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The Audit Program Manager: 4 Areas of Auditor Competency

rookie The Audit Program Manager: 4 Areas of Auditor Competency

Passing a webinar on auditing does not make you competent.

This blog reviews an audit program manager’s four areas of auditor competency; experience, skills, training and education.

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 awhile to become proficient with the software. Auditing is a skill that you learn—just like SolidWorks.

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 identify opportunities for improvement. The purpose of supplier auditing is to confirm that a supplier is capable of meeting your needs, and 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 states, “Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.” As the audit program manager, ensure 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 ensure 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 United States, then you will need to learn 21 CFR 820 (i.e., – the QSR). However, if your company also sells devices in Europe or in Canada, you will need to learn ISO 13485, the Medical Device Directive (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-a-half day lead auditor course in Florida,  MDD in a three-day CE Marking Course in Virginia and 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 had not developed my skills at that point. 

Skills

Third, an auditor needs communication, organizational and analytical skills to be effective as an auditor. 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 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 third-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 third-party auditor, but being shadowed two-three times is not sufficient experience for an auditor (first or second-party). For more information about this topic, please read my blog posting on auditor shadowing.

Posted in: ISO Auditing

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Instructor Effectiveness and the Power of a SNICKERS

The author discusses his personal experience attending a training class, instructor effectiveness and reasons why he learned so much there.

I guess there are still some instructors out there that need to be reminded that we can all read the regulations on our own. We don’t need to pay $1,000+ per day in order to have someone read stuff for us. If that’s what you want, my 10-year old son is a fantastic reader. He’ll record anything you want, in any media format, for a much smaller dollar figure. If you want to learn something that is worth at least as much as your investment of time and money, then you need to find an instructor that can teach effectively.

Four Prerequisites for a Great Instructor:

1. The instructor must be an expert

2. The instructor must inspire participation

3. The instructor must provide practical examples for each student

4. The instructor must get everyone’s attention–and keep it

The most important determining factor of training effectiveness, however, occurs after the course is over When you are teaching quality assurance and regulatory affairs, you must develop your ability to inspire and engage students to Olympic medalist proportions. “Blah, blah, blah…” and “Death by PowerPoint” will get you fired. Don’t read your slides, don’t turn your back on the audience (or they’ll attack) and PLEASE don’t ever ask someone to read the definition of nonconformity out loud to the rest of the group. When I teach a class, you demand my best. I’m six-foot, six inches tall and I have a loud booming voice. My mother has red hair and she was an opera singer. I’ve got the voice to fill any auditorium and stage presence to match. But if you even start to nod off in class, I may just have to throw a Snickers bar at you.

snickers Instructor Effectiveness and the Power of a SNICKERS

This is an essential tool for any instructor. It functions as a tool to prod sleeping students awake, is small enough to cause minimal injury when thrown, serves as an emergency food supply and is gluten free.

If legal counsel recommends against using projectiles to encourage class participation, you might also consider one of my all-time genius ideas. I was scheduled for a two-day course in Ottawa, but the day before I needed to perform an audit in Pennsylvania. Therefore, my flight was the last flight into Ottawa–arriving at approximately 1 a.m. My flight was delayed more than an hour, and the person in front of me was trying to smuggle an extra carton of smokes into the country. Just before 4 a.m. my taxi arrived at the Albert at Bay Suite Hotel. Class started at 8 a.m. I made it to class on time, and excessive consumption of several pots of black coffee helped get me to lunch. Then my legs started getting a little wobbly. Fortunately, there was a convenience store next door that sold my favorite chocolate–the Dark Aero bar! After four of these monstrous doses of cacao, and another pot of coffee, I could have listened to the lecture on Canadian Medical Device Regulations all night.

aero bar Instructor Effectiveness and the Power of a SNICKERS

Hershey’s copied them, but the result was a mere shadow of Nestle’s greatness. Canadians know how to make junk food, tell a joke and play hockey!

Lessons Learned

Despite the physical handicap of sleep deprivation, I still learned a ton from my course in Canada. Here’s why:

1. The instructors were experts. Both instructors were regulatory experts and Canadian. Both instructors taught this course twice a year for multiple years, and one of the instructors actually worked for Health Canada.

2. The instructors were blessed with the perfect audience that was hyper-motivated to pass the course. Everyone in the class worked for a Notified Body that had sponsored them to take the course. In order to stay employed and get a raise, I needed to pass that course. If I failed the exam, I had to absorb the cost to travel back to Ottawa and retake the course in February (BRRRR!).

3. Everyone has different experiences and therefore not every example makes sense to us. Therefore, instructors need to use practical examples that are actionable. In  this course, the instructors brought more than a dozen medical devices to the class. We studied the labeling and intended use of each device. Even students from Japan, Europe and Australia were familiar with some of the products. This was critical, because we all needed to be able to identify incorrect Canadian labeling.

4. The greatest asset of all was the humor of the instructor from Health Canada. He was hilarious. He had everyone laughing at his jokes for the entire course. Most of the jokes were not funny enough for a stand-up routine, but this was a mandatory regulatory course on Canadian regulations. Who would even expect a chuckle. Despite the strengths of these instructors, there is only one reason why I know the Canadian Medical Device Regulations (CMDR) as well as I do. I use them every single week.

Some Examples of How I Used the CMDR:

First, I had to audit 162 days for BSI in 2011. Ninety percent of those 162 days were for companies that required a Canadian Medical Device License. Therefore, I started auditing companies to the Canadian regulations immediately after the course. Second, I was also consulting for companies at the same time I was auditing for BSI. Consulting clients hired me to prepare and submit Canadian Medical Device License Applications for them. I also had to revise and create new procedures specific to the Canadian regulations. I spent another 60+ days in 2011 doing consulting. Finally, I was one of BSI’s instructors that taught the regulatory comparison course, which compared the regulations of the USA, Canada, Europe, Australia and Japan.

