Management Review of Quality Metrics

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3.1 Department heads are responsible for providing data necessary to support the evaluation
 of identified KPI values. This data must be provided on a monthly basis as applicable.
 
 3.2 QA is responsible for identifying and tabulating KPI values. 
 
 action is required, 
 
 4.0 Definitions 
 
 4 KPE ~ Key Performance Indicator. a measureable value that demonstrates the
 
 effectiveness of a quality system 
 
 4.2 MRB — Material Review Board; a group consisting of company leadership Qwith the
 
 responsibility of discussing and deciding the appropriate outcome for any issues that
 
 may affect productquality, regulatory status, or GMP compliance. 
 
 
 

[SOP A-118 | Page 2 of 3]

 Standard Operating IProcedure SOP Ne | Rev 
 
 Management Review of Quality Metrics 
 
 Fi ?oeS References 
 
6.0 isi

 . 
 ,dnerf 3502, SOP, Record Storage, Retention, and Destruction 
 5.2 D-120, SOP, Laboratory Management Structure and Position Requiremenis
 S53 21 CPRPart Pili, 117, 201, 210, 114 
 Procedure 
 6.1 Rouline Review of Quality Systems 
 O&1.1 Quality Management will identify KPI values to monitor quality systems.
 6.1.2 The choice of the KP] values to monitor may change based on changes in
 system nsk, changes un operational processes, and identification of new risks
 discovered during internal and/or external audits. 
 
 6.1.3 Departments where data for KPI values are generated will provide necessary
 
 data to QA on a quarterly basis. Review will be conducted the month after the
 quarter was completed. 
 
 6.1.4 Lf the quarterly review of KPI data indicates risks or problems with a Quality
 
 system, Quality Management will take action as required. Typical action to be
 taken includes but it not limited to: 
 
 614.1 Diseussion of action needed with applicable departments.
 
 6.1.4.3 Initiation ofa meeting with Executive management or the MRE,
 
 GE. Laboratory Management Review is conducted to ensure effectiveness of the yt
 
 laboratory management system: (LMS) in meeting objectives and in meeting the
 requirements of TSO 17025. Refer to SOP 13-120 Laboratory Management
 
 structure and Position Requirements. 
 
 
 

[SOP A-118 | Page 3 of 3]

 SOP Ne Rey 
 Standard Operating P rocedure 
 Page 3 of 3 
 A-118 
 
 7.0 Revision History 
 
 By 
 B 5S. Millar 
 14-1061 
 | Added OTC requirements. D. Popp 
 Revised flaw chart to include additional input, outnut, and process
 2 O8/27/17 | points. Added examples of quality system elements that may require 17-0997 S. Millar
 | ganagement review. 
 Revised entire procedure to tachule reference to Executive 
 3 OI2TA9 | Managernent KPI/Metrics Review. Added applicable CPR. 19-0067 S. Millar
 Removed Process Flow 
 Revised if ensure appropriate CPR reference (removing cosmetic 
 S. Millar 
 and pharma) and add reference to D-120 Management —Laberatory. 
 Revised to update logo and business name. Metric review will be
 performed on a quarterly basis. Removed reference to business CCH 25-0443 se ao &
 metrics. AQR will be covered under metric reporting. 
 
 
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