Case Study: Staff Augmentation Program

At QualityHub, we have experience in staff augmentation for several types of companies and roles. Here are four examples of staff augmentation case studies to give you some background on that experience.

Overcoming Staffing Issues to Gain Compliance

A leader in In-Vitro Diagnostics (henceforth referred to as the Client) reached out to QualityHub to overcome resource constraints and return to compliance. This pioneering company is known for its sophisticated diagnostics systems for acute patient treatment. Despite its success, the Client was still plagued by long-standing systemic issues. Due to FDA enforcement, the Client committed to performing a retrospective review and remediation of approximately 30,000 legacy complaint records. The Client also committed to completing the project under an aggressive deadline — a challenge compounded by limited staffing and a lack of experience. 

Read the complete case study here. 

Multiple Roles – Consent Decree

Staff Augmentation Case Study

For a client under a consent decree, we provided manpower to work within the quality organization due to a lack of personnel on the client end. These projects were six months to over a year. The positions we filled on a temporary basis were:

  • Acting/Interim Quality Manager
  • Acting/Interim Complaints Manager
  • Acting/Interim CAPA Manager
  • Acting/Interim Sustaining Engineering Manager

Quality Manager – Warning Letter

Staff Augmentation Case Study

For a client under a warning letter, we provided an acting/interim quality manager. This person managed the day-to-day quality organization as well as the efforts to address the warning letter and prepare for an FDA reinspection. The duration of the project was over 18 months. For this project, the client was so happy with the individual they asked if he could serve as acting/interim vice president of quality.

Senior Advisor – Warning Letter

Staff Augmentation Case Study

For a client under several warning letters, we provided an acting/interim quality management system senior advisor who provided two specific scopes of work over a 12-month duration:

  • Served as the corporate-level project architect for a company-wide risk management program
  • Served as a coach to an incoming corporate quality vice president

Audit Program Manager – Medical Device

Staff Augmentation Case Study

For a medical device client, we provided an individual who served for over six months as an acting/interim internal audit program manager. This individual also performed several audits in numerous countries while serving in this capacity.

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