Standard Operating Procedure

PENGIRIMAN ALAT KESEHATAN

Delivery of Medical Device
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PENGIRIMAN ALAT KESEHATAN

DELIVERY OF MEDICAL DEVICE

Nama dan Jabatan Tanda Tangan

Name and Designation Signature

Diajukan oleh Sadewo Jiwanggo

Proposed by
Logistic Officer Tanggal/Date:

Riani Resianingrum

Dikaji Oleh Logistic Sr. Assistant Manager Tanggal/Date:

Reviewed by

Retno Wulandari

Director Tanggal/Date:

Disetujui Oleh Bayu Ardhiawan Soedjarwo

Approved by

President Director Tanggal/Date:

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 Standard Operating Procedure

PENGIRIMAN ALAT KESEHATAN

Delivery of Medical Device
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DAFTAR ISI
TABLE OF CONTENTS

1. TUJUAN ....................................................................................................................................................... 3
2. SINGKATAN ................................................................................................................................................ 3
3. RUANG LINGKUP SCOPE .............................................................................................................................. 3
4. DEFINISI DEFINITIONS................................................................................................................................... 3
5. REFERENSI REFERENCE ................................................................................................................................. 3
6. TUGAS DAN TANGGUNG JAWAB TASK AND RESPONSIBILITIES .................................................................... 4
7. PROSEDUR PROCEDURE ............................................................................................................................... 4
8. RIWAYAT PERUBAHAN REVISION HISTORY .................................................................................................. 7
9. LAMPIRAN APPENDIX .................................................................................................................................. 8
10. DISTRIBUSI DOKUMEN DOCUMENT DISTRIBUTION ....................................................................................... 8
11. RIWAYAT PENGKAJIAN KEMBALI REVIEW HISTORY .................................................................................... 8

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 Standard Operating Procedure

PENGIRIMAN ALAT KESEHATAN

Delivery of Medical Device
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1. TUJUAN OBJECTIVES
Prosedur ini bertujuan memberikan petunjuk pemilihan, penanganan dan penilaian jasa pengangkutan
alat kesehatan agar memenuhi persyaratan yang diatur dalam CDAKB.
This procedure aims to provide guidance on the selection, handling and evaluation of medical equipment
transport services to meet the requirements set out in CDAKB.

2. SINGKATAN ABBREVIATIONS
Istilah-istilah yang terdapat pada Standard Operating Procedure mengandung makna yang sama seperti
yang dibawah kecuali:
The terms contained in the Standard Operating Procedure contain the same meaning as those below
except:
BODETABEK : Bogor Depok Tangerang Bekasi
STNK : Surat Tanda Nomor Kendaraan
QA/RA : Quality Assurance/Regulatory Affair
CDAKB/GDPMD : Cara Distribusi Alat Kesehatan yang Baik/ Good Distribution Practice for Medical
Device

3. RUANG LINGKUP SCOPE

Prosedur ini berlaku untuk seluruh proses pengiriman di PT. Ardia Perdana Indonesia.
This procedure applies to the entire shipping process at PT. Ardia Perdana Indonesia.

4. DEFINISI DEFINITIONS
4.1. Kontrak kerja adalah dokumen resmi perjanjian antara pihak ketiga dan pengusaha secara tertulis,
baik untuk waktu tertentu maupun untuk waktu tidak tertentu yang memuat syarat-syarat kerja,
hak dan kewajiban.
An employment contract is an official document of an agreement between a third party and the
employer in writing, both for a certain period of time and for an indefinite period of time which
contains terms of employment, rights and obligations.
4.2. Jasa Pengiriman adalah perusahan yang memberikan jasa untuk melakukan proses pengiriman
barang dari satu tempat ke tempat lain sesuai dengan perjanjian.
Shipping Service are companies that provide services to carry out the process of shipping goods from
one place to another in accordance with the agreement.

