Documenting Processes and Procedures

I once read an SOP that made me even more confused about the process than before I opened it. It was full of technical abbreviations, had no visuals, and skipped over the simple things, like what the process actually starts with and what it produces at the end. That experience stuck with me. It reminded me that an SOP isn’t meant to impress auditors with big words; it’s meant to help real people do real work consistently. If you’re developing or reviewing an SOP, here are 10 things every good one should include: 1️⃣ Purpose – Explain why the SOP exists. What risk, problem, or regulatory need does it address? 2️⃣ Scope – Define the boundaries of the process. What’s included and what’s not? 3️⃣ Roles and Responsibilities – Clearly outline who does what. This eliminates ambiguity and overlaps. A RACI matrix can be very useful here. 4️⃣ Process Steps – Simple, step-by-step instructions that anyone new to the process can follow. 5️⃣ Inputs and Outputs – Identify what triggers the process and what the expected deliverables are. 6️⃣ Risk and Control Matrix – Map each key step to potential risks and the controls in place to mitigate them. This is where assurance meets process management. 7️⃣ Documentation and Recordkeeping – Specify what records should be retained, where they’re stored, and for how long. 8️⃣ References – Link to related policies, standards, or regulatory requirements for context. 9️⃣ Review and Update Cycle – Assign ownership for periodic review to ensure the SOP stays relevant as systems or people change. 🔟 Version Control and Approval History – Track changes over time and show who approved each version for accountability. And yes, include a flowchart. A simple process flow, even if it’s in the appendix, helps people visualize how the pieces connect. It’s often the fastest way to make a process understandable at a glance. A well-written SOP should make your team think, “Oh, this is how it’s supposed to work.” Not, “Who wrote this?” Because clarity, not complexity, is what turns an SOP into a living tool for control and efficiency.

In pharma, most SOPs exist because they have to. But what if your SOPs could be more than just compliance documents? Here are 4 ways to transform your SOPs from regulatory checkboxes into practical tools: 🔄 ────────────────── 1️⃣ PROFILE YOUR USERS LIKE PRODUCTS 🎯 Don't just list job titles. Map out: • Their actual expertise level • When and where they'll use the SOP • Common pain points in their workflow 👉 Example: For a drug synthesis SOP, experienced chemists need quick-reference data while new techs need detailed safety protocols ────────────────── 2️⃣ EMBRACE RADICAL SIMPLICITY 📝 • Use short, clear sentences • Write in active voice • Maintain consistent terminology 👉 Example: Instead of: "The reagent solution should be added to the water sample." Write: "Add reagent to water sample." ────────────────── 3️⃣ FORMAT FOR FINDABILITY 🔍 • Create clear visual hierarchies • Use white space strategically • Add clear section breaks 👉 Example: Instead of: Safety Protocols: Full PPE required in lab area. Safety goggles mandatory. No food/drink permitted... Better: SAFETY REQUIREMENTS □ Full PPE in lab area □ Safety goggles □ No food/drink ────────────────── 4️⃣ BUILD FUNCTIONAL SECTIONS 🏗️ Don't just dump information. Create purposeful sections: • Quick-reference guides • Step-by-step procedures • Troubleshooting matrices • Decision trees 👉 Example: Instead of one long "Procedure" section, break into: 1.0 Sample Preparation    1.1 Equipment Setup    1.2 Safety Checks 2.0 Analysis Steps    2.1 Running Tests    2.2 Recording Results ────────────────── Remember: Every extra minute spent making your SOP more usable saves hours of confusion, mistakes, and workarounds later. What's your biggest SOP pain point? Share below 👇

