HK operates a certified ISO 9001:2008 Quality Assurance system (see certification). We provide all levels of inspection. Our commitment is to inspect and qualify components the way you would if your QA department were in our facility.

Non-conformances happen. HK developed our non-conformance reporting (NCR) and corrective action (CAR) systems as a means of identifying and resolving issues with a pro-active team oriented approach.

Quality planning maps the procedure used by HK to assure product quality. Typically, we define critical functional dimensions and key characteristics in the quality plan. First-article,in-process inspections and frequency of inspections are mapped. Functional testing and frequency will also be listed on the quality plan. Many of our plans include digital pictures describing visual criteria.

Statistical Process Control methods help us monitor and identify process capability. We have developed our own proprietary database based SPC program called HKSPC. HKSPC was developed as a simple easy to use and understand tool to help us communicate quality concepts with our staff as well as with HK customers. Click Here to download a copy of the HKSPC spreadsheet. Contact HK if you are interested in seeing or purchasing the database portion of the program.

HK’s design of experiments template was formatted to meet the requirement of the FDA for medical product validation. We first design a matrix of process variable and key characteristics. Minimum and maximum processing criteria are then defined. Finally, mold testing is performed and results collected to demonstrate process and specification capability. Please contact us if you are interested in seeing HK’s DOE template.