In our previous article, we introduced the advantages of Advanced Product Quality Planning (APQP). This time, I’d like to share how we practically kick-started the APQP framework at Opharmic—and what we learned along the way.
Implementing industrial best practices in a start-up or scale-up environment is never a matter of simply copying traditional approaches. Having successfully certified our ISO 13485 Quality Management System (QMS), we knew that APQP would require another level of streamlined, risk-based, and agile approach—rather than rigid, paper-heavy documentation.
Using a Prototype as a Case Carrier
We selected the one of our real product, a custom high-precision in-vitro cell stimulation device, as our “case carrier” to run a 5‑month APQP exercise. This gave us a real-world context to learn, test, and refine the framework while ensuring that the lessons were directly applicable to our product development journey, all the way to client delivery.
Active Learning Over Passive Training
Before this exercise, our team had diverse levels of understanding about project execution. To align everyone, we adopted active learning instead of traditional lecture-style sessions. Each APQP element was explained in terms of its role, contribution, and required inputs. Then, through working group discussions and hands-on application, members developed deeper understanding and long-term retention. This approach transformed APQP from a theoretical framework into a practical, shared language across the company.
Building Internal Capability: Train-the-Trainer
Scalability requires capability. To prepare Opharmic for growth, we introduced a Train-the-Trainer program. Each APQP task was assigned to an owner, who received task-specific knowledge from an internal subject matter expert (SME). These owners then trained their working groups, creating a chain of knowledge transfer across the organization. This not only built expertise but also empowered future trainers, ensuring sustainability of skills.
Team Structure and Communication
We established a clear team structure:
- A core team for overall governance
- One project leader
- Task-specific working groups with owners and cross-functional members
- SMEs supporting specialized knowledge
Documentation Made Simple
While APQP provides recommended templates, we created user-friendly formats tailored to our team. This lowered barriers to proper documentation and reinforced governance without overwhelming staff.
Team Testimonials on APQP
During our 5‑month APQP trial, every Opharmic team member actively engaged in multiple tasks. This collective effort boosted our shared knowledge of project execution and marked a cultural shift—from ad‑hoc firefighting to systematic planning and execution.
Here’s how different functions reflected on the journey:
- Engineering and Quality perspective:
“The transition was well worth the effort—even with the initial administrative load. It positioned us to move confidently from prototype to mass‑production‑ready products.”
- Cross‑functional alignment:
“APQP forced collaboration across departments, breaking down silos we noticed in early‑stage development. It helped us build stronger bridges between functions.”
- Operations viewpoint:
“By embedding quality from the very beginning, APQP helped us avoid costly late‑stage design changes. It’s about building quality in, not inspecting it later.”
- Market-facing view:
“The full APQP package reassures collaborators that our products are not only innovative, but also stable, reliable, and compliant.”
Looking Ahead
For Opharmic, our APQP journey has been more than a framework exercise—it’s been a transformation in how we collaborate and execute. The lessons we’ve gained are shaping the way we build products, embedding quality and agility into our DNA.
In upcoming articles, we’ll share how we’ve taken these learnings to design a product development process tailored to Opharmic’s unique needs—continuing our march toward excellence and readiness for scale.