5. REFERENSI REFERENCE
Peraturan Menteri Kesehatan Republik Indonesia No.4 Tahun 2014 tentang Cara Distribusi Alat
Kesehatan yang Baik.
Republic of Indonesia Health Minister Regulation No. 4 of 2014 about Good Distribution Practice of
Medical Devices.

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PENGIRIMAN ALAT KESEHATAN

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6. TUGAS DAN TANGGUNG JAWAB TASK AND RESPONSIBILITIES

Level otorisasi dan tanggung jawab sebagai berikut:
The level of authorization and responsibility is as follows:
Penanggung Jawab
Individual Responsible
Admin logistik/Staff logistik
Logistic admin/logistic officer
Logistic Sr. Assistant Manager
Tugas dan Tujuan
Task & Responsibilities
a. Memberikan saran jasa pengiriman barang untuk bergabung
dalam program kerjasama PT. Ardia Perdana Indonesia.
Providing advice on freight services to join the cooperation
program of PT. Ardia Perdana Indonesia.
b. Mengatur pelatihan untuk jasa pengiriman.
Arrange training for shipping services.
c. Memantau kinerja dari jasa pengiriman.
Monitor the performance of shipping services.
d. Memberikan dokumen-dokumen pengiriman kepada kurir.
Provide shipping documents to the courier.
e. Mengambil dokumen-dokumen pengiriman.
Take shipping documents.
f. Menyimpan dokumen-dokumen pengiriman.
Save shipping documents.
a. Menyeleksi jasa pengiriman
Selecting an shipping service

QA/RA a. Melakukan pelatihan CDAKB kepada jasa pengiriman

Conduct CDAKB training for shipping services
Jasa Pengiriman a. Melakukan proses pengiriman sesuai CDAKB.
Shipping Service Carry out the delivery process according to CDAKB.
Staff Gudang a. Mempersiapkan produk untuk pengiriman sesuai dengan SOP
Warehouse Staff dan WI.
Prepare products for shipment according to SOP and WI.

7. PROSEDUR PROCEDURE
7.1. Pemilihan Jasa Pengiriman
The selection of shipping service
7.1.1. Admin logistik/Staff logistik melakukan pemilihan Jasa Pengirimaan dengan
mempertimbangkan aspek legalitas, kompetensi, fasilitas pengiriman, jaringan pelayanan,
kredibiltas, dan harga jasa pengiriman.
Logistics Admin / Logistics staff select Shipping Services by considering aspects of legality,
competence, delivery facilities, service networks, credibility, and the price of shipping
services.
7.1.2. Daftar penilaian kriteria Pemilihan jasa pengiriman terdapat pada LG-P03-F01 revisi terakhir
“Formulir Pemilihan Jasa Pengiriman”

