Upload
lorena
View
226
Download
0
Embed Size (px)
Citation preview
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 1/43
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 2/43
UNILEVER QUALITY
ETHOS
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 3/43
Food safety is a fundaenta!"onsue# e$%e"tation
E&en t'e %e#"e%tion t'at ou#%#odu"ts ay not (e safe )i!!
daa*e ou# (#ands
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 4/43
PREVENTIVE CONTROLSFOR HUMAN FOOD
De!i*'tin* Ou# Consue#s
P#ote"tin* Ou# +#ands
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 5/43
FOOD SAFETYMODERNI,ATION ACTFood Safety Mode#ni-ation A"t. /anua#y01 2344
P#o%osed Ru!e Fina! Ru!eEsta(!is'e
d
Co%!ian"e Dates fo#La#*e +usiness
Fo!!o)in* Pu(!i"ationof Fina! Ru!e
P#e&enti&eCont#o!s fo#Huan Food
Sept 17,2015
1 yr (Sept 19, 2016)
P#e&enti&eCont#o!s fo#Ania! Feed
Sept 17,2015
1 yr (Sept 19, 2016)
P#odu"e Safety Oct 31,2015
2 yrs + 60 d (Dec 31,2017)
Fo#ei*n Su%%!ie#Ve#i5"ationP#o*#a
Oct 31,2015
18 mo (April 31, 2017)
T'i#d Pa#ty
A""#editation
Oct 31,
2015
18 mo (April 31, 2017)
Sanita#y Mr 31, 1 yr (Mr 31, 2017)
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 6/43
PREVENTIVE CONTROLS FORHUMAN FOODS FINAL RULE
Fundaenta! "'an*e to food safety#e*u!ation
En'an"ed enfo#"eent
%o)e#s• Mo#e f#e6uent
ins%e"tions• Mandato#y #e"a!!
aut'o#ity
• Sus%ension of fa"i!ity#e*ist#ation
• Adinist#ati&edetention
Food Safety P!anHa-a#d Ana!ysis and Ris7(ased P#e&enti&e Cont#o!s
Un
%#e"edented a""ess to#e"o#dsSi*ni5"ant %o#tion of FDA
audits )i!! "onsist of#e"o#ds #e&ie)
Ru!e in8uen"ed (y indust#y"oentsP#o&ides 8e$i(i!ity to Indust#y9it' F!e$i(i!ity CoesRes%onsi(i!ity
Su%%!y "'ain ana*eent:Su%%!ie# "ont#o!;FDA e%'asi-es su%%!ie#a%%#o&a! and su%%!ie#
&e#i5"ation
Food Safety Cu!tu#e
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 7/43
PREVENTIVE CONTROLSFOR HUMAN FOOD
FDA fa"to#y ins%e"tions• Systes<(ased ins%e"tion a%%#oa"'
• Lets FDA 7no) 'o) a "o%any is
o%e#atin* )'en ins%e"to#s a#en=t%#esent
• Re"o#ds #e&ie) )i!! (e a "ent#a!"o%onent of FDA ins%e"tions
• Ins%e"tions )i!! (e"oe o#e !i7e anIRS audit
• +ut >MP<fo"used ins%e"tions a#en=t*oin* a)ay
• Co%anies= de"isions )i!! (e (e"oe
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 8/43
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 9/43
PREVENTIVE CONTROLSFOR HUMAN FOOD
Conse6uen"es of fai!u#es "an !eadto
•
Consue# safety issues•Daa*e to "o%any #e%utation
•Mandato#y #e"a!!s
•Fa"to#y #e*ist#ation sus%ended•Potentia! "#iina! !ia(i!ity
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 10/43
PREVENTIVECONTROLS
RE>ULATIONREQUIREMENTS
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 11/43
PREVENTIVE CONTROLSFOR HUMAN FOOD
Food Safety Cu!tu#e
Resou#"es to "ontinuous!yi%#o&e food safety
ana*eent systes in %!a"e
Couni"ation
T#ainin*
Food SafetyTea
PI=s
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 12/43
PREVENTIVE CONTROLSFOR HUMAN FOOD
Food Safety P!an• Must (e %#e%a#ed o# %#e%a#ation
