Statistical Evaluation of QC Charts During Manufacturing

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    CONCEPT OF STATISTICAL QUALITY

    CONRTOL

    f Statistical Quality Control ( SQC ) has been defined as,

    monitoring of quality by application of statistical methods in all stages of production.

    f Functions of SQC

    f 1. A basis for improved evaluation of materials through more representative

    sampling techniques.

    f 2. As a means of achieving sharper control in certain manufacturing processes.

    f The use of SQC permits the evaluation of the magnitude of,

    f 1. Chance variation

    f 2. Assignable variation

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    TERMS WE NEED TO KNOW

    f 1. Mean

    f It is the arithmetic average of a series of values.

    f Formula :

    f 2. Standard Deviation

    f It is an unbiased estimate of the standard deviation of the population.

    f Formula :

    f 3. Range

    f It is the difference between the maximum and the minimum value.

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    TERMS WE NEED TO KNOW

    f 4. Normal Frequency Distribution

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    TERMS WE NEED TO KNOWf Normal Frequency Distribution

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    QUALITY CONTROL CHARTS

    f Used as aids in

    f Controlling and analysing physical, chemical, analytic and biologic parameters of a

    product, such as,

    f 1. Weight variation of tablets and capsules

    f

    2. Thickness of tabletsf 3. Volume of liquid filling in a container

    f 4. No. of defects in parenteral products

    f Highlighting trends for intra- and inter- batch variation.

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    TYPES OF QUALITY CONTROL CHARTS

    f 1. Charts based on variables

    f They are based on continuous distribution of measurements that can measure

    degrees of un-acceptibility

    f 2. Charts based on attributes

    f They refer to go or no-go situations in which each sample inspected is tested todetermine whether it conforms to the requirements.

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    CONTROL CHARTS BY VARIABLESf Example

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    CONTROL CHARTS BY VARIABLE

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    CONTROL CHARTS BY VARIABLE

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    CONTROL CHARTS BY ATTRIBUTES

    f The plan to employ these charts include following steps,

    f 1. Sample should be chosen at random

    f 2. For easier evaluation there should be a fix no. of sample ( n ) taken each time for

    inspection

    f 3. Each sample is evaluated so that the sample is accepted or rejectedf 4. Each sample must be independent i.e., each tablet or ampule has nothing to do

    with another tablet or ampule

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    CONTROL CHARTS BY ATTRIBUTESf Different terms are used for constructing these charts,

    f 1. No. inspected , n

    f 2. No. defective, d

    f 3. Fraction defective, p

    f Formula:

    f 4. Average fraction defective,

    f 5. Upper and lower control limits,

    f Formula:

    f 6. 3 Standard deviation,

    f Formula:

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    CONTROL CHARTS BY ATTRIBUTES

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