Many thought leaders emphasize driving transformations through the lens of people, which I wholeheartedly agree with. People remain the heart of how an organization operates. How do we achieve this? One often overlooked aspect is high-quality procedure documentation.   Procedures are detailed instructions for completing tasks. They are crucial because they: - Improve productivity by eliminating the need to decipher unclear documentation - Break down silos, enhancing team collaboration - Facilitate scalability and growth by simplifying onboarding of new employees - Are the key to consistent and great customer experiences - Manage risks and ensure regulatory compliance - Foster problem-solving and continuous improvement   I’ve seen many organizations struggle with maintaining quality procedure documentation. In one of my consulting projects, we cleaned up a disorganized repository that was a massive pain point for the company.   What’s the key to success? Defining a consistent structure aligned with the business context. The best practice is to organize procedure documentation according to your complete inventory of processes using the Process Inventory framework. This approach offers several benefits: - Scope Definition: Clearly defined boundaries ensure no overlaps in documentation. - Ownership: Assigning a Process Owner for each process ensures accountability for creating and maintaining high-quality documentation. - Employee Alignment: Provides clarity on which employees execute processes, making it easier to close knowledge gaps. - Risk Management Alignment: Helps the risk organization verify that procedures provide the right risk and compliance controls.   This is only possible if an organization inventories every process they perform through the Process Inventory framework. To learn more about this framework, check out my book 'Digital Transformation Success' https://a.co/d/bmYf0oG   #Transformation #PeopleFirst. #ProcessInventory #BusinessScalability #ContinuousImprovement

How I document processes prior to AI adoption (This is one of the most important steps) Many businesses rush into AI without having their processes documented. This leads to ineffective implementations. Result: - Misaligned AI solutions - Inefficient use of AI capabilities - Missed opportunities for process improvement Thorough process documentation is crucial for successful AI integration. Here's my approach to process documentation: 1. Process identification ↳ List all processes potentially suitable for AI 2. Workflow mapping ↳ Create detailed flowcharts of each process 3. Data flow analysis ↳ Track how information moves through the process 4. Task breakdown ↳ Divide processes into discrete, measurable tasks 5. Time and resource allocation ↳ Measure current time and resources for each task 6. Pain point identification ↳ Pinpoint bottlenecks and inefficiencies 7. AI opportunity assessment ↳ Identify where AI can add the most value (See carousel for full breakdown) Proper process documentation ensures AI improves rather than disrupts your operations. Your document has finished loading

Turnover is inevitable, but the loss of institutional knowledge doesn’t have to be. When employees leave, they often take critical knowledge with them. One of the best ways to safeguard that knowledge is to document workflows and SOPs. Unfortunately, this often gets postponed due to a lack of capacity. So here are three easy steps to get it done faster and more effectively with AI: 1️⃣ Pick a process that is most in need of a documentation upgrade. Think of a critical one that solely relies on one person or often causes bottlenecks and frustration. 2️⃣ Record 1-2 virtual training sessions with AI assistants. Tools like Otter. ai, Fireflies. ai, Zoom, and Microsoft Copilot can transcribe discussions in real-time and generate written notes after the meeting. All you need is the trainer sharing their screen and walking a trainee through the process. 3️⃣ Use the transcripts from those meetings to generate SOPs with AI synthesis tools. It’s all about the prompts. Here’s an example of a basic one: "Create an SOP draft from this transcript, focusing on the key compliance steps discussed. Organize the information under headings: Introduction, Procedure, Risks, and FAQs." And voilà ✅ While this is an efficient way to document processes, keep in mind the potential challenges of working with AI, such as handling sensitive and proprietary information. By following these three steps, you'll not only have training videos and written manuals, but you'll also build a system that makes knowledge transfer seamless. Now your turn! Have you tried using AI for process documentation? What was your experience?

Do you have well-documented SOPs? Standard Operating Procedures (SOPs) provide the framework for consistency and scalability. They’re more than documents–they’re a tool that can: ✅ Clarify team roles ✅ Preserve institutional knowledge ✅ Reduce onboarding time ✅ Avoid costly errors ✅ Increase the value of your business If you ever plan to exit, SOPs are non-negotiable. Buyers want confidence that the business can run smoothly without the founder in the driver’s seat. Start with core business activities (what is essential for day-to-day operating and continuity) 🎯Operations & Service Delivery 🎯Finance 🎯Human Resources 🎯Marketing & PR 🎯Sales/Development 🎯IT/Technology Infrastructure You don’t need anything fancy to get started. Google Docs, Loom videos and rough notes are a solid starting point (and certainly will be better than having nothing documented). You can always refine later. 👌 #BusinessOperations #SOPs #GrowthStrategy #SellSideReadiness #Entrepreneurship #ExitPlanning

