Positioning Commissioning and Qualification (C&Q) as an Integrated Value-Driven Activity in Project Delivery and Beyond

Introduction

Project delivery teams working in the pharmaceutical sector have long been valued for their expertise in design and EPCM. While their capabilities are appreciated and aligned with the traditional delivery model, C&Q is often a missed or ignored area. However, as projects move from construction completion towards operational readiness, the C&Q phase becomes critical to qualify the equipment and systems in accordance with regulatory expectations. Though the C&Q phase comes in the latter part of a project, its success depends mainly on early consideration and planning. Hence decisions made during early project phases have a direct impact on the effectiveness and compliance of the C&Q process and therefore regulatory readiness.

However, in most EPCM and manufacturing organizations, C&Q is often deprioritized and considered less important than the design or construction phases. C&Q teams are often brought in at a later stage of a project and the C&Q process is often misclassified (e.g., treated as a paper-based activity to satisfy quality assurance or for audit purposes). These misconceptions are costly, leading to compliance risk and project inefficiencies.

This blog post aims to inspire meaningful change, provide thoughtful insights, awareness and highlight the recognition that C&Q domain deserves. It also aims to convey how a culture change in an organization can make a difference in viewing, managing, and delivering C&Q activities. The intention of the blog is not to criticize the existing project delivery model, instead, the focus is to highlight the gaps and opportunities for C&Q value creation. Ultimately, the decision on project delivery model, lies with the specific need of the project, client and company leadership, or a combination of all.

Current Situation of C&Q in EPCM and Manufacturing Organizations

Regulatory expectations in the pharmaceutical industry are rising. Despite that, in many firms, C&Q is still viewed as a support function involved at the latter stage for compliance formality, focused on generating binders of documentation for regulatory approval. Many firms lack dedicated C&Q teams and instead rely on engineers from cross-functional teams (CFT) with limited C&Q expertise. C&Q teams are often involved during or after the construction phase, limiting their ability to contribute or make decisions as the equipment is already available at site. As a result, deliverables and execution of activities are rushed to meet deadlines leading to quality and data integrity issues. While some leaders recognize the value of involving C&Q from the start of the project, others treat C&Q as a standalone, independent activity from their core working model. While both approaches work, the latter often results in missed opportunities for seamless integration, CFT alignment, and in-house C&Q capability building.

The Reason Behind C&Q Marginalization

Despite C&Q’s critical role and contribution to regulatory compliance and operational readiness, C&Q is often undervalued. This marginalization is not only a matter of delivery model, project requirement or oversight, it is deeply rooted in organization and culture related factors that collectively suppress C&Q’s importance. A few factors that marginalize C&Q are:

1. Leaders’ views on C&Q: Leaders and project managers, often view C&Q as a paperwork handover formality that can be handled by anyone, with no special skills required. They see it as a time-resource-budget consuming activity that yields no visible business value unlike other functions. This misunderstanding exists because leaders naturally prioritize and monitor cost, schedules, and physical progress at site, while quality and documentation is less prioritized and monitored. This lack of understanding and support limits the real contribution C&Q can make, resulting in late involvement, narrow scope, and insufficient funding of C&Q development activities.
2. No key performance indictor (KPI) tracking for C&Q activities: C&Q performance is rarely measured. Without defining clear KPIs and reporting mechanism, it is difficult to measure and justify the importance of C&Q to leadership. This further strengthens the negative perception of C&Q as a mere compliance burden.
3. Lack of C&Q team or misclassification: In many organizations, the C&Q team is either absent as a separate department or misclassified as a part of quality assurance (QA)/quality control (QC) team and not seen as a techno-compliance function, limiting its visibility and influence, and preventing early engagement in key stages where it can contribute. Instead, C&Q is brought in late only for review and approval of deliverables.
4. Not involving C&Q during project proposals and initiation: C&Q is often excluded during proposal development activities, baseline scope discussions, cost estimates, and scheduling, and only gets involved when design, procurement, and construction activities are completed. As a result, list of deliverables/activities and associated work hours are not mutually agreed and adequately allocated, impacting directly on the qualification outcomes.
5. Internal stakeholders are unaware of C&Q: For organizations that serve different industries, internal stakeholders like sales, business development, and other client facing teams are unaware of what C&Q is about, whether a dedicated C&Q team exist in the organization and what value they can deliver. This further suppresses the opportunities and growth for C&Q.
6. Cultural biases and opinions toward C&Q: C&Q is often framed as an administrative activity with limited return on investment (ROI). Project leads may focus on handovers and only see C&Q as a paperwork phase, intended to satisfy the client and auditor. Organizations may also think a dedicated C&Q team is not required. To reduce time, they may think C&Q activity can be managed by construction management professionals, using or replicating documents/templates from previous similar projects. . Over time, these opinions can become an organizational practice, then transform into an organization-wide cultural bias, which can erode the importance, and ultimately the reputation of C&Q teams.
7. Resource constraints: C&Q teams do not typically receive the attention and resources (e.g. personnel, time, and budget) required to deliver tangible results. Some organizations have dedicated team of C&Q specialists, while others include a small team of engineers who serve as C&Q specialists within other departments like process/HVAC/utility teams. In these cases, the thought is that engineers can be utilized for C&Q activities as needed/based on project load, and vice versa. Similarly, budgets are shared and scarce. Any delays occurred during previous phases will likely be adjusted in the C&Q phase, reducing the time for C&Q execution. In some cases, schedules have been developed based on previous projects, without C&Q factored in, which may lead to timeline pressure, rework or compliance issues.
8. Gap in responsibility assignment and skill: Some organizations have the practice of assigning the responsibility of C&Q to the Engineering Manager (EM)/Project Manager (PM) instead of having a dedicated C&Q Lead to manage cost and budget. The focus of the EM/PM is different and may lack adequate C&Q documentation skills and compliance knowledge necessary to guide or manage a C&Q team/C&Q-related phase. This dilutes the importance of C&Q and compromises the quality and compliance as most of the EMs/PMs will not see C&Q apart from the lens of regulatory requirement. C&Q requires a blend of skills and knowledge gained from experience and exposure working with good manufacturing practices (GMP), processing engineering, sanitary equipment design, functionality, compliance, documentation, C&Q and risk-management principles, and more. Hence it is important to have the right people in the team to pave way for project success.
9. Use of outdated tools and C&Q practices: Some organizations use the same traditional practices, procedures, templates, and strategy from a previous project, or adopt a strategy from a previous project and apply it to all future projects without making any improvements. They may convince key stakeholders that this approach is sound by stating that the strategy worked well previously. This resistance to change complicates the way C&Q activities are handled, spoils the reputation of C&Q experts, and reduces the pipeline of incoming C&Q projects.

