QUALITY ANALYSIS CONSULTANTS

wes

WESLEY (WES) M. JOHNSON  PhD.

 

Dr. Johnson has many years of experience in commercial, industrial and government laboratories as an analyst, manager and Quality Control/Quality Assurance officer.

He is retired from teaching Analytical and Environmental Chemistry at Okanagan University College. Along with his colleague Jane Weitzel, he has developed and presented numerous workshops on Quality Control/Quality Assurance, Method Validation, the Estimation of Measurement Uncertainty, Basic Statistics for Validation, Traceability, and Uncertainty Estimation, Accreditation to ISO/IEC Standard 17025, and aspects of classical and instrumental analysis for laboratories in Canada and abroad.

Dr. Johnson assisted in the development of CAN-P-1579 as a member of the Mineral Analysis Working Group set up by the Standards Council of Canada (SCC) to establish an ISO/IEC Standard 17025 accreditation program for laboratories in this industry.

He drafted the Canadian Association for Laboratory Accreditation (CALA – formerly CAEAL) Policy for the Estimation of Measurement Uncertainty for chemistry. He has served as an auditor for private industry and for SCC and CALA in over 50 accreditation visits to numerous laboratories and is an RABQSA Certified Auditor.

His consulting engagements with many laboratories around the world has included assistance in attaining accreditation to ISO/IEC Standard 17025.

 

jane

M.L. JANE WEITZEL

 

Ms. Weitzel has worked in analytical chemistry and Quality Assurance for over 30 years.

Ms. Weitzel has held positions in Quality Assurance at pharmaceutical companies where she was responsible for all Quality-related functions, including oversight of manufacturing and testing labs facilities throughout North America. Over the last 20 years, she has been active in many organizations such as AOAC International and the Standards Council of Canada, where she has developed guides for meeting Quality requirements in the lab.

At AOAC, Ms. Weitzel is Chair of the Analytical Laboratory Accreditation Criteria Committee (ALACC) that wrote the AOAC INTERNATIONAL Accreditation Guidelines for Laboratories and developed a guide on Method Verification. Ms. Weitzel is also Chair of AOAC International’s Technical Division for Laboratory Management.

Ms. Weitzel is active as an educator and consultant on laboratory accreditation to ISO/IEC 17025:2005 including the estimation and use of Measurement Uncertainty. She is a technical assessor for the Standards Council of Canada.

Ms. Weitzel is experienced in implementing, maintaining, and improving compliance with cGMP regulations of many regulatory bodies including US FDA, Health Canada, UK MHRA and others in a drug and biologic manufacturing facility. Implementing and maintaining ISO 9001:2000 Quality Systems in a manufacturing facility has also been part of Jane’s continuing responsibility.