quality planning and analysis-inspection, test and measurement

1. INSPECTION , TEST AND
MEASUREMENT
PRESENTED BY: TANVI KUMBHAR
F.Y.M.PHARM ( QAT ) , SEM 2,
ROLL NO: 526
GUIDE : DR. SONALI MAHAPARALE ,
HOD CHEMISTRY,
DR.D.Y.PATIL COLLEGE OF PHARMACY. 1

2. CONTENTS
 Definitions of inspection and test.
 Seriousness classification.
 Automated inspection.
 How much inspection is necessary.
 Inspection accuracy.
 Errors of measurement.
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3. INSPECTION AND TEST
INSPECTION :
Measurement of output and comparison to specified requirements to determine
CONFORMITY.
TEST :
Involves the comparison to standard and evaluation , diagnosing problems and
making adjustments.
These both processes involves distinguishing between good and bad product,
determine if process is changing , measuring process capability , rating product
quality , measuring instrument precision. 3

4. SERIOUSNESS CLASSIFICATION
• Quality characteristics are decided on their effect on fitness for use.
• Some have Serious i.e. critical importance and many are of minor importance.
In matters such as extent of quality planning , precision of processes , tooling and
instruments, sizes of samples, strictness of criteria for conformance, specification
writing, supplier relations , product audits
More important the
characteristics
Greater the attention it gets
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5. • This classification states that the system must be prepared by the interdepartmental
committee.
1st step
How many
classes or strata
of seriousness to
create.
2nd step
Define each
class
3rd step
Classify each
into its proper
class of
seriousness.
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6. A. Strata of seriousness :
There are basically 2 lists need to be classified.
I. List of quality CHARACTERISTICS derived from specifications.
II. List of DEFECTS i.e. symptoms of nonconformance during manufacture.
These two lists do not behave alike. For eg: the mixing time in tablet formulations
1. Mixing.
2. Demixing.
B. Define each class :
Study of such numerous systems reveals an inner pattern that is useful to any
committee faced with applying concept to its own.
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7. C. Classfication :
 It is a long and tedious but essential task.
 This process if not followed properly leads to many misconceptions and confusions
among the departments which leads to vagueness.
 Hence the designers should also be involved in classification process.
WHO CLASSIFY ?
• An interdepartmental committee is the ideal choice. This provides each
department with the benefits derived from the process, also produces a better final
result.
• some companies assign a staff specialist to prepare a classification, which is then
reviewed by all interested departments. The specialist is usually a quality control
engineer.
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8. AUTOMATED INSPECTION
Widely used to :
I. Reduce inspection.
II. Reduce cost.
III. Reduce error rates.
IV. Shorten inspection time.
V. Avoid inspector monotony.
The techniques used in automatic inspection involves :
• Mechanical gauging.
• Electronic testing.
• Chemical analysis.
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9. • Color discrimination.
• Visual inspection.
 In addition with scheduled maintenance programs for equipment.
 Automatic inspection of nonmanufacturing activities has range of
activities from checking the spelling to checking of bank transactions
for errors. 9

10. Procedure for preparation of automated inspection :
Identification
of the tests to
be performed
• 1st step
Calculate the
economics
needed.
• 2nd step
Trials are
performed to
be ensured .
• 3rd step
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11. • As experienced gained, the concept is extended further and further.
• The newer variation in automated inspection is MACHINE VISION , where
electronic eye inspect and guide an array of industrial processes.
• It involves different operations like :
a. Steering robots to place the cartons at desired place.
b. Inspecting the leaking of ampoules ( HVLD system ).
c. Static division method for ampoule testing.
d. Checking of the details on packaging etc.
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12. At the end –
 Technologically, the “machine” poses many problems. It is less adaptable than the
human being , so some changes may need to be made in the product to offset this
rigidity.
• Specification data stored in the computer’s database are compared to
measurements provided by the measurement sensors to warn the operator when an
adjustment is needed and , in some cases, make the adjustment automatically.
Products
automatically
undergo multi
characteristic checks.
Computer tells
operator whether to
accept or reject
Updates the quality
process statistics.
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13. This new control technology, with its programmable logic, have advantages
over.
 simplifies the operator’s task.
 Reduces the degree of nonconformance at the source .
 Provides information for the inspector.
 Reducing the volume of inspections necessary.
 Makes the inspector function much more reliable.
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14. INSPECTION ACCURACY
• Inspection accuracy depends on:
• High error rates in inspection are due to high degree of MONOTONY.
• Monotony causes an inspector to miss defects that can build up in a short time.
E.g. Hygroscopic substance .
Completeness
of inspection
planning.
1st
Bias and
precision of
instrument.
2nd
Level of
human
errors.
3rd
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15. • When monotonous inspection – detection of only 80-90% defects , remaining are
missed.
• Hence 100% monotonous inspection – is not effective in detecting effects.
• Therefore advantage of automatic inspection is elimination of human errors.
Technique error
Inadvertent
error
Conscious error
Communication
error
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16. • If the measurement is to be conducted regularly so as to discover trends in
performance, then check inspection is necessary.
• In conventional check inspection, a second inspector, i.e., a check inspector,
reviews the decision of the inspector by reexamining the product after it has been
inspected.
• The best practice is to reexamine the rejected product as well as the accepted
product.
• The check inspection reviews :
a. the procedure followed by the inspector,
b. use of wrong issue of the specification,
c. wrong instrument,
d. improper filling out of documents, etc. 16

17. • The of errors may be expressed in terms of percentage defective or in terms of
demerits per unit.
• which reports on a study of inspector accuracy during the production process,
based on accept/reject decisions.
• Accuracy of inspector = Percent of defects correctly identified.
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18. ERRORS OF MEASUREMENT
• There are 2 main sources of the errors.
Variation in
process.
Variation in
product
measurement.
Sources
of errors
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19. • Obviously, any error in these measurements has a direct bearing on the ability to
judge conformance.
• Error measurement done by 2 main process:
ACCURACY PRECISION
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20. ACCURACY :
The extent to which measurement agrees with the “true” value of that unit.
• The difference between the average and the true value is called the error also
systematic error, bias, or inaccuracy.
• . The error can be positive or negative.
• Precision :
• The ability of the instrument to reproduce its own measurements is called its
precision.
• Quantification of precision - standard deviation of replicated measurements and is
expressed by (sigma). 20

21. • Process of error measurement :
Defining test
method.
Define causes
of variability.
Apply
statistical
control,
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22. REFERENCES
• Joseph .A.Juran, A.Blanton Godfrey ; Juran’s Quality Handbook; 5th Edition ; Mc-Graw
Hill Publication ; Pg no : 23.1-23.50.
• Manohar.A.Potdar ; Concepts of Quality Management in Pharmaceutical Industry ;
Career Publication; Pg no : 6.1-6.23.
• Bhaskar Mazmumder, Sanjib Bhattacharya , Abhishek yadav , Total Quality
Management in Pharmaceuticals : A Review , International journal of PharmTech
Research , Vol 3, pg no: 365-375 , Jan-March 2011
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23. THANK YOU !!!!!!!!!!!!
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