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 1

QUALITY POLICYQUALITY OBJECTIVES

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QUALITY MANUALORGANIZATIONAL STRUCTURE

DATA MANAGEMENTPROCESSES-INCLUDE PURCHASING

PRODUCT QUALITY LEADING TO CUSTOMER SATISFACTION

CONTINUOUS IMPROVEMENTQUALITY INSTRUMENT

CONTROL OF DOCUMENT

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555

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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.

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