Presentation of Modified Working Draft Standard - Quality Systems - Volume 1, Module 2 on April 20, 2015
Date Posted: 3-20-2015
The TNI Quality System Expert Committee has prepared a Modified Working Draft Standard for Volume 1 Module 2 - Section 126.96.36.199 (Quality Systems General Requirements). This will be presented publicly for discussion and input.
Webinar: April 20, 2015 1 - 2pm EDT
To register for this Webinar, email Ilona Taunton (firstname.lastname@example.org) and request an invitation to register. There is no registration cost for this meeting.
A link is provided to the Modified Working Draft Standard for your review prior to the meeting: LINK (PDF)
Comments regarding the change discussed below will be requested in writing after the Webinar and will be due by May 20, 2015.
Note: A track changes version of the Standard is available by clicking on this link: LINK (PDF)
Due to a conflict between the language in the proposed Module 5 (Microbiology) and Module 2 (Quality Systems) a Working Draft Standard has been drafted. The conflict involves thermometer verifications, and is as follows:
Module 2 states: All support equipment shall be calibrated or verified at least annually, using a recognized National Metrology Institute, such as NIST, traceable references when available, bracketing the range of use.
The recently advanced language in Module 5 reads as follows:
Temperature Measuring Devices
Temperature measuring devices such as liquid-in-glass thermometers, thermocouples, or platinum resistance thermometers shall be used to assess and document equipment temperatures and shall be the appropriate quality to meet specification(s) in the method.
The graduation and range of the temperature measuring devices shall be appropriate for the required accuracy of the measurement. Temperature measuring devices shall be verified to national or international standards for temperature. Verification shall be performed at least annually (see TNI Volume 1, Module 2, Section 188.8.131.52). This verification may be accomplished by a single point provided that it represents the method mandated temperature and use conditions.
A previous SIR 206 requested clarification on this point. This Working Draft Standard clarifies the requirements of support equipment as they relate to calibration, and eliminates the conflict between Modules 2 & 5.