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Chemistry Laboratory Quality Assurance/Quality Control Plan
Any procedure with hold points for which a matrixed organization is responsible
As noted in the previous list, the required documents for this area of conduct of operations may
be distributed among many activity and site administrative policies. The documents to be
reviewed during assessment planning are the activity or site administrative policies and
procedures. Most of the matrixed organization policies, including QA/QC plans, will not be
examined unless pursuing leads draws an assessor into those documents.
This area is one where the review of safety analyses and the emergency preparedness
documentation prepared for the management of unusual situations is applicable. The quality of
that documentation is a reflection of the preparation to deal with off-normal situations, including
those imposed by adjacent activities.
An examination of roundsheets where parameters are recorded should be informative. Assessors
should identify any out of specification parameters which have been noted, and if any action was
taken as a result. Also, assessors should look for trends where the parameter is close to being out
of specification and appears to require action to avoid an out of specification condition.
The chemistry laboratory QA/QC plan or similar document may provide information on how
samples are tracked including chain of custody procedures. If an activity has a history of
receiving lab results late, especially if the process continued to operate with chemistry out of
specification, it may be necessary to examine the lab's receipt logs and chain of custody forms in
an attempt to identify points of delay.
The method used to forward lab results to the activity should also be examined. A problem may
exist concerning the switching or confusion of samples. If the assessor understands the process,
then it is possible to review sample results and determine if they make sense.
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