DAFTAR ISI

I. Dasar Teori
II. Tujuan
III. Keterangan produk
1. Formula
2. Data Pengujian Bahan Baku
3. Spesifikasi Bahan Baku
4. Spesifikasi Bahan Pengemas
5. Spesifikasi produk
5.1 Pemerian
5.2 Bobot rata-rata
5.3 Kadar Air
5.4 Ukuran Partikel
5.5Angka Lempeng Total (ALT)
5.6 Angka Kapang Khamir (AKK)
5.7 Waktu Hancur
5.8 Patogen
IV. Evaluasi Proses
1. Data trend Pengolahan Rekonsilisai Serbuk Pil
2. Data trend Pengujian Serbuk
3. Data trend rekonsiliasi produksi pil kering
4. Data trend pengujian Pil
5. Data trend In process control
5.1 Data trend IPC diameter pil
5.2 Data trend IPC kemasan primer
a. Data trend IPC hasil coding dan potong poly
b. Data trend IPC hasil filling
5.3 Data trend IPC kemasan sekunder
a. Data trend IPC hasil coding
b. Data trend IPC hasil dos
c. Data trend IPC hasil warapping
5.4 Data trend IPC hasil coding
5.5 Data tren IPC hasil dos
5.6 Data trend IPC bobot karton
6. Data Tren Rekonsiliasi hasil Coding
6.1. Data Tren Rekonsiliasi VDS
6.2 Data Tren Rekonsiliasi Karton
7. Data Tren Rekonsiliasi Hasil Produk Jadi dan Pemakaian Bahan Pengemas
7.1. Data Rekonsiliasi Kartoning
7.2. Data Rekonsiliasi Wrapping
8. Data Tren Rekonsiliasi Hasil Produk Jadi dan Pemakaian Bahan Pengemas
8.1 Data Rekonsiliasi Kartoning
8.2. Data Rekonsiliasi Wrapping
9. Data Tren Rekonsiliasi Produk Akhir
IV Produk komplain, penarikan, dan pengembalian V.
Produk stabilitas
VI. Validasi proses
VII. Kualitas air
VIII. Bahan pengemas primer
IX. HVAC
X. Review dari APR tahun atau PPT tahun lalu
XI. Pengendalian perubahan
XII. Data perhitungan Cp dan Cpk
XIII. Pembahasan
XIV. Kesimpulan dan Rekomendasi
XV. Lampiran
1. Alur Proses
2. Gambar perhitungan Cp dan Cpk

1. Data trend Pengolahan Rekonsilisai Serbuk Pil

2. Data trend Pengujian Serbuk
3. Data trend rekonsiliasi produksi pil kering
4. Data trend pengujian Pil
5. Data trend In process control
5.1 Data trend IPC diameter pil
5.2 Data ternd IPC bobot karton
5.3 Data tend IPC stripping kapsul
5.4 Data trend IPC hasil coding
5.5 Data tren IPC hasil dos
6. Data Tren Rekonsiliasi stripping kapsul
7. Data trend Rekonsiliasi produk
7.1 Data Tren Rekonsiliasi VDS
7.2 Data Tren Rekonsiliasi Karton
8. Data Tren Rekonsiliasi Hasil Produk Jadi dan Pemakaian Bahan Pengemas
8.1 Data Rekonsiliasi Kartoning
8.2. Data Rekonsiliasi Wrapping
9. Data Tren Rekonsiliasi Produk Akhir

