|
KPI Record Management or Key
Performance Indicators record
Month-………………………
Date-…………………………….
1.
Key Performance Indicators for Quality
|
S.N
|
Parameters
|
Units
|
Target of KPI
(On the basis of past year)
|
KPI Actual Report
|
Compline Target
|
|
Out of target
|
Near target
|
Within target
|
|
1.
|
Non-Conforming Products
|
%
|
NMT 2.5%
|
|
|
|
|
|
2.
|
Non-Conforming of Packing Material (Incoming)
|
%
|
NMT 2.5%
|
|
|
|
|
|
3.
|
Non-Conforming of Raw Material
(Incoming)
|
%
|
NMT 2.5%
|
|
|
|
|
|
4.
|
Product Complaints overdue
|
%
|
NMT 5 %
|
|
|
|
|
|
5.
|
Product Recalls
|
Nos.
|
Nil
|
|
|
|
|
|
6.
|
Overdue of schedule Training
|
%
|
NMT 5%
|
|
|
|
|
|
7.
|
RFT of manufactured Batches
|
%
|
100%
|
|
|
|
|
|
S.N
|
Parameters
|
Units
|
Target of KPI
(On the basis of past year)
|
KPI Actual Report
|
Compline Target
|
|
Out of target
|
Near target
|
Within target
|
|
10.
|
Overdue of Deviation
|
%
|
NMT 5 %
|
|
|
|
|
|
11.
|
Overdue of CAPA
|
%
|
NMT 5 %
|
|
|
|
|
|
12.
|
Overdue of Internal Audit
|
%
|
NMT 5 %
|
|
|
|
|
|
13.
|
Overdue of External Audit
|
%
|
NMT 5 %
|
|
|
|
|
|
14.
|
Overdue of Regulatory Audit
|
%
|
NMT 5 %
|
|
|
|
|
2. Non-Conforming Product:
|
Total production (Batches) (A)
|
No. of Batches Hold (B)
|
% of Non-Conforming FG
=(B/A) *100
|
Remarks
|
|
|
|
|
|
3.
Non-Conforming of Packing Material (Incoming)
|
Total no. of consignment received (A)
|
Total No. of consignment pass in Quality without Deviation
|
No. of Non- conforming consignment (B)
|
% of Non-conforming consignment
=(B/A) *100
|
Remarks
|
|
|
|
|
|
|
4.
Non-Conforming Raw Material (Incoming)
|
Total no. of consignment received (A)
|
Total No. of consignment pass in Quality without Deviation
|
No. of Non- conforming consignment (B)
|
% of Non-conforming consignment =(B/A) *100
|
Remarks
|
|
|
|
|
|
|
5.
Product Complaints overdue:
|
Total No. of Received Complaint (A)
|
Complaint overdue (B)
|
Complaint
overdue%
=(B/A)
*100
|
Remarks
|
|
|
|
|
|
6.
Product Recall:
|
Product
|
No. of Batch Recalled
(A)
|
No. of Batch Dispatched
(B)
|
% of Recall Batch
=(A/B) *100
|
Remarks
|
|
|
|
|
|
|
7.
Overdue of schedule Training:
|
No. of Schedule Training (s)
(A)
|
No. of training (s)
conducted on time
|
No. of Overdue training
(B)
|
% of Overdue training
=(B/A) * 100
|
Remarks
|
|
|
|
|
|
|
8.
RFT of Manufactured Batches:
|
No. of Batches manufactured (A)
|
No. of Batches Pass in First time (B)
|
% of RFT
(B/A) *100
|
Remarks
|
|
|
|
|
|
9.
Overdue of Change control:
|
No. of Change Control Initiated
|
No. of Change Control Closed
|
No. of Open Change
Control (A)
|
No. of Overdue of Change control (B)
|
% Overdue
= (B/A) *100
|
Remarks
|
|
|
|
|
|
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|
10.
Overdue of Deviation:
|
No. of Deviation Initiated
|
No. of Deviation Closed
|
No. of Open Deviation (A)
|
No. of Overdue of Deviation (B)
|
% Overdue
= (B/A) *100
|
Remarks
|
|
|
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|
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11.
Overdue of CAPA:
|
No. of CAPA Initiated
|
No. of CAPA Closed
|
No. of Open CAPA (A)
|
No. of Overdue of CAPA (B)
|
% Overdue
= (B/A) *100
|
Remarks
|
|
|
|
|
|
|
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12.
Audit programme
|
Audits
|
Auditor
|
Date of Audit
|
No. of Observation
|
Closed
|
Open (A)
|
No. of Observation Overdue (B)
|
% Overdue (B/A *100)
|
|
Self-inspection
|
|
|
|
|
|
|
|
|
External audit
|
|
|
|
|
|
|
|
|
Regulatory audit
|
|
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