Search

Web

Elsmar.com

The Elsmar Cove Forum > Common Quality Assurance Processes and Tools > FMEA and Control Plans > Requirements or Critical Characteristics! Cutomer driven and "nternal P#A

View Full Version : Requirements for Critical Characteristics, Cutomer driven and Internal
RMedrano $$nd May $%%&! %'('$ PM )ur internal *rocedure +or,s li,e this! no matter +hat the customer is and +hat the symbols-nomenclature they use! our internal *rints are ma,ed +ith either a CC symbol or an FF CC.s are criticals that +e have identi ied internaly and trac, usin/ 0PC and monitor Ca*ability! FF.s are the characteristics that are customer driven and /et the same treatment. "s it common or heard o to use 0PC on characteristics that are not critical! or that you do not monitor ca*ability on1 My boss +ants to *ut CC.s on all o our internal *rints or items that +e are trac,in/ +ith Control Charts. "s this the ri/ht thin/ to do1 "s it not *ossible to *ermanently trac, a variable measurement +ith an 0PC chart i its not a Critical Characteristic1 2ust tryin/ to see +hat others in the Automotive industry have seen or e3*erienced Michael Walmsley $'rd May $%%&! %4($& AM )ur internal *rocedure +or,s li,e this! no matter +hat the customer is and +hat the symbols-nomenclature they use! our internal *rints are ma,ed +ith either a CC symbol or an FF CC.s are criticals that +e have identi ied internaly and trac, usin/ 0PC and monitor Ca*ability! FF.s are the characteristics that are customer driven and /et the same treatment. " you have a *olicy that conveys to your customers that your FMEA.s are *ro*rietary!you can do +ith them as you +ill. "s it common or heard o to use 0PC on characteristics that are not critical! or that you do not monitor ca*ability on1 "t is not common to use 0PC on characteristics that are not critical!but certainly can be done. Es*ecially +hen you may have *urchased *roduction equi*ment that includes automated ins*ection o *rocess

*arameters. What do you mean by 5"s it common or heard o to use 0PC on characteristics that you do not monitor ca*ability on1 6o+ can you do this11111 My boss +ants to *ut CC.s on all o our internal *rints or items that +e are trac,in/ +ith Control Charts. This is valid. "t is +hat you are su**osed to do. "s this the ri/ht thin/ to do1 "s it not *ossible to *ermanently trac, a variable measurement +ith an 0PC chart i its not a Critical Characteristic1 0ure. 6o+ever ! note it in the 5current controls5 column o your FMEA. 7ot your control *lan. e/. " your equi*ment is such that you /et the ins*ection or ree!lo/ it in the FMEA. " the characteristic is not 5s*ecial5!you need not include in your Control Plan. 2ust tryin/ to see +hat others in the Automotive industry have seen or e3*erienced " your com*any does not have a *olicy that conveys that your FMEA.s are *ro*rietary!then ma,e one. #o not roll over and acce*t your customers 5s*ecial5 characteristics. "t ma,es li e 8888. Es*ecially i you *rovide the same com*onent to multi*le customers. 0ee the attached. This +as +ritten *rior to my 9um*in/ shi* to the 6ealthCare industry. RMedrano $'rd May $%%&! %4(:' AM 0o! " +e +ant to trac, a *articular variable! si/ni icant or not! +e need to add the CC symbol to our *rint! but only re lect that in the FMEA and not on the control *lan1 What s*a+ned this +hole question +as that +e recently had our continuous assesment T0 audit in a*ril! and one o the auditors +rote us u* or not havin/ all the CC.s that +ere on our control *lans not on the FMEA.s as +ell. "n an e ort to /o com*letely *a*erless! +e +anted to start enterin/ all variable data that +e collect on lo/sheets into our Com*uteri;ed 0PC system! eliminatin/ the need or the *a*er lo/sheets! but in order to accom*lish this rom +hat you are sayin/ +e +ould need to *lace the CC symbol on every one o these dimensions on our internal *rints! and then re erence them in the FMEA1 sorry i " am bein/ redundant! " am 9ust ma,in/ sure " am understandin/ your reccommendation. Michael Walmsley $'rd May $%%&! %<(%' AM 0o! " +e +ant to trac, a *articular variable! si/ni icant or not! +e need to add the CC symbol to our *rint! but only re lect that in the FMEA and not on the control *lan1 7)= " the variable is not 5critical5 and you +ant to trac, it ! note that you have this covered in the current controls column o your FMEA. #o not

