SOPs: Templates, Tips and Taboos

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SOPs Templates, Tips and Taboos

• Denise Evanovitch,
• Technical Specialist
• CSTM 2005

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Documents, Records, SOPs and Policies

• How are these items different or similar?
• Documentspolicies, SOPs, forms, charts,
  processes and labels
• Recordscompleted forms
• Policies tell us what will be done (eg. Quality
  Policy)
• SOPs tell us how to do it

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Standard Operating Procedures

• Templates what components should be in an SOP?
• Tips good lessons learnedthings you may want
  to use
• Taboos painful lessons learned things you
  may want to avoid
• Try your hand at creating a simple SOP of your
  choice in small groups
• What are your objectives for this session?

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SOPsObjectives

• Describe 3 components that must be incorporated
  in a SOP template
• List 3 tips you found useful
• Explain 3 things to avoid (taboos)
• Develop a simple SOP in small groups
  incorporating the elements from templates, tips
  and taboos

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SOPs

• Many standards and regulations citing the
  necessity for SOPs
• Health Canada FDA GMPs, CSA (Z902), CSTM, CLSI
  (formerly NCCLS), ISO, AABB, QMP-LS OLA
  (provincial), etc.
• SOPs are one of the many key gears in a TQM
  system

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SOPs

• SOPs are just one piece of the quality puzzle

Validation QA
Facilities equipment
Training and competency
Change control
Non-conform.
Documents
Process control
Audits
Suppliers
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Effective SOPs

• Uniform, detailed work instructions
• Linked to training (design, development,
  assessment tools)
• Promote consistency, structure and control
• Meet regulatory requirements
• Available in the workplace

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SOPsTemplates

• There must be processes in place to ensure SOPs
  are
• written formatted reviewed
• approved version controlled
• indexed managed revised
• archived used
• document controlled

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SOPsTemplates

• Each SOP should contain (or be easily linked to
  the SOP)
• Name of organization, title, purpose,
  authorization, version number, references, step
  by step instruction, link to the process, an
  effective/implementation date, pagination,
  rationale, unique number
• Others? Eg. discipline, equipment, scope,
  definitions

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SOPsTemplates

• Key Items for the SOP Header

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SOPsTips

• Standard language
• -promotes consistency and understanding eg. Red
  cells, red blood cells, packed cells or
  concentrated red cells?
• Glossary
• -writers have reference for standard language
• -prevents lengthy Definitions section
• -promotes standardization consistency

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SOPsTips

• Limit the number of writers
• -prevents the duplication of information
• -standardizes the appearance and language
• -less time spent for writer reorientation
• Rationale
• -important to explain why steps are included in
  SOP for future revisions and for user
• -may be contained outside of the SOP eg. SOP
  development file

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SOPsTips

• Link with process map/flow
• -ensures SOP is written, identifies linking SOPs,
  information is not duplicated, monitors progress

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SOPsTips

• Link with SOPs, forms and training
• -reference related SOPs to assist user
• -reference/link all related forms to promote
  understanding of the process
• -allows user to gather all necessary tools to
  correctly complete task
• -helps to prevent writers from duplicating
  instructions
• -should be foundation of training module and
  competency assessment tool

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SOPsTips

• Ensure titles match content
• -create a new SOP for a different topic
• -put your user eyes on
• User acceptancesend out for feedback to
  representative sample of users
• Lots of white space
• -easier to read
• -easier to find specific content

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SOPsTips

• Emergency Revisions
• -develop a process to implement urgent changes
  eg. Critical amendments or directives
• Tracking changes
• -develop a process to gather change information
  for the next SOP revision

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SOPsTips

• Include a flowchart with each SOP
• Begin each work step with a verb
• -eg. Pipette, retrieve, incubate, issue, grade,
  record, document, etc.
• Master index
• Key words-include in glossary
• Consider electronic system

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SOPsTips

• Appoint a document control person in each
  laboratory/department
• Master file-master copies, archived copies
• Documentation of destroyed, controlled copies
  (retrieval/archive process)
• Decide if QC/maintenance will be in separate QC
  procedures or contained in work instruction SOP

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SOPsTips

• What are your tips?

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SOPsTaboos

• Not too much detail, but sufficient
• -leave out specific locations and equipment eg.
  Retrieve reagents from reagent refrigerator NOT
  remove reagents 1, 2 and 3 from upper right shelf
  of the Puffer Hubbard refrigerator
• Avoid trade/commercial names eg. Laboratory film
  not Parafilm
• -if your supplier changes, the SOP will not
  require a revision

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SOPsTaboos

• Dont state work instructions in more than 1 SOP
• -confusing for user
• -difficult to track
• -how will the required changes occur in all of
  the SOPs when revisions are required?
• Dont include forms in the body of the SOP
• -every time the form is changed, the SOP will
  have to be revised

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SOPsTaboos

• Avoid wordiness
• -cannot find needed information
• -consider overview on one side of the document
  detail on the other
• Dont entitle an SOP with Process or
  Procedure
• -makes SOP difficult to find if all titles begin
  with PROCESS FOR

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SOPsTaboos

• What are your taboos?
• What should organizations watch out for when
  developing/distributing SOPs?

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SOP Activity

• In small groups, develop a SOP of your choice on
  flipchart paper
• Use the information in Templates, Tips and Taboos
  to develop your SOP
• Present/explain to large group
• You have 10 minutes

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SOPsObjectives Review

• Describe 3 components that must be incorporated
  in a SOP template
• List 3 tips you found useful
• Explain 3 things to avoid (taboos)
• Develop a simple SOP in a small groupyou just
  did this!

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SOPs

• Any further questions?
• Thank you for your time

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SOPsReferences

• CSA Z902, CSTM
• Health Canada and FDA GMP
• QMP-LS OLA
• CLSI (formerly NCCLS), AABB, ISO
• Berte Lucia, Lupo Bonnie. Quality in Blood
  Banking in Modern Blood Banking and Transfusion
  Practices, 4th ed, by Denise Harmening, 1999

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SOPsReferences, contd

• Nevalainen D., Berte L., Callery M. Quality
  Systems in the Blood Bank Environment, 2nd ed.,
  Abbott Quality Institute and American Association
  of Blood Banks, 1998
• Gagliardi K., Evanovitch D., Heddle N., Boye D.,
  Sunesen S., McMillan S., Frassetto R. Sharing Our
  Strategies (SOS) Manual, QUESTMcMaster
  Transfusion Research Program, 2004