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Continuous Improvement

This is something I tend to be weak on when it comes to answering in an interview (it does not come up much).  Hence this post to begin to get things ticking over in my brain.

Continuous improvement (CI) is something I’ve routinely done as I’ve updated documents, mapped business processes or followed procedures.  I’ve not followed any official 6 sigma methodology (also known as Lean, Agile, Kaizen) as such, though I have the basics if this in my survival kit and ask why 5 times.

Ask Why 5 Times - pinned to the wall of my cubicle/office

Ask Why 5 Times – pinned to the wall of my cubicle/office

CI is a method for identifying opportunities for streamlining work and reducing waste. Continue reading

Policy vs Standard Operating Proceedure vs Operator Instruction

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 buisiness 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

Example of a Before and After Document

Last year I attended an interview for a technical writer role. Nothing came of it.  As part of the application process,  I was tasked with taking a provided “document” and rewriting it into something suitable for a scientific environment.   I retain the copyright to this rewritten instruction.

Here is the before version: Continue reading