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Designing Fit-for-Purpose GCP SOPs: The Cost of a Document

A back-of-the-envelope calculation, based on our experience writing thousands of SOPs, on the cost of a policy, SOP, Work Instruction, form, or template.

Imagine a mid-sized pharmaceutical company writing a cross-functional records retention SOP or policy.  We have six different functions working on the document, with 100 people total who need to train on that document.

Roles Activity Hours Personnel Total
Functions Determination of need for document 1 6 6
Author Document development 6 1 6
Functions Off-line review (three rounds) 3 6 18
Functions Review meetings (three rounds) 3 6 18
Author Review management 6 1 6
Author Comment consolidation and revision 12 1 12
QA Formatting 2 1 2
QA QC review 2 1 2
QA Approval management 1 1 1
Functions Curriculum identification 0.5 6 3
Training Curriculum set-up 1 1 1
Functions Training 0.5 100 50
Training Training Oversight 3 1 3
TOTAL 128

 

We multiply that by a typical number of documents:

Document Type # of Documents x 128 Hours
Policies 15 1920
SOPs 150 19200
Work Instructions 50 6400
Forms 50 6400
Templates 50 6400
TOTAL 315 40320

Thus, a mid-sized organization is devoting over 40,000 hours a year to its quality processes. Since people work about 2,000 hours per year, that’s almost 20 FTEs per year.  If the organization has 1000 employees, that’s 2% of the workforce.  On average, each person is devoting one week out of a year to SOPs.

In a small biotech, let’s assume four different functions are working on an SOP that 20 people have to train on:

Roles Activity Hours Personnel Total
Functions Determination of need for document 1 4 4
Author Document development 6 1 6
Functions Off-line review (three rounds) 3 4 12
Functions Review meetings (three rounds) 3 4 12
Author Review management 6 1 6
Author Comment consolidation and revision 12 1 12
QA Formatting 2 1 2
QA QC review 2 1 2
QA Approval management 1 1 1
Functions Curriculum identification 0.5 4 2
Training Curriculum set-up 1 1 1
Functions Training 0.5 20 10
Training Training Oversight 3 1 3
TOTAL 73

And now we multiply by a more modest number of procedures:

Document Type # of Documents x 73 Hours
Policies 5 365
SOPs 25 1825
Work Instructions 5 365
Forms 15 1095
Templates 5 365
TOTAL 55 4015

That’s two FTE years for a small biotech. In a company with 100 people, that’s the equivalent of 2% of the workforce – about the same as a large company.

Is the equivalent of 2% of the workforce too much to dedicate to SOPs? That depends.  If those SOPs are enabling compliance and promoting efficiency, it may be well worth the cost. But because SOPs have a real cost, we will be even more efficient if we eliminate documents with redundant content.

 

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