Anatomy of an Audit
The actual audits themselves make up an essential part of an ‘Audit Program’… Duh! Most people could have probably guessed that since your audit program is kinda focused on managing the audits of your quality system. However, the details of what goes on during an audit are less inherent. Since we can’t expect everyone in the industry to be a qualified lead auditor (I know I worked in consulting for several years before I became one), this lesson will focus on the bits and pieces that make up an audit.
It won’t teach you how to be an auditor, but it will teach you what someone managing an audit program should know about auditing. Including that, you do not have to be an auditor yourself in order to manage an audit program.
If you are new to auditing and audit programs or even to the medical device industry itself, this lesson will help you understand what is going on to better manage the audits within your program. If all of those things describe you, it is ok. You wouldn’t be the first person to find themselves surprised with this type of unknown responsibility. You also won’t be the last. Startups in particular often discover these roles must be filled and are forced to shuffle around internal staff responsibilities to make it happen.
Unfortunately, it is a thing that just happens. It will all be ok, and this section of the course will help you be better prepared not only to manage an audit program but also to advance your qualifications into auditing in the future if you wish.
In this section, I will discuss the following;
- Anatomy of an Audit:
- Definition
- Party
- Are audits even required?
- Scope & Criteria
- Methods
- Landmarks
- Process (Approaches)
- Nonconformities
That should be enough to get a program manager started, especially if they are just managing a program and not performing the audits under the program. When you are finished with the section, you should have a high-level, basic understanding of what an ‘audit’ is. For a program manager, one of the most critical parts of this section may be the audit landmarks. Understanding and tracking the audit landmarks will allow you to know where in the process an audit is and can help you look forward and begin preparing for the audit follow-up and CAPA stages of your program.