Page 28 - 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
10.0 IMPROVEMENT
10.1 GENERAL
PPTL shall determine and select opportunities for improvement and implement any necessary actions to meet
customer requirements and enhance customer satisfaction. These shall include:
• Improving products and services to meet requirements as well as to address future needs and expectations.
• Correcting, preventing or reducing undesired effects.
• Improving the performance and effectiveness of the QMS.
PPTL plans and organizes how to continually improve its QMS. Continual improvement of the QMS is facilitated
through the use of the Quality Policy, Quality Objectives, Audit Results, Analysis of Data, Corrective and
Preventive Actions and Management Review, Projects and Re-Organization.
10.2 NONCONFORMITY AND CORRECTIVE ACTION
10.2.1 When non-conformity occurs, including any arising from complaints, the organization shall:
• React to the nonconformity and, as applicable:
o Take action to control and correct it.
o Deal with the consequences.
• Evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or
occur elsewhere, by:
o Reviewing and analysing the nonconformity.
o Determining the causes of the nonconformity.
o Determining if similar nonconformities exist or could potentially occur.
• Implement any action needed.
• Review the effectiveness of any corrective action taken.
• Update risks and opportunities determined during planning, if necessary.
• Make changes to the quality management system, if necessary.
• Corrective actions shall be appropriate to the effects of the nonconformities encountered.
PPTL establishes and maintains a nonconformity and corrective action program to eliminate the cause of
nonconformities in order to prevent recurrence. Corrective action appropriate to the impact of the problems
encountered is appropriately carried out.
The documented procedure PPTL/SOP/QA/006 for nonconformity and corrective action defines requirements
for identifying and reviewing nonconformities including customer complaints, determining the causes for
nonconformities and evaluating the need for actions to ensure that nonconformities does not recur. In
addition, it defines requirements for determining and implementing the corrective action needed, recording
results of action taken as well as reviewing the effectiveness of the corrective action taken.
10.2.2 The organization shall retain documented information as evidence of:
• Nature of the nonconformities and any subsequent actions taken.
• Results of any corrective action.
10.3 CONTINUAL IMPROVEMENT
The organization shall continually improve the suitability, adequacy and effectiveness of the quality management
system. The organization shall consider the results of analysis and evaluation, and the outputs from management
review, to determine if there are needs or opportunities that shall be addressed as part of continual improvement.
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