Elements of Quality Management System

Course: Software Quality Assurance
PAF KIET CITY CAMPUS

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Assignment # 1
Software Quality Assurance


7/16/2016


Elements of Quality Management System




SUBMITTED TO:
SIR AZAR EJAZ ATEEQ

MADE BY:
SHAHZEB PIRZADA (5701)

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TABLE OF CONTENT

DESCRIPTION PAGES

COVER PAGE



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QUALITY POLICY
QUALITY OBJECTIVES



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QUALITY MANUAL
ORGANIZATIONAL STRUCTURE
DATA MANAGEMENT
PROCESSES-INCLUDE PURCHASING
PRODUCT QUALITY LEADING TO
CUSTOMER SATISFACTION
CONTINUOUS IMPROVEMENT
QUALITY INSTRUMENT
CONTROL OF DOCUMENT




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1. Quality policy
Quality Policy is a statement issued by the top management of a company, stating
the objectives of the company with regard to manufacture or supply of a product
(or service) that meets the customer's expectations.
The Quality Policy is thus a commitment from the top management to ensure
compliance with the Quality Management System, and to ensure continuous
increase in customer satisfaction.
The management should ensure that all employees are not only aware of, but fully
understand the objectives stated through the Quality Policy.

2. Quality objectives
These measurable steps towards achieving your quality policy are either determined as you
create your QMS or in your management reviews. You need to ask yourself: what will you do to
meet the goals stated in the quality policy? Knowing that perfection is impossible, you must
have some acceptable tolerance defined and measured.
Examples:
 % of on time deliveries
 % of internal scrap
 % defects
Both of these are different for every business. Here is an example:
 Say your company goal/mission is to produce the best widget in the world
 Your Quality Policy may state they will be 99% defect free (among other things)
 The Quality Objectives put metrics on that, typically in terms of the product or service.
What do you consider a defect? (Package is broken, product fails, etc.)
When you are working on document control, make sure that you include your quality policy
and quality objectives. They must be controlled. Control them by:
 Making them part of a procedure
 Making them part of the quality manual
 Making them their own numbered, controlled document
 You may want to handle the quality policy and quality objectives separately because the
quality objectives might change more frequently than the quality policy. This may mean
you do not want the objectives in the quality manual.

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3. Quality manual
An official document produced by a business that details how its quality management
system operates. A typical quality manual will include the company's quality
policy and goals, as well as a detailed description of its quality control system that might
include staff roles and relationships, procedures, systems and any other resources that
relate to producing high quality goods or services.

4. Organizational structure and responsibilities
Quality assurance principles require an organizational structure that links responsibility
for quality directly to the executive level of the company. Large organizations fulfill this
requirement by appointing a quality assurance manager who reports to the CEO. The
organizational structure also has to provide the QA manager with direct organizational
paths into every department. Small businesses can meet these requirements by
assigning the QA responsibilities to someone in management, giving him the authority
to manage QA matters throughout the company and creating a QA reporting path to the
executive level. Employees continue to report to their department manager for
disciplinary and non-QA matters, but report to the person responsible for QA on quality
questions.
5. Data Management
Data management is the development and execution of architectures, policies, practices
and procedures in order to manage the information lifecycle needs of an enterprise in
an effective manner.
6. Processes - including purchasing
 A need has been created, research has been completed and the customer has
decided to make a purchase. All the stages that lead to a conversion have been
finished. However, this doesn’t mean it’s a sure thing. A consumer could still be
lost. Marketing is just as important during this stage as during the previous.
 Marketing to this stage is straightforward: keep it simple. Test your brand’s
purchase process online. Is it complicated? Are there too many steps? Is the load
time too slow? Can a purchase be completed just as simply on a mobile device as
on a desktop computer? Ask these critical questions and make adjustments. If
the purchase process is too difficult, customers, and therefore revenue, can be
easily lost.

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7. Product quality leading to Customer satisfaction
Before we can answer this question of how quality and customer satisfaction are related
we first need to understand what quality actually means. Quality is something we all
look for, and we tend to know it when we see it. However, when we are asked to break
down exactly what quality is, we often become unstuck. Most would agree that it is
highly subjective and that, much like beauty, it lies in the eye of the beholder, but there
is huge variance in the reported attributes or features that matter. This variance in
opinion is a clear challenge but also a great opportunity. It is contended that a greater
understanding of perceived quality could help designers to develop more satisfying
products with a greater chance of commercial success.
8. Continuous improvement including corrective and preventive action
The easiest way I’ve found to explain the difference between Corrective and Preventive
action in continuous improvement is like that; what was done to correct the problem?
Typically a short term fix that may add to quality costs. The Preventive action question
is; what has been done to make sure the problem can’t happen again? Examples are
updates in system documentation, training to updates, Poke-Yoke improvements etc.
9. Quality instruments
The quality process for commercial analytical equipment starts with the selection of the
vendor. It is recommended that vendors be selected who are recognized as having
quality processes in place for instrument design, development, manufacturing, testing,
service, and support, for example, ISO 9001 registration. When the instrument arrives in
the laboratory, the installation process should follow well-documented procedures. This
includes a visual inspection that the instrument is not damaged and checking that the
instrument, documentation and accessories such as cables and tubing are complete.
Before the instrument is used it should be verified that it meets functional and
performance specification. During operation the instruments should be periodically
inspected and tested, verified to meet performance, and calibrated. The instrument
should be labeled with the calibration status, indicating the dates of the last successful
and the next performance verification and calibration. Defective instruments should be
removed from the testing area or should at least be labeled as being "out of order."
Key words Quality assurance Instrumentation Installation qualification Acceptance
testing Validation Software Performance control Performance verification

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10.Control of Document
Learn from industry practitioners and experts why QA Document Control is a prerequisite to
Quality Assurance. Quality assurance document control is the process used in the management,
coordination, control, delivery, or support of an item required for quality assurance purposes.
QA document control is an essential part of the quality assurance system for all aspects of GMP,
GCP and GLP. It allows you to approve, review and update documents; make changes and
identify revision status; control document distribution; and prevent use of obsolete documents,
facilitating proper archiving.