MANAJEMEN

RISIKO MUTU
Oleh: Asset At Taqwa
Tujuan Pembelajaran
• Memahami definisi risiko
• Memahami manajemen risiko mutu di
industri farmasi
PP No 51 tahun 2009
Tentang Pekerjaan Kefarmasian
a. Pengadaan Sediaan Farmasi
b. Produksi Sediaan Farmasi
c. Distribusi atau Penyaluran Sediaan
Farmasi
d. Pelayanan Sediaan Farmasi
Risk
The combination of:
- the probability of occurrence of harm and
- the severity of that harm
(ICH Q9)

Harm
Damage to health, including the damage that can occur from loss of product quality
or availability (ICH Q9)

Hazard
The potential source of harm (ICH Q9)
 Severity = tingkat keparahan, seandainya terjadi

Occurrence = kemungkinan terjadi, tapi belum tentu pernah terjadi

Detection = kemampuan mendeteksi, seandainya terjadi

Risk Priority Number

RPN-1 = Severity x Occurrence
RPN-2 = Severity x Occurrence x Detection
Contoh

Gelas plastik ditaruh Gelas kaca ditaruh Gelas kaca ditaruh

Di pinggir meja Di pinggir meja Di tengah meja
Case Study – Menurut Anda, gelas mana yang risikonya
paling rendah (1/2/3)?

1 2 3

Air mineral (bening) Air urin Air campuran Arsenic (bening)

 Quality Risk Deviation
Penyimpangan belum Penyimpangan sudah
terjadi (potensial) terjadi
Assessment Tools Investigation Tools
- PHA - Fishbone diagram
Quality Risk - FMEA - 5 Why’s
vs Deviation - What If - Event Causal Factor
- FTA Charting
- Etc. - Etc.
 A systematic process for:
- the assessment,
- control,
Quality Risk
- communication, and
Management
- review
of risks to the quality of the drug (medicinal)
product across the product lifecycle (ICH Q9)
QRM Process
 A systematic process of organizing information
to support a risk decision to be made within a
risk management process. It consists of:
Risk - the identification of hazards and
Assessment - the analysis and
- evaluation of risks associated with exposure to
those hazards
(ICH Q9)
 Risk Identification
The systematic use of information to identify
potential sources of harm (hazards) referring to
the risk question or problem description (ICH
Q9)
Risk CONTOH
Assessment Process Menyeberang jalan dengan
Requirement selamat
Hazard Tertabrak mobil
Hazardous Tidak ada fasilitas
Situation penyeberangan

Harm Cedera, wafat

 Risk Analysis
The estimation of the risk associated with the
identified hazards (ICH Q9)

Risk
Assessment CONTOH
Severity 8 High
Occurrence 6 Medium
 Risk Evaluation
The comparison of the estimated risk to given
risk criteria using a quantitative or qualitative
scale to determine the significance of the risk
(ICH Q9)
Risk
Assessment CONTOH

RPN-1 48 High
(Sev x Occ)
 CONTOH
Process Mixer speed meets spec.
Requirement
Hazard Mixer speed does not meet
spec.
Hazardous Worn part (i.e. bearing,
Risk Situation motor), wrong set up

Assessment Harm pH out of spec.

Severity 6
Occurrence 4
Detection 6
RPN-1 24 (Medium)
RPN-2 144 (Medium)
Score Severity Occurrence Detection

10 Critical impact Sangat sering Sangat sulit terdeteksi

8 Major to critical impact Sering Sulit terdeteksi
6 Major impact Kadang-kadang Agak sulit terdeteksi
4 Minor impact Jarang Mudah terdeteksi
2 Very minor impact Sangat jarang Sangat mudah terdeteksi
 Quiz – Lakukan Risk Assessment sampai
memperoleh RPN-1 untuk 1 contoh Hazardous
Situation pada proses berikut ini

Risk
Assessment
 Actions implementing risk management
decisions (ICH Q9)

CONTOH

Risk Control Mitigate Opsi 1: Pembuatan jembatan

Action penyeberangan

Opsi 2: Pembuatan zebra cross

dan rambu penyeberangan

Opsi 3: Pemasangan pagar agar

tidak ada yang menyeberang
jalan
 Risk Reduction
Actions taken to lessen the probability of
occurrence of harm and the severity of that
harm (ICH Q9)
CONTOH
Risk Control Opsi terpilih: Pembuatan jembatan
penyeberangan
Before After
Severity 8 8
Occurrence 6 2
RPN-1 48 (High) 16 (Medium)
 Risk Acceptance
The decision to accept risk (ICH Q9)
Risk Control
Accept or reject the risk
 Process Mixer speed meets spec.
Requirement
Hazard Mixer speed does not meet
spec.
Hazardous Operator set up incorrectly
Situation

Risk Control Harm pH out of spec.

Severity 6
Occurrence 4
Detection 6
RPN-1 24 (Medium)
RPN-2 144 (Medium)
 Quiz – Lakukan Risk Control atas hasil Risk
Assessment yang telah dilakukan pada proses
berikut ini

Risk Control
 Review or monitoring of output/ results of the
risk management process considering (if
appropriate) new knowledge and experience
about risk (ICH Q9)

CONTOH

Risk Review Opsi terpilih: Pembuatan jembatan

penyeberangan

Review:
- Bagaimana tren jumlah kecelakaan sejak
jembatan penyeberangan dibuat 1 tahun
yang lalu?
- Apakah ada risiko lain yang ditimbulkan
sejak adanya jembatan penyeberangan?
 CONTOH

Opsi terpilih: Revisi SOP cara set up mesin

Risk Review Review:

- Bagaimana tren jumlah kejadian
kesalahan set up mixer sejak SOP direvisi
1 tahun yang lalu?
- Apakah operator telah mendapatkan
pelatihan yang memadai terkait SOP
tersebut?
 The sharing of information about risk and risk
management between the decision maker and
other stakeholders (ICH Q9)
Risk
Communication Contoh decision maker & stakeholder:
Kepala pabrik, kepala bagian produksi, kepala
bagian QA, kepala bagian QC
Terima kasih