ืชื•ื›ืŸ ืขื ื™ื™ื ื™ื
ืžืืžืจื™ื ืื—ืจื•ื ื™ื:

ืฆืจื• ืงืฉืจ

ืžืขืจื›ืช ื ื™ื”ื•ืœ ืกื™ื›ื•ื ื™ื โ€“ FMEA | Failure Mode and Effect Analysis

ืžื‘ื•ื

ื™ื™ืฆื•ืจ ืฉืœ ืชืจื•ืคื•ืช ื•ืžื›ืฉื•ืจ ืจืคื•ืื™ (Medical devices) ื•ืคื™ืชื•ื—ื ืžื—ื™ื™ื‘ื™ื ื”ืฉื’ื—ื” ืจืฆื™ืคื” ื•ื”ื“ื•ืงื” ืœื˜ื•ื‘ืช ืฆืžืฆื•ื ืกื™ื›ื•ื ื™ื ืขื“ ืœืžื™ื ื™ืžื•ื ื”ืืคืฉืจื™. ืชืงืœื•ืช ื•ืกื™ื›ื•ื ื™ื ื”ืŸ ื‘ืžื•ืฆืจ ื•ื”ืŸ ื‘ืชื”ืœื™ืš ื”ื™ืฆื•ืจ ืขืœื•ืœื™ื ืœื’ืจื•ื ืœื—ื‘ืจื•ืช ืฆื™ื•ื“ ืจืคื•ืื™ ืœื ื–ืง ื›ืœื›ืœื™ ืขืฆื•ื, ื•ืคื’ื™ืขื•ืช ื‘ืžื˜ื•ืคืœื™ื ื”ืฆื•ืจื›ื™ื ืืช ื”ืžื•ืฆืจื™ื. FMEA (Failure Mode and Effect Analysis) ื”ื™ื ืื—ืช ื”ืฉื™ื˜ื•ืช ื”ืจื•ื•ื—ื•ืช ื‘ืชืขืฉื™ื™ืช ื”Medical Device ืœื ื™ื”ื•ืœ ืกื™ื›ื•ื ื™ื ื‘ืฉืœ ื”ืืคืงื˜ื™ื‘ื™ื•ืช ืฉืœื” ื‘ื–ื™ื”ื•ื™ ืกื™ื›ื•ื ื™ื ืืคืฉืจื™ื™ื, ื•ื›ืš ืžื ื™ืขื” ืฉืœ ืคื’ื™ืขื•ืช ื‘ื’ื•ืฃ ื•ื‘ื ืคืฉ ืืฆืœ ืœืงื•ื—ื•ืช ื•ืืฆืœ ื”ืขื•ื‘ื“ื™ื.

ืฉื™ืžื•ืฉ ื‘ืฉื™ื˜ื” ื–ื• ื›ื•ืœืœืช ื’ื™ื•ืก ืฆื•ื•ืช ืžื•ืžื—ื™ื ื”ืžื ืชื— ืืช ื’ื•ืจืžื™ ื”ืกื™ื›ื•ืŸ ื‘ืื•ืคืŸ ืžื“ืขื™ ื•ืืžืคื™ืจื™, ื•ืžื“ืจื’ ืืช ื’ื•ืจืžื™ ื”ืกื™ื›ื•ืŸ ืœืคื™ ื—ืฉื™ื‘ื•ืช ื•ื“ื—ื™ืคื•ืช ืœื˜ื•ื‘ืช ื˜ื™ืคื•ืœ ื‘ื”ื.