I asked a CEO last week: "What percentage of your company's critical processes exist only in your head?" His answer: "Probably 60%." When I asked why, he said: "No one can document them as well as I can execute them." That's the process paradox that keeps founders trapped: the very expertise that built your business becomes the ceiling that prevents it from scaling. Undocumented processes aren't processes at all. They're tribal knowledge with an expiration date. After implementing EOS with hundreds of entrepreneurial companies, I've identified the Process Component as one of the most neglected of the Six Key Components. Leaders believe documenting processes will: 1. Take too much... time they don't have 2. Stifle creativity and flexibility 3. Be ignored by the team anyway But the data tells a different story. Companies with documented core processes grow 3X faster than those without them. Here's the 3-step framework we use in EOS to break this cycle: 1️⃣ Identify your core processes Don't try to document everything. Start with the 5-7 processes that drive 80% of your business results. For most companies, these include: HR, Marketing, Sales, Operations, Accounting, and Customer Service. 2️⃣ Document at the right level Resist the urge to create 50-page manuals. For each process, identify 5-15 high-level steps that anyone with basic competence could follow. The goal isn't perfection. It's clarity and transferability. 3️⃣ Make them Followed By All This is where most systematization efforts fail. FBA (Followed By All) is the checklist that ensures every Core Process in your business is clearly documented and consistently followed by everyone on the team. Review processes quarterly, measure adherence, and refine based on results. One client who implemented this approach reduced their onboarding time from 12 weeks to 4 weeks. Another increased production capacity by 35% without adding headcount. Every day you delay systematizing your business is another day your growth remains capped by your personal bandwidth. The question isn't whether you need documented processes - it's how much longer you can afford to operate without them. Ready to break free from being the bottleneck in your business? Join hundreds of entrepreneurs who receive my weekly Clarity Break Thoughts: www.markodonnell.me

Some teams 𝘧𝘰𝘭𝘭𝘰𝘸 processes but never document them. Others 𝘥𝘰𝘤𝘶𝘮𝘦𝘯𝘵 processes no one actually follows. To avoid chaos and build something lasting, you need both. • Followed but not documented? You’re one departure away from losing mission-critical knowledge. • Documented but not followed? You just created a binder no one touches. Here’s the framework: 1/ 𝗗𝗘𝗙𝗜𝗡𝗘 𝘁𝗵𝗲 𝗽𝗿𝗼𝗰𝗲𝘀𝘀 Don’t just guess. If it’s being done consistently, there’s already a process—name it. 2/ 𝗗𝗢𝗖𝗨𝗠𝗘𝗡𝗧 𝗶𝘁 This is only 10% of the effort. But it’s the part everyone skips to. 3/ 𝗗𝗥𝗜𝗩𝗘 𝗮𝗱𝗼𝗽𝘁𝗶𝗼𝗻 How will it evolve? Who updates it? When? Without this, your playbook gathers dust. Operations that scale aren’t built by accident. They're engineered—on purpose, and in writing.

Process = Freedom W. Edwards Deming said it best: “If you can’t describe what you are doing as a process, you don’t know what you’re doing.” Growing a business often feels like a fire drill—everything is urgent, everything is changing, and writing down processes feels impossible. Sound familiar? While this might work when you’re just starting out, it won’t scale. By the time you have a handful of employees, transitioning to a process-driven company is no longer optional—it’s essential. Here are 4 rules to live by when documenting key processes: 1️⃣ Identify High-Impact Processes Focus on the 20% of processes that drive 80% of your results—like sales, customer onboarding, or cash flow. Document what truly matters. 2️⃣ Make It Simple and Actionable Processes should be easy to follow. Use clear language, visuals, or checklists. The goal is usability, not perfection. 3️⃣ Ensure Team Ownership Your team should write and own the processes. When they feel invested, they’ll follow and improve them. 4️⃣ Leadership Must Lead by Example The most important rule: Leaders need to use the processes and review them. Give feedback, simplify, and make sure they’re as effective as they are practical. Processes = Freedom. When done right, they free you to focus on strategy, growth, and, yes, even hobbies like photography (me below in the photo:) What about your business? Have you gotten the processes out of your head and into your team’s hands? Let me know in the comments! #Leadership #Processes #ScalingBusiness #Entrepreneurship #Freedom