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Q9 FMEAʧЧģʽЧӦ·ÖÎö.ppt½éÉÜ

PSH/SQQ Annex I.2 Failure Mode Effects Analysis ʧЧģʽЧӦ·ÖÎö (FMEA) I.2: Failure Mode Effects Analysis ʧЧģʽЧӦ·ÖÎö(FMEA) (see IEC 60812 ¼ûIEC60812) Evaluation of potential failure modes for processes The likely effect on outcomes and/or product performance Once failure modes are established, risk reduction can be used to eliminate, reduce or control the potential failures FMEA relies on process understanding Summarize the important modes of failure, factors causing these failures and the likely effects of these failures How to perform?Break down large complex processes into manageable steps I.2: Failure Mode Effects Analysis ʧЧģʽЧӦ·ÖÎö(FMEA) (see IEC 60812 ¼ûIEC60812) ¹¤ÒÕµÄDZÔÚʧЧģʽµÄÆÀ¹À¶Ô½á¹ûºÍ²úÆ·ÐÔÄܵĿÉÄܵÄÓ°ÏìÒ»µ©Ê§Ð§Ä£Ê½½¨Á¢£¬·çÏÕ½µµÍÐж¯ÓÃÓÚÀ´Ïû³ý¡¢½µµÍ»ò¿ØÖÆDZÔÚµÄʧЧÒÀÀµÓÚ¶Ô¹¤ÒÕµÄÀí½â¸ÅÊöÖØÒªµÄʧЧģʽ£¬ÒýÆðʧЧµÄÒòÊýºÍʧЧµÄ¿ÉÄܵÄÓ°Ïì ÈçºÎʵʩ? ½«´óµÄ¸´ÔӵŤÒÕ·Ö½â³ÉÒ×´¦ÀíµÄ²½ÖèI.2: Failure Mode Effects Analysis (FMEA)  Potential Areas of Use(s) Prioritize risks Monitor the effectiveness of risk control activities Equipment and facilities Analyze a manufacturing process to identify high-risk steps or critical parameters I.2: ʧЧģʽЧӦ·ÖÎö(FMEA)  ¿ÉʹÓõÄDZÔÚÁìÓò£ºPrioritize risks ÓÅÏÈ¿¼ÂǵķçÏÕMonitor the effectiveness of risk control activities ¼à¿Ø·çÏÕ¿ØÖƻµÄЧÁ¦Equipment and facilities É豸ºÍÉèÊ©Analyze a manufacturing process to identify high-risk steps or critical parameters ΪÁËʶ±ð¸ß·çÏÕ²½ÖèºÍ¹Ø¼ü²ÎÊý·ÖÎöÒ»¸öÉú²ú¹¤ÒÕI.2: Failure Mode Effects Analysis (FMEA) How to perform? 1. Establish a team 2. Identify the known and potential failure modes: Develop lists of known problems and brainstorm other potentials¡­e.g. Product not meeting specification Process not meeting yield requirements Malfunctioning equipment Software problems Newly identified failure modes should be added at any time I.2: ʧЧģʽЧӦ·ÖÎö(FMEA) ÈçºÎʵʩ? 