Quality Management as Deontological Ethics

I think every quality professional should, somewhere between individual contributor and manager, have to do a deep study into philosophy.

Studying philosophy offers several important benefits for the modern professional, enhancing both personal development and professional capabilities. Here are some reasons why philosophy is valuable in today’s professional quality leader:

Critical Thinking and Problem-Solving: Philosophy teaches individuals to think clearly, carefully, and logically about a wide range of topics. This skill is crucial for analyzing complex problems, making informed decisions, and developing innovative solutions in any professional field.
Communication Skills: Engaging with philosophical texts and discussions enhances one’s ability to read closely, write clearly, and articulate thoughts effectively. These communication skills are essential for conveying ideas persuasively and collaborating with others in a professional setting.
Ethical Reasoning: Philosophy provides a framework for addressing ethical questions and dilemmas. Understanding ethical principles helps professionals navigate moral challenges and make decisions that align with their values and societal norms. Ethical reasoning provides a framework for making decisions that are fair and just to all parties involved, ensuring that the organization’s actions align with its values and ethical standards
Cultural Awareness and Adaptability: Studying philosophy fosters cultural awareness and sensitivity, enabling professionals to work effectively in diverse environments. This awareness is particularly valuable in globalized industries where understanding different perspectives and cultural contexts is crucial.
Leadership and Strategic Thinking: Philosophy encourages big-picture thinking and strategic planning. Leaders who study philosophy are better equipped to anticipate future challenges, understand complex systems, and inspire others with a vision that goes beyond immediate concerns.
Career Versatility: Philosophy graduates pursue careers in various fields, including technology, business, law, government, and journalism. The skills acquired through studying philosophy are transferable and valued across multiple industries, providing a strong foundation for diverse career paths.

I’m certainly not an expert, but I do believe my professional life has benefited from philosophical study. I tend to be drawn to deontological ethics, a branch of moral philosophy that emphasizes the importance of rules, duties, and obligations in determining the morality of actions, rather than focusing on the consequences of those actions.

I can apply deontological ethics to the philosophy of quality management, particularly in the work of one of my favorite thinkers, W. Edwards Deming, which resonates with the principles of duty, rules, and respect for individuals. Here are some of the integrations I draw from:

Duty and Moral Rules: Deontological ethics emphasizes adherence to moral rules and duties. In quality management, this can translate to a commitment to ethical standards and practices that prioritize quality and integrity over short-term gains. Deming’s emphasis on building quality into the product from the start (rather than relying on inspection) aligns with a deontological focus on doing what is right as a matter of principle.
Respect for Individuals: Deontological ethics stresses the importance of treating individuals with respect and dignity. Deming’s philosophy includes driving out fear and fostering an environment where employees can take pride in their work without fear of retribution. This reflects a deontological commitment to respecting the autonomy and rights of workers. Bocheński’s distinction between the nature of authority based on knowledge (epistemic) and authority based on power or obligation (deontic) is a fundamental read for understanding quality culture.
Leadership and Responsibility: Deming’s points on leadership—such as instituting leadership that helps people and systems perform better—can be seen through a deontological lens as a duty to lead ethically and responsibly. This involves creating systems that support ethical behavior and quality improvement as a core value.
Systemic Integrity: Deming’s approach to quality management, which includes breaking down barriers between departments and fostering collaboration, can be aligned with deontological ethics by emphasizing the duty to maintain systemic integrity and fairness. This involves ensuring that all parts of an organization work together ethically to achieve common goals.
Commitment to Continuous Improvement: While utilitarian approaches might focus on outcomes, a deontological perspective in quality management would emphasize the duty to continuously improve processes and systems as a moral obligation, regardless of immediate outcomes. This aligns with Deming’s focus on constant improvement and education.

By integrating deontological ethics into quality management, I feel we can create a framework that not only seeks to improve quality and efficiency but also adheres to ethical principles that respect and empower individuals within the system.

