1. Tell us more about your role at No deviation.
It would be a very long story if I had to detail all my activities at No deviation. I do a bit of everything, from optimising back office operations to business development, running a project and keeping the CEO in check. Jokes aside, my role is primarily to maintain a good relationship with our key clients, keep engagement with the consultants within the company, and generate and work on ideas to better serve our clients.
2. How would you describe a CQV project in a few easy-to-understand words?
Breaking away from the run of the mill textbook description of CQV, I will try to describe it in layman terms. Let’s assume that CQV involves three distinct activities (which, in reality, are interrelated, but that’s for a separate topic of discussion). Let’s take an example of taking possession of a new apartment from the developer.
The developer would need to perform checks against an inspection checklist to ensure that the apartment meets the specifications prior to calling for a key handover to the proud house owner. Any defects detected in the new apartment could be fixed, relatively without the watchful eyes of the homeowner. When the checks are completed and defects are corrected, the developer would then call for handover to the homeowner. This phase would describe commissioning.
The homeowner will be issued the same checklist by the developer to run through each of the items. The homeowner will be putting on a higher degree of scrutiny on the apartment even though the checklist is the same. Every nook and cranny of the apartment will be checked thoroughly. In the event of defects, a recorded punch list will be filled in to be closed by the developer and signed off by the homeowner. At this point, the apartment is totally stock standard and empty but meeting the apartment specification, which the homeowner purchased against. This phase would describe qualification.
On taking possession of the apartment, the homeowner will start to fill the house with furniture, appliances etc. The homeowner will then live in the space and test that the apartment plus everything in it meets the homeowner’s intended use repeatedly, day after day. This phase would describe validation.
Book an informative introductory 15-minute call with JoonLeong to clarify your CQV / Kneat / Paperless validation requirements and to understand how we can support you.
3. What would you tell a client that has contracted No deviation for a CQV project?
That No deviation is the best CQV contractor in town!
4. What are the potential challenges you have faced in CQV projects?
How did you overcome the difficulties they presented?
Undocumented expectations/poorly defined Scope of Work (SoW) is the single largest challenge that I have faced in a recent CQV project delivery. As a result of that, there were a lot of struggles between the service provider and the clients. There is no magic pill to overcome that but to bite the bullet and have an open communication to table the facts and move on. It’s dirty but it’s better when the CEO gives his utmost support!
5. What type of CQV work do you have the greatest passion for?
There’s no favourites there. At the end of the day, as long as the patients benefit from whatever small contribution that I, through Nd, have made, that’s the best reward!
Learn more about our CQV services at No deviation.
You can also read our blog on a practical guide to lean CQV.
If you have any questions regarding CQV in the pharmaceutical industry, please contact Joon at joonleong.ng@nodeviation.com or connect on LinkedIn.
With 15 years of experience across the APAC region with a focus on Commissioning, Qualification & Validation in the pharmaceutical industry, Joon has gathered extensive hands-on as well as management experience. He also possesses in-depth knowledge in Regulation & Guidelines, Project Management, Change Control Process, and Lean Leadership.
