{"id":609,"date":"2016-09-05T21:45:49","date_gmt":"2016-09-05T11:45:49","guid":{"rendered":"http:\/\/paulyeatman.net.au\/?p=609"},"modified":"2020-08-06T11:32:45","modified_gmt":"2020-08-06T00:32:45","slug":"standard-operating-proceedure-vs-operator-instruction","status":"publish","type":"post","link":"https:\/\/paulyeatman.net.au\/index.php\/2016\/09\/05\/standard-operating-proceedure-vs-operator-instruction\/","title":{"rendered":"Policy vs Standard Operating Proceedure vs Operator Instruction"},"content":{"rendered":"

What follows will form part of a post tentatively titled “GMP Technical Writing”. The larger post will incorporate aspects of Writing Technical Reports<\/a> and The Need for Documentation<\/a> 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).<\/p>\n\n\n\n\n\n\n\n\n
<\/td>\nA Policy<\/strong><\/td>\nA SOP<\/strong><\/td>\nAn OI<\/strong><\/td>\n<\/tr>\n
What’s What<\/strong><\/td>\n\u00a0Course of action adopted due to one or more considerations such as legal or regulatory requirements<\/p>\n

Contains regulatory, corporate or scientific policies, rules or principles.\u00a0 Explains why these are considerations.<\/p>\n

generally affect multiple SOPs.\u00a0 If affects one SOP, should include detail in SOP after Additional Information section.<\/p>\n

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

    Each stage in a SOP comprises a number of action or steps. Length dictates their placement in a SOP or an OI:<\/p>\n

      \n
    • \u22644 steps -SOP content.<\/li>\n
    • >4 steps \u2013 place in an OI.<\/li>\n<\/ul>\n<\/td>\n
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    \n
  • How to do something.<\/li>\n
  • Step wise instructions.<\/li>\n
  • Takes place in the now.<\/li>\n
  • Tends to involve single user.<\/li>\n
  • Written to achieve a specified outcome.<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n
Tables<\/strong><\/td>\n\u00a0Informational<\/td>\n\n
    \n
  • Overview only \u2013 Section\/Description.<\/li>\n
  • Stage\/Description.<\/li>\n<\/ul>\n<\/td>\n
Step\/Action<\/td>\n<\/tr>\n
Flow Charts<\/strong><\/td>\n\u00a0Informational<\/p>\n

Must not exceed 1 page.<\/td>\n

Used a process overview.<\/p>\n
    \n
  • If \u22655 sections, a flow chart can be used.<\/li>\n
  • If <5 sections, a Section\/Description table use used.<\/li>\n
  • Must not exceed 1 page.<\/li>\n<\/ul>\n<\/td>\n
\n
    \n
  • Suitable only where instructions are straightforward.<\/li>\n
  • Must not exceed 1 page.<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n
Naming Convention<\/strong><\/td>\n\u00a0N\/A<\/td>\nUse present continuous. eg. Sampling of Water for Injection
\n!!”ing” in the title.<\/td>\n		Use the present simple. Daily Check of Equipment Calibration
\n!!If the proposed title includes “How to…” the it’s likely an OI.<\/td>\n<\/tr>\n
In General<\/strong><\/td>\n\n