3 Major Mistakes during writing SOP – Pharmaceutical Industries

Poorly written and ineffective standard operation procedures have a devastating effect on your compliance and business.

And today, I’m going to share about 3 Major Mistakes during writing SOP – Pharmaceutical Industries.

If you manage to avoid them, you will dramatically improve user engagement and compliance.

Today’s topic is significant because every quality professional has to write or review SOPs at some point in their career.

Unfortunately, most people make grave mistakes when writing or reviewing SOPs, which has become a normality.

Normality, which you must change. SOP’s are the backbone of any operation, and they must serve the users.

If the users can’t follow them correctly, it is a recipe for deviations, batch scrapping, reworks, recalls, and compliance issues.

Many quality managers tend to classify such events as human error and close the case. However, when operators tend to make mistakes, it usually lies on the SOP! Now, let’s explore the most common mistakes people make during writing that lead to those problems.

1- Letting the wrong people write the SOPs!

This is a huge one!

You know what I’m talking about!

Letting managers or even other departments write an SOP without even consulting with the end-user.

If you do something like that, don’t be surprised to get a huge backlash and disagreement from your colleagues!

The end-user always knows better how things work in his arena and must be involved in the writing.

If you do so, expect deviations and people using secret notes instead of your SOP. So, respect the people who need to use the SOP, and involve them throughout the process.

2- Writing over-complicated SOPs.

Many SOPs are so overly complicated and confusing that people have a hard time following them.

If you need a two-hour training to explain an SOP, it has failed! That simple! Written procedures should be clear and straightforward to follow.

Instead of text, consider using diagrams, images, and screenshots.

Think about a step-by-step guide to washing hands that we see everywhere right now, and you probably have to hang in your sterile manufacturing facility.

Imagine it as an SOP without imaging and only description.

You would need much more words to explain the procedure, and it would be much easier to get it wrong.

Next time you go over an SOP, think about simplifying it by reducing text and adding visuals.

3 – Lack of training!

SOP authors often don’t get through training, which teaches them how to write simple, effective, and compliant SOPs.

And you know what, the higher education the authors have, the more training they probably need.

Keeping things simple, and goes beyond that.

Writing excellent SOPs is skill authors need to learn and aim to improve.

Writing good SOPs requires creativity, imagination, openness to collaborate, and much more.

Therefore, seek out people in your organization who do that well and ask them to teach others to do it.

If you like this article 3 Major Mistakes during writing SOP – Pharmaceutical Industries

If you can’t find such people internally, seek them outside the company because it is well worth it, as better SOPs will improve your compliance, KPIs, and harmony at your workplace.


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