Process/Approach

Audit processes are how the auditor will be conducting the audit or their process. This is also referred to as the approach of the audit. There are multiple approaches to an audit. The one that your audit program chooses to utilize will depend on several factors, including if there happens to be a regulatory requirement for a particular approach. Be aware that ISO standards in accordance with Annex A2. of ISO 19011:2018 require the use of the ‘Process Approach’ to auditing.

Process Approach

The ‘Process Approach’ focuses on elements of an individual process and its interconnections with other processes within a system. Best known for it’s ‘turtle diagram’ a visual infographic for process examination.

The turtle diagram above shows a look at the complaint handling process. It also shows how the process approach examines what processes generate inputs into complaint handling and what the complaint handling process generates for outputs. You can also see that it is called a turtle diagram because it looks like a turtle. I suppose it could equally be called a tortoise diagram…

The animal isn’t necessarily the important thing to focus on. The process of a turtle diagram is where the value gets added to the activity. Calling it a turtle diagram is a great reference for memory, but what is most important is to make sure you are capturing all of the steps of the process approach.

You can isolate the steps of the turtle diagram and translate them directly into your audit report templates. This way the turtle is technically there, you just don’t have to actually draw a turtle for each process.

Other Approaches

There are many other approaches to auditing, but only the process approach is specifically required for ISO audits.

The ‘Element Approach’ focuses on elements of the established audit criteria. Commonly known for its use of audit checklists.

Take a look at the below process from the QSR. For example, the first two ‘elements’ of this process are that the manufacture must establish quality audit procedures, and that they conduct quality audits.

The ‘Procedural Approach’ is an audit to verify that you are following a procedure. Therefore, the procedure is the audit criteria instead of a standard or regulation. This is ideal for manufacturing audits and audits of work instructions. It is also a very common effectiveness check for a CA/PA as well.

The ‘Product Approach’ is an audit of a specific manufacturing process for one product or product line. This is typically done in manufacturing or at a contract manufacturer.

There are also ‘Contract Audits’, where you are verifying compliance with contract requirements. This is critical for a contract manufacturer or sterilizer. Another term that may be used for these types of ‘contracts’ is “Supplier Quality Agreement”.

I’m sure there are other terms that these approaches to auditing have been given, but there is nothing universally accepted to standardize the naming for every type of audit imaginable. For example, sometimes ‘remote’, and ‘desktop’ audits mean the same thing. That is why it is important to be clear in your audit program what terminology your organization will use, and exactly what those terms mean.