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WAH ENGINEERING COLLEGE

INSPECTION & QUALITY CONTROL

CREDIT HOURS: 3

Prepared By:

Engr. Junaid Khan

Mechanical Engineering Department
Wah Engineering College
University of Wah

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QC THROUGHOUT PRODUCTION SYSTEM

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PRE-PROCESS QC INSPECTION

The safety and efficacy of the finished dosage form is largely dependent on the
purity and quality of the bulk active drug substance.

 Physical tests such as particle size for raw materials flow properties etc. are
essential tests to assure consistent operation of the production and control
system and to assure quality and efficacy

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PRE-PROCESS QC INSPECTION

To decrease quality risk, the inputs can be inspected prior to production.

Samples are randomly taken and checked. An experienced inspector examines

the sample/prototype to make sure that the raw materials meet the specified
standards Whether development team has clearly communicated the
requirements to the manufacturing team.

Whether equipment's for mass production is similar to that for making

prototypes.

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IN PROCESS QC INSPECTION
The first products that got out of the line are inspected for conformity.

If issues are raised at this stage, the factory can immediately take actions and
avoid delays.

In-process products are rarely checked as it takes technician to reliably detect

errors on unfinished products.

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IN PROCESS INSPECTION

Inspect the test results from in-process tests performed for conformance with
established sampling and testing protocols, analytical methods, and
specifications.

For example, evaluate the tests for weight variation, hardness, and friability.

The inspection must confirm that the in-process tests were done, as described
in the plan, and ascertain that the results are within specifications.

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CLASSIFICATION OF IN-PROCESS INSPECTION
I. Trial run inspection: Tools and machines are checked before operation.
II. First-off inspection: The items produced in the first production run are
inspected and examined with respect to specifications.
III. Inspection by self control: Done by operators, controlling operations at
different levels of production process.
IV. Decentralized inspection: Semi finished goods are inspected either on
machines or in the production line.
V. Centralized inspection: There can be single inspection unit for whole plant
or each section can have inspection unit to inspect the items .The inspection
staff is more experienced and skilled in this case

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CLASSIFICATION OF IN-PRODUCTION
INSPECTION
I. Component dominant: Incoming material must be checked for required
specifications.
II. Set-up dominant: An operation once set at a level, remains at that level for
long. Hence products produced initially if found free from defects and
conforming to specifications, then the operation can be cleared for
continuous operation.
III. Machine dominant: Operation drift away from initial set-up level as
operation proceeds. Hence needs periodic inspection for correcting set up

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STATISTICAL QUALITY CONTROL (SQC)

 Statistical quality control refers to the use of statistical methods in the

monitoring and maintaining of the quality of products and services.

 SQC is particularly important in manufacturing and production processes to

ensure that products meet the desired quality standards. One common SQC
technique is the control chart, which is used to monitor the stability and
performance of a process over time
 All the tools of SQC are helpful in evaluating the quality of services

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 EXAMPLE: CONTROL CHARTS FOR SQC
Imagine you work at a manufacturing plant that produces bolts, and your job is to
ensure that the diameter of these bolts meets a specific quality standard.

 Data Collection: You begin by collecting data on the diameter of bolts produced
over a certain period. Let's say you collect 20 measurements of bolt diameters every
hour for a week. These measurements are the basis for your SQC analysis.

 Data Analysis: You can calculate summary statistics, such as the mean and
standard deviation, for each set of 20 measurements for every hour. This will give
you an overview of the process's performance.

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EXAMPLE:
 Control Chart Creation: You create a control chart to monitor the diameter of the bolts.
The control chart typically consists of:

 A centerline representing the process mean.

 Upper control limits (UCL) and lower control limits (LCL) based on statistical calculations.
These limits are usually set at ±3 standard deviations from the mean.

 Plotting Data: For each hour's measurements, you plot the mean on the control chart and
connect it to the centerline. This is your process mean. If any data points fall outside the
control limits, these are considered out-of-control points and may indicate a problem with
the process. 12
EXAMPLE:
 Interpretation: Now, you regularly update the control chart with new data. If
data points consistently fall within the control limits, it indicates that your
process is in statistical control, and the bolt diameter remains within the
desired range. However, if data points show a pattern of going beyond the
control limits or exhibit trends, this suggests that the process is out of control.
 Action: If the control chart shows that the process is out of control, you
investigate to identify and rectify the cause of the issue. This could involve
adjustments to the production process, machine maintenance, or operator
training.

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 EXAMPLE:
 Continuous Monitoring: You continue to collect data and monitor the process using
control charts to ensure that it remains in control. Regularly updating the control chart is
essential for maintaining product quality.

 Control charts are just one tool in the SQC toolbox. Other SQC techniques, like Pareto
charts, process capability analysis, and hypothesis testing, can be used to further analyze
and improve product or process quality.

 In this example, we focused on a control chart for monitoring a single variable (bolt
diameter), but SQC can be applied to various aspects of quality control in manufacturing
and other industries. The key is to collect data, analyze it, and take appropriate actions to
maintain or improve product quality.
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 ADVANTAGES OF SQC
SQC has the following advantages;

1.Cost reduction: In this method, only a fragmentary output is inspected to ensure the
quality of product, therefore probe cost would be reduced greatly.
2.Huge efficiency: Inspection of a fractional portion requires lesser time and tedium in
comparison to holistic investigation leading to huge escalation in efficiency and
production.
3.Easier to use: Pitching SQC not only reduces process variability but also makes the
process of production-in-control. Even, it is much to apply by an individual without
having such extensive specialized guidance.

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ADVANTAGES OF SQC

4. Authentic anticipation: SQC is the most preeminent approach that can

accurately predict future production. To ensure the degree of perfection and
product performance, SQC provides a great predictability.
5. Prior fault detection: Any deviation from standard control limits depicts
signs of danger in the underlying production process that invites necessary
corrective measurement to be taken earlier. SQC is helpful in early detection of
faults.

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Thank you

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