Conflict Management During Internal and External Quality Audits

Audits are crucial for the pharmaceutical industry, ensuring compliance, product quality, and patient safety. However, conflicts could arise during the audit due to high stakes, differing perspectives, and pressure to meet requirements. Effective conflict management is essential for smooth audits, professional relationships, and compliance. This article explores conflict management during audits, sources, resolution strategies, real-life examples, and best practices.

Conflict is inevitable during audits as two different parties get involved in discussions and external person (auditors) check the compliance status of the site to be audited. Auditors and auditees have diverse backgrounds, interpretations of regulations, and priorities. Unresolved conflicts strain relationships, delay the audit, and may lead to non-compliance. Effective conflict management addresses disagreements constructively, fostering collaboration for quality and compliance.

Common Sources of Conflict
Understanding the root causes of conflict is the first step toward managing it effectively. Some common sources of conflict during internal and external audits in the pharmaceutical industry include:

• Differences in Interpretation: Regulatory guidelines, such as those from the FDA or EMA, can sometimes be open to interpretation. Auditors and auditees may disagree on how specific requirements should be implemented.
• Auditor-Auditee Disagreements: Auditors may identify issues that auditees perceive as minor or irrelevant, leading to tension.
• Lack of Preparedness: Auditees who are unprepared for the audit may feel defensive when issues are raised, while auditors may become frustrated by the lack of organization.
• Communication Gaps: Miscommunication or unclear expectations can escalate minor issues into major conflicts.
• Resource Constraints: Limited time, personnel, or documentation can create pressure and lead to disagreements.

Strategies for Conflict Resolution
Managing conflicts during audits requires a combination of interpersonal skills, professionalism, and a structured approach. Here are some effective strategies:

• Active Listening: Both auditors and auditees should listen to each other’s perspectives without interruption. This helps build mutual respect and understanding.
• Staying Objective: Focus on facts and evidence rather than emotions. Use data and documentation to support discussions.
• Evidence-Based Discussions: Refer to regulatory guidelines, SOPs, and previous audit findings to ground the conversation in objective criteria.
• Maintaining Professionalism: Avoid personal attacks or defensive behaviour. A calm and respectful demeanour can de-escalate tensions.
• Seeking Common Ground: Identify shared goals, such as ensuring patient safety or maintaining compliance, to align both parties’ interests.

Real-Time Examples of Conflict Resolution

• Case 1: Disagreement Over CAPA Implementation

During an internal audit at a pharmaceutical manufacturing site, the auditor identified a recurring deviation in the cleaning process. The auditee argued that the issue was minor and did not warrant a corrective action plan (CAPA). The auditor, however, emphasized the potential risk to product quality.

Resolution: The auditor presented historical data showing the frequency of the deviation and its potential impact. The auditee agreed to implement a CAPA, and both parties worked together to develop a realistic timeline for resolution.

• Case 2: Miscommunication During an FDA Inspection

An FDA inspector raised concerns about incomplete documentation during a pre-approval inspection. The site team felt the request was unreasonable due to time constraints.

Resolution: The quality assurance team acknowledged the concern, provided a detailed plan to complete the documentation, and communicated proactively with the inspector. By maintaining transparency and professionalism, the conflict was resolved without escalating to a formal observation.

• Case 3: Handling a Dispute Over Data Integrity

During a supplier qualification audit at a formulation plant, the auditor raised concerns about discrepancies in batch records and results where he considered the same as a data integrity issue which could lead to the major or critical non-conformity however the auditee argued that the issue was just about the error in Good Documentation Practices and person just made mistake unintentionally hence just a minor concern. The situation was resolved by verifying multiple aspects of the documentation and upon interview with the person who made mistake. The auditee implemented additional training sessions to prevent future misunderstandings.

Best Practices for Conflict Management in Audits
To minimize conflicts and ensure a smooth audit process, pharmaceutical companies can adopt the following best practices:

• Proactive Communication: Establish open lines of communication before the audit begins. Clearly define roles, responsibilities, and expectations.
• Setting Clear Expectations: Share the audit agenda, scope, and criteria in advance to avoid surprises.
• Training Teams: Provide conflict resolution training for both auditors and auditees. Equip teams with the skills to handle disagreements constructively.
• Documenting Everything: Maintain thorough records of discussions, decisions, and actions taken during the audit. This ensures accountability and provides a reference point for future audits.
• Fostering a Collaborative Culture: Encourage a mindset of continuous improvement rather than blame. Emphasize that audits are an opportunity to enhance processes and ensure compliance.

Conclusion:
Conflict management is a critical skill for both auditors and auditees in the pharmaceutical industry. By understanding common sources of conflict, employing effective resolution strategies, and adopting best practices, organizations can transform potentially adversarial situations into opportunities for growth and improvement. Proactive communication, professionalism, and a focus on shared goals are the keys to ensuring smoother, more productive audits. Ultimately, effective conflict management not only enhances compliance but also strengthens relationships and fosters a culture of quality and collaboration.

At PHARMALANE UK, we prioritize conflict management and ensure all our auditors are well-trained to minimize any conflicts. Our experienced auditors/SMEs conduct regular training, making us adept at handling various conflict situations, including those arising from cultural differences. For more information on how we support companies in conducting effective and conflict-free audits, write us at info@pharmalaneuk.com.