QUALITY MANUAL

PANDUANMUTU

PENERAPAN CARA PENGOLAHAN IKAN YANG BAIK (GOOD

MANUFACTURING PRACTICES) DAN PEMENUHAN PERSYARATAN
PROSEDUR OPERASI STANDARD SANTTASI {SANITATIONSTANDARD
OPERA TING PROCEDURE)

FROZEN COOKED TUNA LOINS

AT
DI

PT. TOBA SURIMI INDUSTRIES

COMPANY ADDRESS:
(ALAMA T PER USAHAAN)

Jl. Pulau Pinang 2

Kawasan Industri Medan n
Saentis - Deli Serdang
Telp. (62-61)6871022
Fax. (62-61)6871007
Medan 2 03 71
Sumatera Utara - Indonesia
PT. T O B A SURIMI INDUSTRIES Doc. No.. TSI/SKP/LP/ FP-015
Jln. Pulau Pinang 2, KIM II Medan Revision: 00

LEMBAR PENGESAHAN

Disiapkan Oleh : Diperiksa Oleh

Marlenta Sembiring Sri Handayani

Gindra Tardy
Direktur Utama
PT. T O B A SURIMI INDUSTRIES
Doc. No. : TSI/SKP/Content/FP-0I5
Pulau Pinang 2. KJMII Medan
Revision: 00

CONTENTS
DAFTARISI

PAGE

CONTENT

THE COMPANY POLICY STATEMENT 111

1. C O M P A N Y P R O F I L E 1

2. P L A N T O R G A N I Z A T I O N 2

3. JOB DESCRIPTION 3

4. T A T A L E T A K U P I 9

5. R A W M A T E R I A L D E S C R I P T I O N 10

6. P R O D U C T DESCRIPTION 11

7. F L O W D I A G R A M 12

8. K O N S T R U K S I B A N G U N A N , FASILITAS D A N P E R A L A T A N 13

9. G O O D M A N U F A C T U R I N G P R A C T I C E 14

10. S T A N D A R D S A N I T A T I O N O P E R A T I O N A L P R O C E D U R E 23

11. P E L A B E L A N 33

12. P R O D U C T R E C A L L 34

13. C O N S U M E R ' S C O M P L A I N 38

14. P E L A T I H A N K A R Y A W A N 39

15. A M E N D E M E N 40

Iiilemal vaiidaiion Prepared Bv, /

Date : 10 November 2020
CM
Signalure: / Signature :
Sri Handayani Marlenta Sembiring

Page i
PT. T O B A SURIMI INDUSTRIES
Jl. Pulau Pinang 2. KIM II Medan Doc, No. : TSI/SKP/Content/FP-015
Revision; 00

RECORD KEEPING

INCOMING RAW MATERIAL 41

COLD STORAGE TEMPERATURE REPORT 42
CHILL STORAGE TEMPERATURE REPORT 43
THAWING INSPECTION REPORT 44
CLEANING INSPECTION REPORT 45
SORTING INSPECTION REPORT 46
V A C U U M SEALING INSPECTION REPORT 47
METAL DETECTING REPORT 48
CONTACT FREEZER MONITORING 49
PACKESIG INSPECTION REPORT 50
STUFFING INSPECTION REPORT 51
INCOMING PLASTIC INSPECTION REPORT 52
WAREHOUSE SANITATION AND MAINTENANCE INSPECTION REPORT 53
INCOMING CARTON INSPECTION REPORT 54
DAILY CARTON INSPECTION REPORT 55
MICROBIOLOGYCAL REPORT 56

PERSONAL HYGIENE, PLANT SANITATION & MAINTENANCE

INSPECTION REPORT 57
FORM PEMERIKSAAN TOILET 61
ENVIRONMENT SANITATION INSPECTION REPORT 62

Internal validation Prqjared By,

Date: 10 November 2020

Signatme :
Sri Handavani
IK Signature:
Marlenta Sembiring

Page ii
PT. T O B A SURIND INDUSTRIES
Doc. No.: TSI/SKP/Company Polic\'/ FP-015
Jln. Pulau Pinang 2. KIM UMedan
Revision : 00

THE COMPANY POLICY STATEMENT

Pernyataan Kebijakan Perusahaan

1. Vision Statement
1) To achieve customer's satisfactory constantly.
Mencapai kepuasan pelanggan secara terns menenis
2) To be the leading company in seafood exports.
Menjadi pemimpin export hasil makanan lout

2. Mission statement
1) Complying customer requirementsin accordance to regulation
Memenuhi perminlaan Pelanggan sesuai dengan regulasi yang berlaku.
2) To consistently intolerant to raw materials and supporting materials which are out of
standards
Konsisten untuk tidak toleran pada bahan baku dan bahan penolongyang tidak memenuhi
syarat.
3) To achieve quality and production goal
Pencapaian target mutu dan produksi
4) To develop market by utilizing existing product for extensive offers from the company to
customers.
Melakukan pengembangan dalam pemasaran dengan memanfaatkan produk yang sudah
ada untuk memperluas penawaran Perusahaan kepada pelanggan.

3. Food safety and Quality Policy

PT. Toba Surimi Industries always strives to be better in presenting and ensuringthe
consistency o f quality products, safe, compliant with regulations and always maintain product
safety to customers by;
PT. Toba Surimi Industries senantiasa berupaya menjadi lebih baik dalam menghadirkan dan
menjamin konsistensi produk yang berkualitas, aman, patuh terhadap regulasi dan selalu
menjaga keamanan produk kepada pelanggan dengan :

Internal validation Prepared By,

Date: 10 November 2020

Signature :
Marlenta Senmbiring

Page iii of iv
PT. T O B A SURIMI INDUSTRIES
Doc, No.: TSySKP/Company Policy/ FP-015
Jln. Pulau Pinang 2, KJM II Kdedan
Revision : 00

1) Procuring high quality raw material from the fisherman community. Ensuring long term
sustainability and the protection of the environment and its community
Mendapatkan bahan baku hasil laut yang berkualitas dari komunitas nelayan yang
ditangkap secara alami dan dikelola dengan baik. Memastikan daya dukung sumber alami
untukjangka panjang dan perlindungan terhadap lingkungan dan komunitas di dalamnya

2) Producing safe and legal products to its customers' specifications and maintaining the
highest standard with regards to levels o f technical excellence, innovation, environmental,
social and ethical sensitivity.
Menghasilkan produk - produk yang sah dan aman sesuai dengan spesifikasi pelanggan
ataupun regulasi yang sah resmi dan mempertahankan standard tertinggi didasarkan
pada keunggulan teknis dan sensitivitas terhadap inovasi, lingkungan hidup, sosial dan
etis.
3) Carry out supervision to minimize adulteration to maintain product authenticity.
Melakukan pengawasan untuk meminimalisasi terjadinya pemalsuan untuk menjaga
keaslian produk
4) Upgrading the standard, facilities and the resoiu-ces capabilities continously
Melakukan peningkatan standard, sarana dan kemampuan sumber daya secara
berkelanjutan.

Gindra Tardy

Internal validation Prepared By,

Date : 10 November 2020

Signature: Signature:
Sri Handayani Marlenta Senmbiring

Page iv of iv
PT. T O B A S U R I M I INDUSTRIES
Doc. No.: TSI/SKP/GMP/FP-015
Jl PulauPimi}g2. miUMedaa
Rc\'ision: CX)

9. P R O G R A M P K N E R A P A N C A R A P E N G O L A H A N \ K A ^ V A N G B A I K ( G O O O M A N U T A C I U U I N G P I U C T I C K )
Processing Slq) Goal I'rocediirc Monitoring Regiilariy
Corrective Action Record
Tahajxiii Proses Tujuan Prosedur Who Wliat Wlicn Aaian

Receiving raw Idcntilicalion o f t h e i i - The Tmia loins arrived in the condition of QC - Quality - Ever)' incoming " Reject ifnot Raw material inspection No. 5 2 A / K E P M E N -
niatcrinl coming raw malerials frozen personnel - Temperature raw material meet sjjecilieation report D o c . N o . : KP/20I3
prior going inlo ihe - Checking of 20 kg raw materinl for ever}' TSl/1-lACCP/FM/CRMOl Chapter II.F.Sa
jiroccssing, to mnke Inick on teniiwratiire, color, tcNtiire, odor by - Residue Hea\ - Twice a year Test result ^,^)0I1
sure tliej' are good the raw material Q C . metal (Pb, Mg, Cd) Fish and Fisher}'
qnality, contnminalior - Checking histamine and heavy melal - Residue histamine - Samples are - Reject the lot i f " Histamine analysis Products
free and not Refer :SOP-101 taken from 18 any fish contains rctiort Mazard and
decomposed [)cs i)er lot/truck morc than 40 ppm Controls Guidance
histamine F D A Fourth
Edition-August
Pemrimaau Bahan bahiynng - Daging Tuna loin ditennia dalaiii kondisi QC - Mutu hahan - Setlap l>ahan " DiUilakjika tidak 2019
bahan bahi masukke unit beku. - Snhii baku masuk sesuai dengan Chapter?
pengolohan - Dilakukan pengecekan tcrhodap bahan - Residue logam - 2 kali dalam spesijikaii
diiclcnlijikasi, seban}-ak 20 kg unluk sedap inik mclipnti berat setahun USFDA21 CFR117
seliiiigga bahan suhu, warna, teksiur, aroma, oleh QC bahan
yang diterlina hagus bahi - Residu histauune - Sam/jel diambil " Rijek lotjika
dan bchas dari - Dilakukan pengecekan logaiu berat dan sebonyak IS pes tenlapal ikan
kontaininasi dan histamine ikaii perlot/tnik dengan
dckoiiiposisi Lihal:SOP-J0l kaudungan
histamine
melelnhl 'lOppm

