Part 2: Common (Avoidable) Defects Found in SOPs

By Dee Carri, Friday, 21st March 2014 | 0 comments
Filed under: SOPs, Work Instructions, TPSoP®.

How Much Do You Love Your SOPs Part 2: Defects 

By Dee Carri

Read the introduction to our 'How Much Do You Love Your SOPs' blog series here >

Definition of Defect : “A shortcoming, imperfection or lack” (English Oxford Dictionary)


Despite heroic efforts - hundreds of man years developing procedures and hundreds of thousands of man years in training and using them, non-conformances due to human error remain stubbornly high, representing approximately 30% of recorded deviations / non-compliance incidents.

Working to develop visual, process-based online procedures, we became intrigued by this statistic and started to count anomalies and errors in the text-based procedures we encountered. We were also interested to see how many could be removed or prevented using TPSoP ®.

What we discovered is that errors and / or defects are embedded in many SOPs and Work Instructions during their development and institutionalised during training, thereby creating unavoidable non-compliance when Users follow the procedure as directed.

Further analysis enabled us to identify that, in general, SOPs and Work Instructions operate at a two Sigma Level as shown in figure 1 below. Note that organisations moving from a two Sigma position to a five Sigma position will gain a substantial cost saving and compliance benefit.


Figure 1. The Size of the Prize for SOP Performance Improvement


Defects in SOPs and Work Instructions


In this blog, we share the most common defects that we encounter in our transformation of text-based SOPs using TPSoP®. 





Too much or too little information is provided to the User.

Error precursor, increased risk of error


Related SOPs / Instructions contain contradictory instructions.


Operational vulnerability


Procedures are written in overly technical language – users are unable to understand.

Operational vulnerability


Procedures are authored by someone who is not fluent in the language, resulting in ambiguity or errors.


Operational vulnerability


There are situations where procedures are missing (where they should be in place).


Operational vulnerability


Procedures are duplicated, or partially duplicated, Users don’t know which procedure to apply.


Error precursor, increased risk of error


Procedures are written without an understanding of the literacy and comprehension abilities of the User and therefore contain the incorrect level of detail.


Error precursor, increased risk of error


The SOP / Work Instruction is not quality assured by the person(s) who perform the activity.

Error precursor, increased risk of error


Procedures are difficult to follow due to complexity and length (need to flip back and forth).

Increased risk of error where User has limited time to read.


It is not possible to see the “big picture” due to the volume and interrelationships between procedures.


Increased risk of error, omission or duplication



The procedure cannot be used on its own, or it is difficult to follow without other documents (which may not be readily available).

Error precursor, increased risk of error



Integration with Compliance, Quality standards and Business Rules is not possible using text based referencing.



Increased risk of error, omission or duplication



Documents are multifunctional. A change in an individual function triggers full revision but without all functions being represented in the revision.


There is a risk that revisions introduce new errors where all original functions are not involved in the revision.



It is not possible to contact the author / owner of the procedure to request additional information, notify of errors or provide suggestions for improvement.

The opportunity to correct, prevent and improve is lost or denied


Scope is incorrect or ambiguous.

Error precursor - increased risk of error

Purpose / Objective

Purpose / Objective is incorrect or ambiguous.

Error precursor, increased risk of error


Definitions, including glossary, are incorrect and/or missing .

Error precursor, increased risk of error


References are incorrect and/or missing.

Error precursor, increased risk of error


References not easily found (other documents, legislation, IT application, drawings), out of date or obsolete.

Error precursor, increased risk of error


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.

Error precursor, increased risk of error

Roles & Responsibilities

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.


Diffusion of responsibility


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”


Diffusion of responsibility


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.


Operational vulnerability


The vocabulary around roles is not standard across SOPs and Work Instructions e.g. “Top Management”, “Senior Management” “Senior Leadership Team”.


Operational vulnerability

Procedure Steps

The procedure makes the job less safe or more inefficient.


Operational vulnerability


The procedure steps are missing, incorrect, presented in the wrong order, they are too detailed and / or not sufficiently detailed.

Error precursor, increased risk of error


The procedure steps do not contain references to specific transactions that have to be performed in supporting IT applications, or the references are incorrect.

Error precursor, increased risk of error


The procedure does not describe the best way of working

Reduced effectiveness


Supporting / appended flow-charts, process diagrams are out of date, incorrect, flawed.


Error precursor, increased risk of error


Supporting / appended flow-charts, process diagrams do not conform to a standard notation methodology, so they present differently. This confuses (or confounds) the reader.


Error precursor, increased risk of error


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.


Error precursor, increased risk of error


Training materials (particularly complementary IT application training) have to be created in parallel or after procedures are written.

Duplication and increased risk of errors


Training materials are incorrect, contain gaps or they do not correctly correspond with the version of procedure(s).

Error precursor, increased risk of error


Note: Error precursors exist before an error occurs. If discovered and removed, job-site conditions can be changed to minimize the chance for error.


  • People are being trained on defective procedures, thereby embedding poor practice(s) and creating situations where errors are more likely.

  • Procedures often do not reflect how the activities are performed in “real life”.

  • People are performing steps they are not supposed to do or are not trained to do.

  • Errors, gaps, overlaps and underlaps exist in written procedures (we’ve written about duplication and overlap in part 1 of this series).

  • Substantial benefits in cost reduction and improved compliance effectiveness is available to organisations willing to rethink how they approach the development and implementation of Procedures, SOPs and Work Instructions.


In the next blog in our SOP series, we'll focus on the topic of “Information Availability”. And if you missed the introduction, you can find it here >
In the meantime, we invite you to provide feedback, comments and your experience in the comments section below.


Further learning:
What is TPSoP® and how can it help? >


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