Nomor Nomor lot Tgl Jam Standar Status

 batch 1 2 3
056CR01 2/3/18 14.10 ✔ ✔ ✔ Release
15.55 ✔ ✔ ✔ Release
056CR02 5/3/18 10.19 ✔ ✔ ✔ Release
11.54 ✔ ✔ ✔ Release
056CR03 056CR03.1
056CR03.2 29/3/18 10.53 ✔ ✔ ✔ Release
11.28 ✔ ✔ ✔
056CR03.3
056CR04 056CR04.1
056CR04.2 27/7/18 10.21 ✔ ✔ ✔ Release
11.19 ✔ ✔ ✔ Release
056CR05 27/7/18 14.10 ✔ ✔ ✔ Release
15.42 ✔ ✔ ✔ Release
056CR06 30/7/18 09.43 ✔ ✔ ✔ Release
10.57 ✔ ✔ ✔ Release
056CR07 30/7/18 13.46 ✔ ✔ ✔ Release
14.40
056CR08 056CR08.1 31/7/18 08.56 ✔ ✔ ✔ Release
09.51 ✔ ✔ ✔ Release
056CR08.2 - - - - - -
056CR08.3
056CR08.4
056CR08.5 20/12/18 10.20 ✔ ✔ ✔ Release

056CR09 20/12/18 13.30 ✔ ✔ ✔ Release

14/1/19 09.30 ✔ ✔ ✔ Release
056CR10 20/12/18 08.50 ✔ ✔ ✔ Release
14/1/19 09.55 ✔ ✔ ✔ Release
Standar inspeksi :
1. Hasil las baik
2. Tidak bocor
3. Pemotong harus sama
Nomor Standar Status
Nomor lot Tgl Jam
batch 1 2
056CR01 2/3/18 10.40 ✔ ✔ Release

056CR02 2/3/18 13.10 ✔ ✔ Release

056CR03 056CR03.1
056CR03.2 27/3/18 10.28 ✔ ✔ Release
 056CR03.3
056CR04 056CR04.1
056CR04.2 27/7/18 08.50 ✔ ✔ Release
1/8/18 14.00 ✔ ✔ Release
056CR05 27/7/18 10.00 ✔ ✔ Release
2/8/18 09.05 ✔ ✔ Release
056CR06 27/7/18 11.27 ✔ ✔ Release
056CR07 27/7/18 13.38 ✔ ✔ Release
056CR08 056CR08.1 27/7/18 14.39 ✔ ✔ Release
056CR08.2 - - - - -
056CR08.3
056CR08.4
056CR08.5 20/12/18 09.31 ✔ ✔ Release
14/1/19 08.20 ✔ ✔ Release
056CR09 20/12/18 11.08 ✔ ✔ Release
14/1/19 08.14 ✔ ✔ Release
056CR10 20/12/18 09.50 ✔ ✔ Release
14/1/19 08.19 ✔ ✔ Release
Standar inspeksi :
1. Sesuai dengan penomoran kode produksi
2. Rapi, jelas dan terbaca
 IPC
IPC diameter pil
Hasil Inspeksi
Nomor
tgl Waktu Diameter pil (mm) Status
batch
1 2 3 4 5
056CR01 16/1/18 11.44 7,1 7,1 7,1 7,1 7,1 Release
14.25 7,1 7,1 7,1 7,1 7,1 Release
056CR02 18/1/18 09.25 7,1 7,1 7,1 7,1 7,1 Release
11.03 7,1 7,1 7,1 7,1 7,1 Release
056CR03 20/2/18 14.22 6,9 6,9 7,0 7,0 7,0 Release
14.23 6,9 7,0 7,1 7,0 7,0 Release
056CR04 21/2/18 14.11 7,0 7,0 7,1 7,1 7,1 Release
14.12 7,1 7,1 7,0 7,0 7,0 Release
056CR05 19/3/18 13.15 7,1 7,1 7,1 7,1 7,1 Release
14.45 7,1 7,1 7,1 7,1 7,1 Release
056CR06 20/3/18 14.20 6,9 7,0 7,0 7,1 7,1 Release
14.21 7,1 6,9 7,1 7,1 7,1 Release
056CR07 22/3/18 09.43 7,0 6,9 7,1 7,0 7,0 Release
11.22 7,0 7,1 7,1 7,1 7,0 Release
056CR08 23/3/18 11.27 7,1 7,1 7,1 7,1 7,1 Release
14.36 7,1 7,1 7,1 7,1 7,1 Release
056CR09 26/3/18 14.24 7,1 7,1 7,1 7,1 7,1 Release
14.25 6,9 7,0 7,0 7,0 7,0 Release
056CR10 27/3/18 14.49 7,0 7,1 7,0 7,1 7,1 Release
14.50 6,9 7,0 7,1 7,1 7,1 Release
Parameter Diameter pil : 6,9 mm – 7,1mm

