The purpose of a Quality Assurance Plan is to define the general approach taken to ensure quality throughout the product development process.  It should cover all basic information concerning review, development, and planning for verification, validation, and proving the system can provide the level of support required by the product while minimizing the chance of failure. The plan should provide assurance that the product is developed within industry standard regulations to guide the development team in a course of action that leads to a successful and satisfactory implementation of the product at hand.

Quality Design & Development
Within highly regulated industries, it is critical that a product is developed to ensure approval within the appropriate governing regulatory bodies. To that end, the quality assurance plan must outline the way in which the product or system will be designed and developed to comply with the required standards. For example, within the medical device industry, developing a product to IEC 62304, a standard for medical device software, is extremely beneficial in launching a product within different countries.

Design Review Meetings
Design review meetings must be documented appropriately to provide evidence that the product’s intended use will be achieved. These meetings should be conducted at key milestones within the project, allowing the vision of project stakeholders to stay aligned, and minimize the risk of performing extra or incorrect work.

Project Audits
Project audits are vital to a quality assurance plan. Frequent audits should be utilized to ensure the project is on track and the necessary standards are being followed. Project auditors will take a thorough look at the status of the project and make sure all necessary elements are completed as prescribed. Auditors will work to identify the appropriate documentation needed for a project, for example:

• System software Project Plans
  • Project Plan
  • Risk Analysis
  • Configuration Management
  • Quality Assurance
  • Change Control
  • Problem Reporting & Resolution
  • Product Designs
  • FRS – Functional Requirements Specification
  • ADS – Architectural Design Specification
  • DDS – Detailed Design Specification
  • Traceability Matrix
  • Product Testing
• Verification and Validation Plans
• Product System Tracking
  • Meeting Minutes
  • Status Reports
  • Project Tracking

Utilizing audits will lessen, even eliminate, cutting corners and taking short cuts, acting as a means for risk prevention. Non-conformities will be identified before project completion and corrective actions may be issued as a means of remediation. Audits are a great tool to keep all project stakeholders accountable, ultimately shaping the project to be done correct the first time.

PSI’s motto is, “if you’re cutting corners, you end up in a circle.”