Slide 1 STANDARD OPERATING PROCEDURES Judith Marshall Quality Manager Fera

Slide 2 STANDARD OPERATING PROCEDURES Content of SOPs The aim of this workshop is to enable you to understand the need for SOPs and how to write them

Slide 3 STANDARD OPERATING PROCEDURES What are SOPs and why do we need them What to put in an SOP How to write SOPs

STANDARD OPERATING PROCEDURES A standard operating procedure is the how to do it instruction May be called an SOP, work instruction, desk instruction, procedure, protocol They are for the standard and routine processes, not expected to cover every eventuality no matter how unlikely it is to happen

Slide 5 STANDARD OPERATING PROCEDURES Purpose Describe how to perform routine activities Provide a training aid Guide & standardise working procedures Ensure quality & integrity of data generated/information captured Reconstruction/repeatability Provide an auditing tool

Slide 6 STANDARD OPERATING PROCEDURES Examples of Categories Document control Record control Technical procedures Use of equipment Issuing reports Archiving processes Auditing

Slide 7 STANDARD OPERATING PROCEDURES Keep language simple Short steps Use a direct instruction – add solution A to solution B then replace the stopper and mix Add tolerances eg 5g ± 0.5g Indicate timescales Refer to other SOPs rather than re-write instructions Include flow charts, diagrams and/or photos if these describe something better than words

Slide 8 STANDARD OPERATING PROCEDURES Avoid making it too long (write 2) Don’t need lots of pre-amble Avoid writing in the third person Step wise instructions are best Level of detail is important Explain acronyms

Slide 9 STANDARD OPERATING PROCEDURES Avoid un-necessary specification – don’t say use a blue bucket, if the colour doesn’t matter Avoid alternatives – unless necessary within the technical requirements, then explain what dictates which course of action Avoid ambiguity – can cause extra work if the reader misunderstands

Any questions?

Slide 11 STANDARD OPERATING PROCEDURES What to include (1) A title – short and to the point Edition number – gives document control Issue date – when did it come into use Author – who to speak to if you have questions

Slide 12 STANDARD OPERATING PROCEDURES What to include (2) An introduction – set the scene Scope or exclusions Safety considerations Materials & Equipment

Slide 13 STANDARD OPERATING PROCEDURES What to include (3) A list of SOPs or other documents referred to A list other documents referred to A circulation list

Slide 14 STANDARD OPERATING PROCEDURES What to include (4) The PROCEDURE How to do what you are doing

Slide 15 STANDARD OPERATING PROCEDURES What to include (5) Break it into sections Sections into specific steps Number the steps or bullet point for clarity

Slide 16 Summary SOPs are a requirement of all the standards SOPs needed for the technical procedures undertaken SOPs required for the management of the system eg SOP control, auditing and the overarching processes eg test item control