Value of Intentional Bias in GxP Vendor Audits

December 12, 2023

Professionals reviewing graphs on paper

Discovering intentional bias in GxP Vendor audits: weighing its advantages, drawbacks, and strategies for effective mitigation.

While the prevailing view suggests that GxP auditors should not be biased, there is a valid argument to be made for the inclusion of limited intentional bias in the GxP auditing process. Although complete bias is unquestionably harmful, a moderate level of bias could potentially offer advantages that positively impact GxP auditing.

This may be considered quite thought-provoking, as it challenges the conventional wisdom in auditing by suggesting that intentional bias could actually be beneficial for the pharmaceutical business. Auditors are expected to carry out their duties with honesty, diligence, and a sense of responsibility. When prioritizing diligence and responsibility, intentional bias aids in approaching all audits with equal thoroughness, irrespective of the auditee's size or reputation. In this scenario, the auditor needs to set aside the assumption that this auditee is widely recognized and highly regarded, potentially leading to the presumption of flawless processes without any oversight. The suggested intentional bias here is to treat each auditee as one among many, irrespective of their profile. Also, consider the intentional bias adhered to by all auditors - if there is no documentation, it did not happen. Several scenarios present arguments supporting intentional and controlled bias to uphold objectivity and prevent deeply rooted, uncontrolled biases.

Furthermore, ponder this question: Could it be beneficial to deploy the intentional bias that all regulations might not be followed 100% in some [third world] countries? Could such a statement be considered too bold, or is it conceivable? Below are some arguments against bias, for intentional and controlled bias, and some strategies and practices to help mitigate bias.

Disadvantages of bias in GxP vendor audits

Unconsciously trusts pre-existing belief.

GxP Auditors may unknowingly favor information that aligns with their existing beliefs about a vendor's performance, potentially influencing their evaluation.

Fixates on a particular piece of information.

Auditors might focus on a specific piece of information or data point early in the audit process, which can influence their subsequent judgments and evaluations. For instance, upon discovering a vendor's impressive track record, an auditor might anchor their assessment around this detail, potentially overlooking other critical factors.

Relies on readily available information.

Auditors might rely on readily available information or past experiences when making judgments about a vendor. If they have recently dealt with a vendor facing a similar issue, they may assume that the current vendor shares the same problem, even if the circumstances differ.

Overconfidence

GxP Auditors may overrate their own knowledge, skills, and abilities, assuming they can accurately evaluate a vendor without conducting thorough due diligence. This overconfidence could lead to overlooked risks and vulnerabilities.

Inclined to trust Presented Information.

The way information is presented or framed can influence an auditor's judgment. When a vendor presents information positively, auditors might tend to perceive their performance favorably, even if the underlying data contradicts this view.

Inclined to trust Senior Management.

Auditors might place excessive importance on senior management's opinions or recommendations. This bias could lead to overlooking critical issues if those in authority express confidence in a vendor.

Advantages of intentional and controlled bias in GxP vendor audits

Pre-Existing Beliefs

To prevent unconscious favoritism towards pre-existing beliefs, fostering intentional bias that acknowledges the potential for improvement in all vendor processes is essential.

Known Auditee

To conduct a thorough and investigative GxP vendor audit, auditors should consciously adopt the bias that all vendors can benefit from improvements. Regardless of a vendor's reputation or track record, critical factors in their processes may still require improvement

Due Diligence

Encouraging intentional and controlled bias prompts auditors to consistently conduct thorough due diligence while evaluating vendors, mitigating the risk of overestimating their expertise or being influenced by positively presented information from internal experts. This approach ensures a comprehensive assessment, capturing risks and vulnerabilities during audits.

Human Judgement and Interpretation

Recognizing auditors' human nature highlights the impossibility of achieving complete objectivity. Some level of subjectivity can be unavoidable when interpreting complex data or assessing nuanced situations. Using controlled bias aids auditors in decision-making when clear, objective evidence is lacking.

Risk Assessment and Prioritizations

In pharmaceutical auditing, not all issues or potential risks hold equal importance. Controlled bias can be judiciously applied to prioritize risks based on their perceived significance. For instance, if an auditor believes that a particular process poses a higher risk to patient safety, a slight bias toward scrutinizing that process more closely can be justified.

