Page 25 - PPTL.QM.001 Iss 01 - ISO 9001 Quality Manual - Full [Unsigned]

QUALITY MANUAL

PHILLIPS PHARMACEUTICALS (TANZANIA) LIMITED

DOCUMENT NUMBER ISSUE NUMBER SUPERSEDES EFFECTIVE DATE

PPTL/QM/001 02 01 14.12.2018

9.0 PERFORMANCE EVALUATION

9.1 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION

9.1.1 GENERAL

The organization shall determine the following:

• What needs to be monitored and measured example: customer satisfaction, quality objectives
• The methods for monitoring, measurement, analysis and evaluation needed to ensure valid results.

• When the monitoring and measuring shall be performed example: annual customer survey, quarterly

monitoring of quality objectives

• When the results from monitoring and measurement shall be analysed and evaluated.

With a view to demonstrating conformity of the product or service, ensuring conformity of the quality

management system and continually improving the effectiveness of the quality management system, PPTL

plans and implements the monitoring, measurement, analysis and improvement processes using appropriate

methods including statistical techniques, such as bar charts and line graphs. PPTL shall evaluate the performance

and the effectiveness of the quality management system through an internal audit system as stated in the SOP

Number PPTL/SOP/QA/005, through management review as stated in the SOP Number PPTL/SOP/QA/009, handling

changes and deviations as per the SOP Numbers PPTL/SOP/QA/007 and PPTL/SOP/QA/006 respectively and through

customer satisfaction as stated in the SOP Number PPTL/SOP/CS/003. Individual performances shall also be monitored
as stated in the SOP Number PPTL/SOP/HR/005 that can affect the QMS implementation collectively. The organization

shall retain appropriate documented information as evidence of the results.

9.1.2 CUSTOMER SATISFACTION

PPTL shall monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled.

The organization shall determine the methods for obtaining, monitoring and reviewing this information. PPTL

monitors information relating to customer perception as to whether the organization has met customer

requirements in the following ways:

• Undertaking surveys to establish customers perception of the extent to which PPTL has met their

requirements as stated in the SOP Number PPTL/SOP/CS/003.

• Monitoring compliments from consumers and partners as stated in the SOP Number PPTL/SOP/CS/003.

• Monitoring customer complaints and concerns as stated in the SOP Number PPTL/SOP/CS/003.

• Monitoring data on product and service delivery as stated in the SOP Number PPTL/SOP/DH/008.

9.1.3 ANALYSIS AND EVALUATION

PPTL shall analyse and evaluate appropriate data and information arising from monitoring and measurement. PPTL

shall effectively collect and analyze appropriate data, determine the suitability and effectiveness of its QMS

and evaluate where continual improvement of the effectiveness of the quality management system can be

made. This includes data generated as a result of monitoring and measurement of various processes and from

other relevant sources. The Key Performance Indicators have been developed for key processes in the

organization and shall be monitored quarterly and then presented during the management review as s tated in
the SOP Number PPTL/SOP/QA/009.

In effect it analyses the data in order to provide information on customer satisfaction, conformance to

customer, product or service requirements, characteristics and trends of processes, products and services

including opportunities for preventive action, and suppliers

The results of analysis shall be used to evaluate:

• Conformity of products and services.

• Degree of customer satisfaction.

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