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Use Your Words: Writing Easy to Use Work Instructions (Quality System Documentation Management)

Updated: 3 days ago

In a previous blog post, I shared that I am an avid knitter. Recently, I completed a cotton summer sweater. Because I am a planner, I always read the pattern (aka the instructions) multiple times before I start any knitting project. I do this to ensure that I understand what I need to do to get the perfect knitted item: in this case, a cotton sweater that I can wear throughout August.

This pattern was written differently than what I am used to. I could not figure out the instructions, so I contacted the publisher for clarification. After multiple emails, I was able to knit my summer sweater and the publisher learned that the pattern needed to be revised.

This experience reminded me of other documents that I have become frustrated with in the past, Quality System Documents. In this blog post, I will share five tips on how to write Work Instructions that are clear and easy to use.

A shelf of black binders with white labels on the spine.

Quality System Documents: Work Instructions

Throughout my career, I have written, reviewed, and used Work Instructions. While they do not get the attention that SOPs get, they are vital to the day-to-day activities in any Pharmaceutical and Medical Device company.

Work Instructions provide step-by-step directions for key tasks such as entering quality data into a software program or a database or cleaning a bioreactor. A trained operator should be able to pick up the most current and approved Work Instruction document and execute all steps with no deviations from the instructions.

Unfortunately, I have seen my fair share of badly written Work Instructions which can lead to lost records and even failed batches.

Five Tips for Writing Clear Work Instructions

1. Draft the Work Instructions While Performing the Actions

Many pharmaceutical and medical device companies have software programs, databases and equipment that can be used in a training mode.

When drafting the Work Instructions, it is very easy to miss a step or document the wrong button to push (e.g., “Enter” versus “Submit”). The best way to eliminate this issue is to perform the actions and document them at the same time in your draft document.

2. Create Single Action Steps

Every step in the Work Instructions should just be that…a single step or action. There should be no ANDs or THENs in the step. Once a second action is added to the same step, the step becomes complicated, and an action may be forgotten. Here is an example:

Single Action Steps (correct):

1. Enter the date into the date field.

2. Press the Submit button Enter to move the record to Supervisor review.

Multiple Action Step (incorrect):

Enter the date into the date field then Press the Submit button to move the record to Supervisor review.

3. Screenshots!

A picture or a screenshot is always helpful in explaining where the information should be entered. This is particularly true for entering information into a database and what the button looks like that the operator should be clicking.

When using screenshots or pictures, make sure that they are clear and the item such as the field or button is highlighted in the screenshot.

4. Let the Operators Review

Your operators are the individuals who will be using the Work Instructions daily. If they do not understand the instructions provided, they will not be able to perform their expected activities consistently and accurately.

People in hazmat suits and gloves using a microscope.

Having some of the operators review the draft Work Instructions as part of the approval process will help eliminate vague terms and ensure that all steps are documented and in the correct order.

5. Review For Changes

Changes to software programs, databases and equipment happened. As part of the Change Control process, the Work Instructions should be reviewed to ensure that the steps or screenshots do not need to be revised or updated.

A simple change to a button in a database (e.g., “Enter” is now “Submit”) will require an update to the step and possibly the screenshot where the button is mentioned.

Need to Assess Your Work Instructions and Other Parts of Your Quality System Documentation Management Program?

A stack of papers on a desk near a pen.

If you would like help with your Work Instructions or an assessment of your overall Quality System Document Management Program, please contact me at I have helped many pharmaceutical and medical device companies assess their process for gaps and determine solutions.

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