13485cert

How to Train an Auditor on the Process Approach

In Audit Schedule, Internal Auditing on June 8, 2012 at 5:53 am

Country music fans are loyal blog readers too.

            I have been reviewing the trends for how people find my website, and a large number of you appear to be very interested in my auditing schedules and other audit-related topics. Therefore, this week’s blog is dedicated to training auditors on the process approach.

First, the process approach is just a different way of organizing audits. Instead of auditing by clause, or by procedure, instead you audit each process. Typical processes include:

  1. Design & Development
  2. Purchasing
  3. Incoming inspection
  4. Assembly
  5. Final Inspection
  6. Packaging
  7. Sterilization
  8. Customer Service
  9. Shipping
  10. Management Review
  11. CAPA
  12. Internal Auditing

There are two reasons why the process approach is recommended. First, the process approach identifies linkages between processes as inputs and outputs. Therefore, if there is a problem with communication between departments the process approach will catch it. If only a procedural audit is performed, the lack of communication to the next process is often overlooked. Second, the process approach is a more efficient way to cover all the clauses of the ISO Standard than auditing each clause (i.e. – the element approach).

My rationale for the claim of greater efficiency is simple: there are 19 required procedures in the ISO 13485 Standard, but there are only 12 processes identified above. The “missing” procedures are actually incorporated into each process audit. For example, each process audit requires a review of records as input and outputs. In addition, training records should be sampled for each employee interviewed during an audit. Finally, nonconforming materials can be identified and sampled at incoming inspection, in assembly processes, during final inspection, during packaging, and even during shipment.

The tool that BSI uses to teach the process approach is the “Turtle Diagram”. The following picture illustrates where the name came from.

Illustration of the Process Approach

Process Auditing – “Turtle Diagram”


The first skill to teach a new auditor is the interview. Each process audit should begin with an interview of the process owner. The process owner and the name of the process are typically documented in the center of the turtle diagram. Next most auditors will ask, “Do you have a procedure for ‘x process’?” This is a weak auditing technique, because it is an “closed-ended” or yes/no. This type of question does little to help the auditor gather objective evidence. Therefore I prefer to start with the question, “Could you please describe the process?” This should give you a general overview of the process if you are unfamiliar with it.

After getting a general overview of the process, I like to ask the question: “How do you know how to start the process.” For example, inspectors know that there is material for incoming inspection, because raw materials are in the quarantine area. I have seen visual systems, electronic and paper-based systems for notifying QC inspectors of product to inspect. If there is a record indicating that material needs to be inspected—that is the ideal scenario. A follow-up question is, “What are the outputs of the inspection process?” Once again, the auditor should be looking for paperwork. Sampling these records and other supporting records is how the process approach addresses Clause 4.2.4—control of records.

The next step of the process approach is to “determine what resources are used by incoming inspection.” This includes gages used for measurement, cleanliness of the work environment, etc. This portion of the process approach is where an auditor can review calibration, gowning procedures, and software validation. After “With What Resources,” the auditor then needs to identify all the incoming inspectors on all shifts. From this list the auditor should select people to interview and follow-up with a request for training records.

The sixth step of the process is to request procedures and forms. Many auditors believe that they need to read the procedure. However, if a company has long procedures this could potentially waste valuable time. Instead, I like to ask the inspector to show me where I can find various regulatory requirements in the procedures. This approach has the added benefit of forcing the inspector to demonstrate they are trained in the procedures—a more effective assessment of competency than reviewing a training record.

The seventh and final step of the turtle diagram seems to challenge process owners the most. This is where the auditor should be looking for department Quality Objectives and assessing if the department objectives are linked with company Quality Objectives. Manufacturing often measures first pass yield and reject rates, but every process can be measured. If the process owner doesn’t measure performance, how does the process owner know that all the required work is getting done? The seventh step also is where the auditor can sample and review monitoring and measurement of processes, and the trend analysis can be verified to be an input into the CAPA process.

In my brief description of the process approach I used the incoming inspection process. I typically choose this process for training new auditors, because it is a process that is quite similar in almost every company and it is easy to understand. More importantly, however, the incoming inspection process does a great job of covering more clauses of the Standard than most audits. Therefore, new auditors get a great appreciation for how almost all the clauses can be addressed in one process audit.

If you have questions, or you would like a copy of the turtle diagram I use for documentation of audits, please submit a request on my website contact us page.

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  1. […] a blog post about it on his blog QC Is Dead (Rob also has another blog RA Review). The blog post is “How to Train an Auditor on the Process Approach”. Nevermind if you’re not an auditor. In fact, it doesn’t matter if you are an auditor […]

    • Thank you for the link to my blog Jon. I appreciate it. Hopefully your readers will enjoy it as much as I have enjoyed your postings.

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