Weigliing I To know the weiglil - Raw materials are wciglicd based on spec/ QC Weiglil Everj'weigliing Reweigh No. 5 2 A / K E P M E N -
of incoming raw size and recorded in the record personnel KP/20I3
materials The weigliing is done quickly, while Cliapter ll.F.Sa
weigliing a niaNiiiuiiii of 1 hour.
" The temperature conlrollct! at 5*0 or below U S F D A 2 1 C F R 117

Pcninibangan I Uniukmengetaliiii " Bahan baku ditimbang berdasarkan spec/ QC Herat Setiap Di tinibang ulang
berat bahan bakii size dan dicatat dalam fonn penlmlxnigan
yang iiiasuk " Penlmbangan dilahikan dengan cepal,
waklu penlmbangan luaksimum 1 Jam
" Temperature dikontivl S'C alau Icblh
rendah

Internal validation J'repared B}', 1

Date: 10 November 2020

Signature: / \ Signature: \
Sri Handayani ^ Marlcnta Sembiring
Page 14
PT. T O B A S U I i l M I INDUSTRIES Doc. No.: TSI/SKP/GMP/FP-015
Ji Piilnii Pinmg2, faMUMedan
Revision: 00

Processing Step Goal Procedure Monitoring Regularly

Corrective Action Record
Tahapan Proses Tujuan Prosedur \Vlio What When Acuan

C o l d sloring Product is safely - C o l d room is set to point panel at: -25°C aiid Q C and Tcmpeniture E\'cry - Product w i l l be Recorder chart No. 52A/ K E P M E N -
stoie before storage icuipenilure is kept at - li5 °C Supervisor ofcold hour imnsfcr to the KP/2013
processed - Storing leiiipenitttrc is cliecked once cvcrj' hour by cold slorage storage spare cold slonigc Cold Storage Temperature Chapter lI.F.5a
the opcnilor and shoiiki be visible on the "recorder - Raidjusi mncliinc report
chart". Cliccking rcsnll is recorded on daily form Doc. N o . : U S F D A 2 1 C F R 117
- The cold air circitJalion is spread ci'cii!)' so Ilial all TSI/ENG/CRA-l/O?
carious can gel cnougii cold
- Use FIFO system
Refer to : SOP-054

Peiiyhnpamin Procbik Icrsiinpan - Suhu cold room di set /x)inl panel: -25° C, dan sulii QC dan Suhu Setiap - Produk aknn
beku autnii scbeluui di pcnyinipanan diperlahnnkan -IS "C Supeivisor penyinipanan Jam dipindahkan ke
produksi - Suhu penyimpannn dikonlrol satu jam scknii oleh cold slorage beku cold storage }vng
operator, dan dapal dilihat pada "recorder chart". lain
llasil penieriksaan ditulis dalam form harian - Readjust tnesin
- Slrkulasi udara dingin menyebar
- Menipergunakan sislein FIFO
Lihat :SOP-054

Tliiiw'ing F o r defrosting - Frozen cooked tuna loins is put inside chilled QC T i m e and Evcr\ Process i m m c d i a l c l ) C h i l l e d storage No. 52A/
room for 13 - 16 Iiottrs tempera! urc hottr and adding inspection report KliPMEN-KP/2013
- T h e temperature o f tliawcd frozen pre-cooked sufficient ice No. D o c . : Chapter l l . F . S a
tuna is maintained at not more tlian 4.'l''C TSI/HACCP/FM/CCIVI
Refer to : S O P - I 0 2 personnel 01 Fish and Fisher)'
PrcKliicts
Pehlehaii Unluk - Doging luna loin rebus beku dimasukkan dnlnm IVaktu dan Setiap Dengan segern T h a w i n g inspection Hazard and C o n t r o h
chill room dan dibiarknn sclamo 13-16Jam suhu Jam diproses dan report Guidance F D A
niehlchkan/ - Sidiu daging lima loin rebus yang lelah dlcairkan pcnambahan es Doc. N o . : Fourth E d i l i o i i -
mcncairkan dijaga dibawah 4,4°C QC yang cukiip TSI/HACCP/FM/CCM A u g u s t 2019
produk Lihat: SOP-102 01 Chapter 7

Internal validation Prepared B y ,

Dale : K)Novcmher202l)

Signature : V Sigiiiitiirc:
Sri Handajinii Marlcnta Sembiring

Page 15
PT. T O B A SURIMI I N D U S T R I E S Doc. No.: TSI/SKP/GMP/FP-015
JL Piilou Pinang 2, KJi\f II A-Ialiw
Rcxdsion: 00

Processing S!ep Goal Procedure Monitoring Regularly

Corrective A c t i o n Record
Tahapan Proses Tujuan I'rosadiir Wlio What When Acuan

Cleaning To obtain lender - Clc'iniiTg is pcrfoniicd to (rims and QC - Time E\'en' Reject If not nicel Cleaning Inspection repoH No, 5 2 A / K E P M E N -
tuna mc;il claiii remove dark meat and bones tliat still personnel " Temperature cooking specification No. D o c . : KP/2013
from the dark remains from fish meat " Cleaning sequence T S l / H A C C P / F M / C i R 01 Chapter II.F.5a
meat and bone - Done quickly, clean and aircfiiliy
- T h e product is not out o f refrigeration U S F D A 21 C F R
for morc than 4 hours conuilativcly 117

Pcinbersihnn Unhik - Penibersihan dilakukan unluk QC - Waktu Setiap Ditotakjika tidak

nseiulapnSkaii niembuang daging gelap dan sisa - Suhu urulan sesuai specifikasi
daging luna lulang yang niasih ada pada daging ~ Kebersihan painnsakan
yang bersili dari ikan. ikan
daging ge/ap - Penibersihan dilakukan dengan pisau
(Ian lulang - Waklu maksinium ikan berada diluar
pendingin tidak. lehih dari 4Jam
secara berturut - turut

Sorting T o get a whole - Sorting is done manually QC ' Time Every Reject i f n o t meet Sorting Inspection report No. 52A/
tuna meal - Intact tmia meat is sepcmtc from debris personnel " Tempcriitiire cooking specification No. Doc. : ICEPMEN-KP/2013
- M a x i m u n i lime being outside freezer is * Fish clean sequence T S I / H A C C P / F K V C S l 01 Chapter II.F.5a
less than -1 hours in a row
Ditolakjika tidak U S F D A 21 C F R
Sorfasi Unluk - Dilakukan [>enyorliran secara manual QC - iVaktu Seliap sesuai specifikasi 117
niendapatkan - Daging tuna yang utuh dipisah dari - Suhu urutan
daging luna hancuran ~ Kebersihan pemasaknn
yang utuh " Waklu maksinium ikan berada diluar daging
jjendingin tidak lebih dari 4 Jam
secara berturut - turut

Internal validation Prepared B y ,

D a t e : 10 November 2020
cd
Signature:
Signadirc; ( } ^ ^
Sri Handayani ^ Marlcnta Sembiring

P a g e \6
PT. T O B A S U R I M I INDUSTRIES
Doc. No.: TSI/SKP/GMP/FP-015
Ji Pulau Phimig 3, KIM 11 Medan
Revision: 00

Processing Slc[i Goiil Procedure Moiiiloriiig Regularly

Corrective A c l i o i i Record
Talitifian Proses Tujuan Prosedur Who Whal Wlien A cuan

Weigliing 11 To know the weiglil - Material weight as [x;r spec and recorded QC - Time E\'erj' 30 Reweigh N o . 52A/
ofnialcrial afler " Weighing done in an efficient mailer personnel - Tciupenilure minulcs KEPMEN-
sorting williin nia.\iimnii 1 hoar KP/2013
" Tcmperiitiirc controlled at 5 " C or below Chapter ll.F.5a

U S F D A 21
Peninibangan II Untuk mengetahui " Bahan ditimbang berdasarkan spec dan QC - imtu Sedap 30 Di timbang ulang C F R i 17
berat hahan yang dicatat dalam fonn - Suhu menil
telah di sortir " Penlmbangan dilakukan dengan cepat,
waklu penlmbangan makslmuni I Jam
~ Temperature dikonlrol 5°C atau lebih
rendah

