Role of Quality Control in Operations

Quality Control (QC) may be defined as a system that is used to maintain a desired level
of quality in a product or service. It is a systematic control of various factors that affect
the quality of the product. It depends on materials, tools, machines, type of labor,
working conditions etc. QC is a broad term, it involves inspection at particular stage but
mere inspection does not mean QC. As opposed to inspection, in quality control activity
emphasis is placed on the quality future production. Quality control aims at prevention of
defects at the source, relies on effective feedback system and corrective action
procedure. Quality control uses inspection as a valuable tool.

According to Juran “Quality control is the regulatory process through which we measure
actual quality performance, compare it with standards, and act on the difference”.
Another definition of quality control is from ANSI/ASQC standard (1978) quality control
is defined as “The operational techniques and the activities which sustain a quality of
product or service that will satisfy given needs; also the use of such techniques and
activities”.

Alford and Beatty define QC as “In the broad sense, quality control is the mechanism by
which products are made to measure up to specifications determined from customers,
demands and transformed into sales engineering and manufacturing requirements, it is
concerned with making things right rather than discovering and rejecting those made
wrong”.

Types of Quality Control

QC is not a function of any single department or a person. It is the primary responsibility

of any supervisor to turn out work of acceptable quality. Quality control can be divided
into three main sub-areas, those are:
1. Off-line quality control,
2. Statistical process control
3. Acceptance sampling plans.

1. Off-line quality control:

Its procedure deal with measures to select and choose controllable product and
process parameters in such a way that the deviation between the product or process
output and the standard will be minimized. Much of this task is accomplished through
product and process design.
2. Statistical process control:
SPC involves comparing the output of a process or a service with a standard and
taking remedial actions in case of a discrepancy between the two. It also involves
determining whether a process can produce a product that meets desired specification
or requirements. On-line SPC means that information is gathered about the product,
process, or service while it is functional. The corrective action is taken in that
operational phase. This is real-time basis.
3. Acceptance sampling plans:
A plan that determines the number of items to sample and the acceptance criteria of
the lot, based on meeting certain stipulated conditions (such as the risk of rejecting a
good lot or accepting a bad lot) is known as an acceptance sampling plan.

Steps in Quality Control

1. Formulate quality policy.

2. Set the standards / specifications on the basis of customer’s preference, cost and
profit.
3. Select inspection plan and set up procedure for checking.
4. Detect deviations from set standards of specifications.
5. Take corrective actions or necessary changes to achieve standards.
6. Decide on salvage method i.e., to decide how the defective parts are disposed of,
entire scrap or rework.
7. Coordination of quality problems.
8. Developing quality consciousness both within and outside the organization.
9. Developing procedures for good vendor-vendee relations.

Objectives of Quality Control

1. To improve the companies income by making the production more acceptable to the
customers, i.e., by providing long life, greater usefulness, maintainability etc.
2. To reduce companies cost through reduction of losses due to defects.
3. To achieve interchange ability of manufacture in large scale production.
4. To produce optimal quality at reduced price.
5. To ensure satisfaction of customers with productions or services or high quality level,
to build customer goodwill, confidence and reputation of manufacturer.
6. To make inspection prompt to ensure quality control.
7. To check the variation during manufacturing.
 The broad areas of application of quality control are incoming material control, process
control and finish product control.

Benefits of Quality Control

 Improving the quality of products and services.

 Increasing the productivity of manufacturing processes and commercial business.
 Reducing manufacturing and corporate costs.
 Determining and improving the marketability of products and services.
 Reducing consumer prices of products and services.
 Improving or assuring on time deliveries and availability.
 Assisting the management to become a best quality brand in the market.

Seven Tools for Quality Control

To make rational decisions using data obtained on the product, or process, or from the
consumer, organizations use certain graphical tools. These methods help us learn about
the characteristics of a process, its operating state of affairs and the kind of output we
may expect from it. Graphical methods are easy to understand and provide
comprehensive information; they are a viable tool for the analysis of product and
process data. These tools are effect on quality improvement. The seven quality control
tools are:

1. Pareto charts
2. Check sheets
3. Cause and effect diagram
4. Scatter diagrams
5. Histogram
6. Graphs or flow charts
7. Control charts
 Causes of Variation in Quality
The variation in the quality of product in any mfg process is broadly classified as:
A. Chance causes
B. Assignable causes.

