preventive controls reg com meeting

8/18/2019 Preventive Controls Reg Com Meeting

http://slidepdf.com/reader/full/preventive-controls-reg-com-meeting 1/43



UNILEVER QUALITY

ETHOS



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



PREVENTIVE CONTROLSFOR HUMAN FOOD

De!i*'tin* Ou# Consue#s

P#ote"tin* Ou# +#ands



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)



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




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




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



PREVENTIVECONTROLS

RE>ULATIONREQUIREMENTS




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




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




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




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




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



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?• <




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




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%;



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




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




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




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"?




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*



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




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




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




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!




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



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




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




PREVENTIVECONTROLS

RE>ULATIONIMPLEMENTATION STRATE>Y

CO O S



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




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




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



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



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



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




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




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




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




: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



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



QUALITY

QUESTIONS

preventive controls reg com meeting

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