1. ³ÉÁ¢Ò»¸öС×é2. ʶ±ðÒÑÖªºÍDZÔÚµÄʧЧģʽÉú³ÉÒÑÖªÎÊÌâºÍ¼¯ÌåÌÖÂÛµÄÆäËûDZÔÚÎÊÌâµÄÁбíÀýÈç. ²úÆ·²»·ûºÏ±ê×¼¹¤ÒÕ²»Âú×ãÊÕÂÊÐèÒªÉ豸¹ÊÕÏÈí¼þÎÊÌâз¢ÏÖµÄʧЧÎÊÌâÓ¦¸ÃËæʱ¼Ó½øÀ´¡£I.2: Failure Mode Effects Analysis (FMEA) How to perform? 3. Characterise the severity, probability and detectability An equal number of levels is sometimes helpful Some preference to 3, 4, 5, 6 or 10 levels But: an even number of levels avoids the mid point Use different scales Linear:	1, 2, 3, 4 Exponential:	1, 2, 4, 8 Logarithmic:	1, 10, 100, 1000 Self made:	1, 3, 7, 10 Multiplying different scales will differentiate the outcome I.2: ʧЧģʽЧӦ·ÖÎö(FMEA) ÈçºÎʵʩ? 3. ʶ±ðÑÏÖØÐÔ¡¢¿ÉÄÜÐԺͿɼì²âÐÔÒ»¸öÏ൱µÄÊý×ֵȼ¶³£³£ÊǺÜÓÐÓõÄÒ»°ãÓÅÏÈÑ¡ÔñµÈ¼¶3 £¬4 £¬5 £¬6 »ò10 µ«ÊÇ: Ò»¸öżÊýµÈ¼¶»á±ÜÃâÖÐλÊýÓò»Í¬µÄµÈ¼¶ÏßÐÔµÄ:	1, 2, 3, 4 Ö±ÊýµÄ:	1, 2, 4, 8 ¶ÔÊý:	1, 10, 100, 1000 ×Ô¶¨Òå:	1, 3, 7, 10 ²»Í¬µÄµÈ¼¶µÄ³Ë»ý½«Çø·Ö½á¹ûI.2: Failure Mode Effects Analysis (FMEA) How to perform? 4. Define actions 5. Revisit the ranking 6. Define residual risk 7. Perform a short summary Scope Data from the assessment & control (e.g. No. of identified failure modes) Level of accepted risk without actions i.e. residual risk(e.g. Risk priority Number < 50) Recommended actions, responsibilities and due dates (including approval, if appropriate) Person in charge for follow-up of FMEA I.2: ʧЧģʽЧӦ·ÖÎö(FMEA) ÈçºÎʵʩ? 4. Ïêϸ˵Ã÷ÐÐΪ5. ÖØÐÂÆÀ¼¶6. Ïêϸ˵Ã÷Ê£ÓàµÄ·çÏÕ7. Íê³ÉÒ»¸ö¼ò¶ÌµÄÕªÒª·¶Î§´ÓÆÀ¹ÀºÍ¿ØÖÆÖеõ½µÄÊý¾Ý ( ÀýÈçÒÑʶ±ðʧЧģʽµÄ±àºÅ) ²»ÐèÒª²ÉÈ¡´ëÊ©µÄ¿É½ÓÊܵķçÏյĵȼ¶¼´Ê£Óà·çÏÕ( ±ÈÈç·çÏÕÓÅÏȺÅ< 50) ½¨Òé²ÉÈ¡µÄ´ëÊ©, Ïà¹ØÖ°ÔðºÍÍê³ÉÈÕÆÚ( Èç¹ûÐèÒªÒ²°üÀ¨Åú×¼) ¸ºÔðÏÂÒ»²½FMEA µÄÔðÈÎÈËSeverity (Consequences of failure) 10 Extreme Predicted to cause severe impact to quality (Product out of specifications, no Expert Statement possible) 7 High Predicted to cause significant impact on quality (Failure to meet specifications, no Stability data, Expert Statement possible) 3 Moderate Predicted to cause minor impact on quality (Failure to meet specifications, Stability data available) 1 Low Predicted to have no/minor impact on quality of the product (Quality within