Docstoc

Calibration SA Workshop Sept-Oct 09

Document Sample
Calibration SA Workshop Sept-Oct 09 Powered By Docstoc
					                Implementation Workshop
                             Major Revision to the
                            Calibration Subject Area




                                 Presented by:
                                 Steven Stein
                          Quality Management Office
                          September / October 2009

Brookhaven Science Associates
  U.S. Department of Energy            1
        Special Thanks to the Revision Team
                                L. Bowerman
                                M. Buckley
                                J. Bullis
                                R. Costa
                                R. DeRocher
                                D. Passarello
                                R. Roberts
                                R. Selvey
                                T. Welty
                                P. Zahra
Brookhaven Science Associates
  U.S. Department of Energy            2
        OUTLINE

    Definitions
    Examples of M&TE
    Reasons for changes
    Revised/New Requirements
    Implementation Plan
      • Part of the plan is to hold workshops on the
        revised SA
    Questions/Comments
Brookhaven Science Associates
  U.S. Department of Energy     3
        Definitions

           Calibration: The comparison of a measurement
            instrument or system of unverified accuracy to a
            measurement instrument or system of known
            accuracy to detect any variation from the required
            performance specification.
           Measuring And Test Equipment (M&TE):
            Measuring instruments, measurement standards,
            reference materials, and auxiliary apparatus that
            are necessary to perform a precision
            measurement. The term includes measuring
            equipment used for process monitoring, data
            collection, testing, inspection, and calibration of
            other instruments.
Brookhaven Science Associates
  U.S. Department of Energy      4
        Definitions (cont’d.)

           Out-of-tolerance: A condition in which a
            measured value of a measurement attribute lies
            outside the documented performance
            specifications for the attribute or a state in which
            one or more attributes of an item are not in
            conformance with documented performance
            specifications.




Brookhaven Science Associates
  U.S. Department of Energy       5
        Examples of Equipment / M&TE
       Equipment Type              M&TE                Calibrate
                                  (Yes/No)             (Yes/No)
Freezer                         No           No
Vacuum pump                     No           No
Balance, scale                  Yes          Yes
Microscope                      No           Yes, if used for measurements
Ruler, Tape Measure             Yes          No
Digital Volt Meter (DVM)        Yes          Yes, if not used for reference
pH meter                        Yes          Yes



 Remember: Not all equipment is M&TE and not all M&TE
 needs to be calibrated
Brookhaven Science Associates
  U.S. Department of Energy           6
         Reasons for changes
        Five year periodic review was due
        Extent of Condition (EOC) review:
          •Implementation of calibration program
          significantly impacted by exemption for
          R&D items termed “intrinsic to the
          experiment”
          •Documentation not required for decisions to
          not calibrate items graded as ESH&Q Risk
          “A3” or “A4”


Brookhaven Science Associates
  U.S. Department of Energy     7
        Revised/New Requirements

   The Calibration Flowchart was updated
   Criteria to determine if M&TE needs calibration is now
    based on either internal or external requirement(s)
      • ESH&Q Risk Level is not a consideration
      • R&D items, e.g., “intrinsic to the experiment”, are evaluated on
        funding or peer review requirements, etc.
   New section - Checking the Status of Calibrated Measuring
    and Test Equipment (M&TE)
      • M&TE users to check its condition and if it’s within the calibration
        expiration/due date
   New section - Investigating Out-of-tolerance or Expired
    Measuring and Test Equipment (M&TE) Conditions
      • Calibration Extension Form - process for extending calibration
        expiration/due date



Brookhaven Science Associates
  U.S. Department of Energy              8
        Revised/New Requirements (cont’d.)
   “As Found/As Left” measurements with calibration
    certificate were added to the BNL-QA-101 form
   M&TE that are calibrated on-site ensure appropriate
    work planning and controls are in place
   The exhibit Statement of Work for Calibration of
    M&TE was revised to be applicable for any type
    M&TE
   The new exhibit Examples of Calibration Labels
    shows typical labels that can be used on M&TE
   The Balance-Micropipette Information Form was
    deleted from the subject area.
Brookhaven Science Associates
  U.S. Department of Energy     9
        Implementation Plan


       Implementation Action 1:
       Line organizations review the Calibration Subject
       Area for applicability. If applicable, determine if
       they conform with requirements. If not in
       conformance, proceed to Action 2.
       Affected Staff: Staff responsible for calibration or
       using M&TE
       Due Date: October 23, 2009

Brookhaven Science Associates
  U.S. Department of Energy     10
        Implementation Plan
    Implementation Action 2:
    Line organization develops corrective action plan to
    bring it into conformance with the requirements of the
    Calibration Subject Area.

    Affected Staff: Staff responsible for calibration or
    using M&TE

    Due Date: January 22, 2010

Brookhaven Science Associates
  U.S. Department of Energy     11
         Implementation Plan
Suggested Action Plan:
1. Identify M&TE requiring calibration:
    a. Establish calibration frequency (create/add to
        list of M&TE)
    b. Determine who will calibrate M&TE
    c. Track M&TE calibration expiration/due dates
2. Ensure staff checks M&TE for damage and that it is
   within the calibration expiration/due date
3. Ensure that out-of-tolerance conditions or use
   beyond the calibration expiration/due date is
   investigated
 Brookhaven Science Associates
   U.S. Department of Energy     12
                        Questions/Comments




Brookhaven Science Associates
  U.S. Department of Energy     13
Need more information
or have questions
              Steven Stein, SME Calibration, x5694
             A copy of this presentation is online at:
            http://www.bnl.gov/qmo/ServicesSupport.asp
            (Look for link under the “Training” section)

            Final Thought: A man with one watch knows what
            time it is; a man with two watches never knows.
            Moral: If in doubt, calibrate.



Brookhaven Science Associates
  U.S. Department of Energy         14
        Back up slide

                               Why Calibrate?
           Components age and equipment undergoes changes
            in temperature or humidity or sustains mechanical
            stress, performance degrades. This is called drift.
            Then test results become unreliable. While drift cannot
            be eliminated, it can be detected and either corrected
            or compensated for through the process of calibration.
           Historical Issues
             •   Cost, cost, cost
             •   No clear goals
             •   Limited technical oversight or understanding
             •   Most staff afraid of it
Brookhaven Science Associates
  U.S. Department of Energy             15
        Back up slide

                                Why Calibrate?
        If it’s done right, here is what it buys you!
         Properly calibrated equipment provides confidence
            that your products/services/results meet their
            specifications
         Calibration
             • Optimizes resources;
             • Ensures consistency; and
             • Ensures measurements (and perhaps products) are
               compatible with those made elsewhere.
           By making sure that your measurements are based on
            international standards, you promote acceptance of
            your products/services/results.
Brookhaven Science Associates
  U.S. Department of Energy         16
        Back up slide


                          Why Calibrate?
           Master Instrument List
             •   Description or name;
             •   Unique identifier;
             •   Instrument accuracy, range, etc.;
             •   Calibration frequency;
             •   Location;
             •   Expiration or due date;
             •   Applicable calibration procedure and standards.
Brookhaven Science Associates
  U.S. Department of Energy          17

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:9
posted:3/28/2012
language:
pages:17