A. CHANCE CAUSES
The chance causes are those causes which are inherit in manufacturing process by
virtue of operational and constructional features of the equipments involved in a
manufacturing process.
This is because of

1. Machine vibrations
2. Voltage variations
3. Composition variation of material, etc.

They are difficult to trace and difficult to control, even under best condition of
production. Even though, it is possible to trace out, it is not economical to eliminate.
The chance causes results in only a minute amount of variation in process. Variation
in chance causes is due to internal factors only the general pattern of variation under
chance causes will follow a stable statistical distribution (normal distribution).
Variation within the control limits means only random causes are present.
B. ASSIGNABLE CAUSES
These are the causes which creates ordinary variation in the production quality.
Assignable cause’s variation can always be traced to a specific quality. They occur due
to

1. Lack of skill in operation

2. Wrong maintenance practice
3. New vendors
4. Error in setting jigs and fixtures
5. Raw material defects

Variation due to these causes can be controlled before the defective items are produced.
Any one assignable cause can result in a large amount of variation in process. If the
assignable causes are present, the system will not follow a stable statistical distribution.
When the actual variation exceeds the control limits, it is a signal that assignable causes
extend the process and process should be investigated.
 Role of Quality Assurance in Operations

Quality Assurance (QA) plays an important role in any industrial operations, as part of
GMPs (Good Manufacturing Practices).

QA refers to the step-by-step process of examining whether goods and services meet
specific quality, efficacy and safety requirements, as per their intended use. An
international standard like ISO 9000 is used as a guideline, to ensure that a company’s
QA system is both effective and ready to be implemented.

 Objectives of QA
• Protecting the customers against potential hazards caused by accidental manufacturing
and design defects, or instructions for product usage/storage.
• Making sure of complete compliance with applicable industry regulations, statutes, laws
and guidelines.
• Protecting the product and manufacturer against penalties, negative publicity, loss of
credibility, fiscal losses, etc.
 Importance of QA in Operations
Effective quality assurance helps organizations build better credibility and consumer
confidence, and improving production efficiency and processes. It reduces the chances of
negative publicity and impact on sales as well (e.g. if a finished product were to be
recalled due to quality defects).
Hence, quality assurance in the operations offers tremendous benefits in terms of rising
profits and a stronger reputation. However, every aspect of the production process
needs to be taken into consideration, whether it individually or collectively impacts
product quality.
Most companies set up separate QA departments, with the intent to find and correct
defects in the manufacturing operations before the final product reach the market.

 An overview of QA’s role:

• Development Stage – During R&D, checking the qualification of raw material, vendors,
testing methods, validation, document control, equipment calibration and operating
procedures, personnel recruitment and training, data recording, product demos,
standardisation of pilot batches and more.
•Manufacturing Stage – These are a few examples of the QA unit’s role during
production:
 Preparing, approving and monitoring the implementation of key documents
(Quality Policy and Objectives, Quality Manual, SOP, Master Plan, etc.).
  Approving an equipment calibration, qualification and maintenance schedule, as
well as critical utilities qualification calendar (HVAC, water, gas and power
distribution systems, etc.).
 Ensuring that specifications and test procedures for raw materials, packing
materials, in-process testing, stability testing, etc. are all in place.
 Reviewing training records to check if on-the-job and induction training is taking
place according to the schedule, and whether QC analysts are being validated.
 Ensuring that planned/unplanned changes or deviations are documented,
reviewed and analyzed, and recommending studies, test to be performed.
 Logging and responding to customer complaints, supervising the investigation
into the cause of the issue, providing an investigation report to the customer, etc.
 Initiating, documenting and investigating market returns, reprocessing or
repacking or destruction, and informing higher authorities about the actions.
 Training and leading the internal audit team for each department, interacting with
auditors during external, internal and customer inspections, and intimating the
observations to the management.
 Reviewing and approving manufacturing records and QC testing data before any
in process or finished batch is released, as well as periodic trending of this data.
 Initiating an OOS (out of specification) investigation and reviewing the QC test if
any raw material, packaging, intermediate or stability sample does not meet
established and approved specification periodically.
 Qualifying and auditing calibration service providers for tests and calibrations not
performed in-house, reviewing and preparing Quality and Technical agreements
for other manufacturing sites.
QA System: The Backbone of Quality
 While the development, manufacturing and marketing of products may involve
more than one unit or department, the quality unit is usually independent of
production processes.
 We could also use specialized departments (CFT) incorporated in an
organizational network to handle the quality system and its related duties. In
such a scenario, the QA unit would take on the task of provisioning suitable
systems as well as defining them in SOPs (standard operating procedures) and
higher level instructions.
 Delegating QA functions and decision-making authority to operation
departments and personnel is ideal for larger organizations, to help
ensure quality on the floor.
 Top-level management also needs to be involved in the responsibilities of this
unit, which may be a combination of QA and QC.