Altogether, these factors contribute to the marginalization of C&Q. Until these gaps are addressed C&Q remain a burdensome, suppressed and neglected area.

How Forward-Looking Organizations Treat C&Q

While some organizations view C&Q as a constraint, there are organizations that see potential in C&Q and treat it as a core value-add activity. Forward-looking organizations create an inclusive environment where C&Q can participate, contribute, and collaborate with other departments. Here are some approaches and viewpoints from forward-looking organizations, aimed at improving C&Q utilization and team positioning:

1. Set vision/goals, have clear road map, gain leadership support and sponsor to grow and flourish C&Q.
2. Set the organizational culture up in such a way that no push is required to involve C&Q. Consider C&Q as a part of project delivery model by default.
3. Treat C&Q as a core techno-compliance, value-adding function and give it the same importance as other departments.
4. Set KPIs for C&Q activities; monitor, review, and modify them periodically as needed
5. Involve C&Q subject matter experts (SMEs)/specialists from the early stages of a project’s initiation to help support strategy development, man-hour calculation, schedule preparation, etc.
6. Give the C&Q team continuous work through smart planning, teamwork and strong management support.
7. Set up C&Q activities in a separate department with adequate talent and SMEs.
8. Nurture C&Q teams with periodic training, evaluation and provide opportunities to work /lead on different projects, attend workshops and symposiums.
9. Identify talent from CFT with an interest in C&Q, provide necessary skill development trainings, and groom them for future opportunities.
10. Maintain a well structed repository and library of standards, procedures, workflows, templates, and C&Q deliverables, and periodically make updates.
11. Conduct awareness training to sales, business development and client facing teams, and encourage them to have C&Q involved, during proposal development.
12. Set up a mechanism for sharing lessons learned and feedback.
13. Use digital validation tools and solutions to enhance productivity, knowledge management.
14. Adopt integrated C&Q/risk-based approach to C&Q as defined in The ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) and ASTM-E2500.
15. Develop a C&Q center of excellence or community to share C&Q updates, industry insights, and learnings.
16. Share project success and accolades with C&Q teams to help them feel included and part of the larger organizational team.

Final Thoughts

Although the importance of C&Q and its criticality is well-described in industry guidelines and regulations, many organizations still undervalue C&Q teams and provide inadequate resources, budget, and timeframes to rush facility handover. However, when the same facility enters the operational phase and encounters regulatory observation, budgets are funded, SMEs are brought in, and all required resources and timelines are provided. If the same importance, time, and resources are offered beforehand this costly rework could have been avoided. The misconception, marginalization, and underutilization of C&Q can only be changed by the thought process of the leaders, when they realize the importance of C&Q and take steps to implement an organizational culture change. C&Q will remain invisible in many organizations until organizational leaders at the helm start to view C&Q as an integrated, value-creation activity, and promote and provide opportunities to make C&Q a default activity in project delivery models.

Learn more about the The ISPE Baseline^® Guide: Commissioning and Qualification (Second Edition)

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