Why Commissioning and Qualification Fails: Learning from the Most Common Mistakes
Detailed analysis of the key factors that contribute to failed CQV projects, including inadequate risk assessment, failure to involve subject matter experts, and over-reliance on vendor documentation.
Table of Contents
- Introduction
- Inadequate Risk Assessment
- Failure to Involve Subject Matter Experts (SMEs)
- Over-Reliance on Vendor Documentation
- Conclusion
Introduction
Commissioning and Qualification (CQV) is critical in regulated industries like pharmaceuticals and biotechnology, ensuring that facilities, systems, and equipment meet stringent operational, safety, and quality standards. Despite best efforts, CQV projects often encounter failures, leading to delays, increased costs, and potential non-compliance with regulatory expectations. Understanding the root causes of these failures can help organizations design better strategies to mitigate risks.
This blog examines the most common CQV pitfalls—focusing on inadequate risk assessments, insufficient SME involvement, and over-reliance on vendor documentation—and provides actionable insights for avoiding them.
Inadequate Risk Assessment
A robust risk assessment is the cornerstone of a successful CQV process, as emphasized in regulatory guidelines like ICH Q9 (Quality Risk Management) and ASTM E2500. When organizations neglect or mishandle this step, it often results in misaligned priorities, inadequate testing, and unresolved risks.
Failure to Prioritize Critical Systems
In many CQV projects, teams fail to identify or focus on systems with the greatest impact on product quality and patient safety. This oversight can lead to:
- Allocating resources to non-critical systems, delaying critical milestones.
- Missing crucial validation steps that weaken the qualification effort, and result in incomplete or lacking qualification. This has further impacts once the system has been released from qualification and under GMP production conditions. Often issues with the system which were not identified and addressed in CQV must be rectified during production, resulting in lost time and or negatively imacted PPQ or production batches.
Best Practice: Use system risk assessments (SRAs) early in the project to classify systems as critical or non-critical based on their quality impact. This ensures that testing and validation efforts are proportionate to the risks involved.
Improper Use of Risk Management Tools
Risk management tools such as Failure Mode and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP) are valuable but often misapplied. Common errors include:
- Superficial risk evaluations that overlook complex interactions between systems.
- Lack of cross-functional collaboration in identifying risks. CQV being the only team to carry out and identify what the critical requirements are for the system can lead to an oversimplified or lacking CQV effort. It is important to define the key players involved in the development and approval of both testing and lifecycle documentation to assure that the testing carried out during the CQV phase is both correct and appropriate.
Best Practice: Adopt structured approaches like those outlined in GMP Annex 20 and ASTM E2500 to ensure comprehensive and science-based risk evaluations. Leverage multidisciplinary teams to provide diverse perspectives on potential hazards.
Failure to Involve Subject Matter Experts (SMEs)
SMEs bring specialized knowledge essential for addressing complex CQV challenges. Failure to engage them effectively can lead to flawed decision-making and non-compliance.
Delayed SME Engagement
Organizations often bring SMEs into the project after key design or implementation decisions have been made. This reactive approach can result in:
- Design flaws that require costly rework.
- Missed opportunities to integrate compliance and efficiency considerations early.
Best Practice: Engage SMEs during project scoping and planning phases to ensure their expertise informs critical decisions from the outset.
Insufficient Expertise in Specialized Areas
CQV projects require expertise across various domains, such as automation, microbiology, and regulatory compliance. Insufficient expertise can lead to:
- Non-compliance with specific standards, such as ASME BPE for biopharmaceutical equipment.
- Inefficient or unsafe designs for specialized systems.
Best Practice: Conduct a gap analysis to identify areas where additional expertise is needed. Consider hiring external consultants or training internal staff to address these gaps.
Over-Reliance on Vendor Documentation
Vendor-supplied documentation often serves as a starting point for CQV efforts. However, over-reliance on these materials can lead to significant oversights.
Lack of Verification and Testing
Blindly accepting vendor documentation without independent verification is a common mistake. This can lead to:
- Assumptions that vendor testing aligns with user-specific operational conditions.
- Discovery of discrepancies during late project stages, causing delays.
Best Practice: Adopt a verification-based approach, as recommended in ASTM E2500 and ISPE Baseline Guide Volume 5. Conduct Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) to confirm that systems perform as intended.
Misalignment with Project-Specific Requirements
Vendor documentation is often generic, designed to meet a broad range of client needs. This can result in:
- Documentation that lacks alignment with specific user requirements (URS).
- Gaps in compliance with regulatory or operational standards.
Best Practice: Customize vendor deliverables to align with URS and regulatory requirements. Use traceability matrices to ensure comprehensive coverage of project-specific needs.
Conclusion
CQV failures can often be traced back to preventable mistakes in risk assessment, SME involvement, and reliance on vendor documentation. By prioritizing critical systems, involving experts early, and rigorously verifying vendor information, organizations can streamline their CQV processes and reduce the risk of costly failures. Implementing best practices and adhering to frameworks like ASTM E2500 and GMP Annex 15 ensures compliance and operational excellence.
By learning from common pitfalls, CQV teams can enhance project outcomes, safeguarding both product quality and patient safety.
