No. Dok.

: SOP-OPR-17-10-L1-04

DEVIATION AND CAPA REPORT

SECTION A – DEVIATION DETAILS

Source of Deviation Deviation Report
 Internal Process  Internal Audit Number:
CPAR/0040/PTK/15.1
1.21
 Customer Complaint  External Audit Date issued:
 Others: Quality incident 15.11.2021

Areas affected (Check as applicable): Date deviation

 Receiving  Picking  Redressing detected: 14.11.2021
 Packing  Storage  Dispatch Complainant
 Returns  Order Processing (as applicable): N/A
 Facility  Others: ________________ Affected Client/s:
Abbot,Combiphar,Ethica,MSD,Novartis,Pfizer,San
ofi
Description of Deviation or Observation
Telah terjadi temperature excursion di APL Pontianak pada chiller no.02. Ekskursion terjadi pada tanggal
14 November 2021 dari jam 09:25:01 WIB sampai 09:45:01 WIB selama 20 menit dengan suhu maksimal
pada saat mulai evakuasi mencapai 10.74 °C. dan pada jam 13:04 terjadi kenaikan suhu pada chiller
no.07(chiller back up) selama 20 menit dengan suhu maksimal pada saat mulai evakuasi yaitu 15.67 °C.

Product/ Material Details (where applicable)

SECTION B – IMMEDIATE ACTION

Describe the action taken to contain the Deviation
Action/s Person Target Date

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Responsible

1. Memindahkan produk yang terkena dampak ke chiller lain Fransina (CW) 14.11.2021
dengan suhu 2-8°C
2. Menghubungi teknisi Chiller untuk melakukan pengecekan
Roy Aryando 14.11.2021
masalah yang dialami chiller serta menghubungi team Infra
(BM)

3. Melaporkan ke QA telah terjadi excursion pada chiller no.02

Merry Sirfianti
dan Ch.07 15.11.2021
(BRQA) dan
(BRQA Ass)

SECTION C – NARRATIVE OF EVENTS

Describe in detail the sequence of events that led to the Deviation
Jam 09:17 Security melaporan di WA group chiller no. 2 alarm berbunyi dan suhu
mengalami kenaikan

Jam 09:45 CW dan BM datang ke gudang untuk melakukan evakuasi chiller no.02 dan
melakukan pemindahan produk ke chiller lain. Suhu maksimal pada saat mulai
evakuasi 10.74°C. proses pemindahan produk berlangsung selama kurang lebih
20 menit.
Teknisi juga datang untuk melakukan pengecekan dan chiller di off kan
Jam 12:06 Security menginformasikan kembali chiller no.7 (chiller back up) suhu naik
Security menginformasikan kembali chiller no.7 suhu kembali normal
Jam 12: 09

Jam 12:19 Security menginformasikan kembali chiller no.07 suhu naik kembali diangka 7.1
dan 7.2
Jam 12: 21 Security menginformasikan kembali suhu chiller no.07 kembali normal
Security menginformasikan kembali suhu chiller no.07 normal diangka 5.0 dan
Jam 12:30 3.7

Security menginformasikan kembali chiller no.07 suhu kembali naik 7.1(HS) dan
Jam 12:53
7.0 (CS)

Jam 12:56
Security menginformasikan kembali suhu chiller no.07 naik diangka HS (8.0) dan
CS(8.1)
Jam 13:20

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BRQA tiba dikantor untuk melakukan evakuasi Chiller no.07 (chiller Back Up).
Berisi produk dari chiller no.02
Jam 13:35
Selesai evakuasi chiller no.07
Teknisi datang untuk melakukan pengecekan ch.07 dan chiller di off kan

Chiller no.02

Excursion duration : 20 minutes

Max Temperature at hot spot : 10.74OC
Hot spot raw data
Data TTEC HS Chiller no.02
Suhu Jam Keterangan
Security menginformasikan di group suhu
7.64 Sun Nov 14 09:15:01 2021
ch.02 naik
8.73 Sun Nov 14 09:25:01 2021  
9.76 Sun Nov 14 09:35:01 2021  
Fransina datang dan evakuasi (suhu pada saat
10.74 Sun Nov 14 09:45:01 2021
mulai evakuasi 10.74 degC)
11.53 Sun Nov 14 09:55:01 2021  
13.11 Sun Nov 14 10:05:01 2021 Selesai evakuasi

Chiller no.7

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Excursion duration : 20 minutes

Max Temperature at hot spot : 15.67OC
Hot spot raw data
Rekaman suhu berdasarkan TTEC Chiller no.07

Suhu Jam Keterangan

Sun Nov 14 12:54:55
07.10 2021 Security menginformasikan di WA group
Sun Nov 14 13:04:55
09.67 2021  
Sun Nov 14 13:14:55
12.93 2021  
Sun Nov 14 13:24:55 BRQA tiba dikantor jam 13.20 melakukan
15.67 2021 evakuasi
Sun Nov 14 13:34:55
18.28 2021 Selesai evakuasi jam 13:35
Sun Nov 14 13:44:55
20.10 2021 Chiller di off kan oleh teknisi
SECTION D – RISK ASSESSMENT AND DEVIATION CLASSIFICATION
Use the Deviation Risk Assessment Table in documenting and evaluating the risk/s

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Identified Risk/s Risk Classification

Resiko terhadap Pasien : Pelanggan tidak bisa membeli major
produk jumlah banyak.
Resiko terhadap bisnis : Produk di Hold,kerugian finansial major.