o&e#seen (y a %#e&enti&e "ont#o!s
6ua!i5ed indi&idua!• Qua!ity Mana*e# o# Food Safety Tea
Leade#
• Ha-a#d Ana!ysis
• 9#itten %#e&enti&e "ont#o!s• Must do"uent #ationa!e fo#
se!e"tion of %#e&enti&e "ont#o!s
• 9#itten su%%!y "'ain %#o*#a
• 9#itten #e"a!! %!an
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 13/43
PREVENTIVE CONTROLSFOR HUMAN FOOD
Food Safety P!an
•9#itten %#o"edu#es fo# onito#in*
%#e&enti&e "ont#o!s•9#itten "o##e"ti&e a"tion %#o"edu#es
•9#itten &e#i5"ation %#o"edu#es
GE$a%!e food safety %!an is (ein*de&e!o%ed )it' t'e St A!(ans fa"to#y
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 14/43
PREVENTIVE CONTROLSFOR HUMAN FOOD
Food Safety P!an &s O%e#ationa! HACCP•O%e#ationa! HACCP te%!ate 'as (eenodi5ed to in"!ude %#e&enti&e "ont#o!s
•
Reassess and #e&ie) %!an a*ainst e$a%!eFood Safety P!an
•Must assue %!an )i!! (e #e&ie)ed indetai! (y FDA
•Must 'a&e so!id #ationa!e usti5"ation fo#se!e"tion of %#o"ess "ont#o!s
•Need to assu#e 'a-a#ds in"!uded in t'e
5na! #u!e a#e in"!uded in t'e 'a-a#dana! sis
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 15/43
PREVENTIVE CONTROLSFOR HUMAN FOOD
Ha-a#d Ana!ysis• ID e&a!uate 7no)n o# #easona(!y fo#eseea(!e
'a-a#ds to dete#ine )'et'e# t'e#e a#e anyJ'a-a#ds #e6ui#in* a %#e&enti&e "ont#o!K
•
+io!o*i"a!1 "'ei"a!1 a!!e#*en1 %'ysi"a! 'a-a#ds• Must in"!ude an e&a!uation of en&i#onenta!
%at'o*ens fo# RTE %#odu"ts
• Food safety 'a-a#ds int#odu"ed fo# %u#%oses of
e"onoi" *ain• Must assu#e t'at %#e&enti&e "ont#o!s a#e in
%!a"e fo# in*#edients )it' SAHCODHA :se#iousad&e#se 'ea!t' "onse6uen"es o# deat' to'uans o# ania!s; 'a-a#ds
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 16/43
PREVENTIVE CONTROLS FORHUMAN FOOD
Cu##ent HACCP Ha-a#d Ana!ysis &s Food safety P!an Ha-a#dAna!ysis
• Ha-a#d #easona(!y !i7e!y to o""u# is de5ned as J'a-a#d#e6ui#in* a %#e&enti&e "ont#o!K
•
Must on!y in"!ude t#ue food safety 'a-a#ds• E?*? 'ai#1 %a%e#1 inse"ts ay not (e si*ni5"ant food
safety 'a-a#ds
• Reassess in*#edient 'a-a#d ana!ysis to identifyin*#edients )it' SAHCODHA 'a-a#ds?
•
/usti5"ation de"ision "#ite#ia ust (e #o(ust enou*' to)it'stand #e*u!ato#y s"#utiny
• Food safety 'a-a#ds int#odu"ed fo# %u#%oses of e"onoi"*ain
• A!!e#*en and sanitation "ont#o!s )'i"' ay "u##ent!y (e
PRP=s )i!! ost !i7e!y (e %#e&enti&e "ont#o!s?• <
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 17/43
PREVENTIVE CONTROLSFOR HUMAN FOOD
P#o"ess "ont#o!s:CCP=s1 OPRP=s1
PRP=s;Food a!!e#*en"ont#o!s
Sanitation
Su%%!y "'ain"ont#o!s :Su%%!ie#
"ont#o!s;Re"a!! %!an
Ot'e# "ont#o!s
:e?*? t#ainin*1
P#e&enti&e "ont#o!sP#o&ides assu#an"e t'at any 'a-a#ds#e6ui#in* a %#e&enti&e "ont#o! )i!! (e
e!iinated o# "ont#o!!ed
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 18/43
PREVENTIVE CONTROLSFOR HUMAN FOOD
P#e&enti&e Cont#o!s &s Cu##ent CCP=s1 OPRP=s• T'e#e )i!! (e %#e&enti&e "ont#o!s in
addition to "u##ent CCP=s and OPRP=s t'at)i!! #e6ui#e t'e sae !e&e! of #e"o#d
7ee%in*1 "o##e"ti&e a"tion and &e#i5"ationas a CCP fo# e$a%!e.