Arranging inlo To insert the Inserting the product into plastic bag QC Time Every hour Reject i f docs nol No. 5 2 A /
plastic bag & product into plastic manually [wrsonnel meet the KEPMEM-
Final weighing bag and weighing specification KP/2013
Chapter ir.F6

U S F D A 21 C F R
117
Pcnyusunan Untuk memasukkan Memasukkan produk kcdalam plastic bag QC Waklu Setiap Jam Ditolakjika tidak
dalam plastic bag produk kcdalam secara manual sesuai spesifikasi
dan penlmbangan plastic bag dan
akiur ditimbang

Inlenial validation Prcpjircd B y ,

D a l e : 10 November 2020

Signalnrc: Signature:
Sri Handayani Marlcnta Sembiring

Page 17
PT. T O B A S U R I M I INDUSTRIES
Ji PuinuPinnns 2, K/MIhUeclan Doc. No.: T S I / S K P / G M P / n ' - 0 1 5
Revision: 00

Processing Step Goal Procedure Monitoring Corrective Regularly

Record
Tahapan Proses Tujuan Prosedur \Vlio What When Action Acuan

Vac un III To achieve Ihc proper Running machine before use. Cliecked Ihe quality o f sciiHng QC Result Evcr^' hour Reject ifnot Vacuum Sealing No. 52A/
scaling scaling plasiic, free ever)' hour or every lol nimiber personnel sail meet inspection rejHirt KEPMEN-
from conlaniinalioii Rcferto:SOP-!08 specification N o . Doc. : K:P/2013
TSI/HACCP/FM/FCL Chapter II.F.6
Pemvnkuman Unluk menilaiKitkan Uji coba niesin sebeluni digunakan dan dilakukan /jemeriksann QC l-lasll Setiap Jam Ditolakjika 04
ixnutupan dan plasli muln hasil seal sedap salu jam sekali alau sedap lot iiomor. seal tidak sesuai U S F D A 21 C F R
pouchc yang Lihat: SOP-J OS spe.iifikasi 117
senipurna, behas dari
kontaminasi

Mclal To nielal delecled - Clialleiigc the mclal detector with scnsllivity standards daily, Production Metal Contiinious Rejected Mclal dclecling Fish and Fisher)-
Delecting before start - up, evciy 4 honrs during production, wlicnever employee inclusion product report Products
processing factors change, and at tlieciid of processing, N o . Doc. : Mazard and
witli tester standard: TSI/HACCP/FM/CM Controls
Standard Fc : 2.5 mm DOI Guidance F D A
Standard Sns: 3.5 iiini Fourth E d i t i o n -
Standard non Fc : 3.0 mm August 2019
- A l l o f l h c product passes tlirongh an operating metal detector Chapter 20
- Metal detector operation sliall be recorded by Q C Staff.
- Result o f inspection arc recorded cverj- 15 minutes U S F D A 21 C F R
R c f c r l o : SOP-035 117

Deleksi Uniuk niendeteksi - Lakukan i?engecekan sensHifdns detector logam secara Karyawan Scrpiban Tents Produk
logain logam harian sebeluni dipakal, setiap 4 jam selama produksi, produksi Logam menerus ditolak
kapan saja factor proses berubah, dan pada akhir produksi.
dengan standard tester:
Standard Fc : 2.5 mm
Standard Sns: 3.5 mm
Standard non Fe : 3.0 mm
- Semua produk harus dicek melalul melal detector
- Pcngoi)erasian deleksi logam harus dicatat oleh slajf QC
- l/asil pengamatan dicatat setiap IS menit
Lihat: SOP-035

Intcnial validsition Prepared B y ,

Date ; 10 November 2020

f\h\ Signalnrc:
Sigualnre: / Vr^~^
Sri Handayani Marlcnta Sciiibiriiig

Page IS
 PT. T O B A S U R I M I INDUSTRIES
Doc. No.: TSI/SKI> / G M P / F P - 0 I 5
.//. Pulai! Phtaiig 2. KlMllMcihu
Revision: 00

Processing Step Goal Procedure Monitoring Regularly

Correclivc A c l i o n Record
Tahapan Proses Tnfuan Prosedur Who What When Acuan

Freezing T o f i c c z c l l i c product Freezing by tuiuicl for 2 - 4 QC - Temperature Ever)' - hiold & evaluate Contacl Freezer No. 5 2 A /
cooked tiuia loin liotirs personnel - T i m e freezing hour product since Monitoring FCEPMEN-
The temperature o f freezing at previous check No. Doc. : KP/2013
- 4 1 " C so thai liic product - Readjust conlacl TSl/HACCP/FM/FCF Chapter l l . F . S a
becomes frozen freezer machine 0!
Refer t o : S O P - 0 3 7 U S F D A 21
C F R 117

Pembekiian Membekiiknn produk Peinbchian dengan funnel selama QC - Suhu Seiiap - Menahan produk
daging luna loin 2-4 jam ~ (Vaktu Jam untuk cvaluasi
Suhu peinbekuan ~ 41 °C pembekuan sclanjutnya
sehinggo produk menjadi behi - Penyelelan mesin
Lihat: SOP-037 contact freezer

P n c k i n g and G o o d p a c k i n g and The fisii is packed manually Q C packing Packing Evoiy R e p a c k i n g or reject i f Packing inspection No. 5 2 A /
Inbcling meat lo llic label hour not meet s[)ecinealion report KEPMEN-
No, D o c . : KP/2013
TSI-I[/HACCP/FM/PI Chapter 11. F.6
01
U S F D A 21
Pengemasan Pengepakan yang Ikan dikemas secara manual QC Pengemasan Setiap Dikemas kembali atau C F R . 117
(Ian pelabelan balk dan sesuai pengemasan Jam ditolakjika tidak
dengan label sesuai dengan
spesifikasi

Intcnial validation Prepared B y ,

Date: 10 November 2020

Signature : Signature: \
Sri Handayani ft Marlcnta Sembiring

Page 19
PT. T O B A SURJMI I N D U S T R I E S Doc, No,: TSI/SKP/GMP/FP-015
JL Pulau Ptnang2, KJUUUedan Revision: 00

Processing Step Goal Procedure Monitoring Regularly

Corrective A c t i o n
Tahapan Proses Tujuan Prosedur Who Wliat When Acuan

C o l d storing Product is safety - Tiie temperature o f c o l d storage Q C and Temperature o f Every hour - H o l d & evaluate Recorder chart No, 5 2 A /
Store before is controlled at Supervisor cold storage product since KEPMEN-
exported -18"C or below cold storage previous check Cold Storage KP/2013
- The cold air circulation is - Readjust machine Temperature report Chapter II.F.6
spread evenly so that a l l No. Doc. :
cartoons can get enough cold TSl/ENG/CRM/07 U S F D A 21 C F R
- U s e F I F O system 117

Penyimpanan Produk tersimpan - Suhu cold storage dikonlrol OCdan Suhu cold Setiap jam - Menahan produk
beku aman sebelum di pada -18'''C atau lebih rendah Supervisor slorage untuk evaluasi
export - Sirkulasi udara dingin cold storage selanjutnya
menyebar - Readjust mesin
- Mempergunakan sistem FIFO

Stuffing Stuffing the Checked the container condition. QC Temperature Ever)' Repacking or reject i f not - Logger data No. 52A/
product into refer Container is washed, and than persormel container stufTing meet specification - Stuffing inspection KEPMEN-
container cooled setting the temperature at report KP/2013
-20'^C. Stuffing is done carefully No. Doc, : Chapter II.G
and as quickly as possible T S I / H A C C P / F M / S T 01
U S F D A 21 C F R
117
Pemasukan Menaikkan produk Dilakukan penieriksaan kondisi QC Suhu continer Setiap Dikemas kembali atau
dalam kontiner kedalam kontiner kontiner. Kontiner dicuci kemudian pemasukan ditolak jika tidak sesuai
yang telah diset suhunya pada -20°C. dalam dengan spesifikasi
ditentukan "Stuffing" dilakukan dengan had- continer
hati dan secepat mungkin

Internal validation Prepared B y ,

Date ; 10 November 2020

Signature: Signature :
\
Sri Handayani Marlenta Sembiring

Page 20
PT. T O B A SURIMI I N D U S T R I E S
Doc. No.: TSI/SKP/GMP/FP-015
Ji Pulau Piiiaiig 2. KJMJlMeclau
Revision: 00

Processing Slep Goal Procedure Monitoring Corrective Regularly

Record
Tahapan Proses Tujuan Prosedur Who What When Action Acuan

Plastic bag T o niid good - When the empty plastic b;ig is received, deliver,' condition is QC Defect Incoming Reject if [lot Incoming plastic No. 52A/ K E P M E N -
incoming plastic bag fnie checkc<l. A n y physical dcrecls arc identified [wrsoEuiel plastic bag plastic bag meet insjKction report KP/2013
from dcrecl - Inspection on the plastic poach arc done by sampling specification Chapter 1I.F.6
No. Doc. :
ciieckcd
TSI/HACCP/FM/
- Plastic poach are kept in dr^' room and away from all liazard
and rodents. Tlie storage is arranged in "First In First Ont" FSS05 USFDA21 CFR117
procednre
Refer to : SOP-02'J

