QA From The IRT Specialist's Perspective


Jim Graffam, Cenduit’s VP of Quality Assurance, provides insights into the world of auditing and how to use technology to streamline the auditing process and improve the auditor experience.



Lex Raleigh: Welcome back to Cenduit Quickcasts. I'm your host, Lex Raleigh. My guest today is Cenduit's head of quality, Jim Graffam. Welcome to the program, Jim.

Jim Graffam: Hi Lex. Pleasure to be here.

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Lex Raleigh: Thanks. One of the things that I wanted to start off with talking about is something that, for folks new to auditing or quality assurance, is the difference between practice and process. I know you and I have chatted about it a lot with R&D on the projects that we do, but can you say a few words about what is process, how it differs from practice, and why that difference is important?

Jim Graffam: Sure. Practice is where you reside in the day to day. That's the "how" you're going to execute against. In fact, it may be a practice of executing against a process, but it's everything that goes into getting the job done. The process of the controls, the process is the things that you have to do, the flows that you need to follow, that will assure a reliable outcome. As you know, here at Cenduit, we have a global quality system that's built up off of years of focus and centralization in the IRT industry. Those processes are there for a reason. They're there so that we can develop an IRT solution, allowing for a certain level of customization for any client that may come in, but also to keep us within the bounds of regulations, industry expectations, and individual client expectations based on their specifications.

How this relates to the audit experience is very, very, very important. An audit is to come in and observe. You have theses processes, now show me ... I can read them, and they're documented and that's great; now I want to look at some examples of how you actually follow your process, so it's a really big difference. The process elements are the direct observables and the things that are most important from an audit outcome.

Lex Raleigh: Okay. Do you think it's fair to say that a process is a documented practice, or is that an oversimplification of it?

Jim Graffam: It absolutely is, but the reverse can also be true. Your practice should be to follow a documented process to a large extent. I happen to know you're learned in the martial arts, as am I. Both of us started off as white belts once upon a time and we practiced, we trained, but there were certain things, there were certain katas, there were certain elements that were written down that we had to follow in order to be able to learn to demonstrate our basics in order to go up through the ranks and eventually to become the specialist in, to become a black belt, to have a level of expertise. That came because you practiced and applied your basics into a structured form. That's the analogy towards process.

Lex Raleigh: Great. I really like that analogy, too, because it really speaks to the evolution, but then also the interplay between the practice and the process. As your practice evolves, the process could evolve as well. The goal is to make sure they're in sync.

Jim Graffam: Neither grows too far beyond the other. It's a very symbiotic relationship there.

Lex Raleigh: One of the things I like about that, as well, is that speaking to the evolution, which we're going to come now to auditing. Tell me about what the audit process is about. Does it have anything to do with practice and process, and what are the auditors looking for in this?

Jim Graffam: It has everything to do with practice and process. Let's take a step back and talk about what an audit is. An audit is an examination of your documented structure, documented evidence of your general capabilities. An external auditor may come to us from a client. Ideally they want to do business with us. They will come in and they'll want to know and have a high degree of confidence that we can do the job that they're going to ask us to do. They want to look at, what's your qualification to do your job? They're going to want to look at your background, your training, what training you had before you came here, what your job description is, and really begin to see that it's not just a suggestion of a capability. It's credible capability based on everything that I've come in for the last few days and been able to witness.

An audit may be a sponsor coming back in. They've given us work. We said that we were going to be able to do all these great and wonderful things. Now they want to come back and see that, Did you actually do it? Did you actually follow the process that you spoke so highly of when we visited you the first time? Did you execute it? Did you execute it with quality? They may be coming in to look at one, two, or more studies at a time, bringing in one, two, three, four auditors. They can vary in size, shape, and color.

Lex Raleigh: Right. That's great, too. That sort of explains to me why ... I've been here for a few years and I've seen the same companies come back. That sort of answers the question that, Why would a company come back and audit us again, either every year, every other year? As you're saying, they're looking for consistency. They're looking at, as our practices and processes evolve, have our documentation sets evolved with them, or are we still maintaining that quality?

