Building Our QA System:
A Journey from Chaos to Clarity
We’re a consulting team, working behind the scenes with clients, creating documents, guiding validations, leading audits, and solving compliance puzzles, quality assurance (QA) feels like second nature.
We’ve helped many companies put together robust QA systems. We knew what needed to be done in theory. We had no doubt that this would be a cakewalk for us.
So, when we decided to build one for ourselves, we figured how hard it can be.
Where Do You Even Start?
Our biggest challenge? We don’t make a physical product. No machines, no inventory, no boxes to ship.
Instead, we deliver outputs—regulatory strategies, technical files, gap assessments, audit findings, and so on. These may not sit on a shelf, but they’re still products of our work.
So our first step was a mind map
- What exactly do we deliver?
- What steps go into creating those deliverables?
- Who’s involved and how?
We avoided calling them “services” because each task ends in something tangible, even if it’s digital. That shift in mindset made a huge difference.
Getting Clear on Our Goals
Next up: Quality Objectives.
We kept them simple, specific, and time-bound. Things like:
Any foreign or domestic company intending to sell medical devices in China must comply with NMPA regulations and obtain the appropriate Medical Device Registration Certificate (MDRC).
- Within nine months, have at least three persons qualified to perform each critical task
- Set up a project tracker system within 3 months
- Get at least four trainings accredited within a year
Each team member could relate to at least one of these goals. That made it easier for everyone to stay engaged. We created project charters to meet each of the objectives.
Building Our ‘Production’ Process
Here’s where it got real.
Since every “product” was different, there wasn’t a one-size-fits-all production line. We did a deep dive:
- What are the common steps across projects?
- Where do skillsets overlap?
- How do we handle bottlenecks?
This is where our HR process got looped in. We built a detailed skill matrix, rating proficiency across document types, client sectors, and tools. That fed directly into our training and onboarding.
Our Review Process (a.k.a. QC)
If there’s one thing we learned the most, it’s this: QA isn’t a department—it’s a culture.
Every single team member owns a process, or at least a part of it. From client communication to document delivery, everyone’s input counts.
We made it a point to include everyone in reviews and process improvements. It’s amazing what ideas come out when you invite different perspectives.
The People Factor
If there’s one thing we learned the most, it’s this: QA isn’t a department—it’s a culture.
Every single team member owns a process, or at least a part of it. From client communication to document delivery, everyone’s input counts.
Every single team member owns a process, or at least a part of it. From client communication to document delivery, everyone’s input counts.
We made it a point to include everyone in reviews and process improvements. It’s amazing what ideas come out when you invite different perspectives.
- Defined processes
- Standard templates
- Metrics and goals
- Regular reviews
- Happy clients who notice the difference
No, it didn’t happen overnight. But the hard work was worth it. We’re more efficient, more aligned, and more confident.
What’s Next?
We’re not done.
We’ve set new goals—smaller, sharper, and smarter. We’re continuing to refine, reflect, and recalibrate.
If you have gone through a similar process, please share your experiences. We would love to hear from you.
If you have got questions, or want to set up your own QA process, do get in touch with us. We can hand-hold you through the process.
Ready to transform your QA process? Learn from our journey and start building a smarter, more efficient QA system today!
