Page 18 - qp_17

b) Evaluation for Verification Manufacturer Claim (Total Precision)

1. Calculate manufacturer’s Total SD by this formula: SDT = CVMTx OM

2. Calculate(n-1)•(σ WR),where n=no of replicates
2

2
3. Calculate (n•σ BR),where n=no of replicates

4. Calculate (n-1)/D where n=no of replicates,D=no of days

2
5. Calculate (σ BR)
2

2
2
2
6. Calculate n *(σ BR)

7. Calculate Verification Value Total Precision SDTV
√
•
=
√
2
2
(( − 1) • + ( • )) 2

= =
2
2
−1 4 •( ) 2
� � • + ( )
−1
8. Determine C= Obtain the value from Chi square table according to number of
levels and degree of freedom )
Where, C = Percentage point (Ӽ2 (0.05/L, T),
L = no of QC levels

9. Compare Total Precision (SDT) with Verification Value Total Precision (SDTV)

• If SD T≤SDTV, imprecision of the test is consistent with the manufacturer’s
claim. (ACCEPTABLE& VERIFIED)

Experiment result Manufacturer Comment on
Claim acceptibility
SD (CV%) SD (CV%)
Within Run
Total Imprecision