Organization Structure

Medical Device manufacturer should have a procedure for upgrading and recording organizational structure information and the organizational structure chart. Normally this responsibility is being performed by human resource.

Human Resource should have to upkeep the employment record of all employees including resumes, CV, performance review, certification, diploma, patents, offer letter, employment agreement, resignation letter and termination letter etc.  

Human Resource should also update the organization chart regularly if there is any changes in the organization. Below is a simple sample of the organization chart. Human Resource should complete the chart completely.

Below is the exact wording from FDA website.

820.20(b)	Each manufacturer shall establish and maintain and adequate organizational structure to insure that devices are designed and produced in accordance with the requirements of this part
820.20(b)(1)	Responsibility and authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.
820.20(b)(2)	Resources. Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part.

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.