specifications) ÑÏÖØÐÔ( ʧЧµÄ½á¹û) 10 ¼«¸ß¿ÉÄÜ»á¶Ô²úÆ·²úÆ·²úÉúÑÏÖصÄÓ°Ïì( ²úÆ·OOS, ¿ÉÄÜÎÞר¼ÒÉùÃ÷) 7 ¸ß¿ÉÄܶԲúÆ·ÖÊÁ¿²úÉúÖØ´óµÄÓ°Ïì( ²»ÄÜÂú×ãÖ¸±ê, ûÓÐÎȶ¨ÐÔÊý¾Ý, ¿ÉÄÜÐèҪר¼ÒÉùÃ÷) 3 ÖпÉÄܶԲúÆ·ÖÊÁ¿²úÉúСµÄÓ°Ïì( ²»ÄÜÂú×ãÖ¸±êÒªÇó, ¿ÉÄÜûÓÐÎȶ¨ÐÔÊý¾Ý) 1 µÍ¿ÉÄܶԲúÆ·ÖÊÁ¿ÎÞÓ°Ïì»òºÜ΢СµÄÓ°Ïì( ÖÊÁ¿ÔÚÖ¸±êÖ®ÄÚ) Probability (Likelihood failure will happen) 8 Regular failures Expected to happen regularly 4 Repeated failures Expected to happen in a low frequency 2 Occasional failures Expected to happen infrequently  1 Unlikely failures Unlikely to happen ¿ÉÄÜÐÔ( ʧЧ·¢ÉúµÄ¸ÅÂÊ) 8 ¾­³£Ê§Ð§ÆÚÍûÓйæÂɵķ¢Éú4 Öظ´µÄʧЧÆÚÍûÒԽϵÍƵÂÊ·¢Éú2 ż¶ûʧЧÆÚÍûºÜÉÙ·¢Éú 1 ¼¸ºõ²»»áʧЧ²»Ì«¿ÉÄÜ·¢ÉúDetectability (Ability to find the failure) 4 Normally not detected Failure very likely to be overlooked, hence not detected (no technical solution, no manual control) 3 Likely not detected Failure may be overseen (manual control, spot checks) 2 Regularly detected Failure will normally be detected (manual control, routine work with statistical control) 1 Always detected Failure can and will be detected in all cases (monitoring, technical solution available) ¿É¼ì²âÐÔ( ·¢ÏÖʧЧµÄÄÜÁ¦) 4 ͨ³£²»Äܱ»·¢ÏÖʧЧ·Ç³£ÈÝÒ×±»ºöÊÓ, Òò´Ë²»ÄÜ·¢ÏÖ ( ûÓм¼Êõ½â¾ö·½·¨, ûÓÐÊÖ¶¯¿ØÖÆ) 3 ¿ÉÄÜ·¢ÏÖ²»ÁËʧЧ¿ÉÄܱ»¼ì²éµ½ ( ÊÖ¶¯¿ØÖÆ, ÏÖ³¡¼ì²é) 2 ¶¨ÆÚ¼ì²é¿ÉÒÔ·¢ÏÖʧЧͨ³£¶¼ÄÜ·¢ÏÖ ( ÊÖ¶¯¿ØÖÆ, ͳ¼Æ¿ØÖƵÄÀýÐй¤×÷) 1 Ëæʱ¿ÉÒÔ·¢ÏÖʧЧËæʱ»á±»·¢ÏÖ( ¼ì²âÆ÷, ¼¼Êõ´ëÊ©ÓÐЧ) FMEA: Quantitation of Risk : Severity FMEA: ·çÏÕµÄÊýÖµ: ÑÏÖØÐÔFMEA: Quantitation of Risk : Probability FMEA: ·çÏÕÊýÖµ: ¿ÉÄÜÐÔFMEA: Quantitation of Risk: Detection FMEA: ·çÏÕÊýÖµ: ¿É¼ì²âÐÔSeverity / Probability / Detection (SPD) I.2: Failure Mode Effects Analysis (FMEA) Severity (S) Link to end product functional failure Medical Department involvement Probability (P) Use historical data Similar processes products Detection Method validation studies Historical data I.2: ʧЧģʽЧӦ·ÖÎö(FMEA) ÑÏÖØÐÔ(S) ÁªÏµ×îÖÕ²úÆ·¹¦ÄÜÐÔʧЧÒýÈëҽѧ²¿ÃÅ¿ÉÄÜÐÔ(P) ʹÓÃÀúÊ·Êý¾ÝÀàËƹ¤ÒÕ²úÆ·¿É¼ì²âÐÔ·½·¨ÑéÖ¤Ñо¿ÀúÊ·Êý¾ÝI.2: Failure Mode Effects Analysis (FMEA) I.2: