Unsurpassed quality is what manufacturers want the most. Yes, they also demand lower costs and faster speed to market from their contract manufacturers, and assistance with product design, but the top-ranked requirement is always quality. This is especially true as products get smaller and more complex, or are mission-critical or health-critical, where lives are on the line. High quality means consistent repeatability and reliability, durability, functionality, fewer defects, and perhaps most important, improved customer satisfaction, brand recognition, and greater market share.
We absolutely get it.
Which is why our quality systems are some of the best in the business.
Laser Light Technologies is an ISO 9001:2015- and 13485:2016-certified company. We micromachine some incredibly complex parts and features, with utmost precision. Our high-performing engineering and design teams, quality control systems, inspection systems, and custom inventory management programs are why 98% of our customer deliveries are on time. To achieve this, we continuously monitor and adjust our compliance and validation processes to maintain an effective quality management system, with tight tolerances in the sub-micron range.
Vision Machine Inspections
Parts micromachined by lasers often have features too small to be seen by the naked eye. Laser Light Technologies has a system to ensure optimal inspections and quality. We have the ideal tools for performing visual inspections on your parts and products: high-powered microscopes and specialized instruments for micro-measurement of linear dimensions, height, depth, and 3D profile. Video coordinate-measurement machines are ideal for automated measurement of parts with a wide range of geometric dimensioning and tolerancing (GD&T) requirements. We often use vision systems to perform automated in-line visual inspections to increase the efficiency of the processes.
Confocal laser scanning microscopes are used for applications that require a 3D profile of parts to measure depth/height of the features. Depending on the project, a variety of stereo microscopes provide visual inspections. We collaborate with our customers to validate new design or design changes and also provide first article inspection (FAI) reports and other quality reports as required by their quality systems. Our confocal laser scanning microscope systems utilize a wide range of individual objective lenses and laser scanning to rapidly generate a 3D profile of any part, for the highest accuracy in both shape and surface data. These systems work well for intensive R&D evaluations, where they combine the ability to generate high-resolution optical images with comprehensive software that includes GD&T reporting features.
Our coordinate-measuring machine (CMM) systems, also known as vision machines, use video to identify micro-level flaws with impressive speed and efficiency. These automated optical inspection systems are ideal for testing and measuring high-volume parts production, ensuring we meet every customer’s GD&T specifications.
Quality Control Reports
As a Laser Light Technologies customer, you have access to a variety of reports and methods to help you keep an eye on quality control, including:
- First article inspection reports. Before full production begins, we set up our equipment and do a sample run of your part, measure for accuracy, and send the results to you for verification.
- Statistical report process control status. We provide updates on our process monitoring, so you know what we’re doing to ensure specification-conforming parts and establish statistical process control.
- Collaborative validation and verifications. Our engineering and design teams will work side-by-side with the customer team to validate the production of a new part or product.
Audits Assure System Quality
Laser Light performs internal, external, and customer audits to ensure effective quality management. For the external audit, ISO 9001:2015 and ISO 13485:2016 are audited separately (different time frames). Our external and customer audits have always confirmed high quality, with no major or minor non-conformities or variances.
Our engineering teams use a rigorous, systematic, independent, and documented process for obtaining audit evidence, and evaluating it objectively to determine the extent to which audit criteria are fulfilled via ISO-19011 (guidelines for auditing management systems).
For our internal audits, we combine ISO 9001:2015 and ISO 13485:2016 standards. Cross-functional teams with experienced members perform the internal audit. All team members have completed the auditor training prior to audit, which assesses:
- Risk assessment/mitigation
- Planning and product realization
- Production scheduling, infrastructure, work environment, contamination control, and pest control
- All areas of the facility, including laser areas, clean room, tooling areas, inventory
- Sales, order entry, customer feedback, VOCs, product realization, and customer satisfaction
- Workplace cleanliness, cleaning, and maintenance of the clean room
- IT systems, server maintenance, backups, software maintenance
- Invoices, completed jobs, Great Game of Business documentation
- Calibration, system validations, preventative maintenance
- Order processing, quoting, R&D process
- Internal drawings, process audit, product information file, medical device file
- Software validations and process validations
- Human resources and purchasing
- R&D jobs, process, set-up, line clearance, training, and process validation
- Management commitment and leadership
Audit results are then compiled and analyzed after long brainstorming sessions. The lead auditor delivers a presentation to the CEO and management team. Each finding is categorized into one of the following levels of gravity: major non-conformity, minor non-conformity, observation, or OFI (opportunity for improvement) and corrective actions are assigned if needed.
We understand that your success, and ours, is measured in microns.
This is why a Fortune 500 OEM selected Laser Light Technologies from the hundreds of companies within its complex supply chain to receive its Supplier of the Year Award two years in a row (2018-2019).
Customers seek us out, not just for our engineering and design expertise, but for our commitment to quality. We strive for efficient, error-free, on-time production and continuously monitor and adjust our compliance and validation processes to meet the highest quality expectations—both for ourselves and our customers.