Resiko terhadap produk : Kualitas Produk rusak major

Deviation Classification  Critical  Major  Minor

Further investigation required?

 YES. Proceed to investigation and CAPA process
 NO. Document the identified root cause and other required actions below

IDENTIFIED ROOT CAUSE from the detailed analysis of events (This section applicable for
Deviations classified as Minor):
N/A

OTHER REQUIRED ACTION/S. Describe further planned action/s to avoid recurrence of the Deviation
(This section applicable for Deviations classified as Minor):
Action/s Person Target Date
Responsible
N/A

Recurrence identified
 Yes (Deviation Report No.): ______________
 No
For Deviations classified as Major or Critical proceed to Section E
For Deviations classified as Minor proceed to Section H [Writing “N/A” not required for Sections E – G]

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SECTION E – INVESTIGATION
I. Process Flow Review

Indikasi awal dari hasil

Indikasi awal dari hasil pengecekan teknisi pengecekan teknisi mesin
kapasitor mesin chiller.02 tidak mampu chiller.07 relay tidak mampu
melakukan starting pada saat compressor melakukan starting pada saat
mau hidup compressor mau hidup.

Setelah
dilakukan
penggantian
Pada angka suhu menunjukan >7C alarm Alarm berbunyi relay mesin
berbunyi memberikan notifikasi bahwa suhu memberikan isyarat tetap tidak

tidak normal suhu naik bisa hidup

dan baru
diketahui
kerusakan
pada
kompresor.
team melakukan evakuasi Team melakukan
evakuasi

II. Fishbone Analysis Table

Types Activity Possible Root Cause Results
Man N/A N/A N/A
Machine Kapasitor chiller no.02 Mesin tidak mampu Suhu chiller no.2 dan 07
dan Kompressor chiller melakukan starting naik >8 °C
no.07 rusak
Materials N/A N/A N/A
Methods N/A N/A N/A
Others N/A N/A N/A

III. Five (5) Why’s

Man / Machine / Materials / Methods / Others

1st Why Suhu chiller no.02 meningkat sampai 10.74 °C
2nd Why Suhu chiller no.07 meningkat sampai 15.67

3rd Why Chiller no.02 kapasitor tidak mampu menaikan mesin pada saat
starting

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4th Why Chiller no.07 kompressor tidak mampu menaikan mesin

5th Why Kapasitor dan compressor rusak tidak

Man / Machine / Materials / Methods / Others

1st Why N/A
2nd Why N/A
3rd Why N/A
4th Why N/A
5th Why N/A
SECTION F – ROOT CAUSE
Write the identified root cause below:

Kapasitor (chiller no.02) dan compressor (chiller no.07) rusak sehingga tidak mampu menaikan
mesin pada saat mesin mau melakukan starting.

SECTION G – ACTION PLAN

(Corrective Action and Preventive Action)
Action/s Person Target Date
Responsible

Corrective Action :
1. Mengganti unit kapasitor chiller no.2 dan mengganti Fransina (CW) 30.01.2021
unitcompressor chiller no.07

Preventive Action :

1. Refresh training kepada security mengenai SOP-OPR-

BRQA’s 30.11.2021
18-04-01. Emergeny Response Protocol” and “WI-055-
KPS-03.Emergency response during the Cold Room
trouble”

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SECTION H – APPROVALS
Prepared by Process Owner: Approved by Quality Assurance:

Sintia Dewi
Merry Sirfianti/BRQA
(Name/ Title/ Signature/ Date) (Name/ Signature/ Date)

Reviewed by Department Head: Approved by Country Head1:

Dedy Fachrizal
Roy Aryando
(Name/ Title/ Signature/ Date) (Name/ Signature/ Date)
Not required for Minor Deviation
1

SECTION I – VERIFICATION OF EFFECTIVENESS OF ACTIONS TAKEN

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Action #1
Type of Action  Corrective  Preventive
Action
Methodology of Effectiveness Review
 Trend Analysis  Periodic Check  Surprise Audits
 Sampling  Others

Details:

Effectiveness Definition Metrics

Rating

1 Very Ineffective – The action has had no measurable effect on the

Root Cause
2 Somewhat ineffective – The action may have some effect on the
Root Cause, but it is not reflected in the measures.
3 Somewhat effective – The action has been somewhat effective at
addressing the Root Cause, but it is not as effective as anticipated.
4 Effective – The action has been effective at addressing the Root
Cause
5 Very Effective – The action has been effective beyond expectation
at addressing the Root Cause
Verification Result:
Action #...
#2
Type of Action  Corrective  Preventive
Action
Methodology of Effectiveness Review
 Trend Analysis  Periodic Check  Surprise Audits
 Sampling  Others

Details:

Effectiveness Definition Metrics

Rating

1 Very Ineffective – The action has had no measurable effect on the

Root Cause
2 Somewhat ineffective – The action may have some effect on the
Root Cause, but it is not reflected in the measures.
3 Somewhat effective – The action has been somewhat effective at
addressing the Root Cause, but it is not as effective as anticipated.
4 Effective – The action has been effective at addressing the Root
Cause
5 Very Effective – The action has been effective beyond expectation
at addressing the Root Cause
Verification Result:

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Note: Verification effectiveness shall be performed per action. Add more table/s as necessary.

Verified by Quality Assurance (Name/ Title/ Signature/ Date):

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