Jim Graffam: Absolutely, and they have their processes as well. There may be several things that they need to do to qualify us for use to begin with. As we go and start talking about how important the audit experience is, it's important to recognize that any chance to be in front of the client and to demonstrate your expertise, to demonstrate how specialized you are, is a tremendous opportunity.

Lex Raleigh: Jim, let me play devil's advocate for a second. We've got an auditor, one of our clients, coming back to see us again. How is this not going to be a painful process for them? They're going to go through a mountain of documents. Is this going to be fun for the auditor, or are they going to be waiting anxiously to get done with it and get on with their business?

Jim Graffam: A lot of times, this is their role. They are practiced; they are trained in going into somebody else's company, spending two or three days, so yes. It can absolutely be a painful experience if they're not provided the information that they need in the time frame that they need it. Spending two to three days reviewing documentation, it's not always the most exciting job in the world. There's a certain level of expertise and a certain level of patience that a person must have to go from one company to another company to another company. You definitely have to respect the expertise of the person sitting across the table from you coming in. You want to make that as easy an experience as you can. All they want to do is see that we have the capabilities to do something, or that we did exactly what we said we were going to do.

Lex Raleigh: How are we making it easy for the auditors to achieve this in what's a remarkably short period of time, as you mentioned, coming in and learning who we are and what we're doing and then evaluating against that in just a day or two?

Jim Graffam: My practice in hosting audits is to give them absolutely everything that they might need and allow them to filter based on where their interests are and what direction they want to take. Sometimes you'll have a spoon feeding effect, where, okay, you want to see this document? I will give you this document. I'm much more of the practice of, here's our entire global quality system. We've done something very interesting in the last six to nine months that has gotten some tremendous reviews by the auditors that have come here. We've technologically enabled our audits. We are now using iPads exclusively as reading stations for any audit that we hold. An auditor will come in, or one or two or three or more, and waiting for them is a reading station.

There's an iPad sitting there waiting for them. It has a nice little welcome screen customized for them as well as the key to the guest wireless. Give them a chance to get comfortable, have some coffee, and alongside with the great technological implementation, hard copies all ready, stuff that they can take home, stuff that they can put in their audit report, stuff that they can write on so they don't have to make notes at every last thing that we covered during the opening presentation. We have a global quality system. All of our processes, all of our procedures, all of our work instructions, all of our forms and templates, everything's pre-populated on them and it's the exact same content that's pushed to all the iPads being supported in the room. They will be able to see everything at their fingertips. They'll be able to open up multiple windows. They'll be able to, using multi-gesturing, switch between documents right there without having to share and audit binder. Everybody can look at the same content at the same time and do it in a fast manner.

Lex Raleigh: Right. That sounds like a great enabler, so you're really streamlining the process of the auditors coming in and having access to everything they need in a format that's quick and convenient. Is the benefit, then, that they get up to speed quicker, ask more relevant questions? What else would be a benefit of that?

Jim Graffam: Absolutely. The feedback we've received, speed is a big thing. The ability to get through as much as they want to and having the option to pick and choose what they look at. Let's look at the case of a surveillance audit, an audit where they're coming back in to see that we've performed as we said we would perform. We built one or more studies for them. They come in, we push the entire study onto the iPad. You name it, it's there for everybody to look at. Complete transparency. Pushing something onto an iPad is quick. Why wait?

Lex Raleigh: Right. It sounds like a great improvement and, Jim, I'll give you credit that you almost made me want to be an auditor, making it sound so quick and easy. Not quite, though.

Jim Graffam: Almost. I can understand that.

Lex: You're very good at what you do.

Jim: We appreciate R&D supporting the audits as you always do.

Lex: Well, it's been my pleasure to be a part of that. Jim, I really appreciate you coming out today. It's been great. Always a pleasure talking to you and your insights are always interesting. Jim, thanks for taking the time today.

Jim: No, thank you. Any opportunity to demonstrate really the level of pride that we have in facilitating the audit experience is a great opportunity, so thank you for having me.

Lex: My pleasure. Thank you all for listening. I'm Lex Raleigh. See you next time.