appendix 1: forms - food and drug administration€¦ · appendix 1: forms . this guidance...
TRANSCRIPT
APPENDIX 1: Forms
This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.
This appendix contains a blank model Hazard Analysis Critical Control Point (HACCP) Plan Form and a blank model Hazard Analysis Worksheet.
APPENDIX 1: Forms
405
APPENDIX 1: Forms
406
HA
CC
P PL
AN
FO
RMFI
RM N
AM
E:
FIRM
AD
DRE
SS:
PRO
DU
CT
DES
CRI
PTIO
N:
MET
HO
D O
F D
ISTR
IBU
TIO
N A
ND
STO
RAG
E:
INTE
ND
ED U
SE A
ND
CO
NSU
MER
:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
CRI
TIC
AL
CO
NTR
OL
POIN
T
SIG
NIF
ICA
NT
HA
ZARD
(S)
CRI
TIC
AL
LIMIT
SFO
R EA
CH
PREV
ENTI
VEM
EASU
RE
MO
NIT
ORI
NG
CO
RREC
TIVE
AC
TIO
N(S
) RE
CO
RDS
VERI
FIC
ATIO
NW
HAT
H
OW
FR
EQU
ENC
Y W
HO
SIG
NATU
RE O
F CO
MPA
NY
OFF
ICIA
L: _
____
____
____
____
____
____
____
____
____
____
____
____
____
____
_ D
ATE:
____
____
____
____
____
____
_
PAG
E 1
OF
____
____
____
____
____
____
____
__
APPENDIX 1: Forms
407
HA
CC
P PL
AN
FO
RM(1
) (2
) (3
) (4
) (5
) (6
) (7
) (8
) (9
) (1
0)
CRI
TIC
AL
CO
NTR
OL
POIN
T
SIG
NIF
ICA
NT
HA
ZARD
(S)
CRI
TIC
AL
LIMIT
SFO
R EA
CH
PREV
ENTI
VEM
EASU
RE
MO
NIT
ORI
NG
CO
RREC
TIVE
AC
TIO
N(S
) RE
CO
RDS
VERI
FIC
ATIO
NW
HAT
H
OW
FR
EQU
ENC
Y W
HO
SIG
NATU
RE O
F CO
MPA
NY
OFF
ICIA
L: _
____
____
____
____
____
____
____
____
____
____
____
____
____
____
_ D
ATE:
____
____
____
____
____
____
_
PAG
E 1
OF
____
____
____
____
____
____
____
_
APP
END
IX 1
: FO
RMS
B
APPENDIX 1: Forms
408
HA
ZARD
AN
ALY
SIS
WO
RKSH
EET
FIRM
NA
ME:
FIRM
AD
DRE
SS:
PRO
DU
CT
DES
CRI
PTIO
N:
MET
HO
D O
F D
ISTR
IBU
TIO
N A
ND
STO
RAG
E:
INTE
ND
ED U
SE A
ND
CO
NSU
MER
:
(1)
(2)
(3)
(4)
(5)
(6)
ING
RED
IEN
T/PR
OC
ESSI
NG
STEP
IDEN
TIFY
PO
TEN
TIA
LBI
OLO
GIC
AL,
CH
EMIC
AL,
AN
DPH
YSIC
AL
HA
ZARD
SA
SSO
CIA
TED
WIT
H T
HIS
PR
OD
UC
T A
ND
PRO
CES
S
ARE
AN
Y PO
TEN
TIA
LFO
OD
SA
FETY
HA
ZARD
S SI
GN
IFIC
AN
TAT
TH
IS S
TEP?
(YES
/NO
)
JUST
IFY
YOU
RD
ECIS
ION
FO
RC
OLU
MN
3
WH
AT P
REVE
NTI
VE
MEA
SURE
(S) C
AN
BE
APP
LIED
FO
R TH
ESI
GN
IFIC
AN
T H
AZA
RDS?
IS T
HIS
STE
P A
CRI
TIC
AL
CO
NTR
OL
POIN
T?
(YES
/NO
)
APPENDIX 1: Forms
409
HA
ZARD
AN
ALY
SIS
WO
RKSH
EET
(1)
(2)
(3)
(4)
(5)
(6)
ING
RED
IEN
T/PR
OC
ESSI
NG
STEP
IDEN
TIFY
PO
TEN
TIA
LBI
OLO
GIC
AL,
CH
EMIC
AL,
AN
DPH
YSIC
AL
HA
ZARD
SA
SSO
CIA
TED
WIT
H T
HIS
PR
OD
UC
T A
ND
PRO
CES
S
ARE
AN
Y PO
TEN
TIA
LFO
OD
SA
FETY
HA
ZARD
S SI
GN
IFI
CA
NT
AT T
HIS
STE
P?
(YES
/NO
)
JUST
IFY
YOU
RD
ECIS
ION
FO
RC
OLU
MN
3
WH
AT P
REVE
NTI
VE
MEA
SURE
(S) C
AN
BE
APP
LIED
FO
R TH
ESI
GN
IFIC
AN
T H
AZA
RDS?
IS T
HIS
STE
P A
CRI
TIC
AL
CO
NTR
OL
POIN
T?
(YES
/NO
)
PAG
E 1
OF
____
____
____
____
____
____
____
_
NOTES:
APPENDIX 1: Forms
410