Pharmaceutical Microbiology

Thursday, 6 February 2025

Why are procedures so important?

Aside from the fact that they make the auditor happy and certain regulations require that some of our processes be documented, they play a critical role in making sure our product is good. Right?

Here’s a list of the important benefits of having good procedures in place:

Consistency - they make sure that everybody always does things the same way
Training - they provide a basis for a lot of the training that goes on in our company
Best Practices - they make sure we’ve captured proven and correct methods for our processes
Continuous Improvement - they make sure we have good control over our processes so that we can constantly improve our systems
Regulatory Compliance - the regulations say certain things have to be documented
Quality - ultimately they allow us to consistently produce products and services of the highest quality

What makes a good procedure?

The existence of a procedure is not enough. It actually has to be used. And for it to be used, people have to know it exists and be able to read it, understand it, and follow it.

Here’s what makes a good procedure good:

It has to meet the rules, if there are any
It has to be well-formatted, so people can find what they need to find
It has to be easy to read, so people can understand it and follow it
It has to be as concise as possible
It has to be clear and specific, with few ambiguities
It has to be right
It has to be proven to work

We have a lot of flexibility when it comes to writing our procedures. The regulations tell us what has to be documented, but it doesn’t tell us how. That’s entirely up to us.

Every time we are reviewing a procedure we should come at it with fresh eyes and think it through to make sure we’re not just blindly following something that’s not doing the job, just because it already exists as a procedure in your system.

Templates are a bit tricky. Be careful. They’re great for making sure there’s some sort of consistency across the organization, but if you’re trying to shove your content into a template that’s not suitable it could become a monster to read and use.

Like all writing, if we spend a little time upfront thinking things through, the writing will be clear. Take the time and plan things properly and it’ll be much less overwhelming.