How to Write Standard Operating Procedures

Standard Operating Procedures (referred to as SOPs) is a significant tool and a requirement for most operating in a regulated industry. The main reason for this is in the government do not like to be too specific about how you do business. They prefer writing broad requirements and letting you decide how you are going to abide by the regulation. You are expected to do this by creating written and approved procedures. For example, the regulation require that a company conduct a clinical trial with adequate resources and individuals qualified by training and experience. Now it is up to the company to write procedures identifying what “adequate resources” mean to that company. They should also identify what they consider as “qualified by training”. Does one training session mean that person is trained? Or do they need 2 or 3 training sessions before they are deemed adequately trained. Now, that you understand what the SOP process is about and why you need them, I'll give you a few tips on how to write your standard operating procedures.

Difficulty: Easy

Instructions

Things You'll Need:

• Word processing software
• Knowledge of the process

1. What Standard Operating Procedure Do You Need?
   
   Determining what standard operating procedures you need depends on your business and what you do. There should be a written procedure describing how work will be performed, who will perform the work, and how often the job should be done. In the manufacturing environment, procedures should describe who will approve significant steps in an operation and so forth. All companies need security procedures. That's just good business sense. With technology evolving as fast as it does and with brilliant minds constantly hacking into systems; companies should ensure policies and procedures are in place to address voice activated recorders, email maintenance, camera cell phones and any other gadget one can use to steal company secrets. Companies need good training procedures describing processes employees are expected to know how to complete. And companies should have an operational manual that states how they will do business. If you are new to SOPs and do not know what you need, consult an expert at www.wqats.com for advice.

2. What Should You Write About?
   
   Some companies need more details in their procedures than others. If this is the case, you probably need Work Instructions and SOPs. Let us clarify the difference between SOPs and Work Instructions. A standard operating procedure is written with a general overview of what will be done and who will be responsible for making sure it gets done. A work instruction will provide specific details on how to do something. For example, a work instruction will give step-by-step instructions on how to use a computer, from connecting it to printers and turning it on and off. One should be careful writing work instructions if they are in a changing environment because it will be difficult to maintain compliance. To write an SOP, just think about the process and how you perform the task. Then write it down. The SOP should make it clear that you do a job function in a certain way at a specified time.

3. What Format Should You Use?
   
   Formats generally depend on the person writing them. However, companies should have a standard format or template for employees to use. I recommend that the template contain the following sections:
   
   Heading
   Approval or Effective Date
   Version Control
   Introduction
   Scope
   Purpose
   Procedure Description
   Approval Signature
   Document History

4. Implement a Review Process.
   
   Standard operating procedures should have a defined review process. For example, the standard for the pharmaceutical industry sis 2-year reviews. There is no law or regulation stating it has to be to years and a company can choose their own review time frame.

5. Manage Your Standard Operating Procedures.
   
   SOPs need an audit trail from development to retirement. Most companies hire someone to focus on SOP maintenance which include ensuring the procedure is current, available to employees and retired and removed from use when appropriate.

Tips & Warnings

• Writing SOPs is very time consuming and a person need to have time they can dedicate to that only. Many companies out source this task. Wilson Quality Auditing & Training Services, LLC specializes in writing SOPs for clinical investigators, sponsors and CROs.

[westernmom]

on 4/9/2009 Been doing this all week! Thanks for some great instructions. 5*

[ronfull]

on 3/5/2009 Good, succinct informaion covering the topic, but I'd like to point out two typos that should be fixed in Step 4: "...for the pharmaceutical industry sis 2-year reviews..." (should be 'is') and "...stating it has to be to years and a company..." (should be 'two years'). Since this article involves writing,

[stace08]

on 1/21/2009 excellent information, thank you very much!

[patti80]

on 12/11/2008 Great information. Thanks!

[acole]

on 7/29/2008 Informational. Thanks!