Thursday, 18 July 2019

KPI | Key Performance Indicator


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.


Rahul Kashyap is the executive in a Leading Pharma Company, he author in-depth guide that teach pharma industry owner and workers way to follow, manage and grow the quality work in this Field.

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