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Basic of Quality Assurance (QA)

Quality assurance is a term covering all matters relating to the quality of a product or service, separately or collectively.

ISO 9000 describes quality control as part of quality management that is geared towards quality requirements.

Difference between QA and QC:

QA is a collection of operations in the procedures through which products are created to ensure quality. QA is a instrument of management.

On the other side, QC is a collection of product quality assurance operations. The operations are focused on identifying flaws in the real manufactured goods. QC is a remedial instrument

How does QA & QC Work?

  • Prevention of quality problems through planned and systematic activities including documentation.
  • Establish a successful quality management system and its adequacy evaluation.
  • The activities or methods used to attain and retain the quality, process and service of the product.
  • Finding and eliminating sources of quality issues through instruments & equipment in order to continuously meet customer demands.

Functions of Quality Assurance Department

  • The QA department is accountable for ensuring compliance with a company’s quality policies. It helps to define and prepare the required quality control SOPs
  • It must determine that the item meets all the specifications relevant and that it has been produced according to the organization’s inner norms. Quality surveillance or audit function is also the responsibility of QA
  • QA functions to continuously evaluate activities and advise and guide them towards complete compliance with all relevant inner and external legislation.

Total Quality Control 

The concept of total quality control relates to the process of producing a ideal product through a sequence of measures that require organized effort at every point of manufacturing.

While QA staff are primarily responsible for ensuring product quality, it includes many departments and disciplines within a business. To be efficient, team efforts must be endorsed.

During product and process, quality must be incorporated into a drug product and is affected during routine physical plant layout, space, ventilation, cleanliness and safety


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