• A!!e#*en (at"' "ont#o!
• A!!e#*en %a"7a*in* "ont#o!
• CIP
• Su%%!ie# "ont#o! :CofA=s1in"oin* te%;
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 19/43
PREVENTIVE CONTROLMANA>EMENT
COMPONENTSMonito#in*Monito#in* of CCP=s and OPRP=s s'ou!da!#eady (e )e!! ana*ed
Monito#in* of additiona! %#e&enti&e"ont#o!s ay (e #e6ui#ed
Re"o#ds deonst#atin* !oss of "ont#o!1#at'e# t'an a#ati&e #e"o#ds
deonst#atin* "ont#o! a#e a""e%ta(!e #$%$ cooler temp$ lrms
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 20/43
PREVENTIVE CONTROLMANA>EMENT
COMPONENTSCo##e"tions and Co##e"ti&e A"tionsCo##e"tion :Must %#o&ide e&iden"e t'at t'e "onsue#)as %#ote"ted; Date and tie?
In"!ude #e"o#d 7ee%in* de&iations
9'o )as in&o!&ed in t'e in"ident and ana!ysis
:naestit!es;Dis%osition of %#odu"t :'o) )as unsafe %#odu"t%#e&ented f#o ente#in* dist#i(ution;
Root "ause
Co##e"ti&e a"tion :date and tie;
/usti5"ation of 5na! %#odu"t dis%osition
Ve#i5"ation of "o##e"ti&e a"tion ee"ti&eness
A"tions to %#e&ent #e"u##en"e
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 21/43
PREVENTIVE CONTROLMANA>EMENT
COMPONENTSCo##e"tions and Co##e"ti&e A"tions E$a%!e
9'at is "u##ent!y #e"o#ded
Pasteu#i-ed !i6uid i!7 C of A issin*Salmonella #esu!ts
SNCR. Jout of s%e" %at'o*ensK Jused in%#o"essK
T'is does
not te!! t'e)'o!e sto#y
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 22/43
PREVENTIVE CONTROLMANA>EMENT
COMPONENTSCo##e"tions and Co##e"ti&e A"tions E$a%!e9'at )i!! need to (e #e"o#ded
Pasteu#i-ed !i6uid i!7 C of A issin*Salmonella #esu!ts
Co##e"ti&e a"tion !o* fo# in"identdes"#i%tion.
CofA )as issin* Sa!one!!a #esu!ts? Li6uidi!7 is %asteu#i-ed (y t'e su%%!ie#? T'ete%e#atu#e and a"idity of t'e %#odu"t )as ins%e"i5"ation )'en t'e ate#ia! )as #e"ei&ed?Li6uid i!7 is #e<%asteu#i-ed in t'e i$%asteu#i-ation %#o"ess? Sa!one!!a #esu!ts
#e"ei&ed afte# i!7 )as used )e#e in s%e"?
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 23/43
PREVENTIVE CONTROLMANA>EMENT
COMPONENTSVe#i5"ation of I%!eentationEe"ti&eness
Re"o#ds #e&ie) :onito#in*1
"o##e"ti&e a"tion1 &e#i5"ation1"a!i(#ation #e"o#ds;
Ca!i(#ation a""u#a"y "'e"7s
Di#e"t o(se#&ation &e#i5"ationaudits
P#odu"t testin*
En&i#onenta! onito#in*
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 24/43
PREVENTIVE CONTROLSFOR HUMAN FOOD <
RECORDSDo"uentation and #e"o#ds a#e"#iti"a!
