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
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 (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
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
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)
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