Is It Time to KonMari? Your Compliance Program? (Or, What Sparks Your Compliance Joy?)

Years of heavy regulation have taught life sciences companies one truth about corporate governance: although internal policies can start with the best of intentions, the slightest change in legal requirements, business needs, or risk tolerance can trigger massive compliance change. As the legal and regulatory environment evolve or as the business grows and morphs, a company’s internal policies may require change as well. 

Too often, a company may continue to use and follow an outdated policy or process without much question. Even worse, a company may have an active policy but fails to follow or comply with its requirements, or a policy may simply fall into desuetude. Unnecessary layers of review can stack up quickly under a policy ; ineffective means of delivering information or storing approvals develop over time; and policies may focus disproportionately on outdated risks. For medical technology companies – an industry rife with consolidation and corporate transactions – there may be different business units applying different policies to the same type of arrangement. 

When practice fails to match policy, this can be a bad sign and can send the wrong signals about the value of compliance at your company.

Is it time to apply the KonMari Method? to your compliance program?

Some lawyers and compliance officers may balk at the idea of applying a cleaning and gutting process to a compliance program. They may see advocating for a comprehensive compliance cleaning as tantamount to eliminating longstanding and important policies. For others, old habits die hard, and lawyers (myself included) can sometimes have difficulty with letting go of a past policy or process. 

Still others - myself also included - may find the idea extremely appealing. Like the wildly successful Netflix show, Tidying Up with Marie Kondo,[1] in which the host guides families through an intense and fulfilling process of eliminating the clutter that junks up their lives, using the same approach on your compliance program may be an opportunity to get rid of clutter, inefficiencies, and unnecessary barriers to success. Done right, applying the KonMari Method? to your compliance program – a Compliance Cleaning – can demonstrate your company’s commitment to compliance, help ensure that internal controls remain up-to-date, address appropriate business risks, and eliminate unnecessarily burdensome requirements on the business.

What are the rules of the road for using the KonMari Method? on your compliance program?

First, ground yourself in your program. Just as the Netflix cleaning guru recommends for your home, the goal of a compliance cleaning is to be mindful, to be introspective, and to be forward-looking.[2] Marie Kondo begins her projects with meditation to ground her thoughts and actions in the goals and mission at hand. Similarly, you should begin with a "compliance meditation," using a similar process to ground yourself and your team in mindfulness, introspection, and looking forward. Spend time with your team to make sure they are thinking meaningfully about the following notions and questions:

a. Be Mindful – Are we keeping this policy or process because we’ve always used it? Does it remain useful, effective, and efficient? What are the risks that the policy or process is intended to counterbalance? Do those risks still matter? Are there other less burdensome ways to address these risks?

b. Be Introspective – Where does the compliance program have gaps? Where does it have too much process or too many layers of approval? Which approvals and processes are truly necessary and which approvals and processes can be consolidated or addressed through alternative means?

c. Be Forward-Looking. Does your compliance program address only historical risks or are you looking down the road towards change and evolution in the industry? Is your compliance program structured in a way so that it is adaptable and nimble when those risks start to take shape?

In other words, identify and visualize what you, your team, your leadership, and your business partners believe to be an ideal program. Consider using a stakeholder engagement process that collects observations and recommendations from your key compliance users about the hurdles, challenges, and benefits of the existing compliance program: 

• What challenges or unnecessary hurdles has the compliance program raised?
• Where has the program been successful?
• What does an ideal compliance program look like? What does an effective partnership with compliance look like?
• Are there areas of inefficiency or duplicative process?

Second, use Marie Kondo’s Six Basic Rules,[3] modified for the task at hand:

1. Commit yourself and your team to the process; set timelines and specific monthly or quarterly goals.
2. Identify and visualize your ideal compliance program – streamlined, effective, and focused on partnership.
3. Review all policies, procedures, work instructions, job aids, training materials, and auditing/monitoring plans by category, and review each category at one time. Just as Marie Kondo instructs her clients to make one pile of all items to understand the full scope and universe of their material possessions, the same is true when applying the KonMari Method? to your compliance program. It is critical to understand all of the relevant policies, processes, SOWs, forms, and other documentation on a particular topic and to review it together. You cannot answer the following questions unless you know the full scope of a particular compliance category: Do you have multiple policies that address the same topic? Do you have different reviewers looking at the same arrangement multiple times? Do your policies or procedures vary unnecessarily or include contradictory requirements across different business units? Is there a legitimate reason for applying different policies or processes? 
4. Don’t be afraid to discard and eliminate outdated, inefficient policies, replacing them with streamlined, efficient policies and processes that address the same risks through different means.
5. Follow a set order in reviewing your various policies and processes. Marie Kondo recommends followers of her method to start with clothing, then books, papers, “komono” (miscellaneous), and finally, sentimental items – the hardest to evaluate objectively. For a life sciences company, start with your Code of Conduct. Then, review your U.S. HCP/Health Care Compliance Policies, followed by your International Anti-Corruption/Anti-Bribery Policies, and then other/miscellaneous policies (price transparency? Supply chain licensure? Corporate social responsibility?). For those policies or procedures that you may have a difficult time letting go of – for example, a policy that has served you well for many years – review it last. Take the time to objectively evaluate its usefulness or whether it’s salvageable in any form. 
6. Keep the policy or process only if it sparks your compliance joy. Marie Kondo instructs her followers to “[k]eep only those things that speak to the heart, and discard items that no longer spark joy. Thank them for their service – then let them go.”[4] The same is true for a Compliance Cleaning. In our terminology, keep only those compliance functions, policies, and processes that achieve your organization’s mission and values. Assess whether items that are no longer effective, no longer meaningful, or act as obstacles vs. opportunities to partner with the business: streamline and replace with appropriate alternatives where possible, and discard those items that are no longer workable, reasonable, or practical. In other words, if it does not spark compliance joy, let it go. 

Of course, this is not intended to encourage companies to simply gut their compliance programs altogether. In fact, quite the opposite. Just as a company’s leadership applies continuous improvement exercises to the revenue-generating functions of a business, applying a thoughtful, comprehensive process to streamline and improve your compliance program demonstrates care and positive attention for compliance; helps ensure that the function is aligned with and understands the business’s needs; addresses the most critical risks in the most appropriate and balanced way; and is not overly burdening the business in its process or other requirements. Simply put, it shows that the business holds compliance in the same esteem as its other functions, and that the business depends upon - and needs - a compliance function that can keep up with the demands of the business.

And to a compliance officer's ears, what could spark more compliance joy than that?

[1] Tidying Up with Marie Kondo (Netflix 2018).

[2] The KonMari Method? “places great importance on being mindful, introspective and forward-looking.” KonMari, https://konmari.com/pages/about (last visited March 11, 2019).

[3] See id.

[4] See id.