ืœืคื ื™ ืฉื ืฆืœื•ืœ ืœืคืจื˜ื™ ืžืขืจื›ืช ื”-FMEA ื ื‘ื”ื™ืจ ืžืกืคืจ ืžื•ืฉื’ื™ ื™ืกื•ื“, ืœืคื™ ISO 14971:2019 (Medical devices โ€” Application of risk management to medical devices) ื•ืœืคื™ IEC 60812 (Failure modes and effects analysis (FMEA and FMECA)):

  • ืกื›ื ื” (Hazard): ื›ืœ ื“ื‘ืจ ื”ืขืœื•ืœ ืœื’ืจื•ื ืœื ื–ืง โ€“ ืžืงื•ืจ ื”ื ื–ืง ย ื”ืคื•ื˜ื ืฆื™ืืœื™. ืื™ืŸ ื—ืฉืฉ ืœืคื’ื™ืขื” ืžื”ืกื›ื ื” ืœื›ืฉืขืฆืžื” ืื ืœื ืงื™ื™ื ื’ื•ืจื ืฉื™ื”ืคื•ืš ืื•ืชื” ืœืžืฆื‘ ืžืกื•ื›ืŸ.

ย ืžืฆื‘ ืžืกื•ื›ืŸ (Hazardous situation): ืžืฆื‘ ืฉื‘ื• ืื ืฉื™ื, ืฆื™ื•ื“ ืื• ืกื‘ื™ื‘ื” ื—ืฉื•ืคื™ื ืœืกื›ื ื” ืื—ืช ืื• ื™ื•ืชืจ, ื•ื ื–ืง ืขืœื•ืœ ืœื”ื’ืจื. ืื™ืŸ ื—ืฉืฉ ืœืคื’ื™ืขื” ืžื”ืกื›ื ื” ืœื›ืฉืขืฆืžื”, ืื ืœื ืงื™ื™ื ื’ื•ืจื ืฉื™ื”ืคื•ืš ืื•ืชื” ืœืžืฆื‘ ืžืกื•ื›ืŸ.

ืกื™ื›ื•ืŸ (Risk): ืฉื™ืœื•ื‘ ืฉืœ ื”ืกื™ื›ื•ื™ ืœื’ืจื™ืžืช ื ื–ืง (Probability of Occurrence of Harm) ื•ื—ื•ืžืจืช ื”ื ื–ืง (Severity of Harm). ื‘ืžืขืจื›ืช ื ื™ื”ื•ืœ ืกื™ื›ื•ื ื™ื ืžืกื•ื’ FMEA ืคืงื˜ื•ืจ ื ื•ืกืฃ ืฉื ืœืงื— ื‘ื—ืฉื‘ื•ืŸ ื”ื™ื ื• ื”ื™ื›ื•ืœืช ืœื–ื”ื•ืช ืืช ื ืงื•ื“ืช ื”ื›ืฉืœ ืœืคื ื™ ื”ื•ื•ืฆืจื•ืช ื”ื ื–ืง (Detectability).

ื ื–ืง (Harm): ืคืฆื™ืขื”, ืคื’ื™ืขื” ื‘ื‘ืจื™ืื•ืช, ื ื–ืง ืœืจื›ื•ืฉ ืื• ืžืคื’ืข ืกื‘ื™ื‘ืชื™.

ื ืงื•ื“ืช ื›ืฉืœ (Failure mode): ื”ืื•ืคืŸ ืฉื‘ื• ืงื•ืจื” ื”ื›ืฉืœ.

ื”ืฉืคืขื•ืช ื”ื›ืฉืœ (Failure Effect): ื”ืฉืœื›ื•ืช ื”ื›ืฉืœ, ื‘ืชื•ืš ืื• ืžืขื‘ืจ ืœื’ื‘ื•ืœื•ืช ื”ืžื•ืฆืจ ืื• ื”ืชื”ืœื™ืš.

ื’ื•ืจื ื”ื›ืฉืœ (Failure Cause): ื›ืœ ื”ื ืกื™ื‘ื•ืช ื”ืžื•ื‘ื™ืœื•ืช ืœื›ืฉืœ. ืžืงื•ืจ ื”ื›ืฉืœ ื™ื›ื•ืœ ืœื”ื™ื•ืช ื‘ืกืคืกื™ืคืงืฆื™ื•ืช, ืชื›ื ื•ืŸ, ื™ืฆื•ืจ, ื”ืชืงื ื” ืื• ืื—ื–ืงื” ืฉืœ ืคืจื™ื˜ ืื• ืžื•ืฆืจ.

