Guest Column | August 25, 2020

How Storyboarding Can Bring Clarity To Regulatory Inspection Readiness & Facilitation

By Penelope Przekop

Comic Drawing

Developing storyboards for regulatory inspection readiness and facilitation is a growing trend, yet the tool is shrouded in mystery for many pharma industry professionals. Storyboarding is a powerful approach for boiling down your company’s unique drug development journey into compartmentalized, positive short stories or messages that clarify pivotal points in time or scenarios. They provide a framework for creating clear messaging that can be consistently communicated by the inspection team. This is particularly needed for situations when opportunities for company growth, mitigation of existing gaps, and/or other unique compliance scenarios were self-identified and action was taken to ensure compliance and enable forward movement. They ultimately serve to remove confusion, contradiction, and on-the-spot decision-making when addressing inspection questions about the most difficult, convoluted aspects of your product’s drug development story.  All companies have those; you are not alone.

Just like life, the drug development process is not perfect. And like people, each is unique. Inspection readiness strategies, plans, and activities are crucial for most pharma companies. Invariably, there are always complexities to explain considering the company’s evolution, growth, and development, whether your submission resulted from:

  • The incredible story of how five people morphed into a company of 250 by submission time
  • The exciting story of how your midsize company fearlessly navigated through the unavoidable need to change key vendors multiple times by submission time
  • The complex story of how your large company acquired five other companies and successfully harmonized processes as you moved closer to your third submission

If storyboards are so great, why such mystery? One reason is that inspection readiness processes and tools are not generally described in a standard operating procedure (SOP) nor should they be.  Special inspection readiness activities or the use of helpful tools, including storyboards, are not a regulatory requirement nor are they discussed in industry guidance. Why would they be? Regulators expect us to be inspection ready on day one, yesterday, and now. This being the case, why would the industry formally document our need to prepare for an inspection?  The underlying concept of getting ready is to appear as if you were always ready, right?  If the company requires an 18-month process to get ready to sit down at the table with an inspector for two or more weeks, what does that say about our expertise and compliance? So, instead of documenting our need to get ready and our methods for doing so in SOPs and such, inspection readiness practices are passed from quality and compliance professional to the next, in chilly industry conference venues, and through senior leader declarations like, “Assemble a task force,” and “We need a storyboard!” 

I first heard about storyboards about 20 years ago. Everyone else in the room seemed to know exactly what they were. I had the feeling that asking for clarification would expose me as inexperienced at a time when I was finally starting to be perceived as having some.  I decided that I could figure out what a storyboard was on my own; after all, it sounded like something I should have learned about in second grade. I’d Google it. Oh wait, there was no Google then.  Images of clarifying cartoons and advertising ideas flashed. Perhaps it’s a large white board that QA brings into the inspection room to relay the story?

Not quite.

Now, years later, storyboards are my go-to inspection readiness and facilitation solution, so I’ve decided to take the time to clarify what they are for anyone who feels hesitant to ask … although now you have Google.  

First, an analogy I call, “The Pharma Posse: A True Historical Account of a Rag Tag Team of Adventurers Out to Save the World”:

Imagine that five cousins of the author are asked to read this book so they can be interviewed about it on television. The book has all the right technical elements, including highly dimensional characters, perfect grammar, accurately researched information, stellar descriptions, etc. However, the scenes are not in logical order. Information is duplicated and at times contradictory. Both wonderful and concerning events are described in meticulously accurate detail, yet the ending is unclear. The main point of the story is a mystery.  Was the posse able to save the world or did they just give it a great shot and ride off in a blizzard of sparkling dust? The exciting conclusion hinted at in the title is fuzzy at best. The cousins are left confused.

Then, with their smiling author-cousin sitting next to them, each reader is asked by a famous television reporter:

“What is your cousin’s book about?”

“What’s the main point/message?”

“What happened in the end?”

“Can you summarize the plot?”

Each interprets the book differently and attempts to answer the reporter, whose 5 million viewers are dialed in.

As the answers are provided, the confused reporter asks more and more clarifying questions …. until finally both the mentally exhausted reporter and the viewers are forced to come to their own conclusion, which is not a good one. 

The last thing you want during an inspection is for a confused inspector to come to his own negative conclusion because no one can relay the facts in a consistent and clearly understandable message that provides confidence that the company took the actions necessary to ensure data integrity and patient safety.

Storyboards are the solution, if developed and used as intended.

What Is A Storyboard

A storyboard is a one- to two-page document formatted in a way that enables the development of a consistent, factual, and positive message that can be delivered confidently by all those questioned and provide an accurate high-level response that satisfies the inspectors’ question(s) as quickly as possible. Storyboards help avoid additional questions or exploration on a topic. They also serve as a quick reference guide for obtaining additional information and applicable documentation, if needed. For an example of a completed storyboard, download the attached template (Word format).

