Critical and Analytical Thinking

According to the World Economic Forum’s Future of Jobs Report 2023, analytical and critical thinking are the 1st and 2nd most needed job skills (Quality Control is #10).

Quality Control as a Top 10 Skill

Analytical and critical thinking are two distinct cognitive processes often used interchangeably but have unique characteristics and purposes. Understanding the differences is essential as we hire and develop people.

Analytical Thinking

Analytical thinking involves separating complex information into smaller, more manageable parts to understand the underlying structure and relationships. It is a linear, step-by-step process that examines each component individually to identify patterns, trends, and cause-and-effect relationships. The goal is to draw logical conclusions based on the available data.

Key Aspects of Analytical Thinking:

Breaking Down Problems: Dividing significant, complex problems into smaller parts to better understand them.
Identifying Patterns and Trends: Looking for recurring themes within data.
Making Connections: Understanding relationships between different elements.
Using Data and Evidence: Relying on factual information to draw conclusions.
Problem-Solving: Finding solutions by understanding the root causes of issues.

Steps in Analytical Thinking:

Gathering Relevant Information: Collecting all necessary data.
Breaking Down Data: Dividing information into smaller, manageable parts.
Examining Components: Analyzing each part to understand its role and relationship to the whole.
Identifying Patterns: Looking for trends and cause-and-effect relationships.
Drawing Conclusions: Making logical deductions based on the analysis.

Critical Thinking

On the other hand, critical thinking is a broader cognitive process that involves evaluating information and making judgments based on evidence. It is more holistic and reflective, considering the context, assumptions, and biases behind the information. Critical thinking aims to form well-reasoned judgments and decisions by synthesizing, evaluating, and reflecting on information from various sources.

Key Aspects of Critical Thinking:

Questioning Assumptions: Challenging existing beliefs and avoiding taking information at face value.
Evaluating Evidence: Assessing the reliability and validity of information.
Considering Multiple Perspectives: Considering different viewpoints and being open to revising opinions.
Identifying Logical Fallacies: Recognizing errors in reasoning.
Drawing Conclusions Based on Evidence: Forming judgments well-supported by logical reasoning and evidence.

Steps in Critical Thinking:

Gathering Relevant Information: Collecting all necessary data.
Evaluating Information: Assessing the credibility and relevance of the information.
Asking Questions: Probing more profoundly into the information to uncover hidden biases or unsupported claims.
Formulating Ideas: Developing theories and ideas based on the evaluation.
Considering Alternatives: Exploring different possibilities before reaching a conclusion.
Testing Conclusions: Verifying if the evidence supports the conclusions.

Differences Between Analytical and Critical Thinking

Approach:

Analytical Thinking: Linear and focused, breaking down problems into smaller components.
Critical Thinking: Holistic and reflective, evaluating the credibility and relevance of information.

Goal:

Analytical Thinking: Understand principles and identify patterns.
Critical Thinking: Evaluate credibility, question assumptions, and make informed decisions.

Outcome:

Analytical Thinking: Logical conclusions based on data.
Critical Thinking: Well-reasoned judgments and decisions based on a comprehensive evaluation of information.

While both analytical and critical thinking are essential for effective problem-solving and decision-making, they serve different purposes and involve distinct processes. Analytical thinking focuses on breaking down information to understand its components, whereas critical thinking involves evaluating and synthesizing information to form well-reasoned judgments. Integrating both types of thinking can lead to more robust and informed decision-making.

Here is a table comparing analytical thinking and critical thinking based on the provided information:

Aspect	Analytical Thinking	Critical Thinking
Definition	Breaking down complex information into smaller parts to understand its structure.	Evaluating information and making judgments based on evidence and reasoning.
Approach	Linear, step-by-step process.	Holistic, reflective, and considers multiple perspectives.
Goal	Understand principles, identify patterns, and find connections.	Form well-reasoned judgments and decisions.
Process	– Gather relevant information – Break down data – Examine components – Identify patterns – Draw conclusions	– Gather relevant information – Evaluate information – Ask questions – Formulate ideas – Consider alternatives – Test conclusions
Focus	Facts and evidence within the information.	Evaluating credibility, questioning assumptions, and considering outside knowledge.
Outcome	Logical conclusions based on data.	Well-reasoned judgments and decisions.
Use in Problem-Solving	Used to break down and understand complex problems.	Used to evaluate and make informed decisions about problems.
Examples of Use	Analyzing reports and scientific data analysis.	Evaluating arguments and making decisions.
Traits	– Logical – Detail-oriented – Systematic	– Open-minded – Skeptical – Reflective

