The Attributes of Good Procedure

Good documentation practices when documenting Work as Prescribed stresses the clarity, accuracy, thoroughness and control of the procedural instruction being written.

Clarity and Accuracy: Documentation should be clear and free from errors, ensuring that instructions are understood and followed correctly. This aligns with the concept of being precise in documentation.

Thoroughness: All relevant activities impacting quality should be recorded and controlled, indicating a need for comprehensive documentation practices.

Control and Integrity: The need for strict control over documentation to maintain integrity, accuracy, and availability throughout its lifecycle.

To meet these requirements we leverage three writing principles of precise, comprehensive and rigid.

Type of InstructionDefinitionAttributesWhen NeededWhyDifferencesExample
Precise Exact and accurate, leaving little room for interpretation.– Specific
– Detailed
– Unambiguous
When accuracy is critical, such as in scientific experiments or programming.Regulatory agencies require precise documentation to ensure tasks are performed consistently and correctlyFocuses on exactness and clarity, ensuring tasks are performed without deviation.Instructions for assembling a computer, specifying exact components and steps.
Comprehensive Complete and covering all necessary aspects of a task.– Thorough
– Inclusive
– Exhaustive
When a task is complex and requires understanding of all components, such as in training manuals.Comprehensive SOPs are crucial for ensuring all aspects of a process are covered, ensuring compliance with regulatory requirements.Provides a full overview, ensuring no part of the task is overlooked.Employee onboarding manual covering company policies, procedures, and culture.
Rigid Strict and inflexible, not allowing for changes.– Fixed
– Inflexible
– Consistent
When safety and compliance are paramount, such as batch recordsRigid instructions ensure compliance with strict regulatory standards.Ensures consistency and adherence to specific protocols, minimizing risks.Safety procedures for operating heavy machinery, with no deviations allowed.

When writing documents based on cognitive principles these three are often excellent for detailed task design but there are significant trade-offs inherent in these attributes when we codify knowledge:

  • The more comprehensive the instructions, the less likely that they can be absorbed, understood, and remembered by those responsible for execution – which is why it is important these instructions are followed at time of execution. Moreover, comprehensive instructions also risk can dilute the sense of responsibility felt by the person executing.
  • The more precise the instructions, the less they allow for customization or the exercise of employee initiative.
  • The more rigid the instructions, the less they will be able to evolve spontaneously as circumstances change. They require rigorous change management.

This means these tools are really good for complicated executions that must follow a specific set of steps. Ideal for equipment operations, testing, batch records. But as we shade into complex processes, which relies on domain knowledge, we start decreasing the rigidity, lowering the degree of precision, and walking a fine line on comprehensiveness.

Where organizations continue to struggle is in this understanding that it is not one size fits all. Every procedure is on a continuum and the level of comprehensiveness, precision and rigidity change as a result. Processes involving human judgement, customization for specific needs, or adaptations for changing circumstances should be written to a different standard than those involving execution of a test. It is also important to remember that a document may require high comprehensiveness, medium precision and low rigidity (for example a validation process).

Remember to use them with other tools for document writing. The goal here is to write documents that are usable to reach the necessary outcome.

Brain-Friendly Principles for Document Design

Whether creating Work-as-Prescribed in our documents, or Work-as-Instructed in our training materials, it is important to consider good cognitive practices. If we start from two principles we quickly can start doing some amazing things.

  1. Organize resources so it’s easy to understand. Reduce cognitive load by breaking information down into small, digestible chunks and arranging them into patterns that make sense to the individual. Always start by giving an overview so individuals know how all the smaller chunks fit together.
  2. Use visuals. The brain has an incredible ability to remember visual images so you must exploit that as you look for ways to reinforce key learning points. Create tools that are primarily visual rather than word-based. Use images in place of text (or at least minimize the text). Use videos and animations to help people understand key concepts.

We can drive a lot of effectiveness into our processes by structuring information to make complex documents more transparent and accessible to their users. Visual cues can provide an ‘attention hierarchy’, making sure that what is most important is not overlooked. People tend to find more usable what they find beautiful, and a wall of text simply looks scary, cumbersome, and off-putting for most people. I am a strong advocate of beauty in system design, and I would love to see Quality departments better known for their aesthetic principles and for tying all our documents into good cognitive principles.