ʧЧģʽЧӦ·ÖÎö(FMEA) I.2: Failure Mode Effects Analysis (FMEA) I.2: ʧЧģʽЧӦ·ÖÎö(FMEA) I.2: Failure Mode Effects Analysis (FMEA) I.2: ʧЧģʽЧӦ·ÖÎö(FMEA) I.2: Failure Mode Effects Analysis (FMEA) I.2: ʧЧģʽЧӦ·ÖÎö(FMEA) I.2: Failure Mode Effects Analysis (FMEA) Analyse a granulation process stepbecause only a few parameters are adjustable and many problems can occur by manual operations I.2: ʧЧģʽЧӦ·ÖÎö(FMEA) ·ÖÎöÖÆÁ£¹¤ÒÕ²½ÖèÒòΪ½ö½öºÜÉٵIJÎÊý¿ÉÒÔµ÷Õû£¬ÊÖ¹¤²Ù×÷Ðí¶àÎÊÌⶼ¿ÉÄÜ·¢Éú¡£I.2 Failure Mode Effects Analysis (FMEA) I.2: Failure Mode Effects Analysis (FMEA) Prepare a risk profile I.2: ʧЧģʽЧӦ·ÖÎö(FMEA) ×¼±¸Ò»¸ö·çÏÕÂÖÀªI.2: Failure Mode Effects Analysis (FMEA) Prepare a risk profile: Probability I.2: ʧЧģʽЧӦ·ÖÎö(FMEA) ×¼±¸Ò»¸ö·çÏÕÂÖÀª: ¿ÉÄÜÐÔI.2: Failure Mode Effects Analysis (FMEA) Risk Evaluation Prepare a risk profile: Consequences I.2: ʧЧģʽЧӦ·ÖÎö(FMEA) ·çÏÕÆÀ¹À×¼±¸Ò»¸ö·çÏÕÂÖÀª: ÖØÒªÐÔ£¨ºó¹û£©I.2: Failure Mode Effects Analysis (FMEA) Risk Evaluation Prepare a risk profile: Consequences I.2: ʧЧģʽЧӦ·ÖÎö(FMEA) ·çÏÕÆÀ¹À×¼±¸Ò»¸ö·çÏÕÂÖÀª: ÖØÒªÐÔ£¨ºó¹û£©I.2: ʧЧģʽЧӦ·ÖÎö(FMEA) ·çÏÕÆÀ¹À: ·çÏÕÂÖÀª For high risks, which are not acceptable, risk reduction measures have to be taken as a high priority I.2: Failure Mode Effects Analysis (FMEA) Risk Evaluation: Risk Profile ¶ÔÓÚ²»¿É½ÓÊܵĸ߷çÏÕ£¬ÒòΪһ¸ö¸ßµÄ·çÏÕÒò×Ó·çÏÕÏû¼õ´ëÊ©±ØÐëʵʩI.2: Failure Mode Effects Analysis (FMEA) How to perform? 3. Summary (Risk Evaluation) The effects are rated in terms of their consequences and the causes are assessed in terms of their probabilitiesa) qualitative or b) quantitative Based on these results a risk profile is completed. In this profile the risks are compared with the risk protection level, which determines the accepted probability for defined consequences Use as an aid to prioritise actions! I.2: ʧЧģʽЧӦ·ÖÎö(FMEA) ÈçºÎʵʩ? 3. ×ܽá( ·çÏÕÆÀ¹À) Ч¹ûÔÚÊõÓïºó¹ûÖÐÆÀ¹À£¬Ô­ÒòÔÚÊõÓï¿ÉÄÜÐÔÖÐÆÀ¹Àa) ¶¨ÐÔ»òb) ¶¨Á¿ÔÚÕâЩ½á¹û»ù´¡ÉÏÍê³ÉÒ»¸ö·çÏÕ¾ØÕóÔÚÕâЩ¾ØÕóÖзçÏÕʹÓ÷çÏÕ±£

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