key differences and characteristics of analytical and critical thinking

Synpase Labs Data Integrity Notice

The FDA does not publish many notices on data integrity, so folks should pay attention to yesterday’s publication on Synapse Labs Pvt. Ltd. (Synapse)—a contract research organization (CRO) based in Pune, India, and the need to repeat any studies conducted there.

Section 711 of FDASIA and Regulatory Obligations

Too often, I see folks in pharma focus on 21 CFR Chapter 1, or at best all three chapters, maybe know the guidances and pay attention to little else. Unfortunately, that approach will often get one in trouble.

Section 711 of the Food and Drug Administration Safety and Innovation Act (FDASIA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to enhance the safety and quality of the drug supply chain. Specifically Section 711 amends Section 501(a)(2)(B) of the FD&C Act by adding the following sentence:

“For purposes of paragraph (a)(2)(B), the term ‘current good manufacturing practice’ includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.”

This amendment clarifies that current good manufacturing practice (CGMP) requirements for drugs include:

Implementing oversight and controls over the entire manufacturing process to ensure quality.
Managing the risks related to raw materials, other materials used in manufacturing, and finished drug products to establish their safety.

In essence, Section 711 expands the FDA’s CGMP authority to explicitly cover supply chain management and drug manufacturers’ oversight of their suppliers and contract manufacturing operations. It also allows the FDA to enforce supply chain control requirements during inspections.

The legislative history shows that Congress intended to significantly expand the FDA’s authority over the increasingly global drug supply chain through this provision. It allows the FDA to scrutinize how manufacturers select, qualify, and oversee suppliers of raw materials and contract manufacturers to ensure drug quality and safety.

Please note that the FDA gets this expanded authority without revising 21CFR. That’s how it works; Congress can do that. Will we eventually see some 21 CFR updates? I have no idea.

But what this does mean is that the FDA has the authority to:

Inspect risk management for GMPs, and assume you have it. What does good risk management look like? The agency has adopted ICH Q9(r1) as guidance, so start there.
Inspect your supplier management, which includes qualifying and overseeing suppliers and contract manufacturers.

I’ve started to receive regulatory intelligence that this is coming up in inspections. Expect to be asked for the risk management evidence and for supplier qualification and oversight evidence.

Aging in the Workforce – or Why All Those Years Matter

Source: https://flowingdata.com/2024/06/18/older-or-younger-than-the-population/

Wow, I’m older than a lot of people. When did that happen? (Shout out to my small cohort of fellow Gen-Xers!) So, in a bit of reflection, I want to discuss why I think aging in the quality profession is so critical.

The quality profession is an experience-heavy field. While formal education can provide some necessary theoretical knowledge, the practical skills required for the quality profession can only be mastered through extensive hands-on experience, practical application of skills, and the ability to adapt to real-world challenges.

Key characteristics

Direct Experience: Students participate in activities that require them to apply what they have learned in a practical setting. An old adage is that you must do a job for three years before understanding it. However, you must keep going through the iterations since quality comprises multiple jobs. For example, my progress from deviation reviewer to eQMS implementation, to computer systems quality, to risk champion, to quality engineering, to change management process owner, to computer system implementor, to technology implementor, to validation quality, to operational excellence, to quality systems leader, to validation leader (and I am leaving a lot out). Layering and layering real experience again and again.
Reflection: Reflection is a critical component of experiential learning. Most people don’t do that enough. The quality profession requires us to think about our experiences, analyze what we have learned, and consider how it applies to our work. Audits and inspections are interesting tools that can drive reflection when approached correctly.
Active Participation: Quality professionals must be active agents in their learning process. They take initiative, make decisions, and are responsible for the outcomes of their actions. This active engagement helps to deepen their learning and develop critical thinking skills.
Community Engagement: I joke about being able to tell what company some spent their formative years in. And that is not a good thing. Quality professionals need to seek out collaboration with the wider community members, often through professional organizations.
Integration of Knowledge and Practice: Experiential fields bridge the gap between theoretical knowledge and practical application. Quality professionals must integrate what they have studied with real-world experiences, enhancing their understanding and retention of the material. And then do it again.