Penenmaan Unluk - Ketika plastic hag diterinia, dilakukan penieriksaan QC Kerusakan Penerimaan Ditolakjika
plastic bag niendapatkan lerhadap kondisi pengiriman dan dUdentifikasikan plastic bag plastic bag tidak sesuai
plastic bag kerusakan fisikyang nyata dengan
yang bogus, - Dilakukan penieriksaan lerhadap plastic pouch dengan cara spesifikasi
bebas dari penganibilau sample
kerusakan - Plastic pouch disimpan dalam kondisi yang balk diniana
ruang penyimpanan kering dan jnuh dari semua baliaya dan
binatangpengerat. Penyimpanan jiiga diatur /disusun
sehingga stock yang lama dapat dif)ergunakan terlebih
dahiilu (First In First Out)
Lihat: SOP-029

Packaging T o kepi - Packaging is kept in dry room and away from all hazard and QC Cleanliness Every day Re-c!ejincd Warehouse No. 52A/ K E P M E N -
stonigc packaging away rodents. The storage is arranged in "First In First Out" room and sanitation and KP/20I3
from procedure packaging maintenance Chapter II.F.fi
contamination inspection record
personnel
N o . Doc. :
Penyiiupanan Unluk menyimpan - Kemasan disimpan dalam kondisi yang baik dimana ruang Kebersihan Setiap hari Dibersihkan TSI/QC/Sani(ation/
kemasnn keniasan agar fKnyimpanan kering dan jaiih dari semua hahaya dan ruaiigan dan ulang FM/07
tidak binatang pengerat. Penyimpanan juga diatur / disusun kemasan
QC
terkontaniinasi sehingga slock yang lama dapat dipergunakan terlebih
dahulu (First In First Out)

Internal validation Prepared By,

Date : 10 November 2020

Signature: Sigiiatnn::
Sri llandayani Marlenta Sembiring

Page 21
 PT. T O B A SURIMI INDUSTRIES
Doc. No.: T S I / S K P /GMP/l"P-0I5
.//. Pulau Pinaug 2. KIM 1! Medan
Revision: 00

Processing Slep Goal Procedure Monitoring Regularly

Corrective Action Record
Tahapan Proses Tujuan Prosedur Who What When Acuan

Ciiilon - T o find good carton - When the incoming carton arc QC - Defect carton - Incoming - Reject ifnot specification " Incoming Master/ N o . 52AI
Incoming Tree from defecl rccei\'cd, delivcrj' condiliori is personnel ciirlon linicr Carton report KEPMEN-
- T o cnsnre lhal all checked, and physical defects arc - Carton labels for - Random - Segregate and destroy any N o . Doc. : KP/2013
carton have identified the presence of a sampling, carton slock that docs not TSI/HACCP/FM/Fl Chapter
information or'"Keep - Inspection on Ihe carton arc done "keep frozen contain the proper MOl I1.F.6
frozen below by sampling checked below - IS^C" inco[iiing slalenieni " Daily Master/ Inner
- 18°C" and "contain Refer l o : SOP-053 stalemcnt and the carton - Determine and correct the Ciidon report U S F D A 21
allergen (fish)" presence o f crab ciiusc o f Improper carton No. Doc. : C F R 117
written on it declaration TSl/lIACCP/FM/Fl
M 02
Penerimaan - Unluk niendapatkan - Ketika karlon diterinia, dilakukan QC - Kerusakan - Penerimaan - Ditolakjika tidak sesuai
Carton carton yang bogus, /Knieriksaan lerhadap kondisi karlon karton dengan spesifikasi
bebas dari kerusakan /Kngiriinan dan dUdentifikasikan -Adanya label - Pengambilan - Pisahkan dan hancurkan
- Untuk niendapatkan kerusakan fisikyang nyata. "keep frozen sam/xl stok karton yang tidak
karlon yang - Dilakukan penieriksaan lerhadap below-IS°C" secara ada kalimal/ tulisan yang
berluliskan informasi karlon dengan cara pengambiIan dan Random, benar
"keep frozen below — sample "mengandung setiap - Tenlukan dan koreksi
l^C'dan Lihat: SOP - 053 kepiling" pada penerimaan fxnyebab karton yang
"mengandung karlon karton tidak benar
allergen (psh)"

Carton slorage T o kept Carton away - Cartons are kept in dr^' room and QC Cleanliness room Every day Re-cleaned No. 5 2 A /
from contamination away from a l l hazjird and rodents. personnel KEPMEN-
The storage is arranged in "First In KP/2013
First Out" procednre Cliiipter
11.F.6
Penyimpanan Untuk menyimpan karlon - Karlon disimpan dalam kondisi QC Kebersihan Setiap hari Dibersihkan ulang
karlon agar tidak yang baik diniana ruang ruangan U S F D A 21
terkontaininasi penyimpanan kering dan Jauh dari C F R 117
semua bahaya dan binatang
pengerat. Penyimpanan Juga diatur
/ disusun sehingga slock yang lama
dapat dipergunakan terlebih
dahulu (First In First Out

Internal validation Prc[xircd B y ,

Date : 10 November 2020

A A \ Signature: I
Signature: / \ \ A /
Sri Handayani V^"' Marlcnta Sembiring

Page 22
PT. TOBASUlllMl INDUSTRIES
Jl. Pulau Pim)tg 2. KIMmicdon Doc. No.: TSi/SKiYSSOP/rP-0i5
Revision: 00

10. PROGRAM P E M E N U B A N PERSYARATAN PROSEDUR OPERASI STANDARD SANITASI

(STANDARD SANITATION OPERATIONAL PROCEDURE)

GonI Procedure Monitoring Regiilnrly

Subject Corrective Action Record
Tujunn Prosedur Who What When Aciian

VYnlcr TIic water ~ Tlic walcr used is well QC - Visual check : Odor, color, Evciy' day If water is deemed Chlorine Icsl for water No.'192/MENKES/
snfcly nsccJ is treated and in accordance Personnel Instc unsafe, the production Ircnlnicnt form PER/lV/2010
cleaned with the drinking water lot in touch with il will No. D o c . : TSI/Lab/FM/ O'J
and staiidard. be put on hold for N0.52A/KEPMEN-
satiitaiy " Water is kept in scaled - Internal Micro analysis : -'fwice a target sampling and Microbiological analysis KP/2013 Chapter li
distribution tub 'JTC, llcoli, Conform. month testing No. D o c . : TSl/Lab/FM/03
" Distribution tub is sanitized S.aursus, Kcholerae, EU Rcgiihtioii
every two weeks Salmonella 852/2004 Annex II
Refer to : Manual water - E.\tcrnal micro analysis : -Ever}' 3 Test analysis reiwrt Ch.VII
treatment and steam ILcoli. Coliform, Enlerococi months
- External ciicniical and -Evcrj' Test analysis report USFDA 21 C F R
physical analysis i'car 117

Keoimnan Air yang " Air)xing dlgunakan adalali QC - Pcmeriksaan secara visual: Setiap hari Jika air dianggap
Air dipalcai air yang sudah di Ircalmeni aroma, warna, rasa tidak ainan,
bcrsili dan dan sestiai dengan standard - Analisa mikro inlernal: 'Oua kali production lot yang
saniier air minwn. rPC, E.coii, Coliform, sebidnn terkena Iangsung air
~ Air disimpan di bak S.aurcus, V.cholcrae, terscbut akan diiahan
distribiisi yang lerhnici Salmonella -Setiap 3 untuk pengambilau
- Hak disiribusi disanitasi - Analisa mikro external: biitan sample dan pengtijian
sen'ap salii kali dalam 2 ILcoli, Coliform, Enicrococi
mitiggu - Analisa h'mia dan fisika -Sekali
Uiml: Manual water external seialnin
Ircalmeni ami sleam

Inlcnial ;'alidation Prepared By, i

Date: 10 November 2t)20

Sigaaiurc:
Sri Hnndayani
v
\y
\\/ Signature:
Marlcnln Scmbiring
\

Page 23
PT. TOBA SURIMI INDUSTRIES
Doc. No.: TSI/SKP/SSOP/FP-0I5
M. Pulau Pinang 2. KIMIhUedan
Revision: CX)

Goal Procedure Monitoring Corrective Rcgularl}'

