Purpose
To Lay down a procedure for measurement of key
performance indicator in Pharmaceutical Industries .
Procedure:
Preamble:
- Key performance indicators (KPI) are a
set of quantifiable measures used to gauge performance over time. These metrics
are used to determine progress in achieving its operational goals, and to
compare performance. KPI meeting shall be conducted for the following on
Monthly basis.
- % Non-conforming Incoming Goods
- % Non–conforming finished products
- Product complaint overdue
- Overdue of change control
- Overdue of deviation
- Overdue of CAPA
- Right First Time (RFT) of manufactured Batches
- Product Recall
- Overdue of schedule training
- Internal Audit /Self Inspection, External & Regulatory Audits
- KPI on Non –Confirming incoming goods:
- The objective is to measure supplier product quality through the ratio of Out of specification deliveries.
- KPI for both RM/PM on supplier product quality shall be collected by QC.
The Non-confirming incoming goods is expressed as:
% of delivered OOS = No. of Non-Conforming Consignment(B) X 100
Total No. of Consignment pass in
quality without deviation(A)
The target for KPI of supplier product quality (RM/PM)
shall be established for subsequent year based on the KPIs are maintained in
past year & consolidated report
for past full year is reviewed. For subsequent year
acceptance criteria of KPIs shall be
NMT “2.5%”. In case the KPI figures are higher than the
acceptance criteria, necessary
corrective/preventive actions shall be taken.
KPI for Non-conforming product:
The objective is to measure the ratio of product that
does not meet customer requirements prior to dispatch from the Pontika Aerotech
Limited.
KPI for Finished Goods Non-Conformance shall be
collected by QC.
The Non-Confirming customer product is expressed as
% NC of Finished Goods = No. of Batches hold
-------------------------------------------------------
X 100
Total
production (Batches)
- The Target of KPI for Finished Goods shall be established for subsequent year based on the KPIs are maintained in past year & consolidated report for past full year is reviewed. For subsequent year acceptance criteria of KPIs shall be NMT 2.5%.In case the KPI figures are higher than the acceptance criteria, necessary corrective/ Preventive actions shall be taken.
- Product Complaint Overdue:
- Customer complaint performance gives an assessment of “In home” quality. The number of complaints will be reported by the QA Head.
The Complaint value is used to adjust the complaints
volume for the quantity of product sold and this is calculated as follows:
Complaint Overdue = Complaint Overdue
-------------------------------------------------------
X 100
Total
Number of complaint received
For subsequent year acceptance criteria of KPI shall be
NMT 5 %.
Change control:
The percentage of overdue change controls on the last
working day each month calculated as follows:
The number of pre-approved records that are open beyond
the due date listed in the record divided by the total number of open records.
Overdue Change Control%=No. of approved Change Control
records that are open
beyond the due date
------------------------------------------------------------------------
x100
Total
number of open Change Control records
Open records defined as all records in any status
excluding closed and cancelled records only.
The overdue of change control should not more than 5%.
Deviation:
The percentage of overdue deviation records on the last
working day of each month calculated as follows:
The number of open records that are beyond the due date
listed in the record divided by the total number of open records.
Overdue Deviation %= No. of overdue of deviation
----------------------------------------------------------
x100
Total
number of open Deviation records
The overdue of deviation should not more than 5%.
CAPA:
The percentage of overdue CAPA records on the last
working day of each month calculated as follows: the number of open records
that are beyond the due date listed in the record divided by the total number
of open records.
Overdue CAPA % = No. of overdue of CAPA
---------------------------------------------------------------
x100
Total number of open CAPA records
The overdue of CAPA should not be more than 5%.
Right First time (RFT) Manufacturing
Right first-time batches are defined as batches for
which there were no deviations versus the approved procedures, Method of
Manufacture, Bill of Material or Specification during manufacture (including
packing). Examples of deviations include, but are not limited to, record
errors, process steps & timings, quantity reconciliation errors, process
sequencing, QC testing, cleaning & microbiological testing, equipment or calibration
failure, raw material specification, storage & environmental conditions,
etc.
The number of Right First Time manufactured batches and
the total number of batches shall be reported to allow the calculation of
percentage RFT as follows:
% RFT = No. of batches pass
in first time
---------------------------------------------------------------
x100
Total
number of batches manufactured
The Target of KPI for RFT is 100 %.
Product Recall:
Batch recall shall be monitored monthly with respect to
the no. of batches released. It can be calculated as:
% Batch recall = No. of Batch Recalled
---------------------------------------------- x100
Total No. of batch dispatched
Batch recall should not be more than 0%
Schedule Training:
The percentage of overdue schedule training record on
the last working day of each month calculated as follows:
The number of overdue schedule training of the month
divided by total no. of months training.
No. of overdue training
% of overdue
training = ----------------------------------------------------
x 100
No. of training
conducted on time
The overdue of schedule training should not more than 5
%. Internal, External and Regulatory Audit:
The internal, external and regulatory audit compliance
should be within timeline.
The target of KPI for overdue to compliance of
non-conformance NMT 5%.
The calculation of overdue of audit compliance as:
No. of overdue of audit non- Conformance
Overdue of
Audit =
----------------------------------------------------------------- x 100
No. of open Points
Action plan as KPI includes:
CAPA’s / recommended actions for the risks that require
mitigation.
To closure and sustenance of the output points from KPI
as per agreed timelines.
