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GCP SOPs, Problem solving

What tools do you use to develop your Standard Operating Procedures?

A simple flowchart for troubleshooting a broke...

Image via Wikipedia

Over the years,  I’ve noticed that organisations have one thing in common with their approach to developing SOPs – each does it their own way.

For some, it’s a draining, time consuming activity. For others, it’s an opportunity for improvement. So, what accounts for this difference in attitude?

Using tools, like process mapping, to identify these opportunities locates potential pain points, which might need  prioritising (i.e. points in your process ripe for non-compliances, most likely through a lack of standardisation, duplication, or confusion).

Process mapping is a technique for visually representing a standardized process, breaking it down into constituent parts. The challenge then, is to identify all the steps and decisions in a process in diagrammatic form, capturing: –

  • the flow of information, documents, or materials
  • tasks within the process that transform inputs into outputs
  • where decisions need to be made along the chain
  • dependencies between the process steps

Outline process maps (or flowcharts) show all the actions undertaken, providing a dynamic view of how your organisation can deliver enhanced business value (e.g. improved quality outcomes in clinical research). Through using “what if scenarios” you can compare maps of the process “as is” with the process “to be”.

Swimlane flowcharts (otherwise known as deployment charts), represent actions according to where, or by whom, they’re performed.

Either method, of representing the component parts in a process, simplifies SOP content into a large-scale format, which makes it easier to convert into a written SOP.

As a team exercise, ideally, process mapping leads to communication between departments or functions with an open exchange of ideas, plugging gaps and eliminating overlaps. At the very least, as a basis for SOP development, it provides a common framework, introducing a systematic way of working, which is after all, a necessary part of standardisation. Isn’t it?

What tools does your organisation use to develop its SOPs?

About Dr M

I'm a pharmaceutical industry specialist, with more than 25 years experience, and a background in medical and social sciences. My focus lately is on helping ABPI exam candidates navigate the ins and outs needed to sail through this pharmaceutical industry rite of passage.

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