Subject Record
Tiijuan Prosec/nr Wlio What When Action Acuan

icc safety The ice a. Blocks ice QC - Visual ciieck : Odor, color, Evciy day The ice that In note book No.
used is " Icc is purchased only from approved supplier Personnel taste does not 492/MENK:ES/
clean and " Icc [nust be delivered in a clean container and well - Interna! Micro analysis : -Twice a meet the Microbiologica PER/IV/2010
sanitar}' covered lid TPC, llcoli, Coliform, month standard is 1 analysis
" Ever;' incoming icc is inspected for the quality and S. aureus, Kcholerae, rejected or No. D o c . : No. 52A/
quantity Salmonella replaced TSl/Lab/FM/03 KEPMEN-
" Icc is put into t!ic ice grinding machine - ENtenial micro analysis : -Ever)' 3 KP/2013
" Icc will then be kept in clean chilled hoK and scaled E.coii, Coliform, Enlerococi months Test analysis Chapter II
before distribution report
Refer to : SOP-084 E U Regulation
b. Flakes icc 852/2004 Annex
" Flakes icc used is the production of PT. Toba II Ch.VII
" Flakes ice produced using clean water
Refer to : SOP-138

Kcamanan lis yang a. Es balok QC - Pemeriksaan secara visual. Setiap hari Es yang ddak
lis dijKiicai - Es dilerima dari supplier yang sudah di approve aroma, warna, rasa mementihi
bersili clan ~ Es dilerima mcnggunakan bak terlulup dan bersih - Analisa mikro internal: -Dua kali standard
saniier - Setiap penerimaan es diperiksa mutu dan Jumlohnya TPC. llcoli, Coliform, sebulan dirijek
~ Es dimasukkan kedalam mesin penggiling es S.aureus, Kcholerae, ataupun
" Kemudian es disimpan didalam chill box yang Salmonella diganti
bersih dan ditutup rapat untuk didistribusikan - Analisa mikro external: -Setiap 3
Libal: SOP-0S4 E.coli, Coliform, Enlerococi biilan
b. Flakes ice
' Flakes ice yang dlgunakan adalab hasil produksi
sendiri
'Flakes ice diproduksi menggunakan air bersih
UhatS0P-l3S

Inlcnial validation Prepared Bj', t

Date: 10 November 2020

f\\\ A
Signature: Signature: \
Sri Handayani Miirlcnta Scmbiring
Page 24
PT. TOBA SUl^IMI INDUSTRIES Doc. No,: TSI/SKP /SSOP/FP-015
Jl. Pulau Phiang 2. KJM U Mechn Revision: 00

Goal Procedure Monitoring Corrective Regularly

Subject Record
Tiijuan Prosedur Who What Wlien Actioti Acuan

Condilioii of All the Atler tlic production all the equipments QC Cleanliness and E;'er)' Re- wash Personal Hygiene, Plant No. 52A/ K E P M E N -
equtiJiucnt and cquipmeiUs and and utensil are cleaned with liquid soaps Personnel sanitan,' day Sanitation & Mainlciiaiicc KP/2013
utensils utensils Hint is and llien brushed and rinsed with 100 ppm equipment and Inspection Rcpor! Chapter I1.F.3
in direct contact chlorine walcr. During the processing Ihcy ulcnsil No. Doc.:
with the arc bmshed with soap and rinsed with 100 TSimACCP/FM/PC22 E U Regulation
product is clean ppm chlorine water. Before the prcxiuction, 852/2004 Ch. V
and sanitary' they arc rinsed with 100 ppm chlorine
water. 21 C F R 123
Refer to Cleaning Manual, Page : ! 7
U S F D A 21 C F R 117

Koudisi Seluruh Seluruh pcrlengkapan dan peralalan QC Kebcrsihan dan Setiap Pencucian
pcr/engk-npan peralalan dan setelah selesai produksi dibersihkan sanilasi hari ulang
dan alat - ala( perlmgkapan dengan menggunakan sabun cair pcrlengkapan
yang koniak kemudian di sikal dengan bnish dan dan aim ~ alal
dengan produk disiram/ dibilas dengan airklorin lOOppm.
bersih dan Pada saal proses sedang berlangsung
saniier disikal dengan bnish dengan
menggunakan sabun dan disiram dengan
airklorin lOQppm. Pada saal sebelum
produksi, dibilas dengan air klortn
lOOppm.
Liliai cleaning manual Hal :17

Internal validation Prepared By,

J
Dale : 10 November 2020

SIgnalurc:
Signalurc: [ \/V\
Sri ilaudayaiii Marlcnia Scmbiring

Page 25
PT. TOBA SURIMI INDUSTRIES
Jl. Pulau Piiinns 2. KIM IIlUedaii Doc. No.: TSI/SKP/SSOP/l- '-015
Revision: 00

Goal Procedure Motiitoring Corrective Regularly

Subject Record
'I'ujuan Prosedur Who Wlint When Action Acuan

Cross Tlic equipments. a. Workers or equipments used with raw QC Equipment, Ever;' If the equipTuent Personal H^'giciic, Plant No. 52A/ K E P M E N -
contaminnlion work utensils and material, processing and finished product personnel utensils and day has been used Sanitation & KP/20I3
workers utensils nuisl be separated workers then it is Maintenance Inspection Cliaplerli.F.3
and workers used b. Supervisors maintain that evcrj' worker must separated sanitized/ Report
with the raw clean and sanitize tlieir hands, gloves, and Re-washed. If No. Doe.: EU Regulation
material cantiol be work outfits. Su]>ervisors and technical ill-contact with T S I / H A C C P / F M / P C 22 852/2004 anne.v:II
in direct contact olTicers that go back and forth in the product then the Ch. 11, Ch. I X
with frozen processing line must always clean and product is
product sanitize their hands, gloves, and work outfits. separated and U S F D A 21 C F R
analy/xd 117

Kontamlnasi Feral atan, a. Kaiyawan maupun peralatan yang dipakai QC Pemisaban Setiap Jika peralatan
si long pcrlengkapan kerja pada balian baku, proses dan finished peralatan, hari lerpakai maka
maupun pekerja produk dibuat terpisah. pcrlengkapan disanitasi/ dicuci
yang cllpergunakan b. Supervisor inenekankan bahwa sedap kerja dan ulang. .Jika
pada bahan baku karyawan harus membcrsihkan dan karyawan kontak dengan
ddak boleh inensanitasi tangan, santng tangan, dan produk maka
berscntuhan pakaian kerja. Supervisor dan petugas teknik produk tersebut
dengan bahan yang mondar mandirpada alur proses dipisah dan
yang sudah produk harus selahi membcrsihkan dan dianalisa
dibekukan mensanitosi tangan, sarung tangan dan
pakaian kerja.

Internal ;'iiIidalioa prepared By,

Dale : 10 November 2020

Signature:
A
I \
Signature:
Sri Handayani ^ v Marlciita Seinbiring

Page 26
PT. TOBA SURIMI INDUSTRIES
Jl. Pulau Pinang 2. Kh\-I II Malon Doc. No.: TSI/SKP/SSOP/FP-0I5
Rcwsioii: 00

Goal Procedure Monitorin P Corrective Regularly

Subject Record
Tujuon Prosedur Wiio Wiial When Action Acuan

Facility for Facility for hand a. Facility for !iand \vashing and sanitation is QC Facilit)' Before the If the facility Persona! Hygiene, Plant No. 52A/ K E P M E N -
hand washing and available on even,' entrance of production room personnel hand starting and is not well Sanitation & KP/2013
washing, sanitation is b. Foot washing arc also available on ever)' washing ever)' hour cquipijcd. Maintenance Inspection Chapter II.F2.b7
fool available in each entrance of production room then it must Report
washing processing step c. Facilil;' for hand washing and sanitation are be equipped No. D o c . : USFDA21 CFR
where ever}' also available on ever}' beginning and end of as soon as T S I / H A C C P / F M / P C 22 117
worker must get contaminated and back to work again to the possible
used lo washing processing flow.
their hands d. The resting room is equipment with facility for
properly hand washing, antiseptic soap
c. Facility for hand washing must be always
checked by Q C supervisor before tiie starting of
production and every hour during tlic
production time

Fasiliias Fasilitas cuci a. Fasilitas cuci tangan dan sanitasi tangan QC Fasilitas Sebelum Jika fasiUtas
ciici tangan dan berada disetiap pintu masukruang proses. cuci proses tidak lengkap
tangan. sanitasi tangan b. Tetnpat cuci kaki juga berada disetiap pintu tangan produksi maka dengan
cuci kaki tersedia disetiap masuk niang produksi. berlangsung segera
tahapan proses c. Fasilitas cuci tangan dan sanilasi tangan juga dan sedap dllengkapi
diinana sedap berada pada setiap awal dan akhir jam
karyawan hams terkontaininasi dan kambali lagi bekerja ke alur
nmnbiasakan diri proses.
inareka untuk d Ruang istirahal dllengkapi dengan fasilitas cuci
mencuci tangan tangan, sabun antiseptic
dengan seksama e. Fasilitas cuci tangan selahi diperiksa oleh QC
pada saal diimdai dan setiap jam selaina
produksi berlangsung

