13485cert

How to recruit, hire and train an auditor

In Internal Auditing, ISO 19011, Supplier Audit, Supplier Audits, Supplier Qualification, Training on December 24, 2012 at 11:44 pm

Part 3: Training

Passing a webinar on auditing does not make you competent.

Does your company ask incoming inspectors to update CAD drawings when there is a design change? Of course not. Your company has engineers that are trained to use SolidWorks, and it takes a new engineer a while to become proficient with the software. Auditing is a skill that you learn—just like SolidWorks.

My favorite holiday movie…I’ll be watching this later tonight!

I’ve never met a manager that wondered where the value was in having an engineer update a drawing, but many managers view internal and supplier audits as a necessary evil. Instead of asking the expert how few audit days you can get away with, ask the expert: “What is the purpose of auditing?”

The purpose of internal auditing is to confirm that the management system is effective and to identify opportunities for improvement. The purpose of supplier auditing is to confirm that a supplier is capable of meeting your needs and to identify opportunities for improvement. Therefore, if an auditor has no nonconformities and no opportunities for improvement were identified—what a waste of time!

To receive value from auditing, you need auditors that are competent. In clause 6.2.1 of the ISO 13485 Standard it says, “Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.” As the audit program manager, make sure you recruit people that demonstrate auditing competency.

Education

First, educational background is important for auditors. You cannot expect someone who has never taken a microbiology course in their life to be an effective auditor of sterilization validation. Likewise, someone that has never taken a course in electricity and magnetism will not be effective as an auditor for active implantable devices. Therefore, determine what types of processes the auditor will be auditing. Then make sure that the person you hire to be an auditor has the necessary education to understand the processes they will be auditing.

Training

Second, an auditor needs to be trained before they can audit. The auditor needs training in three different aspects: 1) the process they will be auditing, 2) the standard that is the basis for assessing conformity, and 3) auditing techniques. If you are going to be auditing printed circuit board (PCB) manufacturers with surface-mount technology (SMT), then you need to learn about the types of components used to make PCBs and how these components are soldered to a raw board. I know first-hand that anyone can learn how SMT works, but it took me a few months of studying.

If your company is only selling medical devices in the USA, then you will need to learn 21 CFR 820 (i.e. – the QSR). However, if your company also sells devices in Europe in Canada you will need to learn ISO 13485, the MDD (93/42/EEC as modified by 2007/47/EC), and the Canadian Medical Device Regulations (CMDR). I learned about ISO 13485 in a four-and-half day lead auditor course in Florida, I learned about the MDD in a three-day CE Marking Course in Virginia, and I learned about the CMDR in a two-day course taught by Health Canada in Ontario. A 50-minute webinar on each regulation is not sufficient for auditing.

Finally, you need training on the techniques of auditing. A two day course is typically needed. I took a 50-minute webinar and passed a quiz before conducting my first internal audit, but I was not competent.

Skills

Third, an auditor needs specific skills to be effective as an auditor. The most critical skills are: 1) communications skills, 2) organizational skills, and 3) analytic skills. Communications skills must include the ability to read and write exceptionally well and the auditor needs to be able to verbally communicate with auditees during meetings and interviews. The most difficult challenge for auditors is covering all the items in their agenda in the time available. The auditor rarely has more time than the need to audit any topic, and audit team leaders must be able to manage their own time as well as simultaneously managing the time of several other auditors. 

Experience

Last, but certainly not the least important aspect of auditor competency is experience. This is why 3rd party auditors are required to act as team members under the guidance of a more experienced auditor before they are allowed to perform audits on their own. This is required regardless of how many internal or supplier audits the person may have conducted in the past. More experienced auditors are also required to observe new auditors and recommend modifications in their technique. Once a new auditor has completed a sufficient number of audits as a team member, the auditor is then allowed to practice leading audits while being observed. After six to nine months, a new auditor is finally ready to be a lead auditor on their own. An internal auditor does not need the same degree of experience as a 3rd party auditor, but being shadowed 2-3 times is not sufficient experience for an auditor (1st or 2nd party). For more information about this topic, please read my blog posting on auditor shadowing.

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If you are an audit program manager, and you would like to improve your own competency, please contact me to learn about a new advanced course specifically for audit program managers. I am teaching a course with Brigid Glass. The course is designed specifically for audit program managers—not for inexperienced auditors. It will be a two-day course, and we are offering the course in three different cities: San Diego, CA (April 11/12), Orlando, FL (April 15/16) and Las Vegas, NV (April 17/18). Please Contact Me if you would like to learn more about the course.

Click Here

I am also teaching a one-hour, audio seminar with FX Conferences on January 9th:

“Are Your Suppliers Qualified? Prove It.”

This seminar will cover the areas of supplier qualification, supplier evaluation and supplier auditing. We already have a large number of companies signed-up for the seminar, and I am looking forward to having you join us.

This blog started as a single posting, but I realized that the blog was much too long. Therefore, I split the blog into three separate postings. This is the final “Part 3 of 3”. I hope you have enjoyed it. If you have suggestions for my next posting, please let me know.

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