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List of assessment criteria for the selection of shipping services is available in the latest
revised LG-P03-F01 "Delivery Service Selection Form"
7.1.3. Minimal nilai rata-rata dari hasil pemilihan jasa pengiriman adalah 3.
Minimum average value of the results of the selection of shipping services is 3.
7.1.4. Perusahaan Jasa Pengiriman harus melakukan kontrak kerja dengan PT Ardia Perdana
Indonesia dan harus disetujui dan ditanda tangani oleh direktur.
Shipping service companies must enter into a work contract with PT Ardia Perdana
Indonesia and must be approved and signed by the director.
7.1.5. Perusahaan Jasa Pengiriman harus mendapatkan pelatihan tentang CDAKB yang dilakukan
oleh QA/RA.
Shipping Service Companies must receive training on CDAKB conducted by QA / RA.
7.1.6. Evaluasi terhadap kinerja Jasa Pengiriman harus dilakukan secara berkala untuk proses
perbaikan.
Evaluation of the performance of the Delivery Service must be conducted periodically for the
improvement process.
7.1.7. Minimal nilai persentase hasil evaluasi kinerja jasa pengiriman adalah 70%.
The minimum percentage value of the results of the evaluation of the delivery service
performance is 70%.
7.1.8. Form Evaluasi kinerja Jasa Pengiriman terdapat pada LG-P03-F02 revisi terakhir “Evaluasi
Kinerja Jasa Pengiriman”.
Delivery Service Performance Evaluation Form is contained in the latest revised LG-P03-F02
"Delivery Service Performance Evaluation".
7.2 Proses Pengiriman
Delivery Process
7.2.1 Secara umum, barang yang akan dikirim ke area Jakarta akan dikirim dalam 1 hari kerja
setelah menerima CO (Customer Order), barang yang akan dikirim ke wilayah BODETABEK
akan dikirim dalam 1 hari kerja/hari berikutnya setelah menerima CO (Customer Order),
sementara barang diluar JABODETABEK akan dikirim dalam 1 hari kerja/hari berikutnya
setelah menerima CO (Customer Order).
In general, goods to be sent to the Jakarta area will be sent within 1 working day after
receiving a CO (Customer Order), items to be sent to the BODETABEK area will be sent
within 1 working day / the next day after receiving a CO (Customer Order) , while goods
outside JABODETABEK will be sent within 1 working day / the next day after receiving a
CO (Customer Order).
7.2.4 Staff logistik menyediakan jasa pengiriman pilihan dari daftar vendor yang dipilih setelah
menerima CO (Customer Order) dengan alamat tujuan diluar Jakarta/tidak bisa dijangkau
dengan kurir Ardia Perdana Indonesia.
Logistics staff provide selected shipping agents from the list of vendors selected after
receiving a CO (Customer Order) with a destination address outside Jakarta / unreachable
by the Ardia Perdana Indonesia courier.

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7.2.5 Staff gudang menyiapkan produk sesuai Picking Slip dan staff logistik melakukan inspeksi
pra-pengiriman untuk memastikan bahwa produk dikirimkan dengan jumlah dan kualitas
yang tepat.
Warehouse staff prepare products according to the Picking Slip and logistics staff carry
out pre-shipment inspections to ensure that the products are delivered in the right quantity
and quality.
7.2.6 Staff logistik menyiapkan dokumen yang diperlukan untuk pengiriman. Dokumen-
dokumen tersebut terdiri dari: DO (Delivery Order), dan Invoice.
Logistics staff prepare documents required for shipment. These documents consist of: DO
(Delivery Order), and Invoice.
7.2.7 QA/RA meninjau DO (Delivery Order) dan menyetujui produk untuk pengiriman.
QA / RA reviews the DO (Delivery Order) and approves the product for delivery.
7.2.9 Dalam hal pengiriman produk di wilayah Jakarta/wilayah yang dapat dijangkau oleh kurir
Ardia Perdana Indonesia, pengiriman dapat dilakukan oleh pengangkut internal (PT Ardia
Perdana Indonesia menggunakan kendaraan).
In the case of shipping products in the Jakarta area / areas that can be reached by Ardia
Perdana Indonesia couriers, the delivery can be done by internal carriers (PT Ardia Perdana
Indonesia uses vehicles).
7.2.10 Staff logistik dapat memutuskan untuk menggabungkan pengiriman beberapa produk
yang akan pergi ke tujuan yang sama atau tujuan terdekat, selama jadwal pengiriman
masih diikuti.
Logistics staff may decide to combine shipping of several products that will go to the same
destination or the nearest destination, as long as the shipping schedule is still being
followed.
7.2.11 Dalam kondisi khusus sementara PT. Ardia Perdana Indonesia perlu melakukan
pengiriman dengan jasa pengiriman yang belum termasuk dalam daftar vendor yang
dipilih, logistic Sr. Assistant Manager harus diberitahukan dan harus menyetujui
keputusan tersebut secara tertulis.
Under special conditions while PT. Ardia Perdana Indonesia needs to make deliveries with
a shipping service that is not yet included in the list of selected vendors, Logistics Sr. The
Assistant Manager must be notified and must approve the decision in writing.
7.2.12 Jika jasa pengiriman sebagaimana disebutkan dalam butir 7.2.11 memberikan layanan
kepada PT. Ardia Perdana Indonesia lebih dari 3 kali dalam waktu 3 bulan, maka jasa
pengiriman harus dilatih dan dikualifikasi oleh Logistic Sr. Assistant Manager dan
kemudian dimasukkan dalam daftar vendor terpilih.
If the delivery service referred to in item 7.2.11 provides services to PT. Ardia Perdana
Indonesia more than 3 times in 3 months, the expedition agent must be trained and
qualified by Logistic Sr. Assistant Manager and then included in the list of selected vendors.
7.3 Monitoring Ekspedisi
Expedition Monitoring

