Quality Assurance-Why it’s Important to Have Strong QA Support

For example, production is complete, and the product is now with quality control (QC) for final testing. A member of the QC department recorded the final results but misread the results, which caused the product not to pass specification. The paperwork is now in the hands of QA for review. Let’s take a look at why strong QA support is paramount.

Quality assurance plays many roles in every stage of a company’s procedures and policies—their responsibilities consist of reviewing, inspecting, approving, and assuring compliance.

• • Reviewing – QA should be reviewing the following to make sure everything is compliant and produced correctly. Documents include Batch records, QC data, qualifications, equipment calibration certificates, deviations, CAPA, and other important documents.
  • Approvals – QA has final approvals on all documentation that goes anywhere outside of the company and to the public. QA is the final sign of approval for all products.
  • Compliance – QA is responsible for keeping the entire company in compliance with Good Manufacturing Practices (GMP) under regulatory bodies such as the FDA.
  • Inspecting – QA inspections are necessary to confirm the products are being produced with no defects.
  • Audits – Whether performing an internal audit or handling an FDA audit, QA is responsible and should always be prepared.

Quality Assurance has many different hats within the company and should always be consulted when process and procedures need to be changed. QA can also be split up into different areas such as document control, inspections, audits, documentation, and compliance. When it comes to audits by the FDA or any other agency QA is in control and should always be prepared.