Biomedical Engineering Reference
In-Depth Information
(b) SOPs can control several kinds of process - a person-to-
machine process, a person-to-paper process, a person-
to-person process, or some combination of these;
(c) SOPs promote clarity about what the task is, as well as
the organizational and environmental settings for task
performance;
(d) SOPs defi ne the resources that are necessary for each task,
and the personnel responsible for completing the tasks;
(e) SOPs identify the sequencing of the tasks within a given
process, and the standards that defi ne the satisfactory
completion of the tasks; and
(f) SOPs are a regulatory requirement in manufacturing in
the life sciences industry.
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In fulfi lling these roles, SOPs have a typical form that can
be displayed in a template.
4.1.1 Template for an SOP
An SOP has four major sections:
1. Introductory material;
2. Actions (tasks) and responsibilities;
3. Approvals;
4. Version history.
The
introductory material
includes the SOP's purpose, the
scope of its application, any acronyms and defi nitions that
will clarify its content, any references to other procedures or
controlled documents that are relevant to the content, any
materials that are involved in the process, safety precautions
that must be observed in executing the procedure, and any
policy issues. This is schematized in Figure 4.1. If this SOP
