Policy vs Standard Operating Proceedure vs Operator Instruction

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What follows will form part of a post tentatively titled “GMP Technical Writing”. The larger post will incorporate aspects of Writing Technical Reports and The Need for Documentation and detail the hierarchy of documents within a Quality Management System, what information goes where and how to conduct business process mapping. I’m tossing up on whether to present this as a series of posts or as some sort of presentation style document (pdf or Powerpoint).

A Policy A SOP An OI
What’s What  Course of action adopted due to one or more considerations such as legal or regulatory requirements

Contains regulatory, corporate or scientific policies, rules or principles.  Explains why these are considerations.

generally affect multiple SOPs.  If affects one SOP, should include detail in SOP after Additional Information section.

  • If information >1 page and affects >1 SOP
  • or >3 pages and affects 1 SOP, write a separate policy document
  • Who, what, when where and why.
  • A series of stages describing the sequence of tasks performed
  • Describes processes lasting an extended time (hours, days, weeks).
  • Tends to encompass multiple users.
  • Written with the overall goal of achieving the outcome via a number of specified outcomes.

Each stage in a SOP comprises a number of action or steps. Length dictates their placement in a SOP or an OI:

  • ≤4 steps -SOP content.
  • >4 steps – place in an OI.
  • How to do something.
  • Step wise instructions.
  • Takes place in the now.
  • Tends to involve single user.
  • Written to achieve a specified outcome.
Tables  Informational
  • Overview only – Section/Description.
  • Stage/Description.
 Step/Action
Flow Charts  Informational

Must not exceed 1 page.

 Used a process overview.

  • If ≥5 sections, a flow chart can be used.
  • If <5 sections, a Section/Description table use used.
  • Must not exceed 1 page.
  • Suitable only where instructions are straightforward.
  • Must not exceed 1 page.
Naming Convention  N/A Use present continuous. eg. Sampling of Water for Injection
!!”ing” in the title.		 Use the present simple. Daily Check of Equipment Calibration
!!If the proposed title includes “How to…” the it’s likely an OI.
In General
  • Section headings do not include full stops
  • For all nouns and verbs in document titles, use capitals. Does not apply to section headings.

-Title: Using The Autoclave
-Section Heading: Load the autoclave

  • Be consistent in the use of bullets and font.
  • Be consistent with capitalisation and use of punctuation.
  • Read your work out loud. If you stumble, the reader will too.
  • Plan. Talk to SME’s. Before you begin writing, identify the information type(s).
  • Chunk the information 7±2

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