M PHARM QPA SEMINAR SECOND SEMISTER

1. INSPECTION,TEST AND MEASUREMENT
PRESENTED BY
MR.VILAS KAMBLE
M.PHARM.(II-SEM)
GUIDED BY
DR (MRS) SONALI
MAHAPARALE
PAD.DR.D.Y.PATIL COLLEGE OF PHARMACY
AKURDI,PUNE.
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2. CONTENT
 Introduction
 Types of inspection
 Purpose of inspection and test
 Seriousness Classification
 References
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3. INTRODUCTION
Inspection and testing activities
always involve the evaluation of a
characteristic as it relates to a specific
requirement.
Inspection and testing functions can
be done automatically, manually, or
both in a sequential manner.
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4. INTRODUCTION
Interpretation of
the specification
Measurement of
the quality of the
characteristic
Comparing 1
with 2
Judging
conformance
Processing of
conforming items
Disposition of
nonconforming
items
Recording of
data obtained
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5. TYPES OF INSPECTION
INSPECTION
Attribute
inspection.
Evaluation can be
determined by using the
intrinsic senses of the
human being (i.e., smell,
taste, sight, hearing, and
touch)
Variable
inspection
The inspection and testing
evaluation that is determined
by using any measurement
device e.g. mechanical,
electronic, laser, chemical
device
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6. SUBCLASSIFICATIONS OF INSPECTION
Inspection
Receiving
In-process
inspection
Final
inspection
Layout
inspection
Shipping
inspection
Qualification
inspection
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7. PURPOSE OF INSPECTION AND TEST
The purpose of inspection and test is to
determine the conformance of the
product.
The disposition of product based on the
result of the evaluation.
 This determination involves three main
decision
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8. PURPOSE OF INSPECTION AND TEST
Conformanc
e decision:
• To judge whether the product
conforms to specification.
Fitness-for-
use
decision:
• To decide whether nonconforming
product is fit for use
Communicati
on decision:
• To decide what to communicate to
outsiders and insiders
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9. Inspection planning
For each inspection station, the planner
lists the quality characteristics to be
checked.
To determine these, the planner
considers the various sources of
pertinent product information.
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10. INSPECTION PLANNING
The needs of fitness for use
The product and process specifications
as published by the engineers
The customer’s order, which references
the product specification but may call for
modifications
 The applicable industry standards and
other general-use sources
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11. INSPECTION PLANNING
 For test stations, the planner must
consider the functional and reliability
parameters, such as_
The industrial
standards
Third-party
requirements
Application
environments
Customer
expectations
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12. SERIOUSNESS CLASSIFICATION
 Another way of identifying the vital few
control subjects is through "seriousness
classification.”
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13. SERIOUSNESS CLASSIFICATION
Class A: Very
serious
(demerit value,
100)
• Will surely cause an operating failure of the unit
• Will surely cause intermittent trouble, difficult to locate in the field, e.g., loose
connection
Class B:
Serious
(demerit value,
50)
• Will probably cause an operating failure of the unit in service that cannot be
readily corrected in the field, e.g., protective finish missing from coaxial plug
• Will surely involve increased maintenance or decreased life, e.g., single contact
disk missing,
Class C:
Moderately
serious (demerit
value, 1
0)
• May possibly cause an operating failure of the unit in service, e.g., contact
follow less than minimum,
• Likely to involve increased maintenance or decreased life, e.g., dirty contac
Class D: Not
serious
(demerit value,
1)
• Will not affect operation, maintenance, or life of the unit in service (including
minor deviations from engineering requirements), e.g., sleeving too short, or
• Minor defects of appearance, finish, or workmanship, e.g., slightly scratched
finish.
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14. REFERENCES
 Juran J.M and Godfrey A. ,Quality
Handbook, Published By McGraw-Hill
Publication, Fifth Edition, page no-23.1
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