SOPs

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.