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Principle #1 - Writing Step By Step Procedures That Provide a Roadmap For Controlled and Consistent Performance
Introduction
It is estimated that 90-95% of all our daily activities are habit. Our days are filled with eating habits, work habits, sleeping habits, etc. Stop and think about it for a moment. compare your daily routine from one day to the next. Is it pretty much the same? Do you follow the same procedures throughout the day? Day-in and day-out? It's not surprising if you do, most of us are creatures of habit.
Our lives are governed by procedures. For example: What is your "procedure" when you first get up in the morning? Do you put on the coffee? Shower? Dress? Read the paper? What's your "procedure" when you first arrive at the plant?
Yes, whether we like it or not, our lives are governed by procedures. The main difference between the procedures we follow in our personal lives and the procedures we follow at work is the word written. Because of the critical nature of your industry, you can't take any chances. You must put your procedures in writing. Written procedures form the backbone of your business operation and are the key to Good Manufacturing Practice.
What Are Written Procedures?
Well, written procedures are important tools, and, like any tool, have value only when properly used. For example, the blueprints that a carpenter follows when building a house are his written procedures, his controls. If he doesn't follow his blueprints, the finished house won't turn out as planned. Likewise, your written procedures provide you with detailed step-by-step instructions for executing or controlling the important parts of your business. Each step must be written in a clear and logical sequence. All steps should lead to our final goal - a safe and effective product. Another way you might think of written procedures is as a roadmap, which when carefully followed, help you avoid wrong turns - wrong turns that could put you on the road to mix-ups, errors, and recalls.
So, just as you frequently check your roadmap on a trip, to be sure you are on the right road and headed in the right direction, written procedures need to be checked regularly to stay on the road to quality.
Why Are Written Procedures Important?
Let's examine quickly why written procedures are so important to your operations. Written procedures serve six important functions in your company:
- Standards of performance - Written procedures are important in establishing and enforcing work standards. Where required, written procedures help to ensure that the same job is consistently performed the same way each time.
- Instruction - Written procedures help instruct employees at all levels of the company. For example, if you are a new employee trying to learn the job, or an experienced employee assigned to a different job, written procedures serve as a training guideline.
- Reference - It is difficult to remember every step involved in manufacturing a quality product. Written procedures provide a time-saving checklist needed to make sure each step is carefully followed.
- Control - Written procedures, when well developed, have important control characteristics. They tell you what to look for when auditing and how to evaluate results for compliance.
- Review - Putting your procedures down on paper provides you with the opportunity to see how you can improve your operations and plan for performance improvement.
- Documentation - Finally, written procedures are a record of how you do certain operations. They are basic business documents which are critical to success. For example, when a complaint is received concerning a product, written procedures help document what happened and identify potential causes of the complaint.
Tips
Use these helpful hints for developing well-written procedures and getting them followed:
 | Outline the Job. Outlining the job before you begin writing the procedure will help you to approach it in an organized fashion. You can do this by creating a brief breakdown of the important steps and the key points to remember when performing the job. |
| Write For the Reader. Be sure that you use language that the reader will understand. Additionally, you can increase the readability of the procedure by using short, simple sentences, using familiar, strong and short words, and writing in a conversational style. |
| Use Pictures To Punctuate! A picture is worth a thousand words, and it is therefore very important to use pictures to punctuate procedures. A picture can be any type of illustration or example which clarifies, supports, or reinforces the critical information in a procedure. |
| Put Procedures In a Package In retail, you can have a great product at a great price, but if you don't package and merchandise it properly, it won't sell. Selling written procedures (getting employees to follow them) is no different. The procedures may be well-written, but unless you package them in a way that relates to the needs of employees, you won't get them followed. Pay attention to the following things when packaging procedures: page design, instructions, table of contents, index, dividers, visual layout, and the type of binder you use. |
Summary
Written procedures are essential to the consistent functioning of your company. When you write them, make sure that they are clear, concise, easy to understand, and logical. Having well conceived, well written, and well packaged procedures is the first step toward GMP compliance, and controlled and consistent performance!
