Application Note – SOP N.2 – Ten steps for a perfect “SOP”

Ten steps for a perfect “SOP”

The production of a correct “SOP” document is an effective “piece of paper” for managers, laboratory technicians, servicing people to apply the correct GLP, GMP, to improve the performances, to avoid mistakes, to motivate workforces.

Ten steps for an ideal “SOP”

• 1. Goals to be reached

SOP work best when they are designed to achieve specific results. Decide what business goals will be achieved through better management with SOPs and how those goals will be measured.

• 2. Responsibility

A specific person or team must be dedicated to each single SOP.

• 3.The first draft

Make a detailed list of the steps in the order that they should be done.

A simple way to get started is to observe someone performing the process as it now exists and write down everything that that person does. This list is now a draft of the procedures. If the procedure needs to appear as a flowchart, start with the most reasonable beginning point. Draw the decision that a worker will need to make and actions that follow each decision. Do not try to be perfect with the first draft, because it is very likely that you will need to make many revisions.

• 4. Paragraphs of the SOP

An example of the SOP composition could be:

Title. Scope. Glossary. Standard / References. Responsibility. Safety. Material. Protocol. Non Conformity. Corrective Actions.

• 5. Internal Review 

Provide each worker who performs the procedure with a copy of the draft SOP. Ask the workers to review and suggest changes that will make the procedure easier to understand or more accurate or will improve performance. Assure the workers that their input is important and will be used.

People are much more likely to accept and use a SOP if they feel a sense of ownership in it. Another reason to involve the workers is that they are likely to have good ideas.

• 6. External review

Provide advisers with a copy of the SOP draft. Ask them to suggest any changes that will make it clearer and more effective. Revise the procedure as necessary to incorporate their input.

• 7. Test

There is only one way to be absolutely certain that a procedure is well written and performs as expected. Have someone test the procedure by performing each steps exactly as it is described while the procedures writer watches. Have a person not familiar with the work follow the procedure. Any steps that cause confusion or hesitation for the test worker should be re-considered.

• 8. The final draft in appropriate location

Produce a final draft and post it in an appropriate location. The workplace is one essential location. A master SOP file should be kept in a central location so workers can review little-used SOPs when necessary. It is essential to keep SOPs up to date.

• 9. Training

Train everyone as necessary to follow the procedure exactly. Otherwise, individuals will interpret the meaning of procedures in different ways, leading to inconsistency in work routines and performance.

The trainer will explain and demonstrate both why and how each step in the SOP is performed and then give the learner a chance to practice.

• 10. Audit

An audit will show whether the procedure is being adhered to and whether the objective are being met.

The SOP should be audited when dispensing errors or “near misses” occur, to identify ways of preventing their recurrence.