This is the second installment of our manufacturing superhero series. Let’s focus on Apical Instruments Quality Control Manager Kim Khoe. While she can’t talk to fish like Aquaman or leap tall buildings in a single bound like Superman, she can control product quality with a single solution. Give her a billowy cape and a shirt with a giant “Q” for Quality.
Kim’s quality experience includes setting up companies’ quality management systems, hosting FDA and 3rd party audits, as well as auditing medical device manufacturers, having been a lead auditor for a European Notified Body. She has also filed several FDA 510(k) submissions resulting in clearances and obtained CE marks for various products—hence the ‘single bound’ remark earlier.
To meet FDA and other regulations, Khoe knew she needed a trusty sidekick to help her manage information professionally to show evidence of compliance and avoid costly penalties and brand damage. Early in her career, without a software partner, she experienced firsthand the pain and burden of inefficient paper-based manual processes and the risk of compliance exposure caused by misplaced critical documentation that impeded her ability to prove mandatory compliance.
Khoe points out that having any old product lifecycle management (PLM) system just by itself—while an upgrade from manual processes, true—can still present problems if the solution is a siloed system that requires linking to another Quality Management Solution (QMS) or Application Lifecycle Solution (ALM) system.
Khoe knows the lack of visibility with siloed systems, data duplication, version control, sorting out a master hierarchy—to name but a few of the interoperability challenges—can start snowballing fast. The classical case is key cross-functional team members are unaware of changes due to insufficient transparency with a problem only presenting itself just before shipping to market. Siloed systems are like kryptonite to quality superheroes.
To ensure superior product lifecycle visibility and enhanced collaboration amongst team members, Khoe turned to her trusted partner Arena Solutions because of its all-in-one solution. With an embedded quality management solution, application lifecycle management solution and connection to powerful component databases, Arena was the perfect sidekick to help get the job done. Khoe, who has been using Arena PLM since 2004, has implemented the solution for several international companies to fight errors, product failure and greedy competitors.
“I always insist the company I work for uses Arena,” says Khoe. “Arena can do it all. It can manage your bill of materials (BOM,) your quality system documents, your device returns, your nonconformance and your CAPAs.”
According to Khoe, facets to the ROI that Arena provides customers are numerous and include:
- Shrunk engineering change order (ECO) turnaround time from months to days
- Saved money by removing the need to scan, save and email big documents separately via email
- Removed the need to hire a team to manage the infrastructure associated with an on-premise siloed system.
Khoe also experienced an ROI with reduced costs to meeting compliance mandates. According to Khoe, Arena makes audits easier and less time consuming with a cloud-based solution that consolidates all compliance information into one centralized system. The solution streamlines management of BOMs, the design history file (DHF), the device master record (DMR) and change orders.
“I can give an example that a complete audit trail is in Arena. We had a customer that needed proof that the product is ROHS compliant,” says Khoe. “And pulling the ROHS documents could have cost us $20,000 for this particular job. But with Arena, it saved us all that money because we had the documentation at our fingertips.”
But the bottom line for Khoe, who sings the praises of Arena to her colleagues at other medical device companies, is that Arena provides an all-in-one solution that not only saves time and money but ensures quality.
Khoe points out that even today, some medical device companies tend to operate in silos with defined stage-gate handoff points during the product design process; however, this outdated approach can have a very negative impact on new product introduction (NPI).
“With Arena, we now have BOMs and quality system documents in one place. Everybody has access to it,” says Khoe. “I am not making copies of documents throughout the whole company. Everybody has access to everything—we give our customers access to it.”