Iiilcniiil validation Prepared By,

Dale : 10 November 2020

Signature: Signature:
Sri Handayani Marlenia Scmbiring

Page 27
PT. TOBA SURIMI INDUSTRIBS
JL Puloii Pimng 2, KIM IlMcclan Doc, No.: TSI/SKP/SSOP/FP-015
Re\'isioii: 00

Goal Procedure Monitoring Corrective Regularly

Subject Record
Tujnnii Prosedur Who What When Aclion A cuan

Toilcl Toilet fiicilily a. Toiiel facilily for men and ladies are scpanilcd al the resting-place and far QC Toilcl Everj' Rc-clcan Form pemeriksaan toilcl No. 52A/
facility is available and from Ihe processing room. In ever}' water closet. Good ventilation is pcrsoimcl facility and day No. Doc: KEPMEN-
siilTiciciit mast available. The ininibcr of toilet nnisl be made based on tlie nnmbcr of sanilar;' TSI/ QCAfoilct/ FM/01 KP/20I3
be kept in good workers. PT. Tob;i Snrimi Indiislries has 4 toilets for men and 15 loilcls for Chapter ll.F2.b7
sanitarj- ladies.
condition b. The clcjming scr\'ice staffs clean all the toilcl rooms every morniTig by USFDA 21 CFR
senibbing witli brush and delergenl, and then flushing willi clean \valer. The 117
cleaning sen'icc staffs arc responsible for the cleanliness and sanitary and Ihc
toilet facilily and their work result are monitored by QC. The results arc
recorded into the daily s;niilalion audit fonn
c. MaiiUenance division lakes care of toilcl facility so tliat it is functional and
well maintained.
Refer lo Cleaning Manual Page : 24

Fnsiliins Fasilitas toiiel a. Fasiliias toilet tersedia terpisnh bngi knrynwan laki - laki dan karya^van QC Fasilitas Setiap Dibersihkan
Toilet ynng ctikup perempuan di area! istirahal dan Jauh dari ruang fmigotahon. Selinp IFC dan hari kembali
harus tersedia dllengkapi dengan ventilasiyang baik Jumlah toilet harus bcrdasarknn kebersihan
(Ian (lij'aga Junilali koiyawan. PT. Toba Suriini Industries menilliki 4 toilet untuk laki - toilet
(lalaiii komlisi laki dan 15 toilet imtuk perempuan. Extra toilet disediakan untuk
so/liter dan mengantisifxisi f)eningkatan jumlah karyawan
terawat h. Pelugas kebersihan sedap pagi hari inembersihkan seluruh ntangan kainar
dengan baik mandi dengan earn menyikat yang menggunakan brush dan detergent,
kemudian disiram dengan air bersih. Petugas kebersihan bertanggungjawob
lerliadap kebersilian dan sanitasi maupun fasilitas toilet, dan hasil kerjanya
dimonitor oleh QC. llasilnya dicatat pada form audit sanitn.ii harian.
c. Bagian maintenance nienjaga fasilitas toilet agar toilet dapat dlgunakan dan
berfungsi dengan balk
Lihat cleaning manual hnl: 24

Inlcnial validalion Prepared By, i

Date: 10 November 2020

Signature: (\f / A . Sigiialurc: \

Sri liauclayani Marlciua Scmbiring

Page 28
PT. TOBA SURIMI INDUSTRIES
Ji Piilmi Pinang 2, KJM U Medon Doc. No.: TSI/SKP/SSOP/I-P-015
Revision : 00

Goal Procedure Monitoring Regularly

Subject Corrective Action Record
Tujuan Prosedur Wlio What When Acuan

Handling of To keep the material a. Provide enongli waste bins QC Cleanliness Ever)' day Waste is disposed Personal H)'giene, Plant No. 52A/ K E P M E N -
Waste from being conipicle witli lids personnel waste bins as soon as possible Sanitation & KP/2013
contamination b. Dispose waste inside t!ie Mainlennnce lns|x:ction Chapter II.F.3
provide bins Report
c. The waste bins nuisl be cleaned No. D o c . : E U Regulation
by eveiy day T S I / H A C C P / F M / P C 22 852/2004 Ch.VI
Refer to : Cleaning Manual page:23
USFDA 21 C F R 117

Penanganan Uniiik menjaga a. Menyediakan Icmpat sampah QC Kebersilian Sedap hari Sampah dibuang
sampah bahan supaya lidok yang cuknp dan diberi pemiltip lempal secepalnya
lerkonlaminasi b. Membuang sampah pada sampah
lempal yang sudah disediakan
c. Tempai pcmbuangan sampah
dibcrsiiikan sedap Iwri
Lthai: Cleaning Manual, Hal: 23

Inlcnial \'alidalioa Prepared Bj',

Date : 10 November 2020

Signalure:
Sri Handayani
L\}Y\/ Signature:
MarleiUa Scmbiring

Page 29
I>T. TOBA SURIMI INDUSTRIES
Doc. No.: TSI/SKIVSSOP/I-P-015
Jl. Pulau Pinang 2, KIM llMedan
Re;'i3ion: 00

Goal Procedure Monitoring Corrective Regularly

Subject Record
Tujuan Prosedur Who Wliat When Action Acuan

Prevcnlion of Produci, ulcnsil, ii. A l l cleaning eoniponents and s:initalion malerials used by QC Label/ using Every Keep Ihe "noii Personal Hygiene, Plant No. 52A/
rnlsificiUiou/ and its packaging processing units arc clearly identified and separalctl from personnel ehemieal day food gnide" Sanitation & KEPMEN-
luisusage uuist be protected processing area and cverT,' lubricants and clicniiails. Tlic diila lunterials likely material in a Maintenance Inspection KP/20I3
from forgcrj' of siieet regarding safely of all cleaning and sanitized agents is lubricants, sepamtc place Report Chapter n.F2.b8
clejuilng agents, kept ill Ihe warehouse. sanitized agent from the No. Doe.:
lubricants, or b. Food-gnidc lubric;inls arc kept separately from lliosc of non- etc production TSI/HACCP/FM/PC 22
clieniieals and food grade and labeled correctly room. E U Regulation
physiai! and c. Maiiilcnaiice / ccjuipmeni division keeps all the nou-food grade 852/2004 Annex
physical hibricanls/ cheniiciil in the mainlciKiace room and label llicni 11 Ch. IX
conlaiuinants corrcclly.
d. QC inspccis Ihc processing room every day during the USFDA 21 CFR
production to find out the possible contaminating sources and 123
assure and lhat lo.\ic malcrial is kept and labeled correctly. The
result is recorded inio daily audit sanitation form. USFDA 21 CFR
117
Pencegahan Produk, alal- a. Seluruh komponen pembersih dan bahan - bahan sanilasi yang QC Label/ Setiap Menyimpan
pcnialsuan/ alat (Ian dlgunakan oleh unit pengolahan diidentifikasi secara jelos dan penggunaan hari bahan yang
salah pengemas produk dipisahkan dari area pengolahan dan setiap pelumas dan bahan bahan - bahan "non food
peniakaian harus dilindungi kimia. Lembaran data perihal kcauianann seluruh bahan kimia seperti grade "
dari i>emalsuan/ pembersih dan bahan sanitasi disimpan dalam gudang pabrlk pelumas, ditenipat yang
salah iTemakaian. b. Pelumas food grade disimpan terpisnh dengan pelumas non- bahan saniter terpisah
Bahan fxlunias, food grade dan diberi label .secara benar dan lain - lain dengan
bahan bakar, c. Bagian perawatan/perlengkapan menyimpan semua Jenis ntangan
bahan—hohan pelumas/ bahan kimia yang tidak food grade diruang perawatan produksi
sanilizer, dan memberi label secara benar.
serpihan logam, d. Pengawas mutu mengimsjieksi ruang i>engolahan setiap hari
atau konlaininasi selama proses berlangsung untuk mengetahui kemungkinan
khnia dan Jisik. sumber kontamlnasi dan menyakinkan bahan beracun disimixm
dan diberi label dengan benar hasilnya dicatat dalam form
audit sanitasi harian.

