So, you’ve been assigned to write a Standard Operating Procedure. What a bummer! Or worse, you’ve been told to look over all the SOPs right before an important external audit or a regulatory inspection. No doubt a recipe for disaster!
Last month, we told you the basics about SOPs. We said, “Never start a new task or project unless you can see your way to the end.” Know the who-what-when-where-how to get to the why. This month, we’re showing you the path forward and the best place to start your SOP journey. This article introduces the SOP Writing Cycle and its time-honored four phases — Plan, Do, Check, and Act. And, we lead you to the origin of great procedures that work like a charm, give opportunity for change and improvement, and pass anybody’s scrutiny (even the auditor’s). It’s all about planning.
Many SOP writers assigned to develop a new SOP or revise an old one jump straight into the first draft without thinking through the real SOP writing cycle. The result? A disorganized, dysfunctional product with serious omissions, excess irrelevant content, and other health problems. The SOP produced is at best only marginally useful. In fact, the SOP and the writer jeopardize each other’s credibility from this one simple oversight.
Devoting time to planning how the SOP will be written, from conception to final product, is a surefire way to avoid problems in staying organized and on task. It shortens the draft stage, the review stage, and the writing stage. It starts you out with substance that can self-generate into finished product. Proper preparation avoids the many and sometimes massive rewrites at the end, just when you think you’re done.
SOP Writing Cycle
Writing or revising any SOP leads to change. Things were done one way before the SOP and another way after. Responsibilities, process flow, action steps, interfaces — any one of these can be affected. Every SOP is the sum of architecture, organization, and infrastructure.
One of the earliest and perhaps best known models for managing change is the Plan-Do-Check-Act cycle (PDCA). Originally conceived by Walter Shewhart in the 1930s and later made popular by Dr. W. Edwards Deming, the PDCA is a simple four-step method for managing change. First, you plan the activity. Next, you do what you planned then check what and how you did. Then, you act on what you learned and what you know about the good and bad and ugly of how things went. The result is an opportunity for improving any one step, any combination of steps, the whole cycle, and even the product.
Just as a circle has no end point, the PDCA is actually a continuing spiral of improvement. The PDCA is a framework for managing change to improve a process, a system, a way of doing business, even a philosophy. Look at the four steps:
- PLAN the change for improvement.
- DO what you planned or change for improvement.
- CHECK what you’ve done and change for improvement.
- ACT on what you learn and change for improvement.
Both success and failure using the PDCA involve the good, bad, and ugly. The good that results you want to keep and nurture. The bad you want to avoid or reduce. The ugly you want to get rid of or put to good use. It is what it says it is, a cycle, static and influenced by its construction as well as the environment where it is used.
For SOPs, a few embellishments are called for. The PDCA as a guide for improvement through developing or revising SOPs becomes the blueprint for building products that last. Let’s call it the SOP Writing Cycle. is useful whether you’re developing a single or several SOPs. Follow its path and the results are both change and improvement.
The SOP Writing Cycle starts with preparation, a plan. It can be simple or complex, basic or extensive, based on the scope, the number of SOPs, whether it’s to develop or revise them, time frame for completion, who and how many people need to be involved — each factor contributes to how detailed you need to be. Remember, time spent on planning will shorten the draft and release phases and, in fact, the time the PDCA takes to complete its cycle.
To plan an efficient SOP effort, start with a purpose — what product is expected? Your upper management can help here. Ask them what they have in mind, who they have in mind, and when they want it. Having the purpose leads to defining the scope of the SOP; purpose plus scope give you a working title.
Easy work so far. You captured the purpose of the SOP (why), gave it a scope of application (who-what-when-where), know when you have to finish — now comes the fun part of planning — setting a schedule, figuring out what resources you have to have for research, interviews, writing, reviewing, rewriting, getting approvals, and putting the product in the hands and minds of the users.
Planning means design. It is the action of devising a way to realize or achieve a goal, an objective. It means to have in mind and to arrange the parts accordingly. In simpler words, you plan in order to build an SOP. Teachers plan lessons. Architects plan buildings. People plan retirement (ha ha ha). You, the SOP writer, plan the procedure.
Understand the purpose of the SOP: Decide the function and intention of the procedure, what it is to accomplish, and write it down. Keep in mind the golden rule, Ask not what users can do for the procedure; ask what the procedure can do for the users.
Define the scope of the SOP: Arrange the parts and pieces in your mind and on paper. Fit them into a flow that shows the expected process — the structures, systems, and components that interrelate and interface and together take the user to victory.
Come back next month for a new taste of the SOP Writing Cycle, the DO phase when you breathe life into your plan. After that, we’ll get to the CHECK and ACT phases. Like a great SOP, this series of articles is about helping you be the SOP authority of choice.
Norm Moreau is a consultant and trainer known for developing SOPs and implementing SOP programs that demonstrate GLP/GMP and nuclear QA compliance. His products and services are used to achieve ISO 9001 registration and ISO 17025 accreditation or by organizations that simply want to improve their operational efficiency and effectiveness. Since 2000, Norm has been offering the “Writing SOPs that Work” workshop at the National Meetings of the American Association for Laboratory Animal Science (AALAS). He welcomes comments, questions, even criticisms and can be reached at email@example.com.