Hey, it's Pam

This week I'm looking at something that causes as many problems as bad writing: bad root cause analysis. Every investigation gets documented. If the investigation is shallow, the documentation inherits that weakness. And I've seen some truly creative ways to avoid digging deeper.

Seen a creative non-root-cause in a CAPA report? Hit reply and tell me. I've heard some doozies.

In this issue:

• If your root cause is "operator error," your investigation hasn't started
• 35= years of research, one authoring tool
• The good, the bad, the ugly: Copy Makeovers

I recently worked with a client whose deviation report listed the root cause as: the operator was "lackadaisical." I kid you not.

Here are six root causes that simply don't work because they fail to uncover the real issues.

• Operator error. A process that works only when humans are perfect isn't a process. 
• Insufficient training. The operator was trained. The trained operator still failed. The gap isn't in the trainer or the trainee.
• Procedure not followed. Ask why skipping it was easier than following it. That answer is your root cause.
• Supplier issue. Your incoming inspection accepted the part. That's two failures. You investigated zero.
• Isolated incident. "Isolated" is a conclusion, not a finding. Show the trend data or keep digging.
• Equipment malfunction. Machines drift on a schedule. If PM didn't catch it, the PM program is your root cause.

Each one of these stops the investigation at the first person, part, or machine it meets. A real root cause names the system that let the failure through. Retraining closes the CAPA. It doesn't fix the crack.

We've spent 35+ years studying what makes regulated documents easier to read, review, and approve. Now we've built those principles into a technical writing authoring tool that explains the rationale behind the rewrite according to the science of readability.

Other authoring tools change sentences and paragraphs based on what they scrape from the internet, so the content may be good but it's probably not written for the target reader.

With our tool you can have confidence that the message will be land with the intended reader; guesswork is removed. Want to try it out for free? We're looking for teams who want to try it.

Each issue, we create a sample of regulated-industry writing and show how a few changes make it clearer.

Original

Manufacturing associates who receive materials into the cleanroom document information such as lot number and expiration date; however, disposition status is not something they are trained to focus on. The expectation is that there are checks and balances prior to materials entering the cleanroom to ensure they are appropriate for commercial use. Moreover, the label for "Approved for Specific Use" materials is white and it's not uncommon for Manufacturing associates to receive Conditionally Approved materials for commercial use which are also on white labels. There are no visual cues helping users understand critical information more quickly and efficiently.

Rewrite

This error occurred because materials that had not been approved for commercial use were sent to the cleanroom; these materials were affixed with "Approved for Specific Use" labels, which are white. The label for "Conditionally Approved" materials, which Manufacturing Associates are used to receiving, is also white.

This cause of this error is twofold:

1. Both "Approved for Specific Use" and "Conditionally Approved" labels are white, so Manufacturing Associates confused the two.

2. Checks and balances to ensure the appropriate material was sent to the cleanroom failed. 

Why it works

The original contains unnecessary information, is wordy, and follows a common but flawed structure: it explains why the problem exists before naming the real issue. The real problem is the identical white labels. But because the explanation comes first, readers treat it as the most important point. Readability studies confirm this: readers anchor on the first information they encounter. The rewrite gets straight to the point by explaining what caused the issue.