In 2023, a survey was sent to ISPE members to determine the adoption rate of the fundamentals described in the guide. Those survey results offer insights to the guide’s implementation across various organizations. A new survey would accurately gauge the actual adoption rates and understanding of quality risk management (QRM) based commissioning and qualification (C&Q) implementation.
Key Findings From the 2023 Survey
Awareness of the 2019 Update
The survey revealed that a substantial 85% of respondents were aware of the 2019 update to the guide. This indicates a high level of general awareness in the professional community about the latest developments in adoption of QRM-based C&Q.
Transition to Risk-Based Approaches
Approximately 68% of respondents indicated plans to transition from the traditional impact-assessment-based V-model to the risk-based approach. This shift signifies a growing recognition of the benefits of a more focused and flexible risk-oriented framework on which to apply project management and ensure quality assurance.
Implementation of QRM-Based C&Q
Most respondents are adopting QRM-based C&Q to align with current industry best practices. This trend is driven by corporate initiatives, speed to market, and regulatory expectation.
Knowledge Gaps in C&Q Baseline® Guide Fundamentals
Despite respondents’ awareness of the C&Q guide, there’s a general lack of understanding of the guide’s fundamental principles in the application of QRM-based C&Q. Key gaps include continued use of the unsupported, non-risk-based V-model; how risk assessments are implemented to inform the manufacturing process control strategy; how risk is mitigated through the addition of controls; the role of quality in an integrated C&Q process; and the identification and documentation of critical process parameters (CPPs) in relation to product and process and individual systems.
Variable Definitions of Risk-Based Approaches
The definition of a risk-based approach varied among respondents. Many believe they are using a true risk-based approach when, in fact, they have merely modified past practices and guidance without fully integrating QRM principles. There is an apparent lack of understanding that the application of QRM is a prospective approach to apply quality by design to the design development process so that robust CPP control is optimized.
C&Q Costs Knowledge Gap
There’s a notable lack of understanding regarding the costs of C&Q relative to total installed with equipment and systems verified as fit for intended purpose/qualified or total capital project costs, which include performance qualification/process validation (PQ/PV).
Underuse of Good Engineering Practices (GEPs)
The survey indicated a limited application of GEPs and a limited understanding of the concept of an engineering quality program needed to support the use of commissioning testing and documentation to support qualification. Fundamentally, GEPs deliver documented evidence such that installation and operation meet requirements.
Benefits of Implementing QRM-Based Integrated C&Q
For those who have implemented QRM-based integrated C&Q, several optimized methods have led to reductions in cost and time. These include overall process risk assessments, critical aspects (CAs) and critical design elements identified through system risk assessment (SRA), design review under GEPs providing design qualification as a deliverable, and focused quality reviews and approvals.
Deliverable Examples
Did you know that there are a series of examples available as companion content with the C&Q Baseline® Guide? Use these to your advantage. Examples include user requirement specification (URS), SRA, design qualification, and acceptance and release covering single-use bioreactor, primary packaging (tablet blister), and secondary packaging (blisters).
A new ISPE survey is accessible now via the QR code with the goal of more accurately reflecting industry understanding, adoption, and use of the C&Q Baseline® Guide.
2024 Survey
Given these findings, it is evident that although ISPE members are aware of the 2019 C&Q Baseline® Guide update, they have a significant gap in understanding and proper implementation. The current survey highlights several misconceptions and inconsistencies in the application of C&Q Baseline® Guide principles, especially regarding risk-based approaches and the integration of QRM in C&Q processes.
A new ISPE survey is accessible now via the QR code with the goal of more accurately reflecting industry understanding, adoption, and use of the C&Q Baseline® Guide. We very much appreciate your contribution to this survey, which will aid in our ability to provide additional content, training, and guidance to better equip industry to optimize C&Q and the overall project delivery process.
Take Survey
- By the Commissioning and Qualification Community of Practice Steering Committee