ื“ื•ื’ืžืื•ืช:

ืกื›ื ื” (Hazard)

ืžืฆื‘ ืžืกื•ื›ืŸ (Hazardous Situation)

ืกื™ื›ื•ืŸ (Risk)

ื ื–ืง (Harm)

ื—ืฉืžืœ

ื›ื‘ืœ ื—ืฉืžืœื™ ืฉืœื ื—ื•ื‘ืจ ื›ืจืื•ื™

ื—ืฉื™ืคื” ืœืžืชื— ื’ื‘ื•ื”

ื›ื•ื•ื™ื•ืช ื—ืžื•ืจื•ืช, ืžื•ื•ืช

ืขื•ืžืก ื‘ื™ื•ืœื•ื’ื™

ื”ืกื˜ืจื™ืœื™ื•ืช ืฉืœ ื›ืœื™ ื”ืงื™ื‘ื•ืœ ื”ื™ื™ืขื•ื“ื™ ืœื ื ื‘ื“ืงื” ื›ืจืื•ื™

ื–ื™ื”ื•ื ืžื™ืงืจื•ื‘ื™ืืœื™ ืฉืœ ืžื•ืฆืจ ืกื˜ืจื™ืœื™

ื–ื™ื”ื•ื ื‘ื™ื•ืœื•ื’ื™

ืชืžื™ืกื•ืช ื›ื™ืžื™ื•ืช

ื”ืชื”ืœื™ื›ื™ื ื”ื›ื™ืžื™ื™ื ืœื ืขื‘ืจื• ื•ืœื™ื“ืฆื™ื”

ื–ื™ื”ื•ื ืžื™ื›ืœ ื‘ืคืกื•ืœืช ื›ื™ืžื™ืช

ืชื•ืฆืจืช ืจืขื™ืœื”

ืงื•ืจ

ืื–ืขืงืช “ืื“ื ื ืขื•ืœ ื‘ื—ื“ืจ” ืœื ื ื‘ื“ืงื” ื‘ืžื”ืœืš ื”ื•ื•ืœื™ื“ืฆื™ื” ืฉืœ ื—ื“ืจื™ ื”ืงื™ืจื•ืจ

ืขื•ื‘ื“ื™ื ื ื ืขืœื• ื‘ื—ื“ืจื™ ืงื™ืจื•ืจ ืื• ื‘ืžืงืคื™ืื™ื, ื•ื”ืื–ืขืงื” ืœื ืคืขืœื”

ื›ื•ื•ื™ื•ืช ืงื•ืจ

ื”ื“ืจืš ื”ื™ืขื™ืœื” ื‘ื™ื•ืชืจ ืœืžื ื™ืขืช ื ื–ืงื™ื ื”ื™ื ืื™ืชื•ืจ ืžืฆื‘ื™ ื”ืกื™ื›ื•ืŸ ื”ืคื•ื˜ื ืฆื™ืืœื™ื ื˜ืจื ื”ืชืจื—ืฉื•ืชื.

ื”ื’ื“ืจืช FMEA ืขืœ ืคื™ FMEA reference manual, 4th ed. AIAG: “ืžืชื•ื“ื•ืœื•ื’ื™ื” ืื ืœื™ื˜ื™ืช ื”ืžืฉืžืฉืช ื›ื“ื™ ืœื”ื‘ื˜ื™ื— ืฉื‘ืขื™ื•ืช ืคื•ื˜ื ืฆื™ืืœื™ื•ืช ื ืฉืงืœื• ื•ื˜ื•ืคืœื• ืœืื•ืจืš ืชื”ืœื™ืš ืคื™ืชื•ื— ื”ืžื•ืฆืจ ื•ื”ืชื”ืœื™ืš”ย 

ืขืœ ืคื™ – IEC 60812:2018ืžืชื•ื“ื•ืœื•ื’ื™ื™ืช ื”-FMEA ืžื•ืจื›ื‘ ืžื”ืฉืœื‘ื™ื ื”ืขื™ืงืจื™ื™ื ื”ื‘ืื™ื, ืœืคื™ ืชืžื•ื ื” ืžืก’ 1:

ื”ืฉืœื‘ื™ื ื”ืžืชื•ืืจื™ื ื‘ืชืžื•ื ื” ืžืก’ 1 ื•ื”ืžื•ื’ื“ืจื™ื ื‘IEC 60812:2018:

1. ืชื›ื ื•ืŸ ื”-FMEA

ืชื›ื ื•ืŸ ืžืืคืฉืจ ืืช ืœืฉืงื•ืœ ื”ืกื™ื‘ื•ืช ืœื‘ื™ืฆื•ืข ื”ื ื™ืชื•ื—, ืื™ื–ื” ืžื•ืฆืจ ืื• ืชื”ืœื™ืš ื™ืกื•ืงืจื• ื•ื‘ืื™ืœื• ื ืกื™ื‘ื•ืช, ื•ื‘ื ื•ืกืฃ ืžื” ื”ื“ืจืš ื”ื™ืขื™ืœื” ื•ื”ืืคืงื˜ื™ื‘ื™ืช ื‘ื™ื•ืชืจ ืœื‘ื™ืฆื•ืข ื”ืชื”ืœื™ืš. ืชื•ืฆืื•ืช ืชื”ืœื™ืš ื”ืชื›ื ื•ืŸ ื”ื-

– ืงื‘ื™ืขืช ืžื˜ืจื•ืช ื•ื”ืงืฃ ื”ืื ืœื™ื–ื”.

– ื–ื™ื”ื•ื™ ื’ื‘ื•ืœื•ืช ื”ืื ืœื™ื–ื” ื•ืชืจื—ื™ืฉื™ื ืืคืฉืจื™ื™ื ื‘ืฉื™ืžื•ืฉ ื‘ืžื•ืฆืจ ืื• ื‘ืžื”ืœืš ื”ืชื”ืœื™ืš.

– ื”ื’ื“ืจืช ืงืจื™ื˜ืจื™ื•ื ื™ื ืœืกื•ื’ื™ ื ืงื•ื“ื•ืช ื”ื›ืฉืœ ืฉื™ื˜ื•ืคืœื• ื‘ืžื”ืœืš ื”ืชื”ืœื™ืš.

– ืงื‘ื™ืขืช ื“ืจืš ื”ืชืขื•ื“ ืฉืœ ื”FMEA ื›ืš ืฉืื•ืคืŸ ื”ืฉื™ืžื•ืฉ ื‘ืชื•ืฆืจื™ ื”FMEA (ื“ื•”ื— ืกื•ืคื™) ื™ื”ื™ื” ื‘ืจื•ืจ, ื”ืจืื™ื•ืช ืœืงื‘ืœืช ื”ื”ื—ืœื˜ื•ืช ื‘ืžื”ืœืš ื”ืชื”ืœื™ืš ื™ื”ื™ื• ื‘ืจื•ืจื•ืช, ืื•ืคืŸ ืงื‘ื™ืขืช ื”ื—ื•ืžืจื” ื•ื”ืฆื™ื•ื ื™ื ื”ืื—ืจื™ื ื‘ืžื”ืœืš ื”ืชื”ืœื™ืš ื™ื”ื™ื” ื‘ืจื•ืจ ื•ืขื•ื“.

– ื”ื’ื“ืจืช ื”ืžืงื•ืจื•ืช ืœื‘ื™ืฆื•ืข ื”FMEA- ืžืงื•ืจื•ืช ืžื™ื“ืข, ืžืฉืชืชืคื™ื, ืžืงื•ืจื•ืช ืคื™ื–ื™ื™ื (ืœืžืฉืœ ื—ื“ืจ ืœื‘ื™ืฆื•ืข ื”ืžืคื’ืฉ).