A Reading List

The Right and the Good by W.D. Ross: This classic work introduces Ross’s theory of prima facie duties, which is central to his deontological framework.
The View from Nowhere by Thomas Nagel: This book explores the tension between subjective and objective perspectives, which is relevant to understanding ethical duties and objectivity in decision-making.
On Human Nature by Roger Scruton: Scruton discusses human nature and ethics, providing insights into moral duties and the philosophical underpinnings of ethical behavior.
Intention by G.E.M. Anscombe: This influential work examines the philosophy of action and intention, contributing to discussions on moral responsibility and ethics.
Postures of the Mind by Annette Baier: Baier’s essays explore trust, ethics, and the moral psychology underlying ethical relationships.
What is Authority? by Józef Maria Bocheński: This book delves into the concept of authority, distinguishing between deontic and epistemic authority and is hugely influential.

Inappropriate Uses of Quality Risk Management

Quality Risk Management (QRM) is a vital aspect of pharmaceutical and biotechnology manufacturing, aimed at ensuring product quality and safety. I write a lot about risk management because risk management is so central to what I do. However, inappropriate uses of QRM can lead to significant negative consequences and I think it is a fairly common refrain in my day that an intended use is not an appropriate use of risk management. Let us explore these inappropriate uses, their potential consequences, and provide some examples so folks know what to avoid.

1. Justifying Non-Compliance

Inappropriate Use: Using QRM to justify deviations from Good Practices (GxP) or regulatory standards.

Consequences: This can lead to regulatory non-compliance, resulting in action from regulatory bodies, such as warnings, fines, or even shutdowns. Everytime I read a Warning Letter I imagine that there was some poorly thought out risk assessment. Using risk management this way undermines the integrity of manufacturing processes and can compromise product safety and efficacy.

Example: A company might use risk assessments to justify not adhering to environmental controls, claiming the risk is minimal. This can lead to contamination issues, as seen in cases where inadequate environmental monitoring led to microbial contamination of products.

2. Substituting for Scientific Evidence

Inappropriate Use: Relying on QRM as a substitute for robust scientific data and empirical evidence.

Consequences: Decisions made without scientific backing can lead to ineffective risk mitigation strategies, resulting in product failures or recalls.

Example: A manufacturer might use QRM to decide on process parameters without sufficient scientific validation, leading to inconsistent product quality. For example the inadequate scientific evaluation of raw materials led to variability in cell culture media performance.

3. Supporting Predetermined Conclusions

Inappropriate Use: Manipulating QRM to support conclusions that have already been decided.

Consequences: This biases the risk management process, potentially overlooking significant risks and leading to inadequate risk controls.

Example: In a biopharmaceutical facility, QRM might be used to support the continued use of outdated equipment, despite known risks of cross-contamination, leading to product recalls.

4. Rationalizing Workarounds

Inappropriate Use: Using QRM to justify workarounds that bypass standard procedures or controls.

Consequences: This can introduce new risks into the manufacturing process, potentially leading to product contamination or failure.

Example: A facility might use QRM to justify a temporary fix for a malfunctioning piece of equipment instead of addressing the root cause, leading to repeated equipment failures and production delays.

5. Ignoring Obvious Issues

Inappropriate Use: Conducting risk assessments instead of addressing clear and evident problems directly.

Consequences: This can delay necessary corrective actions, exacerbating the problem and potentially leading to regulatory actions.

Example: A company might conduct a lengthy risk assessment instead of immediately addressing a known contamination source, resulting in multiple batches being compromised.

Inappropriate uses of Quality Risk Management can have severe implications for product quality, regulatory compliance, and patient safety. It is crucial for organizations to apply QRM objectively, supported by scientific evidence, and aligned with regulatory standards to ensure its effectiveness in maintaining high-quality manufacturing processes.

The White Paper in the Quality System

Eventually there will be a thorny topic that needs to be teased out, directed at an audience beyond those involved. This isn’t quite a technical report, or a risk assessment or a program document. It is that chameleon, the white paper.