Efficiency and Resource Allocation

Auditors often work with limited time and resources. Applying controlled bias allows them to concentrate efforts where they perceive the highest risks. This strategic bias can lead to more efficient auditing processes.

Adaptation to Industry Changes

The pharmaceutical industry is constantly evolving with new technologies, processes, and regulations. Limited bias permits GxP auditors to adapt more effectively to these changes. They can use their experience and insights to anticipate potential issues and adjust their approach accordingly.

Continuous Improvement

Introducing some bias can motivate auditors to consistently enhance their knowledge and skills. They may engage in critical thinking and self-reflection to ensure their biases are well-founded, leading to more competent auditors over time.

Defining clear guidelines for bias application in audits is essential, and it is equally important to implement specific methods to mitigate bias during the auditing process.

How to mitigate bias with GxP vendor audits

Awareness

The first step to address cognitive bias is acknowledging its presence. GxP auditors and audit teams should receive training to recognize the various cognitive biases that can influence their judgments and decisions.

Standardized Procedures

Implement standardized audit procedures and checklists that outline the criteria, benchmarks, and steps to follow during the audit. This decreases the reliance on subjective judgements and enhances consistency.

Blind Auditing

Consider conducting blind audits where GxP auditors are not provided with information about the vendor’s identity or past performance until after the audit is complete. This approach helps prevent biases associated with preconceived notions.

Diverse Audit Teams

Form audit teams comprising individuals with diverse backgrounds, experiences, and perspectives. This practice aims to mitigate in-group bias and introduce diverse viewpoints into the evaluation process.

Team Reviews

Incorporate team reviews, where an independent group of individuals critically evaluates the audit process and findings. This can uncover biases that may have gone unnoticed and provide fresh insights.

  • Allocate a specific role in the audit team to challenge assumptions, promote critical thinking, and identify potential biases.
  • Promote an environment fostering open feedback and ongoing learning within the auditing process. Auditors should be able to discuss their findings and decisions openly and learn from past audits.

Independent GxP Auditors

Employ external auditors or third-party firms such as ProPharma for audits; who tend to be less influenced by internal biases, offering impartial perspectives.

Data-Driven Decision-Making

Rely on data and objective metrics whenever feasible. Ensure that the audit process collects and analyzes relevant data and evidence to support conclusions rather than relying solely on subjective impressions.

Multiple Auditors

Employ/utilize multiple auditors to independently assess a single vendor. This can help identify discrepancies and biases in individual assessments, leading to more accurate conclusions.

Periodic Training

Continuously train GxP auditors on cognitive biases, critical thinking, and decision-making skills. Regular training and workshops can reinforce awareness and help auditors apply bias-mitigation techniques effectively.

Audit Review Committees

Establish review committees to evaluate audit findings and decisions. Thes committees can provide an additional layer of scrutiny and objectivity.

Documenting Assumptions

Mandate auditors to explicitly document their assumptions, reasoning, and the judgment sources. This transparency can help identify and address biases in their thought processes.

External Reviews

Pursue external reviews, such as peer reviews or industry benchmarking, to validate objectivity and accuracy.

Regulatory and Ethical Standards

Ensure that auditing practices adhere to industry-specific regulations and ethical standards. Compliance with established guidelines can help reduce bias.

In Summary

In pharmaceutical vendor auditing, striking a balance between avoiding unchecked bias and justifying a controlled level of bias is paramount. Although avoiding unchecked bias is crucial in pharmaceutical vendor auditing, a controlled and well-managed level of bias may be justifiable. This approach enables auditors to navigate the complexities of their work, effectively prioritize tasks, and adapt to the evolving landscape of the pharmaceutical industry. Established processes and consistent training programs play a crucial role in preventing cognitive bias during audits. Finding the right balance is vital, ensuring that any bias deployed contributes to enhancing audit quality and ensuring patient safety.

Contact ProPharma for any questions on the topic, or if you would like to discuss potential collaborations and leverage the expertise of our experienced professionals for a comprehensive GxP audit.

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