FMEA - ืžืขืจื›ืช ืœื ื™ื”ื•ืœ ืกื™ื›ื•ื ื™ื

2. ื‘ื™ืฆื•ืข ื”-FMEA

– ื—ืœื•ืงืช ื”ืคืจื™ื˜ ื”ื ื™ื“ื•ืŸ ืื• ื”ืชื”ืœื™ืš ืœืชืชื™ ื ื•ืฉืื™ื. ืœืžืฉืœ ืฉืœื‘ื™ ืชื”ืœื™ืš ื”ื™ื™ืฆื•ืจ, ืชืช ืžืขืจื›ื•ืช ื”ืžื•ืฆืจ.

– ื–ื™ื”ื•ื™ ืชืคืงื™ื“ ื•ืื•ืคื™ ื•ืจืžืช ื”ืชืคืงื•ื“ ืฉืœ ื›ืœ ืžืจื›ื™ื‘ ื‘ืžื•ืฆืจ, ื•ื”ืื ืžื’ื™ืข ืœืจืžืช ื”ืชืคืงื•ื“ ื”ื ื“ืจืฉืช.

– ื–ื™ื”ื•ื™ ืžืฆื‘ื™ ื›ืฉืœ – ื”ืื•ืคืŸ ืฉื‘ื• ืืœืžื ื˜ื™ื ื‘ืžื•ืฆืจ ืื• ืชื”ืœื™ื›ื™ื ื™ื›ื•ืœื™ื ืœื”ื›ืฉืœ ื‘ืœืžืœื ืืช ืžื˜ืจืชื.

– ืื™ืชื•ืจ ื“ืจื›ื™ื ืœื–ื™ื”ื•ื™ ื”ื›ืฉืœื™ื ื•ื“ืจื›ื™ ืžื ื™ืขื” ื”ืงื™ื™ืžื™ื ื”ื™ื•ื ื‘ืžื•ืฆืจ ืื• ื‘ืชื”ืœื™ืš.

– ืื™ืชื•ืจ ืฉืœ ื”ืฉืคืขื•ืช ื”ื›ืฉืœ (Failure Effects) ื‘ืžืงืจื” ืฉื›ืฉืœ ืฉืชื•ืืจ ื‘ืกื™ืคื™ื ื”ืงื•ื“ืžื™ื ื”ืชืจื—ืฉ.

– ืื™ืชื•ืจ ื’ื•ืจืžื™ ื”ื›ืฉืœ (Failure Cause)

– ืงื‘ื™ืขืช ื”ื—ื•ืžืจื” (Severity) ืฉืœ ืืคืงื˜ ื”ื›ืฉืœ, ื”ืกื‘ื™ืจื•ืช ืœื”ืชืจื—ืฉื•ืช ื ืงื•ื“ืช ื”ื›ืฉืœ (Failure Mode) ื•ืคืจืžื˜ืจื™ื ืื—ืจื™ื, ื›ืžื• detectability, ื‘ืื ื™ื•ื—ืœื˜ ืขืœ ื™ื“ื™ ื”ื™ืฆืจืŸ.

– ืงื‘ื™ืขืช ืคืขื•ืœื•ืช ืœื˜ื™ืคื•ืœ ื‘ื›ืฉืœื™ื ืฉื”ื•ืขืœื• ื‘ืžื”ืœืš ืชื”ืœื™ืš ื”FMEA ื•ื‘ื™ืฆื•ืข.

ืชื™ืขื•ื“ ื•ื“ื™ื•ื•ื— ื‘ื”ืชืื ืœื›ืชื•ื‘ ื‘ืชื›ื ื™ืช

ืกื•ื’ื™ FMEA:
System FMEA
: ืžืฉืžืฉืช ืœื ื™ืชื•ื— ืžืขืจื›ื•ืช ืื• ืชืช-ืžืขืจื›ื•ืช ืฉืœืžื•ืช ื‘ืžื”ืœืš ืชื›ื ื•ืŸ ื”ืžืขืจื›ืช.

Design FMEA ืžืกืชื›ืœ ืขืœ ืฉืœื‘ื™ ืคื™ืชื•ื— ื”ืžื•ืฆืจ ื•ืขืœ ืงื•ืžืคื•ื ื ื˜ื•ืช ื‘ืžื•ืฆืจ.

