Share thisWelcome back you SOP warrior. This month we continue our journey through the PDCA framework by working on the DO phase. Remember our model for continuous improvement? Well, during the DO phase you’ll breathe life into your PLAN by drafting your SOP.
Drafting Phase
Armed with management’s purpose and scope, the drafting phase begins. Yogi Berra once said, If you don't know where you're going, when you get there you'll be lost. Without a clear title, purpose, and scope for your SOPs it is very likely that they will be of limited value. This doesn’t mean that you can’t make adjustments along the way, but a good idea the beginning will serve you well. You might even consider this a mini PDCA!
Every SOP is built to accomplish something. In laboratory management, there are millions of things to control (slight exaggeration intended). So, best to keep it simple for success in providing direction and control. Find the best route from Point A to Point B and write it down. That becomes your draft SOP. The drafting phase consists of determining information needs and collecting information, drafting the SOP, and conducting a peer review.
Information Needs and Collecting Information
To write effective SOPs, information needs to be collected in two broad categories — technical (or content) information and user information categories. Both categories are important. An SOP that is technically accurate, but cannot be understood by the user is an ineffective SOP. On the other hand, a well-written user friendly SOP that is technically inaccurate or incomplete can have serious consequences. So from a planning standpoint the who, what, where, and how of collecting information for the SOP has to be planned out.
The technical information to be collected depends on the subject of the SOP. Technical information has to be accurate and current. Sources of such information include vendor manuals, regulatory documents, Material Safety Data Sheets (MSDS), drawings, subject matter experts, facility, or contractual requirements (statements of work, facility policies and directives} and related SOPs.
For user information consider readability factors and task-related factors. Readability is the quality of written language that makes it easy to read. Readability factors include:
- Grammar, punctuation, and format
- Reader’s experience with the subject
- Age and education level
- Cultural background and language of origin
- Complexity of task