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Department KPIs

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on 14 December 2014

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Transcript of Department KPIs

Mapping
}
Passing Regulatory inspections
ONLY one improvement-related observation from JFDA (Mapping)
Department KPIs
Meet Hikma needs
Fulfill Regulatory Requirements
Meet Hikma Needs
Validation Achievements
Fulfill regulatory requirements
Meet all validation re- validation plans
Response to crisis and requirements
Passing Regulatory inspections
Employees Knowledge
Improve quality systems
Meet All Validation
& Re-validation Plans
Response to Crisis and Requirements
Employees Knowledge
Welcome
Dear Guests!
No machine stoppage due to validation issues
Projects
Authority matrix project
Activation of Auto Sampling Check Masters for FETTE machines.
DDC Re-qualification project
Main Plant Re-Innovation
Penicillin Re-Innovation
OEE, FMECA & SMED project
PQ for PTK tablet machine
PQ for Kilian tablet machine
Eng. Thaer Assi Training/ BirZeit

Mapping Studies
Central Warehouse
Keena Warehouse
Main Plant Phases
Penicillin Plant Phases
etc..
Validation Master Plans
VMP
Main Plant
Penicillin Plant
Kastal Plant
Sterile Area
Computer Systems
Allfill and
DP6 PQs
QUALITY
Minor internal observations (recommendations)
External
Internal
TQM
TIME AND STRESS MANAGEMENT
SOFTWARE VALIDATION
HVAC
LEADERSHIP
Observations were resolved promptly
RIMS
Project
Machine Major Parts (MMP) Project
SAP Change Control Project
From old-fashioned paper based to SAP controlled change controls
- In final stages...
Master Validation Database
Archive System
Improve Quality Systems
Why:
Data look up – time consuming
Data / Status updates – tedious and not synchronized
Sporadic data resources
Regulatory Information Management System
Any urgent Project was dealt with promptly
CAM Blistering
Line
Floran
Central Warehouse
Archive Overview
Two parts
Challenges
(Bi n ed r s) (Ch a o s)
Safety Hazar
Ruins!
Validation archive had the following challenges
d
z
Old System
Another Motivation!
Goals - Vision
New System
Changing prizes theme :)
No longer miss files
Archive search time reduced to less than 30 seconds (For Beginners!!)
As simple as that
How
Obstacles
Missing files

Misplaced files

Shared files

Lent files
Overall Process
Results
Before
After
Before
During
After
Before
During
After
Final Notes
Not only have we got a full working structured addressing system, but also...
Benefits - Features
All Goals achieved
Simple
Manageable
Scalable (rack space + Codes)
Future Work
Maintain current system.
Per-document addressing - expand scope.
Encourage other departments to start similar initiatives (today's meeting!)
THANK YOU :)
e.g.
Goals

Facilitate record tracing.

To prevent record loss.

Reduce lookup time

To create a centralized system to handle validation records.. All you need, in one place!!


Obstacles
Missing Data
Unorganized
Data
Access
R 02/4/7
Side
Set
Rack
File
Current System
Experience
VS

Validation
Impact on Performance

Increase validation-related awareness (minimum level of judgment)

Workfl w
Vision
Centralized Database as a reference for the user and maintenance technician
Enhance knowledge base for plants personnel (QA, User, Eng)
SAVING!

Binders Section.
Files Section.
documents types
sorting method...
Full transcript