&ecords'doc"mettio re"iremetsre e*tesie tro"%o"t re%"ltios
•M-or .oc"s o. /DA ispectios
. yo" didt doc"met it, it didtppe
. yo" did doc"met it, it ppeed
-"st tt 4y
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 25/43
PREVENTIVE CONTROLSFOR HUMAN FOOD <
RECORDS•FDA=s in"#eased #e"o#ds a""ess )i!!si*ni5"ant!y "'an*e t'e natu#e of anins%e"tion and t'e #o!e of
#e"o#d7ee%in*•Instead of (ein* ust fo# inte#na!%u#%oses1 #e"o#ds no) need to (e"onside#ed as a too! in "ouni"atin*
)it' t'e FDA
•Re"o#ds need to (e su"ient!y #o(ustto ustify you# a"tions afte# t'e fa"t
and s'o) FDA you a#e doin* a *ood
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 26/43
PREVENTIVE CONTROLSFOR HUMAN FOOD <
RECORDS• &ecords o.te .orm te sis .or importt"siess decisios
• &ecords te o eerlsti% li.e o. teir o4
• ey re o.te re.ereced yers lter
• e cotroersies rise, records c e• :reseted selectiely d te o"t o.
cote*t
• ;rcteri<ed y dersry or septic
•
oe ito e4 story• Mde p"lic
9e ust assue t'at #e"o#ds )i!! (e"#iti"a!!y #e&ie)ed (y t'e FDA
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 27/43
PREVENTIVE CONTROLSFOR HUMAN FOOD <
RECORDSRe"o#ds Mana*eent• E%!oyees at e&e#y !e&e! need to unde#stand
)'y t'e#e #o!e in #e"o#d 7ee%in* is i%o#tant
• Re"o#ds need to (e )e!! o#*ani-ed and #eadi!y
a""essi(!e• Cent#a! !o"ation
• Cont#o!!ed a""ess
• No (!an7s a#7 as NA
•
Re"o#d a!! info#ation as it o""u#s not (efo#eo# afte#
• Do not use ditto a#7s o# do)n a##o)s
• Do not e$a**e#ate :e?*? e$"essi&e "'#oni"
!ea7a*e due to e6ui%ent dis#e%ai#1 eta!
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 28/43
PREVENTIVE CONTROLMANA>EMENT
COMPONENTSVa!idationMust &a!idate t'at %#e&enti&e"ont#o!s a#e ade6uate to "ont#o!
t'e 'a-a#dRe*u!ation does not #e6ui#efa"to#ies to &a!idate
Sanitation "ont#o!sG A!!e#*en "ont#o!sG
Re"a!! %!an
Su%%!y "'ain %#o*#a=>lidtio re"ired y ?ileer d /SS; 22000
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 29/43
S"pply ;i ;otrols (S"pplier ;otrols)• Additiol records re"iremets
• Approed s"ppliers• @eed ccess to pproed list o.
s"ppliers, certictes d reports4iti 2B rs
• &eceipt proced"res• spectio o. icomi% mterils
d trilers
• ; o. As
• o"d smpli%
• empert"re o. perislei%rediets
PREVENTIVE CONTROLSFOR HUMAN FOOD
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 30/43
Su%%!y C'ain Cont#o!s :Su%%!ie#Cont#o!s;
Fa"to#y e$a%!e
• E&iden"e of su%%!ie# a%%#o&a!
• C of A=s fo# si*ni5"ant 'a-a#ds
• Need to identify )'i"' in*#edients'a&e si*ni5"ant food safety 'a-a#ds
•
In (ound sa%!in* #esu!ts fo#&e#i5"ation of su%%!ie#s %#o"ess"ont#o!s
• In(ound t#ai!e#!oad ins%e"tion#e"o#ds
PREVENTIVE CONTROLSFOR HUMAN FOOD
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 31/43
PREVENTIVECONTROLS
RE>ULATIONIMPLEMENTATION STRATE>Y
CO O S
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 32/43
PREVENTIVE CONTROLSIMPLEMENTATIONRESPONSI+ILITIES
FSMA Stee#in* Coittee :>eo#*ia S-e)"-a71 Pat#i-ia+a#one1 Lau#a P#ot-ann1 To +o!and1 San ,e!!e#1 Mi7eCi#i*!iano1 F#ed Sode#st#o;
P#e&enti&e Cont#o!s I%!eentation Coittee :Sa,e!!e#1 >odf#ey Lee1 And#e) Sie(en(o#n1 >eo#*iaS-e)"-a71 F#ed Sode#st#o1 Mi7e Ci#i*!iano;
Res%onsi(i!ities
» I%!eentation *uidan"e and t#ainin*
» >uidan"e do"uents» Coo#dinate fa"to#y %#e<assessents )it' DNV>L
» Lead %#e%a#ation audits
PREVENTIVE CONTROLS
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 33/43
PREVENTIVE CONTROLSIMPLEMENTATIONRESPONSI+ILITIES
P#odu"t >#ou% Qua!ityCoo#dinate i%!eentation a"ti&ities atfa"to#ies
Fa"to#y Di#e"to#s
Assu#e #esou#"es a#e %#o&ided fo#i%!eentation of #e*u!ation
Lead food safety "u!tu#e at fa"to#y
PREVENTIVE CONTROLS
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 34/43
PREVENTIVE CONTROLSIMPLEMENTATIONRESPONSI+ILITIES
Fa"to#y %#e&enti&e "ont#o!s 6ua!i5edindi&idua!