Therefore, at least once a month, I had a classroom of 6-20 people asking me challenging questions about how to interpret and apply regulations from each of these countries to their products. I used every bit of knowledge I learned in that course in Ottawa and I started using that knowledge immediately after the course. I had peers, superiors, clients and students challenging my knowledge of these topics every day. This is what makes you a subject matter expert. If you need to learn something about Quality Assurance or Regulatory Affairs, a one-hour webinar, reading a blog, taking a five-day, or shadowing another more experienced person is not enough. In the end, all of the above will get you to the level of barely competent!  If you want to learn, you need a great instructor. Then you need to use everything you learned at every opportunity for several years. Some say, “If you can’t do, teach.” I say, “Bring a SNICKERS bar and throw it at them for faking it.”

Posted in: ISO Auditing

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ISO 14971 Risk Management Training: Lessons Learned

%name ISO 14971 Risk Management Training: Lessons Learned

The author discusses the four levels of the Learning Pyramid and lessons learned when he taught an ISO 14971 Risk Management course.

I am in Canada, it’s almost midnight, and my client has me thinking so hard that I can’t sleep. I am here to teach the company’s Canadian facility about ISO 14971:2007—the ISO Standard for Risk Management of medical devices.

Most of the companies that request this training are doing so for one of two reasons: 1) several of their design engineers know almost nothing about risk management, or 2) they have several design engineers that are quite knowledgeable with regard to risk management, but these engineers have not maintained their credentials, and their last risk management training was related to the 2000 version of the Standard. This company falls into the second category.

I always tell students that I learn something by teaching each course. From this company, however, I have learned so much. This company has forced me to re-read the Standard a number of times and reflect on the nuances of almost every single phrase. I have learned more about this Standard in one month than I learned in the 3.5 years since I first took the course I am now teaching. 

4 Levels of the Learning Pyramid

I have developed a model for learning that explains this phenomenon. I call this model the “Learning Pyramid.” At the base of the pyramid, there are “Newbies.”

This is the first of four levels. At the base, students read policies and procedures with the hope of understanding.

In the second level of the pyramid, the student is now asked to watch someone else demonstrate proper procedures. One of my former colleagues has a saying that explains the purpose of this process well, “A picture tells a thousand words, but a demonstration is like a thousand pictures.” This is what our children call “sharing time,” but everyone over 40 remembers this as “show and tell.”

In the third level of the pyramid, the student is now asked to perform the tasks they are learning. This is described as “doing,” but in my auditing courses, I refer to this process as “shadowing.” Trainees will first read the procedures for Internal Auditing (level 1). Next, trainees will shadow the trainer during an audit as a demonstration of proper technique (level 2). During subsequent audits, the trainees will audit and the trainer will shadow the trainee (level 3). During this “doing” phase, the trainer must watch, listen and wait for what I call the “Teachable Moment.” This is a moment when the trainee makes a mistake, and you can use this mistake as an opportunity to demonstrate a difficult subject.

Finally, in the fourth level of the Learning Pyramid, we now allow the trainee to become a trainer. This is where I am at—so I thought. I am an instructor, but I am still learning. I am learning what I don’t know.

The next step in the learning process is to return to the first level. I am re-reading the Standard and procedures until I really understand the nuances that I was unaware of. Then, I will search for examples in the real world that demonstrate these complex concepts I am learning. After searching for examples, I will test my knowledge by attempting to apply the newly acquired knowledge to a 510(k) or CE Marking project for a medical device client. Finally, I will be prepared to teach again.

This reiterative process reminds me of the game Chutes and Ladders, but one key difference is that we never really reach the level of “Guru.” We continue to improve, but never reach our goal of perfection…For further inspiration, try reading “Toyota Under Fire.”

Posted in: Risk Management

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Auditing: Effective Training in 7 Steps

Effective auditing requires effective training. Our author, who has extensive experience, provides 7 steps to effectively train new auditors.

Recently, a client asked me to create a training course on how to train operators. I could have taught the operators myself, but there were so many people that 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 what kinds of 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 most auditors needed feedback.

Deming Cycle

I finally decided to use the Deming Cycle (Plan-Do-Check-Act, (PDCA) as my framework for the training. Most QA Managers are very 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 for medical devices Standard 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 meet the requirements of the ISO 13485 for medical devices Standard, but neither strategy helps to improve  internal auditor’s performance. I have interviewed many audit program managers, maybe 50+, and the most common feedback 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 the auditors have been “shadowed” by the program manager for an arbitrary three times, the auditors are now miraculously “trained.” Let’s see if I can draw an analogy that will 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. I guess that’s why my new Ford Festiva was severely dented on all four sides within six months. You may think my father was a Saint, but I think he might have totaled his tenth car by age 18. At least I contained the damage to one vehicle.

Effective Auditing Requires Effective Training For New Auditors: 7 Steps

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) seven specific recommendations:

1. 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, as you conduct audits they are observing)

2. Have new auditors participate as team members for 10-20 audits, before they are allowed to act as a lead auditor

3. 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

4. Shadow new auditors for 100% of their first audit and gradually observe less with each subsequent audit; try to plan the shadowing into your audit agenda

5. Review the notes of new auditors periodically throughout the audit to provide suggestions for improvement and identify missing information

6. Have new lead auditors submit a draft audit agenda to you before submitting it to the supplier or department manager

7. Have new lead auditors rehearse their first few opening and closing meetings with you in private before conducting the opening and closing meeting (make sure they have an opening/closing meeting checklist to help them)

The question is…was my training successful?

Well, how much follow-up training of the trainers did the client ask for?

Posted in: ISO Auditing

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