๐Ÿ‡ฒ๐Ÿ‡พ NPRA โ€” PKKK/300/UP/064 & UP/014โ€“016

โ—ˆ Seksyen Pengujian Produk & Kosmetik ยท Unit Penyaringan

Balance Performance & Control Charting

Standard Gravimetric Performance Verification (UP/014, UP/015, UP/016) & Shewhart Trend Analysis

Interactive verification suite for analytical balances (Precisa, Sartorius MSE225S, Sartorius Cubis MSU6.6S microbalance, MT XP205DR). Evaluates daily drift, sensitivity errors (ΔE), repeatability standard deviations, and IQC recovery control charts with warning/action limits (2s / 3s).

Daily Performance Check (Borang UP/014)

Routine morning zero point, spirit level bubble, and single standard check
Daily Verification Verdict
Deviation (ΔE = |M − m0|): 0.0002 g (0.20 mg)
Allowed MPE Limit: ± 0.50 mg
Daily Accuracy Status: PASSED โœ“
DAILY BALANCE STATUS
BALANCE OPERATIONAL & WITHIN ACCEPTANCE LIMITS

Sensitivity Check (Borang UP/015)

Multi-point standard mass test across operational range (Class E2/F1 standards)
Test Mass Nominal Value (g) Observed Reading (g) Error (mg)
Point 1 (Low)+0.10 mg
Point 2 (Mid)-0.20 mg
Point 3 (High)+0.30 mg
Point 4 (Max)+0.40 mg
Sensitivity Evaluation
Max Absolute Error (ΔEmax): 0.40 mg
Permissible Threshold: ≤ 0.50 mg
Sensitivity Status: PASSED โœ“
SENSITIVITY VERIFICATION
LINEAR RANGE MEETS NPRA ISO 17025 SPECS

Repeatability Check (Borang UP/016)

10 consecutive weighings of reference mass (evaluates standard deviation s and 2s)
Repeatability Statistics (n = 10)
Mean Weight ($\bar{x}$): 100.00011 g
Std Deviation (s): 0.088 mg
Uncertainty Contribution (2s): 0.175 mg
Max Allowable ($s โ‰ค 0.15mg$): PASSED โœ“
REPEATABILITY STATUS
REPEATABILITY WITHIN ACCEPTABLE ANALYTICAL PRECISION

IQC Control Chart & Trend Analysis (PKKK/300/UP/064)

Shewhart accuracy control chart for Internal Quality Control samples with Warning (2s) & Action (3s) limits
Target Mean (100.0%)
Warning Limits ±2s (90% / 110%)
Action Limits ±3s (85% / 115%)
IQC Sample Recovery (%)