De&e!o% o# o&e#see de&e!o%ent offa"to#y food safety %!ans
Pe#fo# o# o&e#see &e#i5"ation and&a!idation a"ti&ities
Must eet t#ainin* #e6ui#eents
Fa"to#y 6ua!i5ed indi&idua!s
Pe#fo# onito#in* and &e#i5"ationa"ti&ities
T#ainin ust (e a #o #iate to
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 35/43
234 FDA FSMA PROCESSCONTROLS RE>ULATION
IMPLEMENTATIONSe%te(e# O"to(e# No&e(e# De"e(e#
36 37 38 39 B0 B1 B2 B3 BB B5 B6 B7 B8 B9 50 51 52
Milestoes
Descriptio
Septemer /ctory %ps ssessmet
doc"met deeloped #*mple .ood s.ety pl
deeloped d is c"rretlyei% reie4ed y CMA
:repre comm"ictiomeeti% mteril
Octoer ;omm"ictio meeti% .or .ood
s.ety d .ctory ledersiptems
/ctories complete sel.ssessmets
D@>C 4ill e%i icl"di% /SMA:rocess ;otrols re%"ltio s
.oc"s re
@oemerEDecemer Aly<e %ps lysis res"lts F D commo reso"rce
eeds Deelop eeded stdrds' %"idce doc"mets D@>C icl"des /SMA :rocess cotrols re%"ltio .oc"s
re d"ri% "dits /$ Soderstrom completed :reetie cotrols "lied
idiid"l led istr"ctor trii%
P#e%a#ation Co%!ete
e$a%!e IC FSP!an
Co%!ete *a%sassessent CL
De&e!o% "o?ate#ia!
P#o"ess"ont#o!s#e*u!ationand *a%sana!ysis
"ouni"ation eetin*s
Fa"to#ies "ondu"t %#o"ess"ont#o!s #e*u!ation *a%s ana!ysisID #esou#"e and standa#d%#o"edu#e needs
Ana!y-e *a%s ana!ysis #esu!ts1 de&e!o%needed standa#ds *uidan"edo"uents1 de&e!o% F2F t#ainin*st#ate*y ate#ia!
