What to include in SOP Definitions section

#1
Hi there,

Have been writing/editing SOPs for years but am interested in others opinions about what should be included in a Definitions section.

Personally I think it is only terms that require interpretation within the context of the SOP. Terms that are commonly understood by the organization / industry should not be included, rather terms that could be interpreted differently, so the definitions section helps bolster the interpretation within context of the SOP. I personally like small definitions sections. And don't get me started on lengthy Responsibilities sections! :)

Opinions?

Thanks!
 
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qualprod

Trusted Information Resource
#2
Hi there,

Have been writing/editing SOPs for years but am interested in others opinions about what should be included in a Definitions section.

Personally I think it is only terms that require interpretation within the context of the SOP. Terms that are commonly understood by the organization / industry should not be included, rather terms that could be interpreted differently, so the definitions section helps bolster the interpretation within context of the SOP. I personally like small definitions sections. And don't get me started on lengthy Responsibilities sections! :)

Opinions?

Thanks!
Hi there,

Have been writing/editing SOPs for years but am interested in others opinions about what should be included in a Definitions section.

Personally I think it is only terms that require interpretation within the context of the SOP. Terms that are commonly understood by the organization / industry should not be included, rather terms that could be interpreted differently, so the definitions section helps bolster the interpretation within context of the SOP. I personally like small definitions sections. And don't get me started on lengthy Responsibilities sections! :)

Opinions?

Thanks!
What I do is to include acronyms.
For instance, Instead to mention Into the sop, furnaces production manager , I define FPM and this is known in all the system, or any special need, e g. engineering quotation software means EQS. Hope this helps.
 

John C. Abnet

Teacher, sensei, kennari
#3
Good day @kjlcm ;
Not sure what governance (if any) you/your organization is working under in regards to developing SOP,s, however, I would first ask WHY does your organization need a "Definitions section?"

I am in agreement that many organizations (certainly NOT all) have so many terms, local colloquialisms, etc..etc..., that clarifying what is meant by these is sometimes necessary. Indeed, sometimes common terms such as "component" vs. "part" vs "material" have unique and significant meanings/applications, and the lack of clear definition can cause confusion at minimum and lead to nonconformances at most.

Based on my professional experience, IF your organization determines it needs to capture definitions, I would council against including a "definitions section" directly on your SOP,s. The logic for this is that the same term is often used in multiple documents (i.e. SOP,s etc...). If that is the case then by using the method I infer from your original post, your organization will have the "same" definition stated multiple times/redundantly across numerous documents. When I have seen this applied in the real world, it was rare when I would see a same/common definition used consistently.

Instead, IF your organization determines it needs to capture definitions, I would suggest following the lead of certain OEM,s and create stand a lone "terms and definitions" document/list, which can then be referenced as a single point of information instead of redundantly placing the "same" definition across multiple locations.

Hope this helps.
Be well.
 

Sam Lazzara

Trusted Information Resource
#4
In each of my medical device SOPs, I have a section called DEFINITIONS and it says "Refer to Quality System Glossary QSM2". All personnel are trained on QSM2 so they have awareness of its existence.

The Quality System Glossary is conjoined to the Quality Manual and it includes all pertinent quality system definitions.
Over 90% of the definitions come from authoritative external documents such as regulations and standards, with ISO 9001:2015 being the most prolific. The Glossary also includes industry and company-particular abbreviations.

For each definition, an "External Reference" citation is provided. If the same term is defined differently by relevant regulations/standards I provide all of the different definitions. For example, the term MANUFACTURER has many different definitions.
 
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