Cognitive Load Theory

Cognitive load theory (CLT) can help us understand why people struggle so much in reading and understanding contracts. Developed by John Sweller, while initially studying problem-solving, CLT postulates that learning happens best when information is presented in a way that takes into consideration human cognitive structures. Limited working memory capacity is one of the characteristic aspects of human cognition: thus, comprehension and learning can be facilitated by presenting information in ways minimizing working memory load.

Adapted from Atkinson, R.C. and Shiffrin, R.M. (1968). ‘Human memory: A Proposed System and its Control Processes’. In Spence, K.W. and Spence, J.T. The psychology of learning and motivation, (Volume 2). New York: Academic Press. pp. 89–195

Structure and Display

Information structure (how the content is ordered and organized) and information display (how it is visually presented) play a key role in supporting comprehension and performance. A meaningful information structure helps readers preserve continuity, allowing the formation of a useful and easy-to-process mental model. Visual information display facilitates mental model creation by representing information structures and relationships more explicitly, so readers do not have to use cognitive resources to develop a mental model from scratch.

Leveraging in your process/procedure documents

Much of what is considered necessary SOP structure is not based on how people need to find and utilize information. Many of the parts of a document taken for granted (e.g. reference documents, definitions) are relics from paper-based systems. It is past time to reinvent the procedure.

Three things that get in the way of good training

Culture of Delivery

Does training in your organization seem like death by PowerPoint? Is learning viewed as something an expert dumps in the lap of the learner.? However, that’s not what learning is – lectures and one-way delivery end up resulting in very little learning.

For deeper meaning to occur, invest in professionally facilitated experiences that enable staff to form mental models they remember. Get people thinking before and after the training to ensure that the mental model stays fresh in the mind.

Culture of Cutting Time

Avoid the desire for training in shorter and shorter chunks. The demands of the workplace are increasingly complex and stressful, so any time out of the office is a serious cost. The paradox is that by shortening the training, we don’t give the time for structured learning, which sabotages the investment when the training program could be substantially improved by adding the time to allow the learning to be consolidated.

Culture of Un-Fun

We know that learning takes place when people have fun, stress is low, and the environment encourages discovery. Make training cheerful and open rather than dull and quiet. Encourage lots of informal learning opportunities. Give more control to the learner to shape their experience. Have fun!

Competencies in Quality

Competence is the set of demonstrable characteristics and skills that enable, and improve the efficiency of, performance of a job. There are a ton of different models out there, but I like to think in terms of three or four different kinds of competences: professional and methodological skills; social competence; and self-competence which includes personal and activity- and implementation-oriented skills. Another great way to look at these are competencies for inter-personal (maps to social competence), intrapersonal (maps to self-competence), and cognitive (maps to professional and methodological skills).

The ongoing digital transformation (Industry 4.0) leads to changing competence requirements which means new ways of life-long teaching and learning are necessary in order to keep up.

We can look at the 4 competencies across three different categories: Human, Organization and Technology:

  Human Organization Technology
Professional & methodological expertise
(Cognitive)
System thinking
Process thinking
Results oriented work
Complexity management
Business thinking
Problem solving
Sensitization ergonomics
Structured, analytical thinking
Change management
Qualification/further education
Agile methods/tools
Lean Enterprise
Client orientation
Workplace design
Soft/hardware understanding
Cyber-physical system understanding
Usability
Human-machine interfaces
Social Competence
(Inter-personal)
Inter-disciplinary thinking
Managerial competence
Ability to work as a team
Conflict management
Communication
Empathy
Employee satisfaction
Human centering
Social networking  
Self-Competence
(Intrapersonal)
Lifelong learning
Personal initiative
Innovativeness
Independent work
Sense of responsibility
Readiness for change
Process orientation  

When it comes to the professional competencies there is a large spread depending on what our industries requires. As a pharmaceutical quality professional I have different professional expertise than a colleague in the construction industry. What we do have in common is the methodological expertise I listed above.

Understanding competencies is important, it allows us to determine what skills are critical, to mentor and develop our people. It also helps when you are thinking in terms of body of knowledge, and just want communities of practice should be focusing on.