FMEA\MSA\SPC

FMEA:

FMEA

Failure Mode and Effects AnalysisFMEA?1/?2?3?FMEA?

FEMA?P-FMEA?/D-FMEAFMEA?P-FMEAFMEAFMEA

FMEA

FMEA?//?

1?2?3?4?5?6?7?8?9?10?1112?

FMEA

2?1 60 ?

2?2 1972? NAAOFMEA

2?3 1974 Mil-Std-1625(?)FMEA

2?4 1976? FMEA

2?5 1988 FMEA?

2?6 1989 FDA90-4236?FMEA.

2?7 1990? FMEAANSI Z21.64 and Z21.47? FMEAISO9000FMEA?

2?8 1991? ISO9000FMEA

2?9 1993 FDAGMP?FMEA?FTA

2?10 1994? FMEA?QS-9000?QS-9000?

2?11 1995? FMEA2010?

2?12 1996 FDA GMP FMEA?

FMEA?

FMEA//FMEAFMEA?

FMEA?

/ FMEA?2010

FMEA?

FMEA

FMEA?FMEA?FMEA

FMEA

FMEAFMEAFMEA?FMEAFMEA

FMEA

4?1 ?FMEAD-FMEA?

1?

1.1

1.2

1.3?/?

1.4?

1.5?/?

4?2 ?FMEAP-FMEA?

?2?/

2.1?/?

2.2?/?

2.3?/?/?

2.4

2.5?

2.6

4?3 ?FMEAA-FMEA?

4?3?1 FMEA

/?

4?3?2 ?FMEA?

4?4 ?FMEAS-FMEA?

1 2? 3

FMEA?

1?2/ 3 45?/?6?78?910? 11?12

FMEA

6?1

6?1?1

6?1?2

6?1?3

6?2

6?2?1

6?2?2 ?

6?3

6?3?1 ?

6?3?2

6?3?3 /?

6?3?4 ?

6?4

6?4?1 ?

6?4?1?1

6?4?1?2 ?

6?4?1?3

6?4?2

6?4?2?1

6?4?2?2 ?

6?5 ?

6?6 ?

6?6?1 ?

6?6?1?1 ?

6?6?1?2

6?6?1?3

6?7 ?

6?7?1 O D?S?

6?7?2 ?RPN? RPN = ?ODS?

6?8

6?9 ?

FMEA? FMA

7?1 FMA

Failure Mode AnalysisFMA?

7?2 FMEA-

7?2?1

7?2?2 ?

7?2?3

7?2?4 ?/?

7?2?5 ?

7?2?6 FMEA?

7?3 FMA-?

7?3?1

7?3?2 100%

7?3?3 ?

7?3?4 FMA?

8?1 ?

8?1?1

8?1?2 ?

8?2 ?

8?2?1

8?2?2 ?

8?2?3 ?

8?2?4 ?

FMEA?

FMEA

FMEA?FMEA

FMEA?FMEAFMEAFMEAFMEAFMEA?FMEA

MSA:?

/MSASPC

MSA?MeasurementSystemAnalysis?

Bias?Linearity?StabilityR&RRepeatability?Reproducibility?

GageR&R?

ISO10012-2?QS9000

SPC:SPCStatistical Process Control?SPC?

SPC

SPCSPC?

SPC?

....SPC ?SPCSPC"?"?SPC

?

?

?

....:

:

:

:?

: ?

CPK

SPC?

SPC?

SPC?

SPC

SPC?

70SPCSPC?

1?. ?SPC

2?. SPC?

3?. ?SPC?

4?. SPCSPC

5?.