Writing SOPs - Part 4

Before I get started with the next session on Writing SOPs, I want to tell you about a new cyber-friend. I want you to check out http://leadcra.blogspot.com/. Nadia has a wealth of information on her blog discussing the Ins-and Outs of a CRA. Most interesting is the topic on transitioning from Coordinator to CRA. I get a lot of questions about that and even though I've never been a CRA, I attempt to answer it. I think a person with experience can tell you more, so check out her blog. Join as a follower, ask questions and share your experiences, too.

Now, BACK TO WRITING SOPS!!!! I think I have given you enough time to create the PROCEDURE section (or body) of the SOP and to format it to your liking. You do not have to keep the style I'm showing here. Create one of your own. Maybe you want your Responsibility section to be one paragraph and a single statement that all employees are required to follow written procedures and all managers are responsible for appropriate implementation. Develop your style and move forward.

Now, some SOPs are complicated and need a flow chart so if this is the case, create the flow chart for our SOP and label it Attachment 1. If you need a sample checklists, create one and label it Attachment 2 and so forth. When you are through, circulate the procedure to peers for comments. Give them a specific date to return the procedure to you. Review their comments for relevancy. If relevant, edit, change or add to your procedure.

Next time, we will discuss the finalization process!

Until then,

Have a QUALITY day!

Sarah

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

Writing SOPs - Part 1

The first thing you want to do when writing a SOP is identify the person who knows the most about the job. For example, if you need an SOP on how to enter data into SAS, then choose this person who actually performs the task to write the SOP.

The first think you need is wordprocessing software such as Word, Works or OpenOffice.

Your SOP need certain components. I typically start with a header. The header should have the title, version, SOP number and the effective date of the SOP. It should look like the sample above. Go ahead and create the first part of your SOP. Next time, we get down to the nitty-gritty of writing SOPs. We will start with the SOP's purpose, objective, and scope before getting to the actual procedure.

til next time..............

Have a Quality day!

Sarah W.
For more about me, visit www.wqats.com

Creating Standard Operating Procedures

I get constant questions about how to write standard operating procedures (SOPs). Therefore, my next couple of posts will be about SOPs. First you have to stop being intimidated when you are asked to write a SOP. Standard Operating Procedures are nothing more than a business plan. No good business would dare function without a good business plan and that is why the FDA and your management expect you to have them.

Together, you and I are going to write a SOP. So, to start, I want you to think about format, content, who does what, how the task is done and who gets to approve the task. I will come up with one that you actually need which is the standard operating procedure on SOPs. We'll start there next time.

QA Talk - A Year of Change

Happy New Year Everyone!

As 2009 opens, we embrace a year of change and it could not have come at a better time. The economy is a state I would never have expected in my life time. Many colleagues are employed and either can not find work or cannot find work in an environment that will make them happy. Most of America's management continue to have the micro-management mentality where they must see you in the "central" office because they can't monitor your comings and goings if you are home based. Other managers are smart enough to know that it can be an enormous savings for both the company and the employee to have home-based workers. It would be great to see more managers move in that direction, which would save on fuel and time loss sitting in traffic.

Many colleagues have gone the independent route. I urge you to stay abreast of industry current standards. Consider taking online courses at http://www.wqats.com/Training.html. They are affordable and readily available.

The FDA offer several podcast for us to better understand their view about cerain industry practices. Check it out at http://www.fda.gov/cder/drug/podcast/Unapproved_Drugs_ReachMD_DrWoo.htm. Also, check out the new guidances, especially the one on handling information obtained from subjects who have withdrawn or was terminated from a clinical study.

The FDA have now partnered with WebMD to help consumers have even more access to vital information. They have announced that there are about 25 weight loss pills that could be harmful to the public. Web MD can now help them get this information out to the public by showcasing it on their website and in their magazine.