ISO 9001:2008ISO 14001 : 2004 & OHSAS 18001:2007

Part 1 :INTRODUCTION TO THE CONCEPT OF QUALITY, SAFETY (K3) AND ENVIRONTMENT

Airlines

quality

Totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs

Understand, receive, satisfy the expectation from the customer continuously

PRocess

Output of the process, includes :PR

ODUCT

Finished Good : Product with physical characteristic

Information : Report, advice, instruction

Service : work performed

Caracteristic of quality

Quality of

Finished Good

Dimension specification & characteristic of operasional

Shelf life and endurance

Product safety Meet standard Maintenance Using of of energy and

raw material

Quality of

Finished Good

Key element (3)

WeightKE3 Housekeeping, Pest Control,

Sanitization & Maintenance8

KE3.1 Housekeeping, Sanitization & Pest Control

2KE3.2 Maintenance 2KE3.3 Calibration & Verification 2KE3.4 Equipment Cleaning &

Sanitization2

Key element (4)Weight

KE4 Standard Document 8KE4.1 Quality Manual 1KE4.2 Site Master File 1KE4.3 SOP 2KE4.4 Quality System Dossier 1KE4.5 Specification & Testing

Procedure (RM, PM, FP)1

KE4.6 Batch Record 2

Key element (5)Weight

KE5 Validation 10KE5.1 Validation Master

Plan1

KE5.2 URS/DQ 1KE5.3 IQ 1KE5.4 OQ 1KE5.5 PQ 1KE5.6 Process Validation 2KE5.7 Cleaning Validation 1KE5.8 Analytical Method 1KE5.9 Computer Validation 1

Key element (6)Weight

KE6 Production 10KE6.1 Dispensing 2KE6.2 Prevention of cross

contamination2

KE6.3 Batch & Lot numbering system

1KE6.4 Processing Operation 2KE6.5 Packing Operation 2KE6.6 Rejected, Recovered &

Returned Material1

Key element (7)Weight

KE7 Storage Handling & Control 8KE7.1 Starting Material

Handling, Storage & Control

4

KE7.2 Finished Product Handling, Storage & Distribution

2

KE7.3 Returned Goods 1KE7.4 Mapping Temperature 1

Key element (8)Weight

KE8 Laboratory Control 10KE8.1 GLP 1KE8.2 Sampling 1KE8.3 Testing 1KE8.4 Stability Study 1KE8.5 Retained Sample 1KE8.6 Reference Standard 1KE8.7 Record 1KE8.8 Environmental & Water

Monitoring1

KE8.9 OOS Handling 1KE8.10

Material, WIP & Product Releasing

1

Key element (9)

WeightKE9 Contract Manufacture &

Analysis5

KE9.1 Contract Giver 2KE9.2 Contract Acceptor 2KE9.3 The Contract 1

Key element (10)

WeightKE10 Internal & Supplier Audit 8

KE10.1 Self Inspection & Internal Audit

4KE10.2 Supplier Audit 4

Key element (11)

WeightKE11 Complaint & Recall 5

KE11.1 Complaint 3KE11.2 Recall 2

Key element (12)Weight

KE12 Quality System Review 10KE12.1 Product Review 2KE12.2 Quality Risk

Assessment2

KE12.3 Quality Deviation 2KE12.4 Change Control 2KE12.5 Supplier

Qualification1

KE12.6 Management Review 1

Calculation of qac

QAC : (Total of (Score x Weight) / Total

Weight) X 100%

QAC PRAFA vs target

Target QAC 2013 : ≥ 85%

QAC PRAFA vs target

QAC PRAFA on 2013 is below target

Lack of key elements

Score System Implementation Fullfilment Consistency

0 % No No No No25 % Yes No No No50 % Yes Yes No No75 % Yes Yes Yes No100 % Yes Yes Yes Yes

KE mana sajakah yang bobot-nya selalu rendah ??

WeightKE1 Personnel 8

KE1.1 Organization structure 2KE1.2 Key Personnel, Job Des

& competencies 2

KE1.3 Training 2KE1.4 Personnel Hygiene 2

Lack of key elements

WeightKE3 Housekeeping, Pest Control,

Sanitization & Maintenance 8

KE3.1 Housekeeping, Sanitization & Pest Control 2

KE3.2 Maintenance 2KE3.3 Calibration & Verification 2KE3.4 Equipment Cleaning &

Sanitization 2

Lack of key elements

Lack of key elements

And also…..

Target in 2014

How about target in 2014 ???

Target QAC 2014 :

≥ 90%

Target in 2014

Target in 2014

How to achieve the target ??

Target in 2014

WeightResul

tKE1

Personnel 8KE1.1 Organization

structure 2 100%

KE1.2 Key Personnel, Job Des & competencies 2 100%

KE1.3 Training 2 100%KE1.4 Personnel Hygiene 2 100%

Meningkatkan bobot/ result dari KE No. 1 selama 1 bulan ke depan di masing-masing area

Target in 2014

Pengecekan terhadap KE No. 1 harus dilakukan di setiap SIP Bulanan pada masing-masing area dan akan juga di cek pada IQA 6 bulan ke depan Apabila pemenuhan KE No. 1 sudah terlaksana, masing-masing area harus menentukan target KE mana yang harus dipenuhi selanjutnya (begitu seterusnya)

conslusion

Dengan perbaikan bertahap pada masing-masing KE diharapkan target QAC 2014 dapat dicapai