add a s*ecial characteristic to your FMEA !or *rint. #o not add it to your control *lan. )nly add s*ecial characteristics to your FMEA! *rint and control *lan that are required >by RP7 or +hatever ?. #) 7)T *ur*ose ully 5in late5 items to s*ecial characteristic status i they do not meet the criteria. There is no value in this and increased liability== RMedrano $'rd May $%%&! %<(%< AM What i it is an "tem that is already on the control *lan! but is not a s*ecial characteristic! and is currently recorded on a lo/sheet1 you +ouldnt +ant to remove the item! +ould you1 Michael Walmsley $'rd May $%%&! %<('% AM @es " +ould. "t +ould not be a valid entry. The control *lan is s*eci ically meant to trac, valid 5s*ecial5 characteristics. For me ! the criteria used to assi/n s*ecial characteristics +as ( 0everity >4 ! )ccurence>A B 5CC5 >Product 0a ety? 0everity>: ! )ccurence >C and #etection B5D5 such that RP7 >A$% B 50C5 or Customer desi/nated characteristic B 0C These +ould be noted in the FMEA.s ! *rints and control *lans. )utside o this realm! no 5s*ecial5 characteristic +ould be assi/ned in the documentation. RMedrano $'rd May $%%&! %<(C' AM 6mm interestin/ Michael! so you do not have any *rocess *aramaters or any setu* validation activities listed on your control *lans unless they are severe enou/h on your FMEA1 9ust to ma,e sure you understand! +e have no CC>sa ety? characteristics on any o our *arts. We use the CC characteristic as our "nternal version o the 0C-FF symbol. sometimes that con uses *eo*le. "nterestin/ idea.s michael. " +ill have to brin/ these u* to the *o+ers that be.

@es " +ould. "t +ould not be a valid entry. The control *lan is s*eci ically meant to trac, valid 5s*ecial5 characteristics. For me ! the criteria used to assi/n s*ecial characteristics +as ( 0everity >4 ! )ccurence>A B 5CC5 >Product 0a ety? 0everity>: ! )ccurence >C and #etection B5D5 such that RP7 >A$% B

50C5 or Customer desi/nated characteristic B 0C These +ould be noted in the FMEA.s ! *rints and control *lans. )utside o this realm! no 5s*ecial5 characteristic +ould be assi/ned in the documentation. Michael Walmsley $'rd May $%%&! A%(A: AM 6mm interestin/ Michael! so you do not have any *rocess *aramaters or any setu* validation activities listed on your control *lans unless they are severe enou/h on your FMEA1 True. @ou could i you +ish to. Jim Wynne

$'rd May $%%&! A%(CC AM ".ll address the ori/inal questions *resently! but irst! What i it is an "tem that is already on the control *lan! but is not a s*ecial characteristic! and is currently recorded on a lo/sheet1 you +ouldnt +ant to remove the item! +ould you1 @es " +ould. "t +ould not be a valid entry. The control *lan is s*eci ically meant to trac, valid 5s*ecial5 characteristics. " +e ollo+ Michael.s reasonin/ to its lo/ical conclusion! i there are no 5s*ecial5 characteristics! then there is no control *lan. ) course! there has to be a control *lan! so i it.s reserved or s*ecial characteristics only! +e.re orced to ma,e u* s*ecial characteristics that aren.t really s*ecial in order to have somethin/ other than blan,ness on a control *lan. ( rust( "n *oint o act! a control *lan should be used to record all o the *rocess characteristics that must be controlled in order to *roduce a con ormin/ *roduct. RememberEEit.s not su**osed to be an ins*ection *lanEEit.s a *rocess control *lan. 7o+ to the ori/inal questions( "s it common or heard o to use 0PC on characteristics that are not critical! or that you do not monitor ca*ability on1 @es and no. Fut it all de*ends on ho+ 5critical5 is de ined. "t.s easy to la*se into circular reasonin/( "t.s critical! so +e do 0PC! and +e do 0PC because it.s critical. " you.re not monitorin/ ca*ability! +hy do 0PC1 What *ur*ose is bein/ served1 " you.re not doin/ somethin/ to im*rove the *rocess +ith the data your.re collectin/! +hy do it1 "s it not *ossible to *ermanently trac, a variable measurement +ith an 0PC chart i its not a Critical Characteristic1 )thers +ill disa/ree +ith me! but " thin, that most times that 0PC is done in *er*etuity on a /iven *art or characteristic! the *oint o doin/ 0PC has been lost. @ou should use 0PC to *rove that the *rocess *arameters that have been *rescribed +ill *er orm as intended. )nce