Process FMEA: ืžืฉืžืฉืช ืœื ื™ืชื•ื— ืชื”ืœื™ืš ื™ื™ืฆื•ืจ ื•ื”ืจื›ื‘ื”.

Usability/Application FMEA: ืžืฉืžืฉืช ืœื ื™ืชื•ื— ืฉื’ื™ืื•ืช ืžืฉืชืžืฉ ืคื•ื˜ื ืฆื™ืืœื™ื•ืช.

ืชื”ืœื™ืš ื” FMEA ื™ื‘ื•ืฆืข ื‘ื›ืœ ื™ืฆื™ืจื” ืฉืœ ืžืขืจื›ืช ืื• ืชื”ืœื™ืš, ื”ืงืžืช ืžืคืขืœ ื›ื“ื™ ืœื•ื•ื“ื ื‘ื˜ื™ื—ื•ืช, ื™ืขื™ืœื•ืช ื•ืืžื™ื ื•ืช ืฉืœ ื”ืžื•ืฆืจ. ื”ื”ืœื™ืš ืžื‘ื•ืฆืข ื’ื ื‘ื›ืœ ืฉื™ื ื•ื™ ืฉืœ ืžื•ืฆืจ, ื”ืœื™ืš ืื• ืžืชืงืŸ, ื›ื“ื™ ืœื”ืงื˜ื™ืŸ ื›ื›ืœ ื”ืืคืฉืจ ืืช ื”ืกื™ื›ื•ื™ ืœื’ืจื™ืžืช ื ื–ืงื™ื.

ื—ื™ืฉื•ื‘ ืขืจืš ืกื™ื›ื•ืŸ ืœื›ืœ ื ืงื•ื“ืช ื›ืฉืœ ื ืงืจื RPN (Risk Priority Number)/. ืขื‘ื•ืจ ื›ืœ ื ืงื•ื“ืช ื›ืฉืœ ืžื—ืฉื‘ื™ื RPN ืœืคื™ ื”ื ื•ืกื—ื:

ื—ื•ืžืจื” (Severity) *ืกื‘ื™ืจื•ืช (Probability) *ื–ื™ื”ื•ื™ (Detectability) = RPN

ื˜ื™ืคื•ืœ ื‘ื›ืฉืœื™ื ื ืงื‘ืข ืœืคื™ ืขืจืš ื”-RPN. ื›ืœ ื ืงื•ื“ื•ืช ื”ื›ืฉืœ ืฉื–ื•ื”ื• ืขืœ ื™ื“ื™ ืฆื•ื•ืช ื”ืžื•ืžื—ื™ื ืžื“ื•ืจื’ื•ืช ืœืคื™ ืขืจื›ื™ RPN ืžื”ื’ื‘ื•ื” ืœื ืžื•ืš. ื›ื›ืœ ืฉื”ืขืจืš ื’ื‘ื•ื” ื™ื•ืชืจ, ื”ื˜ื™ืคื•ืœ ื‘ื• ื“ื—ื•ืฃ ื™ื•ืชืจ.

ื”ื˜ื™ืคื•ืœ ื‘ื ืงื•ื“ื•ืช ื”ื›ืฉืœ ื›ื•ืœืœ ืืช ื”ืฉืœื‘ื™ื ื”ื‘ืื™ื:

โ€ข ื”ื’ื“ืจืช ื”ืคืขื•ืœื•ืช ื”ื ื“ืจืฉื•ืช ืœื˜ื™ืคื•ืœ ืœืฆื•ืจืš ื”ืคื—ืชื” ืื• ื‘ื™ื˜ื•ืœ ืฉืœ ืคื•ื˜ื ืฆื™ืืœ ื”ื ื–ืง;

โ€ข ื”ืงืฆืืช ืžืฉืื‘ื™ื, ืžื™ืžื•ืŸ, ื–ืžืŸ ื•ื›ื•ื— ืื“ื ืœื‘ื™ืฆื•ืข ืคืขื•ืœื•ืช ืืœื•;

