Part 6: Tracking Standard Operating Procedures: Excel Spreadsheet or Document Software?

Now that you have created your SOPs, you (QA mostly) must track them and monitor them to verify that they are 1)current and 2) being used as written.

A good document tracking software is invaluable for this. If you're in a small company and just starting out, a well designed Microsoft Excel Spreadsheet will suffice for logging and tracking your SOPs. However, as your company grow and the number of procedures developed grows, you will need something like Lotus Notes, Documentum, Trackwise, QPulse or OpenText Livelink (just to name a few that I'm personally familiar with) to manage this process efficiently. There are many choices and various prices out there so do your homework and choose the software that is right for you and your budget.

First - for tracking purposes - you should have the following headings:

> SOP Title
> Date Effective
> SOP Author
> Responsible Department
> Review Due Date
> Date Submitted for Review
> **Currently Under Revision
> Date Review Completed
> Retired

For 10, 15 even 25 SOPs you might be able to track this information using a Microsoft Excel Spreadsheet. However, over the years, as your company soars on the fasttrack of success; even this number may become difficult to sort and maintain accurately and you will need a real database. You can have one built using Microsoft Access or you can purchase off-the-shelf software. Either way, I strongly recommend that you encourage your company to invest in a tracking software.

Now, I realize that QA is usually the last to be granted funds as so many CEOs and managers do not grasp the importance of QA until all hell breaks loose - but it is imperative that you help management understand that this software is important for compliance.

With the software, you will be able to document the history of each SOP and then when the company is inspected (it is never IF, but always a matter of WHEN), QA can pull the history on the requested SOP ensuring the inspector gets only the information requested and not a summary of all your SOPs history (just in case you missed updating one because that will be the one that they spot!).


Second - ask each responsible department to assign a person for the review. Communicate via email or create a form where the responsible author requests the current SOP from QA in the appropriate format for editing. If using Lotus Notes, Documentum and some of the other softwares, all edits and corrections can be done electronically. This is exceptionally advantageous in that if an employee leaves, you will know what was done and pick up where they left off. For all you MICRO-MANAGERS out there, it will also allow you to check on the individuals progress with the SOP.

QA must be diligent in alerting the department as to when a SOP is nearing it's anniversary date for revision. Most companies that I've audited are using an "every-2 years" review cycle. This can lead to trouble if you are seriously understaffed. Consider your resources and set your anniversary review date for the SOPs accordingly. I have found that "every 3 years" is more reasonable unless you have people dedicated to that function alone.

You will note that in the list above, I placed two * in front of "currently under revision". I did that because so many people fail to document when a SOP is under revision and during an audit they are cited for a SOP not being updated. Keep a record of what's currently under revision and when asked about it, you can respond intelligently.

Another area companies tend to forget is the "Does not need revision". In the "history" section of the SOP, have the department manager indicate on the copy routed to them that the SOP is current and does not need revision and maintain a copy of that page. This will validate the "last review date" and provide evidence that somebody did not sit down and falsify (OOPS!) the "last review date" column just because the FDA or a regulatory inspector was in-house.

Yes, your software should be validated - but that's another topic altogether!

Also, when choosing your review period; be it annual, bi-annual or further out, always add a (+ / -) 6 months or something of that nature. This will allow for any unforseen occurrence that might interfere with the review occurring in EXACTLY two years from the effective date and making you non-compliant.

Do not hesitate to retire SOPs that no longer meet your company's needs. Company's evolve and things changes. IMO, it is better to not have SOPs than to have SOPs and not follow them.

Your "SOPs on SOPs" should describe this process. Department heads should ensure compliance within their respective departments and QA should audit and verify that each department is following written procedures and that they are current.

Well - I've taken you through the SOP process. If you have questions, comments or feedback I would greatly appreciate it. It helps me know if I'm blogging in vain.

Until next time,

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

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.