STATISTICAL QUALITY CONTROL Flashcards
The MONITORING OF QUALITY by application of statistical methods in all stages of production.
STATISTICAL QUALITY CONTROL
refers to CHARACTERISTICS OF A PRODUCT from both a qualitative and quantitative point of view.
It refers to the QUALITY OF THE PROCESS as well as the PRODUCT ITSELF.
QUALITY
implies a PROCEDURE by which DECISIONS MAY BE MADE regarding whether production is proceeding according to plan and meeting established standards.
CONTROL
a COLLECTION OF DATA AND NUMBERS, and with the use of mathematics, can ANALYZE AND INTERPRET these DATA for the purpose of making meaningful decisions.
STATISTICS
a field of study concerned with:
1. The collection, organization and summarization of data.
2. The drawing of references about a body of data when only a part of the data is observed.
STATISTICS
Statistical methods involves
LONG PERIOD OF TIME
________ are so COMPLICATED that they cannot be understood or performed by ordinary production and inspection employees
METHODS
_______ monitoring by the production operator is conducted during a production run with MINIMUM SUPERVISION.
IN-PROCESS
_______ are USEFUL only when one is aware that A PROBLEM NEEDS CORRECTION.
TECHNIQUES
The use of _______ is stated in the standard operating procedures (SOP) as a MANDATORY ROUTINE TECHNIQUES as a visual tool that the process is in control.
SQC
The use of SQC is stated in the ___________________ as a mandatory routine techniques as a VISUAL TOOL that the PROCESS IS IN CONTROL.
STANDARD OPERATING PROCEDURES (SOP)
The effective use of the techniques of SQC is applicable only to how many department
ONE
how many basic Quality Control Charts are based on the MEASURABILITY OF THE QUALITY characteristics.
2
This is a chart which makes use of DISCRETE DATA classifying the number of items conforming and the number of items failing TO CONFORM TO ANY SPECIFIED REQUIREMENTS.
ATTRIBUTE CHART (P-chart / Fraction Defective Chart)
This a chart using actual records of NUMERICAL MEASUREMENTS on a full continuous scale such as meter, grams, or liter.
VARIABLE CHART (R-chart & 8)
Involves the AIM or OBJECTOF THE EXPERIMENT.
PLAN OF DESIGN OF THE EXPERIMENT
may be defined as the PROCESS OF REMOVING an appropriate no. of items from a bulk in order to make inferences (logical conclusions) to the entire bulk.
SAMPLING
The _________ must be EMPOWERED to sample at any point or stage of manufacturing and packaging operations.
QUALITY CONTROL INSPECTOR
The _________ must be EMPOWERED to sample at any point or stage of manufacturing and packaging operations.
QUALITY CONTROL INSPECTOR
sampling plan formula
square root of N + 1
known as MILITARY STANDARD – 105 D originated by a committee from military agencies of the USA, Great Britain and Canada.
GOVERNMENT SAMPLING PLAN
The most COMMON AND DISTINCT methods of inspection / testing are based on _____
single or double sampling
In _________, ONLY THE SPECIFIED SAMPLE SIZE is inspected and tested before a decision on the disposition of the batch is made.
SINGLE
In _________, a second sample for inspection / testing is permitted if the FIRST FAILS, but the observed no. of defective will apply to the two samples combined.
DOUBLE SAMPLING
rejected if it contains 4% or more defective tablets
UNACCEPTABLE QUALITY LEVEL (UQL)
if it contains 2% or less defective tablets
ACCEPTABLE QUALITY LEVEL (AQL)
is the RISK OF ERROR on the probability of REJECTING A GOOD BATCH
PRODUCER’S RISK
is the risk of error on the probability of ACCEPTING A DEFECTIVE BATCH
CONSUMER’S RISK
A _______ is one that has been shown by appropriate scientific means to be UNIFORM, within a lot, consistent within lots, and meeting designed criteria WITHIN DEFINED LIMITS.
VALIDATED PRODUCT
samplings are taken with a sample size AS SMALL AS ONE UNIT.
HOMOGENEOUS DOSAGE FORMS
employed for various pharmaceutical operations and may be used as an aid in controlling and analyzing physical, chemical, analytical and biological parameters
CONTROL CHART
_____ chart is one in which several samples are tested and distribution of measurements can, in a sense, measure DEGREES OF DEFECTIVENESS.
VARIABLE
______ chart is one in which each sample inspected is tested to determine whether it CONFORMS TO REQUIREMENTS. It is the so-called “go” or “no-go” situation
ATTRIBUTE
______ charts are more sensitive than _______ chart
VARIABLE, ATTRIBUTE
sampling used in CONTROL CHART BY ATTRIBUTES
RANDOM SAMPLING
the RATIO of the number of DEFECTIVENESS found to the total number of units actually inspected in the batch
FRACTION DEFECTIVE
the ARITHMETIC AVERAGE of a series of values and is calculated by dividing the sum of such values by the no. of values (N) in the series
MEAN / AVERAGE
simplest measure of variation
RANGE
the DIFFERENCE between the HIGHEST and LOWEST VALUE in a series of observations.
RANGE
The measure of variation most commonly used
STANDARD DEVIATION
can be described as being concerned w/ the composition of matter & the changes it undergoes.
CHEMISTRY
is mostly concerned w/ the study of compounds containing the element CARBON.
ORGANIC CHEMISTRY
is the study of ALL elements & compounds other than organic compounds.
INORGANIC CHEMISTRY
is the study of the chemistry of BIOLOGICAL PROCESSES, such as the utilization of foods (carbohydrates, proteins & fats) that produce energy & the synthesis of biologically active compounds in living organisms.
BIOCHEMISTRY
is the study of:
reaction rates – how fast will a reaction go?
mechanisms – what path does a reaction take to get to the
products?
bonding & structure of compounds – how are compounds
formed, & what are their shapes?
thermodynamics – what makes a reaction go & what is the total
energy relationship of a reaction?
PHYSICAL CHEMISTRY
is the study of:
reaction rates – how fast will a reaction go?
mechanisms – what path does a reaction take to get to the
products?
bonding & structure of compounds – how are compounds
formed, & what are their shapes?
thermodynamics – what makes a reaction go & what is the total
energy relationship of a reaction?
PHYSICAL CHEMISTRY
is the study of QUALITATIVE (what is present?) & QUANTITATIVE (how much is present?) analysis (examination) of elements & compounds.
ANALYTICAL CHEMISTRY
