数据分析控制程序ISO13485

B.2: 风险区域为2&3的变量数据OQ取样计划

T检验

Testing mean = null (versus > null)

Calculating power for mean = null + difference α=0.05

假设标准偏差=1

Difference差异效Sample Size Target Power Actual Power 应 取样量 目标把握度 实际把握度 风险区域 1.2 10 0.90 0.918982 OQ Zone 2 1.2 12 0.95 0.967475 OQ Zone 3

Power Curve for 1-Sample t Test 把握度-T检验曲线

Power Curve for 1-Sample t Test1.0SampleSize80.810AssumptionsAlpha0.05StDev10.6Alternative>rewPo0.40.20.00.00.51.01.52.0Difference

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B.3: 风险区域为4的变量数据OQ取样计划

1-Sample t Test T检验

Testing mean = null (versus > null)

Calculating power for mean = null + difference α=0.01

假设标准偏差=1

Difference差异效Sample Size Target Power Actual Power 应 取样量 目标把握度 实际把握度 风险区域 1.2 16 0.95 0.953007 OQ Zone 4

Power Curve for 1-Sample t Test 把握度-T检验曲线

Power Curve for 1-Sample t Test1.0SampleSize140.8AssumptionsAlpha0.01StDev1Alternative>0.6rewPo0.40.20.00.00.51.01.52.0Difference 18 / 28

B.4: 风险区域为1的变量数据PQ取样计划

把握度和取样量

1-Sample t Test T检验

Testing mean = null (versus > null)

Calculating power for mean = null + difference Alpha = 0.1 Assumed standard deviation = 1 α=0.1

假设标准偏差=1

Difference差异效Sample Size Target Power Actual Power 应 取样量 目标把握度 实际把握度 风险区域 PQ Zone 0.6 26 0.9 0.910254 1

Power Curve for 1-Sample t Test 把握度-T检验曲线

Power Curve for 1-Sample t Test1.0SampleSize200.8AssumptionsAlpha0.1StDev1Alternative>0.6rePow0.40.20.00.000.250.500.751.00Difference 19 / 28

B.5: 风险区域为2&3的变量数据PQ取样计划

Power and Sample Size 把握度和取样量

1-Sample t Test T检验

Testing mean = null (versus > null)

Calculating power for mean = null + difference Alpha = 0.05 Assumed standard deviation = 1 α=0.05

假设标准偏差=1

Difference差异效Sample Size Target Power Actual Power 应 取样量 目标把握度 实际把握度 风险区域 0.6 32 0.90 0.908264 PQ Zone 2 0.6 39 0.95 0.952914 PQ Zone 3

Power Curve for 1-Sample t Test 把握度-T检验曲线

Power Curve for 1-Sample t Test1.0SampleSize260.832AssumptionsAlpha0.05StDev10.6Alternative>rePow0.40.20.00.000.250.500.751.00Difference 20 / 28