In part 1, of my SOP blog post, I described why you need to use SOP’s (SOP’s aren’t for SAPS (Part 1)) and now I will describe what has to be in an SOP and what needs to be documented by an SOP.
An SOP is a living document that describes any process and/or assay. It is a document that
covers anything where standardization is involved.
So, what needs to be in SOP? Think of the SOP as a pedantic, step by step description of your process. Every little step, detail, manipulation, etc. If you, in a step, stand on one foot and bay at the Moon for 5 minutes, well then that has to be included. Leaving out any step or detail, no matter how trivial, will result in others not being able to exactly reproduce results from your SOP. This is important since an SOP is your document which all employees will refer to.
It can be a daunting task, writing down every step you did in an assay, a fermentation process, or even writing for an SOP, and for most, that is what makes SOP’s such a daunting document. But, once it is written, you have a document that everyone can use and can be trained with. It is basically a little pain at the beginning for a big reward later.
David Slomczynski, Ph.D; Geometrick Enterprises