The Skills and Courage to Simplify -Where to start 🚀 

Complexity can quickly become overwhelming in the medical device and pharmaceutical industries. If left unaddressed, these complex processes will only continue to grow and demand more and more resources. But with 𝐭𝐡𝐞 𝐫𝐢𝐠𝐡𝐭 𝐬𝐤𝐢𝐥𝐥𝐬 𝐚𝐧𝐝 𝐜𝐨𝐮𝐫𝐚𝐠𝐞, 𝐲𝐨𝐮 𝐜𝐚𝐧 𝐬𝐢𝐦𝐩𝐥𝐢𝐟𝐲 𝐚𝐧𝐝 𝐢𝐦𝐩𝐫𝐨𝐯𝐞 𝐭𝐡𝐞 𝐪𝐮𝐚𝐥𝐢𝐭𝐲 𝐚𝐧𝐝 𝐞𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐜𝐲 of your processes. 💪 

🤔 So, 𝐰𝐡𝐞𝐫𝐞 𝐜𝐚𝐧 𝐲𝐨𝐮 𝐬𝐭𝐚𝐫𝐭 𝐭𝐨 𝐬𝐢𝐦𝐩𝐥𝐢𝐟𝐲? If you don’t have the time and resources, start by looking at your 𝐫𝐞𝐯𝐢𝐞𝐰 𝐩𝐫𝐨𝐜𝐞𝐬𝐬𝐞𝐬 and use the questions below to guide you. This will give you a clear picture of the state of your procedures and areas of concern in your processes. 

👀 𝐂𝐨𝐧𝐬𝐢𝐝𝐞𝐫 𝐭𝐡𝐞 𝐟𝐨𝐥𝐥𝐨𝐰𝐢𝐧𝐠 𝐟𝐚𝐜𝐭𝐨𝐫𝐬: 
• 𝐏𝐫𝐨𝐜𝐞𝐝𝐮𝐫𝐞 𝐜𝐨𝐦𝐩𝐥𝐞𝐱𝐢𝐭𝐲: Are your procedures too complex to follow? Do they contain unnecessary information or lack essential information? Are they unstructured and too long to read? 📜 
Use the five W’s (what, where, when, why, who) and How to structure your procedures. 

• 𝐑𝐞𝐪𝐮𝐢𝐫𝐞𝐦𝐞𝐧𝐭 𝐚𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭: Are your requirements too high or too low? Have you mapped your requirements – internal vs. external? And do you have an overview of your gaps? 🔍 
 
• 𝐂𝐥𝐞𝐚𝐫 𝐫𝐨𝐥𝐞𝐬 𝐚𝐧𝐝 𝐫𝐞𝐬𝐩𝐨𝐧𝐬𝐢𝐛𝐢𝐥𝐢𝐭𝐢𝐞𝐬: Are the roles and responsibilities between Quality and the line of business clearly defined and understood? What are the roles and responsibilities of the owner/author, SME reviewer, and QA approver 🤝 
 
• 𝐏𝐫𝐨𝐜𝐞𝐬𝐬 𝐟𝐥𝐨𝐰: Is your process flow clear and simple? Use a spaghetti diagram as a tool to map the current state and guide you for the future state💡 
 
• 𝐂𝐨𝐦𝐩𝐞𝐭𝐞𝐧𝐜𝐲 𝐚𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭: Are competencies in Quality and the line of business at the right level? 📈 🤝 
 
By focusing on these factors, you’ll be able to identify actionable steps towards reducing complexity and improving the quality and efficiency of your processes. Remember, 𝐬𝐢𝐦𝐩𝐥𝐢𝐜𝐢𝐭𝐲 𝐭𝐚𝐤𝐞𝐬 𝐬𝐤𝐢𝐥𝐥𝐬 𝐚𝐧𝐝 𝐜𝐨𝐮𝐫𝐚𝐠𝐞, 𝐛𝐮𝐭 𝐭𝐡𝐞 𝐫𝐞𝐰𝐚𝐫𝐝𝐬 𝐚𝐫𝐞 𝐰𝐨𝐫𝐭𝐡 𝐢𝐭. 🎯