Sunday, January 3, 2010

Why I Love Auditing - True Stories to Make You Smile

People often say I should write a book. I doubt if I ever will, but I (in many cases along with my colleagues) have experienced some real interesting audits. I will tell you in advance that all of these tales are true. I will also tell you that any names used (other than mine) have been changed to protect the innocent - yes, some of them really were innocent.

I enjoy talking about my audits. I've never been on an audit where I haven't learned something from it. I look at audits as an opportunity to help those who want to get it right - those who are opened minded enough to learn new things instead of thinking they know it all, and as an opportunity for me to learn how other people think.

Since I started auditing, I've investigated 5 potentially fraudulent sites - 3 of them were fraudulent.

Auditing Tale #1:
The CRC documented that the subjects were taking the IP when she was in fact throwing them out. The Clinical Research Associate caught her and reported it to the sponsor. When the Clinical Research Coordinator was questioned about the deceptive act, she claimed she was upset...a good friend had died and she was so upset that she just wasn't thinking clearly. She said she had never had a subject who wasn't 100% compliant (riiight!!) in a clinical trial and when the subject returned the medication unopened, she panic and didn't know what to do. So, because of the stress from the death and work her first thought was to take the pills out that the subject was suppose to take and toss them out.

Well, all auditors know that documentation for all volunteers showing 00% compliance consistently is a red flag! You've been taking medication for three years and for every day for three years you have never missed a pill. Come On!! LOL. Well, that was only the beginning, we also found progress notes and telephone contact logs for subjects going outside the country on vacation - yet, those same subjects had vital signs at the clinic on days that they were on vacation in another country..... lol...... And the greatest one of all - more than 100 ECGs had been altered from the 1970's to match visits subjects were suppose to have had in 1980's and 1990's. They were all written over, scratched out or blacked out and the appropriate visit date written on the ECG. When asked about the dates being changed the CRC stated their ECG was unable to hold the current date. Well, I gotta tell you - if you have an ECG machine that changes the month, day and year 3-4 times in one week..THROW IT OUT!!!!! lol

Yes, somebody reported it to the FDA. No, they never investigated.

Until next time.....

Thursday, July 9, 2009

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!).

- 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!!!


Wednesday, April 15, 2009

Finalizing Standard Operating Procedures (SOPs) - PART 5

Alright. I'm back and we're going to cover the next most important step to getting Standard Operating Procedures up and running at your company or site.

Finalizing SOPs can be hazardous to your health. (lol) You can have a nervous breakdown if you don't start off controlling the situation and continue to control the situation. This is where the "REAL QA" comes out in you. The reason is "different opinions". What you have to do is remember that opinions are like eyes - everybody has one...or two....and only the VALID ones count. You must be willing to give a little to get the process moving through the system. If some one's opinion means the company will be violating a regulation, no matter how they put it, then don't agree to it. If the opinion is do-able and still meets Regulations, give in and give it a chance. If it doesn't work, you can gloat during the revision period. Remember, DIFFERENT DOESN'T MEAN WRONG!

Your biggest problem will occur if you have competitive management styles. In this case, secure a conference room and schedule a meeting with the two managers at the same time and ask them to please come to an agreement on wording so you can get the SOP approved and the company compliant. Always make it tactfully apparent that they are holding up the company's compliance program and you're only trying to keep the company out of trouble with the Regulatory Agencies. Have a solution ready before you sit down with them.

Case Study:
One manager wanted the SOP to read "Clinical Investigator sites will be chosen for an audit as determined by Clinical Operations". The other manager wanted to say "Clinical Investigator sites will be chosen based on clinical operations suggestions due to observed performance". QA can offer a solution by suggesting the sentence reads: "Clinical Investigator sites will be chosen for an audit based on decisions agreed upon by applicable management". Now, this is really a QA Management responsibility. QA should choose which sites to audit and that decision should be based on information retrieved from Clinical Operations dialogue; or something QA read in Monitoring Reports or heard at a meeting - OR....gossip overheard at the water cooler, in the restroom or cafeteria. QA's ears are ALWAYS wide open for tips on non-compliance. When you hear it, research it and jump on it before that molehill becomes a mountain.

Once you get the managers to agree on the wording, quickly close the meeting and "WALK" that SOP around that day for signatures.

Most times, your biggest holdup is going to be management. They always want to be a part of the process but is never around to sign standard operating procedures and policies. They also constantly lose the SOP on their desk or somewhere..... so try really hard not to leave with your senior management, especially if you know they have these habits. Instead, (if you can't do it), ask their assistant to help you by getting the signature and not letting the SOP out of their sight. Make an appointment if you must, but try not to leave it for them to get to later. I'm telling you - you'll thank me later!!!

Always resolve conflicts when they start or your unapproved SOP will be outdated before it get approved - which can take 6 month to a year if you let procrastinators hold you up. Don't let it happen! Take control of the situation.

Keep management's involvement to a minimum. When I say to a minimum, I'm not saying they shouldn't see the SOP or be involved in the process. THEY SHOULD DEFINITELY BE INVOLVED in the process because they are accountable. When I say keep their involvement to a minimum, I mean try to keep the number of people to sign off on your procedure to a minimum. If you don't identify in your SOP on SOPs who signs off on your operating procedures, you can end up with 2-pages of nothing but signatures and a month before the SOP is effective. You have no idea how much trouble big egos can cost! Consider keeping your approval signatures to the 1) author, 2) author's supervisor, 3)head of the SOP's applicable area and the 4) QA Manager. In cases where there are a small number of employees, (like Investigator sites or CROs), two signatures will do: the author and the head of the company or principal investigator. (The PI definitely need to sign off on ALL SOPs in their research center). The author and the approval person should not be the same. If only one person, such as the CEO of a small business writes and approves the SOPs, these should be called "policies", not "SOPs" as we know them. And this is OK because most regulation merely require you have written procedures. The instructions I'm giving here are based on "industry standards".

Once the SOP is approved, each employee affected by the SOP must be trained on it. The author can train the employees or another person delegated by management can perform training. Regardless of who perform the training, make sure they 1)know the procedure and can adequately train the staff 2) document the training, and 3) retain the training record of attendance and content.

The next thing you need to do is set up a Review Process to ensure the SOPs are current. We will discuss that in Part 6. Remember, QA is responsible for maintaining the SOPs and ensuring compliance to the SOPs. QA is responsible for tracking them to ensure they are time, I'll tell you how to do that.

Until then,



Wednesday, January 28, 2009

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 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!


Friday, January 16, 2009

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!


Tuesday, January 13, 2009

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!!


Sunday, January 11, 2009

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


How to Videos & Articles: