LTR 31: Focus on the purpose of a procedure to measure effectiveness

The increasing adoption of Medical Device Single Audit Program (MDSAP) has led to a major shift in current auditing practices in the medical device industry. MDSAP has forced auditors to apply a process-based audit approach rather than a checklist-based approach. The focus in a process-based audit is on process effectiveness and not just element-by-element compliance with regulatory requirements.

As a seasoned auditor with more than 15 years of industry experience, Rick Rios reminds us that external auditors, such as FDA investigators or Notified Body auditors, are not coming in to look for compliance issues. Rather, they are coming in to look at effectiveness of the system and its processes.

So, how do we focus our efforts on process effectiveness? In this episode, Rick offers an invaluable insight - the purpose statement of a procedure provides its design intent, because it serves to provide a framework for establishing objectives to measure the process. It is a review of performance against those objectives that auditors evaluate process effectiveness. That is why we must write a purpose statement clearly and make sure it is understood well by everyone involved in a given process.

About Rick Rios

Rick Rios started his career in the defense industry working as a systems engineer in nuclear programs. Inspired by the Total Quality Management movement, he moved into a Quality and Regulatory role, and later worked in automotive and aerospace industries as an independent auditor. He has been active in the medical device industry as an independent auditor over nearly 15 years. He has successfully developed, integrated, implemented and audited quality systems based on ISO 13485, 21CFR820, MDSAP, EUMDR, DOE QC-1, NQA-1, ISO 9001, ISO 17025, NCSL Z540, and Baldrige Performance Excellence Program.

About Let’s Talk Risk with Dr. Naveen Agarwal

Let’s Talk Risk with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.