Dangerous Documents – Don’t Be Haunted By Your Words

Dangerous Documents – Don’t Be Haunted By Your Words

April 16th, 2014 // 12:26 pm @ jmpickett

Don’t Be Haunted By Your Words

How to Avoid Document Mistakes That Destroy Your Credibility and Lead to Legal Trouble

By Nancy Singer and Joseph Pickett

Nancy Singer is the creator and presenter of the 5-hour in-person seminar and 90 min summary webinar Dangerous Documents: Avoiding Land Mines in Your Emails and Documents. She began her career as an attorney with the United States Department of Justice where she did litigation for the Food and Drug Administration. Joseph Pickett is a freelance writer at josephmpickett.com, and the owner of the pharmaceutical webinar website Expertbriefings.com.

In this article, we offer advice to both FDA and industry on how to write clear, concise reports and SOPs that won’t come back to haunt them in the future.

If you think about it, an electronic document is like a diamond in your wedding ring. It is very precious.
And it lasts forever.

This is especially true in the field of health care products. These products save and enhance lives. The people and entities that regulate and manufacture these drugs and medical devices are highly visible.

That visibility is often a plus, but when things go wrong, it can be a minus.

For FDAers, you and your documents are under the intense scrutiny of:

• Defense lawyers
• Office of the Investigator General (OIG)
• Congress
• Trade associations
• The media

Pharmaceutical and device firms, you do not get off easy, either. You and what you write is being closed watched by:

• The competition
• Federal prosecutors
• State prosecutors
• Plaintiffs’ lawyers
• The media

Basically, people are out to get you in the health care industry. All of these entities have the power to make you look very bad.

So, it is vital to be careful when you write reports and SOPs. Or, six years later at your indictment hearing, you could have prosecutors, the media or Congress saying, “Can you believe they wrote that?”

For FDA – Lack of Specificity or Evidence in  Your EIR Statements

According to the Investigator Operator Manual (IOM) 5.10.4 Narrative Report: “All reports…should be factual, objective and free of unsupportable conclusions…capable of being used as evidence.”
Sounds simple, right?
However, all too often in my career, I have read EIRs with investigator statements like this:
Example 1
“The firm calibrates all of its manufacturing equipment every six months.”
Buzz – wrong answer!
Why? First of all, it is very vague. But there is a deeper problem. In essence, the investigator has just endorsed an unsubstantiated claim of the company! If that company has a recall down the road that injures a customer due to improper calibration, the investigator could have some unpleasant questions to answer.
This is one better way to convey the same information in the EIR:

“I reviewed the firm’s SOP that states that the director of calibration will calibrate all of the manufacturing equipment every six months. (See Exhibit 1). I reviewed the firm’s calibration documentation for the calendar year 2010, and the records reflect that all of the equipment identified in the SOP have been calibrated according to the schedule.”

As you can see, this statement provides clear, concise facts about the SOP. And, it makes clear that the SOP claims are that of the company itself, and that the investigator has verified them.

Example 2

Another example from an EIR:

“The production rooms are cleaned daily.”

A lawyer could have a lot of fun with this one, such as: “If the production rooms are cleaned daily, Mr. Investigator, how can you explain the existence of rodents in the production facility?” Once again, the investigator is setting himself up as the defender of the company’s unsubstantiated policy.

A better way to say this is:

“The SOP on sanitation states that the production rooms are cleaned daily.”

Example 3

Another vague example from an EIR:

“The firm uses Yost Pest Control Services, and the firm has not had problems with pests.”

How nice of you to take the company’s side, Ms. Investigator!

Let’s try that again:

“I reviewed the firm’s pest control reports from the Yost Pest Control Services for 2010, which are attached in Exhibit 1. Out of the 10 reports that I reviewed, I did not see any reports of rodent activity.”

For FDA – Know When To Use Active and Passive Voice

IOM 5.10.4 Narrative Report Elements states: “Generally, EIRs…should be written in the first person using the active voice.”

FDA has stated: “Readers prefer active voice sentences, and we should try to use the active voice in most of our business writing…Active voice identifies the action and who is performing it. Unfortunately, much of government writing is in the passive voice….[it] becomes a habit; one we should all work to change.”

To get away from passive voice, EIR statements by the investigator should include answers to the following:
• Who
• What
• When
• Where
• How and
• Challenge each observation by asking “so what?” (regarding its significance)

If you use the passive voice, it can be difficult to write in the first person and to answer those questions.