IPC Coding
Kemasan primer
Data coding
Nomor Nomor lot Tgl Jam Standar Status
 batch 1 2
056CR01 2/3/18 10.40 ✔ ✔ Release

056CR02 2/3/18 13.10 ✔ ✔ Release

056CR03 056CR03.1
056CR03.2 27/3/18 10.28 ✔ ✔ Release
056CR03.3
056CR04 056CR04.1
056CR04.2 27/7/18 08.50 ✔ ✔ Release
1/8/18 14.00 ✔ ✔ Release
056CR05 27/7/18 10.00 ✔ ✔ Release
2/8/18 09.05 ✔ ✔ Release
056CR06 27/7/18 11.27 ✔ ✔ Release
056CR07 27/7/18 13.38 ✔ ✔ Release
056CR08 056CR08.1 27/7/18 14.39 ✔ ✔ Release
056CR08.2 - - - - -
056CR08.3
056CR08.4
056CR08.5 20/12/18 09.31 ✔ ✔ Release
14/1/19 08.20 ✔ ✔ Release
056CR09 20/12/18 11.08 ✔ ✔ Release
14/1/19 08.14 ✔ ✔ Release
056CR10 20/12/18 09.50 ✔ ✔ Release
14/1/19 08.19 ✔ ✔ Release
Standar inspeksi :
3. Sesuai dengan penomoran kode produksi
4. Rapi, jelas dan terbaca

Data potong poly

Nomor Standar Status
Nomor lot Tgl Jam
batch 1 2 3
056CR01 2/3/18 14.10 ✔ ✔ ✔ Release
15.55 ✔ ✔ ✔ Release
056CR02 5/3/18 10.19 ✔ ✔ ✔ Release
11.54 ✔ ✔ ✔ Release
056CR03 056CR03.1
056CR03.2 29/3/18 10.53 ✔ ✔ ✔ Release
11.28 ✔ ✔ ✔
056CR03.3
 056CR04 056CR04.1
056CR04.2 27/7/18 10.21 ✔ ✔ ✔ Release
11.19 ✔ ✔ ✔ Release
056CR05 27/7/18 14.10 ✔ ✔ ✔ Release
15.42 ✔ ✔ ✔ Release
056CR06 30/7/18 09.43 ✔ ✔ ✔ Release
10.57 ✔ ✔ ✔ Release
056CR07 30/7/18 13.46 ✔ ✔ ✔ Release
14.40
056CR08 056CR08.1 31/7/18 08.56 ✔ ✔ ✔ Release
09.51 ✔ ✔ ✔ Release
056CR08.2 - - - - - -
056CR08.3
056CR08.4
056CR08.5 20/12/18 10.20 ✔ ✔ ✔ Release

056CR09 20/12/18 13.30 ✔ ✔ ✔ Release

14/1/19 09.30 ✔ ✔ ✔ Release IPC Hasil
056CR10 20/12/18 08.50 ✔ ✔ ✔ Release filling
14/1/19 09.55 ✔ ✔ ✔ Release
Standar inspeksi :
5 Hasil las baik
6 Tidak bocor
7 Pemotong harus sama
Nomor Hasil Inspeksi (butir)
Nomor
Jam Tanggal Status
batch lot
I II III IV V VI VII VIII IX X

