Remote Inspection Offers New Option for Meeting Quality and Regulatory Requirements
Written by Andy LaFrazia, President of ControlTek
During this challenging time, the utilization of technology to change previous processes has been fascinating to see. One area where ControlTek has seen a major change is in meeting our quality and regulatory requirements.
External Audits
ControlTek supports the design and manufacture of many regulated products in multiple industries. We are typically audited on a quarterly basis from both Underwriters Laboratories (UL) and TUV/ETL.
As part of a recent product launch for a semiconductor equipment manufacturer, we had a 'hard date' requirement to have a product reviewed and inspected in order to receive full product marking and registration. Due to COVID-19 restrictions put in place by multiple state governments, it was impossible for us to support the normal on-site inspection by a TUV inspector. To support the requirement, we ended up having a virtual audit using video networking. This included inspection of documentation, inventory, work in process, and a live inspection of the required safety testing. All went well and the product was approved for the required marking and manufacturing release!
Internal Auditing
ControlTek also recently completed our first virtual internal audit. The audit was conducted by our quality manager and all documentation, record reviews, objective evidence, and interviews were conducted using video calls/chats and electronic record reviews. As our personnel have become more familiar with video meetings and chat systems, our ability to efficiently work remotely at a safe distance has been confirmed.
Lowering Costs
One aspect of this new reality we are hoping to see is a reduction in the cost associated with our inspection services. Our TUV auditor travels by plane to conduct audits in our area, so you can imagine the cost savings and improved efficiency of being able to conduct audits virtually.
We still recommend an occasional on-site audit, but for companies with a long history of compliance and strong quality systems, moving to partial virtual auditing will have significant benefits.
We have also contacted our quality system auditors to see if ANSI National Accreditation Board (ANAB) will have new guidance on virtual auditing. Discussions have been ongoing and we hope to see changes that will work better for all of industry.