โ€ข ื”ื’ื“ืจืช ืชืืจื™ืš ื™ืขื“ ืœืกื™ื•ื ื”ื˜ื™ืคื•ืœ ื•ื‘ื“ื™ืงืช ื™ืขื™ืœื•ืชื•;

โ€ข ื˜ื™ืคื•ืœ;

โ€ข ืชื™ืขื•ื“ ื›ืœ ื”ืคืขื•ืœื•ืช ืฉื ื ืงื˜ื•, ื‘ื“ื™ืงื•ืช ื”ื™ืขื™ืœื•ืช ื•ื”ืชื•ืฆืื•ืช ืฉืœื”ืŸ ื‘ืชื™ืง FMEA.

ืœืื—ืจ ืกื™ื•ื ื”ื˜ื™ืคื•ืœ, ื—ื•ื–ืจื™ื ืขืœ ื”ืชื”ืœื™ืš ืขื ื”ืคื—ืชืช ื ืงื•ื“ื•ืช ื”ื›ืฉืœ ืฉื”ืฆื˜ืžืฆืžื• ืื• ื‘ื•ื˜ืœื•, ืขื“ ืฉื”ืกื™ื›ื•ืŸ ื”ืžืชืงื‘ืœ ืžื›ืœ ื ืงื•ื“ืช ื›ืฉืœ ื™ื•ืจื“ ืœืจืžื” ืžืชืงื‘ืœืช ืขืœ ื”ื“ืขืช. ืขืœ ืคื™ ืชืงื ื™ ื”ืื™ื›ื•ืช ืœืคืืจืžื” ื•ืฆื™ื•ื“ ืจืคื•ืื™, ื™ืฉ ืœื‘ืฆืข ื”ืœื™ืš FMEA ื‘ืื•ืคืŸ ืชืงื•ืคืชื™.

ื™ืฆื•ื™ืŸ ื›ื™ ื˜ื•ื•ื— ื”ืขืจื›ื™ื ืฉืœ ื”ื—ื•ืžืจื”, ื”ืกื‘ื™ืจื•ืช ื•ื”ื–ื™ื”ื•ื™ ืฉืœ ื ืงื•ื“ื•ืช ื”ื›ืฉืœ ืื™ื ื• ืงื‘ื•ืข. ื™ืฉ ืœื›ืœ ื—ื‘ืจื” ื™ืฆืจื ื™ืช ื•ืžืคืชื—ืช ืืช ื”ื—ื•ืคืฉ ืœืงื‘ื•ืข ื˜ื•ื•ื— ืขืจื›ื™ื ืžื•ืชืื ืื™ืฉื™ืช.

ืœืกื™ื›ื•ื: FMAE ื”ื•ื ื”ืœื™ืš ื ื™ื”ื•ืœ ืกื™ื›ื•ื ื™ื, ื”ืžืฉืœื‘ ืฆื•ื•ืช ืžื•ืžื—ื™ื, ื‘ืžื˜ืจื” ืœืงื‘ื•ืข ืกื“ืจ ืขื“ื™ืคื•ื™ื•ืช ืœื˜ื™ืคื•ืœ ื‘ื ืงื•ื“ื•ืช ื›ืฉืœ. ื”ืงืคื“ื” ืขืœ ื”ืœื™ืš ืชืงื™ืŸ ื•ืจืฆื™ืฃ ืชืืคืฉืจ ืขื‘ื•ื“ื” ื‘ื˜ื•ื—ื” ื•ื™ืขื™ืœื” ื‘ืชืขืฉื™ื™ืช ื”ืคืืจืžื” ื•ื”ืžื›ืฉื•ืจ ื•ืจืคื•ืื™, ื•ื›ืŸ ืชืืคืฉืจ ืœืœืงื•ื—ื•ืช ื•ืœืฆืจื›ื ื™ื ืœืฆืจื•ืš ืžื•ืฆืจื™ื ื‘ืื™ื›ื•ืช ื’ื‘ื•ื”ื”.

