13485cert

How do you shadow an auditor? Did you learn anything?

In Elsmar Cove, FDA Inspections, Internal Auditing, ISO 13485, ISO 19011, Supplier Audit, Supplier Audits, Supplier Quality on November 25, 2012 at 5:43 am

If you are shadowing, you are taking notes so you can discuss your observations with the person you are shadowing later.

Somewhere in your procedure for “Quality Audits”, I’ll bet there is a section on auditor competency. Most companies require that the auditor has completed either a course for internal auditor or a lead auditor course. If the course had an exam, then you might even have evidence for training effectiveness. Demonstrating competency is much harder. One way is to review internal audit reports, but writing reports is just part of what an auditor does. How can you evaluate an auditor’s ability to interview people, take notes, follow audit trails, and manage their time? The most common solution is to require that the auditor “shadow” a more experienced auditor several times, and then the trainee will be “shadowed” by the trainer.

I can’t remember posting any music from John Mayer and the song title fits our subject for this blog.

Shadowing 1st Party Audits:

ISO 19011:2011 defines 1st party audits as internal audits. When 1st party auditors are being shadowed by trainer, or vice versa, there are many opportunities for training. The key successful training of auditors is to recognize teachable moments.

When the trainer is auditing, the trainer should look for opportunities to ask the trainee, “What should I do now?” or “What information do I need to record?” In these situations, the trainer is asking the trainee what they should do BEFORE they do it. If the trainee is not sure, the trainer should explain what, why and how at that moment with real examples.

When the trainer is shadowing, the trainer should watch and wait for a missed opportunity to gather important information. In these situations, the trainer must resist guiding the trainee until after the trainee appears to be done. When it happens sometimes the best tool is simply asking, “Are you sure you got all the information you came for?”

Here are five (5) mistakes that I have observed trainers make when they were shadowing:

1. Splitting up, instead of staying together, is one of the more common mistakes I have observed. This happens when people are more interested in completing an audit than taking every advantage of training opportunities. The trainee may be capable of auditing on their own, but this is no excuse for tag teaming the auditee. This is unfair to the trainee AND the auditee. If an audit is running behind schedule, this is the perfect time to teach a trainee how to recover some time in their schedule. Time management is after all one of the hardest skills for auditors to master.

2. Staying in the conference room, instead of going to where the work is done, is a common criticism of auditors. If the information you need to audit can be found in a conference room, then you could have completed the audit remotely. This type of audit teaches new auditors very little other than how to take notes. These are basic skills that auditors should master in a classroom prior to shadowing.

3. Choosing an administrative process is a mistake, because administrative processes limit the number of aspects of the process approach that can be practiced by an auditor-in-training. Administrative processes rarely have equipment that requires validation or calibration, and both the process inputs and outputs consist only of paperwork, forms or computer records. With raw materials and finished goods to process, the job of the auditor is more challenging because there is more to be aware of.

4. Not providing honest feedback is a huge mistake. Auditors need to be thick skinned or they don’t belong in a role where they are going to criticize others. Before you begin telling other people how to improve, you first need to self-reflect and identify your own strengths and weaknesses. Understanding your own perspective, strengths, weaknesses, and prejudices is critical to being an effective assessor. As a trainer, it is your job to help new auditors to self-reflect and accurately rate their performance against objective standards.

5. “Silent Shadowing” has no value at all. By this I mean shadowing another auditor without asking questions. If you are a trainee you should be mentally pretending you are doing the audit. Whenever the trainer does something different from the way you would do things, you should make a note so you can ask, “Why did you do that?” If you are trainer you should also be mentally pretending you are doing the audit. It is not enough to be present. You job is to identify opportunities for the trainee to improve. The better the trainee, the tougher your job becomes. This is why I training other auditors has helped me improve my own auditing skills.

Shadowing 2nd Party Audits:

If you are developing a new supplier quality engineer that is responsible for performing supplier audits, it is recommended to observe the auditor during some actual supplier audits. Supplier audits are defined as 2nd party audits in the ISO 19011:2011 Standard. The purpose of these audits is not to verify conformity to all the aspects of ISO 13485. Instead, the primary purpose of these audits is to verify that the supplier has adequate controls in place to consistently manufacture conforming product for your company. Therefore, processes such as Management Review (Clause 5.6) and Internal Auditing (Clause 8.2.2) are not typically sampled during a 2nd party audit.

The two most valuable process for a 2nd party auditor to sample are: 1) incoming inspection, and 2) production controls. Using the process approach to auditing, the 2nd party auditor will have an opportunity to verify that the supplier has adequate controls for documents and records for both of these process. Training records for personnel performing these activities can be sampled. The adequacy of raw material storage can be evaluated by following the flow of accepted raw materials leaving the incoming inspection area. Calibration records can be sampled by gathering equipment numbers from calibrated equipment in use by both processes. Even process validation procedures can be assessed by comparing the actual process parameters being used in manufacturing with the documented process parameters in the most recent validation or re-validation reports.

My recommendation is to have the trainee shadow the trainer during the process audit of the incoming inspection process and for the trainer to shadow the trainee during the process audit of production processes. In between the two process audits, the trainee should be asking questions to help them fully understand the process approach to auditing. Supplier auditors should also be coached on techniques for overcoming resistance to observe processes that may involve trade secrets or where competitor products may also be present. During the audit of production processes, the trainer may periodically prompt the trainee to gather information that will be needed for following audit trails to calibration records, document control or for comparing with the validated process parameters. The “teachable moment” is immediately after the trainee missed an opportunity, but while the trainee is still close enough to go back and capture the missing details.

Shadowing 3rd Party Audits:

Use your FDA inspections and ISO certification audits as an opportunity to shadow experienced auditors and to learn what they are looking for.

If you are going to shadow a 3rd party auditor, I recommend two specific people to “shadow” the auditor. First, the process owner should be the guide for whichever process is being audited. This is the person that will be responsible for addressing any nonconformities found in the area, and they should be present during interviews–although they should be coached on when to comment and when to remain quiet and simply observe.  Second, the person that performed an internal audit of the process being audited should be present if at all possible. This person will benefit from seeing how a professional 3rd party auditor performs a process audit, because they will know which things to look for in the future so that auditees in that area are prepared for the next external audit.

If you are an audit program manager, and you would like to learn “What Makes World Class Audit Programs Different?”, please contact me. I am co-teaching an advanced course for audit program managers in April 2013.

For other sources of information related to auditor shadowing, please check out the following links:

1. Internal Auditor Training – Shadowing external auditor? – from Elsmar Cove

2. Developing Supplier Quality Auditor Training Programs – by Seth Mailhot at NixonPeabody

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