The quality profession is a dynamic and interactive learning environment emphasizing learning by doing, reflecting, and applying knowledge in real-world contexts.

Back Up and Recovery Testing

Backup and recovery testing are critical to ensuring data integrity and business continuity for critical computerized systems. They are also a hard regulatory requirement in our computer system lifecycle.

Part 11 (21 CFR 11.10 and 11.30) requires that:
“For the availability of computerized systems supporting critical processes, provisions should be made to ensure continuity of the systems in the event of an incident or system failure. This includes implementing adequate backup and recovery measures, as well as providing sufficient system redundancy and failover mechanisms.”

Part 11 also requires that “The backup and recovery processes must be validated in order to ensure that they operate in an effective and reliable manner.”

Similarly, Annex 11 requires that backup and recovery processes be validated to ensure they operate reliably and effectively. Annex 11 also requires that the validation process be documented and includes a risk assessment of the system’s critical processes.

Similar requirements can be found across the GxP data integrity requirements.

The regulatory requirements require that backup and recovery processes be validated to ensure they can reliably recover the system in case of an incident or failure. This validation process must be documented, including a risk assessment of the system’s critical processes.

Backup and recovery testing:

Verifies Backup Integrity: Testing backups lets you verify that the backup data is complete, accurate, and not corrupted. It ensures that the backed-up data can be reliably restored when needed, maintaining the integrity of the original data.
Validates Recovery Procedures: Regularly testing the recovery process helps identify and resolve any issues or gaps in the recovery procedures. This ensures that the data can be restored wholly and correctly, preserving its integrity during recovery.
Identifies Data Corruption: Testing can reveal data corruption that may have gone unnoticed. By restoring backups and comparing them with the original data, you can detect and address any data integrity issues before they become critical.
Improves Disaster Preparedness: Regular backup and recovery testing helps organizations identify and address potential issues before a disaster strikes. This improves the organization’s preparedness and ability to recover data with integrity in a disaster or data loss incident.
Maintains Business Continuity: Backup and recovery testing helps maintain business continuity by ensuring that backups are reliable and recovery procedures are adequate. Organizations can minimize downtime and data loss, ensuring the integrity of critical business data and operations.

To maintain data integrity, it is recommended that backup and recovery testing be performed regularly. This should follow industry best practices and adhere to the organization’s recovery time objectives (RTOs) and recovery point objectives (RPOs). Testing should cover various scenarios, including full system restores, partial data restores, and data validation checks.

Level	Description	Key Activities	Frequency
Backup Tests	Ensures data is backed up correctly and consistently.	– Check backup infrastructure health – Verify data consistency – Ensure all critical data is covered – Check security settings	Regularly (daily, weekly, monthly)
Recovery Tests	Ensures data can be restored effectively and within required timeframes.	– Test recovery time and point objectives (RTO and RPO) – Define and test various recovery scopes – Schedule tests to avoid business disruption – Document all tests and results	Regularly (quarterly, biannually, annually)
Disaster Recovery Tests	Ensures the disaster recovery plan is effective and feasible.	– Perform disaster recovery scenarios – Test failover and failback operations – Coordinate with all relevant teams and stakeholders	Less frequent (once or twice a year)

By incorporating backup and recovery testing into the data lifecycle, organizations can have confidence in their ability to recover data with integrity, minimizing the risk of data loss or corruption and ensuring business continuity in the face of disasters or data loss incidents.

Aspect	Backup Tests	Recovery Tests
Objective	Verify data integrity and backup processes	Ensure data and systems can be successfully restored
Focus	Data backup and storage	Comprehensive recovery of data, applications, and infrastructure
Processes	Data copy verification, consistency checks, storage verification	Full system restore, spot-checking, disaster simulation
Scope	Data-focused	Broader scope including systems and infrastructure
Frequency	Regular intervals (daily, weekly, monthly)	Less frequent but more thorough
Testing Areas	Backup scheduling, data transfer, storage capacity	Recovery time objectives (RTO), recovery point objectives (RPO), failover/failback
Validation	Backup data is complete and accessible	Restored data and systems are fully functional