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

Writing SOPs - Part 2

In our last session, we created the first part of the SOP, which was the header. (See Part 1 if you haven't done that part yet). Today we are going to start on the 2nd major section of the SOP. This section consists of the Purpose, Scope, Background, Defintions and Abbreviations, and applicable Attachments.

Under the heading "Purpose", describe what the SOP is going to do. Hopefully, it will tell the reader the reason they are performing a task and how to do it.

The next paragraph in this section will be the SOP's "Scope". The scope describes the guidelines, regulations, internal procedures or protocol the task must adhere to. These will be the same criterion used to audit the task for compliance.

The "Background" section is optional. I use the background section to explain basic information about a task - if it is needed. If you are working with novices, the background section comes in handy to help them understand why they are performing the task and why they are performing it a certain way. If your co-workers are experienced people, the background section might not be necessary.

Definitions and Abbreviations are important when you write your SOP with non-standards. For example, everybody in the industry should know what FDA stands for so it is not necessary to put that in the definitions and abbreviations section. However, not everybody knows what WQATS stands for, so it is important to define "WQATS" as "Wilson Quality Auditing & Training Services" in the procedure. Always define abbreviations and terms that are used mostly at your company but not in the industry.

Attachments will be templates or diagrams used to guide the the user in completing the task. Since processes tend to change in the clinical research industry, many companies make templates a "sample" instead of a "100% controlled document". When I say "100% controlled document, it means certain sections and the format remains the same but content can change to match the intended process.

That's it for this session. Complete this part of your SOP. If you have questions on this process and what we've covered thus far, hit me up in the comments section.

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

Have a QUALITY Day!!

Sarah