Quality Systems
Person responsible for maintaining the currency of the Quality Manual.
Who is the Quality Manager?
The smallest concentration of a chemical that can be reported by a laboratory.
What is the REPORTING LIMIT?
Though technically not defined by TNI, the reporting limit will be at or above the LIMIT OF QUANTITATION (LOQ).
Required upon hire and then annually thereafter.
What is DATA INTEGRITY training?
The corrective action procedure always begins with this step.
What is ROOT CAUSE ANALYSIS?
The period of time laboratories are required to retain records.
What is FIVE YEARS?
Fact or Fiction:
The QA staff must conduct all internal audits.
What is FICTION?
All data representative of the current operations shall be used, if generated within the last two (2) years. A minimum of seven (7) samples is required.
What data is used for ongoing verification of DL/LOQ?
Labs are confused about how much data needs to be utilized for the ongoing verifications of the DL/LOQ. Applying both EPA and TNI requirements, you must utilize the most stringent criteria – that requires all of the data from the last 2 years be used.
A procedure to establish the ability of the analyst to perform analyses with acceptable accuracy and precision.
What is the INITIAL DEMONSTRATION OF CAPABILITY?
Fixing an error in data transcription.
What is CORRECTION?
Single point verification of temperature measuring devices is allowed when the working range meets this criterion.
What is LESS THAN 10 oC?
Documents that reflect all phases of current laboratory activities and all methods.
What are standard operating procedures? (SOPs)
The minimum levels, concentrations, or quantities of a target analyte that can be reported with a specific degree of confidence.
What is the LIMIT OF QUANTITATION (LOQ)?
The LOQ is often also used as the reporting limit.
Documented training and/or experience in QA/QC procedures is what this person must possess.
Who is the QUALITY MANAGER?
Taking steps to ensure an error does not reoccur.
What is CORRECTIVE ACTION?
The required frequency of calibration for temperature measuring devices.
What is ANNUALLY?
Person responsible for monitoring standards of performance in Quality Control and Quality Assurance, as well as the validity of the analyses performed and data generated in the laboratory to assure reliable data.
Who is the Technical Manager?
The minimum result which can be reliably discriminated from a blank with a predetermined confidence level.
What is the LIMIT OF DETECTION?
This is also called the MINIMUM DETECTION LIMIT (MDL).
Responsibilities for reporting opinions and interpretations and the responsibilities with respect to method modification and development and validation of new methods are to be defined in this document.
What is a JOB DESCRIPTION?
TNI does allow for interpretations in reporting as long as the person making those interpretations has — relevant knowledge of the technology used ...;
— knowledge of the general requirements expressed in the legislation and standards; and
— an understanding of the significance of deviations found with regard to the normal use of the items, materials, products, etc. concerned.
Evaluating systems for improvement.
What is PREVENTATIVE ACTION?
Containers of prepared reagents must be labelled with this information.
What is a UNIQUE IDENTIFIER and an EXPIRATION DATE?
Person responsible to periodically conduct a review of the laboratory's management system and and testing and/or calibration activities to ensure their continuing suitability and effectiveness and to introduce necessary changes and improvements.
Who is "top management"?
When a large number of analytes are in the LCS it becomes statistically likely that a few will be outside control limits. This condition may not indicate that the system is out of control, therefore corrective action may not be necessary.
What is MARGINAL EXCEEDANCE?
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The Marginal exceedance limit is between 3 and 4 standard deviations from the mean, and the number of allowable exceedances is based on the number of analytes.
The most discussed and debated laboratory position qualifications in the TNI Standard.
Who is the TECHNICAL MANAGER?
The system of activities and checks used to ensure that measurement systems are maintained within prescribed limits, providing protection against “out of control” conditions and ensuring that the results are of acceptable quality.
What is QUALITY CONTROL?
Reports must include the sample preparation and/or analysis time for these kinds of methods.
What are METHODS WITH HOLDING TIMES LESS THAN 72 HOURS?