Page 12 - PPTL.QM.001 Iss 01 - ISO 9001 Quality Manual - Full [Unsigned]
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QUALITY MANUAL
PHILLIPS PHARMACEUTICALS (TANZANIA) LIMITED
DOCUMENT NUMBER ISSUE NUMBER SUPERSEDES EFFECTIVE DATE
PPTL/QM/001 02 01 14.12.2018
6.0 PLANNING
6.1 ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES
In the process of planning for its QMS, PPTL has considered the external and internal issues that are relevant to its
purpose and its strategic direction and that can affect its ability to achieve the intended results of its QMS. It has also
considered the needs and expectations of interested parties. These two considerations have been used to determine
the risks and opportunities that need to be addressed to:
• Give assurance that the QMS can achieve its desired results.
• Enhance desirable effects.
• Prevent or reduce undesired effects.
• Achieve improvement.
The organization has planned actions to address these risks and opportunities and how to carry out the following:
• Integrate and implement the actions into its QMS processes.
• Evaluate the effectiveness of these actions.
PPTL has established a Risk Management Procedure PPTL/SOP/QA/010 which details how risks and opportunities will
be addressed. There is also a Business Continuity Plan that details what would need to be done in case of a major
disaster. The actions taken to address risks and opportunities are proportionate to the potential impact on the
conformity of products and services.
6.2 QUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM
Phillips Pharmaceuticals (Tanzania) Limited applies suitable methods for monitoring and, where applicable,
measurement of the quality management system processes to demonstrate the ability of the processes to
achieve planned results. When planned results are not achieved, correction and corrective action is taken, as
appropriate, to ensure conformity of the service.
6.2.1 PPTL has established Quality Objectives at relevant processes needed for the quality management system. The
Quality Objectives are as follows:
• Consistent with the Quality Policy.
• Measurable.
• Take into account applicable requirements.
• Relevant to the conformity of products and services and to the enhancement of customer satisfaction.
• Can be monitored.
• Can been communicated.
• Can be updated as appropriate.
6.2.2 In the process of planning how to achieve the Quality Objectives, PPTL has determined:
• What will be done?
• What resources will be required?
• Who will be responsible?
• When it will be completed?
• How the results will be evaluated?
Each process area shall set Quality Objectives in terms Key Performance Indicators that shall be monitored quarterly
and the report sent to the QMR. Every six months a consolidated report shall be prepared and discussed as part of the
agenda for the Management Review Meeting. See the attached Quality Objectives as Appendix IX –
PPTL/QMS/QA/026 – Quality Objectives for PPTL as an Organization.
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