Storyboards play a specific role in inspections. It is important to remember how they should not be used:

  • Storyboards do not duplicate or conflict with available Trial Master File (TMF) documentation, SOPs, or other standard documents. Instead, they should reference those documents.
  • They are not intended to provide detailed negative statements and information about an issue that can trigger subject matter experts (SMEs) to inadvertently communicate a not so positive message or pepper their responses with words with negative connotations.
  • They are not long documents filled with background information needed to piece together an answer. SMEs should not be required to interpret storyboard content and decide how to provide it, what to say, how to say it, etc. 
  • Storyboards are not to be provided directly to an inspector; they are internal documents.
  • And lastly, storyboards should not be created for minor issues or those that are clearly and easily explained to inspectors through existing documentation. Doing so overcomplicates the approach.

What Topics Are Best Suited For A Storyboard?

Storyboards are particularly well suited for situations that are difficult to explain and can easily lead to confusion and contradiction during an inspection. You may already have CAPAs, plans, etc. for your storyboard topics. In fact, there may be several CAPAs or sets of documentation that link together to cover the scenario.  Like the five readers in my analogy, if you provide all this great documentation to SMEs in preparation for an inspection, each will likely end up crafting a vastly different explanation of what occurred, why it happened, and the actions taken to remediate the gap. If your company faced an issue that was not fully documented at the time, the risk of confusion and contradiction skyrockets.  Developing a storyboard enables the company to condense the surrounding detailed information into a concise, accurate explanation of what occurred, why it occurred (root cause), and how it was remediated.  The goal is to provide high-level information to address the question asked.  If more detailed questions follow, the storyboard serves as a reference to the more detailed information and documentation to support your high-level response.  

What Are The Key Elements For A successful Storyboard?

Successful storyboards are written in an active, positive voice while remaining honest and clear.  The storyboard should be no more than one to two pages and should include the following:

  • A statement indicating that the company self-identified the gap or issue described in the storyboard: Who or what department identified the issue is too much detail. The company self-identified, accepted responsibility, and went forward to mitigate the situation.
  • A succinct high-level statement of the issue that was self-identified by the company, including when the self-identification occurred: Depending on the nature of the issue, this can be a year, a quarter of a year, or an exact date.
  • Brief background information: not more than one or two paragraphs
  • A list of key actions taken once the issue was identified. These should be short, powerful statements rather than long-winded sentences filled with details.
  • All the above should be written using words and phrases with positive connotations such as self-identified, acted, resolved, investigated, placed priority, remediated, resolved, etc.  
  • Dates should always be included when available. Make sure that all dates are in chronological order.
  • A brief statement regarding the regulatory risk or impact of the issue. This helps the reader understand the gravity of the situation under discussion.
  • A reference/documentation list where additional information can be located. Embed links to the information, if possible.
  • A list of supporting documents that can be provided to the inspector if requested. Embed links to the documents, if possible.

How Are Storyboards Used During Regulatory Inspections?

Storyboard development and study prior to the inspection are powerful activities for inspection preparation. However, the value of the storyboard extends into inspection facilitation. During the inspection, a great set of storyboards can be used for SME preparation prior to meeting with the inspector, as a reference for additional information, and for applicable supporting documentation. The first key to successful storyboard use during your inspection is to have great storyboard content. Once you have that, it is important to understand that being able to quickly refer to storyboards during the inspection will hinge on how you have titled and organized your full set of storyboards. The storyboard title should clearly and accurately relay the storyboard topic and be consistent between the document, file name, and any lists of storyboards that are being used during the inspection. Any member of your inspection team should be able to identify quickly and accurately the relevant storyboard. Leave no room for confusion! 

Download this editable storyboard template (Word format) and put it to use in your organization.

About The Author:

PenelopePenelope Przekop, MSQA, RQAP-GCP, partners with pharma and biotech companies of all sizes to develop risk-based strategic solutions for establishing (or enhancing) clinical and pharmacovigilance quality systems that support growth and ensure long-term compliance. She has 25-plus years of industry experience in strategy development, quality systems and assurance, inspection readiness, and organizational training. Przekop has held leadership positions in both Big Pharma and CROs, including Novartis, Covance, Wyeth, and Johnson & Johnson. She is the author of Six Sigma for Business Excellence (McGraw-Hill) . Her upcoming book, 5-Star Career: Why You Don’t Have Yours Yet and How to Get It (Productivity Press), launches in 2021.