiple sampling of the homogeneous sample under the prescribed conditions.
Precision
is the ability to assess unequivocally the target pathogen or analyte in the presence of components which might be expected to be present
Specificity
is the reproducibility of the assay under a variety of normal, but variable, test conditions.
- different machines, operators, and reagent
Ruggedness
measure of the assay capacity to remain unaffected by small but deliberate changes in test conditions
Robustness
lowest and highest concentrations of an analyte in a sample that can be quantitatively determined with suitable precision and accuracy
Limits of Quantation
lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value.
Limit of Detection
ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of analyte in the sample
Linearity