A white paper can play several important roles in a quality management system:

Establish standards and best practices: White papers can outline recommended procedures, methodologies, and standards for quality within an organization or industry. They can provide detailed guidance on implementing quality processes.
Educating stakeholders: White papers serve as educational tools to inform employees, management, and other stakeholders about quality principles, new technologies, or approaches to improving quality. They help build a shared understanding of quality objectives.
Problem-solving: White papers often follow a problem-solution structure, identifying quality issues and proposing detailed solutions backed by research and data. This can help organizations address specific quality challenges.
Documenting processes: As part of a quality management system, white papers can provide in-depth documentation of complex processes, procedures, or systems. This documentation is crucial for consistency and compliance.
Promoting continuous improvement: By presenting research findings and innovative approaches, white papers can drive continuous improvement efforts in quality management.
Supporting decision-making: The authoritative and data-driven nature of white papers makes them valuable resources for informed decision-making about quality initiatives.
Demonstrating expertise: For organizations, publishing white papers on quality topics can establish thought leadership and demonstrate expertise to clients, partners, and regulatory bodies.
Compliance support: In regulated industries, white papers can help explain how an organization’s quality system meets regulatory requirements or industry standards.
Change management: When implementing new quality processes or technologies, white papers can help communicate the rationale and benefits to stakeholders, supporting change management efforts.
Benchmarking: White papers often include industry data and best practices, allowing organizations to benchmark their quality performance against peers or industry standards.

White Papers and Standards

A standard in a quality system is a documented set of requirements, specifications, or guidelines that define the criteria for quality in processes, products, or services. They offer precise descriptions that serve as an objective basis for organizations and consumers to communicate and conduct business globally. Standards provide organizations with shared procedures, terminology, and expectations to meet stakeholder requirements.

A white paper usually defines what will end up being in a standard, or defends the decision making of the standard. It is a why document.

White Papers and the Program Level

The program is a document that maps requirements to show the various ways to interpret the requirements to specific needs. Program documents, like a validation master plan or contamination control strategy, define the strategic plan that tie the entire program into a pretty package. A white paper then provides more in-depth justification of the rationale.

White Papers are Outward Orientated

When we write a white paper we are usually taking all the decision making a team made and the rationale behind them. It is a place to draw together all those articles and consensus standards we utilized, all the internal technical studies and risk management. White papers are written often aimed for health authorities, auditors, clients and partners.

How to Write a White Paper

Clear goals and target audience

A well-defined purpose is crucial for any white paper. Ask yourself:

What do you want to achieve with this document?
Who is your primary audience? Common ones are health authorities, clients, other parts of the organization.
What action do you want readers to take after reading? Usually it answers questions, but other times there is a translation necessary (e.g. update SOPs)

Concise summary

The executive summary or abstract should:

Be no more than 200-250 words
Highlight the main problem, solution, and key takeaways
Entice the reader to delve into the full document

Strong introduction

A compelling introduction should:

Provide context for the topic
Establish the relevance and importance of the issue
Outline the structure of the paper
Hook the reader with an interesting fact, statistic, or scenario

Problem statement

When defining the problem:

Use data and real-world examples to illustrate its scope and impact
Explain why existing solutions were inadequate
Highlight the consequences of not addressing the issue

Well-researched content

To ensure credibility:

Use a mix of primary and secondary sources
Link to requirements and obligations (i.e. regulatory regulations, consensus standards, industry best practices)
Include recent data
Reference industry reports and academic studies
Conduct original research and risk management as appropriate

Solution(s)

When presenting solutions:

Explain the rationale behind each option
Discuss pros and cons objectively
Provide evidence of effectiveness, such as case studies or pilot results
Clearly state why the recommended or chosen solution is superior

Logical flow and structure

Organize your content with:

A clear, logical progression of ideas
Subheadings and sections for easy navigation
Transitional phrases between sections
A balance of text, visuals, and white space

