Alaina Confer, Procedural Compliance Specialist
After working hard on writing a clear and effective procedure, you should avoid muddying it with unnecessary detail. A solution to keep related information handy to the SOP is to extract that information and include it as attachments to the document. Some good materials for SOP attachments are:
- Process Flows
- Standard Forms/Templates/Sample Forms
Some definitions are necessary to either clarify or standardize a role or term contained in the SOP. However, the SOP may include terms that are defined by the referenced regulations. Consider defining these terms to align them with the company’s philosophy and policies. Ensure the modified definition does not contradict the definition set in the regulations. For example, the FDA GMP regulations (21 CFR 210) define ‘Quality control unit’ as “any person or organizational element designated by the firm to be responsible for the duties relating to quality control”; your organization may choose to further define this unit in an SOP by specifying a qualification or two that the organization requires these individuals to possess to perform the procedure the SOP describes. The purpose of this would be to align the role with the organization’s policies.
A process flow can be beneficial as well. Many individuals view themselves as visual learners; I am quite certain some of them work with you. The process flow will illustrate where the procedure branches in different directions, connects with other procedures, or loops back into the procedure (i.e. when approval criteria have not been met). Process flows are not necessary for short, linear procedures. However, the process flow will be much more valuable for complex and/or cross-functional processes.
Placing forms and templates in attachments to SOPs will provide easy references for the reader. Once again, this assists the visual learners, because as they train on the SOP they can better visualize using the form or template.
It will not always be necessary to have attachments for each SOP. For instance, definitions do not need to be included in an attachment or the SOP if a controlled Glossary of Terms to the SOPs is maintained. In general, though, your readers will appreciate the handy references.