Inlcnial validation Prepared By,

Dale: 10 November2020

Signature : Signalure:
Sri Handayani Marlenia Scmbiring

Page 30
PT. TOBA SURIMI INIDUSTRIES
M. Pulau Pinang 2, miUMadan Doc, No.: TSI/SKP/SSOP/FP-015
Rcv-ision: 00

Goal Procedure Monitoring Regularly

Subject Corrective Action Record
Tujuan Prosedur Who What AVIien Acuan

Personal a. Workers a. Newly hired workers must do HRD Personal " Ever}' newly Sural kelcrangan berbadan No. 52A/ K E P M E N -
hygiene working in Ihe medical cheek up with a doctor hygiene hired workers schat KP/2013
processing room b. Periodical medical check up is HRD " Ever,'year Chapter 11.F.4
nuisl be healthy conducted once a year QC " Ever)' day n. Moved to Pcisonal Hygiene, Plant
and free from c. Sisk workers, with illnesses such ns personnel division with no Sanitation & Maintenance E U Regulation
contagious cough, diarrhea, llu, hand wound direct contact Inspection Report S52/2004 Ch, VIII
diseases will be sent home with the product No. D o c . :
b. Sent home T S I / H A C C P / F M / P C 22 U S F D A 21 C F R
b. Working a. Workers uniform are changed QC Workers " Every da}' Sent home 117
equipments must ever^'day based on the schedule personnel uniform
be clean provided
Refer to : cleaning manual, page: 15

Kesehatan a. Karyawan yang a. Karyawan yang baru masuk HRD Kesehatan - Setiap katyawan
pribadi bekerja memeriksakan kesehatan kc Dokter pribadi yang bam masuk
dsruangan b. Dilakukan pemeriksaan kesehatan ~ Setiap lahun
proses harus secara berkala sedap sclahun HRD
berbadan sehat sekali. " Setiap hari n. Dipindohkan
dan bebas dari c. Kaiyawan yang sakit seperd batuk. QC kebagion yang
peuyakil inemdar diorejiu, tangan luka akan tidak kontak
dipulangkan. dengan produk
b. Dipuiongkan
a. Pakaian karyawan digand sedap
b. Pcrlengkapan hari sesuai dengan jndwal yang QC Seragam - Setiap hari Dipulangkan
kerja liarus sudah ditentukan karyawan
bersih What: cleaning manual, Iiai:l5

Intenial validation Prepared By,

Dale : 10 November 2020

A {
Signalure: (/ \J Signalun::
Sri Handayani Marlcnia Scmbiring

Page 31
PT. TOBA SURIMI INDUS'llllES Doc. No.: TSI/SK1VSSOP/I"I'-015
Jl. I'lihul'InaiigZfClAfllMedaii
Rc\'ision : 00

Goal Procedure Monitoring Corrective Regularly

Subject Record
Ttijiian Pro.sedur Who \\1iat When Action Acuan

Pesl The area in the PT. Toba Suriuii Industries uses contracted QC Rodent Twice a The factor}' Enviromuenl sanitation N o . SIM tCEPMEN-
Mnuagcniciit processing units is service for Pest Control. Wire mesh is pcrsomiel and insects month area is ins])Cction report K:P/2013
cNcmpt from rats, installed in the building to prevent liie and third cleaned up No. D o c : Chapter ll.F2.b5
insects, bird and entrance ofbirds. Observations are recorded [)art TSI/QC /FM/Sanitation 01
otlicr pests. in the daily sanitation audit fonn. If dead E U Regulation
pests due lo pest eonlro! ehemieal arc found, 852/20 04 Annex 11
the animals arc iiimiediatcly disposed by Ch. IX
putting into closed container and buried.
Refer lo SOP-073 U S F D A 21 C F R
117

Manogenieril Jraal di unil PT. Toba Suhmi Industries meinpergunakan QC dan Binatang Dua kali Ungkungan
hama pengolahan hams jasa konlrak terhadap Pest Konlrol. piltak kedga pengeral sebulan pabiik
bebas dan hewan Bangunan dipasang kawai ka.s'sa untuk dan dibersihkan
pengeral, mencegah masuknya buning. Observasi serangga
serangga, bwvng dicatat pada form audit sanitasi harian.
atau haina Apabila diteimd binatang pengganggu yang
lainnya. ma!i karena terkena bahan kimia peinbasmi
hama maka binatang tersebut segera
dibuang dengan cara memasukkatmyo
kedalam suatu wadah yang terlulup dan
dikubur.
Li/iatSOP'073

IiUcnial valid;iiion Prepared By,

Date: 10 November 2020
a
Signahirc:
Signature:
Sri HaiidajTini Marlcnia Scmbiring
\
Page 3 H
PT. TOBA SURIMI INDUSTRIES
Doc. No.:TSI/SKP/Labcls/FP-0I5
Jin. Pulau Pinang 2, KIMIIMedan
Re^'isioIl: 00

11. P E L A B E L A N

1) The finished product labeled is follows :

Produk akhir diberi label yang membawa infomiasi sebagai beiikul:

Name of the product

Nama produk

List of ingredient
Dajiar kandimgan bahan

Net weight
Berat bersih

Bar code
Bar code

Importer/distributor
Pengimpor/ Distributor

Buyer's brand
Merk dagang pembeli

Country of origin
Negara penghasil produk

Allergen list
Dafiar allergen

2) The sanitizing agents, cleaning agents and specification will be checked by store keeper and QC staff
according to requirement/order
Bahan saniter, pembersih, pemberian label dan spesifikasinya diperiksa oleh pelugas giidang dan petugas
pengawas mutu sesuai keperhiannya.

Internal ralidation Prepared By,

Dale: 10 November 2020

Signature:
Marlenta Scmbiring

Page 33
PT. TOBA S U R I M INDUSTRIES
Jl. Pulmi Pinang 3. KLM IJMedan Doc. N o . : TSI/SKP/Product RecaIl/FP-0I5
Re\'ision: 00

12. PROSEDUR PENARBKAN PRODUK (RECALL)

1) Definitions
Peugertian
a Product recall
Product recall is an action taken to \vithdraw food products that have been distributed in the food c}'cle,
which has the potential to cause health problems / risks, or nonconformity in security, quahtj' and
nutrition requirements, and food labels, in an effort to protect consumers
Produci recall adalah Suatu tindakan yang dilakukan untuk penarikan produk pangan yang sudah
didistribusikan dalam peredaran pangan, yang berpotensi menimbulkan gangguan / resiko kesehatan,
atau ditemukan ketidaksesuaian terhadap persyaratan keamanan, mutu dan gizi, serta label pangan,
dalam upaya untuk iTiemberikan perlindungan terhadap konsumen.

b. Product withdrawal
Product withdrawal is anj' measures aimed at achieving the remm of out-of-specification or unfit
products from business customers, but not fiom final consumers.
Segala tindakan yang ditujukan imtuk mencapai pengembalian dari spesifikasi atau produk yang tidak
layak daripeianggan bisnls, letapi tidak dari konsumen akhir.

c. Stock Recovery
Pemulihan stok
Actions carried out by food producers, hnporters or distributors in the form of correction or elimination
of food that has not been distributed or is still under supervision
Tindakan yang dilakukan oleh produsen, importer atau distributor pangan berupa koreksi atau
penghapiisan pangan yang hehnn diedarkan atau masih berada dibawah pengontrolan.

d. Depth of recall
Depending on the product's degree of hazard and extent of distribution, the recall strategy will specify
the level in the distribution chain to which the recall is to extend, i.e. wholesaler, retailer,
user/consumer
Berdasarkan pada tingkat bahaya produk dan tingkat disiribusi, strategi penarikan akan menentukan
tingkat dalam rantai distribusi yang dlgunakan untuk memperpanjang penarikan, yaitu g}-osir,
pengece?; pengguna / konsumen

e. Effectiveness check
Efektivitas pemeriksaan
The purpose of effectiveness checks is to verify that all consignees at the recall depth specified by the
strategy have received notification about the recall and have taken appropriate action
Tujuan pemeriksaan yang efektif adalah untuk memverifikasi bahwa semua penerima pada kedalanian
penarikair adalah ditentukan oleh strategi telah menerima pemberilahuan tentang penarikan dan telah
mengambil tindakan yaiig sesuai

Internal validation Prepared B}', 1

Date: 10 November 2020
/
Signature: / W Signature :
Sri Handaj'ani 0" ^ \ Ivlarlenta Sembiring

Page 34
PT. TOBA SURIMI INDUSTRIES
Ji Pulau Pinang 2. KIMIIMedan Doc. N o . : TSI/SKP/Product Recall/FP-015
Re^'ision: 00

2) Forming product recall team

Pembentukan Team recall produk
Management fonns a team which is responsible for handling product recall.
Management membenluk team yang berlanggimgjawab untuk melakukan recall produk
Team consists of:
Team beranggotakan
a. Quality Assurance (Coordinator team), contact person : Sri Handayani, (061-6871022)
Quality Assurance (Koordinator)
Task : - Propose a request to management to execute product recall
Tugas: Mengajukan siwatpemiolionan recall produk
- Fix a schedule for product recall
-Menentukan jadwal pelaksanaan recall produk
- Organize the product recall and ensure its process Is in accordance with the established
procedmes
Mengkoordinir pelaksanaan recall produk sehingga berJaJan sesuai standard prosedur
yang ditetapkan
b. Production Manager (team member), contact person : Acuan (061-6871022)
Manager Produksi (Anggota team)
Task : Prepare aU related production records and data
Tugas : Mempersiapkan data - data produksi yang akan diperlukan dalam pelaksanaan recall
produk
c. Marketing Manager (team member), contact person : Misnani Wijaya (061-6871022)
Marketing (anggota team)
Task : Prepare all related correspondence file and purchase order with customers
Tugas : Mempersiapkan data - data marketing yang akin diperlukan dalam pelaksanaan recall
pivdiik
d. Export "Import Manager (team member), contact person : Febiy Chou (061-6871022)
Exim (anggota team)
Task : Prepare aU related documents and data
Tugas : Mempersiapkan data - data exim yang akan diperlukan dalam pelaksanaan recall produk
e. Warehouse supervisor (team member), contact person : Tuti Nurani (061-6871022)
Supen'isor gudang (anggota team)
Task : - Secure a space in warehouse for product recall
- Prepare all related documents and data
Tugas : - Mepersiapkan tempat digudang imtukpelaksanaan recall produk
-Mempersiapkan informasi yang diperlukan dalam pelaksanaan recall produk

3) To conduct investigation and coUect information in determining/ identifying the category the recalled
products:
Melakukan investigasi dan mengumpulkan informasi untuk menentukan / mengidentifikasi golongan
kelas produk yang di recall. Penarikan produk diklasifikasi atas 3 golongan yaitu :

Internal %'alidatioii Prepared By, .