you have that evidence! there mi/ht not be any reason to do chartin/ any lon/er. 6avin/ said that! i you are 5*ermanently5 chartin/ some variable! it.s ine so lon/ as some clear and reasonable *ur*ose is bein/ served by it. Bill Ryan $'rd May $%%&! A%(CG AM Maybe ".m not ully undeerstandin/! but there is nothin/ that states a eature is a 5CC5! or anythin/ else! 9ust because you decide you +ish to chart or measure it. While Michael.s methodolo/y or a Control Plan re lects his or/ani;ations requirements or somethin/ bein/ included in their Control Plans! it is not necessarily so +ith other or/ani;ations. " have customers no+ requirin/ A%%H o the *art dra+in/.s eatures re lected in the Control Plan. Jim Wynne $'rd May $%%&! A%(:% AM " have customers no+ requirin/ A%%H o the *art dra+in/.s eatures re lected in the Control Plan. And you +or, in castin/. @ou must have control *lans that read li,e War and Peace. (ee,( RMedrano $'rd May $%%&! AA(%& AM 2ust so everyone understands the +hy behind this... "t irst +as brou/ht u* because +e a currently tryin/ to move as close to *a*erless on the sho* loor as *ossible. Without ma,in/ thin/s too com*licated " had set u* e3cel s*readsheets or the o*erators to lo/ all o our 5lo/sheet5 in ormation on the control *lan! and +e use an Electronic 0PC system called Win0PC to do all o our 0PC data collection. The question +as as,ed o me +hy +e do not sim*ly enter AII variable in ormation into Win0PC instead o havin/ the t+o se*erate systems. Runnin/ this *ast our Quality mana/er! she said that i +e +ere to chart AII o our variable data that +e collect +e +ould have to mar, everythin/ as a CC on our control *lans! *rints! FMEA.s and be held to maintainin/ the ca*ability on every characteristic. When " read our quality manual " inter*reted a CC as a characteristic that has been deemed by J0 as si/ni icant and is trac,ed +ith 0PC. so in other +ords you may or may not trac, somethin/ usin/ a chart..but i the item is a CC on the *rint-control *lan etc then you MJ0T trac, it +ith 0PC there are no other o*tions. Michael Walmsley $'rd May $%%&! AA($% AM "n *oint o act! a control *lan should be used to record all o the *rocess characteristics that must be controlled in order to *roduce a con ormin/ *roduct. RememberEEit.s not su**osed to be an ins*ection *lanEEit.s a *rocess control *lan. 2im ! " a/ree. " thin, the con usion lies in act that maybe " did not clari y +hat " meant by customer desi/nated characteristic alon/ +ith the rest o the criteria " mentioned. "n our ne/otiations +ith the customer ! a 5customer desi/nated

