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

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 - Research Misconduct - Part 1

As many of you know, I specialize in conducting audits of research investigators and various entities in the pharmaceutical and biotechnical industry. I've been auditing for more than 10 years now and in doing so I have been involved with 3 investigator sites guilty of research misconduct (as defined by the Office of Research Integrity or ORI) and countless sites guilty of sloppy practices that looks as bad as research misconduct. These sites were located in Canada, India and the United States. These are only the sites that were discovered because they were unlucky (or lucky depending on your point-of-view) enough to be chosen for an audit.


Do you know that most people go through this job for 20 to 30 years and never identify research misconduct? And I have personally identified 2 and assisted with 1 in less than 5 years. Is research misconduct on the rise or has it been there all along and we've been missing it?

Could you identify alleged research misconduct (i.e. fraudulent practices) if you saw it? Do you know what to look for and how to assess what you find?

I'll be the first to admit that research misconduct is not easy to identify and once you've found it - oh, the work involved! I've spent anywhere from 2 weeks to 1 month investigating misconduct.

In a series of articles on this blog, I will tell you how most of my discoveries come about and then I'll tell you how I handled them.

HEY CRA's! LISTEN UP!!!

Do you know that if you're the CRA for a site that's found to be fraudulent, the FDA could hold you responsible for not identifying the problem?

For one of the sites reported to the Agency, I attended the FDA inspection. The inspector made a point of assessing the CRA's monitoring reports to the site. The investigator also questioned the CRA's experience, and wanted to know why the CRA did not find the problem before I found it. Well, I could not answer that because I honestly did not know. But another colleague told me that the CRA working a clinical site for his company was cited by the FDA for not discovering the misconduct "early enough" in the monitoring practices. I don't know a lot about that situation but I will say that I can imaging any "run-in" with the FDA or any other regulatory agency have got to be pretty unnerving. Finding yourself in a position of defending your expertise, in fact, your performance cannot be stress-free. Additionally, it does not bode well with your company who is probably looking for a scape goat anyway.

For the site where I discovered miscoduct - when I made my report to that company's senior management, the first question asked was "Why didn't the monitors catch this?" then it moved on to "Why didn't the project manager catch it - afterall, they visited the site, too?" The one thing I've learned in the corporate environment is that somebody must always be "blamed". Now, from my standpoint (it's the QA in me), I'm thinking: "How bad is it? Were any subjects hurt? Can the PI be brought into compliance?" Then I realized that management was still stuck on finding a scapegoat so I had to wait for them to play catchup to me. (lol)

Anyway, from my experience, I would caution you to take your monitoring duties seriously and if you don't know the regulations governing monitoring practices, you really should learn them. Compliance is about more than making sure the investigator's site is following the sponsor's instructions (which sometimes contradicts the approved protocol).

In Part 2 of this series, I will discuss "discovering" the misconduct and how it was handled afterwards.

Until then.......

Have a Quality day!