Testing in a Regulated World: An Interview with John McConda


John McConda is a senior consultant for Moser Consulting and cofounder of the Workshop on Regulated Software Testing (WREST). In this interview, Heather Shanholtzer and John talk about the challenges testers face in the regulated world and what participants can expect during a WREST session.

John McConda is a senior consultant for Moser Consulting and cofounder of the Workshop on Regulated Software Testing (WREST). John spent five years in the regulated world helping to create an FDA-validated testing process, and he lead a large testing effort for a federal government contractor. I had the opportunity to talk to John about the challenges testers face in the regulated world and what participants can expect during a WREST session.

Heather Shanholtzer: What are some of the common challenges faced by testers in regulated industries?

John McConda: Regulated testers are often told that there is only one way they are allowed to do their job. In my experience, this is either exaggerated or untrue. The constraints that do exist can create a challenge to test efficiently and effectively while meeting the standards of the regulation. These can be competing goals. I also hear from regulated testers who feel isolated from the larger testing community and trapped in this “boring” career.

Heather Shanholtzer: Do you think there is a place for agile methodologies in regulated industries?

John McConda: Yes, I do. My article for Better Software magazine, “Busted: 5 Myths of Testing Regulated Software,” contains interviews from practitioners who have incorporated agile methodologies for healthcare devices.

Heather Shanholtzer: What is WREST and what industry needs were met by its inception?

John McConda: WREST was formed in 2007 by Karen Johnson and me to help bring regulated testers together to share ideas and solve problems unique to our context. The format follows the original Los Altos Workshops on Software Testing, which created a unique facilitation structure designed to maximize input from all participants. We tell our stories; work through problems; and, depending on the preference of the group, we may produce a work that is published by all attendees. Anyone can publish what we create in the workshop, as long as credit is given to all attendees. Often, the work will be published on attendees’ blogs, professional papers, or on the wrestworkshop.com website.

Heather Shanholtzer: Who can participate in a WREST session?

John McConda: Anyone who wants to contribute! Every part of the day is interactive, so we rely on attendees to come ready to tell their stories, i.e., experience reports, and work through problems and new ideas.

John McConda: We utilize experience reports instead of formal presentations because experience reports are much less formal and serve as a starter to a dialog as opposed to a practiced monologue. Each experience report is usually about twenty minutes, and only clarifying questions are allowed, e.g., “What’s that acronym you just used?” Once the story is told, the forum switches to “open season” where everyone has the chance to start a new “thread” or ask a question on an existing thread. The discussion continues until all threads are exhausted or the group votes to move on to the next topic.

Heather Shanholtzer: What is the big takeaway you hope WREST participants gain from attending your session?

John McConda: Like the Michael Jackson song says, “You Are Not Alone.” I think there’s a tendency for regulated testers to rule out innovations that others take for granted because they hear so often, “We’re regulated, we can’t do that!” When we get together and share our experiences, I often find out that someone else has “done that,” and solved the same problems I’m dealing with now.

Heather Shanholtzer: Is there a specific focus for the WREST sessions this year? Will the focus be different at the STAREAST and Better Software West conferences?

John McConda: We’ve done specific topics before, including test automation, agile testing, regulation roadblocks, and regulation myths, but we’ve found that attendees like to lead the discussion in their own direction, so we’re going with an open format at both conferences this year.

About the author

Heather Shanholtzer's picture Heather Shanholtzer

As Software Quality Engineering's director of publishing, Heather Shanholtzer oversees content generation and dissemination for Better Software magazine, TechWell.com, AgileConnection.com, CMCrossroads.com, and StickyMinds.com.

After nearly ten years of helping software professionals find their literary side, Heather is still excited to discover new voices and she relishes the opportunity to work with industry experts, practitioners, and craftspeople.

If you would like to write for one of our publications, email Heather at HShanholtzer@sqe.com.

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