Performance Objective:

The objective of this assessment is to determine whether a program is in place which assures that Measuring and Test Equipment (M&TE) used in activities affecting quality and safety are properly controlled, calibrated, and adjusted at specified times to maintain accuracy within necessary limits.

Criteria:

  • All M&TE is uniquely identified, calibrated, controlled, and provides accuracy traceability.
  • A recall program maintains the total inventory and status of all M&TE.
  • Out-of-tolerance M&TE is removed from service.
  • Plant equipment calibrated with out-of-tolerance M&TE is evaluated in a timely manner for impact on previous output, current operability and is re-calibrated as necessary.
  • The critical parameters of all M&TE such as range, precision, accuracy, etc. are documented; the documents shall be retrievable, and maintained as quality records.