056CR01 13.10 5/3/18 100 100 100 100 100 100 100 100 100 100 Release

08.06 6/3/18 100 100 100 100 100 100 100 100 100 100 Release

056CR02 11.55 7/3/18 100 100 100 100 100 100 100 100 100 100 Release

10.30 8/3/18 100 100 100 100 100 100 100 100 100 100 Release

056CR03 056CR03.2 14.25 2/4/18 100 100 100 100 100 100 100 100 100 100 Release

08.30 3/4/18 100 100 100 100 100 100 100 100 100 100 Release

056CR04 056CR04.2 11.00 30/7/18 100 100 100 100 100 100 100 100 100 100 Release

08.24 31/7/18 100 100 100 100 100 100 100 100 100 100 Release

056CR05 08.30 1/8/18 100 100 100 100 100 100 100 100 100 100 Release
 08.00 2/8/18 100 100 100 100 100 100 100 100 100 100 Release

056CR06 08.50 2/8/18 100 100 100 100 100 100 100 100 100 100 Release

14.38 8/8/18 100 100 100 100 100 100 100 100 100 100 Release

056CR07 08.58 3/8/18 100 100 100 100 100 100 100 100 100 100 Release

08.16 6/8/18 100 100 100 100 100 100 100 100 100 100 Release

056CR08 056CR08.1 10.40 23/8/18 100 100 100 100 100 100 100 100 100 100 Release

056CR08.2 15.00 16/10/18 100 100 100 100 100 100 100 100 100 100 Release

08.10 17/10/18 100 100 100 100 100 100 100 100 100 100 Release

056CR08.5 10.58 20/12/18 100 100 100 100 100 100 100 100 100 100 Release

10.44 21/1/19 100 100 100 100 100 100 100 100 100 100 Release

056CR09 056CR09 15.00 20/12/18 100 100 100 100 100 100 100 100 100 100 Release

08.15 21/12/18 100 100 100 100 100 100 100 100 100 100 Release

056CR10 056CR10 14.00 21/12/18 100 100 100 100 100 100 100 100 100 100 Release

08.00 3/1/19 100 100 100 100 100 100 100 100 100 100 Release
Kemasan Sekunder

IPC Hasil coding

Coding VDS Coding karton

Nomor Standar Status Standar Status
Nomor lot Tgl Jam Tgl Jam
batch 1 2 1 2
056CR01 6/3/18 15.20 ✔ ✔ Release 8/3/18 09.50 ✔ ✔ Release
056CR02 9/3/18 11.10 ✔ ✔ Release 9/3/18 09.45 ✔ ✔ Release
056CR03 056CR03.1 28/3/18 13.50 ✔ ✔ Release 28/3/18 14.45 ✔ ✔ Release
056CR03.2 3/4/18 11.30 ✔ ✔ Release 3/4/18 14.05 ✔ ✔ Release
056CR03.3 7/8/18 07.35 ✔ ✔ Release 7/8/18 10.02 ✔ ✔ Release
056CR04 056CR04.1 7/8/18 08.00 ✔ ✔ Release 7/8/18 09.35 ✔ ✔ Release
056CR04.2 27/7/18 10.30 ✔ ✔ Release 27/7/18 14.20 ✔ ✔ Release
056CR05 31/7/18 08.30 ✔ ✔ Release 31/7/18 10.00 ✔ ✔ Release
056CR06 1/8/18 08.30 ✔ ✔ Release 2/8/18 09.50 ✔ ✔ Release
056CR07 3/8/18 08.40 ✔ ✔ Release 3/8/18 10.30 ✔ ✔ Release
056CR08 056CR08.1 24/8/18 08.20 ✔ ✔ Release 27/8/18 08.50 ✔ ✔ Release
056CR08.2 17/10/18 09.10 ✔ ✔ Release 17/10/18 15.00 ✔ ✔ Release
PXR 056CR08.3 16/11/18 15.00 ✔ ✔ Release 19/11/18 11.05 ✔ ✔ Release
PXR3 056CR08.4 4/1/19 11.00 ✔ ✔ Release 4/1/19 11.15 ✔ ✔ Release
056CR08.5 20/12/18 12.00 ✔ ✔ Release 20/12/18 13.40 ✔ ✔ Release
056CR09 21/12/18 08.20 ✔ ✔ Release 21/12/18 09.20 ✔ ✔ Release
056CR10 3/1/19 11.00 ✔ ✔ Release 4/1/19 08.15 ✔ ✔ Release
Standar inspeksi :
1. Sesuai dengan penomoran kode produksi
2. Rapi, jelas dan terbaca
IPC hasil dos

