It’s A Charlie Brown Audit


2019-bl-a-charlie-brown-audit-1-page-image

The holiday season is upon us. It’s that wonderful time of year where we reunite with kith and kin and revel in the spirit of the season. Of course, no holiday is complete without a TV special featuring Charlie Brown and the loveable Peanuts gang. Over the years, that hapless, round-headed kid with the black and yellow shirt has helped us celebrate nearly every holiday on the calendar.

I’m sure I speak for all fans when I say the Peanuts holiday shows are always a treat. No matter how many times we’ve seen the shows, we still make it a point to watch them every year, perhaps secretly hoping that Charlie Brown will actually kick the football, that Snoopy might take down the Red Baron or that the elusive giant squash will finally make an appearance and validate Linus’ obsession.

We all know the situations involving the Peanuts will never change. Charlie Brown will always amass a quarry of rocks in his trick-or-treat bag, Lucy will never get voted in as Christmas queen, and nothing shy of the apocalypse would ever convince Linus to part with his blanket.

The Peanuts have always been about tradition, and us die-hard fans wouldn’t have it any other way. But how would their traditional ways work if, say, the gang operated a medical device manufacturing company? Even more, how would they handle a regulatory audit? Since the “Charlie Brown Audit” TV special never aired, I have taken the liberty of rendering the scenario here.

The Call

As with all audit proceedings, Charlie Brown gets the call from the auditor to schedule the inspection. Naturally, only the Peanuts characters ever understand what is being said. To the viewing audience, offscreen voices always sound like someone is practicing the tuba. Anyway, Charlie Brown arranges a site visit and the gang is prepared to handle it in typical Peanuts fashion.

Design Documents?

Skipping over the grand entrance and introductions, the inspector wanted to jump right in and assess whether the Peanuts’ medical device was designed, verified and validated according to its intended purpose as well as meet users’ requirements. The inspector’s request to see the design history file seemed reasonable. He envisioned seeing things like R&D data, a design matrix, risk analysis and maybe even a Failure Modes and Effects Analysis (FMEA). Instead, the gang presents a rough sketch of a pumpkin face that Violet drew on the back of Charlie Brown’s head.

Documentation and ‘Enforced’ Training

Lucy, the gang’s resident fussbudget and self-appointed boss of everyone, is in charge of standard operating procedures (SOPs) and training. She crafts the documents and personally sees to it that they are followed exactly to her specifications. Her SOPs are known for being brief and to the point:

    white paper icon

    Enjoying this article? You may also like the MasterControl Manufacturing Excellence ROI Calculator:

     

    Try the ROI Calculator
  • “Everybody is entitled to my opinion.”
  • “I’m always right.”
  • “Do everything my way, or else!”
  • “I’ll hold the football …”

Snoopy is the most versatile one of the gang and does a lot of different tasks, including helping with documentation. His skills and resourcefulness are unmatched. I dare say not even MacGyver could construct a single-engine fighter plane with invisible weaponry out of a doghouse. Still, despite Snoopy’s seemingly polymathic abilities and level of superiority, he insists on writing all the documents on paper using an antique typewriter. Then, he enlists the services of a navigationally-challenged bird to deliver the documents to the contributors for revisions and signatures.

Corrective and Preventative 'Attempts'

It’s a given that product and process nonconformances will occur in medical device manufacturing. This is where corrective and preventive action (CAPA) comes in. To assess their CAPA processes, the inspector casually asks Charlie Brown about things like quality data, trending, root cause and probable cause investigations and how complaints are escalated.

The freckle-faced, sandal-wearing Peppermint Patty oversees the CAPA processes. Even though she has all the charm and intellect of a feather duster, we enjoy her spunkiness and love of sports. She does have a keen ability to collect and analyze data — as long as it involves the stats of major league baseball players. However, outside of telling her bespectacled sidekick, Marcie, to stop calling her “sir,” Patty’s only experience with launching a CAPA was when her team gave up three runs in the seventh inning over the weekend.

The Shop Floor

Continuing the tour, the inspector asked to visit the manufacturing areas. The ability to present items like clean room certification, environmental monitoring records and deviation or nonconforming material reports (NCMRs) is usually helpful during an audit. Also, according to the U.S. Food and Drug Administration’s (FDA) guidance for devices labeled as sterile, regulatory inspectors appreciate seeing documentation that supports that claim.(1)

When Charlie Brown and the auditor arrive at the first manufacturing station, it turns out that having those materials and documents probably wouldn’t help much. Due to an apparent miscue between their enterprise resource planning (ERP) and manufacturing execution systems (MES), Pigpen was assigned to operate the “sterile” manufacturing equipment. The inspector further scanned the premises and looks quizzically at Charlie Brown, muttering something about noticing a distinct aroma of popcorn and buttered toast.

Linus to the Rescue

Obviously, the gang’s audit experience has become a lengthy warning letter waiting to happen. Needless to say, Charlie Brown is beside himself. He is also beside a tree, leaning his head against it, contemplating how they can remedy yet another ill-fated situation.

For decades, we have been amused and warmed by the day-in-the-life events and antics of the beloved blockhead Charlie Brown and the Peanuts gang. And they have never deviated from the traditional Peanuts rubric. Still, there is a lot we can learn from this motley group, especially Linus. Behind that security blanket is a wealth of valuable insight. “Never jump into a pile of leaves with a wet sucker.” Advice of that caliber is priceless. And there is more where that came from:

  • Although it might be nice to have Lucy stay in a siloed environment, that’s not a good method for creating SOPs the staff can actually use. Integrating business unit-specific systems and using a centralized data repository is the best way to produce complete, up-to-date and accurate documents. It also helps with setting up training processes that are more effective than Lucy’s bare-knuckled approach.
  • Rather than waiting for data to come to you, digitizing data collection and analysis lets you quickly detect and resolve deviations and nonconformances before Peppermint Patty needs to launch a CAPA.
  • The Great Pumpkin isn’t going to find itself. Predictive analytics is the only way to pinpoint the sincerest pumpkin patch where an extraterrestrial vegetable will most likely appear.
  • Everyone knows that Snoopy’s typewriter is iconic to his role of “world-famous writer.” But let’s face it, paper will only lead you down a path of errors, duplicated efforts, misrouted documents and production delays.

Process innovations are as important as product innovations. The medical device industry is still seeing high numbers of Form 483s and warning letters for data- and documentation-related infractions that could be prevented with the right technologies. Transitioning to a digitized, paperless operation would even enable the Peanuts gang to operate an effective and productive manufacturing environment.

 


Reference

“Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile,” U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-information-premarket-notification-510k-submissions-devices-labeled





2019-bl-author-david-jensenDavid Jensen is a content marketing specialist at MasterControl, where he is responsible for researching and writing content for web pages, white papers, brochures, emails, blog posts, presentation materials and social media. He has over 25 years of experience producing instructional, marketing and public relations content for various technology-related industries and audiences. Jensen writes extensively about cybersecurity, data integrity, cloud computing and medical device manufacturing. He has published articles in various industry publications such as Medical Product Outsourcing (MPO) and Bio Utah. Jensen holds a bachelor’s degree in communications from Weber State University and a master’s degree in professional communication from Westminster College.