A five-day lead auditor course is never enough. Effective quality auditor training must include practical feedback from an expert.
What is required for quality auditor training?
The key to training auditors to audit is consistent follow-up over a long period of time (1-2 years, depending upon the frequency of audits). I recommend following the same training process that accredited auditors must complete. I have adapted that process and developed seven (7) specific recommendations.
Training the trainer
One of my clients asked me to create a training course on how to train operators. I could have taught the operators myself, but so many people needed training that we felt it would be more cost-effective to train the trainers. Usually, I have multiple presentations archived that I can draw upon, but this time I had nothing. I had never trained engineers on how to be trainers before—at least not formally. I thought about the problems other quality managers have had in training internal auditors and how I have helped the auditors improve. The one theme I recognized was that effective quality auditor training needs to include practical feedback from an experienced auditor. An expert auditor that is training new auditors needs to identify systematic ways to provide feedback, and setting a benchmark for the number of times feedback will be provided is really helpful.
Improve by observing yourself and other quality auditors
Observing someone else is a great way to learn when you are learning any new skill. Interns often do this, which is also a technique used to train new auditors. This technique is called shadowing. You can learn by watching, but eventually, you need to try to do tasks that are beyond your comfort level, and it is best to practice auditing with an expert watching you.
Practice team member audit preparation
Many of the internal auditing procedures we see require new auditors to conduct three audits as team members before they can audit independently. In contrast, notified body auditors join as team members for 10-20 audits before they can act as lead auditors. During the training period, auditors in training observe multiple lead auditors and multiple quality systems. Each audit allows auditors in training to write nonconformities and receive feedback from a lead auditor. At the beginning of quality auditor training, the focus must be on audit preparation. What are the areas of importance, what are the results of previous audits, are there any previous audit findings to close, etc? This preparation can even be done as practice for a hypothetical audit.
During quality auditor training, practice the opening and closing meetings
Opening and closing meetings are one of the first things to teach a new lead auditor. Have new lead auditors rehearse their first few opening and closing meetings with you in private before conducting the opening and closing meetings. Ensure the lead auditor has an opening/closing meeting checklist to help them. Recording practice sessions is enormously helpful because the trainee can watch and observe their mistakes. As trainees get more experience, the opening and closing meetings should have time limits. Finally, you might ask members of top management to challenge the lead auditor with questions. The lead auditor needs to be comfortable with their decisions and the grading of the audit findings.
How to practice audit team leadership
Have new lead auditors conduct team audits with another qualified lead auditor for 10-20 audits before you allow them to conduct an audit alone. Leading the opening and closing meetings is usually the first area new lead auditors master. The most complicated area to learn is managing a team of auditors. Team members will fall behind schedule during audits, or someone will forget to audit a process. As a lead auditor, you must complete the audits for your assigned processes and communicate with the entire team to ensure everyone else is on schedule. As an observer, you must let lead auditors make mistakes and help them realize them. Initially, a trainer will encourage new lead auditors to give themselves more than enough time. As their training progresses, the timing needs to be shorter and more challenging. Ultimately, you have to push the team beyond its capability to teach new lead auditors to recognize problem signs and teach them how to fix the problems.
Shadow auditors virtually with recordings
Live shadowing is challenging for experts and trainees because you are distracted by listening to the auditee and observing the auditor. However, if an audit is recorded, the person shadowing can watch the recording. The audit is already completed, and there is little need to concentrate on the auditee. A recording allows the observer to focus on the auditor. If a new auditor is conducting their first audit, an expert should shadow the trainee for 100% of the audit. Gradually the observation can decrease with each subsequent audit.
Practice note-taking with recorded audits
Taking detailed notes is something that experts take for granted, but I learned a lot by watching FDA inspectors take notes during an inspection. Have a new auditor observe a few audits before they are allowed to participate. Make sure they take notes and explain what you are doing and why they are observing as you conduct audits. Review the notes of new auditors periodically throughout the audit to provide suggestions for improvement and identify missing information. You can also record a supplier audit or internal audit and let a new trainee take notes on the pre-recorded webinar. This eliminates the need to coordinate schedules to involve the trainee.
Quality auditor training should include practicing audit agenda creation
Have new lead auditors submit a draft audit agenda to you before sending it to the supplier or department manager. Usually, the first audit agenda will need revision and possibly multiple revisions. Make sure you train the person to include enough detail in the agenda, and using a checklist or template is recommended. The agenda creation will be part of the audit preparation, and it can be done without time pressure.
How do you audit the auditing process?
Most quality managers are experienced and have little trouble planning an audit schedule. The next step is to conduct the audit. The problem is that there is very little objective oversight of the auditing process. The ISO 13485 standard for medical devices requires that “Auditors shall not audit their own work.” Therefore, most companies will opt for one of two solutions for auditing the internal audit process: 1) hire a consultant or 2) ask the Director of Regulatory Affairs to audit the internal auditing process.
Both of the above strategies for auditing the internal audit process meet the requirements of ISO 13485, but neither approach helps to improve an internal auditor’s performance. I have interviewed hundreds of audit program managers over the years, and the most common feedback audit program managers give is “Change the wording of this finding” or “You forgot to close this previous finding.” This type of feedback is related to the report-writing phase of the audit process. I rarely hear program managers explain how they help auditors improve at the other parts of the process.
When auditors are first being trained, we typically provide examples of best practices for audit preparation, checklists, interviewing techniques, AND reports. After auditors are “shadowed” by the audit program manager for an arbitrary three times, the auditors are now miraculously “trained.” Let’s see if I can draw an analogy to make my point.
That kind of sounds like watching your 16-year-old drive the family car three times and then giving them a license.
About the Author
Robert Packard is a regulatory consultant with 25+ years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at 802.258.1881 or by email. You can also follow him on LinkedIn, Twitter, and YouTube.