In passive voice, the subject is acted upon. Statements usually are wordy, contain the verb “to be,” and can hide the actor. We want the document to specify who the actor was. So down the road, it is clear who did what.

Example 1:

Passive: “Six records were reviewed, and discrepancies were found in each record.”

In active voice, the subject performs the action.

Active: “I reviewed six records and found discrepancies in each record.”

Example 2:

Passive: “The 483 was annotated by the firm.”

No good. This statement does not answer who, what or when. FDA is going to want to know these things if something goes wrong at the firm someday.

Active: “At the end of the inspection, the firm’s VP QA, Joe Yates, annotated each of the items on the 483.”

Better. Now if the firm does not follow up on the corrective items, FDA knows to whom it needs to speak.

Example 3

Passive: “A list of all batches of SAP drugs manufactured since the last inspection was provided.”

Active: “I asked Mr. Bates to provide a list of all batches of SAP drugs manufactured from Jan-June 2010. He provided the list that is attached to this report as Exhibit 4.”

However, there are times when you do want to use passive voice, such as when the actor is:

Unknown: The office was built in 2006.
Unimportant: The Bates’ response to the 483 was mailed on June 10, 2010.
Better left unsaid (tact): Your form was written incorrectly.

Here are some other examples of acceptable passive voice:

“The previous inspection was classified as VAI.”

“No 483 was issued.”

“The inspection of this Class II device manufacturer was conducted on Nov. 23, 2009.”

For Industry – Problems With Passive Voice

We also want to use active voice in most industry documents. This way, it is clear in, say, 5 years, who did what and when.

IOM 5.3.6.2 states that “in order to establish relationships between violative conditions and responsible individuals, the following types of information would be useful:”
• What orders were issued? When, by whom, to whom, and on whose authority and instructions?
• What follow-up was done to see if orders were carried out? When, by whom, and on whose authority and instructions?
• Who decided corrections were not complete and satisfactory?

Let’s apply this to a typical CAPA documentation. The company should state:

 

• What happened
• Why it happened
• What they did about it
• Why the solutions were effective
• How to make sure it does not happen again

However, oftentimes, the company uses the passive voice in the CAPA report. This can tell what happened without revealing the responsible parties.

Examples 1-3

“Complaints were received.”

“The investigation took place.”

“The corrective action was taken.”

These vague statements can result in the reader of the document (say an FDAer or an attorney) not understanding the root cause of the failure, as well as the compliance story.
Again, we need to understand five years later what the story was, after everyone at the company who was involved may no longer be around.

Example 4

CAPA report states: “2% of the brakes on the hospital beds fail to hold.”

What it should say: “Based on the investigation, the root cause for the brakes of the hospital beds failing to hold is that the operator is not using the correct settings on the new manufacturing equipment to test the brakes. This is the third time the incident has happened by three different operators.”

For Industry – SOP Habit to Avoid – Sloppy Writing

Also on the industry side, company employees are often guilty of other types of poor writing that can cause trouble, too.

Example 1

This is an example a statement I might see in an industry document:

“The purpose of this study was to ensure that the coating material #234 will not affect the leak and tear resistance of the latex gloves.”

The problem here is the company employee has injected bias into the statement. This should be rewritten to be completely neutral:

“The purpose of the study was to determine whether the coating material #234 will affect the leak and tear resistance of the latex gloves.”

Example 2

“If there is not more than one positive test of sterility in the 10 tests, the selected sterilization dose is substantiated.”

The sentence explains the criteria for what a substantiated dose is, but there is no reference.

Example 3

“The raw data collected is located in Appendix 1. The official data for this study can be found in the mechanical test report.”

What is the difference between raw data and official data? Why not just say ‘data’?

Example 4

“This report tested the accuracy of the glucose monitor readings.”

This statement also injects bias. A better way is:

“This report includes the test results of the accuracy of the glucose monitor readings.”

Conclusion

The federal government has been trying for years to encourage the use of plain, clear language in government documents. In 1998, President Clinton directed agencies to write all documents in concise language. OMB also formed a group called the Plain Language Action Network (www.plainlanguage.gov). Vice President Gore even created the “No Gobbledygook” Award, which FDA won on four occasions!

The government wants all of us to use clear language, as in the examples cited above, so we can keep health care products safe and reliable for the future. Hopefully, by following some of these tips, both FDA and industry can produce clearer and more concise documents in the future.

Be sure to check out our upcoming Webinar on Dangerous Documents!