
222 Part II The Step-by-Step Guide to the TIQM Quality System
a random number generation routine or use sampling software to
calculate a number that will achieve your calculated Sample Size.
P2.6.5 Isolate the sampled records in a controlled data store or paper record,
or photocopied image of the source creation document.
For electronic records, write them to the Sample Database before the
record is confirmed and updates can be made.
Note For integrity of the assessment process, the chain of custody of the
sampled records or paper documents must be controlled to prevent tamper-
ing with or altering the electronic records or paper documents. For electronic
records, you must prevent updates to any of the sampled records. For paper
records, you must prevent alteration of the information collected.
P2.6.6 Document the Controls in the Chain of Custody of the Sampled Records
to be assessed that prevents alteration or updates to the data once it
has been extracted for assessment.
For original electronically created data, you must ensure that:
1. The Information Producers are not aware of the timing of the sam-
pling for IQ Assessment. This will bias their information production
activities.
2. The sampling process ensures a statistical random sample (each
record has equal likelihood of being selected) that ensures the mini-
mum number of records given the standard deviation