Date: 10 November 2020

Signature: [ Signature: I
Sri Handayani Ivlarlenta Sembiring

Page 35
PT. TOBA SURIMI INDUSTRIES Doc. N o . : TSI/SKP/Product RecaIl/FP-015
Jl. Pulav Pinang 2. KIMIIMedan Re\'ision : 00

- Category I : products that cause a direct harm to health which may lead to death. E.g. products that are
positive for Salmonella, Listeria, C. botuiinum must be immediately recalled/ withdrawTi &om
distribution
Golongan Kelas I, yaitu : produk yang secara Iangsung mempengaruhi konsekuensi kesehatan yang
merugikan yang inenyebabkan kemalian
Contoh : produk teridentifikasi positif Salmonella, Listeria, C. botuiinum. Produk tersebut hams
Iangsung di recall/ ditarik dari peredarannya
- Category 11: Products that cause a temporary damage to health. E.g. use of unapproved additives
Golongan Kelas II, yaitu : produk yang Iangsung mempenganthi konsekuensi kesehatan yang
merugikan, namiin bersifat sementara (memerlukanwaktuyang bertahap)
Contoh .-penggunaan bahan tambahanyang tidakdisetujui
- Category n i : products that violate food regulations but do not cause harm/ damage to health. E.g.
K'lislabeling product spec
Golongan Kelas III, yaitu : Produk yang melanggar aturan federal undang ~ undang pangan, namiin
tidak menimbulkan konsekuensi kesehatan yang memgikan
Contoh : mislabeling spec produk

4) Identificarions of recalled products consist of:

Identifkasi produk yang akan direcall melipufi:
Name and type of products
Jenis/ nama produk
Production codes and dates
Tanggal dan kode produksi
Quantity
Quantity produk
Shipment date
Tanggal pengiriman produk
Destination / receiver name and address
Nama dan alamatpeianggan (buyer)
- Checkkg production record/ report and warehouse stock report to identify recalled products
Memeriksa catatan laporan produksi dan memeriksa kartu stok digudang untuk melakukan
traceability produk yang direcall

5) To place remaining of recalled products in hold area

Menempatkan sisa produk yang di recall pada daerah hold area

6) To investigate root cause of the recalled products by checking production/ QC records/ reports and to
mn tests on the remaining products in warehouse
Melakukan investigasi akar permasalahan penyebab recall dengan memeriksa Catalan laporan
produksi dan QC serta melakukan analisa sisa produk yang ada digudang

Internal \'alidation Prepared By,

Date; 10 No\'einber 2020

A / qj
Signiiture: ( Signature: 1
Sri Hairdayani Marlenta Sembiring

Page 36
PT. TOBA SURIMI INDUSTRIES
Jl. Pulau Pinang 2, KIMIIMedan Doc. No. : TSI/ SKP /Product RecalI/FP-015
Rewsion: 00

7) Giving information to distributor on the recalled product

Memberikan informasi kepada distributor tentang dataprodukyang ditarik tersebut

8) Report to authorize certification body Vtathin three working days of the decision to the issue recall.
Melapor ke badan sertifjkasi yang menerbitkan sertifikat dalam waktu tiga hari kerja tentang
keputusan imtuk penarikan kembali

9) To contact and submit written notification to competence authority (BKIPM fishing department) about
the problematic product needed to be recalled form buyer's country.
Menghubimgi dan membuat sural pemberitohuan secara tertulis kepada otoritas kompeten/ Fishing
Department BKIPM, bahwa ada produkyang bermasalah di Negara Buyer, sehingga hainis di recall

10) B K I P M team will conduct in^'estigation to Custom authority in North Sumatera that there is product
recaU and request for re-import permit to get them back to origin country.
Team BKIPM tumn ke lapangan untuk melakukan investigasi/penyelidikan, sehingga ditemukan akar
permasalahan imtuk menyelesaikannya

11) If necessary, conduct analysis on the recalled product to S K I P M laboratory

Jika diperlukan analisa product yang di recall ke Laboratorium SKIPM

12) Submit written notification to custom authority in North Smnatera that there is product recall and
request for re-import permit to get them back to origin country
Memberikan infonnasi secara tertulis kepada Direktorat Jenderal Bea dan Cukai Kanwil SUAPUT
Pabean Belawan, bahwa ada produk yang di recall dengan membuat sural permohonan, untuk
penarikan kembali produk ke Negara asal, dengan mengeluarkan surot izin masukproduk (Import)

13) Conduct official product recall

Tarikproduk secara resmi

14) Put Ihe recalled products in hold area

Tempatkan produkyang di recall di hold area

15) Destroy the recalled products and keep ^vritten record about the destmction
Produk dimusnahkan dan dicatat dalam berita acara pemusnahan dan catatan disimpan

16) Mock recall shall be regularly tested at least once a year

Mock recall dievaluasi minimal setahun sekali.

Internal validation Prepared By,

Date: 10 November 2020

Signamre: Signature:
Sri Handaj'ani Marlenta Sembiring

Page 37
PT. TOBA SURIIvfl INDUSTRIES
Ji Pulau Pinang 2. HM U Medan Doc. N o . : TSI/SKP/ Consumer's Complain/FP-015
Re^-ision: 00

13. CONSUMER'S COMPLAIN PROCEDURE

Prosedur Keluhan Konsumen

Production Raw Material

Department Department

# SuDuliers
Quality' Control Department
Action taken

Managing
Director Cold
Info "mation Information Storage

Action taker Information

Action taken Action taken

Production SHIPPING
Manager Marketing Department Deparmient
Information Information

Action taken laformation

BUYER (IMPORTER)

Information & Action taken

Action taken

Supermarkets & Shops

Information Action taken

CONSUMER

Diagram : Consiuner's Complain Procedure

Inleraal \'aIidation Prepared By,

Date: 10 November 2020

Signature: Signature:
Sri Handayani Marlenta Sembiring

Page 38
PT. TOBA SURINO INDUSTRIES
Jl. Puinu Pinang 2. KIMIIMedan Doc. No. :TSI/SKP/Pe]aliIiankar3'aM'aii/FP-015
Revision : 00

14. P E L A T I H A N K A K Y A W A N

Purpose:
Tujuan
Procedure in this part is used as guidelines to perform internal training
Proseduryong ada dalam bagian ini sebagaipanduan untuk melaksamkan peiatihan internal

Prosedur;

1. Create a training program

Membuat program training

2. Determine material to be trained

Menentukan materi - malerl yang akan diberikan

3. Determine training time

Menetapkan waktu training

4. Determine training personnel

Menetapkan personel training

5. Training method is done by direct practice, interview and/or questioner

Melode training dilakukan dengan prakiek Iangsung, test secara interview ataitpim dengan mengisl
questioner

6. Evaluate the training result

Setelah training maka dilakukan evaluasl training

7. Filed training attendance

Mengisl dafiar Iiadir tj-aining

8. Filed training history

Dibuat dafiar rfwayat peiatihan

Monitoring:
Pelaksanaan peiatihan internal dilakukan setiap bulan oleh HRD

Tindakan perbaikan :
Jika pelaksanaan peiatihan tidak dapat dilakukan, maka peiatihan internal dijadwalkan kembali

Pencalaian :
Pelaksanaan peiatihan internal didokumentasikan

Interna] validation prepared By,

Dale : 10 November 2020
/
A ^
Signature: Signalure:
Sri Handaj'ani N-Iarlenta Sembiring

Page 39
FT. TOBA SURIIvn INDUSTRIES
Jl. Pulau Pinang 2, KIMIIMedan Doc. No. : TSI/SKP/amandment/FP-015
Revision: 00

15. AMENDEiMEN

Nomor Bagian yang Uraian Tanggapan

No revisi Pengesahab
perubahan diubah Perubahan Perubahan

Internal v'alidation Prepared By, t

Date: 10 November 2020

Signature: [ Signature:
Sri Handayani ^- " I' Marlenta Sembiring

Page 40