Methods & PT Program
Purpose is to externally assess accuracy, reliability, and to ensure the validity of results.
What is proficiency testing?
This person is responsible for notifying Quality Assurance when a complaint is received.
Who is the person receiving the complaint?
Reference to any deviations or ______ associated with the analysis.
What is investigations?
This event occurs biannually, at minimum, in order to ensure the management systems effectiveness and continued suitability.
What is management review meeting?
The management of the laboratory shall communicate to personnel their duties, responsibilities and authorities.
What is job descriptons?
The laboratory shall use appropriate methods and procedures for all laboratory activities.
What is our 4 validated methods? (GCHS, GCMS, LCMS, ICPMS)
This type of non-conformance shall occur only if it has been documented, technically justified, authorized, and accepted by the client.
What are Deviations?
The name and _______ of the laboratory
Party responsible for being informed of the management review process.
Who are all personnel?
The laboratory shall establish a calibration program which shall be reviewed and adjusted as necessary in order to maintain confidence in the status of calibration.
What is SOP 4000 (Equipment)?
Frequency that PT samples shall be tested for each method.
What is every 4 years?
Party responsible for participating in trend analysis to ensure corrective/preventative action effectiveness.
Who is management?
The _______ of performance of the analysis.
What is date?
This is designed to continually evolve as risk and/or opportunities for improvement are identified.
What is management system?
The laboratory shall monitor, control and record environmental conditions in accordance with relevant specifications, methods or procedures or where they influence the validity of the results.
What is SOP 4003 (Environmental Monitoring and Control)?
All methods, procedures, and supporting documentations, shall be kept up to date and shall be made ____ ______ to personnel.
This nonconformance is associated with test results.
What is investigations?
Statement specifying that report shall not be _______ except in full, without approval of laboratory
What is reproduced?
A questionnaire for identifying opportunities for improvement.
What are client satisfaction surveys?
The laboratory shall be responsible for the impartiality of its laboratory activities and shall not allow commercial, financial or other pressures to compromise impartiality.
What is our Quality Manual?
This shall be initiated if proficiency testing results are found outside of predefined criteria.
What is an investigation?
This type of complaint must be closed within 30 business days of discovery.
What is major?
Information on specific _____ ________ where necessary for the interpretation of the test results.
What is test conditions?
This word is defined as the presence of objectivity. It represents freedom from conflict of interest, freedom from bias, and open-mindedness.
What is impartiality?
The laboratory shall document the competence requirements for each function influencing the results of laboratory activities, including requirements for education, qualification, training, technical knowledge, skills and experience.
What is SOP 1003 (Training) or job descriptions?