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Feb 21, 2017

5 Reasons Why Leslie Knope Should Manage Your SOPs

Cool people make the rules,
they don’t break the rules.

by David Jensen


Marketing Communications

MasterControl


Compliance observations and warning letters regarding standard operating procedures (SOPs)—or the lack of—in life sciences manufacturing facilities are as common as fruitcake during the holidays. How can medical device and pharmaceutical manufacturers hope to reduce the exorbitant number of documentation infractions? Get Leslie Knope to manage your SOPs.

Those of you devoted fans of “Parks and Recreation” recognize Knope as the self-described, yellow-haired, waffle-loving deputy director of the Pawnee, Indiana Parks and Recreation department. Knope, played by the unflinching Amy Poehler, was an enthusiastic, naïve, by-the-book workaholic public servant with nothing but the best of intentions for her beloved town.


Before vacating her deputy director post to go off and build her political dynasty, Knope gave us a peek at her life in the political landscape having achieved all of her aspirations. However, if Knope ever decided to abdicate her post-Pawnee political pilgrimage, she could easily ply her inherent binder-making skills to managing SOPs for a regulated company.

There are certainly plenty of challenges with manually managing SOPs (aka Stacks of Paper). But we all know that obstacles are as much a part of document management as buttons and state dinners are to political campaigns. Rest assured, Leslie Knope would be up to the challenge. She used to eat obstacles with a side of state auditors for breakfast …

“Ron, they’re state auditors. They’re here to slash and burn. We’ve got to fight these guys. They’ve been sent by the Governor, they outrank everyone. Yeah, you’re right, there’s no fight to be had here. I’m not going to fight them—except that I am.”

If Leslie Knope ever decided to abandon politics and become an SOP manager, here are five reasons why the government’s loss would be the life sciences industry’s gain.





This article is related to the White Paper: 
Writing and Enforcing Your SOPs for GxP Compliance Success
To get the full details, please download your free white paper.


#1 She Knows How Much Work is Required to Manage SOPs


The only thing more transparent than the glass-walled offices at the Department of Parks and Recreation was Knope’s work ethic …

“There’s nothing we can’t do if we work hard, never sleep and shirk all other responsibilities in our lives.”

Many companies are moving to automated document management technologies, but most still rely on manual, paper-based processes. The work that goes into drafting, routing, approving, changing, rerouting and reapproving an SOP is arduous and time consuming. After multiple rounds of routings and approvals, the SOP is printed and stored in binders, which are distributed to the applicable departments. 

It goes without saying that Knope was the quintessential binder expert. Binders are ideal for scrapbooking, but using them for SOPs poses all kinds of challenges with routing, revision control, collaboration, etc. An automated document management system integrates all document control and quality management processes. This lets SOP originators and reviewers collaborate and complete approvals concurrently instead of taking turns to review documents. 

#2 She Immerses Herself in Paperwork


When your organization is updating and shuffling around dozens of SOPs, the probability of documents being delayed or getting lost altogether is high. This creates an inordinate amount of paperwork for everyone. Nevertheless, Knope never cloaked her true feelings about paperwork …

“I hate paperwork. I hardly ever do it in my bed on a Saturday night listening to old Spice Girls CDs.”

To speed up change control, SOP originators need to stay close to their documents—usually multiple documents simultaneously—to keep them in motion. This means making phone calls, sending emails or visiting approvers in person. Of course an automated system could complete and track all these tasks, but who better than Leslie Knope to keep badgering … (ahem), keep approvers and stakeholders in the loop and focused on the task at hand …

Senator John McCain: “Has anyone ever told you your tenacity can be a bit intimidating.”
Knope: “Yes, every day of my life since the 4th grade.”




#3 She Knows the Importance of Accountability


Mistakes happen, especially when managing multiple projects involving paper documents. Knope always had a solid strategy for when things went awry …

“You will have bad days, hard days, days where you feel you aren’t getting anywhere. Things will go wrong, and yes, it will usually be Jerry’s fault. You are strong enough to get back up on your feet. You can do hard things.”

Uncontrolled SOPs could lead to nonconformance. The truth is we all know how difficult it is to completely purge outdated documents. Like cast members from “The Walking Dead,” they manage to find their way back to the production areas haunting production staff with outdated or erroneous information.

An automated document control system prevents the circulation of rogue documents. With an automated system, when an SOP is updated, all approvers can be notified, existing documents automatically archived and the newest version distributed upon approval faster than Leslie Knope can say “open your binders.” 

#4 It’s Knope’s Way … Period


With SOPs, there is no room for interpretation, individual freedom, educated guesses or creative license.

Knope was a veritable walking SOP. With every project she had a clear objective and only one way to complete it—her way. The highway was not even an option …  

“If I told you to jump off a bridge, would you do it? I hope so! Because the only way that this [event] is going to happen is if you do everything I say.”

An automated document control system integrates SOP management with training and all other quality management processes. When changes occur, all training tasks are automatically assigned, monitored and verified. 

#5 She Knows the Value of Effective Teamwork


The SOP writing process is an excellent way to collaborate and tap the expertise of your colleagues. It’s important to give all stakeholders, especially those who perform the procedures, an opportunity to provide input. People are more likely to accept and follow an SOP when they have a sense of ownership.

Fans of Parks and Recreation know that Leslie Knope was adept at maintaining the delicate balance of diplomacy and eloquence when communicating with coworkers. For seven seasons, she connected with everyone and exhibited the utmost respect and open mindedness to their opinions …

“Thank you, Mr. Swanson, for your absurd opinion which you share with no one.”

“Calzones are like pizzas but they're harder to eat. They're dumb. And so was that idea.”

“You're all amazing, wonderful people and I really want you to have fun today and not focus on the fact that if one thing goes wrong, we're all gonna lose our jobs.”

It’s obvious that Leslie Knope would be in high demand as an SOP manager. Nevertheless, if you’re using a manual, paper-based system and Knope isn’t answering her phone, you might want to consider automating your document management processes.


What other quality management tasks would you want Leslie Knope to manage for you? Please comment below.



David Jensen is a content marketing specialist at MasterControl. He has been writing technical, marketing and public relations content in technology, professional development, business and regulated environments for more than two decades. He has a bachelor’s degree in communications from Weber State University and a master’s degree in professional communication from Westminster College.





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White Paper: Six Ways to Optimize Your Quality Management System and Ensure FDA and ISO Compliance
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White Paper: Six Corporate Oversights of Quality and Compliance Issues in Pharmaceutical Environments
Analyst Report: A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences (LNS Research)