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7.3.1 Kinerja jasa pengiriman harus didokumentasikan dalam LG-P03-F02 revisi terakhir
“Evaluasi Kinerja Jasa Pengiriman” dan harus ditinjau dan disetujui oleh Logistic Sr.
Assistant manager.
Delivery service performance must be documented in the latest LG-P03-F02 revision of
"Delivery Service Performance Evaluation" and must be reviewed and approved by the Sr.
Logistics. Assistant manager.
7.3.2 Dalam hal ada kekhawatiran mengenai kinerja, QA/RA harus memberikan rekomendasi
tentang rencana aksi, yang dapat terdiri - tetapi tidak terbatas pada pelatihan ulang dan
peningkatan proses dan infrastruktur. Peningkatan tersebut harus dicatat dalam daftar
CAPA (Tindakan Korektif dan Tindakan Pencegahan) yang harus disepakati bersama
antara staff logistik, logistic Sr. Assistant Manager, QA/RA dan jasa pengiriman.
In case there are concerns about performance, QA / RA must provide recommendations
on action plans, which can consist - but are not limited to retraining and improving
processes and infrastructure. These improvements must be recorded in the CAPA
(Corrective and Preventive Measures) list which must be mutually agreed between
logistics staff, logistics Sr. Assistant Manager, QA / RA and expedition agent.
7.3.4 Jika CAPA tidak diselesaikan dengan memuaskan, QA/RA dapat meminta penghentian
perjanjian dengan jasa pengiriman dan staff logistik harus mematuhi permintaan
tersebut.
If the CAPA is not completed satisfactorily, QA / RA can request termination of the
agreement with the expedition agent and the logistics staff must comply with the request.

8. RIWAYAT PERUBAHAN REVISION HISTORY

Revisi Pembuat Tanggal Deskripsi Perubahan

00 Rhian Pradana 24 November Pertama Kali Dikeluarkan

2017 Initial Release
01 Sadewo Jiwanggo 1. Mengganti nomor dokumen SOP-API-007
menjadi LG-P03.
Change the document number SOP-API-007 to
LG-P03.
2. Perubahan dokumen menjadi dwibahasa.
Changing documents to bilingual.
3. Mengubah prosedur sesuai dengan
implementasi terbaru.
Change the procedure according to the latest
implementation.
4. Perubahan Template dokumen
Changes to the document template
5. Menambahkan dan merevisi beberapa form
Add and revise several forms

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9. LAMPIRAN APPENDIX
9.1. Lampiran 1. Pemilihan Jasa Pengiriman (LG-P03-F01 revisi terakhir)
Appendix 1. Delivery Service Selection (LG-P03-F01 latest version)
9.2. Lampiran 2. Evaluasi Kinerja Jasa Pengiriman (LG-P03-F02 revisi terakhir)
Appendix 2. Performance Evaluation of Shipping Services (LG-P03-F02 latest version)

10. DISTRIBUSI DOKUMEN DOCUMENT DISTRIBUTION

10.1. Logistic & Warehouse Department
10.2. QA/RA Department
11. RIWAYAT PENGKAJIAN KEMBALI REVIEW HISTORY
Tanggal Pengkaji Hasil Pengkajian
Date Reviewer Review Result

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