Our Services:
Lemast Consulting is a service oriented Quality Assurance consulting firm. With over 30 years experience in medical device and commercial manufacturing, quality assurance, and operations functions, Lemast has the depth of knowledge you need to improve your operation.
Quality System management, Quality System development, and Quality System implementation are core competencies of Lemast. We are experienced in ISO 9001 and the FDA Quality System Regulation (QSR).
Process Improvement utilizing the right selection of tools; Quality Planning, Lean Six Sigma, Statistical Process Control (SPC), Process Mapping, Workflow Analysis, is the key to successful improvement strategies while minimizing capital expenditures. We are experienced with these tools, a nd more, to help you differentiate yourself from your competition.
We offer experience with new product development and implementation strategies. We have developed and implemented product development systems using ISO 9001 format, FDA Pre-Production Quality Assurance (PPQA), classical Waterfall model, and Rational Unified Process (RUP) methodologies.
Validation and Verification planning for software, hardware, and the integration of both into a system validation is an area Lemast excels. We are experienced in V&V for both medical device and commercial products.
Supplier Assessment and pre-award surveys for new vendors, along with maintenance auditing for established suppliers is another strength of Lemast Consulting. With experience in auditing to ISO and FDA QSR standards, developing and implementing supplier rating programs, Ship-to-Stock (or Dock-to-Stock) programs, Lemast can assist in improving the quality of incoming materials while saving both you and your supplier money.
Certification and Training Synopsis
- Certified Lean Six Sigma Black Belt (LSSBB)
- ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE)
- ASQ Certified Quality Engineer (CQE)
- Reliasoft Block Simulator trained
- IEEE Software Test and Development trained
- ISO 9000 Lead Assessor training
- Demand Flow training
- Statistical Process Control Implementation training
- Project and Program Management training