ืขืœ ืคื™ – IEC 60812:2018ืžืชื•ื“ื•ืœื•ื’ื™ื™ืช ื”-FMEA ืžื•ืจื›ื‘ ืžื”ืฉืœื‘ื™ื ื”ืขื™ืงืจื™ื™ื ื”ื‘ืื™ื, ืœืคื™ ืชืžื•ื ื” ืžืก’ 1:

ื”ืฉืœื‘ื™ื ื”ืžืชื•ืืจื™ื ื‘ืชืžื•ื ื” ืžืก’ 1 ื•ื”ืžื•ื’ื“ืจื™ื ื‘IEC 60812:2018:

1. ืชื›ื ื•ืŸ ื”-FMEA– ืชื›ื ื•ืŸ ืžืืคืฉืจ ืืช ืœืฉืงื•ืœ ื”ืกื™ื‘ื•ืช ืœื‘ื™ืฆื•ืข ื”ื ื™ืชื•ื—, ืื™ื–ื” ืžื•ืฆืจ ืื• ืชื”ืœื™ืš ื™ืกื•ืงืจื• ื•ื‘ืื™ืœื• ื ืกื™ื‘ื•ืช, ื•ื‘ื ื•ืกืฃ ืžื” ื”ื“ืจืš ื”ื™ืขื™ืœื” ื•ื”ืืคืงื˜ื™ื‘ื™ืช ื‘ื™ื•ืชืจ ืœื‘ื™ืฆื•ืข ื”ืชื”ืœื™ืš. ืชื•ืฆืื•ืช ืชื”ืœื™ืš ื”ืชื›ื ื•ืŸ ื”ื-

– ืงื‘ื™ืขืช ืžื˜ืจื•ืช ื•ื”ืงืฃ ื”ืื ืœื™ื–ื”.

– ื–ื™ื”ื•ื™ ื’ื‘ื•ืœื•ืช ื”ืื ืœื™ื–ื” ื•ืชืจื—ื™ืฉื™ื ืืคืฉืจื™ื™ื ื‘ืฉื™ืžื•ืฉ ื‘ืžื•ืฆืจ ืื• ื‘ืžื”ืœืš ื”ืชื”ืœื™ืš.

– ื”ื’ื“ืจืช ืงืจื™ื˜ืจื™ื•ื ื™ื ืœืกื•ื’ื™ ื ืงื•ื“ื•ืช ื”ื›ืฉืœ ืฉื™ื˜ื•ืคืœื• ื‘ืžื”ืœืš ื”ืชื”ืœื™ืš.

– ืงื‘ื™ืขืช ื“ืจืš ื”ืชืขื•ื“ ืฉืœ ื”FMEA ื›ืš ืฉืื•ืคืŸ ื”ืฉื™ืžื•ืฉ ื‘ืชื•ืฆืจื™ ื”FMEA (ื“ื•”ื— ืกื•ืคื™) ื™ื”ื™ื” ื‘ืจื•ืจ, ื”ืจืื™ื•ืช ืœืงื‘ืœืช ื”ื”ื—ืœื˜ื•ืช ื‘ืžื”ืœืš ื”ืชื”ืœื™ืš ื™ื”ื™ื• ื‘ืจื•ืจื•ืช, ืื•ืคืŸ ืงื‘ื™ืขืช ื”ื—ื•ืžืจื” ื•ื”ืฆื™ื•ื ื™ื ื”ืื—ืจื™ื ื‘ืžื”ืœืš ื”ืชื”ืœื™ืš ื™ื”ื™ื” ื‘ืจื•ืจ ื•ืขื•ื“.

– ื”ื’ื“ืจืช ื”ืžืงื•ืจื•ืช ืœื‘ื™ืฆื•ืข ื”FMEA- ืžืงื•ืจื•ืช ืžื™ื“ืข, ืžืฉืชืชืคื™ื, ืžืงื•ืจื•ืช ืคื™ื–ื™ื™ื (ืœืžืฉืœ ื—ื“ืจ ืœื‘ื™ืฆื•ืข ื”ืžืคื’ืฉ).

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