characteristic5 is usually one in +hich ( A? 6ad an )ccurence inde3 in the FMEA >' >+hich means a C*,-P*, K A.''?. This desi/nates borderline nonEcon ormin/ *roduct. or $? Where +e had a di erence o o*inion and could not reach a/reement on severity or occurrence or detection in the FMEA. "n this case ! +e mutually a/reed to add these characteristics to our FMEA.s ! *rints and control *lans . This lo/ic!+ith all o our customers ! has added value. Anythin/ that does not meet this criteria!and that mentioned be ore!is not to be included. We have been told this *oint blan,. Jim Wynne $'rd May $%%&! AA($C AM 2ust so everyone understands the +hy behind this... "t irst +as brou/ht u* because +e a currently tryin/ to move as close to *a*erless on the sho* loor as *ossible. Without ma,in/ thin/s too com*licated " had set u* e3cel s*readsheets or the o*erators to lo/ all o our 5lo/sheet5 in ormation on the control *lan! and +e use an Electronic 0PC system called Win0PC to do all o our 0PC data collection. The question +as as,ed o me +hy +e do not sim*ly enter AII variable in ormation into Win0PC instead o havin/ the t+o se*erate systems. Runnin/ this *ast our Quality mana/er! she said that i +e +ere to chart AII o our variable data that +e collect +e +ould have to mar, everythin/ as a CC on our control *lans! *rints! FMEA.s and be held to maintainin/ the ca*ability on every characteristic. When " read our quality manual " inter*reted a CC as a characteristic that has been deemed by J0 as si/ni icant and is trac,ed +ith 0PC. so in other +ords you may or may not trac, somethin/ usin/ a chart..but i the item is a CC on the *rint-control *lan etc then you MJ0T trac, it +ith 0PC there are no other o*tions. " thin, ".m seein/ a lo/ical disconnection here. )ne o the requirements or s*ecial characteristics in your system is that they must be statistically monitored. That.s ine! and it.s common in the automotive +orld. The *roblem comes in +hen the requirement is a**lied in reverse by sayin/ that statistical monitorin/ o a characteristic de ines that characteristic as 5s*ecial.5 )ne doesn.t lo/ically ollo+ rom the other. 0o lon/ as you ul ill your o+n >and the customer.s? requirements or s*ecial characteristics! you can a**ly any o those requirements to other characteristics +ithout them becomin/ 5s*ecial.5 #on.t let the tail +a/ the do/. RMedrano $'rd May $%%&! AA(C4 AM )h i totally a/ree +ith you 2im un ortunatly the *erson in char/e o the quality system inter*rets them di erently. My su//estion +as to clari y the internal *rocedure to clearly state that "tems mar,ed +ith a CC are "nternally desi/nated Characteristics +here 0PC is REQJ"RE#. FF is a Customer desi/nated characteristic +here 0PC is REQJ"RE#.

and i thin, that +e +ould use the data to im*rove the *rocess! +e 9ust +ouldnt be trac,in/ ca*ability on these non criticals...althou/h +ith the data in the system it +ould be really easy to start doin/ that i needed.

" thin, ".m seein/ a lo/ical disconnection here. )ne o the requirements or s*ecial characteristics in your system is that they must be statistically monitored. That.s ine! and it.s common in the automotive +orld. The *roblem comes in +hen the requirement is a**lied in reverse by sayin/ that statistical monitorin/ o a characteristic de ines that characteristic as 5s*ecial.5 )ne doesn.t lo/ically ollo+ rom the other. 0o lon/ as you ul ill your o+n >and the customer.s? requirements or s*ecial characteristics! you can a**ly any o those requirements to other characteristics +ithout them becomin/ 5s*ecial.5 #on.t let the tail +a/ the do/. Bill Ryan $'rd May $%%&! A$(%% PM 6o+ about usin/ an internal desi/nation o 5CF5 >Control Feature? or somethin/ else i your boss is havin/ a *roblem +ith 5CC5 and 9ust address the 5CF5 requirements in your documentation1 Bill Ryan $'rd May $%%&! %A(CG PM And you +or, in castin/. @ou must have control *lans that read li,e War and Peace. (ee,( @eah E lately they.re /ettin/ *retty len/thy >and then listen to the customer +hine because he-she has to /o throu/h that len/thy a document(bon,( ? RMedrano $Cth May $%%&! %G('G AM Well! " thin, +e may have ound a solution. Win0PC can do more than 9ust standard DEFarLR or MedianLR it can also do *reEcontrol and Run Charts. What i thin, +e are /oin/ to do is clari y our *rocedure so that it clearly sho+s that +e do DEFarLR or +hatnot or our CC-FF items. )ther "tems +ill be trac,ed usin/ PreEControl or Run Charts! but ca*ability +ill not be trac,ed or those. We are undecided about usin/ a third symbol! "t too, us orever to /et the o*erators to remember +hat CC an FF mean! +e dont +ant to con use them +ith another symbol ri/ht no+. Than,s or all your in*ut /uys its been a /reat hel*.