Quality Assurance (QA)
Quality assurance can be defined as "part of?quality management?focused on providing confidence that?quality requirements?will be fulfilled." The confidence provided by quality assurance is?twofold—internally?to management and externally to customers, government agencies, regulators, certifiers, and third parties.
An alternate definition is "all the planned and systematic activities implemented within the quality system that can be demonstrated to provide confidence that a product or service will fulfill requirements for quality."
The?ISO?(International Organization for Standardization) is a driving force behind QA practices and mapping the processes used to implement QA. QA is often paired with the? ISO 9000 international standard. Many companies use ISO 9000 to ensure that their quality assurance system is in place and effective. The concept of QA as a formalized practice started in the manufacturing industry, and it has since spread to most industries.
History of ISO and QA:
Quality has been defined as fitness for use, conformance to requirements, and the pursuit of excellence. Even though the concept of quality has existed from early times, the study and definition of quality have been given prominence only in the last century.
Although simple concepts of quality assurance can be traced back to the Middle Ages, QA practices became more important in the United States during World War II, when high volumes of munitions had to be inspected.
The ISO opened in Geneva in 1947 and published its first standard in 1951 on reference temperatures for industrial measurements. The ISO gradually grew and expanded its scope of standards. The ISO 9000 family of standards was published in 1987; each 9000 number offers different standards for different scenarios.
The 1950s: Quality Assurance and Auditing
The quality profession expanded to include the quality assurance and quality audit functions. The drivers of independent verification of quality were primary industries in which public health and safety were paramount.
QA standards
QA standards have changed and been updated over time, and ISO standards need to change to stay relevant to today's businesses.
The latest in the ISO 9000 series is ISO 9001:2015. The guidance in ISO 9001:2015 includes a stronger customer focus, top management practices and how they can change a company, and keeping apace of continuing improvements. Along with general improvements to ISO 9001, ISO 9001:2015 includes improvements to its structure and more information for risk-based decision-making.
??To implement a QA system, first set goals for the standard.
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??Consider the advantages and trade-offs of each approach, such as maximizing efficacy, reducing cost, or minimizing errors.
??Management must be willing to implement process changes and to work together to support the QA system and establish standards for quality.
Why Companies Use Quality Assurance
Quality assurance should never be overlooked to finish a job in a hurry. The process lets you know if you are using your resources the way you should. You don't want to cut corners with any part of your product’s quality. Cutting corners could result in lost client faith, shrinking profit margins, and eventually, your company’s ability to attract talented employees. Good quality assurance procedures allow both company owners and employees to take pride in their work.
Quality assurance helps a company create products and services that meet customers' needs, expectations, and requirements. It yields high-quality product offerings that build trust and loyalty with customers. The standards and procedures defined by a quality assurance program help prevent product defects before they arise.
What are the types of Quality Assurance functions?
There are five types of Quality Assurance functions.
- Technology Transfer:?This function involves getting a project design document as well as trial and error data and its evaluation. The documents are distributed, checked, and approved.
- Validation:?For the entire system, a validation master plan is prepared. Resource planning for the execution of a validation plan is done.
- Documentation:?This function controls the distribution and archiving of documents. Any change in the document is adopting the proper change control procedures.
- Quality assurance function also involves assuring the quality of products.
- It also involves quality improvement plans.
? Quality assurance methods
Quality assurance utilizes one of three methods:
·?Failure testing, which continually tests a product to determine if it breaks or fails. For physical products that need to withstand stress, this could involve testing the product under heat, pressure, or vibration. Failure testing might involve placing the software under high usage or load conditions for software products.
·?Statistical process control (SPC), a methodology based on objective data and analysis and developed by Walter Shewhart at Western Electric Company and Bell Telephone Laboratories in the 1920s and 1930s. This methodology uses statistical methods to manage and control the production of products.
·?Total quality management (TQM) applies quantitative methods as the basis for?continuous improvement. TQM relies on facts, data, and analysis to support product planning and performance reviews.
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