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TEXT-BASED SOP / PROCEDURE / WORK INSTRUCTION DEFECTS
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RESULT / EFFECT
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General
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Too much or too little information is provided to the User.
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Error precursor, increased risk of error
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Related SOPs / Instructions contain contradictory instructions.
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Operational vulnerability
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Procedures are written in overly technical language – users are unable to understand.
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Operational vulnerability
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Procedures are authored by someone who is not fluent in the language, resulting in ambiguity or errors.
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Operational vulnerability
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There are situations where procedures are missing (where they should be in place).
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Operational vulnerability
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Procedures are duplicated, or partially duplicated, Users don’t know which procedure to apply.
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Error precursor, increased risk of error
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Procedures are written without an understanding of the literacy and comprehension abilities of the User and therefore contain the incorrect level of detail.
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Error precursor, increased risk of error
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The SOP / Work Instruction is not quality assured by the person(s) who perform the activity.
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Error precursor, increased risk of error
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Procedures are difficult to follow due to complexity and length (need to flip back and forth).
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Increased risk of error where User has limited time to read.
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It is not possible to see the “big picture” due to the volume and interrelationships between procedures.
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Increased risk of error, omission or duplication
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The procedure cannot be used on its own, or it is difficult to follow without other documents (which may not be readily available).
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Error precursor, increased risk of error
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Integration with Compliance, Quality standards and Business Rules is not possible using text based referencing.
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Increased risk of error, omission or duplication
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Documents are multifunctional. A change in an individual function triggers full revision but without all functions being represented in the revision.
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There is a risk that revisions introduce new errors where all original functions are not involved in the revision.
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It is not possible to contact the author / owner of the procedure to request additional information, notify of errors or provide suggestions for improvement.
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The opportunity to correct, prevent and improve is lost or denied
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Scope
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Scope is incorrect or ambiguous.
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Error precursor - increased risk of error
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Purpose / Objective
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Purpose / Objective is incorrect or ambiguous.
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Error precursor, increased risk of error
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Definitions
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Definitions, including glossary, are incorrect and/or missing .
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Error precursor, increased risk of error
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References
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References are incorrect and/or missing.
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Error precursor, increased risk of error
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References not easily found (other documents, legislation, IT application, drawings), out of date or obsolete.
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Error precursor, increased risk of error
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References refer to other documents at a document level, not the specific section or activity to which it refers, making it meaningless to the User.
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Error precursor, increased risk of error
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Roles & Responsibilities
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Roles and responsibilities are unclear or so generic that they are meaningless.
For Example: “It is the responsibility of the Manager / Supervisor to ensure that this procedure is followed correctly”.
This statement neither identifies how the Manager / Supervisor will ensure the procedure is followed correctly, nor is the SOP / WI identified that documents their management activity, nor are the the control(s) identified that will be monitored to demonstrate compliance.
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Diffusion of responsibility
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There are roles described in the SOP / WI that have not been assigned to an accountable person who will be accountable e.g. “Top Management”
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Diffusion of responsibility
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The role description on the SOP / Work Instruction is not related to the job title of the individual responsible for performing the instruction. Therefore they don’t recognise that they are accountable to perform an activity.
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Operational vulnerability
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The vocabulary around roles is not standard across SOPs and Work Instructions e.g. “Top Management”, “Senior Management” “Senior Leadership Team”.
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Operational vulnerability
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Procedure Steps
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The procedure makes the job less safe or more inefficient.
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Operational vulnerability
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The procedure steps are missing, incorrect, presented in the wrong order, they are too detailed and / or not sufficiently detailed.
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Error precursor, increased risk of error
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The procedure steps do not contain references to specific transactions that have to be performed in supporting IT applications, or the references are incorrect.
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Error precursor, increased risk of error
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The procedure does not describe the best way of working
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Reduced effectiveness
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Appendices
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Supporting / appended flow-charts, process diagrams are out of date, incorrect, flawed.
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Error precursor, increased risk of error
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Supporting / appended flow-charts, process diagrams do not conform to a standard notation methodology, so they present differently. This confuses (or confounds) the reader.
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Error precursor, increased risk of error
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Users are not trained in how to read flow-charts and process charts and therefore they do not understand the meaning of symbols, flows and interactions.
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Error precursor, increased risk of error
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Training
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Training materials (particularly complementary IT application training) have to be created in parallel or after procedures are written.
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Duplication and increased risk of errors
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Training materials are incorrect, contain gaps or they do not correctly correspond with the version of procedure(s).
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Error precursor, increased risk of error
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