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.