Writing Effective Quality System Documentation

You must follow a good writing process to prepare an effective document. This process starts before the document is written and continues after it is completed. The process also involves more than just the writer.

The basic steps in a good writing process are to:

  • Plan: What is being written? Why are we writing it?
  • Investigate: Collect information and generate ideas.
  • Organize: Group your thoughts into a document outline.
  • Write: Create a draft of the document in the agreed format.
  • Review: Ask users to look at the draft document.
  • Test: Use the document to validate it is correct and complete.
  • Approve: Submit it for management review and approval.
  • Train: Ensure users are trained before issuing the document.
  • Issue: Make it available in the document control system.
  • Maintain: Revise the document to keep it valid and current.

During the writing step, you need to consider these principles:

  • Syntax: the arrangement of words.
  • Vocabulary: the choice of words.
  • Complexity: the level of detail.
  • Numbers: the presentation of numerical information.
  • Format: the way a document looks.
  • Style: conversational and emphasis methods.
  • Organization: of process information.
  • Lists: a sequence of items.
  • Conditions: the decision criteria.
  • Alerts: using warnings, cautions, and notes.
  • Cross-references: to direct the reader to a specific activity.
  • Complex Steps: dealing with non-sequential and alternative steps.