Dos
Nomor Standar Status
Nomor lot Tgl Jam
batch 1 2 3 4
056CR01 8/3/18 11.50 ✔ ✔ ✔ ✔ Release
056CR02 9/3/18 10.00 ✔ ✔ ✔ ✔ Release
056CR03 056CR03.1 3/4/15 15.15 ✔ ✔ ✔ - Release
056CR03.2 4/4/18 09.10 ✔ ✔ ✔ ✔ Release
056CR03.3 16/8/18 11.25 ✔ ✔ ✔ - Release
056CR04 056CR04.1 16/8/18 13.50 ✔ ✔ ✔ - Release
056CR04.2 31/7/18 14.00 ✔ ✔ ✔ - Release
056CR05 1/8/18 13.40 ✔ ✔ ✔ - Release
056CR06 3/8/18 14.30 ✔ ✔ ✔ - Release
056CR07 7/8/18 09.10 ✔ ✔ ✔ - Release
056CR08 056CR08.1 24/8/18 13.30 ✔ ✔ ✔ - Release
056CR08.2 17/10/18 15.45 ✔ ✔ ✔ - Release
PXR 056CR08.3 19/11/18 14.50 ✔ ✔ ✔ - Release
PXR3 056CR08.4 7/1/19 07.50 ✔ ✔ ✔ - Release
056CR08.5 20/12/18 13.20 ✔ ✔ ✔ ✔ Release
056CR09 21/12/18 08.50 ✔ ✔ ✔ ✔ Release
056CR10 3/1/19 15.25 ✔ ✔ ✔ ✔ Release
Standar inspeksi:
8. Jumlah tepat.
9. Kode Produksi kemasan sekunder harus sama dengan kode produksi
pada kemasan primer
10. Kesesuaian untuk parameter yang tercantum pada kemasan primer
dan sekunder (Nama produk, no ijin edar, khasiat)
11. Ada brosur, isi sesuai dengan yang tercantum pada kemasan.
Wrapping

Wrapping TAM Wrapping SOLLAS

Nomor Nomor lot
batch Standar Status Tgl Jam Status
Tgl Jam
1 2 3 4
056CR01 9/3/18 10.40 ✔ ✔ ✔ ✔ Release 9/3/18 10.45 Release
056CR02 12/3/18 07.55 ✔ ✔ ✔ ✔ Release 12/3/18 08.00 Release
056CR03 056CR03.1
056CR03.2 4/4/18 11.50 ✔ ✔ ✔ ✔ Release 4/4/18 11.55 Release
056CR03.3
056CR04 056CR04.1
056CR04.2 1/8/18 09.25 ✔ ✔ ✔ - Release 1/8/18 09.30 Release
056CR05 1/8/18 16.00 ✔ ✔ ✔ - Release 1/8/18 16.05 Release
056CR06 6/8/18 09.10 ✔ ✔ ✔ - Release 6/8/18 09.15 Release
056CR07 7/8/18 14.30 ✔ ✔ ✔ - Release 7/8/18 14.40 Release
056CR08 056CR08.1 27/8/18 08.15 ✔ ✔ ✔ ✔ Release 27/8/18 08.20 Release
056CR08.2 18/10/18 09.00 ✔ ✔ ✔ - Release 18/10/18 09.00 Release
PXR 056CR08.3
PXR3 056CR08.4
056CR08.5 20/12/18 14.35 ✔ ✔ ✔ ✔ Release 20/12/18 14.48 Release
056CR09 21/12/18 09.40 ✔ ✔ ✔ ✔ Release 21/12/18 09.43 Release
056CR10 4/1/19 09.00 ✔ ✔ ✔ ✔ Release 4/1/19 09.05 Release