The design and implementation of quality systems and manufacturing/servicing programs saves time and money. Efficiently analyzing and correcting flawed quality systems programs helps reintroduce products or services to the market…and keeps them on the market.
KARA & Associates can help you meet your quality assurance requirements. The following are some of the key QA consulting services we provide. In addition, we are pleased to discuss any of your specific QA needs.
We are experts in:
- Analyzing, designing, and implementing programs to meet ISO 9001, ISO 13485 and related standards
- Assist with obtaining ISO certifications
- Review and/or prepare QA systems and related documentation
- Conduct audits of QA systems
- Supplier Audits
- Managed and execute process validation (IQ/OQ/PQ) program that comply with FDA and IMDRF (GHTF) guidance documents
- Develop and maintain supplier qualification program, which involved in assessing potential suppliers based on their competence through surveys, on-sites audits, regulatory certifications, etc. Monitored supplier performance through trend analysis (e.g., on-time delivery, quality, support)
- Conduct statistical analysis (e.g., capability, outlier, normality, Design of Experiment (DOE), K-factor, ANVOA)
- Manage and design verification system to support receiving, in-process, & final product inspection and design verification. Incorporated statistical technics such as sampling (C=0, ANSI Z1.4, confidence/ reliability), pre-control, SPC, etc.
Developed, managed, and executed non-conforming materials process, which involved Material Review Boards (MRB) to determine associated risk, assign disposition, and gain appropriate approvals.
“We would highly recommend this group to other companies who are in the process of developing Quality Management Systems and who are seeking ISO certification.”