NeuAge Institute (NAI)

Considering a Quality Assurance Career? How to Carry Out an Audit

Quality Assurance professionals play a critical role in ensuring that products and services meet regulatory requirements, industry standards, and customer expectations. One of the primary tasks of a Quality Assurance professional is to carry out quality audits to ensure compliance with industry-relevant regulations and standards.

The audit process involves a systematic review of an organization’s processes, procedures, and documentation to ensure compliance with regulatory requirements, industry standards, and best practices. If you’re interested in a Quality Assurance career, understanding the fundamentals of auditing can facilitate greater career success further along the road. Read on to learn more.

Types of Audits in the Pharmaceutical Industry

Several types of audits can be carried out, depending on the nature of the audit and the regulatory requirements. Some common types of audits in the pharmaceutical industry include:

  • Internal audits: These audits are carried out by the organization’s own personnel to assess compliance with internal policies and procedures
  • External audits: These audits are carried out by an independent third party to assess compliance with external standards or regulations
  • Supplier audits: These audits are carried out to assess the quality and reliability of suppliers and ensure that they meet the organization’s requirements
  • GMP audits: These audits are carried out to assess compliance with Current Good Manufacturing Practices (CGMPs) 

Procedure for Carrying Out an Audit

The first step in carrying out an audit after quality assurance training is to define the scope of the audit. This involves identifying the processes and systems that will be audited and determining the time frame for the audit. The audit scope should be clearly defined and documented to cover all relevant areas.

The next step is to plan the audit. This involves identifying the audit team, setting the audit objectives, and preparing the audit plan. The audit team should include individuals with relevant expertise and experience in audited areas.

It’s crucial to understand an audit’s procedure during quality assurance training.

During the audit, the audit team will review documentation, interview personnel, and observe processes to assess compliance with regulatory requirements, industry standards, and best practices. The audit team will also identify areas of non-compliance and make recommendations for corrective actions.

After completing the audit, the audit team will prepare an audit report. The audit report should include an executive summary, a description of the audit methodology, a summary of the findings, and corrective action recommendations. The appropriate management personnel should review and approve the audit report before it is issued.

Best Practices for Carrying Out an Audit

It is important to follow best practices to ensure that audits are conducted effectively, efficiently, and consistently. Some best practices for carrying out an audit include:

  • Establishing clear audit objectives
  • Ensuring that the audit team has the necessary expertise and experience
  • Communicating the audit scope and objectives to the auditee
  • Using a risk-based approach to identify areas of focus
  • Using a standardized audit checklist
  • Documenting all observations and findings
  • Maintaining independence and objectivity
  • Providing feedback and recommendations for improvement
Understanding auditing best practices will be useful throughout your quality assurance career.

Auditing is a critical part of the quality assurance process. To ensure that audits are carried out effectively, efficiently, and consistently, it is important to follow best practices and use a risk-based approach. By doing so, quality assurance professionals can help ensure that their organization’s products and services meet regulatory requirements, industry standards, and customer expectations.

Are you interested in a quality assurance career?

Contact the NeuAge Institute to learn how you can get started.

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