Visual elements

Effective visuals can include:

Infographics summarizing key data
Process diagrams explaining complex concepts
Comparison charts for different solutions
Relevant photographs or illustrations

Conclusion and call-to-action

A strong conclusion will:

Recap the main points without introducing new information
Reinforce the urgency of addressing the problem
Provide clear, actionable next steps for the reader, as appropriate
Include contact information or resources for further engagement

References

Properly cite sources by:

Using a consistent citation style (e.g., APA, MLA)
Including a bibliography or reference list at the end
Using footnotes or endnotes for additional context if necessary

Objective tone

Maintain credibility by:

Using a professional, authoritative voice
Avoiding overly promotional language
Acknowledging potential limitations or challenges
Presenting a balanced view of the topic

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 Instruction	Definition	Attributes	When Needed	Why	Differences	Example
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 correctly	Focuses 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 records	Rigid 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.

Types of Work, an Explainer

The concepts of work-as-imagined, work-as-prescribed, work-as-done, work-as-disclosed, and work-as-reported have been discussed and developed primarily within the field of human factors and ergonomics. These concepts have been elaborated by various experts, including Steven Shorrock, who has written extensively on the topic and I cannot recommend enough.

Work-as-Imagined: This concept refers to how people think work should be done or imagine it is done. It is often used by policymakers, regulators, and managers who design work processes without direct involvement in the actual work.
Work-as-Prescribed: This involves the formalization of work through rules, procedures, and guidelines. It is how work is officially supposed to be done, often documented in organizational standards.
Work-as-Done: This represents the reality of how work is actually performed in practice, including the adaptations and adjustments made by workers to meet real-world demands.
Work-as-Disclosed: Also known as work-as-reported or work-as-explained, this is how people describe or report their work, which may differ from both work-as-prescribed and work-as-done due to various factors, including safety and organizational culture[3][4].
Work-as-Reported: This term is often used interchangeably with work-as-disclosed and refers to the accounts of work provided by workers, which may be influenced by what they believe should be communicated to others.
Work-as-Measured: The quantifiable aspects of work that are tracked and assessed, often focusing on performance metrics and outcomes

Aspect	Work-as-Done	Work-as-Imagined	Work-as-Instructed	Work-as-Prescribed	Work-as-Reported	Work-as-Measured
Definition	Actual activities performed in the workplace.	How work is thought to be done, based on assumptions and expectation.	Direct instructions given to workers on task performance.	Formalized work according to rules, policies, and procedures.	Description of work as shared verbally or in writing.	Quantitative assessment of work performance.
Purpose	Achieve objectives in real-world conditions, adapting as necessary.	Conceptual understanding and planning of work.	Ensure tasks are performed correctly and efficiently.	Standardize and control work for compliance and safety.	Communicate work processes and outcomes.	Evaluate work efficiency and effectiveness.
Characteristics	Adaptive, context-dependent, often involves improvisation.	Based on assumptions, may not align with reality.	Clear, direct, and often specific to tasks.	Detailed, formal, assumed to be the correct way to work.	May not fully reflect reality, influenced by audience and context.	Objective, based on metrics and data.

Aspect	Work-as-Measured	Work-as-Judged
Definition	Quantification or classification of aspects of work.	Evaluation or assessment of work based on criteria or standards.
Purpose	To assess, understand, and evaluate work performance using metrics and data.	To form opinions or make decisions about work quality or effectiveness.
Characteristics	Objective and subjective measures, often numerical; can lack stability and validity.	Subjective, influenced by personal biases, experiences, and expectations.
Agency	Conducted by supervisors, managers, or specialists in various fields.	Performed by individuals or groups with authority to evaluate work performance.
Granularity	Can range from coarse (e.g., overall productivity) to fine (e.g., specific actions).	Typically broader, considering overall performance rather than specific details.
Influence	Affected by technological, social, and regulatory contexts.	Affected by preconceived notions and potential biases.

Author: Jeremiah Genest