DNV>L )i!! in"!ude FSMA P#o"ess Cont#o!s #e*u!ation fo"us a#ea :%#e<assessent; in FSSC 22333 %e#iodi" and #e"e#ti5"ation audits
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 36/43
234B FDA FSMA PROCESSCONTROLS RE>ULATION
IMPLEMENTATION /anua#y Fe(#ua#y Ma#"' A%#i! May /une /u!y Au*ust
94
92
9@
90
9
9B
9
9
9
943
944
942
94@
940
94
94B
94
94
94
923
924
922
92@
920
92
92B
92
92
92
9@3
9@4
9@@
9@@
9@0
9@
Mi!estones
Descriptio
!"ry Deelop ?ileer :reetie ;otrols G"lieddiid"l rii%
e Crocers M".ct"rers Associtio 4ill coEtri
D@>C icl"des /SMA :rocess cotrols re%"ltio.oc"s re d"ri% "dits
/er"ry &e.resmets :reetie;otrols G"lieddiid"l rii%sced"led .or 4ee o. 8/e$
/oods :reetie ;otrolsG"lied diid"l rii% sced"led .or4ee o. 22 /e$
Mrc A"%"st /ctories icl"de te /SMA :rocess ;otrols%ps ssessmet i teir "l iterl "dit$
?ileer tem 4ill cod"ct o site /SMA:rocess ;otrols &e%"ltio rediess "dits t.ctories$
D@>C icl"des /SMA :rocess cotrolsre%"ltio .oc"s re d"ri% "dits$ ;omplice4it te /SS; 22000 process cotrolsre%"ltio 4ill e re"ired .or /SS; 22000certictio e%ii% Septemer 2016$
F2F FSMA%#o"ess"ont#o!s
#e*u!ationt#ainin*
%ee##e&ie)
Fa"to#ies in"o#%o#ate FSMA %#o"ess "ont#o!s #e*u!ation #e6ui#eents into t'ei# inte#na!audits
DNV>L )i!! in"!ude FSMA P#o"ess Cont#o!s #e*u!ation fo"us a#ea :%#e<assessent; in FSSC 22333 %e#iodi" and#e"e#ti5"ation audits
On site FSMA %#o"ess "ont#o!s #e*u!ation #eadiness audits
De&e!o%ent of
t#ainin*ate#ia!
PREVENTIVE CONTROLS
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 37/43
PREVENTIVE CONTROLSIMPLEMENTATION
itil Cps Assessmet:reetie cotrols re%"ltio dded to /SS; 22000%ps ssessmet
/ctories eed to complete preetie cotrols
4orseet y 15 @oemerO-ecties
D m-or %ps
Allo4 time to per.ect .ctory
systems D reso"rce %ps
D eeds .or %"idce' trii%mteril
corporte ito iterl "dits
PREVENTIVE CONTROLS
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 38/43
PREVENTIVE CONTROLSIMPLEMENTATION
De&e!o% fa"to#y food safety %!ans
• Food safety teas )i!! need to #eassessHACCP studies and ID %#e&enti&e "ont#o!s
•
T#ansfe# to ne) te%!ate• Uni!e&e# *!o(a! o%e#ationa! HACCP te%!ate
'as (een odi5ed so t'at it "an (e used fo#a food safety %!an
•
E$a%!e St A!(ans food safety %!an is (ein*de&e!o%ed
• Re"a!! and Su%%!y C'ain Cont#o! P#o"edu#es"an (e #efe#en"ed )it' t'e %#e#e6uisite
%#o*#as
PREVENTIVE CONTROLS
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 39/43
PREVENTIVE CONTROLSIMPLEMENTATION
D@>C preEssessmet' .oc"s re»ill "se ?ileer %ps ssessmet tool
» cl"ded d"ri% periodic d recertictio "dits
• H dy 4ill e dded to "dits
• Cps 4ill ot e oEco.ormces"til Septemer 2016
» /SS; 22000 certictio re"ires complice tore%"ltios
• Cps 4ill e mior or m-or ormior oEco.ormces e%ii%Septemer 2016
PREVENTIVE CONTROLS
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 40/43
PREVENTIVE CONTROLSIMPLEMENTATION
G1 .ce to .ce meeti%
»A%ed is ei% deeloped
»@eed .eedc .rom .ctories todeelop %ed
»Most liely trii% ' peer reie4
.ormt• Ali% preetie cotrols
et4ee .ctories
•
Sre %ood prctices
PREVENTIVE CONTROLS
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 41/43
PREVENTIVE CONTROLSIMPLEMENTATION
:rctice "dits
»/ormt' proced"re eeds to edeeloped
»Ie%i G2J
»A"dit tem my icl"de .ctory .oods.ety tem, :C G"lity, CG#, CtM
d re%"ltory Kirs
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 42/43
EY TAEA9AYS
Ie%i prepri% o4 Lo4 te re%"ltio re"iremets
;omplete iitil %ps ssessmet
e dt%e o. D@>C preEssessmets
Deelop .ood s.ety pl "si% e*isti%opertiol A;;: st"dies
&essess d improe records m%emetsystems
&essess d improe correctio d correctiectio doc"mettio
ri "lied idiid"ls
;omm"icte 4ere elp is eeded
8/18/2019 Preventive Controls Reg Com Meeting
http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 43/43
QUALITY
QUESTIONS