QA-Talk: Writing SOPs - Part 3

At this point, you should have completed Parts 1 and 2 of Writing SOPs. If you haven't, you can find them here. Search my blog.

After completing the header, purpose, scope, background, definitions and abbreviations and attachments, you then concentrate on Responsibility and Procedures.

The "Responsibility" section should clearly identify what each applicable person should do to maintain the SOP process. It can be in one, 2 or 3 paragraphs - it is your choice how you want to structure. I am a firm believer in the KISS theory (Keep It Simple Stupid). The main thing you want to point out is who is responsible for making sure the procedure is followed and adhered. This is usually the manager of that department. Employees are responsible for following the procedure as it is written and the head of the company is responsible for overall compliance of all policies and procedures. In the sample above, it will show the responsibilities described for each significant group.

After the Responsibility section, start on the actual "Procedural" section of the SOP. This is the toughest part for most people. To write the procedure section, simply write down what you do. If you are new at this, don't worry about format or any of the other "fluff". Just write down what you do. Once you have written it down, you can format the SOP or get help formatting it. So, let us say you want to write a procedure about selecting a clinical investigator. You would search the internet or consult CROs to help you find doctors specializing in the area of the clinical trial. You will then contact the doctor, explain what you want of him (or her) and ask if they are interested. If interested, you request a copy of a signed current CV, review it and decide if they qualify. You visit the site, verify equipment and patient-base exist, and proceed with site qualification. If that is hat you do, then write it out in the procedure section. Compare your current process to the regulations and make sure you are doing it right.

Once you have completed this section of the SOP, you can format it using "Format-Bullets and Numbering" section of MS Word or applicable word processing software.

Complete this section of your SOP. Questions can be posted in the comment section below if you want me to take a look to see how you're progressing.

Until next time.................

Have a QUALITY day!

Sarah